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Agency for Healthcare Research and Quality

                                                              Evidence Report/Technology Assessment
                                                                                                                    Number 84




    Use of Glycated Hemoglobin and Microalbuminuria
           in the Monitoring of Diabetes Mellitus
                                                                  Summary


 Overview                                                                   Chemistry; it systematically reviews the literature
                                                                            identifying the risk relation between testing for
    Clinical testing to assess levels of disease control                    glycemic control or urine albumin and these
 and progression among persons with type 1 and                              important clinical outcomes.
 type 2 diabetes mellitus is widely recommended to
 clinicians to improve patients’ clinical outcomes.                         Glycemic Control
 Two important foci of recommendations for the                                 The advent of self-monitoring of blood glucose
 followup care of individuals with diabetes include                         (SMBG) has allowed patients to attain glycemic
 monitoring of glycemic status by measurement of                            goals more quickly and has revolutionized the care
 glycated hemoglobin (GHb) and screening for                                of individuals with diabetes mellitus; however, it
 kidney disease with urine albumin to assess overall                        does not provide information regarding glycemic
 disease progression and to detect potential                                control over an extended period of time.
 progression toward end-organ damage. According                             Measurement of glycated hemoglobin, which first
 to the American Diabetes Association’s Clinical                            began in the 1970s, has become the preferred
 Practice Recommendations, monitoring of                                    method of assessing long-term glycemic control.
 glycemic status is considered a cornerstone of                             Of the various GHb fractions, HbA1c is the
 diabetes care and affects how physicians and                               preferred standard for measuring glycemic control
 patients adjust medical therapy as well as                                 over the previous 2-3 months. The American
 behavioral therapy (e.g., diet and exercise).                              Diabetes Association began to make treatment
 Screening for urine albumin among persons with                             recommendations based on HbA1c following
 diabetes is also widely recommended for the                                publication of the results of the Diabetes Control
 detection and treatment of incipient diabetic                              and Complications Trial (DCCT) in the 1990s.
 nephropathy and affects the physician’s                                    The HbA1c has become the gold standard for the
 implementation of therapy to slow progression of                           therapeutic management of diabetes mellitus in
 kidney disease.                                                            research and in the clinical setting.
    Despite widespread recommendations for                                     Glycated hemoglobin testing gives an
 screening of persons with diabetes for both                                assessment of long-term glycemic control; but
 glycemic control and urine albumin, there has not                          what other prognostic information does it provide
 been a systematic assembly of the literature to                            in the management of individuals with diabetes
 assess the risk relation between tests assessing long-                     mellitus? Several large, randomized clinical trials
 term glycemic control or tests assessing the                               have demonstrated that intensive glycemic control
 presence of microalbuminuria with cardiovascular,                          prevents the development and progression of long-
 peripheral vascular, renal, and neurological                               term diabetic microvascular complications. In
 outcomes (all of which represent end-organ effects                         these studies, glycemic goals were assessed using
 of long-term diabetes). The report from which                              glycated hemoglobin as the measure of long-term
 this summary was developed was commissioned                                control. Long-term hyperglycemia, as measured
 by the American Association of Clinical                                    by glycated hemoglobin, is clearly related to the




U . S . D E PA R T M E N T O F H E A LT H A N D H U M A N S E R V I C E S • P u b l i c H e a l t h S e r v i c e
development of diabetic microvascular complications; however,          associated with urinary albumin excretion. Knowledge of the
its relation to the development of macrovascular complications         pooled magnitude of risk associated with current definitions of
is less clear. The relation of glycemic control and cardiovascular     microalbuminuria in addition to an improved understanding of
disease (CVD) in individuals with diabetes remains                     the risk relationship of varying levels of baseline albuminuria
controversial, with some studies demonstrating a positive              with cardiovascular and renal outcomes could have important
association and others showing no association. Another                 implications in screening and treatment recommendations for
important issue that is still an area of active investigation in the   persons with diabetes.
management of diabetes relates to whether there is a threshold
effect of glycated hemoglobin for microvascular and/or                 Reporting the Evidence
macrovascular complications. The issue of a threshold effect of          This report addresses the following key questions in persons
glycated hemoglobin has important implications for where the           with type 1 and type 2 diabetes mellitus:
HbA1c treatment targets are set to prevent diabetic
complications.                                                         Glycemic Control
Urine Albumin                                                          1. What is the risk relationship between glycated hemoglobin and
                                                                          the subsequent risk of microvascular diabetic complications
   Screening tests for microalbuminuria are recommended                   (retinopathy, nephropathy, neuropathy)?
annually for patients with type 1 diabetes of greater than 5
                                                                       2. What is the risk relationship between glycated hemoglobin and
years duration and for all patients with type 2 diabetes from the
                                                                          the subsequent risk of macrovascular diabetic complications
time of diagnosis. Twenty-four hour collection of urine for
                                                                          (coronary artery disease, cerebrovascular disease, peripheral
quantitative assessment of urinary albumin excretion rate is
                                                                          arterial disease)?
currently considered the gold standard measurement of
microalbuminuria. However, this method is frequently                   Urine Albumin
considered to be cumbersome and difficult to carry out in the
outpatient clinical setting, and it is subject to timing and           1. What is the risk relationship between microalbuminuria and
collection inaccuracies. Several other methods of testing, which          renal function?
are considered less difficult to perform in outpatient settings,       2. What is the risk relationship between microalbuminuria and
have been studied and have been demonstrated to have varying              cardiovascular disease and death?
degrees of correlation with 24 hour urine collection for the
detection of urinary albumin. These include random or “spot”           Methodology
testing of a morning urine specimen for urine albumin                     The Evidence-based Practice Center (EPC) recruited six
concentration or albumin-to-creatinine ratio, overnight or             technical and community experts to provide input into the
“timed” urine collections for estimation of albumin excretion          definition of the key questions and to review a draft of the
rates, and dipstick testing. While many experts now support            report. The EPC also recruited representatives from a range of
the use of random or first morning tests for urinary albumin-          other stakeholder organizations to serve as peer reviewers of the
to-creatinine ratio as a convenient and accurate approach to           draft evidence report. These stakeholder organizations included
screening patients, there is currently no clear consensus on           organizations of physicians, allied health professionals, and
standardized testing methods.                                          third party health care payers in addition to consumer
   In a variety of prospective studies, elevated urinary albumin       organizations.
excretion has been shown to be associated with increased risk of          Because of the divergent content of questions related to
progression of kidney disease toward end-stage renal disease           glycemic control and urine albumin, two separate teams of
(ESRD) as well as increased cardiovascular morbidity,                  investigators systematically reviewed literature in these two
cardiovascular mortality, and total mortality. However, few            areas. Investigators from each team executed systematic search
studies have systematically ascertained the magnitude of               strategies pertinent to each set of questions. Thus, search
increase in both renal and cardiovascular risk associated with         strategies and studies identified were different for questions on
microalbuminuria among persons with type 1 and persons with            glycemic control and urine albumin.
type 2 diabetes. Moreover, although observations of renal and
cardiovascular outcomes among persons classified as having             Glycemic Control
microalbuminuria by currently accepted standards have been                Articles published in the English language from 1966, when
reported, it remains unclear whether current definitions of            MEDLINE® began indexing, to April 2002 were accessed
microalbuminuria are optimal in terms of predicting renal and          through PubMed® using MESH and text words for glycated
cardiovascular outcomes. It is unclear as well whether there is a      hemoglobin, diabetes, and individual diabetic complications,
dose-relationship or threshold effect in prediction of outcomes


2
including retinopathy, nephropathy, neuropathy, and                    defined as an abnormal neurological exam, subjective
cardiovascular disease.                                                symptoms, abnormal biothesiometry, or abnormal nerve
   Reviewed studies were restricted to prospective longitudinal        conduction study. Autonomic neuropathy was defined as
cohort studies, non-concurrent prospective cohort studies, and         abnormal R-R interval, orthostatic hypotension, or resting
clinical trials that had data on GHb exposure and outcome data         tachycardia.
on individual microvascular and macrovascular complications          Macrovascular Outcomes
during at least 1 year of followup in at least 50 participants       • Coronary artery disease (CAD)—CAD morbidity was
with type 1 and type 2 diabetes. Because the investigators were        defined as non-fatal myocardial infarction, angina, ischemic
interested in determining the risk relationship between GHb            heart disease, congestive heart failure secondary to ischemic
exposure and microvascular and macrovascular complications             heart disease, coronary artery bypass surgery, and
and in re-examining whether a threshold exists for this                angioplasty. CAD mortality was defined as fatal
relationship, only studies that reported prospective, quantitative     myocardial infarction or sudden cardiac death.
risk data (i.e., incidence rates, regression coefficients with       • Cerebrovascular disease—Cerebrovascular morbidity was
standard errors reported separately, relative hazards, relative        defined as non-fatal stroke, transient ischemic attack, or
odds, relative risk) were included. Retrospective case-control         need for carotid endarterectomy. Cerebrovascular mortality
studies that reported and compared previous GHb values in              was defined as fatal stroke.
individuals with a given outcome versus those without a given
outcome were excluded. Articles that reported data in                • Peripheral arterial disease (PAD)—PAD was defined as
graphical form in which specific quantitative values could not         claudication, peripheral revascularization procedure
be determined were excluded.                                           (angioplasty, bypass surgery, stenting), gangrene, limb
                                                                       amputation, decreased ankle-brachial index, and decreased
   Other exclusion criteria included review articles, animal or in     arm-toe gradient.
vitro studies, non-English language, and studies in which the
design was unclear.                                                  • Others—Outcome data were collected on congestive heart
                                                                       failure not related to ischemic heart disease and presence of
Exposure Variables                                                     atherosclerosis (i.e. carotid intimal-medial thickness,
    Glycated hemoglobin—Data were abstracted on the                    abdominal aortic aneurysm).
biochemical method of measurement, whether the method was            Urine Albumin
traceable to the DCCT standard and/or whether the lab was
certified by the National Glycohemoglobin Standardization                Articles published in the English language from 1966 to
Program (NGSP), and how glycated hemoglobin was reported             April 2002 were identified by searching PubMed® using
(i.e. HbA1c, HbA1, total GHb).                                       MESH and text words for diabetes, proteinuria, and
    Diabetes mellitus—Data were extracted on the type of             cardiovascular or renal outcomes. To obtain additional
diabetes that study participants had and the method of               references not otherwise identified through the electronic
diagnosis/confirmation.                                              search, the investigators searched bibliographies of relevant
                                                                     primary and review articles from the electronic search.
Outcome Variables                                                        After identification of citations through PubMed®, all
Microvascular Outcomes                                               abstracts were reviewed for relevance by a single abstractor. All
• Retinopathy—Incident retinopathy was defined as new                articles to be potentially included in the final review underwent
   onset retinopathy, progression of pre-existing retinopathy,       double review by study authors for data abstraction. Differences
   cataract extraction, incident macular edema, need for focal       in opinion were resolved through consensus adjudication. Data
   or scatter photocoagulation, blindness, or change in visual       abstracted included the following: 1) study design, 2) study
   acuity.                                                           location, 3) numbers of study subjects enrolled, 4) study
                                                                     exclusion criteria, 5) type of diabetes studied and numbers of
• Nephropathy—Incident nephropathy was defined as
                                                                     persons with each type of diabetes included in study, 6)
   development of microalbuminuria and progression of
                                                                     measurement and definitions of microalbuminuria, 7)
   nephropathy as progression from microalbuminuria to
                                                                     descriptive information about study participants (including age,
   macroalbuminuria or progression to ESRD requiring renal
                                                                     gender, race, duration of diabetes, glycemic control, baseline
   replacement therapy. Other nephropathy outcomes
                                                                     diastolic and systolic blood pressure), 8) baseline and followup
   included change in glomerular filtration rate/creatinine
                                                                     measures of urinary albumin excretion, and 9) baseline and
   clearance.
                                                                     followup measures of kidney function (e.g., serum creatinine,
• Neuropathy—Data on peripheral and autonomic                        creatinine clearance, or direct measurement of glomerular
   neuropathy were recorded. Peripheral neuropathy was               filtration rates). For randomized controlled trials featuring


                                                                                                                                     3
medication interventions (e.g., ACE inhibitors vs. other anti-       Findings
hypertension agents), the type of medication, dose, and
frequency were also recorded.                                        Glycemic Control
Exposure Variables                                                   1. What is the risk relationship between glycated hemoglobin and
• Urine albumin—Data were abstracted on the biochemical                 the subsequent risk of microvascular diabetic complications
    method of urine measurement, including the timing of                (retinopathy, nephropathy, neuropathy) in individuals with
    urine specimens and the cutoffs used to define different            type 1 and type 2 diabetes?
    levels of urine albumin exposure at baseline.                       • The evidence reported supports a strong, graded relation
    Microalbuminuria was classified according to the method                 between GHb exposure and the risk of two major
    of ascertainment in each study. Studies reporting only on               microvascular complications of type 1 and type 2
    persons with macroalbuminuria (levels greater than those                diabetes, retinopathy and nephropathy. These patterns
    defined above, unless authors defined microalbuminuria in               are observed for various measures of glycated
    some other fashion) were excluded from analysis.                        hemoglobin (i.e., HbA1c, HbA1, and total GHb).
• Diabetes mellitus—Data were extracted on study                        • The preponderance of the evidence from cohort studies
    participants’ type of diabetes and the reported method of               shows a strong relation between glycated hemoglobin
    diagnosis/confirmation of diabetes within each study.                   and incident retinopathy, incident proliferative
Outcome Variables                                                           retinopathy and macular edema, and progression of
• Renal outcomes—Outcomes reflecting decline in renal                       retinopathy. Compared to the lowest categories of GHb
    function over time were divided into eight categories: 1)               exposure, the unadjusted relative risks for incident
    change in glomerular filtration rate (GFR) at end of study,             retinopathy were 4 to 7 times greater in the highest
    2) rate of change in GFR, 3) change in creatinine clearance             categories of GHb exposure for type 1 diabetes and 1.5
    at end of study, 4) rate of change in creatinine clearance, 5)          to 2.5 times greater in individuals with type 2 diabetes.
    change in 1/serum creatinine at end of study, 6) rate of                The unadjusted relative risk for proliferative retinopathy
    change in 1/serum creatinine, 7) doubling of serum                      was 6 to 7 times greater in individuals in the highest
    creatinine, or 8) need for renal replacement therapy,                   category of GHb exposure compared to the lowest
    including dialysis and transplantation.                                 category for individuals with type 1 diabetes, and the
                                                                            unadjusted relative risk was 3 to 13 times greater for
• Cardiovascular outcomes—Cardiovascular outcomes were
                                                                            individuals with type 2 diabetes although fewer studies
    defined as: 1) incidence of all cause death, 2) incidence of            examined this outcome in type 2 diabetes.
    composite CVD deaths, 3) incidence of death due to
                                                                        • This relation between GHb exposure and retinopathy is
    myocardial infarction, 4) incidence of death due to
                                                                            confirmed in several randomized clinical trials of
    cerebrovascular accident, 5) incidence of CVD morbidity,
                                                                            individuals with type 1 and type 2 diabetes, which show
    and 6) incidence of composite CVD morbidity and
                                                                            comparable risk reductions in these outcomes in
    mortality.
                                                                            individuals randomized to intensive therapy, where the
   Coronary artery disease, cerebrovascular disease, peripheral             HbA1c levels were maintained at approximately 7
arterial disease, and other outcome variables (congestive heart             percent, compared to individuals randomized to
failure not related to ischemic heart disease and presence of               conventional therapy, where the mean HbA1c levels
atherosclerosis) are the same as described for glycemic control             were maintained at approximately 9 percent.
(see above).                                                            • Only a few studies address the relation between glycated
Data Abstraction and Analysis                                               hemoglobin and the risk of blindness; however, the
                                                                            majority suggest that increased glycated hemoglobin is a
   Two investigators reviewed titles and abstracts of identified            risk factor for blindness in individuals with type 1
articles and appropriate studies were selected for data                     diabetes. With the exception of one cohort study and
abstraction. Articles chosen for abstraction were reviewed by               one clinical trial, there are virtually no data on the
two reviewers to ensure that all relevant data had been obtained            relation between glycated hemoglobin and risk of
and were correct.                                                           blindness in individuals with type 2 diabetes.
                                                                        • There are very few studies examining the relation
                                                                            between glycated hemoglobin and the incidence of
                                                                            cataracts.
                                                                        • The majority of studies evaluating the relation between
                                                                            glycated hemoglobin and the risk of nephropathy have



4
evaluated the risk of developing microalbuminuria.                     of autonomic neuropathy in individuals with type 2
    These data show a strong and significant relation                      diabetes.
    between glycated hemoglobin and the risk of                     2. What is the risk relationship between glycated hemoglobin and
    microalbuminuria in individuals with type 1 and type 2             macrovascular diabetic complications (coronary artery disease,
    diabetes. Compared to individuals in the lowest                    cerebrovascular disease, and peripheral arterial disease) in
    category of GHb exposure, those in the highest category            individuals with type 1 and type 2 diabetes?
    had an unadjusted increased risk of microalbuminuria               • In the cohort studies evaluating cardiovascular outcomes
    that was 3 to 9 times greater for type 1 diabetes and an               in individuals with diabetes, there was a positive
    increased risk of microalbuminuria that was 1.4 to 8                   association with GHb exposure; however, the risk
    times greater for type 2 diabetes. This is supported by                estimates are much smaller compared to the risk
    clinical trial data that show significant risk reductions for          estimates for the microvascular complications.
    incident microalbuminuria for individuals randomized
                                                                       • The preponderance of the evidence from cohort studies
    to intensive glycemic control, where, as noted above, the
                                                                           shows a positive association between glycated
    mean HbA1c levels were maintained at approximately 7
                                                                           hemoglobin and risk of fatal and non-fatal coronary
    percent, compared to those randomized to conventional
                                                                           artery disease, particularly among individuals with type
    glycemic control, where the mean HbA1c levels were
                                                                           2 diabetes. Compared to those in the highest category
    maintained at approximately 9 percent. Among
                                                                           of GHb exposure, the unadjusted risk of fatal and non-
    individuals with type 1 diabetes, the unadjusted relative
                                                                           fatal coronary artery disease was 50 percent to 70
    risk reductions were 34 percent to 43 percent, compared
                                                                           percent (relative risk, 1.5 to 1.7) greater than for those
    to 60 percent to 74 percent for individuals with type 2
                                                                           in the lowest category of exposure.
    diabetes.
                                                                       • There are few data on the relation between CAD and
•   Although fewer data exist on the relation between
                                                                           glycated hemoglobin among individuals with type 1
    glycated hemoglobin and risk of macroalbuminuria and
                                                                           diabetes; however most studies have shown a positive
    on the relation between glycated hemoglobin and the
                                                                           association.
    risk of nephropathy progression, several cohort studies
    and clinical trials support a strong and significant               • The relation between glycated hemoglobin and the risk
    positive association in individuals with type 1 and type 2             of PAD appears to be strong and positive in individuals
    diabetes.                                                              with type 1 and type 2 diabetes. Compared to those in
                                                                           the lowest category of GHb exposure, the unadjusted
•   The only studies identified by the search strategy and
                                                                           risk of PAD was 5 to 6 time greater in individuals in the
    inclusion criteria examining the effect of GHb exposure
                                                                           highest category of exposure among individuals with
    on GFR were cohort studies conducted in individuals
                                                                           type 1 diabetes, and the risk was 2 to 4 times greater
    with type 1 diabetes. All studies consistently
                                                                           among individuals with type 2 diabetes.
    demonstrated that increasing levels of glycated
    hemoglobin were associated with a decline in GFR.                  • The risk relationship between cerebrovascular disease
    There are no clinical trial data examining the GFR                     and glycated hemoglobin, which has only been
    outcomes and no data on the relation between glycated                  examined among individuals with type 2 diabetes, is less
    hemoglobin and GFR in individuals with type 2                          clear.
    diabetes.                                                          • There are very few data on the relation between GHb
•   Very few studies examined the association between                      exposure and congestive heart failure or subclinical
    glycated hemoglobin and the risk of ESRD.                              atherosclerosis, assessed by carotid intimal-medial
                                                                           thickness, making it difficult to draw any conclusions
•   Among individuals with type 1 diabetes, there appears
                                                                           regarding these outcomes.
    to be a strong, positive association between glycated
    hemoglobin and the risk of peripheral neuropathy in                • Only a few studies have examined the presence of a
    both cohort studies and clinical trials; however, the                  threshold effect of glycated hemoglobin on the risk of
    evidence of an association between glycated hemoglobin                 developing diabetic complications (i.e. a level of glycated
    and peripheral neuropathy in individuals with type 2                   hemoglobin above which there is a non-constant or
    diabetes yields conflicting results.                                   exponential increase in risk of complications). The
                                                                           majority of these studies have not found a threshold
•   There are fewer data on the association between glycated
                                                                           effect for retinopathy and nephropathy outcomes but,
    hemoglobin and the risk of autonomic neuropathy. In
                                                                           rather, have demonstrated a continuous risk of
    individuals with type 1 diabetes, there appears to be a
                                                                           complications with increasing GHb levels. There are
    positive association. There are also very limited data on
                                                                           very few studies that have attempted to examine the
    the relation between glycated hemoglobin and the risk


                                                                                                                                     5
presence of a threshold effect of glycated hemoglobin on      Future Research
       neuropathy and macrovascular outcomes.
                                                                        For research on glycemic control, future cohort studies and
Urine Albumin                                                        clinical trials should focus on studying the relation between
1. What is the risk relationship between microalbuminuria and        GHb exposure and the risk of macrovascular complications.
   renal function?                                                   Fewer data are available on these outcomes than on
   • Eleven studies reported on this question. The analyses          microvascular outcomes; however, more data are also needed on
       had important limitations including broad variation in        the relation between glycated hemoglobin and the risk of
       methods of assessing levels of urine albumin excretion as     neuropathy, particularly the risk of peripheral and autonomic
       well as substantial heterogeneity in reporting of renal       neuropathy in individuals with type 2 diabetes.
       outcomes.                                                        For research on urine albumin, future work should seek to
   • The preponderance of evidence suggests that the                 define the optimal and most feasible tests for measuring
       presence of microalbuminuria at baseline is associated        microalbuminuria and to standardize measurement of
       with progression of chronic kidney disease.                   microalbuminuria. Future research should also characterize the
   • The relation of urine albumin excretion at baseline to          nature of the relation (e.g. threshold versus linear) between
       progression of chronic kidney disease appears graded;         microalbuminuria and outcomes. In addition, further work is
       higher levels of urine albumin excretion at baseline are      needed to understand whether currently accepted definitions of
       associated with a greater magnitude of decrease in renal      microalbuminuria are optimal in predicting future renal and
       function as well as a faster rate of decline in renal         cardiovascular outcomes.
       function over time.                                              Extension of research in both these areas has important
2. What is the risk relationship between microalbuminuria,           future implications for gaining improved understanding of the
   cardiovascular disease, and death?                                role of glycemic control in the prevention of the cardiovascular
   • Nineteen studies reported on cardiovascular morbidity           sequelae as well as for future development of guidelines for
       and mortality, and 24 reported on all-cause mortality.        screening practices among persons with type 1 and type 2
       The analyses had important limitations including broad        diabetes mellitus.
       variation in methods of assessing levels of urine albumin
       excretion as well as few studies focusing on disease-         Ordering Information
       specific cardiovascular morbidity or mortality.                  The full evidence report from which this summary was taken
   • The preponderance of evidence from these studies                was prepared for AHRQ by the Johns Hopkins Evidence-based
       demonstrates an association between microalbuminuria          Practice Center, Baltimore, MD, under contract No. 290-97-
       at baseline and increased risk of cardiovascular              0006. It is expected to be available in late summer 2003. At
       morbidity, cardiovascular mortality, and all-cause            that time, printed copies may be obtained free of charge from
       mortality.                                                    the AHRQ Publications Clearinghouse by calling 800-358-
   • The relation of urine albumin excretion at baseline to          9295. Requesters should ask for Evidence Report/Technology
       cardiovascular morbidity, cardiovascular mortality, and       Assessment No. 84, Use of Glycated Hemoglobin and
       all-cause mortality appears graded; greater levels of urine   Microalbuminuria in the Monitoring of Diabetes Mellitus.
       albumin excretion at baseline are independently               Internet users will be able to access the report online through
       associated with a greater magnitude of risk of                AHRQ’s Web site at www.ahrq.gov.
       cardiovascular morbidity, cardiovascular mortality, and
       all-cause mortality over time.




                                                                                                                  www.ahrq.gov
                                                                                                          AHRQ Pub. No. 03-E048
                                                                                                                      July 2003

                                                                                                                   ISSN 1530-440X

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Glycasum

  • 1. Agency for Healthcare Research and Quality Evidence Report/Technology Assessment Number 84 Use of Glycated Hemoglobin and Microalbuminuria in the Monitoring of Diabetes Mellitus Summary Overview Chemistry; it systematically reviews the literature identifying the risk relation between testing for Clinical testing to assess levels of disease control glycemic control or urine albumin and these and progression among persons with type 1 and important clinical outcomes. type 2 diabetes mellitus is widely recommended to clinicians to improve patients’ clinical outcomes. Glycemic Control Two important foci of recommendations for the The advent of self-monitoring of blood glucose followup care of individuals with diabetes include (SMBG) has allowed patients to attain glycemic monitoring of glycemic status by measurement of goals more quickly and has revolutionized the care glycated hemoglobin (GHb) and screening for of individuals with diabetes mellitus; however, it kidney disease with urine albumin to assess overall does not provide information regarding glycemic disease progression and to detect potential control over an extended period of time. progression toward end-organ damage. According Measurement of glycated hemoglobin, which first to the American Diabetes Association’s Clinical began in the 1970s, has become the preferred Practice Recommendations, monitoring of method of assessing long-term glycemic control. glycemic status is considered a cornerstone of Of the various GHb fractions, HbA1c is the diabetes care and affects how physicians and preferred standard for measuring glycemic control patients adjust medical therapy as well as over the previous 2-3 months. The American behavioral therapy (e.g., diet and exercise). Diabetes Association began to make treatment Screening for urine albumin among persons with recommendations based on HbA1c following diabetes is also widely recommended for the publication of the results of the Diabetes Control detection and treatment of incipient diabetic and Complications Trial (DCCT) in the 1990s. nephropathy and affects the physician’s The HbA1c has become the gold standard for the implementation of therapy to slow progression of therapeutic management of diabetes mellitus in kidney disease. research and in the clinical setting. Despite widespread recommendations for Glycated hemoglobin testing gives an screening of persons with diabetes for both assessment of long-term glycemic control; but glycemic control and urine albumin, there has not what other prognostic information does it provide been a systematic assembly of the literature to in the management of individuals with diabetes assess the risk relation between tests assessing long- mellitus? Several large, randomized clinical trials term glycemic control or tests assessing the have demonstrated that intensive glycemic control presence of microalbuminuria with cardiovascular, prevents the development and progression of long- peripheral vascular, renal, and neurological term diabetic microvascular complications. In outcomes (all of which represent end-organ effects these studies, glycemic goals were assessed using of long-term diabetes). The report from which glycated hemoglobin as the measure of long-term this summary was developed was commissioned control. Long-term hyperglycemia, as measured by the American Association of Clinical by glycated hemoglobin, is clearly related to the U . S . D E PA R T M E N T O F H E A LT H A N D H U M A N S E R V I C E S • P u b l i c H e a l t h S e r v i c e
  • 2. development of diabetic microvascular complications; however, associated with urinary albumin excretion. Knowledge of the its relation to the development of macrovascular complications pooled magnitude of risk associated with current definitions of is less clear. The relation of glycemic control and cardiovascular microalbuminuria in addition to an improved understanding of disease (CVD) in individuals with diabetes remains the risk relationship of varying levels of baseline albuminuria controversial, with some studies demonstrating a positive with cardiovascular and renal outcomes could have important association and others showing no association. Another implications in screening and treatment recommendations for important issue that is still an area of active investigation in the persons with diabetes. management of diabetes relates to whether there is a threshold effect of glycated hemoglobin for microvascular and/or Reporting the Evidence macrovascular complications. The issue of a threshold effect of This report addresses the following key questions in persons glycated hemoglobin has important implications for where the with type 1 and type 2 diabetes mellitus: HbA1c treatment targets are set to prevent diabetic complications. Glycemic Control Urine Albumin 1. What is the risk relationship between glycated hemoglobin and the subsequent risk of microvascular diabetic complications Screening tests for microalbuminuria are recommended (retinopathy, nephropathy, neuropathy)? annually for patients with type 1 diabetes of greater than 5 2. What is the risk relationship between glycated hemoglobin and years duration and for all patients with type 2 diabetes from the the subsequent risk of macrovascular diabetic complications time of diagnosis. Twenty-four hour collection of urine for (coronary artery disease, cerebrovascular disease, peripheral quantitative assessment of urinary albumin excretion rate is arterial disease)? currently considered the gold standard measurement of microalbuminuria. However, this method is frequently Urine Albumin considered to be cumbersome and difficult to carry out in the outpatient clinical setting, and it is subject to timing and 1. What is the risk relationship between microalbuminuria and collection inaccuracies. Several other methods of testing, which renal function? are considered less difficult to perform in outpatient settings, 2. What is the risk relationship between microalbuminuria and have been studied and have been demonstrated to have varying cardiovascular disease and death? degrees of correlation with 24 hour urine collection for the detection of urinary albumin. These include random or “spot” Methodology testing of a morning urine specimen for urine albumin The Evidence-based Practice Center (EPC) recruited six concentration or albumin-to-creatinine ratio, overnight or technical and community experts to provide input into the “timed” urine collections for estimation of albumin excretion definition of the key questions and to review a draft of the rates, and dipstick testing. While many experts now support report. The EPC also recruited representatives from a range of the use of random or first morning tests for urinary albumin- other stakeholder organizations to serve as peer reviewers of the to-creatinine ratio as a convenient and accurate approach to draft evidence report. These stakeholder organizations included screening patients, there is currently no clear consensus on organizations of physicians, allied health professionals, and standardized testing methods. third party health care payers in addition to consumer In a variety of prospective studies, elevated urinary albumin organizations. excretion has been shown to be associated with increased risk of Because of the divergent content of questions related to progression of kidney disease toward end-stage renal disease glycemic control and urine albumin, two separate teams of (ESRD) as well as increased cardiovascular morbidity, investigators systematically reviewed literature in these two cardiovascular mortality, and total mortality. However, few areas. Investigators from each team executed systematic search studies have systematically ascertained the magnitude of strategies pertinent to each set of questions. Thus, search increase in both renal and cardiovascular risk associated with strategies and studies identified were different for questions on microalbuminuria among persons with type 1 and persons with glycemic control and urine albumin. type 2 diabetes. Moreover, although observations of renal and cardiovascular outcomes among persons classified as having Glycemic Control microalbuminuria by currently accepted standards have been Articles published in the English language from 1966, when reported, it remains unclear whether current definitions of MEDLINE® began indexing, to April 2002 were accessed microalbuminuria are optimal in terms of predicting renal and through PubMed® using MESH and text words for glycated cardiovascular outcomes. It is unclear as well whether there is a hemoglobin, diabetes, and individual diabetic complications, dose-relationship or threshold effect in prediction of outcomes 2
  • 3. including retinopathy, nephropathy, neuropathy, and defined as an abnormal neurological exam, subjective cardiovascular disease. symptoms, abnormal biothesiometry, or abnormal nerve Reviewed studies were restricted to prospective longitudinal conduction study. Autonomic neuropathy was defined as cohort studies, non-concurrent prospective cohort studies, and abnormal R-R interval, orthostatic hypotension, or resting clinical trials that had data on GHb exposure and outcome data tachycardia. on individual microvascular and macrovascular complications Macrovascular Outcomes during at least 1 year of followup in at least 50 participants • Coronary artery disease (CAD)—CAD morbidity was with type 1 and type 2 diabetes. Because the investigators were defined as non-fatal myocardial infarction, angina, ischemic interested in determining the risk relationship between GHb heart disease, congestive heart failure secondary to ischemic exposure and microvascular and macrovascular complications heart disease, coronary artery bypass surgery, and and in re-examining whether a threshold exists for this angioplasty. CAD mortality was defined as fatal relationship, only studies that reported prospective, quantitative myocardial infarction or sudden cardiac death. risk data (i.e., incidence rates, regression coefficients with • Cerebrovascular disease—Cerebrovascular morbidity was standard errors reported separately, relative hazards, relative defined as non-fatal stroke, transient ischemic attack, or odds, relative risk) were included. Retrospective case-control need for carotid endarterectomy. Cerebrovascular mortality studies that reported and compared previous GHb values in was defined as fatal stroke. individuals with a given outcome versus those without a given outcome were excluded. Articles that reported data in • Peripheral arterial disease (PAD)—PAD was defined as graphical form in which specific quantitative values could not claudication, peripheral revascularization procedure be determined were excluded. (angioplasty, bypass surgery, stenting), gangrene, limb amputation, decreased ankle-brachial index, and decreased Other exclusion criteria included review articles, animal or in arm-toe gradient. vitro studies, non-English language, and studies in which the design was unclear. • Others—Outcome data were collected on congestive heart failure not related to ischemic heart disease and presence of Exposure Variables atherosclerosis (i.e. carotid intimal-medial thickness, Glycated hemoglobin—Data were abstracted on the abdominal aortic aneurysm). biochemical method of measurement, whether the method was Urine Albumin traceable to the DCCT standard and/or whether the lab was certified by the National Glycohemoglobin Standardization Articles published in the English language from 1966 to Program (NGSP), and how glycated hemoglobin was reported April 2002 were identified by searching PubMed® using (i.e. HbA1c, HbA1, total GHb). MESH and text words for diabetes, proteinuria, and Diabetes mellitus—Data were extracted on the type of cardiovascular or renal outcomes. To obtain additional diabetes that study participants had and the method of references not otherwise identified through the electronic diagnosis/confirmation. search, the investigators searched bibliographies of relevant primary and review articles from the electronic search. Outcome Variables After identification of citations through PubMed®, all Microvascular Outcomes abstracts were reviewed for relevance by a single abstractor. All • Retinopathy—Incident retinopathy was defined as new articles to be potentially included in the final review underwent onset retinopathy, progression of pre-existing retinopathy, double review by study authors for data abstraction. Differences cataract extraction, incident macular edema, need for focal in opinion were resolved through consensus adjudication. Data or scatter photocoagulation, blindness, or change in visual abstracted included the following: 1) study design, 2) study acuity. location, 3) numbers of study subjects enrolled, 4) study exclusion criteria, 5) type of diabetes studied and numbers of • Nephropathy—Incident nephropathy was defined as persons with each type of diabetes included in study, 6) development of microalbuminuria and progression of measurement and definitions of microalbuminuria, 7) nephropathy as progression from microalbuminuria to descriptive information about study participants (including age, macroalbuminuria or progression to ESRD requiring renal gender, race, duration of diabetes, glycemic control, baseline replacement therapy. Other nephropathy outcomes diastolic and systolic blood pressure), 8) baseline and followup included change in glomerular filtration rate/creatinine measures of urinary albumin excretion, and 9) baseline and clearance. followup measures of kidney function (e.g., serum creatinine, • Neuropathy—Data on peripheral and autonomic creatinine clearance, or direct measurement of glomerular neuropathy were recorded. Peripheral neuropathy was filtration rates). For randomized controlled trials featuring 3
  • 4. medication interventions (e.g., ACE inhibitors vs. other anti- Findings hypertension agents), the type of medication, dose, and frequency were also recorded. Glycemic Control Exposure Variables 1. What is the risk relationship between glycated hemoglobin and • Urine albumin—Data were abstracted on the biochemical the subsequent risk of microvascular diabetic complications method of urine measurement, including the timing of (retinopathy, nephropathy, neuropathy) in individuals with urine specimens and the cutoffs used to define different type 1 and type 2 diabetes? levels of urine albumin exposure at baseline. • The evidence reported supports a strong, graded relation Microalbuminuria was classified according to the method between GHb exposure and the risk of two major of ascertainment in each study. Studies reporting only on microvascular complications of type 1 and type 2 persons with macroalbuminuria (levels greater than those diabetes, retinopathy and nephropathy. These patterns defined above, unless authors defined microalbuminuria in are observed for various measures of glycated some other fashion) were excluded from analysis. hemoglobin (i.e., HbA1c, HbA1, and total GHb). • Diabetes mellitus—Data were extracted on study • The preponderance of the evidence from cohort studies participants’ type of diabetes and the reported method of shows a strong relation between glycated hemoglobin diagnosis/confirmation of diabetes within each study. and incident retinopathy, incident proliferative Outcome Variables retinopathy and macular edema, and progression of • Renal outcomes—Outcomes reflecting decline in renal retinopathy. Compared to the lowest categories of GHb function over time were divided into eight categories: 1) exposure, the unadjusted relative risks for incident change in glomerular filtration rate (GFR) at end of study, retinopathy were 4 to 7 times greater in the highest 2) rate of change in GFR, 3) change in creatinine clearance categories of GHb exposure for type 1 diabetes and 1.5 at end of study, 4) rate of change in creatinine clearance, 5) to 2.5 times greater in individuals with type 2 diabetes. change in 1/serum creatinine at end of study, 6) rate of The unadjusted relative risk for proliferative retinopathy change in 1/serum creatinine, 7) doubling of serum was 6 to 7 times greater in individuals in the highest creatinine, or 8) need for renal replacement therapy, category of GHb exposure compared to the lowest including dialysis and transplantation. category for individuals with type 1 diabetes, and the unadjusted relative risk was 3 to 13 times greater for • Cardiovascular outcomes—Cardiovascular outcomes were individuals with type 2 diabetes although fewer studies defined as: 1) incidence of all cause death, 2) incidence of examined this outcome in type 2 diabetes. composite CVD deaths, 3) incidence of death due to • This relation between GHb exposure and retinopathy is myocardial infarction, 4) incidence of death due to confirmed in several randomized clinical trials of cerebrovascular accident, 5) incidence of CVD morbidity, individuals with type 1 and type 2 diabetes, which show and 6) incidence of composite CVD morbidity and comparable risk reductions in these outcomes in mortality. individuals randomized to intensive therapy, where the Coronary artery disease, cerebrovascular disease, peripheral HbA1c levels were maintained at approximately 7 arterial disease, and other outcome variables (congestive heart percent, compared to individuals randomized to failure not related to ischemic heart disease and presence of conventional therapy, where the mean HbA1c levels atherosclerosis) are the same as described for glycemic control were maintained at approximately 9 percent. (see above). • Only a few studies address the relation between glycated Data Abstraction and Analysis hemoglobin and the risk of blindness; however, the majority suggest that increased glycated hemoglobin is a Two investigators reviewed titles and abstracts of identified risk factor for blindness in individuals with type 1 articles and appropriate studies were selected for data diabetes. With the exception of one cohort study and abstraction. Articles chosen for abstraction were reviewed by one clinical trial, there are virtually no data on the two reviewers to ensure that all relevant data had been obtained relation between glycated hemoglobin and risk of and were correct. blindness in individuals with type 2 diabetes. • There are very few studies examining the relation between glycated hemoglobin and the incidence of cataracts. • The majority of studies evaluating the relation between glycated hemoglobin and the risk of nephropathy have 4
  • 5. evaluated the risk of developing microalbuminuria. of autonomic neuropathy in individuals with type 2 These data show a strong and significant relation diabetes. between glycated hemoglobin and the risk of 2. What is the risk relationship between glycated hemoglobin and microalbuminuria in individuals with type 1 and type 2 macrovascular diabetic complications (coronary artery disease, diabetes. Compared to individuals in the lowest cerebrovascular disease, and peripheral arterial disease) in category of GHb exposure, those in the highest category individuals with type 1 and type 2 diabetes? had an unadjusted increased risk of microalbuminuria • In the cohort studies evaluating cardiovascular outcomes that was 3 to 9 times greater for type 1 diabetes and an in individuals with diabetes, there was a positive increased risk of microalbuminuria that was 1.4 to 8 association with GHb exposure; however, the risk times greater for type 2 diabetes. This is supported by estimates are much smaller compared to the risk clinical trial data that show significant risk reductions for estimates for the microvascular complications. incident microalbuminuria for individuals randomized • The preponderance of the evidence from cohort studies to intensive glycemic control, where, as noted above, the shows a positive association between glycated mean HbA1c levels were maintained at approximately 7 hemoglobin and risk of fatal and non-fatal coronary percent, compared to those randomized to conventional artery disease, particularly among individuals with type glycemic control, where the mean HbA1c levels were 2 diabetes. Compared to those in the highest category maintained at approximately 9 percent. Among of GHb exposure, the unadjusted risk of fatal and non- individuals with type 1 diabetes, the unadjusted relative fatal coronary artery disease was 50 percent to 70 risk reductions were 34 percent to 43 percent, compared percent (relative risk, 1.5 to 1.7) greater than for those to 60 percent to 74 percent for individuals with type 2 in the lowest category of exposure. diabetes. • There are few data on the relation between CAD and • Although fewer data exist on the relation between glycated hemoglobin among individuals with type 1 glycated hemoglobin and risk of macroalbuminuria and diabetes; however most studies have shown a positive on the relation between glycated hemoglobin and the association. risk of nephropathy progression, several cohort studies and clinical trials support a strong and significant • The relation between glycated hemoglobin and the risk positive association in individuals with type 1 and type 2 of PAD appears to be strong and positive in individuals diabetes. with type 1 and type 2 diabetes. Compared to those in the lowest category of GHb exposure, the unadjusted • The only studies identified by the search strategy and risk of PAD was 5 to 6 time greater in individuals in the inclusion criteria examining the effect of GHb exposure highest category of exposure among individuals with on GFR were cohort studies conducted in individuals type 1 diabetes, and the risk was 2 to 4 times greater with type 1 diabetes. All studies consistently among individuals with type 2 diabetes. demonstrated that increasing levels of glycated hemoglobin were associated with a decline in GFR. • The risk relationship between cerebrovascular disease There are no clinical trial data examining the GFR and glycated hemoglobin, which has only been outcomes and no data on the relation between glycated examined among individuals with type 2 diabetes, is less hemoglobin and GFR in individuals with type 2 clear. diabetes. • There are very few data on the relation between GHb • Very few studies examined the association between exposure and congestive heart failure or subclinical glycated hemoglobin and the risk of ESRD. atherosclerosis, assessed by carotid intimal-medial thickness, making it difficult to draw any conclusions • Among individuals with type 1 diabetes, there appears regarding these outcomes. to be a strong, positive association between glycated hemoglobin and the risk of peripheral neuropathy in • Only a few studies have examined the presence of a both cohort studies and clinical trials; however, the threshold effect of glycated hemoglobin on the risk of evidence of an association between glycated hemoglobin developing diabetic complications (i.e. a level of glycated and peripheral neuropathy in individuals with type 2 hemoglobin above which there is a non-constant or diabetes yields conflicting results. exponential increase in risk of complications). The majority of these studies have not found a threshold • There are fewer data on the association between glycated effect for retinopathy and nephropathy outcomes but, hemoglobin and the risk of autonomic neuropathy. In rather, have demonstrated a continuous risk of individuals with type 1 diabetes, there appears to be a complications with increasing GHb levels. There are positive association. There are also very limited data on very few studies that have attempted to examine the the relation between glycated hemoglobin and the risk 5
  • 6. presence of a threshold effect of glycated hemoglobin on Future Research neuropathy and macrovascular outcomes. For research on glycemic control, future cohort studies and Urine Albumin clinical trials should focus on studying the relation between 1. What is the risk relationship between microalbuminuria and GHb exposure and the risk of macrovascular complications. renal function? Fewer data are available on these outcomes than on • Eleven studies reported on this question. The analyses microvascular outcomes; however, more data are also needed on had important limitations including broad variation in the relation between glycated hemoglobin and the risk of methods of assessing levels of urine albumin excretion as neuropathy, particularly the risk of peripheral and autonomic well as substantial heterogeneity in reporting of renal neuropathy in individuals with type 2 diabetes. outcomes. For research on urine albumin, future work should seek to • The preponderance of evidence suggests that the define the optimal and most feasible tests for measuring presence of microalbuminuria at baseline is associated microalbuminuria and to standardize measurement of with progression of chronic kidney disease. microalbuminuria. Future research should also characterize the • The relation of urine albumin excretion at baseline to nature of the relation (e.g. threshold versus linear) between progression of chronic kidney disease appears graded; microalbuminuria and outcomes. In addition, further work is higher levels of urine albumin excretion at baseline are needed to understand whether currently accepted definitions of associated with a greater magnitude of decrease in renal microalbuminuria are optimal in predicting future renal and function as well as a faster rate of decline in renal cardiovascular outcomes. function over time. Extension of research in both these areas has important 2. What is the risk relationship between microalbuminuria, future implications for gaining improved understanding of the cardiovascular disease, and death? role of glycemic control in the prevention of the cardiovascular • Nineteen studies reported on cardiovascular morbidity sequelae as well as for future development of guidelines for and mortality, and 24 reported on all-cause mortality. screening practices among persons with type 1 and type 2 The analyses had important limitations including broad diabetes mellitus. variation in methods of assessing levels of urine albumin excretion as well as few studies focusing on disease- Ordering Information specific cardiovascular morbidity or mortality. The full evidence report from which this summary was taken • The preponderance of evidence from these studies was prepared for AHRQ by the Johns Hopkins Evidence-based demonstrates an association between microalbuminuria Practice Center, Baltimore, MD, under contract No. 290-97- at baseline and increased risk of cardiovascular 0006. It is expected to be available in late summer 2003. At morbidity, cardiovascular mortality, and all-cause that time, printed copies may be obtained free of charge from mortality. the AHRQ Publications Clearinghouse by calling 800-358- • The relation of urine albumin excretion at baseline to 9295. Requesters should ask for Evidence Report/Technology cardiovascular morbidity, cardiovascular mortality, and Assessment No. 84, Use of Glycated Hemoglobin and all-cause mortality appears graded; greater levels of urine Microalbuminuria in the Monitoring of Diabetes Mellitus. albumin excretion at baseline are independently Internet users will be able to access the report online through associated with a greater magnitude of risk of AHRQ’s Web site at www.ahrq.gov. cardiovascular morbidity, cardiovascular mortality, and all-cause mortality over time. www.ahrq.gov AHRQ Pub. No. 03-E048 July 2003 ISSN 1530-440X