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StandardsofMedicalCareinDiabetes—2008
A
MERICAN
D
IABETES
A
SSOCIATION
D
iabetes is a chronic illness that re-quires continuing medical care andpatient self-management educationto prevent acute complications and to re-duce the risk of long-term complications.Diabetescareiscomplexandrequiresthatmanyissues,beyondglycemiccontrol,beaddressed.Alargebodyofevidenceexiststhat supports a range of interventions toimprove diabetes outcomes.These standards of care are intendedto provide clinicians, patients, research-ers, payors, and other interested individ-uals with the components of diabetescare, treatment goals, and tools to evalu-ate the quality of care. While individualpreferences, comorbidities, and other pa-tient factors may require modification of goals, targets that are desirable for mostpatients with diabetes are provided.These standards are not intended to pre-clude more extensive evaluation andmanagement of the patient by other spe-cialists as needed. For more detailed in-formation, refer to refs. 1–3.The recommendations included arescreening,diagnostic,andtherapeuticac-tions that are known or believed to favor-ably affect health outcomes of patientswithdiabetes.Agradingsystem(Table1),developed by the American Diabetes As-sociation (ADA) and modeled after exist-ing methods, was utilized to clarify andcodify the evidence that forms the basisfortherecommendations.Thelevelofev-idence that supports each recommenda-tion is listed after each recommendationusing the letters A, B, C, or E.
I. CLASSIFICATION ANDDIAGNOSIS
 A. Classification
In 1997, ADA issued new diagnostic andclassification criteria (4); in 2003, modi-ficationsweremaderegardingthediagno-sis of impaired fasting glucose (5). Theclassification of diabetes includes fourclinical classes:
●
Type 1 diabetes (results from
-cell de-struction, usually leading to absoluteinsulin deficiency)
●
Type2diabetes(resultsfromaprogres-sive insulin secretory defect on thebackground of insulin resistance)
●
Other specific types of diabetes due toother causes, e.g., genetic defects in
-cell function, genetic defects in insu-lin action, diseases of the exocrine pan-creas(suchascysticfibrosis),anddrug-or chemical-induced (such as in thetreatment of AIDS or after organ trans-plantation)
●
Gestational diabetes mellitus (GDM)(diabetes diagnosed during pregnancy)Some patients cannot be clearly classifiedas type 1 or type 2 diabetes. Clinical pre-sentation and disease progression varyconsiderably in both types of diabetes.Occasionally, patients who otherwisehavetype2diabetesmaypresentwithke-toacidosis. Similarly, patients with type 1may have a late onset and slow (but re-lentless) progression of disease despitehaving features of autoimmune disease.Suchdifficultiesindiagnosismayoccurinchildren, adolescents, and adults. The truediagnosismaybecomemoreobviousovertime.
B. Diagnosis of diabetesRecommendations
●
Thefastingplasmaglucose(FPG)testisthe preferred test to diagnose diabetesinchildrenandnonpregnantadults.(E)
●
Use of the A1C for the diagnosis of di-abetesisnotrecommendedatthistime.(E)Criteria for the diagnosis of diabetes innonpregnantadultsareshowninTable2.Threewaystodiagnosediabetesareavail-able, and each must be confirmed on asubsequent day unless unequivocalsymptoms of hyperglycemia are present. Although the 75-g oral glucose tolerancetest (OGTT) is more sensitive and mod-estly more specific than the FPG to diag-nose diabetes, it is poorly reproducibleand difficult to perform in practice. Be-cause of ease of use, acceptability to pa-tients, and lower cost, the FPG is thepreferred diagnostic test. Although theFPG is less sensitive than the OGTT, thevast majority of people who do not meetdiagnosticcriteriafordiabetesbytheFPGbutwouldbytheOGTTwillhaveanA1Cvalue well below 7.0% (6). Although the OGTT is not recom-mended for routine clinical use, it may be
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The recommendations in this article are based on the evidence reviewed in the following publication:Standards of care for diabetes (Technical Review).
Diabetes Care
17:1514–1522, 1994.Originally approved 1988. Most recent review/revision, October 2007.
Abbreviations:
ABI, ankle-brachial index; ACE, angiotensin-converting enzyme; ADAG, A1C-Derived Average Glucose; ARB, angiotensin receptor blocker; CAD, coronary artery disease; CBG, capillary bloodglucose; CHD, coronary heart disease; CHF, congestive heart failure; CKD, chronic kidney disease; CMS,Centers for Medicare and Medicaid Services; CSII, continuous subcutaneous insulin infusion; CVD, cardio-vascular disease; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis; DMMP,diabetes medical management plan; DPN, distal symmetric polyneuropathy; DPP, Diabetes PreventionProgram; DRS, Diabetic Retinopathy Study; DSME, diabetes self-management education; DSMT, diabetesself-managementtraining;eAG,estimatedaverageglucose;ECG,electrocardiogram;EDIC,Epidemiologyof Diabetes Interventions and Complications; ERP, education recognition program; ESRD, end-stage renaldisease; ETDRS, Early Treatment Diabetic Retinopathy Study; FDA, Food and Drug Administration; FPG,fasting plasma glucose; GDM, gestational diabetes mellitus; GFR, glomerular filtration rate; ICU, intensivecare unit; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; MICU, medical ICU; MNT,medical nutrition therapy; NDEP, National Diabetes Education Program; NPDR, nonproliferative diabeticretinopathy; OGTT, oral glucose tolerance test; PAD, peripheral arterial disease; PDR, proliferative diabeticretinopathy;PPG,postprandialplasmaglucose;RAS,renin-angiotensinsystem;RDA,recommendeddietaryallowance;SICU,surgicalICU;SMBG,self-monitoringofbloodglucose;TSH,thyroid-stimulatinghormone;TZD, thiazolidinedione; UKPDS, U.K. Prospective Diabetes Study.DOI: 10.2337/dc08-S012© 2008 by the American Diabetes Association.
P O S I T I O N S T A T E M E N T
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usefulforfurtherevaluationofpatientsinwhom diabetes is still strongly suspectedbut who have normal FPG or impairedfasting glucose (IFG) (see Section 1.C).Duetolackofevidenceonprognosticsignificance and diagnostic thresholds,the use of the A1C for the diagnosis of diabetesisnotrecommendedatthistime.
C. Diagnosis of pre-diabetes
Hyperglycemia not sufficient to meet thediagnostic criteria for diabetes is catego-rized as either IFG or impaired glucosetolerance (IGT), depending on whether itis identified through the FPG or theOGTT:
●
IFG
FPG 100 mg/dl (5.6 mmol/l) to125 mg/dl (6.9 mmol/l)
●
IGT
2-h plasma glucose 140 mg/dl(7.8 mmol/l) to 199 mg/dl (11.0mmol/l)IFG and IGT have been officially termed“pre-diabetes.” Both categories of pre-diabetesareriskfactorsforfuturediabetesand for cardiovascular disease (CVD) (7).
II. TESTING FOR PRE-DIABETES AND DIABETESIN ASYMPTOMATICPATIENTS
Recommendations
●
Testing to detect pre-diabetes and type2 diabetes in asymptomatic peopleshould be considered in adults who areoverweight or obese (BMI
25 kg/m
2
)and who have one or more additionalrisk factors for diabetes (Table 3). Inthose without these risk factors, testingshould begin at age 45. (B)
●
Iftestsarenormal,repeattestingshouldbe carried out at least at 3-year inter-vals. (E)
●
To test for pre-diabetes or diabetes, ei-ther an FPG test or a 2-h OGTT (75-gglucose load) or both are appropriate.(B)
●
An OGTT may be considered in pa-tients with IFG to better define the riskof diabetes. (E)
●
In those identified with pre-diabetes,identify and, if appropriate, treat otherCVD risk factors. (B)For many illnesses, there is a major dis-tinction between screening and diagnos-tic testing. However, for diabetes, thesame tests would be used for “screening”as for diagnosis. Type 2 diabetes has along asymptomatic phase and significantclinical risk markers. Diabetes may beidentified anywhere along a spectrum of clinical scenarios ranging from a seem-ingly low-risk individual who happens tohave glucose testing, to a higher-risk in-dividualwhotheprovidertestsbecauseof high suspicion of diabetes, to the symp-tomatic patient. The discussion herein isprimarily framed as testing for diabetes inthose without symptoms. Testing for dia-beteswillalsodetectindividualswithpre-diabetes.
 A. Testing for pre-diabetes and type2 diabetes in adults
Type 2 diabetes is frequently not diag-nosed until complications appear, andapproximately one-third of all peoplewith diabetes may be undiagnosed. Al-though the effectiveness of early identifi-cation of pre-diabetes and diabetes
Table 1—
 ADA evidence-grading system for clinical practice recommendations
Level of evidence Description A Clear evidence from well-conducted, generalizable, randomized controlledtrials that are adequately powered, including:
●
Evidence from a well-conducted multicenter trial
●
Evidence from a meta-analysis that incorporated quality ratings in theanalysisCompelling nonexperimental evidence, i.e., “all or none” rule developedby the Centre for Evidence-Based Medicine at OxfordSupportive evidence from well-conducted randomized controlled trialsthat are adequately powered, including:
●
Evidence from a well-conducted trial at one or more institutions
●
Evidence from a meta-analysis that incorporated quality ratings in theanalysisB Supportive evidence from well-conducted cohort studies, including:
●
Evidence from a well-conducted prospective cohort study or registry
●
Evidence from a well-conducted meta-analysis of cohort studiesSupportive evidence from a well-conducted case-control studyC Supportive evidence from poorly controlled or uncontrolled studies,including:
●
Evidence from randomized clinical trials with one or more major orthree or more minor methodological flaws that could invalidate theresults
●
Evidence from observational studies with high potential for bias (suchas case series with comparison with historical controls)
●
Evidence from case series or case reportsConflicting evidence with the weight of evidence supporting therecommendationE Expert consensus or clinical experience
Table 2—
Criteria for the diagnosis of diabetes
1. FPG
126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for atleast 8 h.*OR2. Symptoms of hyperglycemia and a casual plasma glucose
200 mg/dl (11.1mmol/l). Casual is defined as any time of day without regard to time since lastmeal. The classic symptoms of hyperglycemia include polyuria, polydipsia, andunexplained weight loss.OR3. 2-h plasma glucose
200 mg/dl (11.1 mmol/l) during an OGTT. The testshould be performed as described by the World Health Organization, using aglucose load containing the equivalent of 75 g anhydrous glucose dissolved inwater.*
*In the absence of unequivocal hyperglycemia, these criteria should be confirmed by repeat testing on adifferent day (5).
Position Statement
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through mass testing of asymptomatic in-dividualshasnotbeendefinitivelyproven(and rigorous trials to provide such proof are unlikely to occur), pre-diabetes anddiabetes meet established criteria for con-ditions in which early detection is appro-priate. Both conditions are common,increasing in prevalence, and impose sig-nificant public health burdens. There is alongpresymptomaticphasebeforethedi-agnosisoftype2diabetesisusuallymade.Relatively simple tests are available to de-tect preclinical disease (8). Additionally,the duration of glycemic burden is astrong predictor of adverse outcomes,and effective interventions exist to pre-ventprogressionofpre-diabetestodiabe-tes (see Section IV) and to reduce risk of complications of diabetes (see Section VI).Recommendations for testing for pre-diabetes and diabetes in asymptomatic,undiagnosed adults are listed in Table 3.Testing should be considered in all adultswith BMI
25 kg/m
2
and one or morerisk factors for diabetes. Because age is amajor risk factor for diabetes, testing of those without other risk factors shouldbegin no later than age 45.EitherFPGtestingorthe2-hOGTTisappropriate for testing. The 2-h OGTTidentifies people with either IFG or IGTand, thus, more prediabetic people at in-creased risk for the development of dia-betes and CVD. It should be noted thatthe two tests do not necessarily detect thesame prediabetic individuals (9). The ef-ficacy of interventions for primary pre-vention of type 2 diabetes (10–16) hasprimarily been demonstrated among in-dividuals with IGT, not among individu-als with IFG (who do not also have IGT). Asnotedinthediagnosissection(I.B),theFPG test is more convenient, more repro-ducible, less costly, and easier to admin-ister than the 2-h OGTT (4,5). An OGTTmay be useful in patients with IFG to bet-ter define the risk of diabetes.The appropriate interval betweentests is not known (17). The rationale forthe 3-year interval is that false negativeswill be repeated before substantial timeelapses, and there is little likelihood thatan individual will develop significantcomplications of diabetes within 3 yearsof a negative test result.Becauseoftheneedforfollow-upanddiscussion of abnormal results, testingshould be carried out within the healthcare setting. Community screening out-side a health care setting is not recom-mended because people with positivetests may not seek appropriate follow-uptesting and care, and, conversely, theremay be failure to ensure appropriate re-peat testing for individuals who test neg-ative. Community screening may also bepoorly targeted, i.e., it may fail to reachthe groups most at risk and inappropri-ately test those at low risk (the worriedwell) or even those already diagnosed(18,19).
B. Testing for type 2 diabetes inchildren
The incidence of type 2 diabetes in ado-lescents has increased dramatically in thelast decade, especially in minority popu-lations(20),althoughthediseaseremainsrare in the general population (21). Con-sistent with recommendations for adults,children and youth at increased risk forthepresenceorthedevelopmentoftype2diabetes should be tested (22). The rec-ommendations of the ADA consensusstatement on type 2 diabetes in childrenand youth are summarized in Table 4.
C. Screening for type 1 diabetes
Generally, people with type 1 diabetespresent with acute symptoms of diabetesand markedly elevated blood glucose lev-els, and most cases are diagnosed soonafter the onset of hyperglycemia. Wide-spread clinical testing of asymptomaticindividuals for the presence of autoanti-bodies related to type 1 diabetes cannotcurrently be recommended as a means toidentifyindividualsatrisk,forseveralrea-sons:
1
) cutoff values for the immunemarker assays have not been completelyestablished or standardized for clinicalsettings;
2
) there is no consensus as towhat follow-up testing should be under-taken when a positive autoantibody testresult is obtained; and
3
) because the in-cidenceoftype1diabetesislow,testingof healthy individuals will identify only avery small number (
0.5%) who at thatmoment may be “prediabetic.” Finally,though clinical studies are being con-ducted to test various methods of pre-venting type 1 diabetes in high-riskindividuals, no effective intervention hasyet been identified. If studies uncover aneffective means of preventing type 1 dia-betes, targeted screening (e.g., siblings of type1children)maybeappropriateinthefuture.
Table 3—
Criteria for testing for pre-diabetes and diabetes in asymptomatic adult individuals
1. Testing should be considered in all adults who are overweight (BMI
25 kg/m
2
*) andhave additional risk factors:
●
physical inactivity
●
first-degree relative with diabetes
●
members of a high-risk ethnic population (e.g., African American, Latino, Native American, Asian American, and Pacific Islander)
●
women who delivered a baby weighing
9 lb or were diagnosed with GDM
●
hypertension (
140/90 mmHg or on therapy for hypertension)
●
HDL cholesterol level
35 mg/dl (0.90 mmol/l) and/or a triglyceride level
250mg/dl (2.82 mmol/l)
●
women with polycystic ovarian syndrome (PCOS)
●
IGT or IFG on previous testing
●
other clinical conditions associated with insulin resistance (e.g., severe obesityand acanthosis nigricans)
●
history of CVD2. In the absence of the above criteria, testing for pre-diabetes and diabetes should beginat age 45 years3. If results are normal, testing should be repeated at least at 3-year intervals, withconsideration of more frequent testing depending on initial results and risk status.
*At-risk BMI may be lower in some ethnic groups.
Table 4—
Testing for type 2 diabetes inasymptomatic children
Criteria
●
Overweight (BMI
85th percentile forage and sex, weight for height
85thpercentile, or weight
120% of ideal forheight)Plus any two of the following risk factors:
●
Family history of type 2 diabetes in first-or second-degree relative
●
Race/ethnicity (e.g., Native American, African American, Latino, Asian American,and Pacific Islander)
●
Signs of insulin resistance or conditionsassociated with insulin resistance (e.g.,acanthosis nigricans, hypertension,dyslipidemia, or PCOS)
●
Maternal history of diabetes or GDM Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a younger ageFrequency: every 2 yearsTest: FPG preferred
Standards of Medical Care
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