糖尿病-ADA2008年指南

Standards of Medical Care in Diabetes—2008 AMERICAN DIABETES ASSOCIATION D iabetes is a chronic illness that re-quires continuing medical care andpatient self-management education to prevent acute complications and to re- duce the risk of long-term complications. Diabetes care is complex and requires that many issues, beyond glycemic control, be addressed. A large body of evidence exists that supports a range of interventions to improve diabetes outcomes. These standards of care are intended to provide clinicians, patients, research- ers, payors, and other interested individ- uals with the components of diabetes care, treatment goals, and tools to evalu- ate the quality of care. While individual preferences, comorbidities, and other pa- tient factors may require modification of goals, targets that are desirable for most patients with diabetes are provided. These standards are not intended to pre- clude more extensive evaluation and management of the patient by other spe- cialists as needed. For more detailed in- formation, refer to refs. 1–3. The recommendations included are screening, diagnostic, and therapeutic ac- tions that are known or believed to favor- ably affect health outcomes of patients with diabetes. A grading system (Table 1), developed by the American Diabetes As- sociation (ADA) and modeled after exist- ing methods, was utilized to clarify and codify the evidence that forms the basis for the recommendations. The level of ev- idence that supports each recommenda- tion is listed after each recommendation using the letters A, B, C, or E. I. CLASSIFICATION AND DIAGNOSIS A. Classification In 1997, ADA issued new diagnostic and classification criteria (4); in 2003, modi- ficationsweremade regarding the diagno- sis of impaired fasting glucose (5). The classification of diabetes includes four clinical classes: ● Type 1 diabetes (results from �-cell de- struction, usually leading to absolute insulin deficiency) ● Type 2 diabetes (results from a progres- sive insulin secretory defect on the background of insulin resistance) ● Other specific types of diabetes due to other causes, e.g., genetic defects in �-cell function, genetic defects in insu- lin action, diseases of the exocrine pan- creas (such as cystic fibrosis), and drug- or chemical-induced (such as in the treatment of AIDS or after organ trans- plantation) ● Gestational diabetes mellitus (GDM) (diabetes diagnosed during pregnancy) Some patients cannot be clearly classified as type 1 or type 2 diabetes. Clinical pre- sentation and disease progression vary considerably in both types of diabetes. Occasionally, patients who otherwise have type 2 diabetes may present with ke- toacidosis. Similarly, patients with type 1 may have a late onset and slow (but re- lentless) progression of disease despite having features of autoimmune disease. Such difficulties in diagnosismay occur in children, adolescents, and adults. The true diagnosis may becomemore obvious over time. B. Diagnosis of diabetes Recommendations ● The fasting plasma glucose (FPG) test is the preferred test to diagnose diabetes in children and nonpregnant adults. (E) ● Use of the A1C for the diagnosis of di- abetes is not recommended at this time. (E) Criteria for the diagnosis of diabetes in nonpregnant adults are shown in Table 2. Three ways to diagnose diabetes are avail- able, and each must be confirmed on a subsequent day unless unequivocal symptoms of hyperglycemia are present. Although the 75-g oral glucose tolerance test (OGTT) is more sensitive and mod- estly more specific than the FPG to diag- nose diabetes, it is poorly reproducible and difficult to perform in practice. Be- cause of ease of use, acceptability to pa- tients, and lower cost, the FPG is the preferred diagnostic test. Although the FPG is less sensitive than the OGTT, the vast majority of people who do not meet diagnostic criteria for diabetes by the FPG but would by the OGTT will have an A1C value well below 7.0% (6). Although the OGTT is not recom- mended for routine clinical use, it may be ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● 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 blood glucose; 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 Prevention Program; DRS, Diabetic Retinopathy Study; DSME, diabetes self-management education; DSMT, diabetes self-management training; eAG, estimated average glucose; ECG, electrocardiogram; EDIC, Epidemiology of Diabetes Interventions and Complications; ERP, education recognition program; ESRD, end-stage renal disease; ETDRS, Early Treatment Diabetic Retinopathy Study; FDA, Food and Drug Administration; FPG, fasting plasma glucose; GDM, gestational diabetes mellitus; GFR, glomerular filtration rate; ICU, intensive care unit; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; MICU, medical ICU; MNT, medical nutrition therapy; NDEP, National Diabetes Education Program; NPDR, nonproliferative diabetic retinopathy; OGTT, oral glucose tolerance test; PAD, peripheral arterial disease; PDR, proliferative diabetic retinopathy; PPG, postprandial plasma glucose; RAS, renin-angiotensin system; RDA, recommended dietary allowance; SICU, surgical ICU; SMBG, self-monitoring of blood glucose; TSH, thyroid-stimulating hormone; 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 S12 DIABETES CARE, VOLUME 31, SUPPLEMENT 1, JANUARY 2008 useful for further evaluation of patients in whom diabetes is still strongly suspected but who have normal FPG or impaired fasting glucose (IFG) (see Section 1.C). Due to lack of evidence on prognostic significance and diagnostic thresholds, the use of the A1C for the diagnosis of diabetes is not recommended at this time. C. Diagnosis of pre-diabetes Hyperglycemia not sufficient to meet the diagnostic criteria for diabetes is catego- rized as either IFG or impaired glucose tolerance (IGT), depending on whether it is identified through the FPG or the OGTT: ● IFG � FPG 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l) ● IGT � 2-h plasma glucose 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l) IFG and IGT have been officially termed “pre-diabetes.” Both categories of pre- diabetes are risk factors for future diabetes and for cardiovascular disease (CVD) (7). II. TESTING FOR PRE- DIABETES AND DIABETES IN ASYMPTOMATIC PATIENTS Recommendations ● Testing to detect pre-diabetes and type 2 diabetes in asymptomatic people should be considered in adults who are overweight or obese (BMI �25 kg/m2) and who have one or more additional risk factors for diabetes (Table 3). In those without these risk factors, testing should begin at age 45. (B) ● If tests are normal, repeat testing should be 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-g glucose load) or both are appropriate. (B) ● An OGTT may be considered in pa- tients with IFG to better define the risk of diabetes. (E) ● In those identified with pre-diabetes, identify and, if appropriate, treat other CVD risk factors. (B) For many illnesses, there is a major dis- tinction between screening and diagnos- tic testing. However, for diabetes, the same tests would be used for “screening” as for diagnosis. Type 2 diabetes has a long asymptomatic phase and significant clinical risk markers. Diabetes may be identified anywhere along a spectrum of clinical scenarios ranging from a seem- ingly low-risk individual who happens to have glucose testing, to a higher-risk in- dividual who the provider tests because of high suspicion of diabetes, to the symp- tomatic patient. The discussion herein is primarily framed as testing for diabetes in those without symptoms. Testing for dia- betes will also detect individuals with pre- diabetes. A. Testing for pre-diabetes and type 2 diabetes in adults Type 2 diabetes is frequently not diag- nosed until complications appear, and approximately one-third of all people with 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 controlled trials that are adequately powered, including: ● Evidence from a well-conducted multicenter trial ● Evidence from a meta-analysis that incorporated quality ratings in the analysis Compelling nonexperimental evidence, i.e., “all or none” rule developed by the Centre for Evidence-Based Medicine at Oxford Supportive evidence from well-conducted randomized controlled trials that 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 the analysis B 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 studies Supportive evidence from a well-conducted case-control study C Supportive evidence from poorly controlled or uncontrolled studies, including: ● Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results ● Evidence from observational studies with high potential for bias (such as case series with comparison with historical controls) ● Evidence from case series or case reports Conflicting evidence with the weight of evidence supporting the recommendation E 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 at least 8 h.* OR 2. Symptoms of hyperglycemia and a casual plasma glucose �200 mg/dl (11.1 mmol/l). Casual is defined as any time of day without regard to time since last meal. The classic symptoms of hyperglycemia include polyuria, polydipsia, and unexplained weight loss. OR 3. 2-h plasma glucose �200 mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.* *In the absence of unequivocal hyperglycemia, these criteria should be confirmed by repeat testing on a different day (5). Position Statement DIABETES CARE, VOLUME 31, SUPPLEMENT 1, JANUARY 2008 S13 through mass testing of asymptomatic in- dividuals has not been definitively proven (and rigorous trials to provide such proof are unlikely to occur), pre-diabetes and diabetes 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 a long presymptomatic phase before the di- agnosis of type 2 diabetes is usually made. Relatively simple tests are available to de- tect preclinical disease (8). Additionally, the duration of glycemic burden is a strong predictor of adverse outcomes, and effective interventions exist to pre- vent progression of pre-diabetes to diabe- 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 adults with BMI �25 kg/m2 and one or more risk factors for diabetes. Because age is a major risk factor for diabetes, testing of those without other risk factors should begin no later than age 45. Either FPG testing or the 2-h OGTT is appropriate for testing. The 2-h OGTT identifies people with either IFG or IGT and, thus, more prediabetic people at in- creased risk for the development of dia- betes and CVD. It should be noted that the two tests do not necessarily detect the same prediabetic individuals (9). The ef- ficacy of interventions for primary pre- vention of type 2 diabetes (10–16) has primarily been demonstrated among in- dividuals with IGT, not among individu- als with IFG (who do not also have IGT). As noted in the diagnosis section (I.B), the FPG test is more convenient, more repro- ducible, less costly, and easier to admin- ister than the 2-h OGTT (4,5). An OGTT may be useful in patients with IFG to bet- ter define the risk of diabetes. The appropriate interval between tests is not known (17). The rationale for the 3-year interval is that false negatives will be repeated before substantial time elapses, and there is little likelihood that an individual will develop significant complications of diabetes within 3 years of a negative test result. Because of the need for follow-up and discussion of abnormal results, testing should be carried out within the health care setting. Community screening out- side a health care setting is not recom- mended because people with positive tests may not seek appropriate follow-up testing and care, and, conversely, there may be failure to ensure appropriate re- peat testing for individuals who test neg- ative. Community screening may also be poorly targeted, i.e., it may fail to reach the groups most at risk and inappropri- ately test those at low risk (the worried well) or even those already diagnosed (18,19). B. Testing for type 2 diabetes in children The incidence of type 2 diabetes in ado- lescents has increased dramatically in the last decade, especially in minority popu- lations (20), although the disease remains rare in the general population (21). Con- sistent with recommendations for adults, children and youth at increased risk for the presence or the development of type 2 diabetes should be tested (22). The rec- ommendations of the ADA consensus statement on type 2 diabetes in children and youth are summarized in Table 4. C. Screening for type 1 diabetes Generally, people with type 1 diabetes present with acute symptoms of diabetes and markedly elevated blood glucose lev- els, and most cases are diagnosed soon after the onset of hyperglycemia. Wide- spread clinical testing of asymptomatic individuals for the presence of autoanti- bodies related to type 1 diabetes cannot currently be recommended as a means to identify individuals at risk, for several rea- sons: 1) cutoff values for the immune marker assays have not been completely established or standardized for clinical settings; 2) there is no consensus as to what follow-up testing should be under- taken when a positive autoantibody test result is obtained; and 3) because the in- cidence of type 1 diabetes is low, testing of healthy individuals will identify only a very small number (�0.5%) who at that moment may be “prediabetic.” Finally, though clinical studies are being con- ducted to test various methods of pre- venting type 1 diabetes in high-risk individuals, no effective intervention has yet been identified. If studies uncover an effective means of preventing type 1 dia- betes, targeted screening (e.g., siblings of type 1 children)may be appropriate in the future. 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/m2*) and have 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 �250 mg/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 obesity and acanthosis nigricans) ● history of CVD 2. In the absence of the above criteria, testing for pre-diabetes and diabetes should begin at age 45 years 3. If results are normal, testing should be repeated at least at 3-year intervals, with consideration 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 in asymptomatic children Criteria ● Overweight (BMI �85th percentile for age and sex, weight for height �85th percentile, or weight �120% of ideal for height) 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 conditions associated 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 age Frequency: every 2 years Test: FPG preferred Standards of Medical Care S14 DIABETES CARE, VOLUME 31, SUPPLEMENT 1, JANUARY 2008 III. DETECTION AND DIAGNOSIS OF GESTATIONAL DIABETES MELLITUS (GDM) Recommendations ● Screen for GDM using risk factor anal- ysis and, if appropriate, use of an OGTT. (C) ● Women with GDM should be screened for diabetes 6–12 weeks postpartum and should be followed up with subse- quent screening for the development of diabetes or pre-diabetes. (E) Gestational diabetes mellitus is defined as any degree of glucose intolerancewith on- set or first recognition during pregnancy (4). Although most cases resolve with de- livery, the definition applies whether or not the condition persists after pregnancy and does not exclude the possibility that unrecognized glucose intolerance may have antedated or begun concomitantly with the pregnancy. Approximately 7% of all pregnancies (ranging from 1 to 14% depending on the population studied and the diagnostic tests used) are complicated by GDM, resulting in more than 200,000 cases annually. Because of the risks of GDM to the mother and neonate, screening and diag- nosis are warranted. The screening and diagnostic strategies, based on the 2004 ADA position statement on gestational di- abetesmellitus (23), are outlined inTable 5. Results of the Hyperglycemia and Ad- verse Pregnancy Outcomes study were re- ported at ADA’s 67th Annual Scientific Sessions in June 2007. This large-scale (�25,000 pregnant women), multi- national, epidemiologic study demon- strated that risk of adverse maternal, fetal, and neonatal outcomes continuously in- creased as a function ofmaternal glycemia at 24–28 weeks, even within ranges pre- viously considered normal for pregnancy. For most complications, there was no threshold for risk. These results may call for careful reconsideration of the diagnos- tic criteria for GDM. Because women with a history of GDM have a greatly increased subsequent risk for diabetes (24), they should be screened for diabetes 6–12 weeks post- partum, using standard criteria, and should be followed up with subsequent screening for the development of