This document presents standards of care for diabetes from the American Diabetes Association. It discusses: 1) The classification of diabetes into four types: type 1, type 2, other specific types, and gestational diabetes. 2) The diagnostic criteria for diabetes, which can now include an A1C level of ≥6.5% in addition to fasting plasma glucose and oral glucose tolerance test thresholds. 3) Categories of increased risk for diabetes, called prediabetes, which include impaired fasting glucose, impaired glucose tolerance, and an A1C of 5.7-6.4%.

1. P O S I T I O N S T A T E M E N T
Standards of Medical Care in
Diabetesd2013
AMERICAN DIABETES ASSOCIATION
D
iabetes mellitus is a chronic illness These standards of care are revised does not use industry support for these
that requires continuing medical care annually by the ADA’s multidisciplinary purposes.
and ongoing patient self-management Professional Practice Committee, incor-
education and support to prevent acute porating new evidence. For the current I. CLASSIFICATION AND
complications and to reduce the risk of revision, committee members systemati- DIAGNOSIS
long-term complications. Diabetes care is cally searched Medline for human stud-
complex and requires multifactorial risk ies related to each subsection and A. Classification
reduction strategies beyond glycemic con- published since 1 January 2011. Recom- The classification of diabetes includes
trol. A large body of evidence exists that mendations (bulleted at the beginning four clinical classes:
supports a range of interventions to improve of each subsection and also listed in
diabetes outcomes. the “Executive Summary: Standards of c Type 1 diabetes (results from b-cell
These standards of care are intended Medical Care in Diabetesd2013”) were destruction, usually leading to absolute
to provide clinicians, patients, researchers, revised based on new evidence or, in insulin deficiency)
payers, and other interested individuals some cases, to clarify the prior recom- c Type 2 diabetes (results from a pro-
with the components of diabetes care, mendation or match the strength of the gressive insulin secretory defect on the
general treatment goals, and tools to eval- wording to the strength of the evidence. background of insulin resistance)
uate the quality of care. Although individ- A table linking the changes in recom- c Other specific types of diabetes due to
ual preferences, comorbidities, and other mendations to new evidence can be re- other causes, e.g., genetic defects in
patient factors may require modification of viewed at http://professional.diabetes. b-cell function, genetic defects in in-
goals, targets that are desirable for most org/CPR. As is the case for all position sulin action, diseases of the exocrine
patients with diabetes are provided. Spe- statements, these standards of care were pancreas (such as cystic fibrosis), and
cifically titled sections of the standards reviewed and approved by the Executive drug- or chemical-induced (such as in
address children with diabetes, pregnant Committee of ADA’s Board of Directors, the treatment of HIV/AIDS or after or-
women, and people with prediabetes. which includes health care professionals, gan transplantation)
These standards are not intended to pre- scientists, and lay people. c Gestational diabetes mellitus (GDM)
clude clinical judgment or more extensive Feedback from the larger clinical (diabetes diagnosed during pregnancy
evaluation and management of the patient community was valuable for the 2013 that is not clearly overt diabetes)
by other specialists as needed. For more revision of the standards. Readers who
detailed information about management of wish to comment on the “Standards of Some patients cannot be clearly clas-
diabetes, refer to references (1–3). Medical Care in Diabetesd2013” are sified as type 1 or type 2 diabetic. Clinical
The recommendations included are invited to do so at http://professional. presentation and disease progression vary
screening, diagnostic, and therapeutic diabetes.org/CPR. considerably in both types of diabetes.
actions that are known or believed to Members of the Professional Practice Occasionally, patients who otherwise
favorably affect health outcomes of patients Committee disclose all potential finan- have type 2 diabetes may present with
with diabetes. A large number of these cial conflicts of interest with industry. ketoacidosis. Similarly, patients with type
interventions have been shown to be cost- These disclosures were discussed at the 1 diabetes may have a late onset and slow
effective (4). A grading system (Table 1), onset of the standards revision meeting. (but relentless) progression of disease
developed by the American Diabetes Asso- Members of the committee, their em- despite having features of autoimmune
ciation (ADA) and modeled after existing ployer, and their disclosed conflicts of disease. Such difficulties in diagnosis may
methods, was utilized to clarify and codify interest are listed in the “Professional occur in children, adolescents, and
the evidence that forms the basis for the Practice Committee for the 2013 Clinical adults. The true diagnosis may become
recommendations. The level of evidence Practice Recommendations” table (see more obvious over time.
that supports each recommendation is p. S109). The ADA funds development
B. Diagnosis of diabetes
listed after each recommendation using of the standards and all its position state-
the letters A, B, C, or E. ments out of its general revenues and For decades, the diagnosis of diabetes was
based on plasma glucose criteria, either
the fasting plasma glucose (FPG) or the
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
2-h value in the 75-g oral glucose toler-
Originally approved 1988. Most recent review/revision October 2012. ance test (OGTT) (5).
DOI: 10.2337/dc13-S011
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly In 2009, an International Expert
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ Committee that included representatives
licenses/by-nc-nd/3.0/ for details. of the ADA, the International Diabetes
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S11

2. Position Statement
Table 1dADA evidence grading system for clinical practice recommendations PG) remain valid as well (Table 2). Just as
there is less than 100% concordance be-
Level of tween the FPG and 2-h PG tests, there is
evidence Description no perfect concordance between A1C and
either glucose-based test. Analyses of the
A Clear evidence from well-conducted, generalizable RCTs that are adequately National Health and Nutrition Examina-
powered, including: tion Survey (NHANES) data indicate that,
c Evidence from a well-conducted multicenter trial assuming universal screening of the un-
c Evidence from a meta-analysis that incorporated quality ratings in the diagnosed, the A1C cut point of $6.5%
analysis identifies one-third fewer cases of undiag-
Compelling nonexperimental evidence, i.e., “all or none” rule developed by the nosed diabetes than a fasting glucose cut
Centre for Evidence-Based Medicine at the University of Oxford point of $126 mg/dL (7.0 mmol/L) (11),
Supportive evidence from well-conducted RCTs that are adequately powered, and numerous studies have confirmed
including: that at these cut points the 2-h OGTT
c Evidence from a well-conducted trial at one or more institutions value diagnoses more screened people
c Evidence from a meta-analysis that incorporated quality ratings in the analysis with diabetes (12). However, in practice, a
B Supportive evidence from well-conducted cohort studies large portion of the diabetic population re-
c Evidence from a well-conducted prospective cohort study or registry mains unaware of its condition. Thus, the
c Evidence from a well-conducted meta-analysis of cohort studies lower sensitivity of A1C at the designated
Supportive evidence from a well-conducted case-control study cut point may well be offset by the test’s
C Supportive evidence from poorly controlled or uncontrolled studies greater practicality, and wider application
c Evidence from randomized clinical trials with one or more major or three or of a more convenient test (A1C) may actu-
more minor methodological flaws that could invalidate the results ally increase the number of diagnoses made.
c Evidence from observational studies with high potential for bias (such as case As with most diagnostic tests, a test
series with comparison with historical controls) result diagnostic of diabetes should be
c Evidence from case series or case reports repeated to rule out laboratory error,
Conflicting evidence with the weight of evidence supporting the recommendation unless the diagnosis is clear on clinical
E Expert consensus or clinical experience grounds, such as a patient with a hyper-
glycemic crisis or classic symptoms of
hyperglycemia and a random plasma
Federation (IDF), and the European have posited that glycation rates differ by glucose $200 mg/dL. It is preferable
Association for the Study of Diabetes race (with, for example, African Americans that the same test be repeated for confir-
(EASD) recommended the use of the A1C having higher rates of glycation), but this is mation, since there will be a greater likeli-
test to diagnose diabetes, with a threshold controversial. A recent epidemiological hood of concurrence in this case. For
of $6.5% (6), and the ADA adopted this study found that, when matched for FPG, example, if the A1C is 7.0% and a repeat
criterion in 2010 (5). The diagnostic test African Americans (with and without dia- result is 6.8%, the diagnosis of diabetes is
should be performed using a method that betes) indeed had higher A1C than whites, confirmed. However, if two different tests
is certified by the NGSP and standardized but also had higher levels of fructosamine (such as A1C and FPG) are both above the
or traceable to the Diabetes Control and and glycated albumin and lower levels of diagnostic thresholds, the diagnosis of di-
Complications Trial (DCCT) reference as- 1,5 anhydroglucitol, suggesting that their abetes is also confirmed.
say. Although point-of-care (POC) A1C as- glycemic burden (particularly postpran- On the other hand, if two different
says may be NGSP certified, proficiency dially) may be higher (9). Epidemiological tests are available in an individual and the
testing is not mandated for performing studies forming the framework for recom- results are discordant, the test whose result
the test, so use of these assays for diagnostic mending use of the A1C to diagnose diabe- is above the diagnostic cut point should be
purposes could be problematic. tes have all been in adult populations. repeated, and the diagnosis is made based
Epidemiological datasets show a sim- Whether the cut point would be the same on the confirmed test. That is, if a patient
ilar relationship for A1C to the risk of to diagnose children or adolescents with meets the diabetes criterion of the A1C (two
retinopathy as has been shown for the type 2 diabetes is an area of uncertainty results $6.5%) but not the FPG (,126 mg/
corresponding FPG and 2-h PG thresh- (3,10). A1C inaccurately reflects glycemia dL or 7.0 mmol/L), or vice versa, that per-
olds. The A1C has several advantages to with certain anemias and hemoglobinopa- son should be considered to have diabetes.
the FPG and OGTT, including greater thies. For patients with an abnormal hemo- Since there is preanalytical and ana-
convenience (since fasting is not required), globin but normal red cell turnover, such as lytical variability of all the tests, it is also
evidence to suggest greater preanalytical sickle cell trait, an A1C assay without inter- possible that when a test whose result was
stability, and less day-to-day perturbations ference from abnormal hemoglobins should above the diagnostic threshold is re-
during periods of stress and illness. These be used (an updated list is available at www. peated, the second value will be below
advantages must be balanced by greater ngsp.org/interf.asp). For conditions with the diagnostic cut point. This is least
cost, the limited availability of A1C testing abnormal red cell turnover, such as preg- likely for A1C, somewhat more likely for
in certain regions of the developing world, nancy, recent blood loss or transfusion, or FPG, and most likely for the 2-h PG.
and the incomplete correlation between some anemias, the diagnosis of diabetes Barring a laboratory error, such patients
A1C and average glucose in certain indi- must employ glucose criteria exclusively. are likely to have test results near the
viduals. In addition, HbA1c levels may vary The established glucose criteria for margins of the threshold for a diagnosis.
with patients’ race/ethnicity (7,8). Some the diagnosis of diabetes (FPG and 2-h The health care professional might opt to
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3. Position Statement
follow the patient closely and repeat the used A1C to predict the progression to Table 3dCategories of increased risk for
testing in 3–6 months. diabetes demonstrated a strong, continu- diabetes (prediabetes)*
The current diagnostic criteria for ous association between A1C and sub- FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL
diabetes are summarized in Table 2. sequent diabetes. In a systematic review of (6.9 mmol/L) (IFG)
44,203 individuals from 16 cohort stud- OR
C. Categories of increased risk ies with a follow-up interval averaging 5.6 2-h plasma glucose in the 75-g OGTT 140 mg/dL
for diabetes (prediabetes) years (range 2.8–12 years), those with an (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L)
In 1997 and 2003, the Expert Committee A1C between 5.5 and 6.0% had a substan- (IGT)
on Diagnosis and Classification of Diabe- tially increased risk of diabetes with 5-year OR
tes Mellitus (13,14) recognized an inter- incidences ranging from 9 to 25%. An A1C A1C 5.7–6.4%
mediate group of individuals whose range of 6.0–6.5% had a 5-year risk of de-
glucose levels, although not meeting cri- veloping diabetes between 25 to 50% and *For all three tests, risk is continuous, extending be-
low the lower limit of the range and becoming dis-
teria for diabetes, are nevertheless too relative risk (RR) 20 times higher compared proportionately greater at higher ends of the range.
high to be considered normal. These per- with an A1C of 5.0% (15). In a community-
sons were defined as having impaired fast- based study of black and white adults
ing glucose (IFG) (FPG levels 100 mg/dL without diabetes, baseline A1C was a For many illnesses, there is a major dis-
[5.6 mmol/L] to 125 mg/dL [6.9 mmol/L]) stronger predictor of subsequent diabetes tinction between screening and diagnostic
or impaired glucose tolerance (IGT) (2-h and cardiovascular events than was fast- testing. However, for diabetes, the same
values in the OGTT of 140 mg/dL [7.8 ing glucose (16). Other analyses suggest tests would be used for “screening” as for
mmol/L] to 199 mg/dL [11.0 mmol/L]). It that an A1C of 5.7% is associated with diagnosis. Diabetes may be identified any-
should be noted that the World Health diabetes risk similar to that in the high- where along a spectrum of clinical scenar-
Organization (WHO) and a number of risk participants in the Diabetes Prevention ios ranging from a seemingly low-risk
other diabetes organizations define the cut- Program (DPP) (17). individual who happens to have glucose
off for IFG at 110 mg/dL (6.1 mmol/L). Hence, it is reasonable to consider an testing, to a higher-risk individual whom
Individuals with IFG and/or IGT have A1C range of 5.7–6.4% as identifying in- the provider tests because of high suspicion
been referred to as having prediabetes, dividuals with prediabetes. As is the case of diabetes, to the symptomatic patient.
indicating the relatively high risk for the for individuals found to have IFG and The discussion herein is primarily framed
future development of diabetes. IFG and IGT, individuals with an A1C of 5.7–6.4% as testing for diabetes in those without
IGT should not be viewed as clinical should be informed of their increased risk symptoms. The same assays used for test-
entities in their own right but rather risk for diabetes as well as CVD and counseled ing for diabetes will also detect individuals
factors for diabetes as well as cardiovascular about effective strategies to lower their risks with prediabetes.
disease (CVD). IFG and IGT are associated (see Section IV). As with glucose measure-
with obesity (especially abdominal or vis- ments, the continuum of risk is curvilinear, A. Testing for type 2 diabetes and
ceral obesity), dyslipidemia with high tri- so that as A1C rises, the risk of diabetes rises risk of future diabetes in adults
glycerides and/or low HDL cholesterol, and disproportionately (15). Accordingly, inter- Prediabetes and diabetes meet established
hypertension. ventions should be most intensive and criteria for conditions in which early de-
As is the case with the glucose mea- follow-up particularly vigilant for those tection is appropriate. Both conditions are
sures, several prospective studies that with A1Cs above 6.0%, who should be con- common, increasing in prevalence, and
sidered to be at very high risk. impose significant public health burdens.
Table 2dCriteria for the diagnosis of Table 3 summarizes the categories of There is a long presymptomatic phase
diabetes prediabetes. before the diagnosis of type 2 diabetes is
usually made. Relatively simple tests are
A1C $6.5%. The test should be performed in II. TESTING FOR DIABETES IN available to detect preclinical disease. Ad-
a laboratory using a method that is NGSP ASYMPTOMATIC PATIENTS ditionally, the duration of glycemic burden
certified and standardized to the DCCT is a strong predictor of adverse outcomes,
assay.* Recommendations and effective interventions exist to prevent
OR c Testing to detect type 2 diabetes and progression of prediabetes to diabetes (see
FPG $126 mg/dL (7.0 mmol/L). Fasting is prediabetes in asymptomatic people Section IV) and to reduce risk of compli-
defined as no caloric intake for at least 8 h.* should be considered in adults of any cations of diabetes (see Section VI).
OR age who are overweight or obese (BMI Type 2 diabetes is frequently not di-
2-h plasma glucose $200 mg/dL (11.1 mmol/L) $25 kg/m2) and who have one or more agnosed until complications appear, and
during an OGTT. The test should be additional risk factors for diabetes (Table approximately one-fourth of all people
performed as described by the WHO, using 4). In those without these risk factors, with diabetes in the U.S. may be undiag-
a glucose load containing the equivalent of testing should begin at age 45. (B) nosed. The effectiveness of early identifica-
75 g anhydrous glucose dissolved in water.* c If tests are normal, repeat testing at least tion of prediabetes and diabetes through
OR at 3-year intervals is reasonable. (E) mass testing of asymptomatic individuals
In a patient with classic symptoms of c To test for diabetes or prediabetes, the has not been proven definitively, and
hyperglycemia or hyperglycemic crisis, A1C, FPG, or 75-g 2-h OGTT are appro- rigorous trials to provide such proof are
a random plasma glucose $200 mg/dL priate. (B) unlikely to occur. In a large randomized
(11.1 mmol/L). c In those identified with prediabetes, controlled trial (RCT) in Europe, general
*In the absence of unequivocal hyperglycemia, re- identify and, if appropriate, treat other practice patients between the ages of 40–
sult should be confirmed by repeat testing. CVD risk factors. (B) 69 years were screened for diabetes and
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S13

4. Position Statement
then randomly assigned by practice to 24 kg/m2 in South Asians, 25 kg/m2 in seek, or have access to, appropriate follow-up
routine care of diabetes or intensive treat- Chinese, and 26 kg/m2 in African Ameri- testing and care. Conversely, there may be
ment of multiple risk factors. After 5.3 cans (21). Disparities in screening rates, failure to ensure appropriate repeat testing
years of follow-up, CVD risk factors were not explainable by insurance status, are for individuals who test negative. Commu-
modestly but significantly more improved highlighted by evidence that despite nity screening may also be poorly targeted; i.
with intensive treatment. Incidence of first much higher prevalence of type 2 diabe- e., it may fail to reach the groups most at risk
CVD event and mortality rates were not tes, non-Caucasians in an insured popu- and inappropriately test those at low risk (the
significantly different between groups lation are no more likely than Caucasians worried well) or even those already diag-
(18). This study would seem to add sup- to be screened for diabetes (22). Because nosed.
port for early treatment of screen-detected age is a major risk factor for diabetes, test-
diabetes, as risk factor control was excel- ing of those without other risk factors
lent even in the routine treatment arm should begin no later than age 45 years. B. Screening for type 2 diabetes
and both groups had lower event rates The A1C, FPG, or the 2-h OGTT are in children
than predicted. The absence of a control appropriate for testing. It should be noted Recommendations
unscreened arm limits the ability to defi- that the tests do not necessarily detect c Testing to detect type 2 diabetes and
nitely prove that screening impacts out- diabetes in the same individuals. The prediabetes should be considered in chil-
comes. Mathematical modeling studies efficacy of interventions for primary pre- dren and adolescents who are overweight
suggest that screening independent of vention of type 2 diabetes (23–29) has and who have two or more additional
risk factors beginning at age 30 years primarily been demonstrated among in- risk factors for diabetes (Table 5). (E)
or age 45 years is highly cost-effective dividuals with IGT, not for individuals
(,$11,000 per quality-adjusted life- with isolated IFG or for individuals with The incidence of type 2 diabetes in
year gained) (19). specific A1C levels. adolescents has increased dramatically in
Recommendations for testing for di- The appropriate interval between the last decade, especially in minority
abetes in asymptomatic, undiagnosed tests is not known (30). The rationale populations (31), although the disease
adults are listed in Table 4. Testing should for the 3-year interval is that false nega- remains rare in the general pediatric pop-
be considered in adults of any age with tives will be repeated before substantial ulation (32). Consistent with recom-
BMI $25 kg/m2 and one or more of the time elapses, and there is little likelihood mendations for adults, children and
known risk factors for diabetes. In addi- that an individual will develop significant youth at increased risk for the presence
tion to the listed risk factors, certain med- complications of diabetes within 3 years or the development of type 2 diabetes
ications, such as glucocorticoids and of a negative test result. In the modeling should be tested within the health care
antipsychotics (20), are known to in- study, repeat screening every 3 or 5 years setting (33). The recommendations of
crease the risk of type 2 diabetes. There was cost-effective (19). the ADA consensus statement “Type 2
is compelling evidence that lower BMI cut Because of the need for follow-up and Diabetes in Children and Adolescents,”
points suggest diabetes risk in some racial discussion of abnormal results, testing with some modifications, are summa-
and ethnic groups. In a large multiethnic should be carried out within the health rized in Table 5.
cohort study, for an equivalent incidence care setting. Community screening outside
rate of diabetes conferred by a BMI of 30 a health care setting is not recommended
kg/m2 in whites, the BMI cutoff value was because people with positive tests may not C. Screening for type 1 diabetes
Recommendations
c Consider referring relatives of those
Table 4dCriteria for testing for diabetes in asymptomatic adult individuals with type 1 diabetes for antibody test-
ing for risk assessment in the setting
1. Testing should be considered in all adults who are overweight (BMI $25 kg/m2*)
of a clinical research study. (E)
and have additional risk factors:
c physical inactivity
Generally, people with type 1 diabetes
c first-degree relative with diabetes
present with acute symptoms of diabetes
c high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian
and markedly elevated blood glucose
American, Pacific Islander)
levels, and some cases are diagnosed with
c women who delivered a baby weighing .9 lb or were diagnosed with GDM
life-threatening ketoacidosis. Evidence
c hypertension ($140/90 mmHg or on therapy for hypertension)
from several studies suggests that mea-
c HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride
surement of islet autoantibodies in rela-
level .250 mg/dL (2.82 mmol/L)
tives of those with type 1 diabetes
c women with polycystic ovary syndrome
identifies individuals who are at risk for
c A1C $5.7%, IGT, or IFG on previous testing
developing type 1 diabetes. Such testing,
c other clinical conditions associated with insulin resistance (e.g., severe obesity,
coupled with education about symptoms
acanthosis nigricans)
of diabetes and follow-up in an observa-
c history of CVD
tional clinical study, may allow earlier
2. In the absence of the above criteria, testing for diabetes should begin at age 45 years.
identification of onset of type 1 diabetes
3. If results are normal, testing should be repeated at least at 3-year intervals, with
and lessen presentation with ketoacidosis
consideration of more frequent testing depending on initial results (e.g., those with
at time of diagnosis. This testing may be
prediabetes should be tested yearly) and risk status.
appropriate in those who have relatives
*At-risk BMI may be lower in some ethnic groups. with type 1 diabetes, in the context of
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5. Position Statement
Table 5dTesting for type 2 diabetes in asymptomatic children* screen women with risk factors for type
Criteria 2 diabetes (Table 4) for diabetes at their
c Overweight (BMI .85th percentile for age and sex, weight for height .85th percentile, or initial prenatal visit, using standard diag-
weight .120% of ideal for height) nostic criteria (Table 2). Women with di-
Plus any two of the following risk factors: abetes found at this visit should receive
c Family history of type 2 diabetes in first- or second-degree relative a diagnosis of overt, not gestational,
c Race/ethnicity (Native American, African American, Latino, Asian American, Pacific diabetes.
Islander) GDM carries risks for the mother and
c Signs of insulin resistance or conditions associated with insulin resistance (acanthosis neonate. The Hyperglycemia and Ad-
nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational- verse Pregnancy Outcome (HAPO) study
age birth weight) (37), a large-scale (;25,000 pregnant
c Maternal history of diabetes or GDM during the child’s gestation women) multinational epidemiological
Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a younger age study, demonstrated that risk of adverse
Frequency: every 3 years maternal, fetal, and neonatal outcomes
continuously increased as a function of
*Persons aged 18 years and younger. maternal glycemia at 24–28 weeks, even
within ranges previously considered nor-
mal for pregnancy. For most complica-
clinical research studies (see, for example, GDM at 24–28 weeks of gestation, tions, there was no threshold for risk.
http://www.diabetestrialnet.org). However, using a 75-g 2-h OGTT and the di- These results have led to careful recon-
widespread clinical testing of asymptomatic agnostic cut points in Table 6. (B) sideration of the diagnostic criteria for
low-risk individuals cannot currently be c Screen women with GDM for persistent GDM. After deliberations in 2008–
recommended, as it would identify very diabetes at 6–12 weeks postpartum, 2009, the International Association of
few individuals in the general population using the OGTT and nonpregnancy Diabetes and Pregnancy Study Groups
who are at risk. Individuals who screen diagnostic criteria. (E) (IADPSG), an international consensus
positive should be counseled about their c Women with a history of GDM should group with representatives from multiple
risk of developing diabetes and symptoms have lifelong screening for the de- obstetrical and diabetes organizations,
of diabetes, followed closely to prevent de- velopment of diabetes or prediabetes at including ADA, developed revised rec-
velopment of diabetic ketoacidosis, and least every 3 years. (B) ommendations for diagnosing GDM.
informed about clinical trials. Clinical c Women with a history of GDM found The group recommended that all women
studies are being conducted to test various to have prediabetes should receive not known to have prior diabetes
methods of preventing type 1 diabetes in lifestyle interventions or metformin to undergo a 75-g OGTT at 24–28 weeks
those with evidence of autoimmunity. prevent diabetes. (A) of gestation. Additionally, the group de-
Some interventions have demonstrated veloped diagnostic cut points for the fast-
modest efficacy in slowing b-cell loss early For many years, GDM was defined as ing, 1-h, and 2-h plasma glucose
in type 1 diabetes (34,35), and further re- any degree of glucose intolerance with measurements that conveyed an odds
search is needed to determine whether onset or first recognition during preg- ratio for adverse outcomes of at least
they may be effective in preventing type nancy (13), whether or not the condition 1.75 compared with women with the
1 diabetes. persisted after pregnancy, and not ex- mean glucose levels in the HAPO study.
cluding the possibility that unrecognized Current screening and diagnostic strate-
glucose intolerance may have antedated gies, based on the IADPSG statement
III. DETECTION AND or begun concomitantly with the preg- (38), are outlined in Table 6.
DIAGNOSIS OF GDM nancy. This definition facilitated a uniform These new criteria will significantly
strategy for detection and classification of increase the prevalence of GDM, primar-
Recommendations GDM, but its limitations were recognized ily because only one abnormal value, not
c Screen for undiagnosed type 2 diabetes for many years. As the ongoing epidemic two, is sufficient to make the diagnosis.
at the first prenatal visit in those with of obesity and diabetes has led to more The ADA recognizes the anticipated sig-
risk factors, using standard diagnostic type 2 diabetes in women of childbearing nificant increase in the incidence of GDM
criteria. (B) age, the number of pregnant women with diagnosed by these criteria and is sensitive
c In pregnant women not previously undiagnosed type 2 diabetes has increased to concerns about the “medicalization” of
known to have diabetes, screen for (36). Because of this, it is reasonable to pregnancies previously categorized as nor-
mal. These diagnostic criteria changes are
being made in the context of worrisome
Table 6dScreening for and diagnosis of GDM worldwide increases in obesity and diabe-
tes rates, with the intent of optimizing ges-
Perform a 75-g OGTT, with plasma glucose measurement fasting and at 1 and 2 h, at 24–28
tational outcomes for women and their
weeks of gestation in women not previously diagnosed with overt diabetes.
babies.
The OGTT should be performed in the morning after an overnight fast of at least 8 h.
Admittedly, there are few data from
The diagnosis of GDM is made when any of the following plasma glucose values are exceeded:
randomized clinical trials regarding ther-
c Fasting: $92 mg/dL (5.1 mmol/L)
apeutic interventions in women who will
c 1 h: $180 mg/dL (10.0 mmol/L)
now be diagnosed with GDM based on
c 2 h: $153 mg/dL (8.5 mmol/L)
only one blood glucose value above the
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6. Position Statement
specified cut points (in contrast to the older IV. PREVENTION/DELAY A1C of 5.7–6.4%, IGT, or IFG should be
criteria that stipulated at least two abnor- OF TYPE 2 DIABETES counseled on lifestyle changes with goals
mal values). However, there is emerging similar to those of the DPP (7% weight
observational and retrospective evidence Recommendations loss and moderate physical activity of at
that women diagnosed with the new c Patients with IGT (A), IFG (E), or an A1C least 150 min/week). Regarding drug
criteria (even if they would not have of 5.7–6.4% (E) should be referred to an therapy for diabetes prevention, metfor-
been diagnosed with older criteria) have effective ongoing support program tar- min has a strong evidence base and dem-
increased rates of poor pregnancy out- geting weight loss of 7% of body weight onstrated long-term safety (53). For other
comes similar to those of women with and increasing physical activity to at least drugs, issues of cost, side effects, and lack
GDM by prior criteria (39,40). Expected 150 min/week of moderate activity such of persistence of effect in some studies
benefits to these pregnancies and offspring as walking. (54) require consideration. Metformin
are inferred from intervention trials that c Follow-up counseling appears to be was less effective than lifestyle modifica-
focused on women with more mild hyper- important for success. (B) tion in the DPP and DPPOS, but may be
glycemia than identified using older GDM c Based on the cost-effectiveness of diabetes cost-saving over a 10-year period (51). It
diagnostic criteria and that found modest prevention, such programs should be was as effective as lifestyle modification
benefits (41,42). The frequency of follow- covered by third-party payers. (B) in participants with a BMI of at least 35
up and blood glucose monitoring for these c Metformin therapy for prevention of kg/m2, but not significantly better than
women is not yet clear, but likely to be less type 2 diabetes may be considered in placebo than those over age 60 years
intensive than for women diagnosed by the those with IGT (A), IFG (E), or an A1C of (23). In women in the DPP with a history
older criteria. It is important to note that 5.7–6.4% (E), especially for those with of GDM, metformin and intensive lifestyle
80–90% of women in both of the mild BMI .35 kg/m2, aged ,60 years, and modification led to an equivalent 50% re-
GDM studies (whose glucose values over- women with prior GDM. (A) duction in the risk of diabetes (55). Met-
lapped with the thresholds recommended c At least annual monitoring for the de- formin therefore might reasonably be
herein) could be managed with lifestyle velopment of diabetes in those with recommended for very high-risk individ-
therapy alone. prediabetes is suggested. (E) uals (those with a history of GDM, the
The American College of Obstetri- c Screening for and treatment of modifi- very obese, and/or those with more severe
cians and Gynecologists announced in able risk factors for CVD is suggested. (B) or progressive hyperglycemia).
2011 that they continue to recommend People with prediabetes often have
use of prior diagnostic criteria for GDM RCTs have shown that individuals at other cardiovascular risk factors, such as
(43). Several other countries have high risk for developing type 2 diabetes obesity, hypertension, and dyslipidemia.
adopted the new criteria, and a report (those with IFG, IGT, or both) can signif- Assessing and treating these risk factors is
from the WHO on this topic is pending icantly decrease the rate of onset of diabetes an important aspect of reducing cardio-
at the time of publication of these stand- with particular interventions (23–29). metabolic risk. In the DPP and DPPOS,
ards. The National Institutes of Health is These include intensive lifestyle modifica- cardiovascular event rates have been very
planning to hold a consensus develop- tion programs that have been shown to be low, perhaps due to appropriate manage-
ment conference on this topic in 2013. very effective (;58% reduction after 3 ment of cardiovascular risk factors in all
Because some cases of GDM may years) and use of the pharmacological arms of the study (56).
represent pre-existing undiagnosed type agents metformin, a-glucosidase inhibi-
2 diabetes, women with a history of tors, orlistat, and thiazolidinediones, each V. DIABETES CARE
GDM should be screened for diabetes of which has been shown to decrease inci-
6–12 weeks postpartum, using nonpreg- dent diabetes to various degrees. Follow-up A. Initial evaluation
nant OGTT criteria. Because of their pre- of all three large studies of lifestyle interven- A complete medical evaluation should be
partum treatment for hyperglycemia, use tion has shown sustained reduction in the performed to classify the diabetes, detect
of the A1C for diagnosis of persistent di- rate of conversion to type 2 diabetes, with the presence of diabetes complications,
abetes at the postpartum visit is not rec- 43% reduction at 20 years in the Da Qing review previous treatment and risk factor
ommended (44). Women with a history study (47), 43% reduction at 7 years in the control in patients with established diabe-
of GDM have a greatly increased subse- Finnish Diabetes Prevention Study (DPS) tes, assist in formulating a management
quent risk for diabetes (45) and should (48), and 34% reduction at 10 years in plan, and provide a basis for continuing
be followed up with subsequent screen- the U.S. Diabetes Prevention Program care. Laboratory tests appropriate to the
ing for the development of diabetes or Outcomes Study (DPPOS) (49). A cost- evaluation of each patient’s medical condi-
prediabetes, as outlined in Section II. effectiveness model suggested that lifestyle tion should be performed. A focus on the
Lifestyle interventions or metformin interventions as delivered in the DPP are components of comprehensive care (Table
should be offered to women with a his- cost-effective (50), and actual cost data 7) will assist the health care team to ensure
tory of GDM who develop prediabetes, from the DPP and DPPOS confirm that life- optimal management of the patient with
as discussed in Section IV. In the pro- style interventions are highly cost-effective diabetes.
spective Nurses’ Health Study II, risk of (51). Group delivery of the DPP interven-
subsequent diabetes after a history of tion in community settings has the poten- B. Management
GDM was significantly lower in women tial to be significantly less expensive while People with diabetes should receive med-
who followed healthy eating patterns. still achieving similar weight loss (52). ical care from a team that may include
Adjusting for BMI moderately, but not Based on the results of clinical trials physicians, nurse practitioners, physician’s
completely, attenuated this association and the known risks of progression of assistants, nurses, dietitians, pharmacists,
(46). prediabetes to diabetes, persons with an and mental health professionals with
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7. Position Statement
Table 7dComponents of the comprehensive diabetes evaluation and conditions, physical activity, eating
Medical history patterns, social situation and cultural fac-
c Age and characteristics of onset of diabetes (e.g., DKA, asymptomatic laboratory finding) tors, and presence of complications of di-
c Eating patterns, physical activity habits, nutritional status, and weight history; growth and abetes or other medical conditions.
development in children and adolescents
c Diabetes education history C. Glycemic control
c Review of previous treatment regimens and response to therapy (A1C records)
c Current treatment of diabetes, including medications, medication adherence and barriers
1. Assessment of glycemic control
Two primary techniques are available for
thereto, meal plan, physical activity patterns, and readiness for behavior change
c Results of glucose monitoring and patient’s use of data
health providers and patients to assess the
c DKA frequency, severity, and cause
effectiveness of the management plan on
c Hypoglycemic episodes
glycemic control: patient self-monitoring
c Hypoglycemia awareness
of blood glucose (SMBG) or interstitial
c Any severe hypoglycemia: frequency and cause
glucose, and A1C.
c History of diabetes-related complications
c Microvascular: retinopathy, nephropathy, neuropathy (sensory, including history of foot a. Glucose monitoring
lesions; autonomic, including sexual dysfunction and gastroparesis) Recommendations
c Macrovascular: CHD, cerebrovascular disease, and PAD c Patients on multiple-dose insulin (MDI)
c Other: psychosocial problems*, dental disease* or insulin pump therapy should do
Physical examination SMBG at least prior to meals and snacks,
c Height, weight, BMI occasionally postprandially, at bedtime,
c Blood pressure determination, including orthostatic measurements when indicated prior to exercise, when they suspect low
c Fundoscopic examination* blood glucose, after treating low blood
c Thyroid palpation glucose until they are normoglycemic,
c Skin examination (for acanthosis nigricans and insulin injection sites) and prior to critical tasks such as driv-
c Comprehensive foot examination ing. (B)
c Inspection c When prescribed as part of a broader
c Palpation of dorsalis pedis and posterior tibial pulses educational context, SMBG results may
c Presence/absence of patellar and Achilles reflexes be helpful to guide treatment decisions
c Determination of proprioception, vibration, and monofilament sensation and/or patient self-management for
Laboratory evaluation patients using less frequent insulin in-
c A1C, if results not available within past 2–3 months jections or noninsulin therapies. (E)
If not performed/available within past year c When prescribing SMBG, ensure that
c Fasting lipid profile, including total, LDL and HDL cholesterol and triglycerides patients receive ongoing instruction
c Liver function tests and regular evaluation of SMBG tech-
c Test for urine albumin excretion with spot urine albumin-to-creatinine ratio nique and SMBG results, as well as their
c Serum creatinine and calculated GFR ability to use SMBG data to adjust ther-
c TSH in type 1 diabetes, dyslipidemia or women over age 50 years apy. (E)
Referrals c Continuous glucose monitoring (CGM)
c Eye care professional for annual dilated eye exam in conjunction with intensive insulin
c Family planning for women of reproductive age regimens can be a useful tool to lower
c Registered dietitian for MNT A1C in selected adults (aged $25 years)
c DSME with type 1 diabetes. (A)
c Dentist for comprehensive periodontal examination c Although the evidence for A1C lower-
c Mental health professional, if needed ing is less strong in children, teens, and
younger adults, CGM may be helpful
*See appropriate referrals for these categories. in these groups. Success correlates with
adherence to ongoing use of the device.
(C)
c CGM may be a supplemental tool to
expertise and a special interest in diabetes. of problem-solving skills in the various SMBG in those with hypoglycemia
It is essential in this collaborative and in- aspects of diabetes management. Imple- unawareness and/or frequent hypogly-
tegrated team approach that individuals mentation of the management plan re- cemic episodes. (E)
with diabetes assume an active role in their quires that the goals and treatment plan
care. are individualized and take patient pref- Major clinical trials of insulin-treated
The management plan should be erences into account. The management patients that demonstrated the benefits of
formulated as a collaborative therapeutic plan should recognize diabetes self- intensive glycemic control on diabetes
alliance among the patient and family, management education (DSME) and on- complications have included SMBG as
the physician, and other members of the going diabetes support as an integral part of multifactorial interventions, sug-
health care team. A variety of strategies component of care. In developing the gesting that SMBG is a component of
and techniques should be used to provide plan, consideration should be given to effective therapy. SMBG allows patients
adequate education and development the patient’s age, school or work schedule to evaluate their individual response to
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S17

8. Position Statement
therapy and assess whether glycemic tar- one study of insulin-naïve patients with and for the burgeoning work on “artificial
gets are being achieved. Results of SMBG suboptimal initial glycemic control, use pancreas” systems.
can be useful in preventing hypoglycemia of structured SMBG (a paper tool to col-
and adjusting medications (particularly lect and interpret 7-point SMBG profiles b. A1C
prandial insulin doses), medical nutrition over 3 days at least quarterly) reduced Recommendations
therapy (MNT), and physical activity. A1C by 0.3% more than in an active con- c Perform the A1C test at least two
The frequency and timing of SMBG trol group (65). Patients should be taught times a year in patients who are meet-
should be dictated by the particular needs how to use SMBG data to adjust food in- ing treatment goals (and who have
and goals of the patient. SMBG is espe- take, exercise, or pharmacological therapy stable glycemic control). (E)
cially important for patients treated with to achieve specific goals, and the ongoing c Perform the A1C test quarterly in pa-
insulin to monitor for and prevent asymp- need for and frequency of SMBG should be tients whose therapy has changed or
tomatic hypoglycemia and hyperglyce- re-evaluated at each routine visit. who are not meeting glycemic goals. (E)
mia. Most patients with type 1 diabetes Real-time CGM through the measure- c Use of POC testing for A1C provides
and others on intensive insulin regimens ment of interstitial glucose (which corre- the opportunity for more timely treat-
(MDI or insulin pump therapy) should do lates well with plasma glucose) is available. ment changes. (E)
SMBG at least prior to meals and snacks, These sensors require calibration with
occasionally postprandially, at bedtime, SMBG, and the latter are still recommended Because A1C is thought to reflect aver-
prior to exercise, when they suspect low for making acute treatment decisions. age glycemia over several months (63) and
blood glucose, after treating low blood CGM devices have alarms for hypo- and has strong predictive value for diabetes
glucose until they are normoglycemic, hyperglycemic excursions. A 26-week ran- complications (71,72), A1C testing
and prior to critical tasks such as driving. domized trial of 322 type 1 diabetic pa- should be performed routinely in all pa-
For many patients, this will require test- tients showed that adults aged $25 years tients with diabetes, at initial assessment
ing 6–8 times daily, although individual using intensive insulin therapy and CGM and then as part of continuing care. Mea-
needs may be greater. Although there are experienced a 0.5% reduction in A1C surement approximately every 3 months
few rigorous studies, a database study of (from ;7.6 to 7.1%) compared with usual determines whether patient’s glycemic tar-
almost 27,000 children and adolescents intensive insulin therapy with SMBG (66). gets have been reached and maintained.
with type 1 diabetes showed that, after Sensor use in children, teens, and adults to For any individual patient, the frequency
adjustment for multiple confounders, in- age 24 years did not result in significant of A1C testing should be dependent on
creased daily frequency of SMBG was sig- A1C lowering, and there was no significant the clinical situation, the treatment regimen
nificantly associated with lower A1C difference in hypoglycemia in any group. used, and the judgment of the clinician.
(20.2% per additional test per day, level- Importantly, the greatest predictor of A1C Some patients with stable glycemia well
ing off at five tests per day) and with fewer lowering in this study for all age-groups within target may do well with testing
acute complications (57). The optimal was frequency of sensor use, which was only twice per year, while unstable or
frequency of SMBG for patients on non- lower in younger age-groups. In a smaller highly intensively managed patients (e.g.,
intensive regimens, such as those with RCT of 129 adults and children with base- pregnant type 1 diabetic women) may be
type 2 diabetes on basal insulin, is not line A1C ,7.0%, outcomes combining tested more frequently than every 3
known, although a number of studies A1C and hypoglycemia favored the group months. The availability of the A1C result
have used fasting SMBG for patient or pro- utilizing CGM, suggesting that CGM is also at the time that the patient is seen (POC
vider titration of the basal insulin dose. beneficial for individuals with type 1 dia- testing) has been reported in small studies
The evidence base for SMBG for patients betes who have already achieved excellent to result in increased intensification of ther-
with type 2 diabetes on noninsulin therapy control (67). apy and improvement in glycemic control
is somewhat mixed. Several randomized A trial comparing CGM plus insulin (73,74). However, two recent systematic
trials have called into question the clinical pump to SMBG plus multiple injections reviews and meta-analyses found no signif-
utility and cost-effectiveness of routine of insulin in adults and children with type icant difference in A1C between POC and
SMBG in non–insulin-treated patients 1 diabetes showed significantly greater laboratory A1C usage (75,76).
(58–60). A recent meta-analysis suggested improvements in A1C with “sensor- The A1C test is subject to certain
that SMBG reduced A1C by 0.25% at 6 augmented pump” therapy (68,69), but limitations. Conditions that affect eryth-
months (61), while a Cochrane review con- this trial did not isolate the effect of CGM rocyte turnover (hemolysis, blood loss)
cluded that the overall effect of SMBG in itself. Overall, meta-analyses suggest that and hemoglobin variants must be consid-
such patients is small up to 6 months after compared with SMBG, CGM lowers A1C ered, particularly when the A1C result
initiation and subsides after 12 months (62). by ;0.26% (70). Altogether, these data does not correlate with the patient’s clin-
Because the accuracy of SMBG is suggest that, in appropriately selected pa- ical situation (63). In addition, A1C does
instrument and user dependent (63), it tients who are motivated to wear it most of not provide a measure of glycemic vari-
is important to evaluate each patient’s the time, CGM reduces A1C. The technol- ability or hypoglycemia. For patients
monitoring technique, both initially and ogy may be particularly useful in those with prone to glycemic variability (especially
at regular intervals thereafter. Optimal hypoglycemia unawareness and/or fre- type 1 diabetic patients or type 2 diabetic
use of SMBG requires proper review and quent episodes of hypoglycemia, although patients with severe insulin deficiency),
interpretation of the data, both by the pa- studies as yet have not shown significant glycemic control is best judged by the
tient and provider. Among patients who reductions in severe hypoglycemia (70). combination of results of self-monitoring
checked their blood glucose at least once CGM forms the underpinning for the de- and the A1C. The A1C may also serve as a
daily, many reported taking no action velopment of pumps that suspend insulin check on the accuracy of the patient’s me-
when results were high or low (64). In delivery when hypoglycemia is developing ter (or the patient’s reported SMBG
S18 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

9. Position Statement
results) and the adequacy of the SMBG there are significant differences in how microvascular (retinopathy and nephro-
testing schedule. A1C relates to average glucose in children pathy) and neuropathic complications.
Table 8 contains the correlation be- or in African American patients is an area Follow-up of the DCCT cohorts in the Ep-
tween A1C levels and mean plasma glu- for further study. For the time being, the idemiology of Diabetes Interventions and
cose levels based on data from the question has not led to different recom- Complications (EDIC) study (80,81) dem-
international A1C-Derived Average Glu- mendations about testing A1C or to dif- onstrated persistence of these microvascu-
cose (ADAG) trial utilizing frequent ferent interpretations of the clinical lar benefits in previously intensively treated
SMBG and CGM in 507 adults (83% Cau- meaning of given levels of A1C in those subjects, even though their glycemic con-
casian) with type 1, type 2, and no diabe- populations. trol approximated that of previous stan-
tes (77). The ADA and the American For patients in whom A1C/eAG and dard arm subjects during follow-up.
Association for Clinical Chemistry have measured blood glucose appear discrep- The Kumamoto Study (82) and UK
determined that the correlation (r 5 ant, clinicians should consider the possi- Prospective Diabetes Study (UKPDS)
0.92) is strong enough to justify reporting bilities of hemoglobinopathy or altered (83,84) confirmed that intensive glycemic
both an A1C result and an estimated av- red cell turnover, and the options of more control was associated with significantly
erage glucose (eAG) result when a clini- frequent and/or different timing of SMBG decreased rates of microvascular and neu-
cian orders the A1C test. The table in pre- or use of CGM. Other measures of chronic ropathic complications in patients with
2009 versions of the “Standards of Medi- glycemia such as fructosamine are avail- type 2 diabetes. Long-term follow-up of
cal Care in Diabetes” describing the cor- able, but their linkage to average glucose the UKPDS cohorts showed persistence of
relation between A1C and mean glucose and their prognostic significance are not the effect of early glycemic control on
was derived from relatively sparse data as clear as is the case for A1C. most microvascular complications (85).
(one 7-point profile over 1 day per A1C Subsequent trials in patients with
reading) in the primarily Caucasian type 1 2. Glycemic goals in adults more long-standing type 2 diabetes, de-
diabetic participants in the DCCT (78). Recommendations signed primarily to look at the role of
Clinicians should note that the numbers c Lowering A1C to below or around 7% intensive glycemic control on cardiovas-
in the table are now different, as they are has been shown to reduce microvas- cular outcomes, also confirmed a benefit,
based on ;2,800 readings per A1C in the cular complications of diabetes and if although more modest, on onset or pro-
ADAG trial. implemented soon after the diagnosis gression of microvascular complications.
In the ADAG trial, there were no sig- of diabetes is associated with long-term The Veterans Affairs Diabetes Trial
nificant differences among racial and eth- reduction in macrovascular disease. (VADT) showed significant reductions
nic groups in the regression lines between Therefore, a reasonable A1C goal for in albuminuria with intensive (achieved
A1C and mean glucose, although there many nonpregnant adults is ,7%. (B) median A1C 6.9%) compared with stan-
was a trend toward a difference between c Providers might reasonably suggest dard glycemic control, but no difference
African/African American participants more stringent A1C goals (such as in retinopathy and neuropathy (86,87).
and Caucasian ones. A small study com- ,6.5%) for selected individual pa- The Action in Diabetes and Vascular Dis-
paring A1C to CGM data in type 1 di- tients, if this can be achieved without ease: Preterax and Diamicron MR Con-
abetic children found a highly statistically significant hypoglycemia or other ad- trolled Evaluation (ADVANCE) study of
significant correlation between A1C and verse effects of treatment. Appropriate intensive versus standard glycemic con-
mean blood glucose, although the corre- patients might include those with short trol in type 2 diabetes found a statistically
lation (r 5 0.7) was significantly lower duration of diabetes, long life expec- significant reduction in albuminuria, but
than in the ADAG trial (79). Whether tancy, and no significant CVD. (C) not in neuropathy or retinopathy, with an
c Less stringent A1C goals (such as A1C target of ,6.5% (achieved median
Table 8dCorrelation of A1C with average
,8%) may be appropriate for patients A1C 6.3%) compared with standard ther-
glucose
with a history of severe hypoglycemia, apy achieving a median A1C of 7.0% (88).
limited life expectancy, advanced mi- Analyses from the Action to Control Car-
crovascular or macrovascular complica- diovascular Risk in Diabetes (ACCORD)
Mean plasma glucose tions, extensive comorbid conditions, trial have shown lower rates of onset or
A1C (%) mg/dL mmol/L and those with long-standing diabetes in progression of early-stage microvascular
whom the general goal is difficult to at- complications in the intensive glycemic
6 126 7.0 tain despite DSME, appropriate glucose control arm compared with the standard
7 154 8.6 monitoring, and effective doses of mul- arm (89,90).
8 183 10.2 tiple glucose-lowering agents including Epidemiological analyses of the DCCT
9 212 11.8 insulin. (B) and UKPDS (71,72) demonstrate a curvi-
10 240 13.4 linear relationship between A1C and mi-
11 269 14.9 Hyperglycemia defines diabetes, and crovascular complications. Such analyses
12 298 16.5 glycemic control is fundamental to the suggest that, on a population level, the
These estimates are based on ADAG data of ;2,700 management of diabetes. The DCCT greatest number of complications will be
glucose measurements over 3 months per A1C (71), a prospective RCT of intensive ver- averted by taking patients from very poor
measurement in 507 adults with type 1, type 2, and sus standard glycemic control in patients control to fair or good control. These anal-
no diabetes. The correlation between A1C and av- with relatively recently diagnosed type 1 yses also suggest that further lowering of
erage glucose was 0.92 (ref. 77). A calculator for
converting A1C results into eAG, in either mg/dL or
diabetes, showed definitively that A1C from 7 to 6% is associated with further
mmol/L, is available at http://professional.diabetes improved glycemic control is associ- reduction in the risk of microvascular
.org/eAG. ated with significantly decreased rates of complications, albeit the absolute risk
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S19

10. Position Statement
reductions become much smaller. Given All three of these trials were conducted in was associated with excess mortality in
the substantially increased risk of hypogly- participants with more long-standing di- either arm, but the association was stron-
cemia (particularly in those with type 1 di- abetes (mean duration 8–11 years) and ger in those randomized to the standard
abetes, but also in the recent type 2 diabetes either known CVD or multiple cardiovas- glycemic control arm (97). Unlike the
trials), the concerning mortality findings in cular risk factors. Details of these three case with the DCCT trial, where lower
the ACCORD trial (91), and the relatively studies are reviewed extensively in an achieved A1C levels were related to sig-
much greater effort required to achieve ADA position statement (94). nificantly increased rates of severe hypo-
near-normoglycemia, the risks of lower gly- The ACCORD study enrolled partici- glycemia, in ACCORD every 1% decline
cemic targets may outweigh the potential pants with either known CVD or two or in A1C from baseline to 4 months into the
benefits on microvascular complications more major cardiovascular risk factors trial was associated with a significant de-
on a population level. However, selected and randomized them to intensive glyce- crease in the rate of severe hypoglycemia
individual patients, especially those with mic control (goal A1C ,6%) or standard in both arms (96).
little comorbidity and long life expectancy glycemic control (goal A1C 7–8%). The The primary outcome of ADVANCE
(who may reap the benefits of further low- glycemic control comparison was halted was a combination of microvascular
ering of glycemia below 7%), may, based early due to the finding of an increased events (nephropathy and retinopathy)
on provider judgment and patient prefer- rate of mortality in the intensive arm com- and major adverse cardiovascular events
ences, adopt more intensive glycemic tar- pared with the standard arm (1.41% vs. (MI, stroke, and cardiovascular death).
gets (e.g., an A1C target ,6.5%) as long as 1.14% per year; HR 1.22; 95% CI 1.01– Intensive glycemic control (to a goal A1C
significant hypoglycemia does not become 1.46), with a similar increase in cardiovas- ,6.5% vs. treatment to local standards)
a barrier. cular deaths. This increase in mortality in significantly reduced the primary end
CVD, a more common cause of death the intensive glycemic control arm was point. However, this was due to a significant
in populations with diabetes than micro- seen in all prespecified patient subgroups. reduction in the microvascular outcome, pri-
vascular complications, is less clearly The primary outcome of ACCORD (non- marily development of macroalbuminuria,
impacted by levels of hyperglycemia or fatal MI, nonfatal stroke, or cardiovascu- with no significant reduction in the macro-
the intensity of glycemic control. In the lar death) was nonsignificantly lower in vascular outcome. There was no difference
DCCT, there was a trend toward lower the intensive glycemic control group in overall or cardiovascular mortality be-
risk of CVD events with intensive control, due to a reduction in nonfatal MI, both tween the intensive compared with the
and in 9-year post-DCCT follow-up of the when the glycemic control comparison standard glycemic control arms (88).
EDIC cohort participants previously ran- was halted and all participants transi- The VADT randomized participants
domized to the intensive arm had a sig- tioned to the standard glycemic control with type 2 diabetes uncontrolled on
nificant 57% reduction in the risk of intervention (91), and at completion of insulin or maximal-dose oral agents (me-
nonfatal myocardial infarction (MI), stroke, the planned follow-up (95). dian entry A1C 9.4%) to a strategy of
or CVD death compared with those pre- Exploratory analyses of the mortality intensive glycemic control (goal A1C
viously in the standard arm (92). The ben- findings of ACCORD (evaluating vari- ,6.0%) or standard glycemic control,
efit of intensive glycemic control in this ables including weight gain, use of any with a planned A1C separation of at least
type 1 diabetic cohort has recently been specific drug or drug combination, and 1.5%. The primary outcome of the VADT
shown to persist for several decades (93). hypoglycemia) were reportedly unable to was a composite of CVD events. The cu-
In type 2 diabetes, there is evidence identify a clear explanation for the excess mulative primary outcome was nonsig-
that more intensive treatment of glycemia mortality in the intensive arm (91). The nificantly lower in the intensive arm
in newly diagnosed patients may reduce ACCORD investigators subsequently (86). An ancillary study of the VADT
long-term CVD rates. During the UKPDS published additional epidemiological demonstrated that intensive glycemic
trial, there was a 16% reduction in car- analyses showing no increase in mortality control significantly reduced the primary
diovascular events (combined fatal or in the intensive arm participants who CVD outcome in individuals with less
nonfatal MI and sudden death) in the achieved A1C levels below 7% nor in atherosclerosis at baseline (assessed by
intensive glycemic control arm that did those who lowered their A1C quickly af- coronary calcium) but not in persons
not reach statistical significance (P 5 ter trial enrollment. In fact, although there with more extensive baseline atheroscle-
0.052), and there was no suggestion of was no A1C level at which intensive arm rosis (98). A post hoc analysis showed a
benefit on other CVD outcomes such as participants had significantly lower mor- complex relationship between duration
stroke. However, after 10 years of follow- tality than standard arm participants, the of diabetes before glycemic intensifica-
up, those originally randomized to inten- highest risk for mortality was observed in tion and mortality: mortality in the inten-
sive glycemic control had significant intensive arm participants with the high- sive vs. standard glycemic control arm
long-term reductions in MI (15% with est A1C levels (96). was inversely related to duration of dia-
sulfonylurea or insulin as initial pharma- The role of hypoglycemia in the ex- betes at the time of study enrollment.
cotherapy, 33% with metformin as initial cess mortality findings was also complex. Those with diabetes duration less than
pharmacotherapy) and in all-cause mor- Severe hypoglycemia was significantly 15 years had a mortality benefit in the in-
tality (13% and 27%, respectively) (85). more likely in participants randomized tensive arm, while those with duration of
Three more recent large trials to the intensive glycemic control arm. 20 years or more had higher mortality in
(ACCORD, ADVANCE, and VADT) sug- However, excess mortality in the inten- the intensive arm (99).
gested no significant reduction in CVD sive versus standard arms was only sig- The evidence for a cardiovascular ben-
outcomes with intensive glycemic control nificant for participants with no severe efit of intensive glycemic control primarily
in participants who had more advanced hypoglycemia, and not for those with one rests on long-term follow-up of study
type 2 diabetes than UKPDS participants. or more episodes. Severe hypoglycemia cohorts treated early in the course of type
S20 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

11. Position Statement
1 and type 2 diabetes and subset analyses of The issue of pre- versus postprandial c preprandial: #95 mg/dL (5.3 mmol/L),
ACCORD, ADVANCE, and VADT. A SMBG targets is complex (102). Elevated and either:
group-level meta-analysis of the latter three postchallenge (2-h OGTT) glucose values c 1-h postmeal: #140 mg/dL (7.8 mmol/L)
trials suggests that glucose lowering has a have been associated with increased car- or
modest (9%) but statistically significant diovascular risk independent of FPG in c 2-h postmeal: #120 mg/dL (6.7 mmol/L)
reduction in major CVD outcomes, pri- some epidemiological studies. In diabetic
marily nonfatal MI, with no significant subjects, some surrogate measures of For women with pre-existing type 1
effect on mortality. However, heterogeneity vascular pathology, such as endothelial or type 2 diabetes who become pregnant, a
of the mortality effects across studies was dysfunction, are negatively affected by recent consensus statement (106) recom-
noted, precluding firm summary measures postprandial hyperglycemia (103). It is mended the following as optimal glycemic
of the mortality effects. A prespecified sub- clear that postprandial hyperglycemia, goals, if they can be achieved without ex-
group analysis suggested that major CVD like preprandial hyperglycemia, contrib- cessive hypoglycemia:
outcome reduction occurred in patients utes to elevated A1C levels, with its rela-
without known CVD at baseline (HR 0.84, tive contribution being higher at A1C c premeal, bedtime, and overnight glu-
95% CI 0.74–0.94) (100). Conversely, the levels that are closer to 7%. However, cose 60–99 mg/dL (3.3–5.4 mmol/L)
mortality findings in ACCORD and sub- outcome studies have clearly shown c peak postprandial glucose 100–129
group analyses of the VADT suggest that A1C to be the primary predictor of com- mg/dL (5.4–7.1 mmol/L)
the potential risks of intensive glycemic plications, and landmark glycemic con- c A1C ,6.0%
control may outweigh its benefits in some trol trials such as the DCCT and UKPDS
patients, such as those with very long du- relied overwhelmingly on preprandial
ration of diabetes, known history of severe SMBG. Additionally, an RCT in patients D. Pharmacological and overall
hypoglycemia, advanced atherosclerosis, with known CVD found no CVD benefit approaches to treatment
and advanced age/frailty. Certainly, provid- of insulin regimens targeting postpran-
ers should be vigilant in preventing severe dial glucose compared with those 1. Insulin therapy for type 1 diabetes
hypoglycemia in patients with advanced targeting preprandial glucose (104). A Recommendations
disease and should not aggressively at- reasonable recommendation for post- c Most people with type 1 diabetes should
tempt to achieve near-normal A1C levels prandial testing and targets is that for in- be treated with MDI injections (three
in patients in whom such a target cannot dividuals who have premeal glucose to four injections per day of basal and
be safely and reasonably easily achieved. values within target but have A1C values prandial insulin) or continuous sub-
Severe or frequent hypoglycemia is an ab- above target, monitoring postprandial cutaneous insulin infusion (CSII). (A)
solute indication for the modification of plasma glucose (PPG) 1–2 h after the start c Most people with type 1 diabetes
treatment regimens, including setting of the meal and treatment aimed at reduc- should be educated in how to match
higher glycemic goals. Many factors, in- ing PPG values to ,180 mg/dL may help prandial insulin dose to carbohydrate
cluding patient preferences, should be lower A1C. intake, premeal blood glucose, and
taken into account when developing a pa- Glycemic goals for children are pro- anticipated activity. (E)
tient’s individualized goals (101). vided in Section VIII.A.1.a. As regards goals c Most people with type 1 diabetes
Recommended glycemic goals for for glycemic control for women with should use insulin analogs to reduce
many nonpregnant adults are shown in GDM, recommendations from the Fifth hypoglycemia risk. (A)
Table 9. The recommendations are based International Workshop-Conference on c Consider screening those with type 1
on those for A1C values, with listed blood Gestational Diabetes Mellitus (105) were diabetes for other autoimmune dis-
glucose levels that appear to correlate to target maternal capillary glucose con- eases (thyroid, vitamin B12 deficiency,
with achievement of an A1C of ,7%. centrations of: celiac) as appropriate. (B)
The DCCT clearly showed that inten-
Table 9dSummary of glycemic recommendations for many nonpregnant adults with diabetes sive insulin therapy (three or more in-
jections per day of insulin, CSII, or insulin
A1C ,7.0%* pump therapy) was a key part of im-
Preprandial capillary plasma glucose 70–130 mg/dL* (3.9–7.2 mmol/L) proved glycemia and better outcomes
Peak postprandial capillary plasma glucose† ,180 mg/dL* (,10.0 mmol/L) (71,92). At the time of the study, therapy
c *Goals should be individualized based on:
was carried out with short- and intermedi-
c duration of diabetes
ate-acting human insulins. Despite better
c age/life expectancy
microvascular outcomes, intensive insulin
c comorbid conditions
therapy was associated with a high rate in
c known CVD or advanced microvascular complications
severe hypoglycemia (62 episodes per 100
c hypoglycemia unawareness
patient-years of therapy). Since the time of
c individual patient considerations
the DCCT, a number of rapid-acting and
c More or less stringent glycemic goals may be appropriate
long-acting insulin analogs have been de-
for individual patients veloped. These analogs are associated with
c Postprandial glucose may be targeted if A1C goals are
less hypoglycemia with equal A1C lower-
not met despite reaching preprandial glucose goals ing in type 1 diabetes (107,108).
†Postprandial glucose measurements should be made 1–2 h after the beginning of the meal, generally peak Recommended therapy for type 1 di-
levels in patients with diabetes. abetes consists of the following components:
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S21

12. Position Statement
1) use of MDI injections (three to four in- diabetes (111). This 2012 position state- Energy balance, overweight, and obesity
jections per day of basal and prandial in- ment is less prescriptive than prior algo- c Weight loss is recommended for all
sulin) or CSII therapy; 2) matching of rithms and discusses advantages and overweight or obese individuals who
prandial insulin to carbohydrate intake, disadvantages of the available medication have or are at risk for diabetes. (A)
premeal blood glucose, and anticipated classes and considerations for their use. A c For weight loss, either low-carbohydrate,
activity; and 3) for most patients (espe- patient-centered approach is stressed, low-fat calorie-restricted, or Mediterra-
cially if hypoglycemia is a problem), use taking into account patient preferences, nean diets may be effective in the short-
of insulin analogs. There are excellent re- cost and potential side effects of each term (up to 2 years). (A)
views available that guide the initiation class, effects on body weight, and hypo- c For patients on low-carbohydrate diets,
and management of insulin therapy glycemia risk. The position statement re- monitor lipid profiles, renal function,
to achieve desired glycemic goals affirms metformin as the preferred initial and protein intake (in those with ne-
(107,109,110). Although most studies of agent, barring contraindication or intoler- phropathy) and adjust hypoglycemic
MDI versus pump therapy have been small ance, either in addition to lifestyle coun- therapy as needed. (E)
and of short duration, a systematic review seling and support for weight loss and c Physical activity and behavior modifi-
and meta-analysis concluded that there exercise, or when lifestyle efforts alone cation are important components of
were no systematic differences in A1C or have not achieved or maintained glycemic weight loss programs and are most
rates of severe hypoglycemia in children goals. Metformin has a long-standing helpful in maintenance of weight
and adults between the two forms of inten- evidence base for efficacy and safety, is loss. (B)
sive insulin therapy (70). inexpensive, and may reduce risk of car-
Because of the increased frequency diovascular events (85). When metformin
Recommendations for primary
of other autoimmune diseases in type 1 fails to achieve or maintain glycemic goals,
prevention of type 2 diabetes
diabetes, screening for thyroid dysfunc- another agent should be added. Although c Among individuals at high risk for de-
tion, vitamin B12 deficiency, or celiac there are a number of trials comparing veloping type 2 diabetes, structured
disease should be considered based on dual therapy to metformin alone, few di- programs that emphasize lifestyle
signs and symptoms. Periodic screening rectly compare drugs as add-on therapy. changes that include moderate weight
in absence of symptoms has been recom- Comparative effectiveness meta-analyses loss (7% body weight) and regular
mended, but the effectiveness and opti- (112) suggest that overall each new class physical activity (150 min/week), with
mal frequency are unclear. of noninsulin agents added to initial ther- dietary strategies including reduced
apy lowers A1C around 0.9–1.1%. calories and reduced intake of dietary
2. Pharmacological therapy for hyper- Many patients with type 2 diabetes fat, can reduce the risk for developing
glycemia in type 2 diabetes eventually benefit from insulin therapy. diabetes and are therefore recom-
Recommendations The progressive nature of type 2 diabetes mended. (A)
c Metformin, if not contraindicated and if and its therapies should regularly be c Individuals at risk for type 2 diabetes
tolerated, is the preferred initial pharma- explained in a matter-of-fact manner to should be encouraged to achieve the
cological agent for type 2 diabetes. (A) patients, avoiding using insulin as a threat U.S. Department of Agriculture (USDA)
c In newly diagnosed type 2 diabetic or describing it as a failure or punishment. recommendation for dietary fiber (14 g
patients with markedly symptomatic Providing patients with an algorithm for fiber/1,000 kcal) and foods containing
and/or elevated blood glucose levels or self-titration of insulin doses based on whole grains (one-half of grain intake).
A1C, consider insulin therapy, with or SMBG results improves glycemic control (B)
without additional agents, from the in type 2 diabetic patients initiating c Individuals at risk for type 2 diabetes
outset. (E) insulin (113). For more details on phar- should be encouraged to limit their
c If noninsulin monotherapy at maximal macotherapy for hyperglycemia in type intake of sugar-sweetened beverages
tolerated dose does not achieve or main- 2 diabetes, including a table of informa- (SSBs). (B)
tain the A1C target over 3–6 months, tion about currently approved classes
add a second oral agent, a glucagon-like of medications for treating hyperglyce-
peptide-1 (GLP-1) receptor agonist, or mia in type 2 diabetes, readers are referred Recommendations for management
insulin. (A) to the ADA-EASD position statement of diabetes
c A patient-centered approach should be (111). Macronutrients in diabetes management
used to guide choice of pharmacological c The mix of carbohydrate, protein, and
agents. Considerations include efficacy, fat may be adjusted to meet the meta-
cost, potential side effects, effects on E. MNT bolic goals and individual preferences
weight, comorbidities, hypoglycemia General recommendations of the person with diabetes. (C)
risk, and patient preferences. (E) c Individuals who have prediabetes or c Monitoring carbohydrate, whether by
c Due to the progressive nature of type 2 diabetes should receive individualized carbohydrate counting, choices, or ex-
diabetes, insulin therapy is eventually MNT as needed to achieve treatment perience-based estimation, remains a key
indicated for many patients with type 2 goals, preferably provided by a regis- strategy in achieving glycemic control. (B)
diabetes. (B) tered dietitian familiar with the com- c Saturated fat intake should be ,7% of
ponents of diabetes MNT. (A) total calories. (B)
The ADA and EASD have recently c Because MNT can result in cost-savings c Reducing intake of trans fat lowers LDL
partnered on guidance for individualiza- and improved outcomes (B), MNT cholesterol and increases HDL choles-
tion of use of medication classes and should be adequately covered by in- terol (A); therefore, intake of trans fat
combinations in patients with type 2 surance and other payers. (E) should be minimized. (E)
S22 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

13. Position Statement
Other nutrition recommendations loss diets has not been established. A type 2 diabetes. One-year results of the in-
c If adults with diabetes choose to use systematic review of 80 weight loss studies tensive lifestyle intervention in this trial
alcohol, they should limit intake to a of $1-year duration demonstrated that show an average 8.6% weight loss, signifi-
moderate amount (one drink per day or moderate weight loss achieved through cant reduction of A1C, and reduction in
less for adult women and two drinks diet alone, diet and exercise, and meal re- several CVD risk factors (138), with benefits
per day or less for adult men) and should placements can be achieved and main- sustained at 4 years (139). At the time this
take extra precautions to prevent hypo- tained (4.8–8% weight loss at 12 months) article was going to press, the Look AHEAD
glycemia. (E) (125). Both low-fat low-carbohydrate and trial was halted early, after 11 years of fol-
c Routine supplementation with anti- Mediterranean style eating patterns have low-up, because there was no significant
oxidants, such as vitamins E and C and been shown to promote weight loss with difference in the primary cardiovascular
carotene, is not advised because of lack similar results after 1 to 2 years of follow- outcome between the weight loss and stan-
of evidence of efficacy and concern re- up (126–129). A meta-analysis showed dard care group (http://www.nih.gov/news/
lated to long-term safety. (A) that at 6 months, low-carbohydrate diets health/oct2012/niddk-19.htm). Multiple
c It is recommended that individualized were associated with greater improvements cardiovascular risk factors were improved
meal planning include optimization of in triglyceride and HDL cholesterol concen- with weight loss, and those participants
food choices to meet recommended di- trations than low-fat diets; however, LDL on average were on fewer medications to
etary allowance (RDA)/dietary reference cholesterol was significantly higher on the achieve these improvements.
intake (DRI) for all micronutrients. (E) low-carbohydrate diets (130). Although numerous studies have at-
Because of the effects of obesity on tempted to identify the optimal mix of
MNT is an integral component of di- insulin resistance, weight loss is an im- macronutrients for meal plans of people
abetes prevention, management, and self- portant therapeutic objective for over- with diabetes, a recent systematic review
management education. In addition to its weight or obese individuals who are at (140) confirms that there is no most effec-
role in preventing and controlling diabetes, risk for diabetes (131). The multifactorial tive mix that applies broadly, and that
the ADA recognizes the importance of intensive lifestyle intervention used in the macronutrient proportions should be indi-
nutrition as an essential component of an DPP, which included reduced intake of fat vidualized. It must be clearly recognized
overall healthy lifestyle. A full review of the and calories, led to weight loss averaging that regardless of the macronutrient mix,
evidence regarding nutrition in preventing 7% at 6 months and maintenance of 5% total caloric intake must be appropriate to
and controlling diabetes and its complica- weight loss at 3 years, associated with a weight management goal. Further, individ-
tions and additional nutrition-related rec- 58% reduction in incidence of type 2 di- ualization of the macronutrient composi-
ommendations can be found in the ADA abetes (23). An RCT looking at high-risk tion will depend on the metabolic status
position statement “Nutrition Recommen- individuals in Spain showed that the of the patient (e.g., lipid profile, renal func-
dations and Interventions for Diabetes” Mediterranean dietary pattern reduced tion) and/or food preferences. A variety of
(114), which is being updated as of 2013. the incidence of diabetes in the absence dietary meal patterns are likely effective in
Achieving nutrition-related goals requires a of weight loss by 52% compared with the managing diabetes including Mediterra-
coordinated team effort that includes the ac- low-fat control group (132). nean-style, plant-based (vegan or vegetar-
tive involvement of the person with predia- Although our society abounds with ian), low-fat and lower-carbohydrate eating
betes or diabetes. Because of the complexity examples of high-calorie nutrient-poor patterns (127,141–143).
of nutrition issues, it is recommended that a foods, large increases in the consumption It should be noted that the RDA for
registered dietitian who is knowledgeable of SSBs have coincided with the epidemics digestible carbohydrate is 130 g/day and is
and skilled in implementing nutrition of obesity and type 2 diabetes. In a meta- based on providing adequate glucose as the
therapy into diabetes management and analysis of eight prospective cohort stud- required fuel for the central nervous system
education be the team member who pro- ies (n 5 310,819), a diet high in consump- without reliance on glucose production
vides MNT. tion of SSBs was associated with the from ingested protein or fat. Although
Clinical trials/outcome studies of development of type 2 diabetes (n 5 brain fuel needs can be met on lower
MNT have reported decreases in A1C at 15,043). Individuals in the highest versus carbohydrate diets, long-term metabolic
3–6 months ranging from 0.25 to 2.9% lowest quantile of SSB intake had a 26% effects of very low-carbohydrate diets are
with higher reductions seen in type 2 greater risk of developing diabetes (133). unclear and such diets eliminate many
diabetes of shorter duration. Multiple For individuals with type 2 diabetes, foods that are important sources of energy,
studies have demonstrated sustained im- studies have demonstrated that moderate fiber, vitamins, and minerals and are im-
provements in A1C at 12 months and lon- weight loss (5% of body weight) is associ- portant in dietary palatability (144).
ger when a registered dietitian provided ated with decreased insulin resistance, im- Saturated and trans fatty acids are the
follow-up visits ranging from monthly to proved measures of glycemia and lipemia, principal dietary determinants of plasma
3 sessions per year (115–122). Studies in and reduced blood pressure (134); longer- LDL cholesterol. There is a lack of evi-
nondiabetic individuals suggest that term studies ($52 weeks) showed mixed dence on the effects of specific fatty acids
MNT reduces LDL cholesterol by 15–25 effects on A1C in adults with type 2 diabetes on people with diabetes, so the recom-
mg/dL up to 16% (123) and support a (135–137), and in some studies results mended goals are consistent with those
role for lifestyle modification in treating were confounded by pharmacological for individuals with CVD (123,145).
hypertension (123,124). weight loss therapy. Look AHEAD (Action
Although the importance of weight loss for Health in Diabetes) is a large clinical trial Reimbursement for MNT
for overweight and obese individuals is well designed to determine whether long-term MNT, when delivered by a registered
documented, an optimal macronutrient weight loss will improve glycemia and pre- dietitian according to nutrition practice
distribution and dietary pattern of weight vent cardiovascular events in subjects with guidelines, is reimbursed as part of the
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S23

14. Position Statement
Medicare program as overseen by the Current best practice of DSME is a DSMS and to assist diabetes educators
Centers for Medicare and Medicaid Serv- skill-based approach that focuses on in a variety of settings to provide evidence-
ices (CMS), as well as many health in- helping those with diabetes make in- based education and self-management
surance plans. formed self-management choices. DSME support (152). The standards, recently up-
has changed from a didactic approach dated, are reviewed and updated every 5
F. Diabetes self-management focusing on providing information to years by a task force representing key or-
education and support more theoretically based empowerment ganizations involved in the field of diabetes
Recommendations models that focus on helping those with education and care.
c People with diabetes should receive diabetes make informed self-management
DSME and diabetes self-management decisions. Care of diabetes has shifted to DSME and DSMS providers and peo-
support (DSMS) according to National an approach that is more patient centered ple with prediabetes
Standards for Diabetes Self-Manage- and places the person with diabetes The new standards for DSME and DSMS
ment Education and Support when and his or her family at the center of the also apply to the education and support of
their diabetes is diagnosed and as care model working in collaboration people with prediabetes. Currently, there
needed thereafter. (B) with health care professionals. Patient- are significant barriers to the provision of
c Effective self-management and quality centered care is respectful of and respon- education and support to those with pre-
of life are the key outcomes of DSME sive to individual patient preferences, diabetes. However, the strategies for sup-
and DSMS and should be measured needs, and values and ensures that patient porting successful behavior change and
and monitored as part of care. (C) values guide all decision making (154). the healthy behaviors recommended for
c DSME and DSMS should address people with prediabetes are largely iden-
psychosocial issues, since emotional Evidence for the benefits of DSME and tical to those for people with diabetes. As
well-being is associated with positive DSMS barriers to care are overcome, providers of
diabetes outcomes. (C) Multiple studies have found that DSME is DSME and DSMS, given their training and
c DSME and DSMS programs are appro- associated with improved diabetes knowl- experience, are particularly well equipped
priate venues for people with prediabetes edge and improved self-care behavior to assist people with prediabetes in de-
to receive education and support to de- (146), improved clinical outcomes such veloping and maintaining behaviors that
velop and maintain behaviors that can as lower A1C (147,148,150,151,155– can prevent or delay the onset of diabetes
prevent or delay the onset of diabetes. (C) 158), lower self-reported weight (146), im- (152,186).
c Because DSME and DSMS can result in proved quality of life (149,156,159),
cost-savings and improved outcomes (B), healthy coping (160), and lower costs Reimbursement for DSME and DSMS
DSME and DSMS should be adequately (161). Better outcomes were reported for DSME, when provided by a program that
reimbursed by third-party payers. (E) DSME interventions that were longer and meets national standards for DSME and is
included follow-up support (DSMS) recognized by the ADA or other approval
DSME and DSMS are essential ele- (146,162–165), that were culturally bodies, is reimbursed as part of the Medicare
ments of diabetes care (146–151), and re- (166,167) and age appropriate (168,169) program as overseen by the CMS. DSME
cently updated National Standards for and were tailored to individual needs and is also covered by most health insurance
Diabetes Self-Management Education and preferences, and that addressed psychoso- plans. Although DSMS has been shown to
Support (152) are based on evidence for its cial issues and incorporated behavioral be instrumental for improving outcomes, as
benefits. Education helps people with dia- strategies (146,150,170,171). Both indi- described in the “Evidence for the benefits of
betes initiate effective self-management and vidual and group approaches have been DSME and DSMS,” and can be provided in
cope with diabetes when they are first di- found effective (172,173). There is growing formats such as phone calls and via tele-
agnosed. Ongoing DSME and DSMS also evidence for the role of community health health, it currently has limited reimburse-
help people with diabetes maintain effec- workers and peer (174–180) and lay lead- ment as face-to-face visits included as
tive self-management throughout a lifetime ers (181) in delivering DSME and DSMS in follow-up to DSME.
of diabetes as they face new challenges and conjunction with the core team (182).
treatment advances become available. Diabetes education is associated with G. Physical activity
DSME helps patients optimize metabolic increased use of primary and preventive Recommendations
control, prevent and manage complica- services (161,183) and lower use of acute, c Adults with diabetes should be advised
tions, and maximize quality of life in a inpatient hospital services (161). Patients to perform at least 150 min/week of
cost-effective manner (153). who participate in diabetes education are moderate-intensity aerobic physical
DSME and DSMS are the ongoing more likely to follow best practice treat- activity (50–70% of maximum heart
processes of facilitating the knowledge, ment recommendations, particularly rate), spread over at least 3 days/week
skill, and ability necessary for diabetes among the Medicare population, and with no more than two consecutive
self-care. This process incorporates the have lower Medicare and commercial days without exercise. (A)
needs, goals, and life experiences of the claim costs (184,185). c In the absence of contraindications,
person with diabetes. The overall objec- adults with type 2 diabetes should be
tives of DSME and DSMS are to support The National Standards for Diabetes encouraged to perform resistance train-
informed decision making, self-care behav- Self-Management Education and ing at least twice per week. (A)
iors, problem-solving, and active collabo- Support
ration with the health care team to improve The National Standards for Diabetes Self- Exercise is an important part of the
clinical outcomes, health status, and qual- Management Education and Support are diabetes management plan. Regular exer-
ity of life in a cost-effective manner (152). designed to define quality DSME and cise has been shown to improve blood
S24 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

15. Position Statement
glucose control, reduce cardiovascular risk at least one set of five or more different non-PDR (NPDR), vigorous aerobic or
factors, contribute to weight loss, and resistance exercises involving the large resistance exercise may be contraindi-
improve well-being. Furthermore, regular muscle groups (189). cated because of the risk of triggering
exercise may prevent type 2 diabetes in vitreous hemorrhage or retinal detach-
high-risk individuals (23–25). Structured Evaluation of the diabetic patient before ment (198).
exercise interventions of at least 8 weeks’ recommending an exercise program Peripheral neuropathy. Decreased pain
duration have been shown to lower A1C by Prior guidelines suggested that before sensation in the extremities results in
an average of 0.66% in people with type recommending a program of physical activ- increased risk of skin breakdown and
2 diabetes, even with no significant change ity, the provider should assess patients with infection and of Charcot joint destruc-
in BMI (187). Higher levels of exercise in- multiple cardiovascular risk factors for cor- tion. Prior recommendations have ad-
tensity are associated with greater improve- onary artery disease (CAD). As discussed vised non–weight-bearing exercise for
ments in A1C and in fitness (188). A joint more fully in Section VI.A.5, the area of patients with severe peripheral neuropa-
position statement of the ADA and the screening asymptomatic diabetic patients thy. However, studies have shown that
American College of Sports Medicine for CAD remains unclear, and a recent ADA moderate-intensity walking may not
(ACSM) summarizes the evidence for the consensus statement on this issue con- lead to increased risk of foot ulcers or
benefits of exercise in people with type 2 cluded that routine screening is not recom- reulceration in those with peripheral
diabetes (189). mended (196). Providers should use clinical neuropathy (199). All individuals with
judgment in this area. Certainly, high-risk peripheral neuropathy should wear
Frequency and type of exercise patients should be encouraged to start with proper footwear and examine their feet
The U.S. Department of Health and Human short periods of low-intensity exercise and daily to detect lesions early. Anyone
Services’ Physical Activity Guidelines for increase the intensity and duration slowly. with a foot injury or open sore should
Americans (190) suggest that adults over Providers should assess patients for be restricted to non–weight-bearing ac-
age 18 years do 150 min/week of moder- conditions that might contraindicate cer- tivities.
ate-intensity, or 75 min/week of vigorous tain types of exercise or predispose to Autonomic neuropathy. Autonomic neu-
aerobic physical activity, or an equivalent injury, such as uncontrolled hyperten- ropathy can increase the risk of exercise-
combination of the two. In addition, the sion, severe autonomic neuropathy, se- induced injury or adverse event through
guidelines suggest that adults also do vere peripheral neuropathy or history of decreased cardiac responsiveness to exer-
muscle-strengthening activities that in- foot lesions, and unstable proliferative cise, postural hypotension, impaired ther-
volve all major muscle groups $2 days/ retinopathy. The patient’s age and pre- moregulation, impaired night vision due to
week. The guidelines suggest that adults vious physical activity level should be impaired papillary reaction, and unpredict-
over age 65 years, or those with disabili- considered. able carbohydrate delivery from gastropa-
ties, follow the adult guidelines if possible resis predisposing to hypoglycemia (200).
or (if this is not possible) be as physically Exercise in the presence of nonoptimal Autonomic neuropathy is also strongly as-
active as they are able. Studies included in glycemic control sociated with CVD in people with diabetes
the meta-analysis of effects of exercise in- Hyperglycemia. When people with type (201,202). People with diabetic autonomic
terventions on glycemic control (187) 1 diabetes are deprived of insulin for 12– neuropathy should undergo cardiac inves-
had a mean number of sessions per 48 h and are ketotic, exercise can worsen tigation before beginning physical activity
week of 3.4, with a mean of 49 min per hyperglycemia and ketosis (197); there- more intense than that to which they are
session. The DPP lifestyle intervention, fore, vigorous activity should be avoided accustomed.
which included 150 min/week of moder- in the presence of ketosis. However, it is Albuminuria and nephropathy. Physical
ate-intensity exercise, had a beneficial not necessary to postpone exercise based activity can acutely increase urinary pro-
effect on glycemia in those with predia- simply on hyperglycemia, provided the tein excretion. However, there is no evi-
betes. Therefore, it seems reasonable to patient feels well and urine and/or blood dence that vigorous exercise increases the
recommend that people with diabetes ketones are negative. rate of progression of diabetic kidney
try to follow the physical activity guide- Hypoglycemia. In individuals taking in- disease, and there is likely no need for
lines for the general population. sulin and/or insulin secretagogues, phys- any specific exercise restrictions for peo-
Progressive resistance exercise im- ical activity can cause hypoglycemia if ple with diabetic kidney disease (203).
proves insulin sensitivity in older men medication dose or carbohydrate con-
with type 2 diabetes to the same or even a sumption is not altered. For individuals H. Psychosocial assessment and care
greater extent as aerobic exercise (191). on these therapies, added carbohydrate Recommendations
Clinical trials have provided strong evidence should be ingested if pre-exercise glucose c It is reasonable to include assessment of
for the A1C lowering value of resistance levels are ,100 mg/dL (5.6 mmol/L). Hy- the patient’s psychological and social
training in older adults with type 2 dia- poglycemia is rare in diabetic individuals situation as an ongoing part of the
betes (192,193) and for an additive ben- who are not treated with insulin or insulin medical management of diabetes. (E)
efit of combined aerobic and resistance secretagogues, and no preventive mea- c Psychosocial screening and follow-up
exercise in adults with type 2 diabetes sures for hypoglycemia are usually ad- may include, but is not limited to, at-
(194,195). In the absence of contraindi- vised in these cases. titudes about the illness, expectations
cations, patients with type 2 diabetes for medical management and out-
should be encouraged to do at least two Exercise in the presence of specific comes, affect/mood, general and di-
weekly sessions of resistance exercise (ex- long-term complications of diabetes abetes-related quality of life, resources
ercise with free weights or weight ma- Retinopathy. In the presence of prolifer- (financial, social, and emotional), and
chines), with each session consisting of ative diabetic retinopathy (PDR) or severe psychiatric history. (E)
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S25

16. Position Statement
c Screen for psychosocial problems such incorporate psychological assessment The hospitalized patient should be
as depression and diabetes-related and treatment into routine care rather treated by a physician with expertise in
distress, anxiety, eating disorders, than waiting for identification of a specific the management of diabetes. For further
and cognitive impairment when self- problem or deterioration in psychological information on management of patients
management is poor. (B) status (170). Although the clinician may with hyperglycemia in the hospital, see
not feel qualified to treat psychological Section IX.A. For further information
It is important to establish that emotional problems (219), utilizing the patient- on management of DKA or hyperglycemic
well-being is part of diabetes care and self- provider relationship as a foundation nonketotic hyperosmolar state, refer to the
management. Psychological and social can increase the likelihood that the pa- ADA statement on hyperglycemic crises
problems can impair the individual’s tient will accept referral for other services. (222).
(204–207) or family’s ability to carry out Collaborative care interventions and
diabetes care tasks and therefore compro- using a team approach have demon-
mise health status. There are opportuni- strated efficacy in diabetes and depres- K. Hypoglycemia
ties for the clinician to assess psychosocial sion (220,221). Recommendations
status in a timely and efficient manner so c Individuals at risk for hypoglycemia
that referral for appropriate services can should be asked about symptomatic
be accomplished. A systematic review and I. When treatment goals are not met and asymptomatic hypoglycemia at
meta-analysis showed that psychosocial For a variety of reasons, some people with each encounter. (C)
interventions modestly but significantly diabetes and their health care providers c Glucose (15–20 g) is the preferred
improved A1C (standardized mean differ- do not achieve the desired goals of treat- treatment for the conscious individual
ence 20.29%) and mental health out- ment (Table 9). Rethinking the treatment with hypoglycemia, although any form
comes. However, there was a limited regimen may require assessment of barri- of carbohydrate that contains glucose
association between the effects on A1C ers including income, health literacy, may be used. If SMBG 15 min after
and mental health, and no intervention diabetes distress, depression, and com- treatment shows continued hypogly-
characteristics predicted benefit on both peting demands, including those related cemia, the treatment should be re-
outcomes (208). to family responsibilities and dynamics. peated. Once SMBG glucose returns to
Other strategies may include culturally normal, the individual should consume a
Key opportunities for screening of
appropriate and enhanced DSME and meal or snack to prevent recurrence of
psychosocial status occur at diagnosis,
DSMS, co-management with a diabetes
during regularly scheduled management hypoglycemia. (E)
team, referral to a medical social worker
visits, during hospitalizations, at discov- c Glucagon should be prescribed for all
for assistance with insurance coverage, or
ery of complications, or when problems individuals at significant risk of severe
change in pharmacological therapy. Initi-
with glucose control, quality of life, or hypoglycemia, and caregivers or family
ation of or increase in SMBG, utilization
adherence are identified. Patients are members of these individuals should
of CGM, frequent contact with the pa-
likely to exhibit psychological vulnerabil- be instructed on its administration.
tient, or referral to a mental health pro-
ity at diagnosis and when their medical Glucagon administration is not limited
fessional or physician with special
status changes (e.g., the end of the hon- to health care professionals. (E)
expertise in diabetes may be useful.
eymoon period), when the need for in- c Hypoglycemia unawareness or one or
tensified treatment is evident, and when more episodes of severe hypoglycemia
complications are discovered (206). J. Intercurrent illness should trigger re-evaluation of the
Depression affects about 20–25% of The stress of illness, trauma, and/or sur- treatment regimen. (E)
people with diabetes (207) and increases gery frequently aggravates glycemic con- c Insulin-treated patients with hypogly-
the risk for MI and post-MI (209,210) and trol and may precipitate diabetic cemia unawareness or an episode of
all-cause (211) mortality. Other issues ketoacidosis (DKA) or nonketotic hyper- severe hypoglycemia should be advised
known to impact self-management and osmolar statedlife-threatening conditions to raise their glycemic targets to strictly
health outcomes include but are not limited that require immediate medical care to pre- avoid further hypoglycemia for at least
to attitudes about the illness, expectations vent complications and death. Any condi- several weeks, to partially reverse hy-
for medical management and outcomes, tion leading to deterioration in glycemic poglycemia unawareness, and to re-
affect/mood, general and diabetes-related control necessitates more frequent monitor- duce risk of future episodes. (A)
quality of life, diabetes-related distress ing of blood glucose and (in ketosis-prone c Ongoing assessment of cognitive func-
(212,213), resources (financial, social, patients) urine or blood ketones. Marked tion is suggested with increased vigilance
and emotional) (214), and psychiatric his- hyperglycemia requires temporary adjust- for hypoglycemia by the clinician, pa-
tory (215–217). Screening tools are avail- ment of the treatment program and, if ac- tient, and caregivers if low cognition
able for a number of these areas (170). companied by ketosis, vomiting, or and/or declining cognition is found. (B)
Indications for referral to a mental health alteration in level of consciousness, imme-
specialist familiar with diabetes manage- diate interaction with the diabetes care Hypoglycemia is the leading limiting
ment may include gross disregard for the team. The patient treated with noninsulin factor in the glycemic management of type
medical regimen (by self or others) (217), therapies or MNT alone may temporarily 1 and insulin-treated type 2 diabetes (223).
depression, possibility of self-harm, debil- require insulin. Adequate fluid and caloric Mild hypoglycemia may be inconvenient
itating anxiety (alone or with depression), intake must be assured. Infection or dehy- or frightening to patients with diabetes,
indications of an eating disorder (218), or dration is more likely to necessitate hospi- and more severe hypoglycemia can cause
cognitive functioning that significantly talization of the person with diabetes than acute harm to the person with diabetes or
impairs judgment. It is preferable to the person without diabetes. others, if it causes falls, motor vehicle
S26 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

17. Position Statement
accidents, or other injury. A large cohort unconsciousness) should be treated using c Although small trials have shown gly-
study suggested that among older adults emergency glucagon kits, which require a cemic benefit of bariatric surgery in
with type 2 diabetes, a history of severe prescription. Those in close contact with, patients with type 2 diabetes and BMI
hypoglycemia was associated with greater or having custodial care of, people with 30–35 kg/m2, there is currently in-
risk of dementia (224). Conversely, in a hypoglycemia-prone diabetes (family sufficient evidence to generally rec-
substudy of the ACCORD trial, cognitive members, roommates, school personnel, ommend surgery in patients with BMI
impairment at baseline or decline in cog- child care providers, correctional institu- ,35 kg/m2 outside of a research pro-
nitive function during the trial was signif- tion staff, or coworkers) should be in- tocol. (E)
icantly associated with subsequent structed in use of such kits. An individual c The long-term benefits, cost-effectiveness,
episodes of severe hypoglycemia (225). does not need to be a health care pro- and risks of bariatric surgery in indivi-
Evidence from the DCCT/EDIC trial, fessional to safely administer glucagon. duals with type 2 diabetes should be
which involved younger adults and ado- Care should be taken to ensure that un- studied in well-designed controlled trials
lescents with type 1 diabetes, suggested no expired glucagon kits are available. with optimal medical and lifestyle therapy
association of frequency of severe hypo- Prevention of hypoglycemia is a crit- as the comparator. (E)
glycemia with cognitive decline (226). As ical component of diabetes management.
discussed in the Section VIII.A.1.a, a few Particularly for insulin-treated patients, Gastric reduction surgery, either gas-
studies have suggested that severe hypo- SMBG and, for some patients, CGM to tric banding or procedures that involve
glycemia in very young children is associ- detect incipient hypoglycemia and assess bypassing, transposing, or resecting sec-
ated with mild impairments in cognitive adequacy of treatment are a key compo- tions of the small intestine, when part of a
function. nent of safe therapy. Patients should un- comprehensive team approach, can be an
As described in the Section V.b.2, derstand situations that increase their risk effective weight loss treatment for severe
severe hypoglycemia was associated with of hypoglycemia, such as when fasting for obesity, and national guidelines support
mortality in participants in both the stan- tests or procedures, during or after in- its consideration for people with type
dard and intensive glycemia arms of the tense exercise, and during sleep and that 2 diabetes who have BMI of 35 kg/m2
ACCORD trial, but the relationships with increase the risk of harm to self or others or greater. Bariatric surgery has been
achieved A1C and treatment intensity from hypoglycemia, such as with driving. shown to lead to near- or complete nor-
were not straightforward. An association Teaching people with diabetes to balance malization of glycemia in ;40–95% of
of severe hypoglycemia with mortality insulin use, carbohydrate intake, and patients with type 2 diabetes, depending
was also found in the ADVANCE trial exercise is a necessary but not always on the study and the surgical procedure
(227), but its association with other out- sufficient strategy for prevention. In type (230–232). A meta-analysis of studies of
comes such as pulmonary and skin disor- 1 diabetes and severely insulin-deficient bariatric surgery involving 3,188 patients
ders raises the question of whether severe type 2 diabetes, the syndrome of hypo- with diabetes reported that 78% had re-
hypoglycemia is a marker for a sicker pa- glycemia unawareness, or hypoglycemia- mission of diabetes (normalization of
tient, rather than a cause of mortality. An associated autonomic failure, can severely blood glucose levels in the absence of
association of self-reported severe hypo- compromise stringent diabetes control medications) and that the remission rates
glycemia with 5-year mortality has also and quality of life. The deficient counter- were sustained in studies that had follow-
been reported in clinical practice (228). regulatory hormone release and autonomic up exceeding 2 years (233). Remission
At the time this statement went to press, responses in this syndrome are both risk rates tend to be lower with procedures
the ADA and The Endocrine Society were factors for, and caused by, hypoglycemia. A that only constrict the stomach and
finalizing a Hypoglycemia Work Group corollary to this “vicious cycle” is that sev- higher with those that bypass portions
report, where the causes of and associa- eral weeks of avoidance of hypoglycemia of the small intestine. Additionally, there
tions with hypoglycemia are discussed in has been demonstrated to improve is a suggestion that intestinal bypass pro-
depth. counter-regulation and awareness to some cedures may have glycemic effects that are
Treatment of hypoglycemia (plasma extent in many patients (229). Hence, independent of their effects on weight,
glucose ,70 mg/dL) requires ingestion of patients with one or more episodes of perhaps involving the incretin axis.
glucose- or carbohydrate-containing severe hypoglycemia may benefit from There is also evidence for diabetes
foods. The acute glycemic response cor- at least short-term relaxation of glycemic remission in subjects who are less obese.
relates better with the glucose content targets. One randomized trial compared adjust-
than with the carbohydrate content of able gastric banding to “best available”
the food. Although pure glucose is the medical and lifestyle therapy in subjects
preferred treatment, any form of carbohy- L. Bariatric surgery with type 2 diabetes and BMI 30–40 kg/m2
drate that contains glucose will raise Recommendations (234). Overall, 73% of surgically treated
blood glucose. Added fat may retard and c Bariatric surgery may be considered for patients achieved “remission” of their di-
then prolong the acute glycemic response. adults with BMI $35 kg/m2 and type 2 abetes compared with 13% of those trea-
Ongoing activity of insulin or insulin sec- diabetes, especially if the diabetes or ted medically. The latter group lost only
retagogues may lead to recurrence of hypo- associated comorbidities are difficult to 1.7% of body weight, suggesting that
glycemia unless further food is ingested control with lifestyle and pharmaco- their therapy was not optimal. Overall
after recovery. logical therapy. (B) the trial had 60 subjects, and only 13
Severe hypoglycemia (where the in- c Patients with type 2 diabetes who have had a BMI under 35 kg/m2, making it dif-
dividual requires the assistance of an- undergone bariatric surgery need life- ficult to generalize these results widely to
other person and cannot be treated with long lifestyle support and medical diabetic patients who are less severely
oral carbohydrate due to confusion or monitoring. (B) obese or with longer duration of diabetes.
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S27

18. Position Statement
In a recent nonrandomized study of 66 age previously immunized when they HBV in long-term care facilities and hos-
people with BMI of 30–35 kg/m2, 88% were ,65 years of age if the vaccine pitals have been reported to the CDC,
of participants had remission of their was administered .5 years ago. Other with the majority involving adults with
type 2 diabetes up to 6 years after surgery indications for repeat vaccination in- diabetes receiving “assisted blood glucose
(235). clude nephrotic syndrome, chronic monitoring,” in which such monitoring is
Bariatric surgery is costly in the short- renal disease, and other immunocom- done by a health care professional with
term and has some risks. Rates of mor- promised states, such as after trans- responsibility for more than one patient.
bidity and mortality directly related to the plantation. (C) HBV is highly transmissible and stable for
surgery have been reduced considerably c Administer hepatitis B vaccination to long periods of time on surfaces such as
in recent years, with 30-day mortality unvaccinated adults with diabetes who lancing devices and blood glucose meters,
rates now 0.28%, similar to those of are aged 19 through 59 years. (C) even when no blood is visible. Blood suf-
laparoscopic cholecystectomy (236). c Consider administering hepatitis B vac- ficient to transmit the virus has also been
Longer-term concerns include vitamin cination to unvaccinated adults with found in the reservoirs of insulin pens,
and mineral deficiencies, osteoporosis, diabetes who are aged $60 years. (C) resulting in warnings against sharing
and rare but often severe hypoglycemia such devices between patients.
from insulin hypersecretion. Cohort Influenza and pneumonia are common, The CDC analyses suggest that, ex-
studies attempting to match subjects preventable infectious diseases associated cluding persons with HBV-related risk
suggest that the procedure may reduce with high mortality and morbidity in the behaviors, acute HBV infection is about
longer-term mortality rates (237). Recent elderly and in people with chronic dis- twice as high among adults with diabetes
retrospective analyses and modeling eases. Though there are limited studies aged $23 years compared with adults
studies suggest that these procedures reporting the morbidity and mortality of without diabetes. Seroprevalence of anti-
may be cost-effective, when one considers influenza and pneumococcal pneumonia body to HBV core antigen, suggesting past
reduction in subsequent health care costs specifically in people with diabetes, ob- or current infection, is 60% higher among
(238–240). servational studies of patients with a va- adults with diabetes than those without,
Some caution about the benefits of riety of chronic illnesses, including and there is some evidence that diabetes
bariatric surgery might come from recent diabetes, show that these conditions are imparts a higher HBV case fatality rate.
studies. Propensity score–adjusted anal- associated with an increase in hospital- The age differentiation in the recommen-
yses of older severely obese patients with izations for influenza and its complica- dations stems from CDC economic mod-
high baseline mortality in Veterans Af- tions. People with diabetes may be at els suggesting that vaccination of adults
fairs Medical Centers found that the use increased risk of the bacteremic form of with diabetes who were aged 20–59 years
of bariatric surgery was not associated pneumococcal infection and have been would cost an estimated $75,000 per
with decreased mortality compared with reported to have a high risk of nosocomial quality-adjusted life-year saved, while
usual care during a mean 6.7 years of bacteremia, which has a mortality rate as cost per quality-adjusted life-year saved
follow-up (241). A study that followed high as 50% (243). increased significantly at higher ages. In
patients who had undergone laparo- Safe and effective vaccines are avail- addition to competing causes of mortality
scopic adjustable gastric banding able that can greatly reduce the risk of in older adults, the immune response to
(LAGB) for 12 years found that 60% serious complications from these diseases the vaccine declines with age (246).
were satisfied with the procedure. Nearly (244,245). In a case-control series, influ- These new recommendations regard-
one out of three patients experienced enza vaccine was shown to reduce dia- ing HBV vaccinations serve as a reminder
band erosion, and almost half required betes-related hospital admission by as to clinicians that children and adults with
removal of their bands. The authors’ con- much as 79% during flu epidemics diabetes need a number of vaccinations,
clusion was that “LAGB appears to result (244). There is sufficient evidence to sup- both those specifically indicated because
in relatively poor long-term outcomes” port that people with diabetes have of diabetes as well as those recommended
(242). Studies of the mechanisms of gly- appropriate serological and clinical re- for the general population (http://www.
cemic improvement and long-term bene- sponses to these vaccinations. The Cen- cdc.gov/vaccines/recs/).
fits and risks of bariatric surgery in ters for Disease Control and Prevention
individuals with type 2 diabetes, espe- (CDC) Advisory Committee on Immuni- VI. PREVENTION AND
cially those who are not severely obese, zation Practices recommends influenza MANAGEMENT OF DIABETES
will require well-designed clinical trials, and pneumococcal vaccines for all indi- COMPLICATIONS
with optimal medical and lifestyle ther- viduals with diabetes (http://www.cdc.
apy of diabetes and cardiovascular risk gov/vaccines/recs/). A. CVD
factors as the comparator. Late in 2012, the Advisory Commit- CVD is the major cause of morbidity and
tee on Immunization Practices of the CDC mortality for individuals with diabetes
M. Immunization recommended that all previously unvac- and the largest contributor to the direct
Recommendations cinated adults with diabetes aged 19 and indirect costs of diabetes. The common
c Annually provide an influenza vaccine through 59 years be vaccinated against conditions coexisting with type 2 diabetes
to all diabetic patients $6 months of hepatitis B virus (HBV) as soon as possible (e.g., hypertension and dyslipidemia) are
age. (C) after a diagnosis of diabetes is made and clear risk factors for CVD, and diabetes
c Administer pneumococcal polysaccharide that vaccination be considered for those itself confers independent risk. Numerous
vaccine to all diabetic patients $2 years aged $60 years, after assessing risk and studies have shown the efficacy of con-
of age. A one-time revaccination is rec- likelihood of an adequate immune re- trolling individual cardiovascular risk
ommended for individuals .64 years of sponse (246). At least 29 outbreaks of factors in preventing or slowing CVD in
S28 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

19. Position Statement
people with diabetes. Large benefits are c If ACE inhibitors, ARBs, or diuretics are pressure to ,140 mmHg systolic and
seen when multiple risk factors are ad- used, serum creatinine/estimated glo- ,80 mmHg diastolic in individuals with
dressed globally (247,248). There is evi- merular filtration rate (eGFR) and serum diabetes (252,255–257). The evidence for
dence that measures of 10-year coronary potassium levels should be monitored. benefits from lower systolic blood pres-
heart disease (CHD) risk among U.S. (E) sure targets is, however, limited.
adults with diabetes have improved signif- c In pregnant patients with diabetes and The ACCORD trial examined
icantly over the past decade (249). chronic hypertension, blood pressure whether blood pressure lowering to sys-
target goals of 110–129/65–79 mmHg tolic blood pressure ,120 mmHg pro-
are suggested in the interest of long- vides greater cardiovascular protection
1. Hypertension/blood pressure term maternal health and minimizing than a systolic blood pressure level of
control impaired fetal growth. ACE inhibitors 130–140 mmHg in patients with type 2
Recommendations and ARBs are contraindicated during diabetes at high risk for CVD (258). The
Screening and diagnosis pregnancy. (E) blood pressure achieved in the intensive
c Blood pressure should be measured at group was 119/64 mmHg and in the stan-
every routine visit. Patients found to Hypertension is a common comor- dard group 133/70 mmHg; the goals were
have elevated blood pressure should bidity of diabetes, affecting the majority of attained with an average of 3.4 medica-
have blood pressure confirmed on a patients, with prevalence depending on tions per participant in the intensive
separate day. (B) type of diabetes, age, obesity, and ethnic- group and 2.1 in the standard therapy
Goals ity. Hypertension is a major risk factor for group. The hazard ratio for the primary
c People with diabetes and hypertension both CVD and microvascular complica- end point (nonfatal MI, nonfatal stroke,
should be treated to a systolic blood tions. In type 1 diabetes, hypertension is and CVD death) in the intensive group
pressure goal of ,140 mmHg. (B) often the result of underlying nephropa- was 0.88 (95% CI 0.73–1.06, P 5 0.20).
c Lower systolic targets, such as ,130 thy, while in type 2 diabetes it usually Of the prespecified secondary end points,
mmHg, may be appropriate for certain coexists with other cardiometabolic risk only stroke and nonfatal stroke were sta-
individuals, such as younger patients, factors. tistically significantly reduced by inten-
if it can be achieved without undue sive blood pressure treatment, with a
treatment burden. (C) Screening and diagnosis hazard ratio of 0.59 (95% CI 0.39–0.89,
c Patients with diabetes should be treated Measurement of blood pressure in the P 5 0.01) and 0.63 (95% CI 0.41–0.96,
to a diastolic blood pressure ,80 mmHg. office should be done by a trained in- P 5 0.03), respectively. Absolute stroke
(B) dividual and follow the guidelines es- event rates were low; the number needed
Treatment tablished for nondiabetic individuals: to treat to prevent one stroke over the
c Patients with a blood pressure .120/ measurement in the seated position, course of 5 years with intensive blood
80 mmHg should be advised on life- with feet on the floor and arm supported pressure management is 89. Serious ad-
style changes to reduce blood pressure. at heart level, after 5 min of rest. Cuff size verse event rates (including syncope and
(B) should be appropriate for the upper arm hyperkalemia) were higher with intensive
c Patients with confirmed blood pressure circumference. Elevated values should be targets (3.3% vs. 1.3%, P 5 0.001). Rates
$140/80 mmHg should, in addition to confirmed on a separate day. of albuminuria were reduced with more
lifestyle therapy, have prompt initia- Home blood pressure self-monitoring intensive blood pressure goals, but there
tion and timely subsequent titration of and 24-h ambulatory blood pressure were no differences in renal function in
pharmacological therapy to achieve monitoring may provide additional evi- this 5-year trial (and in fact more adverse
blood pressure goals. (B) dence of “white coat” and masked hyper- events related to reduced eGFR with more
c Lifestyle therapy for elevated blood tension and other discrepancies between intensive goals) nor in other microvascu-
pressure consists of weight loss, if office and “true” blood pressure. Studies lar complications.
overweight; Dietary Approaches to in nondiabetic populations found that Other recent randomized trial data
Stop Hypertension (DASH)-style di- home measurements may better correlate include those of the ADVANCE trial in
etary pattern including reducing so- with CVD risk than office measurements which treatment with an ACE inhibitor
dium and increasing potassium intake; (250,251). However, the preponderance and a thiazide-type diuretic reduced the
moderation of alcohol intake; and in- of the evidence of benefits of treatment of rate of death but not the composite
creased physical activity. (B) hypertension in people with diabetes is macrovascular outcome. However, the
c Pharmacological therapy for patients based on office measurements. ADVANCE trial had no specified targets
with diabetes and hypertension should for the randomized comparison, and the
be with a regimen that includes either Treatment goals mean systolic blood pressure in the in-
an ACE inhibitor or an angiotensin Epidemiological analyses show that blood tensive group (135 mmHg) was not as low
receptor blocker (ARB). If one class is pressure .115/75 mmHg is associated as the mean systolic blood pressure even
not tolerated, the other should be sub- with increased cardiovascular event rates in the ACCORD standard-therapy group
stituted. (C) and mortality in individuals with diabetes (259). Post hoc analysis of achieved blood
c Multiple-drug therapy (two or more (252–254) and that systolic blood pres- pressure in several hypertension treat-
agents at maximal doses) is generally sure above 120 mmHg predicts long-term ment trials has suggested no benefit of
required to achieve blood pressure end-stage renal disease (ESRD). Random- lower achieved systolic blood pressure.
targets. (B) ized clinical trials have demonstrated the As an example, among 6,400 patients
c Administer one or more antihyperten- benefit (reduction of CHD events, stroke, with diabetes and CAD enrolled in one
sive medications at bedtime. (A) and nephropathy) of lowering blood trial, “tight control” (achieved systolic
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S29

20. Position Statement
blood pressure ,130 mmHg) was not as- appropriately have lower systolic targets including a large subset with diabetes,
sociated with improved cardiovascular such as ,130 mmHg. This would espe- an ACE inhibitor reduced CVD outcomes
outcomes compared with “usual care” cially be the case if this can be achieved (270). In patients with congestive heart
(achieved systolic blood pressure 130– with few drugs and without side effects of failure (CHF), including diabetic sub-
140 mmHg) (260). Similar finding therapy. groups, ARBs have been shown to reduce
emerged from an analysis of another trial, major CVD outcomes (271–274), and in
but additionally those with achieved sys- Treatment strategies type 2 diabetic patients with significant
tolic blood pressure (,115 mmHg) had Although there are no well-controlled nephropathy, ARBs were superior to cal-
increased rates of CVD events (though studies of diet and exercise in the treat- cium channel blockers for reducing heart
lower rates of stroke) (261). ment of elevated blood pressure or hy- failure (275). Though evidence for dis-
Observational data, including those pertension in individuals with diabetes, tinct advantages of RAS inhibitors on
derived from clinical trials, may be in- the DASH study in nondiabetic individu- CVD outcomes in diabetes remains con-
appropriate to use for defining blood als has shown antihypertensive effects flicting (255,269), the high CVD risks as-
pressure targets since sicker patients similar to pharmacological monotherapy. sociated with diabetes, and the high
may have low blood pressure or, con- Lifestyle therapy consists of reducing prevalence of undiagnosed CVD, may still
versely, healthier or more adherent pa- sodium intake (to below 1,500 mg/day) favor recommendations for their use as
tients may achieve goals more readily. A and excess body weight; increasing con- first-line hypertension therapy in people
recent meta-analysis of randomized trials sumption of fruits, vegetables (8–10 serv- with diabetes (252).
of adults with type 2 diabetes comparing ings per day), and low-fat dairy products Recently, the blood pressure arm of
prespecified blood pressure targets found (2–3 servings per day); avoiding excessive the ADVANCE trial demonstrated that
no significant reduction in mortality or alcohol consumption (no more than two routine administration of a fixed combi-
nonfatal MI. There was a statistically servings per day for men and no more nation of the ACE inhibitor perindopril
significant 35% relative reduction in than one serving per day for women) and the diuretic indapamide significantly
stroke, but the absolute risk reduction (264); and increasing activity levels reduced combined microvascular and
was only 1% (262). Other outcomes, such (252). These nonpharmacological strate- macrovascular outcomes, as well as CVD
as indicators of microvascular complica- gies may also positively affect glycemia and total mortality. The improved out-
tions, were not examined. Another and lipid control and as a result should comes could also have been due to
meta-analysis that included both trials be encouraged in those with even mildly lower achieved blood pressure in the
comparing blood pressure goals and trials elevated blood pressure. Their effects on perindopril-indapamide arm (259). An-
comparing treatment strategies con- cardiovascular events have not been es- other trial showed a decrease in morbidity
cluded that a systolic treatment goal of tablished. Nonpharmacological therapy and mortality in those receiving benaze-
130–135 mmHg was acceptable. With is reasonable in diabetic individuals with pril and amlodipine compared with bena-
goals ,130 mmHg, there were greater re- mildly elevated blood pressure (systolic zepril and hydrochlorothiazide (HCTZ).
ductions in stroke, a 10% reduction in blood pressure .120 mmHg or diastolic The compelling benefits of RAS inhibitors
mortality, but no reduction of other blood pressure .80 mmHg). If the blood in diabetic patients with albuminuria or
CVD events and increased rates of serious pressure is confirmed to be $140 mmHg renal insufficiency provide additional ra-
adverse events. Systolic blood pressure systolic and/or $80 mmHg diastolic, tionale for use of these agents (see Section
,130 mmHg was associated with re- pharmacological therapy should be initi- VI.B). If needed to achieve blood pressure
duced onset and progression of albumin- ated along with nonpharmacological targets, amlodipine, HCTZ, or chlorthali-
uria. However, there was heterogeneity in therapy (252). done can be added. If eGFR is ,30 mL/
the measure, rates of more advanced renal Lowering of blood pressure with regi- min/m2, a loop diuretic rather than HCTZ
disease outcomes were not affected, and mens based on a variety of antihypertensive or chlorthalidone should be prescribed.
there were no significant changes in reti- drugs, including ACE inhibitors, ARBs, Titration of and/or addition of further
nopathy or neuropathy (263). b-blockers, diuretics, and calcium channel blood pressure medications should be
This change in the “default” systolic blockers, has been shown to be effective in made in timely fashion to overcome clin-
blood pressure target is not meant to reducing cardiovascular events. Several ical inertia in achieving blood pressure
downplay the importance of treating hy- studies suggested that ACE inhibitors may targets.
pertension in patients with diabetes or to be superior to dihydropyridine calcium Evidence is emerging that health in-
imply that lower targets than ,140 channel blockers in reducing cardiovascu- formation technology can be used safely
mmHg are generally inappropriate. The lar events (265–267). However, a variety of and effectively as a tool to enable attain-
clear body of evidence that systolic blood other studies have shown no specific ad- ment of blood pressure goals. Using
pressure over 140 mmHg is harmful sug- vantage to ACE inhibitors as initial treat- a telemonitoring intervention to direct
gests that clinicians should promptly ini- ment of hypertension in the general titrations of antihypertensive medications
tiate and titrate therapy in an ongoing hypertensive population, but rather an ad- between medical office visits has been
fashion to achieve and maintain systolic vantage on cardiovascular outcomes of ini- demonstrated to have a profound impact
blood pressure below 140 mmHg in vir- tial therapy with low-dose thiazide diuretics on systolic blood pressure control (276).
tually all patients. Additionally, patients (252,268,269). An important caveat is that most
with long life expectancy (in whom there In people with diabetes, inhibitors of patients with hypertension require
may be renal benefits from long-term the renin-angiotensin system (RAS) may multiple-drug therapy to reach treatment
stricter blood pressure control) or those have unique advantages for initial or early goals (252). Identifying and addressing
in whom stroke risk is a concern might, therapy of hypertension. In a nonhyper- barriers to medication adherence (such
as part of shared decision making, tension trial of high-risk individuals, as cost and side effects) should routinely
S30 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

21. Position Statement
be done. If blood pressure is refractory CVD risk factors (family history of MI) are greatest in people with high base-
despite confirmed adherence to optimal CVD, hypertension, smoking, dysli- line CVD risk (known CVD and/or very
doses of at least three antihypertensive pidemia, or albuminuria) (A) high LDL cholesterol levels), but overall
agents of different classifications, one of c For lower-risk patients than the above the benefits of statin therapy in people
which should be a diuretic, clinicians (e.g., without overt CVD and under the with diabetes at moderate or high risk
should consider an evaluation for sec- age of 40 years), statin therapy should for CVD are convincing.
ondary forms of hypertension. Growing be considered in addition to lifestyle There is an increased risk of incident
evidence suggests that there is an associ- therapy if LDL cholesterol remains diabetes with statin use (289,290), which
ation between increase in sleep-time above 100 mg/dL or in those with may be limited to those with risk factors
blood pressure and incidence of CVD multiple CVD risk factors. (C) for diabetes. These patients may benefit
events. A recent RCT of 448 participants c In individuals without overt CVD, the additionally from diabetes screening
with type 2 diabetes and hypertension goal is LDL cholesterol ,100 mg/dL when on statin therapy. In an analysis of
demonstrated reduced cardiovascular (2.6 mmol/L). (B) one of the initial studies suggesting that
events and mortality with median c In individuals with overt CVD, a lower statins are linked to risk of diabetes, the
follow-up of 5.4 years if at least one an- LDL cholesterol goal of ,70 mg/dL cardiovascular event rate reduction with
tihypertensive medication was given at (1.8 mmol/L), using a high dose of a statins outweighed the risk of incident di-
bedtime (277). statin, is an option. (B) abetes even for patients at highest risk for
During pregnancy in diabetic women c If drug-treated patients do not reach diabetes. The absolute risk increase was
with chronic hypertension, target blood the above targets on maximal tolerated small (over 5 years of follow-up, 1.2% of
pressure goals of systolic blood pressure statin therapy, a reduction in LDL participants on placebo developed diabe-
110–129 mmHg and diastolic blood pres- cholesterol of ;30–40% from baseline tes and 1.5% on rosuvastatin) (291). The
sure 65–79 mmHg are reasonable, as they is an alternative therapeutic goal. (B) relative risk-benefit ratio favoring statins
contribute to long-term maternal health. c Triglycerides levels ,150 mg/dL (1.7 is further supported by meta-analysis of
Lower blood pressure levels may be asso- mmol/L) and HDL cholesterol .40 individual data of over 170,000 persons
ciated with impaired fetal growth. During mg/dL (1.0 mmol/L) in men and .50 from 27 randomized trials. This demon-
pregnancy, treatment with ACE inhibi- mg/dL (1.3 mmol/L) in women are strated that individuals at low risk of vas-
tors and ARBs is contraindicated because desirable (C). However, LDL cholesterol– cular disease, including those undergoing
they can cause fetal damage. Antihyper- targeted statin therapy remains the primary prevention, received benefits
tensive drugs known to be effective and preferred strategy. (A) from statins that included reductions in
safe in pregnancy include methyldopa, c Combination therapy has been shown major vascular events and vascular death
labetalol, diltiazem, clonidine, and pra- not to provide additional cardiovascu- without increase in incidence of cancer or
zosin. Chronic diuretic use during preg- lar benefit above statin therapy alone deaths from other causes (280).
nancy has been associated with restricted and is not generally recommended. (A) Low levels of HDL cholesterol, often
maternal plasma volume, which might c Statin therapy is contraindicated in associated with elevated triglyceride lev-
reduce uteroplacental perfusion (278). pregnancy. (B) els, are the most prevalent pattern of
dyslipidemia in persons with type 2 di-
2. Dyslipidemia/lipid management Evidence for benefits of lipid-lowering abetes. However, the evidence base for
Recommendations therapy drugs that target these lipid fractions is
Screening Patients with type 2 diabetes have an significantly less robust than that for
c In most adult patients with diabetes, increased prevalence of lipid abnormali- statin therapy (292). Nicotinic acid has
measure fasting lipid profile at least ties, contributing to their high risk of been shown to reduce CVD outcomes
annually. (B) CVD. Multiple clinical trials demon- (293), although the study was done in a
c In adults with low-risk lipid values strated significant effects of pharmacolog- nondiabetic cohort. Gemfibrozil has been
(LDL cholesterol ,100 mg/dL, HDL ical (primarily statin) therapy on CVD shown to decrease rates of CVD events in
cholesterol .50 mg/dL, and trigly- outcomes in subjects with CHD and for subjects without diabetes (294,295) and
cerides ,150 mg/dL), lipid assessments primary CVD prevention (279,280). Sub- in the diabetic subgroup of one of the
may be repeated every 2 years. (E) analyses of diabetic subgroups of larger larger trials (294). However, in a large trial
Treatment recommendations and goals trials (281–285) and trials specifically in specific to diabetic patients, fenofibrate
c Lifestyle modification focusing on the subjects with diabetes (286,287) showed failed to reduce overall cardiovascular
reduction of saturated fat, trans fat, and significant primary and secondary pre- outcomes (296).
cholesterol intake; increase of n-3 fatty vention of CVD events 1/2 CHD deaths Combination therapy, with a statin
acids, viscous fiber, and plant stanols/ in diabetic populations. Meta-analyses in- and a fibrate or statin and niacin, may be
sterols; weight loss (if indicated); and cluding data from over 18,000 patients efficacious for treatment for all three lipid
increased physical activity should be with diabetes from 14 randomized trials fractions, but this combination is associ-
recommended to improve the lipid of statin therapy, followed for a mean of ated with an increased risk for abnormal
profile in patients with diabetes. (A) 4.3 years, demonstrate a 9% proportional transaminase levels, myositis, or rhabdo-
c Statin therapy should be added to life- reduction in all-cause mortality and 13% myolysis. The risk of rhabdomyolysis is
style therapy, regardless of baseline reduction in vascular mortality, for each higher with higher doses of statins and
lipid levels, for diabetic patients: mmol/L reduction in LDL cholesterol with renal insufficiency and seems to be
c with overt CVD (A) (288). As is the case in nondiabetic indi- lower when statins are combined with
c without CVD who are over the age of viduals, absolute reductions in “hard” fenofibrate than gemfibrozil (297). In the
40 years and have one or more other CVD outcomes (CHD death and nonfatal ACCORD study, the combination of
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S31

22. Position Statement
fenofibrate and simvastatin did not re- glucose control, or if the patient has variable, and this variable response is
duce the rate of fatal cardiovascular increased cardiovascular risk (e.g., multi- poorly understood (307). Reduction of
events, nonfatal MI, or nonfatal stroke, ple cardiovascular risk factors or long CVD events with statins correlates very
as compared with simvastatin alone, in duration of diabetes). Very little clinical closely with LDL cholesterol lowering
patients with type 2 diabetes who were trial evidence exists for type 2 diabetic (279). If initial attempts to prescribe a
at high risk for CVD. Prespecified sub- patients under the age 40 years, or for statin leads to side effects, clinicians
group analyses suggested heterogeneity type 1 diabetic patients of any age. In the should attempt to find a dose or alterna-
in treatment effects according to sex, Heart Protection Study (lower age limit tive statin that the patient can tolerate.
with a benefit of combination therapy 40 years), the subgroup of ;600 patients There is evidence for significant LDL
for men and possible harm for women, with type 1 diabetes had a reduction in cholesterol lowering from even ex-
and a possible benefit for patients with risk proportionately similar to that of pa- tremely low, less than daily, statin doses
both triglyceride level $204 mg/dL and tients with type 2 diabetes, although not (308). When maximally tolerated doses
HDL cholesterol level #34 mg/dL (298). statistically significant (282). Although of statins fail to significantly lower LDL
The AIM-HIGH trial randomized over the data are not definitive, consideration cholesterol (,30% reduction from the
3,000 patients (about one-third with di- should be given to similar lipid-lowering patient’s baseline), there is no strong ev-
abetes) with established CVD, low levels goals in type 1 diabetic patients as in type idence that combination therapy should
of HDL cholesterol, and triglyceride levels 2 diabetic patients, particularly if they be used to achieve additional LDL cho-
of 150–400 mg/dL to statin therapy plus have other cardiovascular risk factors. lesterol lowering. Niacin, fenofibrate,
extended release niacin or matching pla- ezetimibe, and bile acid sequestrants all
cebo. The trial was halted early due to lack Alternative lipoprotein goals offer additional LDL cholesterol lowering
of efficacy on the primary CVD outcome Virtually all trials of statins and CVD to statins alone, but without evidence
and a possible increase in ischemic stroke outcome tested specific doses of statins that such combination therapy for LDL
in those on combination therapy (299). against placebo, other doses of statin, or cholesterol lowering provides a signifi-
Hence, combination lipid-lowering ther- other statins, rather than aiming for spe- cant increment in CVD risk reduction
apy cannot be broadly recommended. cific LDL cholesterol goals (301). Placebo- over statin therapy alone.
controlled trials generally achieved LDL
Dyslipidemia treatment and target cholesterol reductions of 30–40% from Treatment of other lipoprotein frac-
lipid levels baseline. Hence, LDL cholesterol lower- tions or targets
For most patients with diabetes, the first ing of this magnitude is an acceptable out- Hypertriglyceridemia should be ad-
priority of dyslipidemia therapy (unless come for patients who cannot reach LDL dressed with dietary and lifestyle changes.
severe hypertriglyceridemia with risk of cholesterol goals due to severe baseline Severe hypertriglyceridemia (.1,000
pancreatitis is the immediate issue) is to elevations in LDL cholesterol and/or in- mg/dL) may warrant immediate pharma-
lower LDL cholesterol to a target goal of tolerance of maximal, or any, statin doses. cological therapy (fibric acid derivative,
,100 mg/dL (2.60 mmol/L) (300). Life- Additionally for those with baseline LDL niacin, or fish oil) to reduce the risk of
style intervention, including MNT, in- cholesterol minimally above 100 mg/dL, acute pancreatitis. In the absence of se-
creased physical activity, weight loss, prescribing statin therapy to lower LDL vere hypertriglyceridemia, therapy target-
and smoking cessation, may allow some cholesterol about 30–40% from baseline ing HDL cholesterol or triglycerides lacks
patients to reach lipid goals. Nutrition in- is probably more effective than prescrib- the strong evidence base of statin therapy.
tervention should be tailored according to ing just enough to get LDL cholesterol If the HDL cholesterol is ,40 mg/dL and
each patient’s age, type of diabetes, phar- slightly below 100 mg/dL. the LDL cholesterol is between 100 and
macological treatment, lipid levels, and Clinical trials in high-risk patients, 129 mg/dL, a fibrate or niacin might be
other medical conditions and should fo- such as those with acute coronary syn- used, especially if a patient is intolerant to
cus on the reduction of saturated fat, cho- dromes or previous cardiovascular events statins. Niacin is the most effective drug
lesterol, and trans unsaturated fat intake (302–304), have demonstrated that more for raising HDL cholesterol. It can signif-
and increases in n-3 fatty acids, viscous aggressive therapy with high doses of sta- icantly increase blood glucose at high doses,
fiber (such as in oats, legumes, citrus), tins to achieve an LDL cholesterol of ,70 but at modest doses (750–2,000 mg/day)
and plant stanols/sterols. Glycemic con- mg/dL led to a significant reduction in significant improvements in LDL choles-
trol can also beneficially modify plasma further events. Therefore, a reduction in terol, HDL cholesterol, and triglyceride
lipid levels, particularly in patients with LDL cholesterol to a goal of ,70 mg/dL is levels are accompanied by only modest
very high triglycerides and poor glycemic an option in very high-risk diabetic pa- changes in glucose that are generally ame-
control. tients with overt CVD (305). Some ex- nable to adjustment of diabetes therapy
In those with clinical CVD or over age perts recommend a greater focus on (299,309,310).
40 years with other CVD risk factors, non–HDL cholesterol, apolipoprotein B Table 10 summarizes common treat-
pharmacological treatment should be (apoB), or lipoprotein particle measure- ment goals for A1C, blood pressure, and
added to lifestyle therapy regardless of ments to assess residual CVD risk in LDL cholesterol.
baseline lipid levels. Statins are the drugs statin-treated patients who are likely to
of choice for LDL cholesterol lowering have small LDL particles, such as people
and cardioprotection. In patients other with diabetes (306), but it is unclear 3. Antiplatelet agents
than those described above, statin treat- whether clinical management would Recommendations
ment should be considered if there is an change with these measurements. c Consider aspirin therapy (75–162
inadequate LDL cholesterol response to In individual patients, LDL choles- mg/day) as a primary prevention strategy
lifestyle modifications and improved terol lowering with statins is highly in those with type 1 or type 2 diabetes
S32 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

23. Position Statement
at increased cardiovascular risk (10-year The Antithrombotic Trialists’ (ATT) In 2010, a position statement of the
risk .10%). This includes most men collaborators recently published an indi- ADA, the American Heart Association
aged .50 years or women aged .60 vidual patient-level meta-analysis of the (AHA), and the American College of
years who have at least one additional six large trials of aspirin for primary pre- Cardiology Foundation (ACCF) updated
major risk factor (family history of CVD, vention in the general population. These prior joint recommendations for primary
hypertension, smoking, dyslipidemia, or trials collectively enrolled over 95,000 prevention (315). Low-dose (75–162
albuminuria). (C) participants, including almost 4,000 mg/day) aspirin use for primary preven-
c Aspirin should not be recommended with diabetes. Overall, they found that as- tion is reasonable for adults with diabetes
for CVD prevention for adults with pirin reduced the risk of vascular events and no previous history of vascular dis-
diabetes at low CVD risk (10-year CVD by 12% (RR 0.88, 95% CI 0.82–0.94). ease who are at increased CVD risk (10-
risk ,5%, such as in men aged ,50 The largest reduction was for nonfatal year risk of CVD events over 10%) and
years and women aged ,60 years with MI with little effect on CHD death (RR who are not at increased risk for bleeding.
no major additional CVD risk factors), 0.95, 95% CI 0.78–1.15) or total stroke. This generally includes most men over
since the potential adverse effects from There was some evidence of a difference age 50 years and women over age 60 years
bleeding likely offset the potential in aspirin effect by sex. Aspirin signifi- who also have one or more of the follow-
benefits. (C) cantly reduced CHD events in men but ing major risk factors: 1) smoking, 2) hy-
c In patients in these age-groups with not in women. Conversely, aspirin had pertension, 3) dyslipidemia, 4) family
multiple other risk factors (e.g., 10- no effect on stroke in men but signifi- history of premature CVD, and 5) albu-
year risk 5–10%), clinical judgment is cantly reduced stroke in women. Notably, minuria.
required. (E) sex differences in aspirin’s effects have not However, aspirin is no longer recom-
c Use aspirin therapy (75–162 mg/day) been observed in studies of secondary mended for those at low CVD risk
as a secondary prevention strategy in prevention (311). In the six trials exam- (women under age 60 years and men
those with diabetes with a history of ined by the ATT collaborators, the effects under age 50 years with no major CVD
CVD. (A) of aspirin on major vascular events were risk factors; 10-year CVD risk under 5%)
c For patients with CVD and docu- similar for patients with or without diabe- as the low benefit is likely to be out-
mented aspirin allergy, clopidogrel (75 tes: RR 0.88 (95% CI 0.67–1.15) and 0.87 weighed by the risks of significant bleed-
mg/day) should be used. (B) (95% CI 0.79–0.96), respectively. The ing. Clinical judgment should be used for
c Combination therapy with aspirin (75– confidence interval was wider for those those at intermediate risk (younger pa-
162 mg/day) and clopidogrel (75 mg/day) with diabetes because of their smaller tients with one or more risk factors, or
is reasonable for up to a year after an number. older patients with no risk factors; those
acute coronary syndrome. (B) Based on the currently available evi- with 10-year CVD risk of 5–10%) until
dence, aspirin appears to have a modest further research is available. Use of aspirin
Aspirin has been shown to be effective effect on ischemic vascular events with in patients under the age of 21 years is
in reducing cardiovascular morbidity and the absolute decrease in events depend- contraindicated due to the associated
mortality in high-risk patients with pre- ing on the underlying CVD risk. The risk of Reye syndrome.
vious MI or stroke (secondary prevention). main adverse effects appear to be an Average daily dosages used in most
Its net benefit in primary prevention increased risk of gastrointestinal bleed- clinical trials involving patients with di-
among patients with no previous cardio- ing. The excess risk may be as high as 1–5 abetes ranged from 50 to 650 mg but
vascular events is more controversial, both per 1,000 per year in real-world settings. were mostly in the range of 100 to 325
for patients with and without a history of In adults with CVD risk greater than 1% mg/day. There is little evidence to sup-
diabetes (311). Two recent RCTs of aspirin per year, the number of CVD events pre- port any specific dose, but using the
specifically in patients with diabetes failed vented will be similar to or greater than lowest possible dosage may help reduce
to show a significant reduction in CVD end the number of episodes of bleeding in- side effects (316). In the U.S., the most
points, raising further questions about the duced, although these complications do common low dose tablet is 81 mg. Al-
efficacy of aspirin for primary prevention in not have equal effects on long-term though platelets from patients with dia-
people with diabetes (312,313). health (314). betes have altered function, it is unclear
what, if any, impact that finding has on
the required dose of aspirin for cardio-
Table 10dSummary of recommendations for glycemic, blood pressure, and lipid control for protective effects in the patient with di-
most adults with diabetes abetes. Many alternate pathways for
A1C ,7.0%*
platelet activation exist that are indepen-
Blood pressure ,140/80 mmHg**
dent of thromboxane A2 and thus not
Lipids
sensitive to the effects of aspirin (317).
LDL cholesterol ,100 mg/dL (,2.6 mmol/L)†
Therefore, while “aspirin resistance” ap-
Statin therapy for those with history of MI or age over 401
pears higher in the diabetic patients when
other risk factors
measured by a variety of ex vivo and in
vitro methods (platelet aggregometry,
*More or less stringent glycemic goals may be appropriate for individual patients. Goals should be in- measurement of thromboxane B2), these
dividualized based on duration of diabetes, age/life expectancy, comorbid conditions, known CVD or ad- observations alone are insufficient to em-
vanced microvascular complications, hypoglycemia unawareness, and individual patient considerations.
**Based on patient characteristics and response to therapy, lower systolic blood pressure targets may be
pirically recommend higher doses of as-
appropriate. †In individuals with overt CVD, a lower LDL cholesterol goal of ,70 mg/dL (1.8 mmol/L), using pirin be used in the diabetic patient at this
a high dose of a statin, is an option. time.
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S33

24. Position Statement
Clopidogrel has been demonstrated Treatment Although asymptomatic diabetic patients
to reduce CVD events in diabetic individ- c In patients with known CVD, consider found to have a higher coronary disease
uals (318). It is recommended as adjunc- ACE inhibitor therapy (C) and use as- burden have more future cardiac events
tive therapy in the first year after an acute pirin and statin therapy (A) (if not (326–328), the role of these tests beyond
coronary syndrome or as alternative ther- contraindicated) to reduce the risk of risk stratification is not clear. Their rou-
apy in aspirin-intolerant patients. cardiovascular events. In patients with a tine use leads to radiation exposure and
prior MI, b-blockers should be contin- may result in unnecessary invasive testing
ued for at least 2 years after the event. (B) such as coronary angiography and revas-
4. Smoking cessation
c Avoid thiazolidinedione treatment in cularization procedures. The ultimate
Recommendations
patients with symptomatic heart fail- balance of benefit, cost, and risks of
c Advise all patients not to smoke or use
ure. (C) such an approach in asymptomatic pa-
tobacco products. (A)
c Metformin may be used in patients tients remains controversial, particularly
c Include smoking cessation counseling
with stable CHF if renal function is in the modern setting of aggressive CVD
and other forms of treatment as a rou-
normal. It should be avoided in unstable risk factor control.
tine component of diabetes care. (B)
or hospitalized patients with CHF. (C) In all patients with diabetes, cardio-
A large body of evidence from epide- vascular risk factors should be assessed
Screening for CAD is reviewed in a at least annually. These risk factors
miological, case-control, and cohort stud-
recently updated consensus statement include dyslipidemia, hypertension,
ies provides convincing documentation
(196). To identify the presence of CAD smoking, a positive family history of
of the causal link between cigarette smok-
in diabetic patients without clear or sug- premature coronary disease, and the
ing and health risks. Much of the work
gestive symptoms, a risk factor–based ap- presence of micro- or macroalbu-
documenting the impact of smoking on
health did not separately discuss results proach to the initial diagnostic evaluation minuria. Abnormal risk factors should
and subsequent follow-up has intuitive be treated as described elsewhere in
on subsets of individuals with diabetes,
appeal. However, recent studies con- these guidelines. Patients at increased
but suggests that the identified risks are at
cluded that using this approach fails to CHD risk should receive aspirin and a
least equivalent to those found in the
identify which patients with type 2 diabe- statin, and ACE inhibitor or ARB therapy
general population. Other studies of in-
tes will have silent ischemia on screening if hypertensive, unless there are contra-
dividuals with diabetes consistently dem-
tests (201,321). indications to a particular drug class.
onstrate that smokers have a heightened
Candidates for cardiac testing include Although clear benefit exists for ACE
risk of CVD, premature death, and in-
those with 1) typical or atypical cardiac inhibitor and ARB therapy in patients
creased rate of microvascular complica-
symptoms and 2) an abnormal resting with nephropathy or hypertension, the
tions of diabetes. Smoking may have a
role in the development of type 2 diabetes. ECG. The screening of asymptomatic pa- benefits in patients with CVD in the
tients remains controversial. Intensive absence of these conditions are less clear,
One study in smokers with newly diag-
medical therapy that would be indicated especially when LDL cholesterol is con-
nosed type 2 diabetes found that smoking
cessation was associated with amelioration anyway for diabetic patients at high risk comitantly controlled (329,330).
for CVD seems to provide equal outcomes
of metabolic parameters and reduced blood
to invasive revascularization (322,323).
pressure and albuminuria at 1 year (319).
There is also some evidence that silent B. Nephropathy screening and
The routine and thorough assessment
myocardial ischemia may reverse over treatment
of tobacco use is important as a means of
time, adding to the controversy concern- Recommendations
preventing smoking or encouraging ces-
ing aggressive screening strategies (324). General recommendations
sation. A number of large randomized
Finally, a recent randomized observa- c To reduce the risk or slow the progres-
clinical trials have demonstrated the effi-
tional trial demonstrated no clinical ben- sion of nephropathy, optimize glucose
cacy and cost-effectiveness of brief coun-
efit to routine screening of asymptomatic control. (A)
seling in smoking cessation, including the
use of quitlines, in the reduction of patients with type 2 diabetes and normal c To reduce the risk or slow the pro-
ECGs (325). Despite abnormal myocar- gression of nephropathy, optimize
tobacco use. For the patient motivated
dial perfusion imaging in more than one blood pressure control. (A)
to quit, the addition of pharmacological
in five patients, cardiac outcomes were Screening
therapy to counseling is more effective
essentially equal (and very low) in c Perform an annual test to assess urine
than either treatment alone. Special con-
screened compared with unscreened pa- albumin excretion in type 1 diabetic
siderations should include assessment of
tients. Accordingly, the overall effective- patients with diabetes duration of $5
level of nicotine dependence, which is
ness, especially the cost-effectiveness, of years and in all type 2 diabetic patients
associated with difficulty in quitting and
such an indiscriminate screening strategy starting at diagnosis. (B)
relapse (320).
is now questioned. c Measure serum creatinine at least annually
Newer noninvasive CAD screening in all adults with diabetes regardless of the
5. CHD screening and treatment methods, such as computed tomography degree of urine albumin excretion. The
Recommendations (CT) and CT angiography have gained in serum creatinine should be used to esti-
Screening popularity. These tests infer the presence mate GFR and stage the level of chronic
c In asymptomatic patients, routine of coronary atherosclerosis by measuring kidney disease (CKD), if present. (E)
screening for CAD is not recommended, the amount of calcium in coronary arter- Treatment
as it does not improve outcomes as long ies and, in some circumstances, by c In the treatment of the nonpregnant
as CVD risk factors are treated. (A) direct visualization of luminal stenoses. patient with modestly elevated (30–299
S34 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

25. Position Statement
mg/day) (C) or higher levels ($300 pressure (,140 mmHg) resulting from Assessment of albuminuria status and
mg/day) of urinary albumin excretion treatment using ACE inhibitors provides a renal function
(A), either ACE inhibitors or ARBs are selective benefit over other antihyperten- Screening for increased urinary albumin
recommended. sive drug classes in delaying the progres- excretion can be performed by measure-
c Reduction of protein intake to 0.8–1.0 sion of increased urinary albumin excretion ment of the albumin-to-creatinine ratio
g/kg body wt per day in individuals and can slow the decline in GFR in patients in a random spot collection; 24-h or
with diabetes and the earlier stages of with higher levels of albuminuria (337– timed collections are more burdensome
CKD and to 0.8 g/kg body wt per day in 339). In type 2 diabetes with hypertension and add little to prediction or accuracy
the later stages of CKD may improve and normoalbuminuria, RAS inhibition (358,359). Measurement of a spot urine
measures of renal function (urine al- has been demonstrated to delay onset of for albumin only, whether by immunoas-
bumin excretion rate, GFR) and is microalbuminuria (340,341). In the latter say or by using a dipstick test specific for
recommended. (C) study, there was an unexpected higher rate microalbumin, without simultaneously
c When ACE inhibitors, ARBs, or diu- of fatal cardiovascular events with olmesar- measuring urine creatinine, is somewhat
retics are used, monitor serum creati- tan among patients with preexisting CHD. less expensive but susceptible to false-
nine and potassium levels for the ACE inhibitors have been shown to negative and false-positive determina-
development of increased creatinine or reduce major CVD outcomes (i.e., MI, tions as a result of variation in urine
changes in potassium. (E) stroke, death) in patients with diabetes concentration due to hydration and other
c Continued monitoring of urine albu- (270), thus further supporting the use of factors.
min excretion to assess both response these agents in patients with albuminuria, a Abnormalities of albumin excretion
to therapy and progression of disease is CVD risk factor. ARBs do not prevent onset and the linkage between albumin-to-
reasonable. (E) of albuminuria in normotensive patients creatinine ratio and 24-h albumin excre-
c When eGFR ,60 mL/min/1.73 m2, with type 1 or type 2 diabetes (342,343); tion are defined in Table 11. Because of
evaluate and manage potential com- however, ARBs have been shown to reduce variability in urinary albumin excretion,
plications of CKD. (E) the rate of progression from micro- to mac- two of three specimens collected within a
c Consider referral to a physician expe- roalbuminuria as well as ESRD in patients 3- to 6-month period should be abnormal
rienced in the care of kidney disease for with type 2 diabetes (344–346). Some ev- before considering a patient to have de-
uncertainty about the etiology of kid- idence suggests that ARBs have a smaller veloped increased urinary albumin excre-
ney disease, difficult management is- magnitude of rise in potassium compared tion or had a progression in albuminuria.
sues, or advanced kidney disease. (B) with ACE inhibitors in people with ne- Exercise within 24 h, infection, fever,
phropathy (347,348). Combinations of CHF, marked hyperglycemia, and
Diabetic nephropathy occurs in 20–40% drugs that block the renin-angiotensin- marked hypertension may elevate urinary
of patients with diabetes and is the single aldosterone system (e.g., an ACE inhibitor albumin excretion over baseline values.
leading cause of ESRD. Persistent albu- plus an ARB, a mineralocorticoid antago- Information on presence of abnormal
minuria in the range of 30–299 mg/24 h nist, or a direct renin inhibitor) provide urine albumin excretion in addition to
(historically called microalbuminuria) additional lowering of albuminuria (349– level of GFR may be used to stage CKD.
has been shown to be the earliest stage 352). However, such combinations have The National Kidney Foundation classifi-
of diabetic nephropathy in type 1 diabetes been found to provide no additional car- cation (Table 12) is primarily based on
and a marker for development of nephrop- diovascular benefit and have higher ad- GFR levels and therefore differs from
athy in type 2 diabetes. It is also a well- verse event rates (353), and their effects other systems, in which staging is based
established marker of increased CVD risk on major renal outcomes have not yet primarily on urinary albumin excretion
(331,332). Patients with microalbuminuria been proven. (360). Studies have found decreased
who progress to more significant levels Other drugs, such as diuretics, cal- GFR in the absence of increased urine al-
($300 mg/24 h, historically called mac- cium channel blockers, and b-blockers, bumin excretion in a substantial percent-
roalbuminuria) are likely to progress to should be used as additional therapy to age of adults with diabetes (361). Serum
ESRD (333,334). However, a number of further lower blood pressure in patients creatinine should therefore be measured
interventions have been demonstrated to already treated with ACE inhibitors or at least annually in all adults with
reduce the risk and slow the progression ARBs (275), or as alternate therapy in
of renal disease. the rare individual unable to tolerate
Intensive diabetes management with ACE inhibitors or ARBs.
the goal of achieving near-normoglycemia Studies in patients with varying stages Table 11dDefinitions of abnormalities in
has been shown in large prospective ran- of nephropathy have shown that protein albumin excretion
domized studies to delay the onset and restriction of dietary protein helps slow
progression of increased urinary albumin the progression of albuminuria, GFR de-
Spot collection
excretion in patients with type 1 cline, and occurrence of ESRD (354–
Category (mg/mg creatinine)
(335,336) and type 2 (83,84,88,89) dia- 357), although more recent studies have
betes. The UKPDS provided strong evi- provided conflicting results (140). Die- Normal ,30
dence that control of blood pressure can tary protein restriction might be consid- Increased urinary
reduce the development of nephropathy ered particularly in patients whose albumin excretion* $30
(255). In addition, large prospective ran- nephropathy seems to be progressing de-
*Historically, ratios between 30 and 299 have been
domized studies in patients with type 1 spite optimal glucose and blood pressure called microalbuminuria and those 300 or greater
diabetes have demonstrated that achieve- control and use of ACE inhibitor and/or have been called macroalbuminuria (or clinical al-
ment of lower levels of systolic blood ARBs (357). buminuria).
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S35

26. Position Statement
diabetes, regardless of the degree of urine disease. Consultation with a nephrologist for a comprehensive eye exam, which
albumin excretion. when stage 4 CKD develops has been found should be performed at least initially
Serum creatinine should be used to to reduce cost, improve quality of care, and and at intervals thereafter as recom-
estimate GFR and to stage the level of keep people off dialysis longer (364). How- mended by an eye care professional. (E)
CKD, if present. eGFR is commonly ever, nonrenal specialists should not delay c Women with pre-existing diabetes who
coreported by laboratories or can be educating their patients about the progres- are planning pregnancy or who have
estimated using formulae such as the sive nature of diabetic kidney disease; the become pregnant should have a com-
Modification of Diet in Renal Disease renal preservation benefits of aggressive prehensive eye examination and be
(MDRD) study equation (362). Recent re- treatment of blood pressure, blood glucose, counseled on the risk of development
ports have indicated that the MDRD is and hyperlipidemia; and the potential need and/or progression of diabetic reti-
more accurate for the diagnosis and strat- for renal replacement therapy. nopathy. Eye examination should oc-
ification of CKD in patients with diabetes cur in the first trimester with close
than the Cockcroft-Gault formula (363). C. Retinopathy screening and follow-up throughout pregnancy and
GFR calculators are available at http:// treatment for 1 year postpartum. (B)
www.nkdep.nih.gov. Recommendations Treatment
The role of continued annual quanti- General recommendations c Promptly refer patients with any level
tative assessment of albumin excretion c To reduce the risk or slow the pro- of macular edema, severe NPDR, or any
after diagnosis of albuminuria and insti- gression of retinopathy, optimize gly- PDR to an ophthalmologist who is
tution of ACE inhibitor or ARB therapy cemic control. (A) knowledgeable and experienced in the
and blood pressure control is unclear. c To reduce the risk or slow the pro- management and treatment of diabetic
Continued surveillance can assess both gression of retinopathy, optimize blood retinopathy. (A)
response to therapy and progression of pressure control. (A) c Laser photocoagulation therapy is in-
disease. Some suggest that reducing al- Screening dicated to reduce the risk of vision loss
buminuria to the normal (,30 mg/g) or c Adults and children aged $10 years in patients with high-risk PDR, clini-
near-normal range may improve renal with type 1 diabetes should have an cally significant macular edema, and in
and cardiovascular prognosis, but this ap- initial dilated and comprehensive eye some cases of severe NPDR. (A)
proach has not been formally evaluated in examination by an ophthalmologist or c Anti–vascular endothelial growth fac-
prospective trials. optometrist within 5 years after the tor (VEGF) therapy is indicated for di-
Complications of kidney disease cor- onset of diabetes. (B) abetic macular edema. (A)
relate with level of kidney function. When c Patients with type 2 diabetes should c The presence of retinopathy is not a
the eGFR is ,60 mL/min/1.73 m2, screen- have an initial dilated and compre- contraindication to aspirin therapy for
ing for complications of CKD is indicated hensive eye examination by an oph- cardioprotection, as this therapy does
(Table 13). Early vaccination against hepa- thalmologist or optometrist shortly not increase the risk of retinal hemor-
titis B is indicated in patients likely to prog- after the diagnosis of diabetes. (B) rhage. (A)
ress to end-stage kidney disease. c Subsequent examinations for type 1
Consider referral to a physician expe- and type 2 diabetic patients should be Diabetic retinopathy is a highly specific
rienced in the care of kidney disease when repeated annually by an ophthalmologist vascular complication of both type 1 and
there is uncertainty about the etiology of or optometrist. Less frequent exams type 2 diabetes, with prevalence strongly
kidney disease (heavy proteinuria, active (every 2–3 years) may be considered related to the duration of diabetes. Di-
urine sediment, absence of retinopathy, following one or more normal eye exams. abetic retinopathy is the most frequent
rapid decline in GFR, resistant hyperten- Examinations will be required more fre- cause of new cases of blindness among
sion). Other triggers for referral may in- quently if retinopathy is progressing. (B) adults aged 20–74 years. Glaucoma, cata-
clude difficult management issues (anemia, c High-quality fundus photographs can racts, and other disorders of the eye occur
secondary hyperparathyroidism, metabolic detect most clinically significant di- earlier and more frequently in people with
bone disease, or electrolyte disturbance) or abetic retinopathy. Interpretation of diabetes.
advanced kidney disease. The threshold for the images should be performed by a In addition to duration of diabetes,
referral may vary depending on the fre- trained eye care provider. While retinal other factors that increase the risk of, or
quency with which a provider encounters photography may serve as a screening are associated with, retinopathy include
diabetic patients with significant kidney tool for retinopathy, it is not a substitute chronic hyperglycemia (365), nephrop-
athy (366), and hypertension (367). In-
Table 12dStages of CKD tensive diabetes management with the
goal of achieving near-normoglycemia
GFR (mL/min/1.73 m2 has been shown in large prospective ran-
Stage Description body surface area) domized studies to prevent and/or delay
the onset and progression of diabetic ret-
1 Kidney damage* with normal or increased GFR $90 inopathy (71,83,84,90). Lowering blood
2 Kidney damage* with mildly decreased GFR 60–89 pressure has been shown to decrease the
3 Moderately decreased GFR 30–59 progression of retinopathy (255), al-
4 Severely decreased GFR 15–29 though tight targets (systolic ,120
5 Kidney failure ,15 or dialysis mmHg) do not impart additional benefit
*Kidney damage defined as abnormalities on pathological, urine, blood, or imaging tests. Adapted from ref. (90). Several case series and a controlled
359. prospective study suggest that pregnancy
S36 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

27. Position Statement
Table 13dManagement of CKD in diabetes risk of development of significant retinop-
athy with a 3-year interval after a normal
GFR Recommended examination (376). Examinations will be
required more frequently if retinopathy is
All patients Yearly measurement of creatinine, urinary albumin excretion, potassium progressing (377).
45–60 Referral to nephrology if possibility for nondiabetic kidney disease exists The use of retinal photography with
(duration of type 1 diabetes ,10 years, heavy proteinuria, abnormal remote reading by experts has great po-
findings on renal ultrasound, resistant hypertension, rapid fall in GFR, tential in areas where qualified eye care
or active urinary sediment on ultrasound) professionals are not available and may
Consider need for dose adjustment of medications also enhance efficiency and reduce costs
Monitor eGFR every 6 months when the expertise of ophthalmologists
Monitor electrolytes, bicarbonate, hemoglobin, calcium, phosphorus, can be utilized for more complex exami-
parathyroid hormone at least yearly nations and for therapy (378). In-person
Assure vitamin D sufficiency exams are still necessary when the photos
Consider bone density testing are unacceptable and for follow-up of ab-
Referral for dietary counseling normalities detected. Photos are not a
30–44 Monitor eGFR every 3 months substitute for a comprehensive eye
Monitor electrolytes, bicarbonate, calcium, phosphorus, parathyroid exam, which should be performed at least
hormone, hemoglobin, albumin, weight every 3–6 months initially and at intervals thereafter as rec-
Consider need for dose adjustment of medications ommended by an eye care professional.
,30 Referral to nephrologist Results of eye examinations should be
Adapted from http://www.kidney.org/professionals/KDOQI/guideline_diabetes/.
documented and transmitted to the refer-
ring health care professional.
in type 1 diabetic patients may aggravate acuity. Recombinant monoclonal neutral-
retinopathy (368,369); laser photocoa- izing antibody to VEGF is a newly ap- D. Neuropathy screening and
gulation surgery can minimize this risk proved therapy that improves vision and treatment
(369). reduces the need for laser photocoa- Recommendations
One of the main motivations for gulation in patients with macular edema c All patients should be screened for distal
screening for diabetic retinopathy is the (372). Other emerging therapies for reti- symmetric polyneuropathy (DPN) start-
long-established efficacy of laser photo- nopathy include sustained intravitreal de- ing at diagnosis of type 2 diabetes and 5
coagulation surgery in preventing visual livery of fluocinolone (373) and the years after the diagnosis of type 1 diabetes
loss. Two large trials, the Diabetic Reti- possibility of prevention with fenofibrate and at least annually thereafter, using
nopathy Study (DRS) in patients with (374,375). simple clinical tests. (B)
PDR and the Early Treatment Diabetic The preventive effects of therapy and c Electrophysiological testing is rarely
Retinopathy Study (ETDRS) in patients the fact that patients with PDR or macular needed, except in situations where the
with macular edema, provide the stron- edema may be asymptomatic provide clinical features are atypical. (E)
gest support for the therapeutic benefits strong support for a screening program c Screening for signs and symptoms of
of photocoagulation surgery. The DRS to detect diabetic retinopathy. As retinop- cardiovascular autonomic neuropathy
(370) showed that panretinal photocoag- athy is estimated to take at least 5 years to (CAN) should be instituted at diagnosis
ulation surgery reduced the risk of severe develop after the onset of hyperglycemia, of type 2 diabetes and 5 years after the
vision loss from PDR from 15.9% in un- patients with type 1 diabetes should have diagnosis of type 1 diabetes. Special
treated eyes to 6.4% in treated eyes, with an initial dilated and comprehensive eye testing is rarely needed and may not
greatest risk-benefit ratio in those with examination within 5 years after the onset affect management or outcomes. (E)
baseline disease (disc neovascularization of diabetes. Patients with type 2 diabetes, c Medications for the relief of specific
or vitreous hemorrhage). who generally have had years of undiag- symptoms related to painful DPN and
The ETDRS (371) established the nosed diabetes and who have a significant autonomic neuropathy are recom-
benefit of focal laser photocoagulation risk of prevalent diabetic retinopathy at mended, as they improve the quality of
surgery in eyes with macular edema, par- time of diabetes diagnosis, should have an life of the patient. (E)
ticularly those with clinically significant initial dilated and comprehensive eye exam-
macular edema, with reduction of dou- ination soon after diagnosis. Examinations The diabetic neuropathies are hetero-
bling of the visual angle (e.g., 20/50 to should be performed by an ophthalmologist geneous with diverse clinical manifesta-
20/100) from 20% in untreated eyes to or optometrist who is knowledgeable and tions. They may be focal or diffuse. Most
8% in treated eyes. The ETDRS also veri- experienced in diagnosing the presence of common among the neuropathies are
fied the benefits of panretinal photocoag- diabetic retinopathy and is aware of its chronic sensorimotor DPN and autonomic
ulation for high-risk PDR and in older- management. Subsequent examinations neuropathy. Although DPN is a diagnosis
onset patients with severe NPDR or less- for type 1 and type 2 diabetic patients are of exclusion, complex investigations to
than-high-risk PDR. generally repeated annually. Less frequent exclude other conditions are rarely needed.
Laser photocoagulation surgery in exams (every 2–3 years) may be cost effec- The early recognition and appropri-
both trials was beneficial in reducing the tive after one or more normal eye exams, ate management of neuropathy in the
risk of further visual loss, but generally not and in a population with well-controlled patient with diabetes is important for a
beneficial in reversing already diminished type 2 diabetes there was essentially no number of reasons: 1) nondiabetic
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S37

28. Position Statement
neuropathies may be present in patients some societies have developed guidelines history of the disease process, but may
with diabetes and may be treatable; 2) a for screening for CAN, the benefits of so- have a positive impact on the quality of
number of treatment options exist for phisticated testing beyond risk stratifica- life of the patient.
symptomatic diabetic neuropathy; 3) up tion are not clear (384).
to 50% of DPN may be asymptomatic and Gastrointestinal neuropathies (e.g.,
patients are at risk for insensate injury to esophageal enteropathy, gastroparesis, E. Foot care
their feet; and 4) autonomic neuropathy, constipation, diarrhea, fecal inconti- Recommendations
and particularly CAN, is associated with nence) are common, and any section of c For all patients with diabetes, perform
substantial morbidity and even mortality. the gastrointestinal tract may be affected. an annual comprehensive foot exami-
Specific treatment for the underlying Gastroparesis should be suspected in in- nation to identify risk factors predictive
nerve damage is currently not available, dividuals with erratic glucose control or of ulcers and amputations. The foot
other than improved glycemic control, with upper gastrointestinal symptoms examination should include inspection,
which may modestly slow progression without other identified cause. Evalua- assessment of foot pulses, and testing for
(89) but not reverse neuronal loss. Effec- tion of solid-phase gastric emptying using loss of protective sensation (LOPS) (10-g
tive symptomatic treatments are available double-isotope scintigraphy may be done monofilament plus testing any one of
for some manifestations of DPN (379) and if symptoms are suggestive, but test re- the following: vibration using 128-Hz
autonomic neuropathy. sults often correlate poorly with symp- tuning fork, pinprick sensation, ankle
toms. Constipation is the most common reflexes, or vibration perception thresh-
Diagnosis of neuropathy lower-gastrointestinal symptom but can old). (B)
DPN. Patients with diabetes should be alternate with episodes of diarrhea. c Provide general foot self-care education
screened annually for DPN using tests Diabetic autonomic neuropathy is to all patients with diabetes. (B)
such as pinprick sensation, vibration per- also associated with genitourinary tract c A multidisciplinary approach is rec-
ception (using a 128-Hz tuning fork), 10-g disturbances. In men, diabetic autonomic ommended for individuals with foot
monofilament pressure sensation at the neuropathy may cause erectile dysfunc- ulcers and high-risk feet, especially
distal plantar aspect of both great toes and tion and/or retrograde ejaculation. Eval- those with a history of prior ulcer or
metatarsal joints, and assessment of ankle uation of bladder dysfunction should be amputation. (B)
reflexes. Combinations of more than one performed for individuals with diabetes c Refer patients who smoke, have LOPS
test have .87% sensitivity in detecting who have recurrent urinary tract infec- and structural abnormalities, or have
DPN. Loss of 10-g monofilament percep- tions, pyelonephritis, incontinence, or a history of prior lower-extremity com-
tion and reduced vibration perception palpable bladder. plications to foot care specialists for
predict foot ulcers (380). Importantly, in ongoing preventive care and lifelong
patients with neuropathy, particularly Symptomatic treatments surveillance. (C)
when severe, causes other than diabetes DPN. The first step in management of c Initial screening for peripheral arterial
should always be considered, such as neu- patients with DPN should be to aim for disease (PAD) should include a history
rotoxic medications, heavy metal poison- stable and optimal glycemic control. Al- for claudication and an assessment of
ing, alcohol abuse, vitamin B12 deficiency though controlled trial evidence is lack- the pedal pulses. Consider obtaining
(especially in those taking metformin for ing, several observational studies suggest an ankle-brachial index (ABI), as many
prolonged periods (381), renal disease, that neuropathic symptoms improve not patients with PAD are asymptom-
chronic inflammatory demyelinating neu- only with optimization of control, but atic. (C)
ropathy, inherited neuropathies, and vas- also with the avoidance of extreme blood c Refer patients with significant claudi-
culitis (382). glucose fluctuations. Patients with painful cation or a positive ABI for further
Diabetic autonomic neuropathy. The DPN may benefit from pharmacological vascular assessment and consider ex-
symptoms and signs of autonomic dys- treatment of their symptoms: many ercise, medications, and surgical op-
function should be elicited carefully dur- agents have confirmed or probable effi- tions. (C)
ing the history and physical examination. cacy confirmed in systematic reviews of
Major clinical manifestations of diabetic RCTs (379), with several U.S. Food and Amputation and foot ulceration, con-
autonomic neuropathy include resting Drug Administration (FDA)-approved for sequences of diabetic neuropathy and/or
tachycardia, exercise intolerance, ortho- the management of painful DPN. PAD, are common and major causes of
static hypotension, constipation, gastro- Treatment of autonomic neuropathy. morbidity and disability in people with
paresis, erectile dysfunction, sudomotor Gastroparesis symptoms may improve diabetes. Early recognition and manage-
dysfunction, impaired neurovascular func- with dietary changes and prokinetic ment of risk factors can prevent or delay
tion, and, potentially, autonomic failure in agents such as metoclopramide or eryth- adverse outcomes.
response to hypoglycemia (383). romycin. Treatments for erectile dysfunc- The risk of ulcers or amputations is
CAN, a CVD risk factor (93), is the tion may include phosphodiesterase type increased in people who have the follow-
most studied and clinically important 5 inhibitors, intracorporeal or intraure- ing risk factors:
form of diabetic autonomic neuropathy. thral prostaglandins, vacuum devices, or
CAN may be indicated by resting tachy- penile prostheses. Interventions for other c Previous amputation
cardia (.100 bpm), orthostasis (a fall in manifestations of autonomic neuropathy c Past foot ulcer history
systolic blood pressure .20 mmHg upon are described in the ADA statement on c Peripheral neuropathy
standing without an appropriate heart neuropathy (380). As with DPN treat- c Foot deformity
rate response); it is also associated with ments, these interventions do not change c Peripheral vascular disease
increased cardiac event rates. Although the underlying pathology and natural c Visual impairment
S38 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

29. Position Statement
c Diabetic nephropathy (especially pa- however, identification of the patient with cannot be accommodated with commercial
tients on dialysis) LOPS can easily be carried out without therapeutic footwear may need custom-
c Poor glycemic control this or other expensive equipment. molded shoes.
c Cigarette smoking Initial screening for PAD should Foot ulcers and wound care may
include a history for claudication and an require care by a podiatrist, orthopedic
assessment of the pedal pulses. A diag- or vascular surgeon, or rehabilitation
Many studies have been published nostic ABI should be performed in any specialist experienced in the management
proposing a range of tests that might patient with symptoms of PAD. Due to of individuals with diabetes. Guidelines
usefully identify patients at risk for foot the high estimated prevalence of PAD in for treatment of diabetic foot ulcers have
ulceration, creating confusion among patients with diabetes and the fact that recently been updated (387).
practitioners as to which screening tests many patients with PAD are asymptom-
should be adopted in clinical practice. An atic, an ADA consensus statement on PAD VII. ASSESSMENT OF
ADA task force was therefore assembled (386) suggested that a screening ABI be COMMON COMORBID
in 2008 to concisely summarize recent performed in patients over 50 years of age CONDITIONS
literature in this area and then recommend and be considered in patients under 50
what should be included in the compre- years of age who have other PAD risk fac- Recommendations
hensive foot exam for adult patients with tors (e.g., smoking, hypertension, hyper- c For patients with risk factors, signs or
diabetes. Their recommendations are sum- lipidemia, or duration of diabetes .10 symptoms, consider assessment and
marized below, but clinicians should refer years). Refer patients with significant treatment for common diabetes-asso-
to the task force report (385) for further symptoms or a positive ABI for further ciated conditions (see Table 14). (B)
details and practical descriptions of how vascular assessment and consider exer-
to perform components of the comprehen- cise, medications, and surgical options In addition to the commonly appre-
sive foot examination. (386). ciated comorbidities of obesity, hyperten-
At least annually, all adults with di- Patients with diabetes and high-risk sion, and dyslipidemia, diabetes is also
abetes should undergo a comprehensive foot conditions should be educated re- associated with other diseases or condi-
foot examination to identify high-risk garding their risk factors and appropriate tions at rates higher than those of age-
conditions. Clinicians should ask about management. Patients at risk should un- matched people without diabetes. A few
history of previous foot ulceration or derstand the implications of the loss of of the more common comorbidities are
amputation, neuropathic or peripheral protective sensation, the importance of described herein and listed in Table 14.
vascular symptoms, impaired vision, to- foot monitoring on a daily basis, the
bacco use, and foot care practices. A proper care of the foot, including nail Hearing impairment
general inspection of skin integrity and and skin care, and the selection of appro- Hearing impairment, both high frequency
musculoskeletal deformities should be priate footwear. Patients with LOPS and low/mid frequency, is more common
done in a well-lit room. Vascular assess- should be educated on ways to substitute in people with diabetes, perhaps due to
ment would include inspection and as- other sensory modalities (hand palpation, neuropathy and/or vascular disease. In an
sessment of pedal pulses. visual inspection) for surveillance of early NHANES analysis, hearing impairment
The neurologic exam recommended foot problems. The patients’ understand- was about twice as great in people with
is designed to identify LOPS rather than ing of these issues and their physical abil- diabetes compared with those without,
early neuropathy. The clinical examina- ity to conduct proper foot surveillance after adjusting for age and other risk
tion to identify LOPS is simple and and care should be assessed. Patients factors for hearing impairment (388).
requires no expensive equipment. Five with visual difficulties, physical con- Controlling for age, race, and other demo-
simple clinical tests (use of a 10-g mono- straints preventing movement, or cogni- graphic factors, high frequency loss in
filament, vibration testing using a 128-Hz tive problems that impair their ability to those with diabetes was significantly asso-
tuning fork, tests of pinprick sensation, assess the condition of the foot and to in- ciated with history of CHD and with pe-
ankle reflex assessment, and testing vi- stitute appropriate responses will need ripheral neuropathy, while low/mid
bration perception threshold with a bio- other people, such as family members, frequency loss was associated with low
thesiometer), each with evidence from to assist in their care. HDL cholesterol and with poor reported
well-conducted prospective clinical co- People with neuropathy or evidence health status (389).
hort studies, are considered useful in the of increased plantar pressure (e.g., ery-
diagnosis of LOPS in the diabetic foot. thema, warmth, callus, or measured
The task force agrees that any of the five pressure) may be adequately managed Table 14dCommon comorbidities for which
tests listed could be used by clinicians to with well-fitted walking shoes or athletic increased risk is associated with diabetes
identify LOPS, although ideally two of shoes that cushion the feet and redistrib-
Hearing impairment
these should be regularly performed dur- ute pressure. Callus can be debrided
Obstructive sleep apnea
ing the screening examdnormally the with a scalpel by a foot care specialist
Fatty liver disease
10-g monofilament and one other test. or other health professional with experi-
Low testosterone in men
One or more abnormal tests would sug- ence and training in foot care. People
Periodontal disease
gest LOPS, while at least two normal tests with bony deformities (e.g., hammer-
Certain cancers
(and no abnormal test) would rule out toes, prominent metatarsal heads, bun-
Fractures
LOPS. The last test listed, vibration as- ions) may need extra-wide or -depth
Cognitive impairment
sessment using a biothesiometer or simi- shoes. People with extreme bony
Depression
lar instrument, is widely used in the U.S.; deformities (e.g., Charcot foot) who
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S39

30. Position Statement
Obstructive sleep apnea analysis (400). Several high-quality RCTs community-dwelling people over the
Age-adjusted rates of obstructive sleep have not shown a significant effect (401). age of 60 years, the presence of diabetes
apnea, a risk factor for CVD, are signifi- at baseline significantly increased the age-
cantly higher (4- to 10-fold) with obesity, Cancer and sex-adjusted incidence of all-cause
especially with central obesity, in men Diabetes (possibly only type 2 diabetes) is dementia, Alzheimer disease, and vascu-
and women (390). The prevalence in gen- associated with increased risk of cancers lar dementia compared with rates in those
eral populations with type 2 diabetes may of the liver, pancreas, endometrium, co- with normal glucose tolerance (410). In a
be up to 23% (391), and in obese partic- lon/rectum, breast, and bladder (402). substudy of the ACCORD study, there
ipants enrolled in the Look AHEAD trial The association may result from shared were no differences in cognitive outcomes
exceeded 80% (392). Treatment of sleep risk factors between type 2 diabetes and between intensive and standard glycemic
apnea significantly improves quality of cancer (obesity, age, and physical inactiv- control, although there was significantly
life and blood pressure control. The evi- ity) but may also be due to hyperinsuline- less of a decrement in total brain volume
dence for a treatment effect on glycemic mia or hyperglycemia (401,403). Patients by magnetic resonance imaging in partic-
control is mixed (393). with diabetes should be encouraged ipants in the intensive arm (411). The ef-
to undergo recommended age- and sex- fects of hyperglycemia and insulin on the
Fatty liver disease appropriate cancer screenings and to re- brain are areas of intense research interest.
Unexplained elevation of hepatic trans- duce their modifiable cancer risk factors
aminase concentrations is significantly (obesity, smoking, and physical inactivity). Depression
associated with higher BMI, waist circum- As discussed in Section V.H, depression is
ference, triglycerides, and fasting insulin, Fractures highly prevalent in people with diabetes
and with lower HDL cholesterol. Type 2 Age-matched hip fracture risk is signifi- and is associated with worse outcomes.
diabetes and hypertension are indepen- cantly increased in both type 1 (summary
dently associated with transaminase ele- RR 6.3) and type 2 diabetes (summary RR VIII. DIABETES CARE IN
vations in women (394). In a prospective 1.7) in both sexes (404). Type 1 diabetes SPECIFIC POPULATIONS
analysis, diabetes was significantly associ- is associated with osteoporosis, but in
ated with incident nonalcoholic chronic type 2 diabetes an increased risk of hip A. Children and adolescents
liver disease and with hepatocellular car- fracture is seen despite higher bone min- Recommendations
cinoma (395). Interventions that improve eral density (BMD) (405). One study c As is the case for all children, children
metabolic abnormalities in patients with showed that prevalent vertebral fractures with diabetes or prediabetes should be
diabetes (weight loss, glycemic control, were significantly more common in men encouraged to engage in at least 60 min
treatment with specific drugs for hyper- and women with type 2 diabetes, but of physical activity each day. (B)
glycemia or dyslipidemia) are also benefi- were not associated with BMD (406). In
cial for fatty liver disease (396). three large observational studies of older 1. Type 1 diabetes
adults, femoral neck BMD T-score and Three-quarters of all cases of type 1 di-
Low testosterone in men the WHO fracture risk algorithm abetes are diagnosed in individuals ,18
Mean levels of testosterone are lower in (FRAX) score were associated with hip years of age. It is appropriate to consider
men with diabetes compared with age- and nonspine fracture, although fracture the unique aspects of care and manage-
matched men without diabetes, but risk was higher in diabetic participants ment of children and adolescents with
obesity is a major confounder (397). The compared with participants without dia- type 1 diabetes. Children with diabetes
issue of treatment in asymptomatic men is betes for a given T-score and age or for a differ from adults in many respects, in-
controversial. The evidence for effects of tes- given FRAX score risk (407). It is appro- cluding changes in insulin sensitivity re-
tosterone replacement on outcomes is priate to assess fracture history and risk lated to sexual maturity and physical
mixed, and recent guidelines suggest that factors in older patients with diabetes and growth, ability to provide self-care, super-
screening and treatment of men without recommend BMD testing if appropriate vision in child care and school, and
symptoms are not recommended (398). for the patient’s age and sex. For at-risk unique neurologic vulnerability to hypo-
patients, it is reasonable to consider stan- glycemia and DKA. Attention to such is-
Periodontal disease dard primary or secondary prevention sues as family dynamics, developmental
Periodontal disease is more severe, but strategies (reduce risk factors for falls, en- stages, and physiological differences re-
not necessarily more prevalent, in pa- sure adequate calcium and vitamin D in- lated to sexual maturity are all essential
tients with diabetes than those without take, avoid use of medications that lower in developing and implementing an opti-
(399). Numerous studies have suggested BMD, such as glucocorticoids), and to con- mal diabetes regimen. Although recom-
associations with poor glycemic control, sider pharmacotherapy for high-risk pa- mendations for children and adolescents
nephropathy, and CVD, but most studies tients. For patients with type 2 diabetes are less likely to be based on clinical trial
are highly confounded. A comprehensive with fracture risk factors, avoiding use of evidence, expert opinion and a review of
assessment, and treatment of identified thiazolidinediones is warranted. available and relevant experimental data
disease, is indicated in patients with dia- are summarized in the ADA statement on
betes, but the evidence that periodontal Cognitive impairment care of children and adolescents with type
disease treatment improves glycemic con- Diabetes is associated with significantly 1 diabetes (412).
trol is mixed. A meta-analysis reported a increased risk of cognitive decline, a Ideally, the care of a child or adoles-
significant 0.47% improvement in A1C, greater rate of cognitive decline, and cent with type 1 diabetes should be pro-
but noted multiple problems with the qual- increased risk of dementia (408,409). vided by a multidisciplinary team of
ity of the published studies included in the In a 15-year prospective study of a specialists trained in the care of children
S40 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

31. Position Statement
with pediatric diabetes. At the very least, against the risks of hypoglycemia and the should be confirmed on at least three
education of the child and family should developmental burdens of intensive regi- separate days. Normal blood pressure
be provided by health care providers mens in children and youth. Age-specific levels for age, sex, and height and appro-
trained and experienced in childhood glycemic and A1C goals are presented in priate methods for determinations are
diabetes and sensitive to the challenges Table 15. available online at www.nhlbi.nih.gov/
posed by diabetes in this age-group. It is health/prof/heart/hbp/hbp_ped.pdf.
essential that DSME, MNT, and psycho- b. Screening and management
social support be provided at the time of of chronic complications in iii. Dyslipidemia
diagnosis and regularly thereafter by in- children and adolescents Recommendations
dividuals experienced with the educational, with type 1 diabetes Screening
nutritional, behavioral, and emotional needs i. Nephropathy c If there is a family history of hypercho-
of the growing child and family. It is Recommendations lesterolemia or a cardiovascular event
expected that the balance between adult c Annual screening for microalbuminuria,
before age 55 years, or if family history is
supervision and self-care should be defined with a random spot urine sample for unknown, then consider obtaining a
and that it will evolve with physical, psy- albumin-to-creatinine ratio, should be fasting lipid profile on children .2 years
chological, and emotional maturity. considered once the child is 10 years of of age soon after diagnosis (after glucose
age and has had diabetes for 5 years. (B) control has been established). If family
a. Glycemic control c Treatment with an ACE inhibitor, ti-
history is not of concern, then consider
Recommendations trated to normalization of albumin ex- the first lipid screening at puberty ($10
c Consider age when setting glycemic years of age). For children diagnosed
cretion, should be considered when
goals in children and adolescents with elevated albumin-to-creatinine ratio is with diabetes at or after puberty, con-
type 1 diabetes. (E) subsequently confirmed on two addi- sider obtaining a fasting lipid profile
tional specimens from different days. (E) soon after the diagnosis (after glucose
While current standards for diabetes control has been established). (E)
management reflect the need to lower ii. Hypertension c For both age-groups, if lipids are ab-
glucose as safely possible, special consid- Recommendations normal, annual monitoring is reason-
eration should be given to the unique c Blood pressure should be measured at able. If LDL cholesterol values are within
risks of hypoglycemia in young children. each routine visit. Children found to the accepted risk levels (,100 mg/dL
Glycemic goals may need to be modified have high-normal blood pressure or [2.6 mmol/L]), a lipid profile repeated
to take into account the fact that most hypertension should have blood pres- every 5 years is reasonable. (E)
children ,6 or 7 years of age have a form sure confirmed on a separate day. (B) Treatment
of “hypoglycemic unawareness,” includ- c Initial treatment of high-normal blood c Initial therapy may consist of optimi-
ing immaturity and a relative inability to pressure (systolic or diastolic blood pres- zation of glucose control and MNT
recognize and respond to hypoglycemic sure consistently above the 90th percen- using a Step 2 AHA diet aimed at a
symptoms, placing them at greater risk tile for age, sex, and height) includes decrease in the amount of saturated fat
for severe hypoglycemia and its sequelae. dietary intervention and exercise, aimed in the diet. (E)
In addition, and unlike the case in type 1 at weight control and increased physical c After the age of 10 years, the addition
diabetic adults, young children below the activity, if appropriate. If target blood of a statin in patients who, after MNT
age of 5 years may be at risk for perma- pressure is not reached with 3–6 months and lifestyle changes, have LDL choles-
nent cognitive impairment after episodes of lifestyle intervention, pharmacological terol .160 mg/dL (4.1 mmol/L), or LDL
of severe hypoglycemia (413–415). Fur- treatment should be considered. (E) cholesterol .130 mg/dL (3.4 mmol/L)
thermore, the DCCT demonstrated that c Pharmacological treatment of hyperten- and one or more CVD risk factors, is
near-normalization of blood glucose lev- sion (systolic or diastolic blood pressure reasonable. (E)
els was more difficult to achieve in ado- consistently above the 95th percentile for c The goal of therapy is an LDL choles-
lescents than adults. Nevertheless, the age, sex, and height or consistently terol value ,100 mg/dL (2.6 mmol/L). (E)
increased frequency of use of basal-bolus .130/80 mmHg, if 95% exceeds that
regimens and insulin pumps in youth value) should be considered as soon as People diagnosed with type 1 diabetes
from infancy through adolescence has the diagnosis is confirmed. (E) in childhood have a high risk of early
been associated with more children c ACE inhibitors should be considered subclinical (420–422) and clinical (423)
reaching ADA blood glucose targets for the initial treatment of hypertension, CVD. Although intervention data are
(416,417) in those families in which following appropriate reproductive lacking, the AHA categorizes children
both parents and the child with diabetes counseling due to its potential terato- with type 1 diabetes in the highest tier
participate jointly to perform the re- genic effects. (E) for cardiovascular risk and recommends
quired diabetes-related tasks. Further- c The goal of treatment is a blood pres- both lifestyle and pharmacological treat-
more, recent studies documenting sure consistently ,130/80 or below ment for those with elevated LDL choles-
neurocognitive sequelae of hyperglyce- the 90th percentile for age, sex, and terol levels (424,425). Initial therapy
mia in children provide another compel- height, whichever is lower. (E) should be with a Step 2 AHA diet, which
ling motivation for achieving glycemic restricts saturated fat to 7% of total calo-
targets (418,419). It is important that blood pressure ries and restricts dietary cholesterol to
In selecting glycemic goals, the bene- measurements are determined correctly, 200 mg/day. Data from randomized clin-
fits on long-term health outcomes of using the appropriate size cuff, and with ical trials in children as young as 7 months
achieving a lower A1C should be balanced the child seated and relaxed. Hypertension of age indicate that this diet is safe and
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S41

32. Position Statement
Table 15dPlasma blood glucose and A1C goals for type 1 diabetes by age-group
Plasma blood glucose goal
range (mg/dL)
Before Bedtime/
Values by age (years) meals overnight A1C Rationale
Toddlers and preschoolers (0–6) 100–180 110–200 ,8.5% c Vulnerability to hypoglycemia
c Insulin sensitivity
c Unpredictability in dietary intake and physical activity
c A lower goal (,8.0%) is reasonable if it can be
achieved without excessive hypoglycemia
School age (6–12) 90–180 100–180 ,8% c Vulnerability of hypoglycemia
c A lower goal (,7.5%) is reasonable if it can be
achieved without excessive hypoglycemia
Adolescents and young adults (13–19) 90–130 90–150 ,7.5% c A lower goal (,7.0%) is reasonable if it can be
achieved without excessive hypoglycemia
Key concepts in setting glycemic goals:
c Goals should be individualized and lower goals may be reasonable based on benefit-risk assessment.
c Blood glucose goals should be modified in children with frequent hypoglycemia or hypoglycemia unawareness.
c Postprandial blood glucose values should be measured when there is a discrepancy between preprandial blood glucose values and A1C
levels and to help assess glycemia in those on basal/bolus regimens.
does not interfere with normal growth should be made to eye care professionals individuals compared with 0.3–1% in the
and development (426,427). with expertise in diabetic retinopathy, an general population) (432,433). Symptoms
Neither long-term safety nor cardio- understanding of the risk for retinopathy of celiac disease include diarrhea, weight
vascular outcome efficacy of statin therapy in the pediatric population, and experi- loss or poor weight gain, growth failure,
has been established for children. How- ence in counseling the pediatric patient abdominal pain, chronic fatigue, malnutri-
ever, recent studies have shown short-term and family on the importance of early pre- tion due to malabsorption, and other
safety equivalent to that seen in adults and vention/intervention. gastrointestinal problems, and unexplained
efficacy in lowering LDL cholesterol levels, hypoglycemia or erratic blood glucose con-
improving endothelial function and caus- v. Celiac disease centrations.
ing regression of carotid intimal thickening Recommendations Screening for celiac disease includes
(428–430). No statin is approved for use c Consider screening children with type measuring serum levels of tissue trans-
under the age of 10 years, and statin treat- 1 diabetes for celiac disease by measuring glutaminase or antiendomysial antibodies,
ment should generally not be used in chil- tissue transglutaminase or antiendomysial then small bowel biopsy in antibody-
dren with type 1 diabetes prior to this age. antibodies, with documentation of nor- positive children. Recent European guide-
For postpubertal girls, issues of pregnancy mal total serum IgA levels, soon after the lines on screening for celiac disease in
prevention are paramount, since statins are diagnosis of diabetes. (E) children (not specific to children with type
category X in pregnancy. See Section VIII.B c Testing should be considered in chil- 1 diabetes) suggested that biopsy might
for more information. dren with growth failure, failure to gain not be necessary in symptomatic children
weight, weight loss, diarrhea, flatulence, with positive antibodies, as long as further
iv. Retinopathy abdominal pain, or signs of malabsorp- testing such as genetic or HLA testing was
Recommendations tion or in children with frequent un- supportive, but that asymptomatic but at-
c The first ophthalmologic examination explained hypoglycemia or deterioration risk children should have biopsies (434).
should be obtained once the child is in glycemic control. (E) One small study that included children
$10 years of age and has had diabetes c Consider referral to a gastroenterolo- with and without type 1 diabetes sugges-
for 3–5 years. (B) gist for evaluation with possible en- ted that antibody-positive but biopsy-neg-
c After the initial examination, annual doscopy and biopsy for confirmation of ative children were similar clinically to
routine follow-up is generally recom- celiac disease in asymptomatic children those who were biopsy positive and that
mended. Less frequent examinations with positive antibodies. (E) biopsy-negative children had benefits
may be acceptable on the advice of an c Children with biopsy-confirmed celiac from a gluten-free diet but worsening on a
eye care professional. (E) disease should be placed on a gluten- usual diet (435). Because this study was
free diet and have consultation with a small and because children with type 1 di-
Although retinopathy (like albuminuria) dietitian experienced in managing both abetes already need to follow a careful diet,
most commonly occurs after the onset of diabetes and celiac disease. (B) it is difficult to advocate for not confirming
puberty and after 5–10 years of diabetes the diagnosis by biopsy before recommend-
duration (431), it has been reported in Celiac disease is an immune-mediated dis- ing a lifelong gluten-free diet, especially in
prepubertal children and with diabetes order that occurs with increased frequency asymptomatic children. In symptomatic
duration of only 1–2 years. Referrals in patients with type 1 diabetes (1–16% of children with type 1 diabetes and celiac
S42 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

33. Position Statement
disease, gluten-free diets reduce symptoms school and day care setting (442) for fur- families (http://www.endo-society.org/
and rates of hypoglycemia (436). ther discussion. clinicalpractice/transition_of_care.cfm).
vi. Hypothyroidism e. Transition from pediatric to adult 2. Type 2 diabetes
Recommendations care The incidence of type 2 diabetes in ado-
c Consider screening children with type Recommendations lescents is increasing, especially in ethnic
1 diabetes for thyroid peroxidase and c As teens transition into emerging minority populations (31). Distinction
thyroglobulin antibodies soon after adulthood, health care providers and between type 1 and type 2 diabetes in
diagnosis. (E) families must recognize their many children can be difficult, since the preva-
c Measuring thyroid-stimulating hor- vulnerabilities (B) and prepare the de- lence of overweight in children continues
mone (TSH) concentrations soon after veloping teen, beginning in early to to rise and since autoantigens and ketosis
diagnosis of type 1 diabetes, after me- mid adolescence and at least 1 year may be present in a substantial number of
tabolic control has been established, prior to the transition. (E) patients with features of type 2 diabetes
is reasonable. If normal, consider re- c Both pediatricians and adult health (including obesity and acanthosis nigri-
checking every 1–2 years, especially if care providers should assist in pro- cans). Such a distinction at the time of
the patient develops symptoms of thy- viding support and links to resources diagnosis is critical because treatment reg-
roid dysfunction, thyromegaly, or an for the teen and emerging adult. (B) imens, educational approaches, and die-
abnormal growth rate. (E) tary counsel will differ markedly between
Care and close supervision of diabetes the two diagnoses.
Autoimmune thyroid disease is the most management is increasingly shifted from Type 2 diabetes has a significant in-
common autoimmune disorder associ- parents and other older adults through- cidence of comorbidities already present
ated with diabetes, occurring in 17–30% out childhood and adolescence. How- at the time of diagnosis (448). It is recom-
of patients with type 1 diabetes (437). ever, the shift from pediatrics to adult mended that blood pressure measurement,
About one-quarter of type 1 diabetic chil- health care providers often occurs very a fasting lipid profile, microalbuminuria as-
dren have thyroid autoantibodies at the abruptly as the older teen enters the next sessment, and dilated eye examination be
time of diagnosis of their diabetes (438), developmental stage referred to as emerg- performed at the time of diagnosis. There-
and the presence of thyroid autoantibod- ing adulthood (443), a critical period for after, screening guidelines and treatment
ies is predictive of thyroid dysfunction, young people who have diabetes; during recommendations for hypertension, dysli-
generally hypothyroidism but less com- this period of major life transitions, youth pidemia, microalbuminuria, and retinopa-
monly hyperthyroidism (439). Subclini- begin to move out of their parents’ home thy in youth with type 2 diabetes are similar
cal hypothyroidism may be associated and must become more fully responsible to those for youth with type 1 diabetes. Ad-
with increased risk of symptomatic hypo- for their diabetes care including the many ditional problems that may need to be ad-
glycemia (440) and with reduced linear aspects of self management, making med- dressed include polycystic ovarian disease
growth (441). Hyperthyroidism alters ical appointments, and financing health and the various comorbidities associated
glucose metabolism, potentially resulting care once they are no longer covered un- with pediatric obesity such as sleep apnea,
in deterioration of metabolic control. der their parents’ health insurance hepatic steatosis, orthopedic complica-
(444,445). In addition to lapses in health tions, and psychosocial concerns. The
c. Self-management care, this is also a period of deterioration ADA consensus statement on this subject
No matter how sound the medical regi- in glycemic control, increased occurrence (33) provides guidance on the prevention,
men, it can only be as good as the ability of acute complications, psycho-social- screening, and treatment of type 2 diabetes
of the family and/or individual to imple- emotional-behavioral issues, and emergence and its comorbidities in young people.
ment it. Family involvement in diabetes of chronic complications (444–447).
remains an important component of opti- Though scientific evidence continues 3. Monogenic diabetes syndromes
mal diabetes management throughout to be limited, it is clear that early and Monogenic forms of diabetes (neonatal
childhood and adolescence. Health care ongoing attention be given to compre- diabetes or maturity-onset diabetes of the
providers who care for children and adoles- hensive and coordinated planning for young) represent a small fraction of chil-
cents, therefore, must be capable of seamless transition of all youth from dren with diabetes (,5%), but the ready
evaluating the educational, behavioral, emo- pediatric to adult health care (444,445). availability of commercial genetic testing
tional, and psychosocial factors that impact A comprehensive discussion regarding is now enabling a true genetic diagnosis
implementation of a treatment plan and the challenges faced during this period, with increasing frequency. It is important
must work with the individual and family to including specific recommendations, is to correctly diagnose one of the mono-
overcome barriers or redefine goals as ap- found in the ADA position statement “Di- genic forms of diabetes, as these children
propriate. abetes Care for Emerging Adults: Recom- may be incorrectly diagnosed with type 1
mendations for Transition From Pediatric or type 2 diabetes, leading to nonoptimal
d. School and day care to Adult Diabetes Care Systems” (445). treatment regimens and delays in diag-
Since a sizable portion of a child’s day is The National Diabetes Education Pro- nosing other family members.
spent in school, close communication gram (NDEP) has materials available to The diagnosis of monogenic diabetes
with and cooperation of school or day facilitate the transition process (http://ndep should be considered in the following
care personnel is essential for optimal di- .nih.gov/transitions/), and The Endocrine settings: diabetes diagnosed within the
abetes management, safety, and maximal Society (in collaboration with the ADA first 6 months of life; in children with
academic opportunities. See the ADA po- and other organizations has developed strong family history of diabetes but with-
sition statement on diabetes care in the transition tools for clinicians and youth/ out typical features of type 2 diabetes
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S43

34. Position Statement
(nonobese, low-risk ethnic group); in chil- participated in preconception diabetes number may be relatively or absolutely
dren with mild fasting hyperglycemia (100– care programs and women who initiated contraindicated during pregnancy. Sta-
150 mg/dL [5.5–8.5 mmol]), especially if intensive diabetes management after they tins are category X (contraindicated for
young and nonobese; and in children with were already pregnant. The preconcep- use in pregnancy) and should be discon-
diabetes but with negative autoantibodies tion care programs were multidisciplinary tinued before conception, as should ACE
without signs of obesity or insulin resis- and designed to train patients in diabetes inhibitors (450). ARBs are category C
tance. A recent international consensus self-management with diet, intensified (risk cannot be ruled out) in the first tri-
document discusses in further detail the di- insulin therapy, and SMBG. Goals were mester but category D (positive evidence
agnosis and management of children with set to achieve normal blood glucose con- of risk) in later pregnancy and should
monogenic forms of diabetes (449). centrations, and .80% of subjects ach- generally be discontinued before preg-
ieved normal A1C concentrations before nancy. Since many pregnancies are un-
B. Preconception care they became pregnant. In all five studies, planned, health care professionals caring
Recommendations the incidence of major congenital malfor- for any woman of childbearing potential
c A1C levels should be as close to normal mations in women who participated in should consider the potential risks and
as possible (,7%) in an individual pa- preconception care (range 1.0–1.7% of benefits of medications that are contrain-
tient before conception is attempted. (B) infants) was much lower than the inci- dicated in pregnancy. Women using med-
c Starting at puberty, preconception dence in women who did not participate ications such as statins or ACE inhibitors
counseling should be incorporated in (range 1.4–10.9% of infants) (106). One need ongoing family planning counsel-
the routine diabetes clinic visit for all limitation of these studies is that partici- ing. Among the oral antidiabetic agents,
women of childbearing potential. (C) pation in preconception care was self- metformin and acarbose are classified as
c Women with diabetes who are con- selected rather than randomized. Thus, category B (no evidence of risk in hu-
templating pregnancy should be eval- it is impossible to be certain that the lower mans) and all others as category C. Poten-
uated and, if indicated, treated for malformation rates resulted fully from tial risks and benefits of oral antidiabetic
diabetic retinopathy, nephropathy, improved diabetes care. Nonetheless, agents in the preconception period must
neuropathy, and CVD. (B) the evidence supports the concept that be carefully weighed, recognizing that
c Medications used by such women malformations can be reduced or preven- data are insufficient to establish the safety
should be evaluated prior to conception, ted by careful management of diabetes be- of these agents in pregnancy.
since drugs commonly used to treat di- fore pregnancy. For further discussion of preconcep-
abetes and its complications may be Planned pregnancies greatly facilitate tion care, see the ADA’s consensus state-
contraindicated or not recommended in preconception diabetes care. Unfortu- ment on pre-existing diabetes and
pregnancy, including statins, ACE in- nately, nearly two-thirds of pregnancies pregnancy (106) and the position state-
hibitors, ARBs, and most noninsulin in women with diabetes are unplanned, ment (451) on this subject.
therapies. (E) leading to a persistent excess of malfor-
c Since many pregnancies are unplanned, mations in infants of diabetic mothers. To
consider the potential risks and benefits minimize the occurrence of these devas- C. Older adults
of medications that are contraindicated tating malformations, standard care for all Recommendations
in pregnancy in all women of child- women with diabetes who have child- c Older adults who are functional, cog-
bearing potential and counsel women bearing potential, beginning at the onset nitively intact, and have significant life
using such medications accordingly. (E) of puberty or at diagnosis, should include expectancy should receive diabetes
1) education about the risk of malforma- care with goals similar to those de-
Major congenital malformations re- tions associated with unplanned pregnan- veloped for younger adults. (E)
main the leading cause of mortality and cies and poor metabolic control and 2) c Glycemic goals for some older adults
serious morbidity in infants of mothers use of effective contraception at all times, might reasonably be relaxed, using in-
with type 1 and type 2 diabetes. Obser- unless the patient has good metabolic dividual criteria, but hyperglycemia
vational studies indicate that the risk of control and is actively trying to conceive. leading to symptoms or risk of acute
malformations increases continuously Women contemplating pregnancy hyperglycemic complications should
with increasing maternal glycemia during need to be seen frequently by a multidis- be avoided in all patients. (E)
the first 6–8 weeks of gestation, as defined ciplinary team experienced in the man- c Other cardiovascular risk factors
by first-trimester A1C concentrations. agement of diabetes before and during should be treated in older adults with
There is no threshold for A1C values be- pregnancy. The goals of preconception consideration of the time frame of
low which risk disappears entirely. How- care are to 1) involve and empower the benefit and the individual patient.
ever, malformation rates above the 1–2% patient in the management of her diabe- Treatment of hypertension is indicated
background rate of nondiabetic pregnan- tes, 2) achieve the lowest A1C test results in virtually all older adults, and lipid
cies appear to be limited to pregnancies in possible without excessive hypoglycemia, and aspirin therapy may benefit those
which first-trimester A1C concentrations 3) assure effective contraception until sta- with life expectancy at least equal to the
are .1% above the normal range for a ble and acceptable glycemia is achieved, time frame of primary or secondary
nondiabetic pregnant woman. and 4) identify, evaluate, and treat long- prevention trials. (E)
Preconception care of diabetes ap- term diabetes complications such as c Screening for diabetes complications
pears to reduce the risk of congenital retinopathy, nephropathy, neuropathy, should be individualized in older
malformations. Five nonrandomized hypertension, and CHD (106). adults, but particular attention should
studies compared rates of major malfor- Among the drugs commonly used in be paid to complications that would
mations in infants between women who the treatment of patients with diabetes, a lead to functional impairment. (E)
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35. Position Statement
Diabetes is an important health condi- reducing the risk of microvascular com- screening test for CFRD is not recom-
tion for the aging population; at least 20% plications and more likely to suffer seri- mended. (B)
of patients over the age of 65 years have ous adverse effects from hypoglycemia. c During a period of stable health, the
diabetes, and this number can be expected However, patients with poorly controlled diagnosis of CFRD can be made in
to grow rapidly in the coming decades. diabetes may be subject to acute compli- cystic fibrosis patients according to
Older individuals with diabetes have cations of diabetes, including dehydration, usual glucose criteria. (E)
higher rates of premature death, functional poor wound healing, and hyperglycemic c Patients with CFRD should be treated
disability, and coexisting illnesses such as hyperosmolar coma. Glycemic goals with insulin to attain individualized
hypertension, CHD, and stroke than those at a minimum should avoid these conse- glycemic goals. (A)
without diabetes. Older adults with diabe- quences. c Annual monitoring for complications
tes are also at greater risk than other older Although control of hyperglycemia of diabetes is recommended, beginning
adults for several common geriatric syn- may be important in older individuals 5 years after the diagnosis of CFRD. (E)
dromes, such as polypharmacy, depres- with diabetes, greater reductions in mor-
sion, cognitive impairment, urinary bidity and mortality may result from CFRD is the most common comorbidity
incontinence, injurious falls, and persistent control of other cardiovascular risk fac- in persons with cystic fibrosis, occurring
pain. tors rather than from tight glycemic con- in about 20% of adolescents and 40–50%
A consensus report on diabetes and trol alone. There is strong evidence from of adults. The additional diagnosis of di-
older adults (452) influenced the follow- clinical trials of the value of treating abetes in this population is associated
ing discussion and recommendations. hypertension in the elderly (453,454). with worse nutritional status, more severe
The care of older adults with diabetes is There is less evidence for lipid-lowering inflammatory lung disease, and greater
complicated by their clinical and func- and aspirin therapy, although the benefits mortality from respiratory failure. Insulin
tional heterogeneity. Some older individ- of these interventions for primary and insufficiency related to partial fibrotic de-
uals developed diabetes years earlier and secondary prevention are likely to apply struction of the islet mass is the primary
may have significant complications; oth- to older adults whose life expectancies defect in CFRD. Genetically determined
ers who are newly diagnosed may have equal or exceed the time frames seen in function of the remaining b-cells and in-
had years of undiagnosed diabetes with clinical trials. sulin resistance associated with infection
resultant complications or may have truly Special care is required in prescribing and inflammation may also play a role.
recent-onset disease and few or no com- and monitoring pharmacological therapy Encouraging new data suggest that early
plications. Some older adults with diabe- in older adults. Costs may be a significant detection and aggressive insulin therapy
tes are frail and have other underlying factor, especially since older adults tend have narrowed the gap in mortality be-
chronic conditions, substantial diabetes- to be on many medications. Metformin tween cystic fibrosis patients with and
related comorbidity, or limited physical may be contraindicated because of renal without diabetes and have eliminated
or cognitive functioning. Other older in- insufficiency or significant heart failure. the sex difference in mortality (455).
dividuals with diabetes have little comor- Thiazolidinediones, if used at all, should Recommendations for the clinical
bidity and are active. Life expectancies are be used very cautiously in those with, or management of CFRD can be found in
highly variable for this population, but at risk for, CHF and have also been the recent ADA position statement on this
often longer than clinicians realize. Pro- associated with fractures. Sulfonylureas, topic (456).
viders caring for older adults with diabe- other insulin secretagogues, and insulin
tes must take this heterogeneity into can cause hypoglycemia. Insulin use re- IX. DIABETES CARE IN
consideration when setting and prioritiz- quires that patients or caregivers have good SPECIFIC SETTINGS
ing treatment goals. visual and motor skills and cognitive abil-
There are few long-term studies in ity. Dipeptidyl peptidase 4 (DPP-4) inhib- A. Diabetes care in the hospital
older adults demonstrating the benefits of itors have few side effects, but their costs Recommendations
intensive glycemic, blood pressure, and may be a barrier to some older patients; the c All patients with diabetes admitted to the
lipid control. Patients who can be latter is also the case for GLP-1 agonists. hospital should have their diabetes clearly
expected to live long enough to reap the Screening for diabetes complications identified in the medical record. (E)
benefits of long-term intensive diabetes in older adults also should be individual- c All patients with diabetes should have
management, who have good cognitive ized. Particular attention should be paid an order for blood glucose monitoring,
and functional function, and who choose to complications that can develop over with results available to all members of
to do so via shared decision making may short periods of time and/or that would the health care team. (E)
be treated using therapeutic interventions significantly impair functional status, c Goals for blood glucose levels:
and goals similar to those for younger such as visual and lower-extremity com- c Critically ill patients: Insulin ther-
adults with diabetes. As with all patients, plications. apy should be initiated for treatment
DSME and ongoing DSMS are vital com- of persistent hyperglycemia starting
ponents of diabetes care for older adults at a threshold of no greater than 180
and their caregivers. D. Cystic fibrosis–related diabetes mg/dL (10 mmol/L). Once insulin
For patients with advanced diabetes Recommendations therapy is started, a glucose range of
complications, life-limiting comorbid ill- c Annual screening for cystic fibrosis– 140–180 mg/dL (7.8–10 mmol/L) is
ness, or substantial cognitive or func- related diabetes (CFRD) with OGTT recommended for the majority of
tional impairment, it is reasonable to set should begin by age 10 years in all pa- critically ill patients. (A)
less intensive glycemic target goals. These tients with cystic fibrosis who do not c More stringent goals, such as 110–
patients are less likely to benefit from have CFRD (B). Use of A1C as a 140 mg/dL (6.1–7.8 mmol/L) may be
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S45

36. Position Statement
appropriate for selected patients, as previously undiagnosed diabetes, or hos- mortality was significantly higher in
long as this can be achieved without pital-related hyperglycemia (fasting the intensive versus the conventional
significant hypoglycemia. (C) blood glucose $126 mg/dL or random group in both surgical and medical pa-
c Critically ill patients require an intrave- blood glucose $200 mg/dL occurring tients, as was mortality from cardiovascu-
nous insulin protocol that has demon- during the hospitalization that reverts to lar causes. Severe hypoglycemia was also
strated efficacy and safety in achieving normal after hospital discharge). The dif- more common in the intensively treated
the desired glucose range without in- ficulty distinguishing between the second group (6.8% vs. 0.5%, P , 0.001). The
creasing risk for severe hypoglycemia. (E) and third categories during the hospitali- precise reason for the increased mortality
c Non–critically ill patients: There is no zation may be overcome by measuring an in the tightly controlled group is un-
clear evidence for specific blood glucose A1C in undiagnosed patients with hyper- known. The results of this study lie in
goals. If treated with insulin, the pre- glycemia, as long as conditions interfering stark contrast to a famous 2001 single-
meal blood glucose targets generally with A1C utility (hemolysis, blood trans- center study that reported a 42% relative
,140 mg/dL (7.8 mmol/L) with ran- fusion) have not occurred. The manage- reduction in intensive care unit (ICU)
dom blood glucose ,180 mg/dL (10.0 ment of hyperglycemia in the hospital has mortality in critically ill surgical patients
mmol/L) are reasonable, provided often been considered secondary in im- treated to a target blood glucose of 80–110
these targets can be safely achieved. portance to the condition that prompted mg/dL (458). Importantly, the control
More stringent targets may be appro- admission (457). However, a body of lit- group in NICE-SUGAR had reasonably
priate in stable patients with previous erature now supports targeted glucose good blood glucose management, main-
tight glycemic control. Less stringent control in the hospital setting for poten- tained at a mean glucose of 144 mg/dL,
targets may be appropriate in those tial improved clinical outcomes. Hyper- only 29 mg/dL above the intensively man-
with severe comorbidities. (E) glycemia in the hospital may result from aged patients. Accordingly, this study’s
c Scheduled subcutaneous insulin with stress, decompensation of type 1 or type 2 findings do not disprove the notion that
basal, nutritional, and correction com- or other forms of diabetes, and/or may be glycemic control in the ICU is important.
ponents is the preferred method for iatrogenic due to withholding of antihy- However, they do strongly suggest that it
achieving and maintaining glucose con- perglycemic medications or administra- may not be necessary to target blood glu-
trol in non–critically ill patients. (C) tion of hyperglycemia-provoking agents cose values ,140 mg/dL and that a highly
c Glucose monitoring should be initiated such as glucocorticoids or vasopressors. stringent target of ,110 mg/dL may actu-
in any patient not known to be diabetic There is substantial observational ev- ally be dangerous.
who receives therapy associated with idence linking hyperglycemia in hospital- In a recent meta-analysis of 26 trials
high risk for hyperglycemia, including ized patients (with or without diabetes) to (N 5 13,567), which included the NICE-
high-dose glucocorticoid therapy, initi- poor outcomes. Cohort studies as well SUGAR data, the pooled RR of death with
ation of enteral or parenteral nutrition, as a few early RCTs suggested that in- intensive insulin therapy was 0.93 as
or other medications such as octreotide tensive treatment of hyperglycemia im- compared with conventional therapy
or immunosuppressive medications. (B) proved hospital outcomes (457–459). In (95% CI 0.83–1.04) (465). Approxi-
If hyperglycemia is documented and general, these studies were heterogeneous mately half of these trials reported hypo-
persistent, consider treating such pa- in terms of patient population, blood glu- glycemia, with a pooled RR of intensive
tients to the same glycemic goals as pa- cose targets and insulin protocols used, therapy of 6.0 (95% CI 4.5–8.0). The
tients with known diabetes. (E) provision of nutritional support, and the specific ICU setting influenced the find-
c A hypoglycemia management protocol proportion of patients receiving insulin, ings, with patients in surgical ICUs ap-
should be adopted and implemented which limits the ability to make meaning- pearing to benefit from intensive insulin
by each hospital or hospital system. A ful comparisons among them. Recent tri- therapy (RR 0.63, 95% CI 0.44–0.91),
plan for preventing and treating hypo- als in critically ill patients have failed to whereas those in other medical and
glycemia should be established for each show a significant improvement in mor- mixed critical care settings did not. It
patient. Episodes of hypoglycemia in tality with intensive glycemic control was concluded that, overall, intensive in-
the hospital should be documented in (460,461) or have even shown increased sulin therapy increased the risk of hypo-
the medial record and tracked. (E) mortality risk (462). Moreover, these re- glycemia but provided no overall benefit
c Consider obtaining an A1C on patients cent RCTs have highlighted the risk of on mortality in the critically ill,
with diabetes admitted to the hospital if severe hypoglycemia resulting from such although a possible mortality benefit to
the result of testing in the previous 2–3 efforts (460–465). patients admitted to the surgical ICU was
months is not available. (E) The largest study to date, NICE- suggested.
c Consider obtaining an A1C in patients SUGAR (Normoglycaemia in Intensive
with risk factors for undiagnosed di- Care Evaluation and Survival Using Glu- 1. Glycemic targets in hospitalized
abetes who exhibit hyperglycemia in cose Algorithm Regulation), a multicen- patients
the hospital. (E) ter, multinational RCT, compared the
c Patients with hyperglycemia in the effect of intensive glycemic control (target Definition of glucose abnormalities in
hospital who do not have a prior di- 81–108 mg/dL, mean blood glucose at- the hospital setting
agnosis of diabetes should have ap- tained 115 mg/dL) to standard glycemic Hyperglycemia in the hospital has been
propriate plans for follow-up testing control (target 144–180 mg/dL, mean defined as any blood glucose .140 mg/dL
and care documented at discharge. (E) blood glucose attained 144 mg/dL) on (7.8 mmol/L). Levels that are significantly
outcomes among 6,104 critically ill par- and persistently above this may require
Hyperglycemia in the hospital can re- ticipants, almost all of whom required me- treatment in hospitalized patients. A1C
present previously known diabetes, chanical ventilation (462). Ninety-day values .6.5% suggest, in undiagnosed
S46 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

37. Position Statement
patients, that diabetes preceded hospitali- glucose values are ,70 mg/dL (3.9 specific clinical settings including paren-
zation (466). Hypoglycemia has been de- mmol/L), unless the event is easily ex- teral nutrition (476), enteral tube feedings
fined as any blood glucose ,70 mg/dL plained by other factors (such as a missed and with high dose glucocorticoid therapy
(3.9 mmol/L). This is the standard defini- meal). There is some evidence that system- (468).
tion in outpatients and correlates with the atic attention to hyperglycemia in the There are no data on the safety and
initial threshold for the release of counter- emergency room leads to better glycemic efficacy of oral agents and injectable non-
regulatory hormones. Severe hypoglyce- control in the hospital for those subse- insulin therapies such as GLP-1 analogs
mia in hospitalized patients has been de- quently admitted (471). and pramlintide in the hospital. They are
fined by many as ,40 mg/dL (2.2 mmol/L), Occasional patients with a prior his- generally considered to have a limited role
although this is lower than the ;50 mg/dL tory of successful tight glycemic control in in the management of hyperglycemia in
(2.8 mmol/L) level at which cognitive im- the outpatient setting who are clinically conjunction with acute illness. Continu-
pairment begins in normal individuals stable may be maintained with a glucose ation of these agents may be appropriate
(467). As with hyperglycemia, hypoglyce- range below the above cut points. Con- in selected stable patients who are
mia among inpatients is also associated versely, higher glucose ranges may be expected to consume meals at regular
with adverse short- and long-term out- acceptable in terminally ill patients or in intervals, and they may be initiated or
comes. Early recognition and treatment patients with severe comorbidities, as well resumed in anticipation of discharge once
of mild to moderate hypoglycemia (40– as in those in patient care settings where the patient is clinically stable. Specific
69 mg/dL [2.2–3.8 mmol/L]) can prevent frequent glucose monitoring or close caution is required with metformin, due
deterioration to a more severe episode nursing supervision is not feasible. to the possibility that a contraindication
with potential adverse sequelae (468). Clinical judgment, combined with may develop during the hospitalization,
ongoing assessment of the patient’s clini- such as renal insufficiency, unstable he-
Critically ill patients cal status, including changes in the trajec- modynamic status, or need for an imaging
Based on the weight of the available tory of glucose measures, the severity of study that requires a radio-contrast dye.
evidence, for the majority of critically ill illness, nutritional status, or concurrent
patients in the ICU setting, insulin infusion use of medications that might affect glu- 3. Preventing hypoglycemia
should be used to control hyperglycemia, cose levels (e.g., steroids, octreotide), In the hospital, multiple risk factors for
with a starting threshold of no higher than must be incorporated into the day-to- hypoglycemia are present. Patients with
180 mg/dL (10.0 mmol/L). Once intrave- day decisions regarding insulin dosing or without diabetes may experience hy-
nous insulin is started, the glucose level (468). poglycemia in the hospital in association
should be maintained between 140 and with altered nutritional state, heart fail-
180 mg/dL (7.8 and 10.0 mmol/L). Greater 2. Antihyperglycemic agents in ure, renal or liver disease, malignancy,
benefit maybe realized at the lower end of hospitalized patients infection, or sepsis. Additional triggering
this range. Although strong evidence is In the hospital setting, insulin therapy is events leading to iatrogenic hypoglycemia
lacking, somewhat lower glucose targets the preferred method of glycemic control include sudden reduction of corticoste-
may be appropriate in selected patients. in majority of clinical situations (468). In roid dose, altered ability of the patient to
One small study suggested that medical the ICU, intravenous infusion is the pre- report symptoms, reduction of oral in-
intensive care unit (MICU) patients treated ferred route of insulin administration. take, emesis, new NPO status, inappro-
to targets of 120–140 mg/dL had less neg- When the patient is transitioned off intra- priate timing of short- or rapid-acting
ative nitrogen balance than those treated to venous insulin to subcutaneous therapy, insulin in relation to meals, reduction of
higher targets (469). However, targets precautions should be taken to prevent rate of administration of intravenous dex-
,110 mg/dL (6.1 mmol/L) are not recom- hyperglycemia escape (472,473). Outside trose, and unexpected interruption of
mended. Use of insulin infusion protocols of critical care units, scheduled subcuta- enteral feedings or parenteral nutrition.
with demonstrated safety and efficacy, re- neous insulin that delivers basal, nutri- Despite the preventable nature of many
sulting in low rates of hypoglycemia, are tional, and correction (supplemental) inpatient episodes of hypoglycemia, insti-
highly recommended (468). components is preferred. Typical dosing tutions are more likely to have nursing
schemes are based on body weight, with protocols for the treatment of hypoglyce-
Non–critically ill patients some evidence that patients with renal in- mia than for its prevention. Tracking such
With no prospective RCT data to inform sufficiency should be treated with lower episodes and analyzing their causes are
specific glycemic targets in non–critically doses (474). Prolonged therapy with important quality-improvement activities
ill patients, recommendations are based sliding-scale insulin (SSI) as the sole (468).
on clinical experience and judgment regimen is ineffective in the majority of
(470). For the majority of non–critically patients, increases risk of both hypogly- 4. Diabetes care providers in the
ill patients treated with insulin, premeal cemia and hyperglycemia, and has re- hospital
glucose targets should generally be ,140 cently been shown in a randomized trial Inpatient diabetes management may be
mg/dL (7.8 mmol/L) with random blood to be associated with adverse outcomes in effectively championed and/or provided
glucose ,180 mg/dL (10.0 mmol/L), as general surgery patients with type 2 diabe- by primary care physicians, endocrinolo-
long as these targets can be safely achieved. tes (475). SSI is potentially dangerous in gists, intensivists, or hospitalists. Involve-
To avoid hypoglycemia, consideration type 1 diabetes (468). The reader is referred ment of appropriately trained specialists
should be given to reassessing the insulin to several recent publications and reviews or specialty teams may reduce length of
regimen if blood glucose levels fall below that describe currently available insulin stay, improve glycemic control, and im-
100 mg/dL (5.6 mmol/L). Modification of preparations and protocols and provide prove outcomes (468). In the care of di-
the regimen is required when blood guidance in use of insulin therapy in abetes, implementation of standardized
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S47

38. Position Statement
order sets for scheduled and correction- treatment goals, physiological parame- hematocrit and for interfering substances.
dose insulin may reduce reliance on ters, and medication usage. Consistent Any glucose result that does not correlate
sliding-scale management. As hospitals carbohydrate meal plans are preferred with the patient’s status should be con-
move to comply with “meaningful use” by many hospitals because they facilitate firmed through conventional laboratory
regulations for electronic health records, matching the prandial insulin dose to the sampling of plasma glucose. The FDA
as mandated by the Health Information amount of carbohydrate consumed (481). has become increasingly concerned about
Technology Act, efforts should be made Because of the complexity of nutrition is- the use of POC blood glucose meters in
to assure that all components of struc- sues in the hospital, a registered dietitian, the hospital and is presently reviewing
tured insulin order sets are incorporated knowledgeable and skilled in MNT, matters related to their use.
into electronic insulin order sets (477,478). should serve as an inpatient team mem-
A team approach is needed to estab- ber. The dietitian is responsible for inte- 8. Discharge planning and DSME
lish hospital pathways. To achieve glyce- grating information about the patient’s Transition from the acute care setting is a
mic targets associated with improved clinical condition, eating, and lifestyle high-risk time for all patients, not just those
hospital outcomes, hospitals will need habits and for establishing treatment with diabetes or new hyperglycemia. Al-
multidisciplinary support to develop in- goals in order to determine a realistic though there is an extensive literature
sulin management protocols that effec- plan for nutrition therapy (482,483). concerning safe transition within and
tively and safely enable achievement of from the hospital, little of it is specific to
glycemic targets (479). 7. Bedside blood glucose monitoring diabetes (490). It is important to remember
POC blood glucose monitoring per- that diabetes discharge planning is not a
5. Self-management in the hospital formed at the bedside is used to guide separate entity, but is part of an overall dis-
Self-management of diabetes in the hos- insulin dosing. In the patient who is charge plan. As such, discharge planning
pital may be appropriate for competent receiving nutrition, the timing of glucose begins at admission to the hospital and is
adult patients who have a stable level of monitoring should match carbohydrate updated as projected patient needs change.
consciousness, have reasonably stable exposure. In the patient who is not re- Inpatients may be discharged to var-
daily insulin requirements, successfully ceiving nutrition, glucose monitoring is ied settings, including home (with or
conduct self-management of diabetes at performed every 4 to 6 h (484,485). More without visiting nurse services), assisted
home, have physical skills needed to frequent blood glucose testing ranging living, rehabilitation, or skilled nursing
successfully self-administer insulin and from every 30 min to every 2 h is required facilities. The latter two sites are generally
perform SMBG, have adequate oral in- for patients on intravenous insulin infusions. staffed by health professionals, so diabe-
take, and are proficient in carbohydrate Safety standards should be estab- tes discharge planning will be limited to
counting, use of multiple daily insulin lished for blood glucose monitoring pro- communication of medication and diet
injections or insulin pump therapy, and hibiting sharing of finger-stick lancing orders. For the patient who is discharged
sick-day management. The patient and devices, lancets, needles, and meters to to assisted living or to home, the optimal
physician, in consultation with nursing reduce the risk of transmission of blood program will need to consider the type
staff, must agree that patient self- borne diseases. Shared lancing devices carry and severity of diabetes, the effects of the
management is appropriate under the essentially the same risk as is conferred from patient’s illness on blood glucose levels,
conditions of hospitalization. sharing of syringes and needles (486). and the capacities and desires of the pa-
Patients who use CSII pump therapy Accuracy of blood glucose measure- tient. Smooth transition to outpatient care
in the outpatient setting can be candidates ments using POC meters has limitations should be ensured. The Agency for Health-
for diabetes self-management in the hos- that must be considered. Although the care Research and Quality (AHRQ) recom-
pital, provided that they have the mental FDA allows a 1/2 20% error for blood mends that at a minimum, discharge plans
and physical capacity to do so (468). A glucose meters, questions about the ap- include the following:
hospital policy and procedures delineat- propriateness of these criteria have been
ing inpatient guidelines for CSII therapy raised (388). Glucose measures differ sig- c Medication reconciliation: The pa-
are advisable, and availability of hospital nificantly between plasma and whole tient’s medications must be cross-
personnel with expertise in CSII therapy blood, terms that are often used inter- checked to ensure that no chronic
is essential. It is important that nursing changeably and can lead to misinterpre- medications were stopped and to en-
personnel document basal rates and bolus tation. Most commercially available sure the safety of new prescriptions.
doses taken on a regular basis (at least capillary blood glucose meters introduce a c Whenever possible, prescriptions for
daily). correction factor of ;1.12 to report a new or changed medication should be
“plasma-adjusted” value (487). filled and reviewed with the patient and
6. MNT in the hospital Significant discrepancies between family at or before discharge.
The goals of MNT are to optimize glyce- capillary, venous, and arterial plasma c Structured discharge communication:
mic control, to provide adequate calories samples have been observed in patients Information on medication changes,
to meet metabolic demands, and to with low or high hemoglobin concentra- pending tests and studies, and follow-up
create a discharge plan for follow-up tions, hypoperfusion, and the presence of needs must be accurately and promptly
care (457,480). The ADA does not en- interfering substances particularly communicated to outpatient physicians.
dorse any single meal plan or specified maltose, as contained in immunoglobu- c Discharge summaries should be trans-
percentages of macronutrients, and the lins (488). Analytical variability has been mitted to the primary physician as soon
term “ADA diet” should no longer be described with several POC meters (489). as possible after discharge.
used. Current nutrition recommenda- Increasingly newer generation POC blood c Appointment keeping behavior is
tions advise individualization based on glucose meters correct for variation in enhanced when the inpatient team
S48 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

39. Position Statement
schedules outpatient medical follow- order to avoid a potentially dangerous impaired consciousness or cognition may
up prior to discharge. Ideally the in- hiatus in care. These supplies/prescrip- lead to drivers being evaluated for fitness to
patient care providers or case managers/ tions should include the following: drive. For diabetes, this typically arises
discharge planners will schedule fol- when the person has had a hypoglycemic
low-up visit(s) with the appropriate c Insulin (vials or pens) if needed episode behind the wheel, even if this did
professionals, including the primary c Syringes or pen needles (if needed) not lead to a motor vehicle accident.
care provider, endocrinologist, and di- c Oral medications (if needed) Epidemiological and simulator data
abetes educator (491). c Blood glucose meter and strips suggest that people with insulin-treated
c Lancets and lancing device diabetes have a small increase in risk of
Teaching diabetes self-management to c Urine ketone strips (type 1) motor vehicle accidents, primarily due to
patients in hospitals is a challenging task. c Glucagon emergency kit (insulin-treated) hypoglycemia and decreased awareness
Patients are ill, under increased stress related c Medical alert application/charm of hypoglycemia. This increase (RR 1.12–
to their hospitalization and diagnosis, and 1.19) is much smaller than the risks asso-
in an environment not conducive to learn- More expanded diabetes education can ciated with teenage male drivers (RR 42),
ing. Ideally, people with diabetes should be be arranged in the community. An out- driving at night (RR 142), driving on rural
taught at a time and place conducive to patient follow-up visit with the primary roads compared with urban roads (RR
learning: as an outpatient in a recognized care provider, endocrinologist, or diabetes 9.2), and obstructive sleep apnea (RR
program of diabetes education. For the educator within 1 month of discharge is 2.4), all of which are accepted for unre-
hospitalized patient, diabetes “survival advised for all patients having hyperglyce- stricted licensure.
skills” education is generally a feasible ap- mia in the hospital. Clear communication The ADA position statement on di-
proach to provide sufficient information with outpatient providers either directly or abetes and driving (493) recommends
and training to enable safe care at home. via hospital discharge summaries facilitates against blanket restrictions based on the
Patients hospitalized because of a crisis re- safe transitions to outpatient care. Provid- diagnosis of diabetes and urges individual
lated to diabetes management or poor care ing information regarding the cause or the assessment by a health care professional
at home need education to prevent subse- plan for determining the cause of hyper- knowledgeable in diabetes if restrictions
quent episodes of hospitalization. An as- glycemia, related complications and co- on licensure are being considered. Pa-
sessment of the need for a home health morbidities, and recommended treatments tients should be evaluated for decreased
referral or referral to an outpatient diabetes can assist outpatient providers as they awareness of hypoglycemia, hypoglyce-
education program should be part of dis- assume ongoing care. mia episodes while driving, or severe hy-
charge planning for all patients. poglycemia. Patients with retinopathy or
DSME cannot wait until discharge, B. Diabetes and employment peripheral neuropathy require assess-
especially in those new to insulin ther- Any person with diabetes, whether in- ment to determine if those complications
apy or in whom the diabetes regimen has sulin treated or noninsulin treated, interfere with operation of a motor vehi-
been substantially altered during the should be eligible for any employment cle. Health care professionals should be
hospitalization. for which he/she is otherwise qualified. cognizant of the potential risk of driving
It is recommended that the following Employment decisions should never be with diabetes and counsel their patients
areas of knowledge be reviewed and based on generalizations or stereotypes about detecting and avoiding hypoglyce-
addressed prior to hospital discharge: regarding the effects of diabetes. When mia while driving.
questions arise about the medical fitness
c Identification of health care provider of a person with diabetes for a particular D. Diabetes management in
who will provide diabetes care after job, a health care professional with ex- correctional institutions
discharge pertise in treating diabetes should per- People with diabetes in correctional facil-
c Level of understanding related to the form an individualized assessment. See ities should receive care that meets na-
diagnosis of diabetes, SMBG, and ex- the ADA position statement on diabetes tional standards. Because it is estimated
planation of home blood glucose goals and employment (492). that nearly 80,000 inmates have diabetes,
c Definition, recognition, treatment, and correctional institutions should have
prevention of hyperglycemia and hy- C. Diabetes and driving written policies and procedures for the
poglycemia A large percentage of people with diabetes management of diabetes and for training
c Information on consistent eating in the U.S. and elsewhere seek a license to of medical and correctional staff in di-
patterns drive, either for personal or employment abetes care practices. See the ADA posi-
c When and how to take blood glucose– purposes. There has been considerable de- tion statement on diabetes management
lowering medications including insulin bate whether, and the extent to which, in correctional institutions (494) for fur-
administration (if going home on in- diabetes may be a relevant factor in de- ther discussion.
sulin) termining the driver ability and eligibility
c Sick-day management for a license. X. STRATEGIES FOR
c Proper use and disposal of needles and People with diabetes are subject to a IMPROVING DIABETES CARE
syringes great variety of licensing requirements ap-
plied by both state and federal jurisdic- Recommendations
It is important that patients be pro- tions, which may lead to loss of c Care should be aligned with compo-
vided with appropriate durable medical employment or significant restrictions nents of the Chronic Care Model
equipment, medication, supplies, and on a person’s license. Presence of a medical (CCM) to ensure productive inter-
prescriptions at the time of discharge in condition that can lead to significantly actions between a prepared proactive
care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S49

40. Position Statement
practice team and an informed acti- six core elements for the provision of op- weight management, effective coping),
vated patient. (A) timal care of patients with chronic dis- b) disease self-management (medication
c When feasible, care systems should ease: 1) delivery system design (moving taking and management; self-monitoring
support team-based care, community from a reactive to a proactive care delivery of glucose and blood pressure when clin-
involvement, patient registries, and system where planned visits are coordi- ically appropriate), and c) prevention of
embedded decision support tools to nated through a team based approach), diabetes complications (self-monitoring
meet patient needs. (B) 2) self-management support, 3) decision of foot health; active participation in
c Treatment decisions should be timely support (basing care on evidence-based, screening for eye, foot, and renal compli-
and based on evidence-based guide- effective care guidelines), 4) clinical infor- cations; immunizations). High-quality
lines that are tailored to individual mation systems (using registries that can DSME has been shown to improve patient
patient preferences, prognoses, and provide patient-specific and population- self-management, satisfaction, and glu-
comorbidities. (B) based support to the care team), 5) cose control (184,516), as has delivery
c A patient-centered communication community resources and policies (iden- of ongoing DSMS so that gains achieved
style should be employed that in- tifying or developing resources to support during DSME are sustained (134,135,152).
corporates patient preferences, assesses healthy lifestyles), and 6) health systems National DSME standards call for an
literacy and numeracy, and addresses (to create a quality-oriented culture). Re- integrated approach that includes clinical
cultural barriers to care. (B) definition of the roles of the clinic staff content and skills, behavioral strategies
and promoting self-management on the (goal-setting, problem solving), and ad-
There has been steady improvement in the part of the patient are fundamental to dressing emotional concerns in each
proportion of diabetic patients achieving the successful implementation of the needed curriculum content area.
recommended levels of A1C, blood pres- CCM (501). Collaborative, multidisci-
sure, and LDL cholesterol in the last 10 plinary teams are best suited to provide Objective 3: Change the system
years, both in primary care settings and in such care for people with chronic of care
endocrinology practices. Mean A1C na- conditions such as diabetes and to facili- The most successful practices have an in-
tionally has declined from 7.82% in 1999– tate patients’ performance of appropriate stitutional priority for providing high qual-
2000 to 7.18% in 2004 based on NHANES self-management (163,165,220,502). ity of care (517). Changes that have been
data (495). This has been accompanied by NDEP maintains an online resource shown to increase quality of diabetes care
improvements in lipids and blood pressure (www.betterdiabetescare.nih.gov) to help include basing care on evidence-based
control and led to substantial reductions in health care professionals design and im- guidelines (518), expanding the role of
end-stage microvascular complications in plement more effective health care deliv- teams and staff (501,519), redesigning the
those with diabetes. Nevertheless in some ery systems for those with diabetes. Three processes of care (520), implementing elec-
studies only 57.1% of adults with diag- specific objectives, with references to lit- tronic health record tools (521,522), acti-
nosed diabetes achieved an A1C of ,7%, erature that outlines practical strategies to vating and educating patients (523,524),
only 45.5% had a blood pressure ,130/80 achieve each, are outlined below. and identifying and/or developing and en-
mmHg, and just 46.5% had a total choles- gaging community resources and public
terol ,200 mg/dL, with only 12.2% of Objective 1: Optimize provider and policy that support healthy lifestyles
people with diabetes achieving all three team behavior (525). Recent initiatives such as the
treatment goals (496). Evidence also sug- The care team should prioritize timely and Patient-Centered Medical Home show
gests that progress in risk factor control appropriate intensification of lifestyle and/ promise to improve outcomes through co-
may be slowing (497). Certain patient or pharmaceutical therapy of patients who ordinated primary care and offer new op-
groups, such as patients with complex co- have not achieved beneficial levels of blood portunities for team-based chronic disease
morbidities, financial or other social hard- pressure, lipid, or glucose control (503). care (526). Alterations in reimbursement
ships, and/or limited English proficiency, Strategies such as explicit goal setting that reward the provision of appropriate
may present particular challenges to goal- with patients (504); identifying and ad- and high-quality care rather than visit-
based care (498,499). Persistent variation dressing language, numeracy, or cultural based billing (527) and that can accommo-
in quality of diabetes care across providers barriers to care (505–508); integrating evi- date the need to personalize care goals may
and across practice settings even after ad- dence-based guidelines and clinical infor- provide additional incentives to improve
justing for patient factors indicates that mation tools into the process of care diabetes care (528).
there remains potential for substantial fur- (509–511); and incorporating care manage- It is clear that optimal diabetes man-
ther improvements in diabetes care. ment teams including nurses, pharmacists, agement requires an organized, system-
Although numerous interventions to and other providers (512–515) have each atic approach and involvement of a
improve adherence to the recommended been shown to optimize provider and team coordinated team of dedicated health
standards have been implemented, a ma- behavior and thereby catalyze reduction in care professionals working in an environ-
jor barrier to optimal care is a delivery A1C, blood pressure, and LDL cholesterol. ment where patient-centered high-quality
system that too often is fragmented, lacks care is a priority.
clinical information capabilities, often Objective 2: Support patient behavior
duplicates services, and is poorly de- change References
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an ambulatory population. Diabetes
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Prevalence of diabetes and high risk for cidence of type 2 diabetes with lifestyle Steinrauf H, et al.; Type 1 Diabetes
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2010;33:562–568 24. Tuomilehto J, Lindström J, Eriksson JG, preservation of beta-cell function. N
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a Group. Prevention of type 2 diabetes 35. Orban T, Bundy B, Becker DJ, et al.;
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35:1648–1653 25. Pan XR, Li GW, Hu YH, et al. Effects of onset type 1 diabetes: a randomised,
13. Expert Committee on the Diagnosis and diet and exercise in preventing NIDDM double-blind, placebo-controlled trial.
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1197 Preservation of pancreatic beta-cell diabetes mellitus among a racially/
14. Genuth S, Alberti KG, Bennett P, et al.; function and prevention of type 2 di- ethnically diverse population of preg-
Expert Committee on the Diagnosis abetes by pharmacological treatment of nant women, 1999-2005. Diabetes Care
and Classification of Diabetes Mellitus. insulin resistance in high-risk Hispanic 2008;31:899–904
Follow-up report on the diagnosis of women. Diabetes 2002;51:2796–2803 37. Metzger BE, Lowe LP, Dyer AR, et al.;
diabetes mellitus. Diabetes Care 2003; 27. Chiasson JL, Josse RG, Gomis R, HAPO Study Cooperative Research
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42. Position Statement
and Pregnancy Study Groups Consensus intervention: follow-up of the Finnish 59. O’Kane MJ, Bunting B, Copeland M,
Panel. International association of di- Diabetes Prevention Study. Lancet 2006; Coates VE; ESMON Study Group. Effi-
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39. O’Sullivan EP, Avalos G, O’Reilly M, abetes incidence and weight loss in the 1177
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using new diagnostic criteria. Diabetologia search Group. The cost-effectiveness of glucose in patients with non-insulin
2011;54:1670–1675 lifestyle modification or metformin in treated type 2 diabetes: economic eval-
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Eunice Kennedy Shriver National In- 52. Ackermann RT, Finch EA, Brizendine E, II, Dekker JM, Nijpels G, Bot SD. Self-
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42. Crowther CA, Hiller JE, Moss JR, and weight loss associated with metfor- chemistry. Position statement executive
McPhee AJ, Jeffries WS, Robinson JS; min in the Diabetes Prevention Program summary: guidelines and recommenda-
Australian Carbohydrate Intolerance
Outcomes Study. Diabetes Care 2012; tions for laboratory analysis in the di-
Study in Pregnant Women (ACHOIS)
35:731–737 agnosis and management of diabetes
Trial Group. Effect of treatment of ges-
54. DREAM Trial Investigators. Incidence of mellitus. Diabetes Care 2011;34:1419–
tational diabetes mellitus on pregnancy
diabetes following ramipril or rosiglita- 1423
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zone withdrawal. Diabetes Care 2011; 64. Wang J, Zgibor J, Matthews JT, Charron-
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34:1265–1269 Prochownik D, Sereika SM, Siminerio L.
43. Committee on Obstetric Practice. Com-
55. Ratner RE, Christophi CA, Metzger BE, Self-monitoring of blood glucose is as-
mittee opinion no. 504: screening and
et al.; Diabetes Prevention Program Re- sociated with problem-solving skills in
diagnosis of gestational diabetes melli-
tus. Obstet Gynecol 2011;118:751–753 search Group. Prevention of diabetes in hyperglycemia and hypoglycemia. Di-
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69. Slover RH, Welsh JB, Criego A, et al. Interventions and Complications Re- intensive glucose lowering in type 2 di-
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the ACCORD, ADVANCE, and VA Di-
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1163 85. Holman RR, Paul SK, Bethel MA,
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75. Al-Ansary L, Farmer A, Hirst J, et al. Matthews DR, Neil HA. 10-year follow-
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78. Rohlfing CL, Wiedmeyer HM, Little RR, 89. Ismail-Beigi F, Craven T, Banerji MA, et al. The association between symp-
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44. Position Statement
J Diabetes Complications 2011;25:355– (EASD). Diabetes Care 2012;35:1364– with a registered dietitian improves
361 1379 short-term clinical outcomes for rural
100. Turnbull FM, Abraira C, Anderson RJ, 112. Bennett WL, Maruthur NM, Singh S, Kentucky patients with chronic diseases.
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diabetes mellitus: implications of recent rected titration for achieving glycaemic DASH Collaborative Research Group. A
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554–559 analogue: an assessment of two different terns on blood pressure. N Engl J Med
102. American Diabetes Association. Post- fasting plasma glucose targets–the 1997;336:1117–1124
prandial blood glucose. Diabetes Care TITRATE study. Diabetes Obes Metab 125. Franz MJ, VanWormer JJ, Crain AL, et al.
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long-term simvastatin treatment. Circu- S78 2082–2090
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45. Position Statement
lifestyle modification for the prevention Fatty Acids, Cholesterol, Protein, and controlled diabetes. Arch Intern Med
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diabetes. N Engl J Med 2008;358:580– of intensive blood-pressure control in high-risk hypertensive patients ran-
591 type 2 diabetes mellitus. N Engl J Med domized to angiotensin-converting en-
249. Ford ES. Trends in the risk for coronary 2010;362:1575–1585 zyme inhibitor or calcium channel
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255. UK Prospective Diabetes Study Group. Randomized Trial (FACET) in patients Endpoint reduction in hypertension
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278. Sibai BM. Treatment of hypertension in with atorvastatin in type 2 diabetes in 299. Boden WE, Probstfield JL, Anderson T,
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54. Position Statement
Endocrine Society, the International Pediatric Endocrine Society. Diabetes medical intensive care unit patients:
Society for Pediatric and Adolescent Care 2010;33:2697–2708 a randomized, controlled study. Crit
Diabetes, Juvenile Diabetes Research 457. Clement S, Braithwaite SS, Magee MF, Care 2012;16:R56
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2485 458. van den Berghe G, Wouters P, Weekers guideline. J Clin Endocrinol Metab
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gitudinal cohort study. Diabetes Care Rydén L. Glycometabolic state at ad- emergency department: a randomized
2001;24:1536–1540 mission: important risk marker of mor- trial using insulins aspart and detemir
447. Laing SP, Jones ME, Swerdlow AJ, tality in conventionally treated patients compared with usual care. J Hosp Med
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448. Eppens MC, Craig ME, Cusumano J, (DIGAMI) study. Circulation 1999;99: discontinuation of an intensive insulin
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Care 2006;29:1300–1306 in critically ill adults: a meta-analysis. Conversion from intravenous insulin to
449. Hattersley A, Bruining J, Shield J, JAMA 2008;300:933–944 subcutaneous insulin after cardiovascu-
Njolstad P, Donaghue KC. The diagnosis 461. Brunkhorst FM, Engel C, Bloos F, et al.; lar surgery: Transition to Target study.
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pentastarch resuscitation in severe sep- 474. Baldwin D, Zander J, Munoz C, et al. A
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462. Finfer S, Chittock DR, Su SY, et al.;
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tensive versus conventional glucose
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S78 2262–2267 agement of patients with type 2 diabetes
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453. Curb JD, Pressel SL, Cutler JA, et al.; 449–461 476. Pasquel FJ, Spiegelman R, McCauley M,
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in older diabetic patients with isolated study data. CMAJ 2009;180:821–827 477. Schnipper JL, Liang CL, Ndumele CD,
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55. Position Statement
health care institutions. Diabetes Care 494. American Diabetes Association. Diabetes disparities in diabetes medication ad-
2004;27(Suppl. 1):S55–S57 management in correctional institutions. herence. J Health Commun 2011;16
481. Curll M, Dinardo M, Noschese M, Diabetes Care 2011;34(Suppl. 1):S75–S81 (Suppl. 3):268–278
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tent carbohydrate meal plans in hospi- 2008;31:81–86 in a diabetes disease-management pro-
talised patients with diabetes. Qual Saf 496. Cheung BM, Ong KL, Cherny SS, Sham gram. Diabetes Educ 2004;30:263–273
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483. Boucher JL, Swift CS, Franz MJ, et al. term and recent progress in blood pres- 510. Garg AX, Adhikari NK, McDonald H, et al.
Inpatient management of diabetes and sure levels among U.S. adults with Effects of computerized clinical decision
diagnosed diabetes, 1988-2008. Dia- support systems on practitioner perfor-
hyperglycemia: implications for nutri-
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tion practice and the food and nutrition
498. Kerr EA, Heisler M, Krein SL, et al. Be- review. JAMA 2005;293:1223–1238
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485. Umpierrez GE. Basal versus sliding-scale cemic control among insured Latinos domized trial of the effect of community
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487. D’Orazio P, Burnett RW, Fogh-Andersen 501. Coleman K, Austin BT, Brach C, Wagner with diabetes mellitus: a systematic review.
N, et al.; International Federation of EH. Evidence on the Chronic Care Pharmacotherapy 2008;28:421–436
Clinical Chemistry Scientific Division Model in the new millennium. Health Aff 514. Davidson MB, Ansari A, Karlan VJ. Effect
Working Group on Selective Electrodes (Millwood) 2009;28:75–85 of a nurse-directed diabetes disease
and Point of Care Testing. Approved 502. Parchman ML, Zeber JE, Romero RR, management program on urgent care/
IFCC recommendation on reporting re- Pugh JA. Risk of coronary artery disease emergency room visits and hospital-
sults for blood glucose (abbreviated). in type 2 diabetes and the delivery of care izations in a minority population. Di-
Clin Chem 2005;51:1573–1576 consistent with the chronic care model abetes Care 2007;30:224–227
488. Dungan K, Chapman J, Braithwaite SS, in primary care settings: a STARNet 515. Stone RA, Rao RH, Sevick MA, et al.
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lack of timely, appropriate clinical deci- controlled trial. Diabetes Care 2010;33:
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489. Boyd JC, Bruns DE. Quality specifica-
504. Grant RW, Pabon-Nau L, Ross KM, 516. Berikai P, Meyer PM, Kazlauskaite R,
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simulation modeling of errors in insulin
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dose. Clin Chem 2001;47:209–214 intensification: patient views compared agement targets is associated with better
490. Shepperd S, McClaran J, Phillips CO, with current treatment guidelines. Di- glycemic control. Diabetes Care 2007;
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491. Agency for Healthcare Research and cation with diabetic patients who have ment strategies on the management of
Quality. Adverse events after hospital low health literacy. Arch Intern Med diabetes: a systematic review and meta-
discharge [article online]. Available from 2003;163:83–90 analysis. Lancet 2012;379:2252–2261
http://psnet.ahrq.gov/primer.aspx?pri- 506. Rosal MC, Ockene IS, Restrepo A, et al. 518. O’Connor PJ, Bodkin NL, Fradkin J,
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492. American Diabetes Association. Diabetes culturally tailored diabetes self- current status and future directions. Di-
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34(Suppl. 1):S82–S86 income Latinos: Latinos en Control. 519. Peikes D, Chen A, Schore J, Brown R.
493. American Diabetes Association. Diabetes Diabetes Care 2011;34:838–844 Effects of care coordination on hospi-
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56. Position Statement
beneficiaries: 15 randomized trials. 523. Battersby M, Von Korff M, Schaefer J, in North Carolina. J Public Health
JAMA 2009;301:603–618 et al. Twelve evidence-based principles Manag Pract 2008;14(Suppl.):S73–S81
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ferent paths to high-quality care: three support in primary care. Jt Comm J Qual centered medical home and diabetes.
archetypes of top-performing practice Patient Saf 2010;36:561–570 Diabetes Care 2011;34:1047–1053
sites. Ann Fam Med 2007;5:233–241 524. Grant RW, Wald JS, Schnipper JL, et al. 527. Rosenthal MB, Cutler DM, Feder J. The
521. Cebul RD, Love TE, Jain AK, Hebert CJ. Practice-linked online personal health ACO rulesdstriking the balance be-
Electronic health records and quality of
records for type 2 diabetes mellitus: tween participation and transformative
diabetes care. N Engl J Med 2011;365:
825–833 a randomized controlled trial. Arch In- potential. N Engl J Med 2011;365:e6
522. Ralston JD, Hirsch IB, Hoath J, Mullen tern Med 2008;168:1776–1782 528. Washington AE, Lipstein SH. The Pa-
M, Cheadle A, Goldberg HI. Web-based 525. Pullen-Smith B, Carter-Edwards L, tient-Centered Outcomes Research In-
collaborative care for type 2 diabetes: Leathers KH. Community health am- stitutedpromoting better information,
a pilot randomized trial. Diabetes Care bassadors: a model for engaging com- decisions, and health. N Engl J Med
2009;32:234–239 munity leaders to promote better health 2011;365:e31
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