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Standards of Medical Care for Patients with Diabetes Mellitus

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Standards of Medical Care for Patients with Diabetes Mellitus POSITION STATEMENT Standards of Medical Care for Patients With Diabetes Mellitus AMERICAN DIABETES ASSOCIATION iabetes is a chronic illness that re- CLASSIFICATION, fied through a FPG or an oral glucose tol- quires continuing medical care and DIAGNOSIS, AND erance test (OGTT): D patient self-management education SCREENING to prevent acute complications and to re- IFG ϭ FPG Ն110 mg/dl (6.1 mmol/l) and duce the risk of long-term complications. Classification Ͻ126 mg/dl (7.0 mmol/l) Diabetes care is complex and requires that In 1997, the American Diabetes Associa- Or FPG 110 mg/dl (6.1 mmol/l) many issues, beyond glycemic control, be tion issued new diagnostic and classifica- to 125 mg/dl (6.9 mmol/l) addressed. A large body of evidence exists tion criteria (3). IGT ϭ 2-h PG Ն140 mg/dl (7.8 mmol/l) Ͻ that supports a range of interventions to The classification of diabetes mellitus and 200 mg/dl (11.1 mmol/l) improve diabetes outcomes. includes four clinical classes Or 2-h PG 140 mg/dl (7.8 mmol/l) to These standards of care are intended 199 mg/dl (11.0 mmol/l) ● ␤ to provide clinicians, patients, research- Type 1 diabetes ( -cell destruction, ers, payers, and other interested persons usually leading to absolute insulin de- Both categories, IFG and IGT, are risk with the components of diabetes care, ficiency) factors for future diabetes and cardiovas- ● Type 2 diabetes (Results from a pro- treatment goals, and tools to evaluate the cular disease. Recent studies have shown gressive insulin secretory defect on the quality of care. While individual prefer- that lifestyle interventions can reduce the background of insulin resistance) rate of progression to type 2 diabetes (5– ences, comorbidities, and other patient ● Other specific types of diabetes (due to 7). factors may require modification of goals, other causes, e.g., genetic defects in targets that are desirable for most patients ␤-cell function, genetic defects in insu- with diabetes are provided. These stan- lin action, diseases of the exocrine pan- Screening dards are not intended to preclude more creas, drug or chemical induced) Generally, people with type 1 diabetes extensive evaluation and management of ● Gestational diabetes mellitus (GDM) present with acute symptoms of diabetes the patient by other specialists as needed. (diagnosed during pregnancy) and markedly elevated blood glucose lev- For more detailed information, refer to els. Type 2 diabetes is frequently not di- Skyler (Ed.): Medical Management of Type Diagnosis agnosed until complications appear, and 1 Diabetes (1) and Zimmerman (Ed.): Criteria for the diagnosis of diabetes in approximately one-third of all people Medical Management of Type 2 Diabetes nonpregnant adults are shown in Table 2. with diabetes may be undiagnosed. Al- (2). Three ways to diagnosis diabetes are avail- though the burden of diabetes is well The recommendations included are able and each must be confirmed on a known, the natural history is well charac- diagnostic and therapeutic actions that subsequent day. Because of ease of use, terized, and there is good evidence for are known or believed to favorably affect acceptability to patients and lower cost, benefit from treating cases diagnosed health outcomes of patients with diabetes. the fasting plasma glucose (FPG) is the through usual clinical care, there are no A grading system (Table 1), developed by preferred test. randomized trials demonstrating the ben- the Association and modeled after exist- Hyperglycemia not sufficient to meet efits of early diagnosis through screening ing methods, was utilized to clarify and the diagnostic criteria for diabetes is cate- of asymptomatic individuals (8). Never- codify the evidence that forms the basis gorized as either impaired fasting glucose theless, there is sufficient indirect evi- for the recommendations (IFG) or impaired glucose tolerance dence to justify opportunistic screening (IGT), depending on whether it is identi- in a clinical setting of individuals at high ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● risk. Criteria for testing for diabetes in Originally approved 1988. Most recent review/revision, October 2001. asymptomatic, undiagnosed adults are Abbreviations: ACE, angiotensin-converting enzyme; ALLHAT, Antihypertensive and Lipid-Lowering listed in Table 3. The recommended Treatment to Prevent Heart Attack Trial; ARB, angiotensin receptor blocker; CAD, coronary artery disease; CHD, coronary heart disease; CVD, cardiovascular disease; DCCB, dihydropyridine calcium channel block- screening test for nonpregnant adults is er; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis; DRS, Diabetic Retinopathy the FPG. Study; ESRD, end-stage renal disease; ETDRS, Early Treatment Diabetic Retinopathy Study; FPG, fasting The incidence of type 2 diabetes in plasma glucose; GCT, glucose challenge test; GDM, gestational diabetes mellitus; GFR, glomerular filtration children and adolescents has been shown rate; HRC, high-risk characteristic; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; MNT, medical nutrition therapy; NPDR, nonproliferative diabetic retinopathy; OGTT, oral glucose tolerance test; to be increasing. Consistent with screen- PDR, proliferative diabetic retinopathy; PPG, postprandidial plasma glucose; SMBG, self-monitoring of ing recommendations for adults, only blood glucose; UKPDS, U.K. Prospective Diabetes Study. children and youth at increased risk for DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 S33 Position Statement Table 1 —ADA evidence grading system for clinical practice recommendations mg/dl at 1 h; Ն155 mg/dl at 2 h; Ն140 mg/dl at 3 h. Two or more of the plasma Level of glucose values must be met or exceeded evidence Description for a positive diagnosis. The test should be done in the morning after an overnight A Clear evidence from well-conducted, generalizable, randomized controlled trials fast of 8–14 h. The diagnosis can be made that are adequately powered including: using a 75-g glucose load, but that test is ● Evidence from a well-conducted multicenter trial not as well validated for detection of at- ● Evidence from a meta-analysis that incorporated quality ratings in the analysis. risk infants or mothers as the 100-g ● Compelling nonexperimental evidence, i.e., “all or none” rule developed by OGTT. Center for Evidence Based Medicine at Oxford* Low risk status requires no glucose Supportive evidence from well-conducted randomized controlled trials that are testing, but this category is limited to adequately powered including: those women meeting all of the following ● Evidence from a well-conducted trial at one or more institutions characteristics: ● Evidence from a meta-analysis that incorporated quality ratings in the analysis B Supportive evidence from well-conducted cohort studies ● Age Ͻ25 years ● Evidence from a well-conducted prospective cohort study or registry ● Weight normal before pregnancy ● Evidence from a well-conducted prospective cohort study ● Member of an ethnic group with a low ● Evidence from a well-conducted meta-analysis of cohort studies prevalence of GDM Supportive evidence from well-conducted case-control study ● No known diabetes in first-degree rela- C Supportive evidence from poorly controlled or uncontrolled studies tives ● Evidence from randomized clinical trials with one or more major or three or ● No history of abnormal glucose toler- more minor methodological flaws that could invalidate the results ance ● Evidence from observational studies with high potential for bias (such as case ● No history of poor obstetric outcome series with comparison to historical controls) ● Evidence from case series or case reports Recommendations Conflicting evidence with the weight of evidence supporting the recommendation A-Level evidence E Expert consensus or clinical experience *Either all patients died prior to therapy and at least some survived with therapy, or some patients died ● In those with IFG/IGT, lifestyle modifi- without therapy and none died with therapy. Example: use of insulin in the treatment of DKA. cation should be considered. Expert consensus the presence or the development of type 2 lenge test [GCT]) and perform a diag- diabetes should be tested (9). See Table 4. nostic OGTT on that subset of women ● The FPG is the preferred test to screen exceeding the glucose threshold value for and diagnose diabetes. Detection and diagnosis of GDM on the GCT. When the two-step ap- ● Screen for diabetes in high-risk, asymp- Risk assessment for GDM should be un- proach is employed, a glucose thresh- tomatic, undiagnosed adults and chil- dertaken at the first prenatal visit. Women old value Ն140 mg/dl identifies ϳ80% dren within the health care setting. with clinical characteristics consistent of women with GDM, and the yield is ● Screen for diabetes in pregnancy using with a high risk for GDM (those with further increased to 90% by using a cut- risk factor analysis and screening tests marked obesity, personal history of GDM, off of Ն130 mg/dl. as noted. glycosuria, or a strong family history of diabetes) should undergo glucose testing Diagnostic criteria for the 100-g OGTT is INITIAL EVALUATION — A com- as soon as possible (10). A fasting plasma as follows: Ն95 mg/dl fasting; Ն180 plete medical evaluation should be per- glucose Ն126 mg/dl or a casual plasma glucose Ն200 mg/dl meets the threshold Table 2 —Criteria for the diagnosis of diabetes* for the diagnosis of diabetes, if confirmed on a subsequent day. High-risk women 1. Symptoms of diabetes and a casual plasma glucose Ն200 mg/dl (11.1 mmol/l). Casual is not found to have GDM at the initial defined as any time of day without regard to time since last meal. The classic symptoms of screening and average-risk women diabetes include polyuria, polydipsia, and unexplained weight loss. should be tested between 24 and 28 OR weeks of gestation. Testing should follow 2. FPG Ն126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h. one of two approaches: OR Ն ● 3. 2-h PG 200 mg/dl (11.1 mmol/l) during an OGTT.
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