POSITION STATEMENT

Standards of Medical Care for Patients With 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- ( -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- ● (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, ; 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. The test should be performed as One-step approach: perform a diagnos- described by the World Health Organization (4), using a glucose load containing the tic OGTT. equivalent of 75 g anhydrous glucose dissolved in water. ● Two-step approach: perform an initial *In the absence of unequivocal hyperglycemia with acute metabolic decompensation, these criteria should screening by measuring the plasma or be confirmed by repeat testing on a different day. The OGTT is not recommended for routine clinical use, but serum glucose concentration 1 h after a may be required in the evaluation of patients with IFG (see text) or when diabetes is still suspected despite 50-g oral glucose load (glucose chal- a normal FPG.

S34 DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 Position Statement

Table 3 —Criteria for testing for diabetes in asymptomatic adult individuals of intensive glycemic control in the reduc- tion of cardiovascular disease. 1. Testing for diabetes should be considered in all individuals at age 45 years and above In the Diabetes Control and Compli- and, if normal, it should be repeated at 3-year intervals. cations Trial (DCCT), 1,441 patients with 2. Testing should be considered at a younger age or be carried out more frequently in type 1 diabetes were randomized to either individuals who standard or intensive care (11). The stan- ● are overweight (BMI Ն25 kg/m2) dard care group received one to two daily ● have a first-degree relative with diabetes insulin injections and routine follow-up ● are members of a high-risk ethnic population (e.g., African-American, Latino, Native with treatment aimed at minimizing American, Asian-American, Pacific Islander) symptoms. Patients in the intensive care ● have delivered a baby weighing Ͼ9 lb or have been diagnosed with GDM group were treated with multiple daily in- ● are hypertensive (Ն140/90 mmHg) jections or continuous insulin infusion, ● have an HDL cholesterol level Յ35 mg/dl (0.90 mmol/l) and/or a triglyceride level received intensive diabetes self- Ն250 mg/dl (2.82 mmol/l) management education, and were fol- ● on previous testing, had IGT or IFG lowed closely by a health care team with ● have other clinical conditions associated with insulin resistance (e.g. PCOS or active case management that included acanthosis nigricans) monthly visits and weekly phone contact. The intensive treatment group achieved a mean HbA of ϳ7% while the standard formed to classify the patient, detect the self-management should be emphasized, 1c care group maintained an approximate presence or absence of diabetes complica- and the plan should emphasize the in- HbA of 9%. With a mean of 6.5 years of tions, assist in formulating a management volvement of the patient in problem- 1c follow-up, there were significant reduc- plan, and provide a basis for continuing solving as much as possible. A variety of care. If the diagnosis of diabetes has al- strategies and techniques should be em- tions in the incidence and rate of progres- ready been made, the evaluation should ployed to provide adequate education sion of retinopathy, albuminuria, and review the previous treatment and the and development of problem-solving clinical neuropathy in the intensive past and present degrees of glycemic con- skills in the various aspects of diabetes group. trol. Laboratory tests appropriate to the management. Implementation of the The U.K. Prospective Diabetes Study evaluation of each patient’s general med- management plan requires that each as- (UKPDS) enrolled newly diagnosed ical condition should be performed. Ele- pect be understood and agreed on by the adults with type 2 diabetes (12,13). After ments of the initial medical evaluation are patient and the care providers and that 3 months of dietary treatment that re- ϳ included in Table 5. the goals and treatment plan are reason- duced average HbA1c results from 9to Ͼ able. 7%, patients with FPG 6.0 mmol/l (107 Management plan mg/dl) were randomized to either inten- People with diabetes should receive med- Glycemic control sive or standard treatment. In the inten- ical care from a physician-coordinated Glycemic control is fundamental to the sive treatment group, patients were team. Such teams include, but are not management of diabetes. Prospective ran- assigned to initial therapy with insulin, limited to, physicians, nurses, dietitians, domized clinical trials have shown that sulfonylurea, or metformin. In the stan- and mental health professionals with ex- achieving glycemic control is associated dard care group, patients were main- pertise and a special interest in diabetes. It with decreased rates of retinopathy, ne- tained on lifestyle interventions until is essential in this collaborative and inte- phropathy, and neuropathy, and epide- symptoms of marked hyperglycemia de- grated team approach that individuals miological studies support the potential veloped. Over time, both groups experi- with diabetes assume an active role in their care. The management plan should be for- Table 4 —Testing for type 2 diabetes in children mulated as an individualized therapeutic ● Criteria* alliance among the patient and family, the physician, and other members of the Overweight (BMI Ͼ85th percentile for age and sex, weight for height Ͼ85th percentile, or health care team. Any plan should recog- weight Ͼ120% of ideal for height) nize diabetes self-management education Plus as an integral component of care. In de- Any two of the following risk factors: veloping the plan, consideration should Family history of type 2 diabetes in first- or second-degree relative be given to the patient’s age, school or Race/ethnicity (Native American, African-American, Latino, Asian-American, Pacific work schedule and conditions, physical Islander) activity, eating patterns, social situation Signs of insulin resistance or conditions associated with insulin resistance (acanthosis and personality, cultural factors, and nigricans, hypertension, dyslipidemia, or PCOS) presence of complications of diabetes or ● Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a younger age other medical conditions. Treatment ● Frequency: every 2 years goals must be set together with the pa- ● Test: FPG preferred tient, family, and health care team. Patient *Clinical judgment should be used to test for diabetes in high-risk patients who do not meet these criteria.

DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 S35 Position Statement

Table 5 —Components of the initial visit

Medical history ● Symptoms, results of laboratory tests, and special examination results related to the diagnosis of diabetes ● Prior A1C records ● Eating patterns, nutritional status, and weight history; growth and development in children and adolescents ● Details of previous treatment programs, including nutrition and diabetes self-management education, attitudes, and health beliefs ● Current treatment of diabetes, including medications, meal plan, and results of glucose monitoring and patients’ use of data ● Exercise history ● Frequency, severity, and cause of acute complications such as ketoacidosis and hypoglycemia ● Prior or current infections, particularly skin, foot, dental, and genitourinary infections ● Symptoms and treatment of chronic eye; kidney; nerve; genitourinary (including sexual), bladder, and gastrointestinal function (including symptoms of celiac disease in type 1 diabetic patients); heart; peripheral vascular; foot; and cerebrovascular complications associated with diabetes ● Other medications that may affect blood glucose levels ● Risk factors for : smoking, hypertension, obesity, dyslipidemia, and family history ● History and treatment of other conditions, including endocrine and eating disorders ● Family history of diabetes and other endocrine disorders ● Lifestyle, cultural, psychosocial, educational, and economic factors that might influence the management of diabetes ● Tobacco, alcohol and/or controlled substance use ● Contraception and reproductive and sexual history

Physical examination ● Height and weight measurement (and comparison to norms in children and adolescents) ● Sexual maturation staging (during pubertal period) ● Blood pressure determination, including orthostatic measurements when indicated, and comparison to age-related norms ● Fundoscopic examination ● Oral examination ● Thyroid palpation ● Cardiac examination ● Abdominal examination (e.g., for hepatomegaly) ● Evaluation of pulses by palpation and with auscultation ● Hand/finger examination ● Foot examination ● Skin examination (for acanthosis nigricans and insulin-injection sites) ● Neurological examination ● Signs of diseases that can cause secondary diabetes (e.g., hemochromatosis, pancreatic disease)

Laboratory evaluation ● A1C ● Fasting lipid profile, including total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol ● Test for microalbuminuria in type 1 diabetic patients who have had diabetes for at least 5 years and in all patients with type 2 diabetes. Some advocate beginning screening of pubertal children before 5 years of diabetes. ● Serum creatinine in adults (in children if proteinuria is present) ● Thyroid-stimulating hormone (TSH) in all type 1 diabetic patients; in type 2 if clinically indicated ● Electrocardiogram in adults ● Urinalysis for ketones, protein, sediment

Referrals ● Eye exam, if indicated ● Family planning for women of reproductive age ● MNT, as indicated ● Diabetes educator, if not provided by physician or practice staff ● Behavioral specialist, as indicated ● Foot specialist, as indicated ● Other specialties and services as appropriate enced deterioration in glycemic control. ments groups (7 vs. 7.9%) was associated A recent systematic review examined A 0.9% difference in HbA1c values be- with significant reductions in all micro- cardiovascular outcomes in type 1 diabe- tween the intensive and standard treat- vascular end points. tes and included data from six random-

S36 DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 Position Statement

Table 6 —Glycemic control for nonpregnant individuals with diabetes though large evening meals can be fol- lowed by plasma glucose values up to 180 Additional action mg/dl. There are now pharmacological Normal Goal suggested* agents that primarily modify PPG and thereby reduce A1C in parallel. Thus, in Plasma values† individuals who have premeal glucose Average preprandial glucose (mg/dl) Ͻ110 90–130 Ͻ90/Ͼ150 values within targets but who are not Average bedtime glucose (mg/dl) Ͻ120 110–150 Ͻ110/Ͼ180 meeting A1C targets, consideration of monitoring PPG 1–2 h after the start of Whole blood values‡ the meal and treatment aimed at reducing Ͻ Ͻ Ͼ Average preprandial glucose (mg/dl) 100 80–120 80/ 140 average PPG values Ͻ180 mg/dl may Ͻ Ͻ Ͼ Average bedtime glucose (mg/dl) 110 100–140 100/ 160 lower A1C. However, it should be noted Ͻ Ͻ Ͼ A1C (%) 6 7 8 that this approach has not been validated The values shown in this table are by necessity generalized to the entire population of individuals with to reduce complications in outcome stud- diabetes. Patients with comorbid diseases, the very young and older adults, and others with unusual con- ies in patients with either type 1 or type 2 ditions or circumstances may warrant different treatment goals. These values are for nonpregnant adults. *Values above/below these levels are not “goals” nor are they “acceptable” in most patients. They are an diabetes. indication for a significant change in the treatment plan. “Additional action suggested” depends on individual For information on glycemic control patient circumstances. Such actions may include enhanced diabetes self-management education, coman- for women with GDM, refer to the Amer- agement with a diabetes team, referral to an endocrinologist, change in pharmacological therapy, initiation ican Diabetes Association position state- of or increase in SMBG, or more frequent contact with the patient. A1C is referenced to a nondiabetic range of 4.0–6.0% (mean 5.0%, SD 0.5%). †Values callibrated to plasma glucose, ‡measurement of capillary blood ment on Gestational Diabetes Mellitus glucose. (10). For information on glycemic control during pregnancy in women with pre- existing diabetes, refer to Medical Manage- ized controlled trials comparing intensive vascular complications; however, inten- ment of Pregnancy Complicated by Diabetes insulin therapy versus conventional treat- sive control has been found to increase (3rd ed.) (17). ment (14). This review noted moderate risk of hypoglycemia and weight gain. treatment effects of glycemic control on Epidemiological analyses suggest that Referral for diabetes management macrovascular events. In the UKPDS, the there is no threshold or lower limit of A1C For a variety of reasons (e.g., intercurrent trend toward a reduction in cardiovascu- above normal levels at which further low- illness, diabetic ketoacidosis [DKA], re- lar events did not reach statistical signifi- ering has no benefit. An average A1C current hypoglycemia), it may not be pos- cance. However, epidemiological analysis Ͼ8% is associated with a higher risk of sible to provide care that achieves the of the UKPDS cohort showed a statisti- complications, at least in patients with desired goals of treatment (Table 6). In cally significant effect of HbA1c lowering reasonably long life expectancies. The rel- such instances, additional actions sug- with an approximate 14% reduction in ative benefit of achieving an A1C of 7% is gested may include enhanced diabetes all-cause mortality and myocardial infarc- documented in randomized controlled self-management education, comanage- tion for every 1% reduction in HbA1c clinical trials with relative risk reductions ment with a diabetes team, or referral to (15). All of the above studies demon- of 15–30% per 1% absolute reduction in an endocrinologist if the patient is cur- strated an increased risk of hypoglycemia A1C. rently being followed by a primary care and weight gain associated with intensive Recommended glycemic goals for provider. glycemic control. nonpregnant individuals are shown in Ta- A major limitation to the available ble 6 . Less stringent treatment goals may Intercurrent illness data is that they do not identify the opti- be appropriate for patients with limited The stress of illness frequently aggravates mum level of control for particular pa- life expectancies, in the very young or glycemic control and necessitates more tients, as there are individual differences older adults, and in individuals with co- frequent monitoring of blood glucose and in the risks of hypoglycemia, weight gain, morbid conditions. Severe or frequent hy- urine or blood ketones. Marked hypergly- and other adverse effects. Furthermore, poglycemia is an indication for the cemia requires temporary adjustment of with multifactorial interventions, it is un- modification of treatment regimens, in- the treatment program, and, if accompa- clear how different components (e.g., ed- cluding setting higher glycemic goals. nied by ketosis, frequent interaction with ucational interventions, glycemic targets, Postprandial glucose monitoring and the diabetes care team. The patient treated lifestyle changes, and pharmacological therapies targeting postprandial excur- with oral glucose-lowering agents or agents) contribute to the reduction of sions may be necessary to reach A1C goals medical nutrition therapy (MNT) alone complications. There are no clinical trial and/or to reduce the risk of hypoglyce- may temporarily require insulin. Ade- data available for the effects of glycemic mia. (16) quate fluid and caloric intake must be as- control in patients with advanced compli- Elevated postchallenge (2-h OGTT) sured. Infection or dehydration is more cations, the elderly (Ն65 years of age), or glucose values have been associated with likely to necessitate hospitalization of the young children (Ͻ13 years of age). increased cardiovascular risk indepen- person with diabetes than the person In summary, treatment regimens that dent of fasting plasma glucose in some without diabetes. The hospitalized pa- reduced average A1C to ϳ7% (ϳ1% epidemiological studies. Postprandial tient should be treated by a physician above the upper limits of normal) were plasma glucose (PPG) levels Ͼ140 mg/dl with expertise in the management of dia- associated with fewer long-term, micro- are unusual in nondiabetic individuals, betes. A vomiting illness accompanied

DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 S37 Position Statement with ketosis may indicate DKA, a life- for patients with type 2 diabetes is not ment goals (and who have stable glyce- threatening condition that requires im- known, but should be sufficient to facili- mic control) and quarterly in patients mediate medical care to prevent tate reaching glucose goals. When adding whose therapy has changed or who are complications and death; the possibility to or modifying therapy, type 1 and type 2 not meeting glycemic goals. of DKA should always be considered. (18) diabetic patients should test more often than usual. The role of SMBG in stable MNT Recommendations diet-treated patients with type 2 diabetes MNT is an integral component of diabetes A-Level evidence is not known. management and of diabetes self- ● Lowering A1C has been associated with Because the accuracy of SMBG is in- management education. A review of the a reduction of microvascular and neu- strument- and user-dependent, it is im- evidence and detailed information can be ropathic complications of diabetes. portant for health care providers to found in the American Diabetes Associa- evaluate each patient’s monitoring tech- tion technical review and position state- B-Level evidence nique, both initially and at regular inter- ment titled “Evidence-Based Nutrition ● vals thereafter. In addition, optimal use of Principles and Recommendations for the Develop or adjust the management SMBG requires proper interpretation of Treatment and Prevention of Diabetes plan to achieve normal or near-normal the data. Patients should be taught how to and Related Complications” (21,22). glycemia with an A1C test goal of Յ7%. ● use the data to adjust food intake, exer- Goals of MNT that apply to all per- Self-monitoring of blood glucose is an cise, or pharmacological therapy to sons with diabetes are as follows: integral component of therapy achieve specific glycemic goals. Health 1) Attain and maintain optimal metabolic Expert consensus professionals should evaluate at regular outcomes including intervals the patient’s ability to use SMBG ● blood glucose levels in the normal ● Less stringent treatment goals may be data to guide treatment. range or as close to normal as is safely appropriate for patients with limited possible to prevent or reduce the risk life expectancies, in the very young or Recommendations for complications of diabetes ● older adults, and in individuals with Expert consensus a lipid and lipoprotein profile that re- comorbid conditions. duces the risk for macrovascular dis- ● Include SMBG in the management ease Assessment of glycemic control plan. ● blood pressure levels that reduce the Techniques are available for health pro- ● Instruct the patient in SMBG and rou- risk for vascular disease viders and patients to assess the effective- tinely evaluate the patient’s technique 2) Prevent and treat the chronic compli- ness of the management plan on glycemic and ability to use data to adjust therapy. cations of diabetes. Modify nutrient in- control. take and lifestyle as appropriate for the A1C prevention and treatment of obesity, dys- Self-monitoring of blood glucose By performing an A1C test, health provid- lipidemia, cardiovascular disease, hyper- The American Diabetes Association’s con- ers can measure a patient’s average glyce- tension, and nephropathy. sensus statements on self-monitoring of mia over the preceding 2–3 months and, 3) Improve health through healthy food blood glucose (SMBG) provide a compre- thus, assess treatment efficacy. choices and physical activity hensive review of the subject (19,20). As A1C testing should be performed 4) Address individual nutritional needs stated earlier, major clinical trials assess- routinely in all patients with diabetes, first taking into consideration personal and ing the impact of glycemic control on di- to document the degree of glycemic con- cultural preferences and lifestyle while re- abetes complications have included trol at initial assessment, then as part of specting the individual’s wishes and will- SMBG as part of multifactorial interven- continuing care. Since the A1C test re- ingness to change. tions, suggesting that SMBG is a compo- flects a mean glycemia over the preceding Goals of medical nutrition therapy nent of effective therapy. SMBG allows 2–3 months, measurement approxi- that apply to specific situations include patients to evaluate their individual re- mately every 3 months is required to de- the following: sponse to therapy and assess if glycemic termine whether a patient’s metabolic 1) For youth with type 1 diabetes, to pro- targets are being achieved. Results of control has reached and been maintained vide adequate energy to ensure normal SMBG are useful in preventing hypogly- within the target range. Thus, regular per- growth and development; integrate insu- cemia and adjusting medications, MNT, formance of the A1C test permits detec- lin regimens into usual eating and physi- and physical activity. tion of departures from the target range in cal activity habits. The frequency and timing of SMBG a timely fashion. For any individual pa- 2) For youth with type 2 diabetes, to fa- should be dictated by the particular needs tient, the frequency of A1C testing should cilitate changes in eating and physical ac- and goals of the patients. Daily SMBG is be dependent on the treatment regimen tivity habits that reduce insulin resistance especially important for patients treated used and on the judgment of the clinician. and improve metabolic status. with insulin to monitor for and prevent 3). For pregnant and lactating women, to asymptomatic hypoglycemia. For most Recommendations provide adequate energy and nutrients patients with type 1 diabetes and preg- Expert consensus needed for successful outcomes. nant women taking insulin, SMBG is rec- 4) For older adults, to provide for the nu- ommended three or more times daily. The ● Perform the A1C test at least two times tritional and psychosocial needs of an ag- optimal frequency and timing of SMBG a year in patients who are meeting treat- ing individual.

S38 DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 Position Statement

5) For individuals treated with insulin or Before beginning a physical activity cardiovascular risk factors, when possi- insulin secretagogues, to provide self- program, the patient with diabetes should ble, and clinicians should be alert for management education for treatment have a detailed medical evaluation with signs of atherosclerosis. (and prevention) of hypoglycemia, acute appropriate diagnostic studies. This ex- illnesses, and exercise-related blood glu- amination should screen for the presence Blood pressure control cose problems. of macro- and microvascular complica- Hypertension (blood pressure Ն140/90 6) For individuals at risk for diabetes, to tions that may be worsened by the phys- mmHg) is a common comorbidity of dia- decrease risk by encouraging physical ac- ical activity program (see next section betes, affecting 20–60% of people with tivity and promoting foods choices that regarding coronary heart disease [CHD] diabetes, depending on age, obesity, and facilitate moderate weight loss or at least screening). Identification of areas of con- ethnicity. Hypertension is also a major prevent weight gain. cern will allow the design of an individu- risk factor for cardiovascular disease and Achieving nutrition-related goals re- alized physical activity plan that can microvascular complications such as ret- quires a coordinated team effort that in- minimize risk to the patient. inopathy and nephropathy. In type 1 di- cludes the person with diabetes. Because All levels of physical activity, includ- abetes, hypertension is often the result of of the complexity of nutrition issues, it is ing leisure activities, recreational sports, underlying nephropathy. In type 2 diabe- recommended that a registered dietitian, and competitive professional perfor- tes, hypertension is likely to be present as knowledgeable and skilled in implement- mance, can be performed by people with part of the metabolic syndrome (i.e., obe- ing nutrition therapy into diabetes man- diabetes who do not have complications sity, hyperglycemia, dyslipidemia) that is agement and education, is the team and have good glycemic control. The abil- accompanied by high rates of CVD. member who provides MNT. However, it ity to adjust the therapeutic regimen (in- Randomized clinical trials have dem- is essential that all team members are sulin therapy and MNT) to allow safe onstrated the incontrovertible benefitof knowledgeable about nutrition therapy participation is an important manage- lowering blood pressure to Ͻ140 mmHg and are supportive of the person with di- ment strategy. systolic and Ͻ80 mmHg diastolic in per- abetes who needs to make lifestyle sons with diabetes (30,31). Epidemio- changes. Recommendations logic analyses show that blood pressures MNT involves a nutrition assessment B-Level evidence Ͼ120/80 mmHg are associated with in- to evaluate the patient’s food intake, met- creased cardiovascular event rates and abolic status, lifestyle and readiness to ● A regular physical activity program, mortality in persons with diabetes (32). make changes; goal setting; dietary in- adapted to the presence of complica- Therefore, a target blood pressure goal of struction; and evaluation. To facilitate tions, is recommended for all patients Ͻ130/80 mmHg is reasonable if it can be adherence, the plan should be individu- with diabetes who are capable of partic- safely achieved. alized and take into account cultural, life- ipating. Although there are no well-controlled style, and financial considerations. studies of diet and exercise in the treat- Monitoring of glucose and A1C, lipids, PREVENTION AND ment of hypertension in persons with di- blood pressure, and renal status is essen- MANAGEMENT OF abetes, reducing sodium intake, body tial to evaluate nutrition-related out- DIABETES COMPLICATIONS weight (when indicated) and alcohol con- comes. If goals are not met, changes must sumption and increasing activity levels be made in the overall diabetes care and Cardiovascular disease: management have been shown to be effective in reduc- management plan. of risk factors and screening for ing blood pressure in nondiabetic indi- CAD viduals (33). These nonpharmacological Recommendations Cardiovascular disease (CVD) is the ma- strategies may also positively affect glyce- B-Level evidence jor cause of mortality for persons with di- mia and lipid control. abetes. It is also a major contributor to Lowering of blood pressure with reg- ● People with diabetes should receive in- morbidity and direct and indirect costs of imens based on antihypertensive drugs dividualized MNT as needed to achieve diabetes. Type 2 diabetes is an indepen- including angiotensin-converting en- treatment goals, preferably provided by dent risk factor for macrovascular disease zyme (ACE) inhibitors, angiotensin re- a registered dietitian familiar with the and its common coexisting conditions ceptor blockers (ARBs), ␤-blockers, components of diabetes MNT (19). (e.g., hypertension and dyslipidemia) are diuretics, and calcium channel blockers also risk factors. has been shown to be effective in lowering Physical activity Studies have shown the efficacy of re- cardiovascular events and/or, in some Association technical reviews on exercise ducing cardiovascular risk factors in pre- studies, slowing progression of nephrop- in patients with diabetes have shown the venting or slowing CVD. Evidence is athy and retinopathy. Other classes of hy- value of exercise in the diabetes manage- summarized in the following sections and pertensive drugs have not been studied in ment plan (23,24). Regular exercise has reviewed in detail in the American Diabe- diabetic patients with respect to improv- been shown to improve blood glucose tes Association technical reviews on hy- ing outcomes. There is no conclusive ev- control, reduce cardiovascular risk fac- pertension (25), dyslipidemia (26), idence favoring one class of drugs, tors, contribute to weight loss and im- aspirin therapy (27), and smoking cessa- although several studies suggest that ACE prove well-being. Furthermore, regular tion (28) and in the consensus statement inhibitors may be superior to dihydropyr- exercise may prevent type 2 diabetes in on CHD in people with diabetes (29). idine calcium channel blockers (DCCBs) high-risk individuals. Emphasis should be placed on reducing in reducing cardiovascular events

DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 S39 Position Statement

Table 7 —Target lipid levels for adult patients with diabetes C-Level evidence

● Goal Level of evidence In patients with microalbuminuria or overt nephropathy, in whom ACE in- LDL cholesterol Ͻ100 mg/dl (2.6 mmol/l) B hibitors or ARBs are not well tolerated, HDL cholesterol Men: Ͼ45 mg/dl (1.15 mmol/l) C a non-DCCB should be considered. Women: Ͼ55 mg/dl (1.40 mmol/l) Triglycerides Ͻ150 mg/dl (1.7 mmol/l) C Expert consensus Note: The recent NCEP/ATP III guidelines suggest that in patients with triglycerides Ն200 mg/dl, the “non-HDL cholesterol” be calculated with a goal being Ͻ130 (45). ● If ACE inhibitors or ARBs are used, monitor renal function and serum po- tassium levels. (34,35). ACE inhibitors have been shown Treatment ● In elderly hypertensive patients, blood to decrease the risk of progression of ne- A-Level evidence pressure should be lowered gradually phropathy in patients with type 1 diabetes to avoid complications. ● and to decrease cardiovascular events in ● Patients with diabetes should be treated Patients not achieving target blood type 2 diabetic patients with or without to a diastolic blood pressure Ͻ80 pressure on three drugs including a di- hypertension. ARBs have been shown to mmHg. uretic and patients with severe renal reduce the rate of progression of ne- ● Patients with a systolic blood pressure disease, should be referred to a special- phropathy in patients with type 2 diabe- ist experienced in the care of patients ␣ of 130–139 mmHg or a diastolic blood tes. The -blocker arm of the pressure of 80–89 mmHg should be with hypertension. Antihypertensive and Lipid-Lowering given lifestyle/behavioral therapy alone Treatment to Prevent Heart Attack Trial for a maximum of 3 months and then, if Lipid management (ALLHAT) was terminated after interim Patients with type 2 diabetes have an in- ␣ targets are not achieved, in addition, analysis showed that -blockers were should be treated pharmacologically. creased prevalence of lipid abnormalities substantially less effective in reducing ● Patients with hypertension (systolic that contributes to higher rates of CVD. congestive heart failure than diuretic ther- blood pressure Ն140 or diastolic blood Lipid management aimed at lowering apy (36). Many patients will require three pressure Ն90 mmHg) should receive LDL cholesterol, raising HDL cholesterol, or more drugs to reach target goals. drug therapy in addition to lifestyle/ and lowering triglycerides has been Before beginning treatment, patients behavioral therapy. shown to reduce macrovascular disease with elevated blood pressures should ● Initial drug therapy may be with ACE and mortality in patients with type 2 dia- have their blood pressure re-examined inhibitors, ARBs, ␤-blockers, or diuret- betes mellitus, particularly those who within 1 month to confirm the presence of ics. Additonal drugs may be chosen have had prior cardiovascular events. hypertension unless the diastolic blood In three secondary prevention studies Ͼ from these classes or another drug pressure is 110 mmHg. Patients with class. using HMG CoA reductase inhibitors (st- hypertension should be seen as often as ● In hypertensive patients with mi- atins), patients with diabetes achieved needed until adequate blood pressure croalbuminuria or clinical albumin- significant reductions in coronary and ce- control is obtained and then seen as uria/nephropathy, an ACE inhibitor or rebrovascular events (37–39). A primary necessary; in these patients, other car- an ARB should be strongly considered. prevention study using statins showed a diovascular risk factors, including hyper- If one class is not tolerated, the other similar trend of reduced events in the lipidemia, smoking, urinary albumin should be substituted. small number of patients with diabetes excretion (assessed before initiation of ● In patients over age 55 years, with hy- (40). In two studies using the fibric acid treatment), and glycemic control, should pertension or without hypertension but derivative gemfibrozil, reductions in car- be carefully assessed and treated. with another cardiovascular risk factor diovascular end points were also achieved (history of CVD, dyslipidemia, mi- (41,42). In the Helsinki Heart Study, a Recommendations croalbuminuria, smoking), an ACE in- primary prevention trial, a trend toward hibitor (if not contraindicated) should significant reductions in CHD events was Screening and Diagnosis be considered to reduce the risk of car- observed in the small group of subjects Expert consensus diovascular events. with diabetes mellitus (41). In the Veter- ● In patients with a recent myocardial in- ans Affairs High-Density Lipoprotein ● Blood pressure should be measured at farction, ␤-blockers, in addition, Cholesterol Intervention Trial (VA-HIT), every routine diabetes visit. Patients should be considered to reduce mortal- a secondary trial, a significant reduction found to have systolic blood pressure ity. in events occurred with improved HDL Ն130 or diastolic blood pressure Ն80 and triglycerides and no change in LDL mmHg should have blood pressure cholesterol. (42) confirmed on a separate day. B-Level evidence Target lipid levels are shown in Table ● Orthostatic measurement of blood 7. Nutrition assessment and intervention, pressure should be performed to assess ● Patients with diabetes should be treated increased physical activity, and weight for the presence of autonomic neurop- to a systolic blood pressure Ͻ130 loss should allow some patients to reach athy. mmHg. these lipid levels. Nutrition intervention

S40 DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 Position Statement should be tailored according to each pa- B-Level evidence Aspirin therapy in diabetes tient’s age, type of diabetes, pharmacolog- Aspirin blocks thromboxane synthesis by ical treatment, lipid levels and other ● Lowering triglycerides and increasing acetylating platelet cyclo-oxygenase and medical conditions and should focus on HDL cholesterol are associated with a has been used as a primary and secondary the reduction of saturated and choles- reduction in cardiovascular events. therapy to prevent cardiovascular events terol intake. Glycemic control can also in diabetic and nondiabetic individuals. beneficially modify plasma lipid levels. In One large meta-analysis and several clin- particular, triglycerides may be signifi- Goals ical trials demonstrate the efficacy of us- cantly reduced with optimal glucose low- B-Level evidence ing aspirin as a preventive measure for ering. cardiovascular events including Pharmacological treatment is indi- ● Lower LDL cholesterol to Ͻ100 mg/dl and myocardial infarction. Many trials cated if there is an inadequate response to (2.6 mmol/l) as the primary goal of have shown an approximate 30% de- lifestyle modifications and improved glu- therapy for adults. crease in myocardial infarction and a 20% cose control. The first priority of pharma- decrease in stroke in a wide range of pa- cological therapy is to lower LDL C-Level evidence tients, including young and middle-aged cholesterol to a target goal of Ͻ100 mg/dl patients, patients with and without a his- (2.60 mmol/l). For LDL lowering, statins tory of cardiovascular disease, males and ● Lower triglycerides to Ͻ150 mg/dl (1.7 are the drugs of choice. Statins raise HDL females, and patients with hypertension. mmol/l) and raise HDL cholesterol to modestly, but a greater increase is usually Dosages used in most clinical trials Ͼ45 mg/dl (1.15 mmol/l) in men and achieved with fibrates. ranged from 75–325 mg/day. There is no Ͼ55 mg/dl (1.40 mmol/l) in women. In patients with LDL between 100 evidence to support any specific dose, but mg/dl (2.60 mmol/l) and 129 mg/dl (3.30 using the lowest possible dosage and en- mmol/l), a variety of treatment strategies Screening teric-coated preparations may help re- are available, including more aggressive Expert consensus duce side effects. nutrition intervention and pharmacolog- There is no evidence for a specific age ical treatment with a statin. In addition, if ● at which to start aspirin, but at ages below Ͻ In adult patients, test for lipid disorders the HDL is 40 mg/dl and the LDL is at least annually and more often if 30 years, when the risk of CVD is low, between 100 and 129 mg/dl, a fibric acid needed to achieve goals. In adults with there is no evidence of benefit of aspirin such as fenofibrate might be used. low-risk lipid values (Table 6), repeat for primary prevention. Niacin is the best drug for raising lipid assessments every 2 years. In a secondary analysis of some stud- HDL but may significantly increase blood ● In children Ͼ2 years of age, perform a ies, aspirin therapy may have lessened the glucose (43). However, glycemic control lipid profile after diagnosis of diabetes beneficial effects of ACE inhibitors in pa- may be maintained with appropriate ad- and when glucose control has been es- tients with established CVD (i.e., prior justment of diabetes therapy and moder- myocardial infarction, angina, and con- Յ tablished. If values are considered low ate does of nicotinic acid ( 3 g/day). risk and there is no family history, as- gestive heart failure) (46). However, Combination therapy, with a statin sessments should be repeated every 5 pending additional studies, therapy with and a fibrate, may be efficacious for pa- years. ACE inhibitors does not preclude the use tients needing treatment for all three lipid of aspirin. Clopidogrel has been demon- fractions, but this combination is associ- started to reduce CVD rates in nondia- ated with an increased risk for myositis Treatment A-Level evidence betic individuals. Adjunctive therapy in and/or rhabdomyolysis. very high–risk patients or as alternative Following the recommendations of ● therapy in aspirin-intolerant patients the National Cholesterol Education Pro- MNT focusing on the reduction of sat- should be considered. gram’s Report of the Expert Panel on urated fat and cholesterol intake, Blood Cholesterol Levels in Children and weight loss, and increased physical ac- Adolescents, LDL cholesterol should be tivity has been shown to improve the Յ Recommendation lowered to 110 mg/dl (2.80 mmol/l) in lipid profile in patients with diabetes. A-Level evidence children with cardiovascular risk factors ● Patients who do not achieve lipid goals in addition to diabetes (44). with lifestyle modifications require pharmacological therapy. ● Use aspirin therapy (75–325 mg/day) ● Statins should be used as first-line in all adult patients with diabetes and Recommendations pharmacologic therapy for LDL lower- macrovascular disease. ing. ● Consider beginning aspirin therapy ● Therapy with fibrates in patients with (75–325 mg/day) for primary preven- General recommendations low HDL has been shown to reduce tion in patients Ն40 years of age with A-Level evidence CVD rates and progression of carotid diabetes and one or more other cardio- intimal medial progression. When pre- vascular risk factors. ● Lowering LDL cholesterol is associated scribing fibrates, in combination ther- ● Do not use aspirin in patients Ͻ21 with a reduction in cardiovascular apy with a statin, care is needed to years of age because of the increased events. minimize the risk of myositis. risk of Reye’s syndrome.

DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 S41 Position Statement

B-Level evidence symptoms of CAD, a risk factor–based ical albuminuria (Ն300 mg/24 h) and de- approach to the initial diagnostic evalua- creasing glomerular filtration rate (GFR) ● Consider aspirin therapy for patients tion and subsequent follow-up is recom- over a period of years. Once clinical albu- between 30 and 40 years of age with mended. At least annually, cardiovascular minuria occurs, the risk for ESRD is high other cardiovascular risk factors. risk factors should be assessed. These risk in type 1 diabetes and significant in type 2 factors include dyslipidemia, hyperten- diabetes. Smoking Cessation sion, smoking, a positive family history of Over the past several years, a number A large body of evidence from epidemio- premature coronary disease, and the pres- of interventions have been demonstrated logical, case-control, and cohort studies ence of micro- or macroalbumuninuria. to reduce the risk and to slow the progres- provides convincing documentation of Candidates for screening exercise stress sion of renal disease. Intensive diabetes the causal link between cigarette smoking (ECG) testing include those with 1) typi- management with the goal of achieving and health risks (28). Cigarette smoking cal or atypical cardiac symptoms; 2)an near normoglycemia has been shown in accounts for one of every five deaths in the abnormal resting ECG; 3) a history of pe- large prospective randomized studies to U.S. and is the most important modifiable ripheral or carotid occlusive disease; 4) delay the onset of microalbuminuria and cause of premature death. Much of the sedentary lifestyle, age Ͼ35 years, and the progression of microalbuminuria to prior work documenting the impact of plans to begin a vigorous exercise pro- clinical albuminuria in patients with type smoking on health did not discuss sepa- gram; or 5) those with two or more risk 1 (49,50) and type 2 diabetes (12). The rately results on subsets of individuals factors noted above. There is, however, UKPDS conclusively proved that hyper- with diabetes, suggesting the identified no current evidence that exercise testing tension control can slow the progression risks are at least equivalent to those found in asymptomatic patients with risk factors of nephropathy (31). In addition, large in the general population. Other studies improves prognosis. Patients with abnor- prospective randomized studies in pa- of individuals with diabetes consistently mal exercise ECG and patients unable to tients with type 1 and type 2 diabetes have found a heightened risk of morbidity and perform an exercise ECG require addi- demonstrated that treatment with ACE premature death associated with the de- tional/alternative testing. Currently, inhibitors and ARBs provides a selective velopment of macrovascular complica- stress nuclear perfusion and stress ECHO benefit over other antihypertensive agents tions among smokers. Smoking is also are valuable next-level diagnostic proce- in delaying the progression from mi- related to the premature development of dures. A consultation with a cardiologist croalbuminuria to clinical albuminuria microvascular complications of diabetes is recommended regarding further and can slow the decline in GFR in pa- and may have a role in the development of work-up (29). tients with clinical albuminuria (51–55). type 2 diabetes. In addition, ACE inhibitors have been A number of large randomized clini- Recommendations shown to reduce severe cardiovascular cal trials have demonstrated the efficacy Expert consensus disease (i.e., myocardial infarction, and cost-effectiveness of counseling in stroke, death), thus further supporting changing smoking behavior. Such stud- ● Perform exercise stress testing in the use of these agents in patients with ies, combined with the others specificto asymptomatic diabetic patients based microalbuminuria (55). ARBs have also individuals with diabetes, suggest that on the criteria outlined above. Consider been shown to reduce the rate of progres- smoking cessation counseling is effective a risk factor–based strategy for the di- sion of albuminuria and clinical nephrop- in reducing tobacco use (47,48). agnosis of CAD that might include athy in patients with type 2 diabetes (56– The routine and thorough assessment stress ECG and/or stress ECHO and/or 58). of tobacco use is important as a means of perfusion imaging. A meta-analysis of several small stud- preventing smoking or encouraging ces- ● Refer patients with signs and symptoms ies has shown that protein restriction may sation. Special considerations should in- of CVD or with positive noninvasive be of benefit in some patients whose ne- clude assessment of level of nicotine test for CAD to a cardiologist for further phropathy seems to be progressing de- dependence, which is associated with dif- evaluation. spite optimal glucose and blood pressure ficulty in quitting and relapse. control (59). SCREENING AND Screening for microalbuminuria can Recommendations MANAGEMENT OF OTHER be performed by three methods: 1) mea- A-Level evidence COMPLICATIONS surement of the albumin-to-creatinine ra- tio in a random, spot collection; 2) 24-h ● Advise all patients not to smoke. Nephropathy screening and collection with creatinine, allowing the si- treatment multaneous measurement of creatinine B-Level evidence Diabetic nephropathy occurs in 20–40% clearance; and 3) timed (e.g., 4-h or over- of patients with diabetes and is the single night) collection. At least two of three ● Include smoking cessation counseling leading cause of end-stage renal disease tests measured within a 6-month period and other forms of treatment as a rou- (ESRD). Persistent albuminuria in the should show elevated levels before a pa- tine component of diabetes care. range of 30–299 mg/24 h (microalbu- tient is designated as having microalbu- minuria) has been shown to be the earliest minuria. Abnormalities of albumin CHD screening and treatment stage of diabetic nephropathy and is also a excretion are defined in Table 8. To identify the presence of CHD in dia- significant marker for CVD. Patients with The role of annual urine protein dip- betic patients without clear or suggestive microalbuminuria likely progress to clin- stick testing and microalbumuria assess-

S42 DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 Position Statement

Table 8 —Definitions of abnormalities in albumin excretion increased in people who have had diabe- tes Ͼ10 years, are male, have poor glu- 24-h collection Timed collection Spot collection cose control, or have cardiovascular, Category (mg/24 h) (␮g/min) (␮g/mg creatinine) retinal, or renal complications. The fol- lowing foot-related risk conditions are as- Normal Ͻ30 Ͻ20 Ͻ30 sociated with an increased risk of Microalbuminuria 30–299 20–199 30–299 amputation: Clinical albuminuria Ն300 Ն200 Ն300 Because of variability in urinary albumin excretion, two of three specimens collected within a 3- to 6-month ● Peripheral neuropathy with loss of pro- period should be abnormal before considering a patient to have crossed one of these diagnostic thresholds. Exercise within 24 h, infection, fever, congestive heart failure, marked hyperglycemia, and marked hyper- tective sensation ● tension may elevate urinary albumin excretion over baseline values. Altered biomechanics (in the presence of neuropathy) ● Evidence of increased pressure (erythe- ment is less clear after diagnosis of ical albuminuria, ARBs are the initial ma, hemorrhage under a callus) ● Bony deformity microalbuminuria and institution of ACE agents of choice. ● inhibitor or ARB therapy and blood pres- Peripheral vascular disease (decreased sure control. Many experts recommend ● If one class is not tolerated, the other or absent pedal pulses) ● A history of ulcers or amputation continued surveillance both to assess re- should be substituted. ● sponse to therapy and progression of dis- Severe nail pathology ease. B-Level evidence For a complete discussion on the Targeted patient education and appropri- treatment of nephropathy, see the Amer- ● With the onset of overt nephropathy, ate footwear can reduce the risk of ulcer- ican Diabetes Association’s position state- initiate protein restriction to Յ0.8 g ation. For a detailed review of the Ϫ Ϫ ment “Diabetic Nephropathy” (60). kg 1 body wt day 1 (ϳ10% of daily evidence and further discussion, see the calories), the current adult recom- American Diabetes Association’s techni- Recommendations mended daily allowance for protein. cal review and position statement titled Further restriction may be useful in “Preventive Foot Care in Persons With Di- General recommendations slowing the decline of GFR in selected abetes” (61,62). A-Level evidence patients. Problems involving the feet, espe- ● Combination of ACE inhibitors and cially ulcers and wound care, may require ● To reduce the risk and/or slow the pro- ARBs will decrease albuminuria more care by a podiatrist, orthopedic surgeon, gression of nephropathy, optimize glu- than with either agent alone. or rehabilitation specialist experienced in cose control. the management of persons with diabetes. ● To reduce the risk and/or slow the pro- Expert consensus For a complete discussion on wound care, gression of nephropathy, optimize see the American Diabetes Association’s blood pressure control. ● If ACE inhibitors or ARBs are used, consensus statement on diabetic foot monitor serum potassium levels for the wound care (63). Screening development of hyperkalemia. ● Expert consensus Consider referral to a physician experi- Recommendations enced in the care of diabetic renal dis- A-Level evidence ● Perform an annual test for the presence ease when the GFR has fallen to either Ϫ Ϫ of microalbuminia in 1) type 1 diabetic Ͻ70 ml min 1 1.73 m 2, serum cre- ● A multidisplinary approach is recom- patients who have had diabetes Ͼ5 atinine has increased to Ͼ2.0 mg/dl mended for persons with foot ulcers years and 2) all type 2 diabetic patients (Ͼ180 ␮mol/l), or difficulties occur in and high risk feet, especially those with starting at diagnosis. the management of hypertension or hy- a history of prior ulcer or amputation perkalemia. Treatment ● Consider the use of non-DCCBs in pa- A-Level evidence tients unable to tolerate ACE inhibitors B-Level evidence or ARBs. ● In the treatment of albuminuria/ ● The foot examination can be accom- nephropathy, both ACE inhibitors and Foot care plished in a primary care setting and ARBs can be used: Amputation and foot ulceration are one of should include the use of a Semmes- • in hypertensive and nonhypertensive the most common consequences of dia- Weinstein monofilament, tuning fork, type 1 diabetic patients with mi- betic neuropathy and a major cause of palpation, and a visual examination. croalbuminuria or clinical albumin- morbidity and disability in people with ● Educate all patients, especially those uria, ACE inhibitors are the initial diabetes. Early recognition and manage- with risk factors or prior lower- agents of choice; ment of independent risk factors can pre- extremity complications, about the risk • in hypertensive type 2 diabetic pa- vent or delay adverse outcomes. and prevention of foot problems, and tients with microalbuminuria or clin- The risk of ulcers or amputations is reinforce self-care behavior.

DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 S43 Position Statement

C-Level evidence for the therapeutic benefit of photocoag- Recommendations ulation surgery (71–77). ● Refer high-risk patients to foot care spe- The DRS tested whether scatter (pan- General Recommendations cialists for ongoing preventive care and retinal) photocoagulation surgery could A-Level evidence life-long surveillance. reduce the risk of vision loss from PDR. ● Refer patients with claudication for fur- Severe visual loss (i.e., best acuity of ● Optimal glycemic control can substan- ther vascular assessment and consider 5/200 or worse) was seen in 15.9% of un- tially reduce the risk and progression of exercise and surgical options. treated eyes vs. 6.4% of treated eyes. The diabetic retinopathy. benefit was greatest among patients ● Optimal blood pressure control can re- Expert consensus whose baseline evaluation revealed high- duce the risk and progression of dia- risk characteristics (HRCs) (chiefly disc betic retinopathy. ● Perform a comprehensive foot exami- neovascularization or vitreous hemor- ● Aspirin therapy does not prevent reti- nation annually on patients with diabe- rhage with any retinal neovasculariza- nopathy or increase the risks of hemor- tes to identify risk factors predictive of tion). Of control eyes with HRCs, 26% rhage. ulcers and amputations. Perform a vi- progressed to severe visual loss vs. 11% of sual inspection of patients’ feet at each treated eyes. Given the risk of a modest Screening routine visit. loss of visual acuity and of contraction of B-Level evidence visual field from panretinal laser surgery, Diabetic retinopathy screening and such therapy has been primarily recom- ● Patients with type 1 diabetes should treatment mended for eyes approaching or reaching have an initial dilated and comprehen- Diabetic retinopathy is a highly specific HRCs. sive eye examination by an ophthalmol- vascular complication of both type 1 and The ETDRS established the benefitof ogist or optometrist within 3–5 years type 2 diabetes. The prevalence of reti- focal laser photocoagulation surgery in after the onset of diabetes. nopathy is strongly related to the duration eyes with macular edema, particularly ● Patients with type 2 diabetes should of diabetes. Diabetic retinopathy is esti- those with clinically significant macular have an initial dilated and comprehen- mated to be the most frequent cause of edema. In patients with clinically signifi- sive eye examination by an ophthalmol- new cases of blindness among adults aged cant macular edema after 2 years, 20% of ogist or optometrist shortly after the 20–74 years. untreated eyes had a doubling of the vi- diagnosis of diabetes is made. Intensive diabetes management with sual angle (e.g., 20/50 to 20/100) com- ● Subsequent examinations for type 1 the goal of achieving near normoglycemia pared with 8% of treated eyes. Other and type 2 diabetic patients should be has been shown in large prospective ran- results from the ETDRS indicate that, pro- repeated annually by an ophthalmolo- domized studies to prevent and/or delay vided careful follow-up can be main- gist or optometrist who is knowledge- the onset of diabetic retinopathy (11,12). tained, scatter photocoagulation surgery able and experienced in diagnosing In addition to glycemic control, several is not recommended for eyes with mild or the presence of diabetic retinopathy other factors seem to increase the risk of moderate nonproliferative diabetic reti- and is aware of its management. Exam- retinopathy. The presence of nephropa- nopathy (NPDR). When retinopathy is inations will be required more fre- thy is associated with retinopathy. High more severe, scatter photocoagulation quently if retinopathy is progressing. blood pressure is an established risk fac- surgery should be considered, and usu- ● When planning pregnancy, women tor for the development of macular edema ally should not be delayed, if the eye has with pre-existing diabetes should have and is associated with the presence of pro- reached the high-risk proliferative stage. a comprehensive eye examination and liferative diabetic retinopathy (PDR). In older-onset patients with severe NPDR should be counseled on the risk of de- Lowering blood pressure, as shown in the or less than high-risk PDR, the risk of se- velopment and/or progression of dia- UKPDS, has been shown to decrease the vere visual loss and vitrectomy is reduced betic retinopathy. Women with progression of retinopathy. Several case ϳ50% by laser photocoagulation surgery diabetes who become pregnant should series and a controlled prospective study at these earlier stages. have a comprehensive eye examination suggest that pregnancy in type 1 diabetic Laser photocoagulation surgery in in the first trimester and close fol- patients may aggravate retinopathy (64). both the DRS and the ETDRS was benefi- low-up throughout pregnancy and for During pregnancy and 1 year postpar- cial in reducing the risk of further visual 1 year postpartum. This guideline does tum, retinopathy may be transiently ag- loss, but generally not beneficial in revers- not apply to women who develop GDM gravated; laser surgery can minimize this ing already diminished acuity. This pre- because such individuals are not at in- risk (65). ventive effect and the fact that patients creased risk for diabetic retinopathy. One of the main motivations for with PDR or macular edema may be screening for diabetic retinopathy is the asymptomatic provide strong support for Treatment established efficacy of laser photocoagu- a screening program to detect diabetic ret- A-Level evidence lation surgery in preventing visual loss. inopathy. Two large National Institutes of Health– For a detailed review of the evidence ● Laser therapy can reduce the risk of vi- sponsored trials, the Diabetic Retinopa- and further discussion, see the American sion loss in patients with high-risk thy Study (DRS) (66–70) and the Early Diabetes Association’s technical review characteristics. Treatment Diabetic Retinopathy Study and position statement on this subject ● Promptly refer patients with any level of (ETDRS), provide the strongest support (64,78). macular edema, severe NPDR, or any

S44 DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 Position Statement

PDR to an ophthalmologist who is in women with diabetes are unplanned, retinopathy, nephropathy, neuropathy, knowledgeable and experienced in the leading to a persistent excess of malfor- and CVD. management and treatment of diabetic mations in infants of diabetic mothers. To ● Oral antidiabetic agents and ARBs retinopathy. minimize the occurrence of these devas- should be discontinued before preg- tating malformations, standard care for all nancy. PREVENTIVE CARE women with diabetes who have child- bearing potential should include 1) edu- Immunization Preconception Care cation about the risk of malformations Influenza and pneumonia are common, Major congenital malformations remain associated with unplanned pregnancies preventable infectious diseases associated the leading cause of mortality and serious and poor metabolic control and 2) use of with high mortality and morbidity in the morbidity in infants of mothers with type effective contraception at all times unless elderly and in people with chronic dis- 1 and type 2 diabetes. Observational stud- the patient is in good metabolic control eases. There are limited studies reporting ies indicate that the risk of malformations and actively trying to conceive. the morbidity and mortality of influenza increases continuously with increasing Women contemplating pregnancy and pneumococcal pneumonia specifi- maternal glycemia during the first 6–8 need to be seen frequently by a multidis- cally in people with diabetes. Observa- weeks of gestation, as indexed by first tri- ciplinary team experienced in the man- tional studies of patients with a variety of mester A1C concentrations. There is no agement of diabetes before and during chronic illnesses, including diabetes, threshhold for A1C values above which pregnancy. Teams may vary but should show that these conditions are associated the risk begins or below which it disap- include a diabetologist, internist or family with an increase in hospitalizations for in- pears. However, malformation rates physician, an obstetrician, a diabetes ed- fluenza and its complications. Based on a above the 1–2% background rate seen in ucator, a dietitian, a social worker, and case-control series, influenza vaccine has nondiabetic pregnancies appear to be lim- other specialists as necessary. The goals been shown to reduce diabetes-related ited to pregnancies in which first trimes- of preconception care are to 1) integrate hospital admission by as much as 79% ter A1C concentrations are Ͼ1% above the patient into the management of her during flu epidemics (86). People with di- the normal range. diabetes, 2) achieve the lowest A1C test abetes may be at increased risk of the bac- Five nonrandomized studies have results possible without excessive hypo- teremic form of pneumococcal infection compared rates of major malformations in glycemia, 3) assure effective contracep- and have been reported to have a high risk the infants between women who partici- tion until stable and acceptable glycemia of nosocomial bacteremia, which has a pated in preconception diabetes care pro- is achieved, and 4) identify, evaluate, and mortality rate as high as 50%. grams and women who initiated intensive treat long-term diabetic complications Safe and effective vaccines are avail- diabetes management after they were al- such as retinopathy, nephropathy, neu- able which can greatly reduce the risk of ready pregnant. The preconception care ropathy, hypertension, and CAD. serious complications from these diseases programs were multidisciplinary and de- For further discussion, see the Amer- (87,88). There is sufficient evidence to signed to train patients in diabetes self- ican Diabetes Association’s technical re- support that people with diabetes have management with diet, intensified insulin view and position statement on this appropriate seriologic and clinical re- therapy, and self-monitoring of blood subject (84,85). sponses to these vaccinations. The Cen- glucose. Goals were set to achieve normal ters for Disease Control’s Advisory Ͼ blood glucose concentrations, and 80% Recommendations Committee on Immunization Practices of subjects achieved normal A1C concen- B-Level evidence recommends influenza and pneumococ- trations before they became pregnant cal vaccines for all persons over 65 years (79–83). In all five studies, the incidence ● A1C levels should be normal or as close of age as well as for all persons of any age of major congenital malformations in to normal as possible in an individual with diabetes. women who participated in preconcep- patient before conception is attempted. For a complete discussion on the pre- tion care (range 1.0–1.7% of infants) was vention of influenza and pneumococcal much lower than the incidence in women disease in people with diabetes, consult who did not participate (range 1.4– C-Level evidence the technical review and position state- 10.9% of infants). One limitation of these ment on this subject (89,90). ● studies is that participation in preconcep- ACE inhibitors should be discontinued tion care was self-selected by patients before pregnancy. Recommendations rather than randomized. Thus, it is im- C-Level evidence possible to be certain that the lower mal- Expert consensus formation rates resulted fully from ● Annually provide an influenza vaccine improved diabetes care. Nonetheless, the ● All women with diabetes and child- to all diabetic patients 6 months of age overwhelming evidence supports the bearing potential should be educated or older. concept that malformations can be re- about the need for good glucose control ● Provide at least one lifetime pneumo- duced or prevented by careful manage- before pregnancy. They should partici- coccal vaccine for adults with diabetes. ment of diabetes before pregnancy. pate in family planning. A one-time revaccination is recom- Planned pregnancies greatly facilitate ● Women with diabetes who are contem- mended for individuals Ͼ64 years of preconceptional diabetes care. Unfortu- plating pregnancy should be evaluated age previously immunized when they nately, nearly two-thirds of pregnancies and, if indicated, treated for diabetic were Ͻ65 years of age if the vaccine was

DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 S45 Position Statement

administered more than 5 years ago. zolidinediones should not be used in pa- least annually thereafter, by an individual Other indications for repeat vaccina- tients with congestive heart failure experienced with the nutritional needs of tion include nephrotic syndrome, (NYHA Class III and IV). ␣-Glucosidase the growing child and the behavioral is- chronic renal disease, and other immu- inhibitors are safe but may not be well sues that have an impact on adolescent nocompromised states, such as postor- tolerated and may not be effective as diets. Caution must be exercised to avoid gan transplantation. monotherapy. Drugs should be started at overaggressive dietary manipulation in the lowest dose and titrated up gradually the very young. Assessment of lifestyle SPECIAL CONSIDERATIONS until targets are reached or side effects de- needs should be accompanied by possible velop. modifications of the diabetic regimen. For Care of older adults with diabetes Cardiovascular risk reduction contin- example, an adolescent who requires Diabetes is an important health condition ues to be important as in younger pa- more flexibility might be switched to a for the aging population; ϳ10% of pa- tients; there is strong evidence from three– or four–insulin injection program tients over the age of 65 years have diabe- clinical trials of the value of treating hy- or continuous subcutaneous insulin in- tes. The number of older persons with pertension in the elderly. There is less ev- jection (CSII). diabetes can be expected to grow rapidly idence for lipid lowering and aspirin A major issue deserving emphasis in over the coming decades. Unfortunately, therapy although diabetes patients have this age-group is that of “adherence.” No there are no long-term studies demon- such an elevated risk for CVD that aggres- matter how sound the medical regimen, it strating the benefits of tight glycemic con- sive management of lipids and aspirin use can only be as good as the ability of the trol in persons over 65 years of age. In when not contraindicated are probably family and/or individual to implement it. approaching the elderly patient, a reasonable interventions. Health care providers who care for chil- thoughtful individualized approach, con- dren and adolescents, therefore, must be sistent with the heterogeneity of the aging capable of evaluating the behavioral, process, should be used. However, pa- Children and adolescents emotional, and psychosocial factors that tients who can be expected to live long Approximately three-quarters of all newly interfere with implementation and then enough to reap the benefits of long-term diagnosed cases of type 1 diabetes occur must work with the individual and family glycemic control (10–20 years) and who in individuals younger than 18 years. to resolve problems that occur and/or to are active, cognitively intact, and willing Care of this group requires integration of modify goals as appropriate. to undertake the responsibility of self diabetes management with the compli- The incidence of type 2 diabetes in management should be encouraged to do cated physical and emotional growth children and adolescents has been shown so. needs of children, adolescents, and their to be increasing. Although there are insuf- For patients with advanced diabetes families. ficient data to make definite recommen- complications, life-limiting comorbid ill- Diabetes care for children of this age- dations, a recent American Diabetes ness, or cognitive or functional impair- group should be provided by a team that Association consensus statement pro- ment, it is reasonable to set higher target can deal with these special medical, edu- vides guidance to the prevention, screen- goals. These patients are less likely to ben- cational, nutritional, and behavioral issues. ing, and treatment of type 2 diabetes in efit from reducing microvascular compli- At the time of initial diagnosis, it is young people. The ideal goal of treatment cations and more likely to suffer serious extremely important to establish the goals is normalization of blood glucose and adverse effects from hypoglycemia. of care and to begin diabetes self- A1C values. Accurate diagnosis and clas- Chronic hyperglycemia can cause a cata- management education. A firm educa- sification of diabetes is crucial in deter- bolic state leading to malnutrition, func- tional base should be provided so that the mining appropriate treatment for these tional impairment, and symptom with individual and family can become in- patients. Many patients can be managed decreased quality of life. Also, patients creasingly independent in the self- initially with MNT and exercise, but most with poorly controlled diabetes may be management of diabetes. Glycemic goals will eventually require drug therapy. Suc- subject to acute complications of diabe- may need to be modified to take into ac- cessful control of comorbidities, such as tes, including hyperglycemic hyperosmo- count the fact that most children younger hypertension and hyperlipidemia, is also lar coma. Reasonable targets, not based than 6 or 7 years have a form of “hypogly- important. For further discussion, see the on evidence, would be a fasting glucose cemic unawareness,” in that they lack the American Diabetes Association consensus Ͻ140 mg/dl and postprandial glucose cognitive capacity to recognize and re- statement “Type 2 Diabetes in Children Ͻ200–220 mg/dl. spond to hypoglycemic symptoms and and Adolescents” (9). Older patients can be treated with the may be at greater risk for the sequelae of Information should be supplied to same drug regimens as younger patients, hypoglycemia. the school or day care setting so that but special care is required in prescribing Intercurrent illnesses are more fre- school personnel are aware of the diagno- and monitoring drug therapy. Metformin quent in young children. Sick-day man- sis of diabetes in the student and of the is often contraindicated because of renal agement rules, including assessment for signs, symptoms, and treatment of hypo- insufficiency or heart failure. Sulfonyl- ketosis with every illness, must be estab- glycemia. It is desirable that blood glu- ureas and other insulin secretogogues can lished and taught to prevent severe hy- cose testing be performed at the school or cause hypoglycemia. Insulin can also perglycemia and DKA that requires day care setting before lunch and when cause hypoglycemia as well as requiring hospitalization and may lead to severe signs or symptoms of abnormal blood good visual and motor skills and cognitive morbidity and even death (18). MNT glucose levels are present. ability of the patient or a caregiver. Thia- should be provided at diagnosis, and at For further discussion, see the Amer-

S46 DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 Position Statement ican Diabetes Association’s position state- dria, VA, American Diabetes Association, Turner RC, Holman RR: Association of ment “The Care of Children With 1998 glycaemia with macrovascular and micro- Diabetes in the School and Day Care Set- 3. Expert Committee on the Diagnosis and vascular complications of type 2 diabetes ting” (91). Classification of Diabetes Mellitus: Report (UKPDS 35): prospective observational of the Expert Committee on the Diagnosis study. BMJ 321:405–412, 2000 and Classification of Diabetes Mellitus. 16. American Diabetes Association: Postpran- Strategies for successful guideline Diabetes Care 25 (Suppl. 1):S5–S20, 2002 dial blood glucose (Consensus State- implementation 4. World Health Organization: Diabetes ment). Diabetes Care 24:775–778, 2001 In recent years, numerous health care or- Mellitus: Report of a WHO Study Group. 17. 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The DaQing IGT and AD, Purnell JQ, Wheeler M: Evidence- accessible at the point of service, such Diabetes Study. Diabetes Care 20:537– based nutrition principles and recom- as on patient charts, in examining 544, 1997 mendations for the treatment and rooms, or on office computer systems. 7. Available on the internet. www.prevent prevention of diabetes and related com- diabetes.com. Accessed October 2001 ● Systems changes, such as provision of plications (Technical Review). Diabetes 8. Engelgau ME, Narayan KMV, Herman automated reminders to providers and Care 25: 148–198, 2002 WH: Screening for type 2 diabetes (Tech- 22. American Diabetes Association: Evi- patients, profiling or reporting of data nical Review). Diabetes Care 10:1563– dence-based nutrition principles and rec- to providers, and identification of pa- 1580, 2000 ommendations for the treatment and tients at risk because of abnormal target 9. American Diabetes Association: Type 2 prevention of diabetes and related com- values or a lack of reported values. diabetes in children and adolescents ● Practice changes, such as scheduling of (Consensus Statement). Diabetes Care 23: plications (Position Statement). Diabetes dedicated diabetes visits and group vis- 381–389, 2000 Care 25 (Suppl. 1):S50-S60, 2002 10. American Diabetes Association: Gesta- 23. Schneider SH, Ruderman NB: Exercise its. and NIDDM (Technical Review). Diabetes ● Delivery of diabetes self-management tional diabetes mellitus (Position State- ment). Diabetes Care 25 (Suppl. 1):S94– Care 13:785–789, 1990 education. 24. Wasserman DH, Zinman B: Exercise in ● Availability of case management ser- S96, 2002 11. Diabetes Control and Complications Trial individuals with IDDM (Technical Re- vices, usually by a nurse. view). Diabetes Care 17:924–937, 1994 ● Research Group: The effect of intensive Availability and involvement of expert treatment of diabetes on the development 25. Arauz-Pacheco C, Parrott MA, Raskin P: consultants, such as endocrinologists and progression of long-term complica- The treatment of hypertension in adult and diabetes educators. tions in insulin-dependent diabetes mel- patients with diabetes mellitus (Technical ● Because these interventions are gener- litus. N Engl J Med 329:977–986, 1993 Review). Diabetes Care 25:134–147, 2002 ally provided as components of a mul- 12. UK Prospective Diabetes Study Group: 26. Haffner SM: Management of dyslipidemia tifactorial intervention, it is difficult to Intensive blood-glucose control with sul- in adults with diabetes (Technical Re- assess the contribution of each compo- phonylureas or insulin compared with view). Diabetes Care 21:160–178, 1998 conventional treatment and risk of com- 27. Colwell JA: Aspirin therapy in diabetes nent; however, it is clear that optimal (Technical Review). Diabetes Care 20: diabetes management requires an orga- plications in patients with type 2 diabetes (UKPDS 33). Lancet 352:837–853, 1998 1767–1771, 1997 nized, systematic approach and in- 13. UK Prospective Diabetes Study Group: 28. Haire-Joshu D, Glasgow RE, Tibbs TL: volvement of a health care team. Effect of intensive blood-glucose control Smoking and diabetes (Technical Re- ● Simple tools such as flow charts may be with metformin on complications in over- view). Diabetes Care 22:1887–1898, 1999 useful in smaller practices. weight patients with type 2 diabetes (UK- 29. American Diabetes Association: Consen- PDS 34). Lancet 352:854–865, 1998 sus development conference on the diag- 14. Lawson ML, Gerstein HC, Tsui E, Zinman nosis of coronary heart disease in people References B: Effect of intensive therapy on early ma- with diabetes (Consensus Statement). Di- 1. 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