P O S I T I O N                  S T A T E M E N T




Standards of Medical Care in Diabetes–2006

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Position Statement

Table 1—ADA evidence grading system for clinical practice recommendations                         ●   ...
Standards of Medical Care

Table 3—Criteria for testing for diabetes in asymptomatic adult individuals                    ...
Position Statement

BMI 25 kg/m2. The rationale for this            Diagnostic criteria for the 100-g OGTT        delay th...
Standards of Medical Care

interventions were associated with 31,        of diabetes. In the Finnish Diabetes Pre-       L...
Position Statement

Table 5—Components of the comprehensive diabetes evaluation
 Medical history
   ● Symptoms, results of...
Standards of Medical Care

Table 6—Summary of recommendations for adults with diabetes                                    ...
Position Statement

Table 7—Correlation between A1C level and         tients with severe acute illness, periop-     lower ...
Standards of Medical Care

    strategy in achieving glycemic control.         dants, such as vitamins E and C and        ...
Position Statement

little data are currently available on the      cause the brain and central nervous sys-       Optimal...
Standards of Medical Care

Antioxidants                                        when their diabetes is diagnosed and as    ...
Position Statement

as bodily movement produced by the              late 30 min of moderate intensity activ-      should b...
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
Dm criterios ada 2006
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Dm criterios ada 2006

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Dm criterios ada 2006

  1. 1. P O S I T I O N S T A T E M E N T Standards of Medical Care in Diabetes–2006 D AMERICAN DIABETES ASSOCIATION iabetes is a chronic illness that re- quires continuing medical care and patient self-management education CONTENTS 2. Dyslipidemia/lipid man- to prevent acute complications and to re- agement duce the risk of long-term complications. I. CLASSIFICATION AND DIAGNOSIS, 3. Antiplatelet agents Diabetes care is complex and requires that p. S4 4. Smoking cessation many issues, beyond glycemic control, be A. Classification addressed. A large body of evidence exists 5. Coronary heart disease screen- B. Diagnosis that supports a range of interventions to ing and treatment improve diabetes outcomes. B. Nephropathy screening and These standards of care are intended II. SCREENING FOR DIABETES, treatment to provide clinicians, patients, research- p. S5 C. Retinopathy screening and ers, payors, and other interested individ- III. DETECTION AND DIAGNOSIS treatment uals with the components of diabetes OF GESTATIONAL DIABETES D. Neuropathy screening and care, treatment goals, and tools to evalu- MELLITUS, p. S7 treatment ate the quality of care. While individual E. Foot care preferences, comorbidities, and other pa- IV. PREVENTION/DELAY OF TYPE 2 tient factors may require modification of DIABETES, p. S7 VII. DIABETES CARE IN SPECIFIC goals, targets that are desirable for most V. DIABETES CARE, p. S8 POPULATIONS, p. S26 patients with diabetes are provided. A. Initial evaluation A. Children and adolescents These standards are not intended to pre- B. Management B. Preconception care clude more extensive evaluation and C. Glycemic control C. Older individuals management of the patient by other spe- 1. Assessment of glycemic cialists as needed. For more detailed in- control formation, refer to refs. 1–3. VIII. DIABETES CARE IN SPECIFIC The recommendations included are a. S e l f - m o n i t o r i n g o f SETTINGS, p. S29 blood glucose diagnostic and therapeutic actions that A. Diabetes care in the hospital are known or believed to favorably affect b. A1C B. Diabetes care in the school and health outcomes of patients with diabetes. 2. Glycemic goals D. Medical nutrition therapy day care setting A grading system (Table 1), developed by E. Diabetes self-management edu- C. Diabetes care at diabetes camps the American Diabetes Association (ADA) cation D. Diabetes management in cor- and modeled after existing methods, was F. Physical activity rectional institutions utilized to clarify and codify the evidence G. Psychosocial assessment and care that forms the basis for the recommenda- H. Referral for diabetes management IX. HYPOGLYCEMIA AND EMPLOY- tions. The level of evidence that supports I. Intercurrent illness MENT/LICENSURE, p. S34 each recommendation is listed after each J. Hypoglycemia recommendation using the letters A, B, C, K. Immunization or E. X. THIRD-PARTY REIMBURSEMENT VI. PREVENTION AND MANAGE- FOR DIABETES CARE, SELF- MANAGEMENT EDUCATION, I. CLASSIFICATION AND MENT OF DIABETES COMPLICA- DIAGNOSIS TIONS, p. S17 AND SUPPLIES, p. S34 A. Cardiovascular disease A. Classification 1. Hypertension/blood pres- XI. STRATEGIES FOR IMPROVING In 1997, the ADA issued new diagnostic sure control DIABETES CARE, p. S34 and classification criteria (4); in 2003, ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● modifications were made regarding the Originally approved 1988. Most recent review/revision, October 2005. diagnosis of impaired fasting glucose Abbreviations: ABI, ankle-brachial index; AMI, acute myocatdial infarction; ARB, angiotensin receptor block- er; CAD, coronary artery disease; CBG, capillary blood glucose; CHD, coronary heart disease; CHF, congestive (IFG) (5). The classification of diabetes heart failure; CKD, chronic kidney disease; CVD, cardiovascular disease; DCCB, dihydropyridine calcium channel includes four clinical classes: blocker; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis; DMMP, diabetes medical management plan; DPN, distal symmetric polyneuropathy; DPP, Diabetes Prevention Program; DRI, dietary ● reference intake; DRS, Diabetic Retinopathy Study; DSME, diabetes self-management education; DSMT, diabetes Type 1 diabetes (results from -cell de- self-management training; ECG, electrocardiogram; ESRD, end-stage renal disease; ETDRS, Early Treatment struction, usually leading to absolute Diabetic Retinopathy Study; FDA, Food and Drug Administration; FPG, fasting plasma glucose; GDM, gestational insulin deficiency). diabetes mellitus; GFR, glomerular filtration rate; HRC, high-risk characteristic; ICU, intensive care unit; IFG, ● Type 2 diabetes (results from a progres- impaired fasting glucose; IGT, impaired glucose tolerance; MNT, medical nutrition therapy; NPDR, nonprolif- sive insulin secretory defect on the erative diabetic retinopathy; OGTT, oral glucose tolerance test; PAD, peripheral arterial disease; PDR, proliferative diabetic retinopathy; PPG, postprandial plasma glucose; RDA, recommended dietary allowance; SMBG, self- background of insulin resistance). monitoring of blood glucose; TZD, thiazolidinedione; UKPDS, U.K. Prospective Diabetes Study. ● Other specific types of diabetes due to © 2006 by the American Diabetes Association. other causes, e.g., genetic defects in S4 DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006
  2. 2. Position Statement Table 1—ADA evidence grading system for clinical practice recommendations ● IFG FPG 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l) ● IGT 2-h plasma glucose 140 mg/dl Level of evidence Description (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l) A Clear evidence from well-conducted, generalizable, randomized controlled trials that are adequately powered including: Recently, IFG and IGT have been offi- ● Evidence from a well-conducted multicenter trial cially termed “pre-diabetes.” Both catego- ● Evidence from a meta-analysis that incorporated quality ratings in the ries, IFG and IGT, are risk factors for analysis future diabetes and cardiovascular dis- ● Compelling nonexperimental evidence, i.e., “all or none” rule developed ease (CVD). by Center for Evidence Based Medicine at Oxford In the absence of unequivocal hyper- Supportive evidence from well-conducted randomized controlled trials that are glycemia, these criteria should be con- adequately powered including: firmed by repeat testing on a different ● Evidence from a well-conducted trial at one or more institutions day. The OGTT is not recommended for ● Evidence from a meta-analysis that incorporated quality ratings in the routine clinical use but may be required analysis in the evaluation of patients with IFG (see B Supportive evidence from well-conducted cohort studies text) or when diabetes is still suspected ● Evidence from a well-conducted prospective cohort study or registry despite a normal FPG, as with the post- ● Evidence from a well-conducted meta-analysis of cohort studies partum evaluation of women with GDM. Supportive evidence from a well-conducted case-control study C Supportive evidence from poorly controlled or uncontrolled studies II. SCREENING FOR ● Evidence from randomized clinical trials with one or more major or three DIABETES or more minor methodological flaws that could invalidate the results ● Evidence from observational studies with high potential for bias (such as Recommendations case series with comparison to historical controls) ● Screening to detect pre-diabetes (IFG ● Evidence from case series or case reports or IGT) and diabetes should be consid- Conflicting evidence with the weight of evidence supporting the ered in individuals 45 years of age, recommendation particularly in those with a BMI 25 E Expert consensus or clinical experience kg/m2. Screening should also be con- sidered for people who are 45 years of age and are overweight if they have an- -cell function, genetic defects in insu- in practice. Because of ease of use, accept- other risk factor for diabetes (Table 3). lin action, diseases of the exocrine pan- ability to patients, and lower cost, the Repeat testing should be carried out at creas (such as cystic fibrosis), and drug FPG is the preferred diagnostic test. It 3-year intervals. (E) or chemical induced (such as in the should be noted that the vast majority of ● Screen for pre-diabetes and diabetes in treatment of AIDS or after organ trans- people who meet diagnostic criteria for high-risk, asymptomatic, undiagnosed plantation). diabetes by OGTT, but not by FPG, will adults and children within the health ● Gestational diabetes mellitus (GDM) have an A1C value 7.0%. The use of the care setting. (E) (diagnosed during pregnancy). A1C for the diagnosis of diabetes is not ● To screen for diabetes/pre-diabetes, ei- recommended at this time. ther an FPG test or 2-h OGTT (75-g B. Diagnosis Hyperglycemia not sufficient to meet glucose load) or both are appropriate. the diagnostic criteria for diabetes is cate- (B) Recommendations gorized as either IFG or impaired glucose ● An OGTT may be considered in pa- ● The FPG is the preferred test to diag- tolerance (IGT), depending on whether it tients with IFG to better define the risk nose diabetes in children and nonpreg- is identified through a FPG or an OGTT: of diabetes. (E) nant adults. (E) ● The use of the A1C for the diagnosis of diabetes is not recommended at this Table 2—Criteria for the diagnosis of diabetes time. (E) 1. Symptoms of diabetes and a casual plasma glucose 200 mg/dl (11.1 mmol/l). Criteria for the diagnosis of diabetes in Casual is defined as any time of day without regard to time since last meal. nonpregnant adults are shown in Table 2. The classic symptoms of diabetes include polyuria, polydipsia, and Three ways to diagnose diabetes are avail- unexplained weight loss. able, and each must be confirmed on a OR subsequent day unless unequivocal 2. FPG 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least symptoms of hyperglycemia are present. 8 h. Although the 75-g oral glucose tolerance OR test (OGTT) is more sensitive and mod- 3. 2-h plasma glucose 200 mg/dl (11.1 mmol/l) during an OGTT. The test should estly more specific than fasting plasma be performed as described by the World Health Organization, using a glucose (FPG) to diagnose diabetes, it is glucose load containing the equivalent of 75-g anhydrous glucose dissolved poorly reproducible and rarely performed in water. DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006 S5
  3. 3. Standards of Medical Care Table 3—Criteria for testing for diabetes in asymptomatic adult individuals may be considered in patients with IFG to 1. Testing for diabetes should be considered in all individuals at age 45 years and above, better define the risk of diabetes. particularly in those with a BMI 25 kg/m2*, and, if normal, should be repeated at The incidence of type 2 diabetes in 3-year intervals. children and adolescents has increased 2. Testing should be considered at a younger age or be carried out more frequently in dramatically in the last decade. Consis- individuals who are overweight (BMI 25 kg/m2*) and have additional risk factors: tent with screening recommendations for ● are habitually physically inactive adults, only children and youth at in- ● have a first-degree relative with diabetes creased risk for the presence or the devel- ● are members of a high-risk ethnic population (e.g., African American, Latino, opment of type 2 diabetes should be Native American, Asian American, Pacific Islander) tested (11) (Table 4). ● have delivered a baby weighing 9 lb or have been diagnosed with GDM The effectiveness of screening may ● are hypertensive ( 140/90 mmHg) also depend on the setting in which it is ● have an HDL cholesterol level 35 mg/dl (0.90 mmol/l) and/or a triglyceride level performed. In general, community 250 mg/dl (2.82 mmol/l) screening outside a health care setting ● have PCOS may be less effective because of the failure ● on previous testing, had IGT or IFG of people with a positive screening test to ● have other clinical conditions associated with insulin resistance (e.g. PCOS or seek and obtain appropriate follow-up acanthosis nigricans) testing and care or, conversely, to ensure ● have a history of vascular disease appropriate repeat testing for individuals who screen negative. That is, screening *May not be correct for all ethnic groups. PCOS, polycystic ovary syndrome. outside of clinical settings may yield ab- normal tests that are never discussed with There is a major distinction between di- uals (e.g., siblings of type 1 diabetic a primary care provider, low compliance agnostic testing and screening. Both uti- patients). These studies may uncover an ef- with treatment recommendations, and a lize the same clinical tests, which should fective means of preventing type 1 diabetes, very uncertain impact on long-term be done within the context of the health in which case targeted screening may be ap- health. Community screening may also be care setting. When an individual exhibits propriate in the future. poorly targeted, i.e., it may fail to reach symptoms or signs of the disease, diag- the groups most at risk and inappropri- nostic tests are performed, and such tests ately test those at low risk (the worried do not represent screening. The purpose Type 2 diabetes well) or even those already diagnosed of screening is to identify asymptomatic Type 2 diabetes is frequently not diag- (12,13). individuals who are likely to have diabe- nosed until complications appear, and On the basis of expert opinion, tes or pre-diabetes. Separate diagnostic approximately one-third of all people screening should be considered by health tests using standard criteria are required with diabetes may be undiagnosed. Indi- care providers at 3-year intervals begin- after positive screening tests to establish a viduals at high risk should be screened for ning at age 45, particularly in those with definitive diagnosis as described above. diabetes and pre-diabetes. Criteria for testing for diabetes in asymptomatic, un- Type 1 diabetes diagnosed adults are listed in Table 3. The Table 4—Testing for type 2 diabetes in chil- Generally, people with type 1 diabetes effectiveness of early diagnosis through dren present with acute symptoms of diabetes screening of asymptomatic individuals Criteria: and markedly elevated blood glucose lev- has not been determined (6). ● Overweight (BMI 85th percentile for els. Because of the acute onset of symp- Screening should be carried out age and sex, weight for height 85th toms, most cases of type 1 diabetes are within the health care setting. Either an percentile, or weight 120% of ideal for detected soon after symptoms develop. FPG test or 2-h OGTT (75-g glucose load) height) Widespread clinical testing of asymptom- is appropriate. The 2-h OGTT identifies Plus any two of the following risk factors: atic individuals for the presence of auto- people with IGT, and thus, more people ● Family history of type 2 diabetes in first- antibodies related to type 1 diabetes who are at increased risk for the develop- or second-degree relative cannot be recommended at this time as a ment of diabetes and CVD. It should be ● Race/ethnicity (Native American, African means to identify individuals at risk. Rea- noted that the two tests do not necessarily American, Latino, Asian American, sons for this include the following: 1) cut- detect the same individuals (7). It is im- Pacific Islander) off values for some of the immune marker portant to recognize that although the ef- ● Signs of insulin resistance or conditions assays have not been completely estab- ficacy of interventions for primary associated with insulin resistance lished in clinical settings; 2) there is no con- prevention of type 2 diabetes have been (acanthosis nigricans, hypertension, sensus as to what action should be taken demonstrated among individuals with dyslipidemia, or PCOS) when a positive autoantibody test result is IGT (8 –10), such data among individuals ● Maternal history of diabetes or GDM obtained; and 3) because the incidence of with IFG (who do not also have IGT) are Age of initiation: age 10 years or at onset of type 1 diabetes is low, testing of healthy not available. The FPG test is more con- puberty, if puberty occurs at a younger age children will identify only a very small num- venient to patients, more reproducible, Frequency: every 2 years ber ( 0.5%) who at that moment may be less costly, and easier to administer than Test: FPG preferred “pre-diabetic.” Clinical studies are being the 2-h OGTT (4,5). Therefore, the rec- Clinical judgment should be used to test for diabetes conducted to test various methods of pre- ommended initial screening test for non- in high-risk patients who do not meet these criteria. venting type 1 diabetes in high-risk individ- pregnant adults is the FPG. An OGTT PCOS, polycystic ovary syndrome. S6 DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006
  4. 4. Position Statement BMI 25 kg/m2. The rationale for this Diagnostic criteria for the 100-g OGTT delay the onset of type 2 diabetes. Five interval is that false negatives will be re- are as follows: 95 mg/dl fasting, 180 well-designed randomized controlled tri- peated before substantial time elapses, mg/dl at 1 h, 155 mg/dl at 2 h, and als have been reported (8 –10,15,16). The and there is little likelihood of an individ- 140 mg/dl at 3 h. Two or more of the strategies shown to be effective in pre- ual developing any of the complications plasma glucose values must be met or ex- venting diabetes relied on lifestyle modi- of diabetes to a significant degree within 3 ceeded for a positive diagnosis. The test fication or glucose-lowering drugs that years of a negative screening test result. should be done in the morning after an have been approved for treating diabetes. Testing should be considered at a younger overnight fast of 8 –14 h. The diagnosis In the Finnish study (9), middle-aged age or be carried out more frequently in can be made using a 75-g glucose load, obese subjects with IGT were randomized individuals who are overweight and have but that test is not as well validated for to receive either brief diet and exercise one or more of the other risk factors for detection of at-risk infants or mothers as counseling (control group) or intensive type 2 diabetes. the 100-g OGTT. individualized instruction on weight re- Low-risk status requires no glucose duction, food intake, and guidance on in- testing, but this category is limited to creasing physical activity (intervention III. DETECTION AND those women meeting all of the following group). After an average follow-up of 3.2 DIAGNOSIS OF GDM characteristics: years, there was a 58% relative reduction in the incidence of diabetes in the inter- Recommendations ● Age 25 years. vention group compared with the control ● Screen for diabetes in pregnancy using ● Weight normal before pregnancy. subjects. risk factor analysis and, if appropriate, ● Member of an ethnic group with a low In the Diabetes Prevention Program use of an OGTT. (C) prevalence of GDM. (DPP) (8), enrolled subjects were slightly ● Women with GDM should be screened ● No known diabetes in first-degree rela- younger and more obese but had nearly for diabetes 6 –12 weeks postpartum tives. identical glucose intolerance compared and should be followed up with subse- ● No history of abnormal glucose toler- with subjects in the Finnish study. About quent screening for the development of ance. 45% of the participants were from minor- diabetes or pre-diabetes. (E) ● No history of poor obstetric outcome. ity groups (e.g., African American, His- panic), and 20% were 60 years of age. Subjects were randomized to one of three Risk assessment for GDM should be un- IV. PREVENTION/DELAY intervention groups, which included the dertaken at the first prenatal visit. Women OF TYPE 2 DIABETES intensive nutrition and exercise counsel- with clinical characteristics consistent ing (“lifestyle”) group or either of two with a high risk for GDM (those with Recommendations masked medication treatment groups: the marked obesity, personal history of GDM, ● Individuals at high risk for developing biguanide metformin group or the pla- glycosuria, or a strong family history of diabetes need to become aware of the cebo group. The latter interventions were diabetes) should undergo glucose testing benefits of modest weight loss and par- combined with standard diet and exercise as soon as possible (14). An FPG 126 ticipating in regular physical activity. recommendations. After an average fol- mg/dl or a casual plasma glucose 200 (A) low-up of 2.8 years, a 58% relative reduc- mg/dl meets the threshold for the diagno- ● Patients with IGT should be given tion in the progression to diabetes was sis of diabetes and needs to be confirmed counseling on weight loss as well as in- observed in the lifestyle group and a 31% on a subsequent day unless unequivocal struction for increasing physical activ- relative reduction in the progression of symptoms of hyperglycemia are present. ity. (A) diabetes was observed in the metformin High-risk women not found to have GDM ● Patients with IFG should be given group compared with control subjects. at the initial screening and average-risk counseling on weight loss as well as in- On average, 50% of the lifestyle group women should be tested between 24 and struction for increasing physical activ- achieved the goal of 7% weight reduc- 28 weeks of gestation. Testing should fol- ity. (E) tion and 74% maintained at least 150 low one of two approaches: ● Follow-up counseling appears impor- min/week of moderately intense activity. tant for success. (B) In the troglitazone arm of the DPP (dis- ● One-step approach: perform a diagnos- ● Monitoring for the development of diabe- continued after a mean of 0.9 years when tic 100-g OGTT tes in those with pre-diabetes should be the drug was withdrawn from the mar- ● Two-step approach: perform an initial performed every 1–2 years. (E) ket), troglitazone markedly reduced the screening by measuring the plasma or ● Close attention should be given to, and incidence of diabetes during the period serum glucose concentration 1 h after a appropriate treatment given for, other the drug was given (16a). 50-g oral glucose load (glucose chal- CVD risk factors (e.g., tobacco use, hy- In the Da Qing Study (10), men and lenge test) and perform a diagnostic pertension, dyslipidemia). (A) women from health care clinics in the city 100-g OGTT on that subset of women ● Drug therapy should not be routinely of Da Qing, China, were screened with exceeding the glucose threshold value used to prevent diabetes until more in- OGTT, and those with IGT were random- on the glucose challenge test. When the formation is known about its cost- ized by clinic to a control group or to one two-step approach is used, a glucose effectiveness. (E) of three active treatment groups: diet threshold value 140 mg/dl identifies only, exercise only, or diet plus exercise. 80% of women with GDM, and the Studies have been initiated in the last de- Subjects were reexamined biannually, yield is further increased to 90% by us- cade to determine the feasibility and ben- and after an average of 6 years’ follow-up, ing a cutoff of 130 mg/dl. efit of various strategies to prevent or the diet, exercise, and diet plus exercise DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006 S7
  5. 5. Standards of Medical Care interventions were associated with 31, of diabetes. In the Finnish Diabetes Pre- Lifestyle or medication? 46, and 42% reductions in risk of devel- vention Study, weight loss averaged 9.2 lb The DPP is the only study in which a com- oping type 2 diabetes, respectively. at 1 year, 7.7 lb after 2 years, and 4.6 lb parison of the two was made, and lifestyle Three other studies, each using a dif- after 5 years (9); “moderate exercise,” modification was nearly twice as effective ferent class of glucose-lowering agent, such as brisk walking, for 30 min/day was in preventing diabetes (58 vs. 31% rela- have shown a reduction in progression to suggested. In the Finnish study, there was tive reductions, respectively). The greater diabetes with pharmacological interven- a direct relationship between adherence benefit of weight loss and physical activity tion. In the Troglitazone in Prevention of with the lifestyle intervention and the re- strongly suggests that lifestyle modifica- Diabetes (TRIPOD) study (15), Hispanic duced incidence of diabetes. tion should be the first choice to prevent women with previous GDM were ran- In the DPP (8), the lifestyle group lost or delay diabetes. Modest weight loss (5– domized to receive either placebo or tro- 12 lb at 2 years and 9 lb at 3 years (mean 10% of body weight) and modest physical glitazone (a drug now withdrawn from weight loss for the study duration was activity (30 min daily) are the recom- commercial sale in the U.S. but belonging 12 lb or 6% of initial body weight). In mended goals. Because this intervention to the thiazolidinedione [TZD] class). Af- both of these studies, most of the partici- not only has been shown to prevent or ter a median follow-up of 30 months, tro- pants were obese (BMI 30 kg/m2). delay diabetes, but also has a variety of glitazone treatment was associated with a A low-fat ( 25% fat) intake was rec- other benefits, health care providers 56% relative reduction in progression to ommended; if reducing fat did not pro- should urge all overweight or sedentary diabetes. In the STOP-IDDM trial (16), duce weight loss to goal, calorie individuals to adopt these changes, and participants with IGT were randomized restriction was also recommended. Par- such recommendations should be made in a double-blind fashion to receive either ticipants weighing 120 –174 lb (54 –78 at every opportunity. the -glucosidase inhibitor acarbose or a kg) at baseline were instructed to follow a When all factors are considered, there placebo. After a mean follow-up of 3.3 1,200-kcal/day diet (33 g fat), those 175– is insufficient evidence to support the use years, a 25% relative risk reduction in 219 lb (79 –99 kg) were instructed to fol- of drug therapy as a substitute for, or rou- progression to diabetes, based on one low a 1,500-kcal/day diet (42 g fat), those tinely used in addition to, lifestyle modi- OGTT, was observed in the acarbose- 220 –249 lb (100 –113 kg) were in- fication to prevent diabetes. Public health treated group compared with the placebo structed to follow an 1,800-kcal/day diet messages, health care professionals, and group. If this diagnosis was confirmed by (50 g fat), and those 250 lb (114 kg) health care systems should all encourage a second OGTT, a 36% relative risk re- were instructed to follow a 2,000-kcal/ behavior changes to achieve a healthy life- duction was observed in the acarbose day diet (55 g fat). style. Further research is necessary to un- group compared with the placebo group. derstand better how to facilitate effective Finally, in the XENical in the pre- and efficient programs for the primary vention of Diabetes in Obese Subjects Pharmacological interventions prevention of type 2 diabetes. (XENDOS) study, orlistat was examined Three diabetes prevention trials used for its ability to delay type 2 diabetes pharmacological therapy, and all have re- when added to lifestyle change in a group ported a significant lowering of the inci- V. DIABETES CARE with BMI 30 kg/m2 with or without dence of diabetes. The biguanide IGT. After 4 years of treatment, the effect metformin reduced the risk of diabetes by A. Initial evaluation of orlistat addition corresponded to a 31% in the DPP (8), the -glucosidase A complete medical evaluation should be 45% risk reduction in the IGT group, inhibitor acarbose reduced the risk by performed to classify the patient, detect with no effect observed in those without 32% in the STOP-IDDM trial (16), and the presence or absence of diabetes com- IGT (16b). the TZD troglitazone reduced the risk by plications, assist in formulating a manage- Our knowledge of the early stages of 56% in the TRIPOD study (15). ment plan, and provide a basis for hyperglycemia that portend the diagnosis In the DPP, metformin was about half continuing care. If the diagnosis of diabe- of diabetes, and the recent success of ma- as effective as diet and exercise in delaying tes has already been made, the evaluation jor intervention trials, clearly show that the onset of diabetes overall, but it was should review the previous treatment and individuals at high risk can be identified nearly ineffective in older individuals the past and present degrees of glycemic and diabetes delayed, if not prevented. ( 60 years of age) or in those who were control. Laboratory tests appropriate to The cost-effectiveness of intervention less overweight (BMI 30 kg/m2). Con- the evaluation of each patient’s general strategies is unclear, but the huge burden versely, metformin was as effective as life- medical condition should be performed. resulting from the complications of diabe- style modification in individuals aged A focus on the components of compre- tes and the potential ancillary benefits of 24 – 44 years or in those with a BMI 35 hensive care (Table 5) will assist the some of the interventions suggest that an kg/m2. Thus, the population of people in health care team to ensure optimal man- effort to prevent diabetes is worthwhile. whom treatment with metformin has agement of the patient with diabetes. equal benefit to that of a lifestyle interven- tion is only a small subset of those who are B. Management Lifestyle modification likely to have pre-diabetes (IFG or IGT). People with diabetes should receive med- In well-controlled studies that included a There are also data to suggest that ical care from a physician-coordinated lifestyle intervention arm, substantial ef- blockade of the renin-angiotensin system team. Such teams may include, but are forts were necessary to achieve only mod- (17) may lower the risk of developing di- not limited to, physicians, nurse practitio- est changes in weight and exercise, but abetes, but more studies are necessary be- ners, physician’s assistants, nurses, dieti- those changes were sufficient to achieve fore these drugs can be recommended for tians, pharmacists, and mental health an important reduction in the incidence preventing diabetes. professionals with expertise and a special S8 DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006
  6. 6. Position Statement Table 5—Components of the comprehensive diabetes evaluation Medical history ● Symptoms, results of laboratory tests, and special examination results related to the diagnosis of diabetes ● Prior A1C records ● Eating patterns, nutritional status, and weight history; growth and development in children and adolescents ● Details of previous treatment programs, including nutrition and diabetes self-management education, attitudes, and health beliefs ● Current treatment of diabetes, including medications, meal plan, and results of glucose monitoring and patients’ use of data ● Exercise history ● Frequency, severity, and cause of acute complications such as ketoacidosis and hypoglycemia ● Prior or current infections, particularly skin, foot, dental, and genitourinary infections ● Symptoms and treatment of chronic eye; kidney; nerve; genitourinary (including sexual), bladder, and gastrointestinal function (including symptoms of celiac disease in type 1 diabetic patients); heart; peripheral vascular; foot; and cerebrovascular complications associated with diabetes ● Other medications that may affect blood glucose levels ● Risk factors for atherosclerosis: smoking, hypertension, obesity, dyslipidemia, and family history ● History and treatment of other conditions, including endocrine and eating disorders ● Assessment for mood disorder ● Family history of diabetes and other endocrine disorders ● Lifestyle, cultural, psychosocial, educational, and economic factors that might influence the management of diabetes ● Tobacco, alcohol, and/or controlled substance use ● Contraception and reproductive and sexual history Physical examination ● Height and weight measurement (and comparison to norms in children and adolescents) ● Sexual maturation staging (during pubertal period) ● Blood pressure determination, including orthostatic measurements when indicated, and comparison to age-related norms ● Fundoscopic examination ● Oral examination ● Thyroid palpation ● Cardiac examination ● Abdominal examination (e.g., for hepatomegaly) ● Evaluation of pulses by palpation and with auscultation ● Hand/finger examination ● Foot examination ● Skin examination (for acanthosis nigricans and insulin-injection sites) ● Neurological examination ● Signs of diseases that can cause secondary diabetes (e.g., hemochromatosis, pancreatic disease) Laboratory evaluation ● A1C ● Fasting lipid profile, including total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol, liver function tests with further evaluation for fatty liver or hepatitis if abnormal ● Test for microalbuminuria in type 1 diabetic patients who have had diabetes for at least 5 years and in all patients with type 2 diabetes; some advocate beginning screening of pubertal children before 5 years of diabetes ● Serum creatinine and calculated GFR in adults (check creatinine in children if proteinuria is present) ● Thyroid-stimulating hormone (TSH) in all type 1 diabetic patients; in type 2 if clinically indicated ● Electrocardiogram in adults, if clinically indicated ● Urinalysis for ketones, protein, sediment Referrals ● Eye exam, if indicated ● Family planning for women of reproductive age ● MNT, as indicated ● Diabetes educator, if not provided by physician or practice staff ● Behavioral specialist, as indicated ● Foot specialist, as indicated ● Other specialties and services as appropriate interest in diabetes. It is essential in this alliance among the patient and family, the should be given to the patient’s age, collaborative and integrated team ap- physician, and other members of the school or work schedule and conditions, proach that individuals with diabetes as- health care team. Any plan should recog- physical activity, eating patterns, social sume an active role in their care. nize diabetes self-management education situation and personality, cultural factors, The management plan should be for- (DSME) as an integral component of care. and presence of complications of diabetes mulated as an individualized therapeutic In developing the plan, consideration or other medical conditions. A variety of DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006 S9
  7. 7. Standards of Medical Care Table 6—Summary of recommendations for adults with diabetes known but should be sufficient to facili- Glycemic control tate reaching glucose goals. Patients with A1C 7.0%* type 2 diabetes on insulin typically need Preprandial capillary plasma glucose 90–130 mg/dl (5.0–7.2 mmol/l) to perform SMBG more frequently than Peak postprandial capillary plasma glucose† 180 mg/dl ( 10.0 mmol/l) those not using insulin. When adding to Blood pressure 130/80 mmHg or modifying therapy, type 1 and type 2 Lipids‡ diabetic patients should test more often LDL 100 mg/dl ( 2.6 mmol/l) than usual. The role of SMBG in stable Triglycerides 150 mg/dl ( 1.7 mmol/l) diet-treated patients with type 2 diabetes HDL 40 mg/dl ( 1.1 mmol/l)§ is not known. Key concepts in setting glycemic goals: Because the accuracy of SMBG is in- ● A1C is the primary target for glycemic control strument and user dependent (20), it is ● Goals should be individualized important for health care providers to ● Certain populations (children, pregnant women, and evaluate each patient’s monitoring tech- elderly) require special considerations nique, both initially and at regular inter- ● More stringent glycemic goals (i.e., a normal A1C, 6%) vals thereafter. In addition, optimal use of may further reduce complications at the cost of increased SMBG requires proper interpretation of risk of hypoglycemia the data. Patients should be taught how to ● Less intensive glycemic goals may be indicated in patients use the data to adjust food intake, exer- with severe or frequent hypoglycemia cise, or pharmacological therapy to ● Postprandial glucose may be targeted if A1C goals are not achieve specific glycemic goals. Health met despite reaching preprandial glucose goals professionals should evaluate at regular intervals the patient’s ability to use SMBG *Referenced to a nondiabetic range of 4.0 – 6.0% using a DCCT-based assay. †Postprandial glucose mea- surements should be made 1–2 h after the beginning of the meal, generally peak levels in patients with data to guide treatment. diabetes. ‡Current NCEP/ATP III guidelines suggest that in patients with triglycerides 200 mg/dl, the “non-HDL cholesterol” (total cholesterol minus HDL) be utilized. The goal is 130 mg/dl (34). §For women, b. A1C it has been suggested that the HDL goal be increased by 10 mg/dl. Recommendations ● Perform the A1C test at least two times strategies and techniques should be used gets, postprandial SMBG may be appro- a year in patients who are meeting treat- to provide adequate education and devel- priate. (E) ment goals (and who have stable glyce- opment of problem-solving skills in the ● Instruct the patient in SMBG and rou- mic control). (E) various aspects of diabetes management. tinely evaluate the patient’s technique ● Perform the A1C test quarterly in pa- Implementation of the management plan and ability to use data to adjust therapy. tients whose therapy has changed or requires that each aspect is understood (E) who are not meeting glycemic goals. (E) and agreed on by the patient and the care ● Use of point-of-care testing for A1C al- providers and that the goals and treat- The ADA’s consensus statements on lows for timely decisions on therapy ment plan are reasonable. SMBG provide a comprehensive review of changes, when needed. (E) the subject (18,19). Major clinical trials C. Glycemic control assessing the impact of glycemic control By performing an A1C test, health provid- 1. Assessment of glycemic control. on diabetes complications have included ers can measure a patient’s average glyce- Techniques are available for health pro- SMBG as part of multifactorial interven- mia over the preceding 2–3 months (20) viders and patients to assess the effective- tions, suggesting that SMBG is a compo- and, thus, assess treatment efficacy. A1C ness of the management plan on glycemic nent of effective therapy. SMBG allows testing should be performed routinely in control. patients to evaluate their individual re- all patients with diabetes, first to docu- sponse to therapy and assess whether gly- ment the degree of glycemic control at a. Self-monitoring of blood glucose cemic targets are being achieved. Results initial assessment and then as part of con- of SMBG can be useful in preventing hy- tinuing care. Since the A1C test reflects Recommendations poglycemia and adjusting medications, mean glycemia over the preceding 2–3 ● Clinical trials using insulin that have MNT, and physical activity. months, measurement approximately ev- demonstrated the value of tight glyce- The frequency and timing of SMBG ery 3 months is required to determine mic control have used self-monitoring should be dictated by the particular needs whether a patient’s metabolic control has of blood glucose (SMBG) as an integral and goals of the patients. Daily SMBG is been reached and maintained within the part of the management strategy. (A) especially important for patients treated target range. Thus, regular performance ● SMBG should be carried out three or with insulin to monitor for and prevent of the A1C test permits detection of de- more times daily for patients using mul- asymptomatic hypoglycemia and hyper- partures from the target (Table 6) in a tiple insulin injections. (A) glycemia. For most patients with type 1 timely fashion. For any individual patient, ● For patients using less frequent insulin diabetes and pregnant women taking in- the frequency of A1C testing should be injections or oral agents or medical nu- sulin, SMBG is recommended three or dependent on the clinical situation, the trition therapy (MNT) alone, SMBG is more times daily. The optimal frequency treatment regimen used, and the judg- useful in achieving glycemic goals. (E) and timing of SMBG for patients with type ment of the clinician. ● To achieve postprandial glucose tar- 2 diabetes on oral agent therapy is not The A1C test is subject to certain lim- S10 DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006
  8. 8. Position Statement Table 7—Correlation between A1C level and tients with severe acute illness, periop- lower limit of A1C at which further low- mean plasma glucose levels on multiple test- eratively, following myocardial ering does not reduce the risk of compli- ing over 2–3 months (23) infarction, and in pregnancy. (B) cations, at the risk of increased hypoglycemia (particularly in those with Mean plasma glucose Glycemic control is fundamental to the type 1 diabetes). However, the absolute management of diabetes. The goal of ther- risks and benefits of lower targets are un- A1C (%) mg/dl mmol/l apy is to acheive an A1C as close to nor- known. The risks and benefits of an A1C 6 135 7.5 mal as possible (representing normal goal of 6% are currently being tested in 7 170 9.5 fasting and postprandial glucose concen- an ongoing study (ACCORD [Action to 8 205 11.5 trations) in the absence of hypoglycemia. Control Cardiovascular Risk in Diabetes]) 9 240 13.5 However, this goal is difficult to achieve in type 2 diabetes. 10 275 15.5 with present therapies (24). Prospective Elevated postchallenge (2-h OGTT) 11 310 17.5 randomized clinical trials such as the glucose values have been associated with 12 345 19.5 DCCT (25) and the U.K. Prospective Di- increased cardiovascular risk indepen- abetes Study (UKPDS) (26,27) have dent of FPG in some epidemiological shown that improved glycemic control is studies. Postprandial plasma glucose itations. Conditions that affect erythro- associated with sustained decreased rates (PPG) levels 140 mg/dl are unusual in cyte turnover (hemolysis, blood loss) and of retinopathy, nephropathy, and neu- nondiabetic individuals, although large hemoglobin variants must be considered, ropathy (28). In these trials, treatment evening meals can be followed by plasma particularly when the A1C result does not regimens that reduced average A1C to glucose values up to 180 mg/dl. There are correlate with the patient’s clinical situa- 7% ( 1% above the upper limits of now pharmacological agents that primar- tion (20). The availability of the A1C re- normal) were associated with fewer long- ily modify PPG and thereby reduce A1C sult at the time that the patient is seen term microvascular complications; how- in parallel. Thus, in individuals who have (point of care testing) has been reported ever, intensive control was found to premeal glucose values within target but to result in the frequency of intensifica- increase the risk of severe hypoglycemia who are not meeting A1C targets, consid- tion of therapy and improvement in gly- and weight gain (29,30). The potential of eration of monitoring PPG 1–2 h after the cemic control (21,22). intensive glycemic control to reduce CVD start of the meal and treatment aimed at Glycemic control is best judged by is supported by epidemiological studies reducing PPG values 180 mg/dl may the combination of the results of the pa- (25–30) and a recent meta-analysis (31), lower A1C. However, it should be noted tient’s SMBG testing (as performed) and but this potential benefit on CVD events that the effect of these approaches on mi- the current A1C result. The A1C should has not yet been demonstrated in a ran- cro- or macrovascular complications has be used not only to assess the patient’s domized clinical trial. not been studied (32). control over the preceding 2–3 months Recommended glycemic goals for As regards goals for glycemic control but also as a check on the accuracy of the nonpregnant individuals are shown in Ta- for women with GDM, recommendations meter (or the patient’s self-reported re- ble 6. A major limitation to the available from the Fourth International Workshop- sults) and the adequacy of the SMBG test- data is that they do not identify the opti- Conference on Gestational Diabetes sug- ing schedule. Table 7 contains the mum level of control for particular pa- gest lowering maternal capillary blood correlation between A1C levels and mean tients, as there are individual differences glucose concentrations to 95 mg/dl (5.3 plasma glucose levels based on data from in the risks of hypoglycemia, weight gain, mmol/l) fasting, 140 mg/dl (7.8 the Diabetes Control and Complications and other adverse effects. Furthermore, mmol/l) at 1 h, and/or 120 mg/dl (6.7 Trial (DCCT) (23). with multifactorial interventions, it is un- mmol/l) at 2 h after the meal (32a). For clear how different components (e.g., ed- further information on GDM, refer to the 2. Glycemic goals ucational interventions, glycemic targets, ADA position statement (14). For infor- lifestyle changes, pharmacological mation on glycemic control during preg- Recommendations agents) contribute to the reduction of nancy in women with preexisting ● Lowering A1C has been associated with complications. There are no clinical trial diabetes, refer to ref. 33. a reduction of microvascular and neu- data available for the effects of glycemic ropathic complications of diabetes. (A) control in patients with advanced compli- ● The A1C goal for patients in general is an D. MNT cations, the elderly ( 65 years of age), or A1C goal of 7%. (B) young children ( 13 years of age). Less ● The A1C goal for the individual patient is stringent treatment goals may be appro- Recommendations an A1C as close to normal ( 6%) as priate for patients with limited life expect- ● People with diabetes should receive in- possible without significant hypoglyce- ancies, in the very young or older adults, dividualized MNT as needed to achieve mia. (E) and in individuals with comorbid condi- treatment goals, preferably provided by ● Less stringent treatment goals may be tions. Severe or frequent hypoglycemia is a registered dietitian familiar with the appropriate for patients with a history an indication for the modification of treat- components of diabetes MNT. (B) of severe hypoglycemia, patients with ment regimens, including setting higher ● Both the amount (grams) of carbohy- limited life expectancies, very young glycemic goals. drate as well as the type of carbohydrate children or older adults, and individu- More stringent goals (i.e., a normal in a food influence blood glucose level. als with comorbid conditions. (E) A1C, 6%) should be considered in in- Monitoring total grams of carbohy- ● Aggressive glycemic management with dividual patients based on epidemiologi- drate, whether by use of exchanges or insulin may reduce morbidity in pa- cal analyses suggesting that there is no carbohydrate counting, remains a key DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006 S11
  9. 9. Standards of Medical Care strategy in achieving glycemic control. dants, such as vitamins E and C and MNT involves a nutrition assessment (A) -carotene, is not advised because of to evaluate the patient’s food intake, met- ● The use of the glycemic index/glycemic lack of evidence of efficacy and concern abolic status, lifestyle, readiness to make load may provide an additional benefit related to long-term safety. (A) changes, goal setting, dietary instruction, over that observed when total carbohy- ● Benefit from chromium supplementa- and evaluation. To facilitate adherence, drate is considered alone. (B) tion in people with diabetes or obesity the plan should be individualized and ● Low-carbohydrate diets (restricting to- has not been conclusively demon- take into account individual cultural, life- tal carbohydrate to 130 g/day) are not strated and, therefore, cannot be rec- style, and financial considerations. Moni- recommended in the management of ommended. (E) toring of glucose and A1C, lipids, blood diabetes. (E) pressure, and renal status is essential to ● To reduce the risk of nephropathy, pro- MNT is an integral component of diabetes evaluate nutrition-related outcomes. If tein intake should be limited to the rec- prevention, management, and self- goals are not met (Table 6), changes must ommended dietary allowance (RDA) management education. In addition to its be made in the overall diabetes care and (0.8 g/kg) in those with any degree of role in preventing and controlling diabe- management plan. CKD. (B) tes, the ADA recognizes the importance of ● Saturated fat intake should be 7% of nutrition as an essential component of an Weight management (37) total calories. (A) overall healthy lifestyle . These guidelines Overweight and obesity are strongly ● Intake of trans fat should be minimized. are based on principles of good nutrition linked to the development of type 2 dia- (E) for the overall population from the 2005 betes and can complicate its management. ● Weight loss is recommended for all Dietary Guidelines and the RDAs from the Obesity is also an independent risk factor overweight (BMI 25.0 –29.9 kg/m2) or Institute of Medicine of the National for hypertension and dyslipidemia as well obese (BMI 30.0 kg/m2) adults who Academies of Sciences. A review of the as CVD, which is the major cause of death have, or are at risk for developing, type evidence and detailed information can be in those with diabetes. Moderate weight 2 diabetes. (E) found in the 2002 ADA technical review loss improves glycemic control, reduces ● The primary approach for achieving on this topic (35) and the 2004 ADA CVD risk, and can prevent the develop- weight loss is therapeutic lifestyle Statements regarding dietary carbohy- ment of type 2 diabetes in those with pre- change, which includes a reduction in drate (36) and weight management. (37). diabetes. Therefore, weight loss is an energy intake and an increase in phys- Goal of MNT that applies to individ- important therapeutic strategy in all over- ical activity. A moderate decrease in ca- uals with pre-diabetes: weight or obese individuals who have loric balance (500 –1,000 kcal/day) will type 2 diabetes or are at risk for develop- result in a slow but progressive weight ● Decrease the risk of diabetes and CVD ing diabetes. The primary approach for loss (1–2 lb/week). For most patients, by promoting physical activity and achieving weight loss, in the vast majority weight loss diets should supply at least healthy food choices that result in mod- of cases, is therapeutic lifestyle change, 1,000 –1,200 kcal/day for women and erate weight loss that is maintained or, which includes a reduction in energy in- 1,200 –1,600 kcal/day for men. (E) at a minimum, prevents weight gain. take and an increase in physical activity. A ● Initial physical activity recommenda- moderate decrease in caloric balance tions should be modest and based on Goal of MNT that applies to all individu- (500 –1,000 kcal/day) will result in a slow the patient’s willingness and ability, als with diabetes: but progressive weight loss (1–2 lb/ gradually increasing the duration and week). For most patients, weight loss di- frequency to 30 – 45 min of moderate ● Prevent and treat the chronic complica- ets should supply at least 1,000 –1,200 aerobic activity, 3–5 days/week (goal at tions of diabetes by attaining and main- kcal/day for women and 1,200 –1,600 least 150 min/week). Greater activity taining optimal metabolic outcomes, kcal/day for men. levels of at least 1 h/day of moderate including blood glucose and A1C level, In selected patients, drug therapy to (walking) or 30 min/day of vigorous LDL and HDL cholesterol and triglyc- achieve weight loss as an adjunct to life- (jogging) activity may be needed to eride levels, blood pressure, and body style change may be appropriate (38). achieve successful long-term weight weight (Table 6). However, it is important to note that re- loss. (E) gain of weight commonly occurs on dis- ● Drug therapy for obesity and surgery to Achieving nutrition-related goals requires continuation of medication. In patients induce weight loss may be appropriate a coordinated team effort that includes with severe/morbid obesity, surgical op- in selected patients. (E) the active involvement of the person with tions, such as gastric bypass and gastro- ● Nonnutritive sweeteners are safe when pre-diabetes or diabetes. Because of the plasty, may be appropriate and allow consumed within the acceptable daily complexity of nutrition issues, it is recom- significant improvement in glycemic con- intake levels established by the Food mended that a registered dietitian who is trol with reduction or discontinuation of and Drug Administration (FDA). (A) knowledgeable and skilled in implement- medications (39). It is important to fully ● If adults with diabetes choose to use ing nutrition therapy into diabetes man- evaluate the patient for existing or risk for alcohol, daily intake should be limited agement and education be the team CVD and improve glycemic control pre- to a moderate amount (one drink per member who provides MNT. However, it operatively in order to decrease the risk of day or less for adult women and two is essential that all team members are complications. It is important to counsel drinks per day or less for adult men); knowledgeable about nutrition therapy patients on the risks of surgery, including one drink is defined as 12 oz beer, 5 oz and are supportive of the person with di- mortality, depression, hypoglycemia, nu- wine, or 1.5 oz distilled spirits. (A) abetes who needs to make lifestyle tritional deficiencies, osteoporosis, and ● Routine supplementation with antioxi- changes. weight regain over the long term. Very S12 DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006
  10. 10. Position Statement little data are currently available on the cause the brain and central nervous sys- Optimal macronutrient mix long-term consequences of surgery for tem have an absolute requirement for For those individuals seeking guidance weight loss in people with diabetes. The glucose as an energy source, restricting regarding macronutrient distribution, the potential benefits should be weighed total carbohydrate to 130 g/day is not DRIs may be helpful The DRI report rec- against short- and long-term risks (40). recommended. ommends that to meet the body’s daily Physical activity is an important com- nutritional needs while minimizing risk ponent of a comprehensive weight- Dietary protein for chronic diseases, adults (in general, management program. Regular In the U.S., mean protein intake from not specifically those with diabetes) moderate-intensity physical activity en- foods (not including supplements) ac- should consume 45– 65% of total energy hances long-term weight maintenance. counts for 15–20% of average energy in- from carbohydrate, 20 –35% from fat, Regular activity also improves insulin take, is fairly consistent across all ages and 10 –35% from protein (41). Although sensitivity, glycemic control, and selected from childhood to old age, and appears to numerous studies have attempted to risk factors for CVD (i.e., hypertension be similar in individuals with diabetes. identify the optimal combination of ma- and dyslipidemia), and increased aerobic The dietary reference intake (DRI)- cronutrients for those with diabetes, it is un- fitness decreases the risk of coronary heart acceptable macronutrient distribution likely that any one such combination of disease (CHD). Initial physical activity range for protein is 10 –35% of energy in- macronutrients exists. The best mix of car- recommendations should be modest, take and the RDA is 0.8 g high-quality bohydrate, protein, and fat appears to vary based on the patient’s willingness and protein kg body wt 1 day 1 (41). depending on individual circumstances. ability, gradually increasing the duration Dietary intake of protein is similar to and frequency to 30 – 45 min of moderate that of the general public in individuals Fiber aerobic activity, 3–5 days/week, when with diabetes and usually does not exceed Similar to the general population, people possible. Greater activity levels of at least 20% of energy intake. Intake of protein in with diabetes are encouraged to choose a 1 h/day of moderate (walking) or 30 min/ this range may be a risk factor for the de- variety of fiber-containing foods, such as day of vigorous (jogging) activity may be velopment of diabetic nephropathy (42). legumes, fiber-rich cereals ( 5 g fiber/ needed to achieve successful long-term Based on studies in patients with varying serving), as well as fruits, vegetables, and weight loss. stages of nephropathy (42– 44), it seems whole-grain products because they pro- prudent to limit protein intake in those vide vitamins, minerals, fiber, and other Dietary carbohydrate (36) with diabetes to the RDA (0.8 g/kg), substances important for good health. Regulation of blood glucose to achieve which would be 10% of total calories. near-normal levels is a primary goal in the management of diabetes, and thus, di- Dietary fat Reduced calorie sweetners etary techniques that limit hyperglycemia Saturated and trans fatty acids are the Reduced calorie sweeteners approved by following a meal are important in limiting principal dietary determinant of plasma the FDA include sugar alcohols (erythri- the complications of diabetes. Both the LDL cholesterol, the major risk factor for tol, hydrogenated starch hydrolysates, amount (grams) and type of carbohydrate CVD. In nondiabetic individuals, reduc- isomalt, lactitol, maltitol, mannitol, sorbi- in a food influence blood glucose level. ing saturated and trans fatty acids and tol, and xylitol) and tagatose. Studies us- The total amount of carbohydrate con- cholesterol intake decreases plasma total ing subjects with and without diabetes sumed is a strong predictor of glycemic and LDL cholesterol but may also reduce have shown that sugar alcohols produce a response, and thus, monitoring total HDL cholesterol. Importantly, the ratio of lower postprandial glucose response than grams of carbohydrate, whether by use of LDL to HDL cholesterol is not adversely sucrose or glucose and have lower avail- exchanges or carbohydrate counting, re- affected. Studies in individuals with dia- able energy. Sugar alcohols contain, on mains a key strategy in achieving glycemic betes demonstrating the effects of specific average, 2 calories/gram (one-half the control. A recent analysis of the random- percentages of dietary saturated and trans calories of other sweeteners such as su- ized controlled trials that have examined fatty acids and specific amounts of dietary crose). With foods containing sugar alco- the efficacy of the glycemic index (a mea- cholesterol on CVD risk are not available. hols, subtraction of one-half of sugar sure of the effect of type of carbohydrate) However, those with diabetes are consid- alcohol grams from total carbohydrate on overall blood glucose control indicates ered to be at similar risk to those with a grams is appropriate, particularly when that the use of this technique may provide past history of CVD. Therefore, because of using the carbohydrate counting method an additional benefit over that observed a lack of specific information, the goal for for meal planning. There is no evidence when total carbohydrate is considered dietary fat intake (amount and type) for that the amounts of sugar alcohol likely to alone. individuals with diabetes is the same as be consumed will result in significant re- Low-carbohydrate diets are not rec- for those without diabetes with a history duction in energy intake or long-term im- ommended in the management of diabe- of CVD. The most recent guidelines from provement in glycemia. The use of sugar tes. Although dietary carbohydrate is the the National Cholesterol Education Pro- alcohols appears to be safe. major contributor to postprandial glucose gram recommend that total fat be 25– The FDA has approved five nonnutri- concentration, it is an important source of 35% of total calories and saturated fat tive sweeteners for use in the U.S.: acesul- energy, water-soluble vitamins and min- 7% (34). Guidelines from the American fame potassium, aspartame, neotame, erals, and fiber. Thus, in agreement with Heart Association also recommend that saccharin, and sucralose. All have under- the National Academy of Sciences–Food saturated fat be 7% in those with diabe- gone rigorous scrutiny and have been and Nutrition Board (41), a recom- tes, given their increased risk of CVD shown to be safe when consumed by the mended range of carbohydrate intake is (45,46). Intake of trans fat should be public, including people with diabetes 45– 65% of total calories. In addition, be- minimized. and women who are pregnant. DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006 S13
  11. 11. Standards of Medical Care Antioxidants when their diabetes is diagnosed and as provement to evaluate the effectiveness of Since diabetes may be a state of increased needed thereafter. (B) the DSME provided and to identify op- oxidative stress, there has been interest in ● DSME should be provided by health portunities for improvement. prescribing antioxidant vitamins to indi- care providers who are qualified to pro- viduals with diabetes. While observa- vide that DSME based on their profes- Reimbursement for DSME tional studies have shown a correlation sional training and continuing DSME is reimbursed as part of the Medi- between dietary or supplemental con- education. (E) care program as overseen by the Center sumption of antioxidants and a variety of ● DSME should address psychosocial is- for Medicare and Medicaid Services clinical outcomes such as prevention of sues, since emotional well-being is (CMS) (http://www.hcfa.gov/coverage). disease states (35,47), large placebo- strongly associated with positive diabe- controlled clinical trials have failed to tes outcomes. (C) F. Physical activity show a benefit and, in some instances, ● DSME should be reimbursed by third- have suggested adverse effects (35,47). party payors. (E) Recommendations ● To improve glycemic control, assist Chromium DSME is an essential element of diabetes with weight maintenance, and reduce Several small studies have suggested a care (52–58), and National Standards for risk of CVD, at least 150 min/week of role for chromium supplementation in DSME are based on evidence for its ben- moderate-intensity aerobic physical ac- the management of glucose intolerance, efits. Education helps people with diabe- tivity (50 –70% of maximum heart rate) body weight, GDM, and corticosteroid- tes initiate effective self-care when they is recommended and/or at least 90 min/ induced diabetes (48 –50). Also, placebo- are first diagnosed. Ongoing DSME also week of vigorous aerobic exercise controlled studies conducted in China helps people with diabetes maintain effec- ( 70% of maximum heart rate). The found that chromium supplementation tive self-management as their diabetes physical activity should be distributed had beneficial effects on glycemia, al- presents new challenges and treatment over at least 3 days/week and with no though it is important to note that the advances become available. DSME helps more than 2 consecutive days without study population in China may have had patients optimize metabolic control, pre- physical activity. (A) vent and manage complications, and ● In the absence of contraindications, marginal baseline chromium status. A re- cent FDA statement indicated that there is maximize quality of life, in a cost-effective people with type 2 diabetes should be insufficient evidence to support any of the manner. encouraged to perform resistance exer- proposed health claims for chromium cise three times a week, targeting all supplementation. The FDA concluded Evidence for the benefits of DSME major muscle groups, progressing to that although a small study suggested that Since the 1990s, there has been a shift three sets of 8 –10 repetitions at a chromium picolinate may reduce the risk from a didactic approach with DSME fo- weight that cannot be lifted more than of insulin resistance, the existence of a re- cusing on providing information to a 8 –10 times. (A) lationship between chromium picolinate skill-based approach that focuses on and either insulin resistance or type 2 di- helping those with diabetes make in- Indications for graded exercise test abetes was highly uncertain (see “chro- formed self-management choices. Several with electrocardiogram monitoring studies have found that DSME is associ- ● A graded exercise test with electrocar- mium picolinate and insulin resistance” at www.cfsan.fda.gov/ dms/qhccr.html). ated with improved diabetes knowledge diogram (ECG) monitoring should be In addition, a meta-analysis of random- (53), improved self-care behavior (53), seriously considered before undertak- ized controlled trials suggested no benefit improved clinical outcomes such as lower ing aerobic physical activity with inten- of chromium picolinate supplementation A1C (54,55,57,58), lower self-reported sity exceeding the demands of everyday in reducing body weight (51). weight (53), and improved quality of life living (more intense than brisk walk- (56). Better outcomes were reported for ing) in previously sedentary diabetic in- DSME that were longer and included fol- dividuals whose 10-year risk of a Alcohol low-up support (53), were tailored to in- coronary event is likely to be 10%. For individuals with diabetes, the same dividual needs and preferences (52), and precautions apply regarding the use of al- addressed psychosocial issues (52, ADA technical reviews on exercise in pa- cohol that apply to the general popula- 53,57). tients with diabetes have summarized the tion. If individuals choose to use alcohol, value of exercise in the diabetes manage- alcohol-containing beverages should be The national standards for DSME ment plan (59,60). Regular exercise has limited to a moderate amount (less than ADA-recognized DSME programs have been shown to improve blood glucose one drink per day for adult women and staff that includes at least a registered control, reduce cardiovascular risk fac- less than two drinks per day for adult men). nurse and a registered dietitian; these staff tors, contribute to weight loss, and im- One alcohol containing beverage is defined must be certified diabetes educators or prove well-being. Furthermore, regular as 12 oz beer, 5 oz wine, or 1.5 oz distilled have recent experience in diabetes educa- exercise may prevent type 2 diabetes in spirits. Each contains 15 g alcohol. tion and management. The curriculum of high-risk individuals (8 –10). ADA-recognized DSME programs must E. DSME cover all areas of diabetes management, Definitions with the assessed needs of the individual The following definitions are based on Recommendations determining which areas are addressed. those outlined in “Physical Activity and ● People with diabetes should receive All ADA-recognized DSME programs uti- Health,” the 1996 report of the Surgeon DSME according to national standards lize a process of continuous quality im- General (61). Physical activity is defined S14 DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006
  12. 12. Position Statement as bodily movement produced by the late 30 min of moderate intensity activ- should be ingested if pre-exercise glucose contraction of skeletal muscle that re- ity on most, ideally all, days of the week. levels are 100 mg/dl (5.6 mmol/l) (71). quires energy expenditure in excess of The American College of Sports Medicine We agree with this recommendation for resting energy expenditure. Exercise is a now recommends resistance training be individuals on insulin and/or an insulin subset of physical activity: planned, struc- included in fitness programs for adults secretagogue. However, the revised tured, and repetitive bodily movement with type 2 diabetes (64). Resistance ex- guidelines clarify that supplementary car- performed to improve or maintain one or ercise improves insulin sensitivity to bohydrate is generally not necessary for more components of physical fitness. Aer- about the same extent as aerobic exercise individuals treated only with diet, met- obic exercise consists of rhythmic, re- (65). Two clinical trials published in 2002 formin, -glucosidase inhibitors and/or peated, and continuous movements of the provided strong evidence for the value of TZDs without insulin or a secretagogue same large muscle groups for at least 10 resistance training in type 2 diabetes (72). min at a time. Examples include walking, (66,67). bicycling, jogging, swimming, water aer- Exercise in the presence of specific obics, and many sports. Resistance exer- Evaluation of the diabetic patient long-term complications of diabetes cise consists of activities that use before recommending an exercise Retinopathy. In the presence of prolif- muscular strength to move a weight or program erative diabetic retinopathy (PDR) or se- work against a resistive load. Examples Before beginning a program of physical vere nonproliferative diabetic retinopathy include weight lifting and exercises using activity more vigorous than brisk walk- (NPDR), vigorous aerobic or resistance weight machines. ing, people with diabetes should be as- exercise may be contraindicated because sessed for conditions that might be of the risk of triggering vitreous hemor- Effects of structured exercise associated with increased likelihood of rhage or retinal detachment (73). interventions on glycemic control CVD or that might contraindicate certain Peripheral neuropathy. Decreased pain and body weight in type 2 diabetes types of exercise or predispose to injury, sensation in the extremities would result Boule et al. (62) undertook a systematic ´ such as uncontrolled hypertension, se- in increased risk of skin breakdown and review and meta-analysis on the effects of vere autonomic neuropathy, severe pe- infection and of Charcot joint destruc- structured exercise interventions in clini- ripheral neuropathy, and preproliferative tion. Therefore, in the presence of severe cal trials of duration 8 weeks on HbA1c or proliferative retinopathy or macular peripheral neuropathy, it may be best to and body mass in people with type 2 di- edema. The patient’s age and previous encourage non–weight-bearing activities abetes. Twelve aerobic training studies physical activity level should be consid- such as swimming, bicycling, or arm ex- and two resistance training studies were ered. ercises (74,75). included (totaling 504 subjects), and the A recent systematic review for the Autonomic neuropathy. Autonomic results were pooled using standard meta- U.S. Preventive Services Task Force came neuropathy can increase the risk of exer- analytic statistical methods. Postinterven- to the conclusion that stress tests should cise-induced injury by decreasing cardiac tion HbA1c was significantly lower in usually not be recommended to detect responsiveness to exercise, postural hy- exercise than control groups. Metaregres- ischemia in asymptomatic individuals at potension, impaired thermoregulation sion confirmed that the beneficial effect of low CAD risk ( 10% risk of a cardiac due to impaired skin blood flow and exercise on HbA1c was independent of event over 10 years) because the risks of sweating, impaired night vision due to any effect on body weight. Therefore, subsequent invasive testing triggered by impaired papillary reaction, impaired structured exercise programs had a statis- false-positive tests outweighed the ex- thirst increasing risk of dehydration, and tically and clinically significant beneficial pected benefits from detection of previ- gastroparesis with unpredictable food de- effect on glycemic control, and this effect ously unsuspected ischemia (68,69) livery (74). Autonomic neuropathy is also was not mediated primarily by weight strongly associated with CVD in people loss. Exercise in the presence of with diabetes (76,77). People with dia- Boule et al. (63) later undertook a ´ nonoptimal glycemic control betic autonomic neuropathy should defi- meta-analysis of the interrelationships Hyperglycemia. When people with type nitely undergo cardiac investigation among exercise intensity, exercise vol- 1 diabetes are deprived of insulin for before beginning physical activity more ume, change in cardiorespiratory fitness, 12– 48 h and ketotic, exercise can worsen intense than they are accustomed to. and change in HbA1c. This meta-analysis hyperglycemia and ketosis (70). Vigorous Microalbuminuria and nephropathy. provides support for higher-intensity aer- activity should probably be avoided in the Physical activity can acutely increase uri- obic exercise in people with type 2 diabe- presence of ketosis. Therefore, provided nary protein excretion. There is no evi- tes as a means of improving HbA1c. These the patient feels well and urine and/or dence from clinical trials or cohort studies results would provide support for en- blood ketones are negative, it is not nec- demonstrating that vigorous exercise in- couraging type 2 diabetic individuals who essary to postpone exercise based simply creases the rate of progression of diabetic are already exercising at moderate inten- on hyperglycemia. kidney disease. There may be no need for sity to consider increasing the intensity of Hypoglycemia. In individuals taking in- any specific exercise restrictions for peo- their exercise in order to obtain additional sulin and/or insulin secretagogues, phys- ple with diabetic kidney disease (78). benefits in both aerobic fitness and glyce- ical activity can cause hypoglycemia if mic control. medication dose or carbohydrate con- G. Psychosocial assessment and care sumption is not altered. Hypoglycemia Frequency of exercise would be rare in diabetic individuals who Recommendations The U.S. Surgeon General’s report (61) are not treated with insulin or insulin ● Preliminary assessment of psychologi- recommended that most people accumu- secretagogues. Added carbohydrate cal and social status should be included DIABETES CARE, VOLUME 29, SUPPLEMENT 1, JANUARY 2006 S15

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