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standards of medical care in diabetes

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Standards of Medical Care in Diabetes AMERICAN DIABETES ASSOCIATION D iabetes is a chronic illness that re- quires continuing medical care and patient 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 persons with the components of diabetes care, treatment goals, and tools to evaluate the quality of care. While individual prefer- ences, comorbidities, and other patient factors may require modification of goals, targets that are desirable for most patients with diabetes are provided. These stan- dards are not intended to preclude more extensive evaluation and management of the patient by other specialists as needed. For more detailed information, refer to Bode (Ed.): Medical Management of Type 1 Diabetes (1), Zimmerman (Ed.): Medical Management of Type 2 Diabetes (2), and Klingensmith (Ed): Intensive Diabetes Management (3). The recommendations included are diagnostic and therapeutic actions that are known or believed to favorably affect health outcomes of patients with diabetes. A grading system (Table 1), developed by the American Diabetes Association (ADA) and modeled after existing methods, was utilized to clarify and codify the evidence that forms the basis for the recommenda- tions. The level of evidence that supports each recommendation is listed after each recommendation using the letters A, B, C, or E. CLASSIFICATION, DIAGNOSIS, AND SCREENING Classification In 1997, the ADA issued new diagnostic and classification criteria (4); in 2003, modifications were made regarding the diagnosis of impaired fasting glucose (IFG) (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, drug or chemical induced). ● Gestational diabetes mellitus (GDM) (diagnosed during pregnancy). Diagnosis 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 fasting plasma glucose (FPG) to diagnose diabetes, it is poorly reproducible and rarely performed in practice. Because of ease of use, accept- ability to patients, and lower cost, the FPG is the preferred screening and diag- nostic test. It should be noted that the vast majority of people who meet diagnostic criteria for diabetes by OGTT, but not by FPG, will have an A1C value 7.0%. The use of the A1C for the diagnosis of diabe- tes is not recommended at this time. Hyperglycemia not sufficient to meet the diagnostic criteria for diabetes is cate- gorized as either IFG or impaired glucose tolerance (IGT), depending on whether it is identified through FPG or an 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) Recently, IFG and IGT have been offi- cially termed “pre-diabetes.” Both catego- ries, IFG and IGT, are risk factors for future diabetes and cardiovascular dis- ease (CVD). Recent studies have shown that modest weight loss and regular phys- ical activity can reduce the rate of progres- sion of IGT to type 2 diabetes (6 – 8). Drug therapy (metformin [8], acarbose [9], and orlistat [10] and troglitazone [no longer clinically available] [11]) has been shown to be effective in reducing progression to diabetes, though generally not as effec- tively as intensive lifestyle interventions. Screening Generally, people with type 1 diabetes present with acute symptoms of diabetes and markedly elevated blood glucose lev- els. Type 2 diabetes is frequently not di- agnosed until complications appear, and approximately one-third of all people with diabetes may be undiagnosed. Al- though the burden and natural history of diabetes is well known and although there is good evidence for benefit from treating cases diagnosed in the context of usual clinical care, there are no randomized tri- als demonstrating the benefits of early diagnosis through screening of asymp- tomatic individuals (12). Nevertheless, there is sufficient indirect evidence to jus- ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● The recommendations in this paper 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 2003. Abbreviations: ABI, ankle-brachial index; ARB, angiotensin receptor blocker; CAD, coronary artery disease; CHD, coronary heart disease; CSII, continuous subcutaneous insulin injection; CVD, cardiovascular disease; FPG, fasting plasma glucose; GCT, glucose challenge test; DCCB, dihydropyridine calcium channel blocker; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis; DRS, Diabetic Retinopathy Study; ECG, electrocardiogram; eGFR, estimated GFR; ESRD, end-stage renal disease; ETDRS, Early Treatment Diabetic Retinopathy Study; GDM, gestational diabetes mellitus; GFR, glomerular filtration 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; PAD, peripheral arterial disease; PDR, proliferative diabetic retinopathy; PPG, postprandidial plasma glu- cose; SMBG, self-monitoring of blood glucose; UKPDS, U.K. Prospective Diabetes Study. © 2004 by the American Diabetes Association. POSITION STATEMENT DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S15

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Standards of Medical Care in DiabetesAMERICAN DIABETES ASSOCIATIONDiabetes is a chronic illness that re-quires continuing medical care andpatient self-management educationto prevent acute complications and to re-duce the risk of long-term complications.Diabetes care is complex and requires thatmany issues, beyond glycemic control, beaddressed. A large body of evidence existsthat supports a range of interventions toimprove diabetes outcomes.These standards of care are intendedtoprovideclinicians,patients,research-ers, payors, and other interested personswiththecomponents of diabetes care,treatment goals, and tools to evaluate thequalityofcare.Whileindividualprefer-ences, comorbidities, andother patientfactors may require modication of goals,targets that are desirable for most patientswithdiabetesareprovided. Thesestan-dards are not intended to preclude moreextensive evaluation and management ofthe patient by other specialists as needed.For moredetailedinformation, refer toBode (Ed.): Medical Management of Type 1Diabetes(1), Zimmerman(Ed.): MedicalManagement of Type2Diabetes(2), andKlingensmith(Ed): Intensive DiabetesManagement (3).Therecommendationsincludedarediagnosticandtherapeuticactions thatare known or believed to favorably affecthealth outcomes of patients with diabetes.A grading system (Table 1), developed bythe American Diabetes Association (ADA)and modeled after existing methods, wasutilized to clarify and codify the evidencethat forms the basis for the recommenda-tions. The level of evidence that supportseach recommendation is listed after eachrecommendation using the letters A, B, C,or E.CLASSIFICATION,DIAGNOSIS, ANDSCREENINGClassicationIn 1997, the ADA issued new diagnosticandclassicationcriteria(4); in2003,modicationsweremaderegardingthediagnosis of impairedfastingglucose(IFG) (5). Theclassicationof diabetesincludes four clinical classes:Type 1 diabetes (results from-cell de-struction, usuallyleadingtoabsoluteinsulin deciency).Type 2 diabetes (results froma progres-sive insulinsecretorydefect onthebackground of insulin resistance).Other specic types of diabetes (due toother causes, e.g., geneticdefects in-cell function, genetic defects in insu-lin action, diseases of the exocrine pan-creas, drug or chemical induced).Gestational diabetes mellitus (GDM)(diagnosed during pregnancy).DiagnosisCriteriaforthediagnosisof diabetesinnonpregnant adults are shown in Table 2.Three ways to diagnose diabetes are avail-able, andeachmustbeconrmedonasubsequent day unless unequivocalsymptoms of hyperglycemia are present.Although the 75-g oral glucose tolerancetest (OGTT) is more sensitive and mod-estlymorespecicthanfastingplasmaglucose (FPG) to diagnose diabetes, it ispoorly reproducible and rarely performedin practice. Because of ease of use, accept-abilitytopatients, andlower cost, theFPG is the preferred screening and diag-nostic test. It should be noted that the vastmajorityofpeoplewhomeetdiagnosticcriteria for diabetes by OGTT, but not byFPG, will have an A1C value 7.0%. Theuse of the A1C for the diagnosis of diabe-tes is not recommended at this time.Hyperglycemia not sufcient to meetthe diagnostic criteria for diabetes is cate-gorized as either IFG or impaired glucosetolerance (IGT), depending on whether itis identied through FPG or an OGTT:IFG FPG 100 mg/dl (5.6 mmol/l) to125 mg/dl (6.9 mmol/l)IGT 2-h plasma glucose 140 mg/dl(7.8 mmol/l) to 199 mg/dl (11.0mmol/l)Recently, IFGandIGThavebeenof-cially termed pre-diabetes. Both catego-ries, IFGandIGT, areriskfactors forfuturediabetes andcardiovascular dis-ease(CVD). Recentstudieshaveshownthat modest weight loss and regular phys-ical activity can reduce the rate of progres-sion of IGTto type 2 diabetes (68). Drugtherapy (metformin [8], acarbose [9], andorlistat[10]andtroglitazone[nolongerclinically available] [11]) has been shownto be effective in reducing progression todiabetes, thoughgenerallynot aseffec-tively as intensive lifestyle interventions.ScreeningGenerally, peoplewithtype1diabetespresent with acute symptoms of diabetesand markedly elevated blood glucose lev-els. Type 2 diabetes is frequently not di-agnosed until complications appear, andapproximatelyone-thirdof all peoplewithdiabetesmaybeundiagnosed. Al-though the burden and natural history ofdiabetes is well known and although thereis good evidence for benet from treatingcasesdiagnosedinthecontext of usualclinical care, there are no randomized tri-als demonstratingthebenets of earlydiagnosis throughscreeningof asymp-tomaticindividuals (12). Nevertheless,there is sufcient indirect evidence to jus-Therecommendationsinthispaperarebasedontheevidencereviewedinthefollowingpublication:Standards of care for diabetes (Technical Review). Diabetes Care 17:15141522, 1994.Originally approved 1988. Most recent review/revision, October 2003.Abbreviations: ABI, ankle-brachial index; ARB, angiotensinreceptorblocker; CAD, coronaryarterydisease; CHD, coronary heart disease; CSII, continuous subcutaneous insulin injection; CVD, cardiovasculardisease; FPG, fasting plasma glucose; GCT, glucose challenge test; DCCB, dihydropyridine calcium channelblocker; DCCT, DiabetesControl andComplicationsTrial; DKA, diabeticketoacidosis; DRS, DiabeticRetinopathy Study; ECG, electrocardiogram; eGFR, estimated GFR; ESRD, end-stage renal disease; ETDRS,Early Treatment Diabetic Retinopathy Study; GDM, gestational diabetes mellitus; GFR, glomerular ltrationrate; 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;PAD, peripheral arterial disease; PDR, proliferative diabetic retinopathy; PPG, postprandidial plasma glu-cose; SMBG, self-monitoring of blood glucose; UKPDS, U.K. Prospective Diabetes Study. 2004 by the American Diabetes Association.P O S I T I O N S T A T E ME N TDIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S15tifyopportunisticscreeninginaclinicalsetting of individuals at high risk. Criteriafor testing for diabetes in asymptomatic,undiagnosed adults are listed in Table 3.The recommended screening test for non-pregnant adults is the FPG. The OGTT ismore sensitive for the diagnosis of diabe-tesandpre-diabetes, but isimpracticaland expensive as a screening procedure.Theincidenceof type2diabetesinchildrenandadolescents has increaseddramaticallyinthelast decade. Consis-tent with screening recommendations foradults, onlychildrenandyouthat in-creased risk for the presence or the devel-opment of type 2diabetes shouldbetested (13) (Table 4).Detection and diagnosis of GDMRisk assessment for GDM should be un-dertaken at the rst prenatal visit. Womenwithclinical characteristics consistentwithahighriskfor GDM(thosewithmarked obesity, personal history of GDM,glycosuria, orastrongfamilyhistoryofdiabetes) should undergo glucose testingassoonaspossible(14).AnFPG126mg/dloracasualplasmaglucose200mg/dl meets the threshold for the diagno-sis of diabetes and needs to be conrmedon a subsequent day unless unequivocalsymptoms of hyperglycemia are present.High-risk women not found to have GDMat theinitial screeningandaverage-riskwomen should be tested between 24 and28 weeks of gestation. Testing should fol-low one of two approaches:One-step approach: performa diagnos-tic 100-g OGTTTwo-step approach: perform an initialscreening by measuring the plasma orserum glucose concentration 1 h after a50-goral glucoseload(glucosechal-lenge test [GCT]) and perform a diag-nostic100-gOGTTonthatsubsetofwomenexceedingtheglucosethresh-old value on the GCT. When the two-step approach is used, a glucosethreshold value 140 mg/dl identies80%ofwomenwithGDM,andtheyield is further increased to 90% by us-ing a cutoff of 130 mg/dl.Diagnostic criteria for the 100-g OGTTare as follows: 95mg/dl fasting,180 mg/dl at 1 h, 155 mg/dl at 2 h,and 140 mg/dl at 3 h. Two or more ofthe plasma glucose values must be metor exceededfor apositivediagnosis.The test should be done in the morningafter an overnight fast of 814 h. Thediagnosis can be made using a 75-g glu-coseload, butthattestisnotaswellTable 1ADA evidence grading system for clinical practice recommendationsLevel ofevidence DescriptionA 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 Center for Evidence Based Medicine at OxfordSupportive 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 analysisB Supportive evidence from well-conducted cohort studies Evidence from a well-conducted prospective cohort study or registry Evidence from a well-conducted prospective cohort study Evidence from a well-conducted meta-analysis of cohort studiesSupportive evidence from a well-conducted case-control studyC Supportive evidence from poorly controlled or uncontrolled studies Evidence from randomized clinical trials with one or more major or three or more minor methodological aws that couldinvalidate the results Evidence from observational studies with high potential for bias (such ascase series with comparison to historical controls) Evidence from case series or case reportsConicting evidence with the weight of evidence supporting the recommendationE Expert consensus or clinical experienceTable 2Criteria for the diagnosis of diabetes1. Symptoms of diabetes and a casual plasma glucose 200 mg/dl (11.1 mmol/l). Casual is dened as any time of day without regard to timesince last meal. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss.OR2. FPG 126 mg/dl (7.0 mmol/l). Fasting is dened as no caloric intake for at least 8 h.OR3. 2-h PG 200 mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as described by the World Health Organization (4a),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 conrmed by repeat testing on a different day. The OGTT is not recommended for routineclinical use, but may be required in the evaluation of patients with IFG (see text) or when diabetes is still suspected despite a normal FPG.Position StatementS16 DIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004validated for detection of at-risk infantsor mothers as the 100-g OGTT.Low-riskstatus requires noglucosetesting,butthiscategoryislimitedtothose women meeting all of the follow-ing characteristics: Age 25 years. Weight normal before pregnancy. Memberof anethnicgroupwithalow prevalence of GDM. Noknowndiabetes inrst-degreerelatives.No history of abnormal glucose tol-erance.Nohistoryof poor obstetricout-come.RecommendationsThe FPG is the preferred test to screenforanddiagnosediabetesinchildrenand nonpregnant adults. (E)Screen for diabetes in high-risk, asymp-tomatic,undiagnosedadultsandchil-dren within the health care setting. (E)Inthosewithpre-diabetes(IFG/IGT),l i festyl e modi cati on shoul d bestronglyrecommendedandprogres-sion of glycemic abnormalities followedby screening at least yearly. (A)Screen for diabetes in pregnancy usingrisk factor analysis and screening testsas noted; theOGTTis thepreferredscreening test in pregnancy. (E)INITIAL EVALUATIONA complete medical evaluation should beperformedtoclassifythepatient, detectthe presence or absence of diabetes com-plications, assist in formulating a manage-ment plan, andprovide a basis forcontinuing care. If the diagnosis of diabe-tes has already been made, the evaluationshould reviewthe previous treatment andthe past and present degrees of glycemiccontrol. Laboratorytestsappropriatetotheevaluationof eachpatientsgeneralmedical condition should be performed.Afocusonthecomponentsof compre-hensive care (Table 5) will assist thehealth care team to ensure optimal man-agement of the patient with diabetes.MANAGEMENTPeople withdiabetes shouldreceivemedical carefromaphysician-coordi-natedteam. Suchteams mayinclude,but are not limited to, physicians,nurse practitioners, physicians assis-tants, nurses, dietitians, pharmacists, andmental healthprofessionalswithexper-tise and a special interest in diabetes. It isessential inthis collaborativeandinte-gratedteamapproachthat individualswithdiabetes assumeanactiveroleintheir care.The management plan should be for-mulated as an individualized therapeuticalliance among the patient and family, thephysician, andother members of thehealth care team. Any plan should recog-nize diabetes self-management educationas an integral component of care. In de-velopingtheplan, considerationshouldbegiventothepatientsage, school orworkscheduleandconditions, physicalactivity, eatingpatterns, social situationandpersonality, cultural factors, andpresence of complications of diabetes orTable 3Criteria for testing for diabetes in asymptomatic adult individuals1. Testing for diabetes should be considered in all individuals at age 45 years and above, particularly in those with a BMI 25 kg/m2*, and, ifnormal, should be repeated at 3-year intervals.2. Testing should be considered at a younger age or be carried out more frequently in individuals who are overweight (BMI 25 kg/m2*) andhave additional risk factors: are habitually physically inactive have a rst-degree relative with diabetes are members of a high-risk ethnic population (e.g., African American, Latino, Native American, Asian American, Pacic Islander) have delivered a baby weighing 9 lb or have been diagnosed with GDM are hypertensive (140/90 mmHg) have an HDL cholesterol level 35 mg/dl (0.90 mmol/l) and/or a triglyceride level 250 mg/dl (2.82 mmol/l) have PCOS on previous testing, had IGT or IFG have other clinical conditions associated with insulin resistance (e.g. PCOS or acanthosis nigricans) have a history of vascular disease*May not be correct for all ethnic groups. PCOS, polycystic ovary syndrome.Table 4Testing for type 2 diabetes in children CriteriaOverweight (BMI 85th percentile for age and sex, weight for height 85th percentile, or weight 120% of ideal for height)PlusAny two of the following risk factors:Family history of type 2 diabetes in rst- or second-degree relativeRace/ethnicity (Native American, African American, Latino, Asian American, Pacic Islander)Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, or PCOS) Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a younger age Frequency: every 2 years Test: FPG preferredClinical judgment should be used to test for diabetes in high-risk patients who do not meet these criteria. PCOS, polycystic ovary syndrome.Standards of Medical CareDIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S17other medical conditions. Avarietyofstrategies and techniques should be usedto provide adequate education and devel-opmentofproblem-solvingskillsinthevarious aspects of diabetes management.Implementation of the management planrequiresthat eachaspect isunderstoodand agreed on by the patient and the careprovidersandthat thegoalsandtreat-ment plan are reasonable.Glycemic controlGlycemiccontrol isfundamental tothemanagement of diabetes. Prospective ran-domized clinical trials such as the Diabe-tes Control andComplications TrialTable 5Components of the comprehensive diabetes evaluationMedical history Symptoms, results of laboratory tests, and special examination results related to the diagnosis of diabetes Prior AIC 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 (includingsymptoms of celiac disease in type 1 diabetic patients); heart; peripheral vascular; foot; and cerebrovascular complications associated withdiabetes Other medications that may affect blood glucose levels Risk factors for atherosclerosis: smoking, hypertension, obesity, dyslipidemia, and family history History and treatment of other conditions, including endocrine and eating disorders Assessment for mood disorder Family history of diabetes and other endocrine disorders Lifestyle, cultural, psychosocial, educational, and economic factors that might inuence the management of diabetes Tobacco, alcohol, and/or controlled substance use Contraception and reproductive and sexual historyPhysical 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/nger 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 prole, 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, if clinically indicated Urinalysis for ketones, protein, sedimentReferrals 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 appropriatePosition StatementS18 DIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004(DCCT) (15) and the U.K. Prospective Di-abetes Study (UKPDS) (16,17) haveshown that improved glycemic control isassociated with sustained decreased ratesof retinopathy, nephropathy, andneu-ropathy(18). Inthesetrials, treatmentregimens that reducedaverageA1Cto7%(1%abovetheupper limits ofnormal) were associated with fewer long-term microvascular complications; how-ever, intensive control was foundtoincrease the risk of severe hypoglycemiaand weight gain (19,20). Epidemiologicalstudies support the potential of intensiveglycemic control in the reduction of CVD(1520).Recommendedglycemic goals fornonpregnant individuals are shown in Ta-ble 6. A major limitation to the availabledata are that they do not identify the op-timum level of control for particular pa-tients, as there are individual differencesin the risks of hypoglycemia, weight gain,andotheradverseeffects. Furthermore,with multifactorial interventions, it is un-clear how different components (e.g., ed-ucational interventions, glycemic targets,lifestylechanges, andpharmacologicalagents) contributetothereductionofcomplications. There are no clinical trialdataavailablefortheeffectsofglycemiccontrol in patients with advanced compli-cations, the elderly (65 years of age), oryoung children (13 years of age). Lessstringent treatment goals may be appro-priate for patients with limited life expect-ancies, in the very young or older adults,and in individuals with comorbid condi-tions. Severe or frequent hypoglycemia isan indication for the modication of treat-mentregimens,includingsettinghigherglycemic goals.Morestringent goals(i.e., anormalA1C, 6%) can be considered in individ-ual patients basedonepidemiologicalanalyses that suggest that there is no lowerlimit of A1Cat whichfurtherloweringdoes not reduce risk of complications, atthe risk of increased hypoglycemia (par-ticularlyinthosewithtype1diabetes).However, the absolute risks and benetsof lower targets are unknown. The risksand benets of an A1C goal of 6% arecurrently being tested in an ongoing study(ACCORD [Action to Control Cardiovas-cular Risk in Diabetes]) in type 2 diabetes(21). Elevated postchallenge (2-h OGTT)glucose values have been associated withincreasedcardiovascular riskindepen-dent of FPGinsome epidemiologicalstudies. Postprandial plasma glucose(PPG) levels 140 mg/dl are unusual innondiabeticindividuals, althoughlargeevening meals can be followed by plasmaglucose values up to 180 mg/dl. There arenow pharmacological agents that primar-ily modify PPG and thereby reduce A1Cin parallel. Thus, in individuals who havepremeal glucose values within target butwho are not meeting A1C targets, consid-eration of monitoring PPG 12 h after thestart of the meal and treatment aimed atreducingPPGvalues 180mg/dl maylower A1C. However, it should be notedthat the effect of these approaches on mi-cro- or macrovascular complications hasnot been studied (22).For information on glycemic controlfor women with GDM, refer to the ADApositionstatementGestationalDiabetesMellitus (14). For information on glyce-mic control during pregnancy in womenwith preexisting diabetes, refer to MedicalManagementofPregnancyComplicatedbyDiabetes (3rd ed.) (23).Referral for diabetes managementFor a variety of reasons, some people withdiabetesandtheirhealthcareprovidersdo not achieve the desired goals of treat-ment (Table 6). In such instances, addi-t i onal act i ons suggest ed i ncl udeenhanced diabetes self-management edu-cation, comanagement withadiabetesteam, change in pharmacological therapy,initiation of or increase in self-monitoringof blood glucose (SMBG), more frequentcontact with the patient, and referral to anendocrinologist.Intercurrent illnessThe stress of illness frequently aggravatesglycemiccontrol andnecessitatesmorefrequent monitoring of blood glucose andurine or blood ketones. A vomiting illnessaccompanied by ketosis may indicate di-abeti c ketoaci dosi s (DKA), a l i fe-threatening condition that requiresimmediate medical care to prevent com-plications anddeath; thepossibilityofDKAshouldalwaysbeconsidered(24).Markedhyperglycemiarequirestempo-rary adjustment of the treatment programand, if accompanied by ketosis, frequentinteractionwiththediabetescareteam.Thepatient treatedwithoral glucose-lowering agents or medical nutrition ther-apy (MNT) alone may temporarily requireTable 6Summary of recommendations for adults with diabetesGlycemic controlAIC 7.0%*Preprandial plasma glucose 90130 mg/dl (5.07.2 mmol/l)Postprandial plasma glucose 180 mg/dl (10.0 mmol/l)Blood pressure 130/80 mmHgLipidsLDL 100 mg/dl (2.6 mmol/l)Triglycerides 150 mg/dl (1.7 mmol/l)HDL 40 mg/dl (1.1 mmol/l)Key concepts in setting glycemic goals: Goals should be individualized Certain populations (children, pregnant women,and elderly) require special considerations Less intensive glycemic goals may be indicatedin patients with severe or frequenthypoglycemia More stringent glycemic goals (i.e. a normalA1C, 6%) may further reduce complicationsat the cost of increased risk of hypoglycemia(particularly in those with type 1 diabetes) Postprandial glucose may be targeted if AICgoals are not met despite reaching preprandialglucose goals*Referenced to a nondiabetic range of 4.06.0% using a DCCT-based assay. Postprandial glucose mea-surementsshouldbemade1-2hafterthebeginningofthemeal,generallypeaklevelsinpatientswithdiabetes. Current NCEP/ATPIII guidelinessuggest that inpatientswithtriglycerides200mg/dl, thenon-HDL cholesterol (total cholesterol minus HDL) be utilized. The goal is 130 mg/dl (61). For women,it has been suggested that the HDL goal be increased by 10 mg/dl.Standards of Medical CareDIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S19insulin. Adequate uid and caloric intakemust be assured. Infection or dehydrationismorelikelytonecessitatehospitaliza-tion of the person with diabetes than theperson without diabetes. The hospitalizedpatient should be treated by a physicianwith expertise in the management of dia-betes, andrecent studies suggest thatachieving very stringent glycemic controlmayreducemortalityintheimmediatepostmyocardial infarctionperiod(25).Aggressiveglycemicmanagement withinsulin may reduce morbidity in patientswith severe acute illness (26).For informationonmanagement ofpatients in the hospital, refer to the ADAposition statement titled HyperglycemicCrises in Diabetes (24).RecommendationsLowering A1Chas been associated witha reduction of microvascular and neu-ropathic complications of diabetes. (A)Developor adjust the managementplan to achieve normal or near-normalglycemia with an A1C goal of 7%. (B)Morestringent goals (i.e., anormalA1C, 6%) can be considered in indi-vidual patients. (B)LoweringA1Cmaylowertheriskofmyocardial infarction and cardiovascu-lar death. (B)Aggressive glycemic management withinsulinmayreducemorbidityinpa-tients with severe acute illness, periop-eratively andfollowing myocardialinfarction. (B)Lessstringenttreatmentgoalsmaybeappropriate for patients with a historyofseverehypoglycemia, patientswithlimitedlifeexpectancies, veryyoungchildren or older adults, and individu-als with comorbid conditions. (E)ASSESSMENT OF GLYCEMICCONTROLTechniquesareavailableforhealthpro-viders and patients to assess the effective-ness of the management plan on glycemiccontrol.SMBGThe ADAs consensus statements onSMBGprovide a comprehensive reviewofthesubject(27,28). Majorclinical trialsassessing the impact of glycemic controlon diabetes complications have includedSMBG as part of multifactorial interven-tions, suggesting that SMBG is a compo-nent of effectivetherapy. SMBGallowspatientstoevaluatetheir individual re-sponse to therapy and assess whether gly-cemic targets are being achieved. Resultsof SMBG can be useful in preventing hy-poglycemiaandadjustingmedications,MNT, and physical activity.ThefrequencyandtimingofSMBGshould be dictated by the particular needsand goals of the patients. Daily SMBG isespeciallyimportantforpatientstreatedwithinsulintomonitorforandpreventasymptomatichypoglycemia. For mostpatientswithtype1diabetesandpreg-nant women taking insulin, SMBG is rec-ommended three or more times daily. Theoptimal frequencyandtimingof SMBGforpatientswithtype2diabetesisnotknown but should be sufcient to facili-tate reaching glucose goals. When addingto or modifying therapy, type 1 and type 2diabeticpatientsshouldtestmoreoftenthanusual. Theroleof SMBGinstablediet-treated patients with type 2 diabetesis not known.Because the accuracy of SMBG is in-strument- and user-dependent (29), it isimportant for healthcareproviders toevaluateeachpatientsmonitoringtech-nique, both initially and at regular inter-vals thereafter. In addition, optimal use ofSMBGrequiresproperinterpretationofthe data. Patients should be taught howtouse the data to adjust food intake, exer-cise, or pharmacological therapy toachievespecicglycemicgoals. Healthprofessionalsshouldevaluateat regularintervals the patients ability to use SMBGdata to guide treatment.RecommendationsSMBG is an integral component of dia-betes therapy. (B)Include SMBGinthe managementplan. (E)Instruct the patient in SMBG and rou-tinelyevaluatethepatientstechniqueand ability to use data to adjust therapy.(E)A1CBy performing an A1Ctest, health provid-ers can measure a patients average glyce-mia over the preceding 23 months (29)and, thus, assess treatment efcacy. A1Ctesting should be performed routinely inall patientswithdiabetes, rsttodocu-ment thedegreeof glycemiccontrol atinitial assessment and then as part of con-tinuingcare. SincetheA1Ctestreectsmeanglycemiaover thepreceding23months, measurement approximately ev-ery3months is requiredtodeterminewhether a patients metabolic control hasbeen reached and maintained within thetargetrange. Thus, regularperformanceof the A1C test permits detection of de-parturesfromthetarget (Table6) inatimely fashion. For any individual patient,thefrequencyof A1Ctestingshouldbedependent ontheclinical situation, thetreatment regimenused, andthejudg-ment of the clinician.Glycemiccontrol isbest judgedbythe combination of the results of the pa-tients SMBG testing (as performed) andthe current A1C result. The A1C shouldbeusednot onlytoassessthepatientscontrol overthepreceding23monthsbut also as a check on the accuracy of themeter (or thepatientsself-reportedre-sults) and the adequacy of the SMBG test-ing schedule. Table 7 contains thecorrelation between A1C levels and meanplasma glucose levels based on data fromthe DCCT (30).RecommendationsPerform the A1C test at least two timesa year in patients who are meeting treat-ment goals (and who have stable glyce-miccontrol)andquarterlyinpatientswhose therapy has changed or who arenot meeting glycemic goals. (E)MNTMNT is an integral component of diabetesmanagement anddiabetes self-manage-ment education. A review of the evidenceand detailed information can be found intheADAtechnical reviewandpositionstatement inthis area(31,32). Peoplewithdiabetesshouldreceiveindividual-ized MNT as needed to achieve treatmentgoals, preferably provided by a registereddietitian familiar with the components ofTable 7Correlation between A1Clevel andmean plasma glucose levels (30)AIC (%)Mean plasma glucosemg/dl mmol/l6 135 7.57 170 9.58 205 11.59 240 13.510 275 15.511 310 17.512 345 19.5Position StatementS20 DIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004diabetes MNT. Goals of MNT that applyto all persons with diabetes are as follows:Attainandmaintainrecommendedmetabolic outcomes, including glucoseand A1C levels; LDL cholesterol, HDLcholesterol, andtriglyceride levels;bloodpressure;andbodyweight(seeTable 6).Prevent and treat the chronic complica-tions andcomorbidities of diabetes.Modify nutrient intake and lifestyle asappropriate for the preventionandtreatment of obesity, dyslipidemia,CVD, hypertension, and nephropathy.Improvehealththroughhealthyfoodchoices and physical activity.Address individual nutritional needs,taking into consideration personal andcultural preferences and lifestyle whilerespecting the individuals wishes andwillingness to change.Goals of MNT that apply to specic situ-ations include the following:For youth with type 1 diabetes, provideadequate energy toensure normalgrowth and development; integrate in-sulinregimens intousual eatingandphysical activity habits.For youth with type 2 diabetes, facilitatechangesineatingandphysical activityhabits that reduce insulin resistance andimprove metabolic status.For pregnant andlactatingwomen,provide adequate energy and nutrientsneeded for optimal outcomes.For older adults, provide for the nutri-tional and psychosocial needs of an ag-ing individual.For individuals treated with insulin orinsulinsecretagogues, provide self-management educationfor treatment(andprevention) of hypoglycemia,acute illnesses, andexercise-relatedblood glucose problems.For individuals at risk for diabetes, de-crease risk by encouraging physical ac-tivity and promoting foods choices thatfacilitatemoderateweight loss or atleast prevent weight gain.Achieving nutrition-related goals requiresacoordinatedteameffort that includesthe person with diabetes. Because of thecomplexity of nutrition issues, it is recom-mended that a registered dietitian, knowl-edgeableandskilledinimplementingnutritiontherapyintodiabetesmanage-ment and education, is the team memberwho provides MNT. However, it is essen-tial that all teammembers are knowledge-able about nutritiontherapyandaresupportiveof thepersonwithdiabeteswho needs to make lifestyle changes.MNT involves a nutrition assessmentto evaluate the patients food intake, met-abolicstatus, lifestyleandreadiness tomake changes, goal setting, dietaryinstruction,andevaluation.Tofacilitateadherence, the plan should be individu-alized and take into account cultural, life-style, and nancial considerations.Monitoringof glucoseandA1C, lipids,blood pressure, and renal status is essen-tial toevaluate nutrition-relatedout-comes. If goals arenot met (Table6),changes must be made in the overall dia-betes care and management plan.RecommendationsPeople with diabetes should receive in-dividualized MNT as needed to achievetreatment goals, preferably provided byaregistereddietitianfamiliarwiththecomponents of diabetes MNT. (B)PHYSICAL ACTIVITYADA technical reviews on exercise in pa-tients with diabetes have summarized thevalue of exercise in the diabetes manage-mentplan(33,34).Regularexercisehasbeenshowntoimprovebloodglucosecontrol, reducecardiovascular riskfac-tors, contributetoweight loss, andim-provewell-being. Furthermore, regularexercisemaypreventtype2diabetesinhigh-risk individuals (68).Beforebeginningaphysical activityprogram, the patient with diabetes shouldhaveadetailedmedical evaluationwithappropriatediagnosticstudies. Thisex-amination should screen for the presenceof macro- andmicrovascular complica-tions that may be worsened by the phys-ical activityprogram(seenext sectionregardingcoronaryheartdisease[CHD]screening). Identication of areas of con-cern will allow the design of an individu-alizedphysical activityplanthat canminimize risk to the patient.All levels of physical activity, includ-ingleisureactivities,recreationalsports,andcompetitive professional perfor-mance, can be performed by people withdiabetes who do not have complicationsand have good glycemic control. The abil-ity to adjust the therapeutic regimen (in-sulintherapyandMNT) toallowsafeparticipationis animportant manage-ment strategy.RecommendationsAregular physical activityprogram,adaptedtothepresenceof complica-tions, is recommended for all patientswith diabetes who are capable of partic-ipating. (B)PREVENTION ANDMANAGEMENT OFDIABETES COMPLICATIONSI. CVD: management of risk factorsand screening for coronary arterydiseaseCVDisthemajorcauseofmortalityforpersonswithdiabetes.Itisalsoamajorcontributortomorbidityanddirectandindirect costs of diabetes. Type 2 diabetesis an independent risk factor for macro-vascular disease, and its common coexist-ingconditions (e.g., hypertensionanddyslipidemia) are also risk factors.Studies have shown the efcacy of re-ducing cardiovascular risk factors in pre-ventingor slowingCVD. Evidence issummarized in the following sections andreviewedindetail intheADAtechnicalreviews on hypertension (35), dyslipide-mia (36), aspirin therapy (37), and smok-ingcessation(38)andintheconsensusstatement on CHD in people with diabe-tes(39).Emphasisshouldbeplacedonreducing cardiovascular riskfactors,whenpossible,andcliniciansshouldbealertforsignsandsymptomsofathero-sclerosis.A. Blood pressure controlHypertension(bloodpressure140/90mmHg) is a common comorbidity of dia-betes, affectingthemajorityof peoplewith diabetes, depending on type of dia-betes, age, obesity, and ethnicity. Hyper-tension is also a major risk factor for CVDand microvascular complications such asretinopathyandnephropathy.Intype1diabetes, hypertension is often the resultof underlying nephropathy. In type 2 di-abetes, hypertensionmaybepresent aspart of the metabolic syndrome (i.e., obe-sity, hyperglycemia, dyslipidemia) that isaccompanied by high rates of CVD.Randomized clinical trials have dem-onstrated the benet (reduction of CHDevents, stroke, and nephropathy) of low-ering blood pressure to 140 mmHg sys-tolic and 80 mmHg diastolic in personsStandards of Medical CareDIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S21withdiabetes (4043). Epidemiologicanalyses showthat bloodpressures115/75mmHgareassociatedwithin-creasedcardiovascular event rates andmortality in persons with diabetes(40,44,45). Therefore, a target bloodpressure goal of 130/80 mmHg is rea-sonable if it can be safely achieved.Although there are no well-controlledstudiesofdietandexerciseinthetreat-ment of hypertension in persons with di-abetes, reducing sodium intake and bodyweight (when indicated), increasing con-sumption of fruits, vegetables, and low-fatdairyproducts, avoidingexcessivealco-hol consumption, and increasing activitylevels have been shown to be effective inreducingbloodpressureinnondiabeticindividuals(46a). Thesenonpharmaco-logical strategies may also positively affectglycemiaandlipidcontrol.Theireffectsoncardiovasculareventshavenot beenwell measured.Lowering of blood pressure with reg-imensbasedonantihypertensivedrugs,including ACE inhibitors, angiotensin re-ceptor blockers(ARBs), -blockers, di-uretics, andcalciumchannel blockers,has been shown to be effective in loweringcardiovascular events. Several studiessuggest that ACE inhibitors may be supe-rior to dihydropyridine calcium channelblockers (DCCBs) in reducing cardiovas-cular events (47,48). Additionally, recentdata in people with diabetic nephropathyindicate that ARBs may be superior to DC-CBs for reducingcardiovascular events(49). Conversely, intherecentlycom-pletedInternational Verapamil Study(INVEST) of morethan22,000peoplewithcoronaryarterydiseaseandhyper-tension, the nondihydropyridine calciumchannel blocker, verapamil, demon-strated a similar reduction in cardiovascu-lar mortalitytoa-blocker. Moreover,this relationship held true in the diabeticsubgroup (49a).ACEinhibitorshavebeenshowntoimprove cardiovascular outcomes inhigh-cardiovascular-risk patients with orwithout hypertension (50,51). In patientswith congestive heart failure, ACE inhib-itors are associated with better outcomeswhen compared with ARBs. ARBs also im-prove cardiovascular outcomes inthesubset of patients with hypertension, dia-betes, andend-organinjury(52). Thecompellingeffect of ACEinhibitors orARBs in patients with albuminuria or re-nal insufciency provide additional ratio-nale for use of these agents (see section IIbelow).TheALLHAT(AntihypertensiveandLipid-LoweringTreatment toPreventHeart AttackTrial), alargerandomizedtrial of different initial bloodpressurepharmacological therapies, foundnolargedifferencesbetweeninitial therapywith a chlorthalidone, amlodipine and lis-inopril. Diuretics appeared slightly moreeffectivethanother agents, particularlyfor reducing heart failure (53). The-blocker arm of the ALLHAT was termi-natedafterinterimanalysisshowedthatdoxazosin was substantially less effectivein reducing congestive heart failure thandiuretic therapy (54).Beforebeginningtreatment,patientswithelevatedbloodpressures shouldhavetheir bloodpressurereexaminedwithin 1 month to conrmthe presence ofhypertension. Asystolicbloodpressure160mmHgoradiastolicbloodpres-sure100mmHg, however, mandatesthat immediate pharmacological therapybeinitiated. Patientswithhypertensionshouldbeseenasoftenasneededuntilthe recommended blood pressure goal isobtained and then seen as necessary (40).Inthesepatients, other cardiovascularriskfactors,includingobesity,hyperlip-idemia, smoking, presence of microalbu-minuria (assessedbefore initiationoftreatment), and glycemic control, shouldbecarefullyassessedandtreated. Manypatients will require three or more drugsto reach target goals.RecommendationsScreening and diagnosisBlood pressure should be measured ateveryroutinediabetes visit. Patientsfoundtohavesystolicbloodpressure130 or diastolic blood pressure 80mmHgshouldhave bloodpressureconrmed on a separate day. (C)GoalsPatients with diabetes should be treatedtoa systolic bloodpressure 130mmHg. (B)Patients with diabetes should be treatedtoa diastolic bloodpressure 80mmHg. (B)TreatmentPatients withhypertension(systolicblood pressure 140 or diastolic bloodpressure90mmHg)shouldreceivedrug therapy in addition to lifestyle andbehavioral therapy. (A)Multipledrugtherapy(twoor moreagents at proper doses) is generally re-quiredtoachievebloodpressuretar-gets. (B)Patients with a systolic blood pressureof 130139 mmHg or a diastolic bloodpressureof 8089mmHgshouldbegivenlifestyleandbehavioral therapyalone for a maximum of 3 months andthen, if targets are not achieved, in ad-dition, be treated with pharmacologicalagents that block the renin-angiotensinsystem. (E)Initial drugtherapyfor thosewithabl ood pressure 140/90 mmHgshouldbewithadrugclass demon-stratedtoreduceCVDevents inpa-tients withdiabetes (ACEinhibitors,ARBs, -blockers, diuretics, andcal-cium channel blockers). (A)All patientswithdiabetesandhyper-tensionshouldbetreatedwitharegi-men that includes either an ACEinhibitor or ARB. If one class is not tol-erated, the other should be substituted.If needed to achieve blood pressure tar-gets, a thiazide diuretic shouldbeadded. (E)If ACE inhibitors, ARBs, or diuretics areused, monitor renal functionandse-rum potassium levels. (E)Whiletherearenoadequatehead-to-headcomparisons of ACEinhibitorsand ARBs, there is clinical trial supportfor each of the following statements:Inpatientswithtype1diabetes,withhypertensionandanydegreeofalbu-minuria, ACEinhibitors have beenshown to delay the progression of ne-phropathy. (A)In patients with type 2 diabetes, hyper-tension, andmicroalbuminuria, ACEinhibitors and ARBs have been shownto delay the progression to macroalbu-minuria. (A)In those with type 2 diabetes, hyperten-sion, macroalbuminuria, and renal in-sufciency, ARBs have been shown todelay the progression of nephropathy.(A)In elderly hypertensive patients, bloodpressureshouldbeloweredgraduallyto avoid complications. (E)Patients not achievingtarget bloodpressure despite multiple drug therapyshould be referred to a physician expe-Position StatementS22 DIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004rienced in the care of patients with hy-pertension. (E)Orthostatic measurement of bloodpressure should be performed in peo-ple withdiabetes andhypertensionwhen clinically indicated. (E)B. Lipid managementPatients with type 2 diabetes have an in-creased prevalence of lipid abnormalitiesthatcontributestohigherratesofCVD.Lipidmanagement aimedat loweringLDL cholesterol, raising HDL cholesterol,andlowering triglycerides has beenshowntoreducemacrovasculardiseaseand mortality in patients with type 2 dia-betes, particularlythosewhohavehadprior cardiovascular events.In studies using HMG(hydroxymeth-ylglutaryl)CoAreductaseinhibitors(st-atins), patients withdiabetes achievedsignicant reductions in coronary and ce-rebrovascular events (5558). Intwostudies usingthebricacidderivativegembrozil, reductions in cardiovascularend points were also achieved (59,60).Target lipid levels are shown in Table6. Lifestyle intervention including MNT,increasedphysical activity, weight loss,and smoking cessation should allowsomepatients to reach these lipid levels. Nutri-tioninterventionshouldbetailoredac-cordingtoeachpatients age, typeofdiabetes, pharmacological treatment,lipid levels, and other medical conditionsand should focus on the reduction of sat-uratedfat, cholesterol, andtransunsat-uratedfat intake. Glycemiccontrol canalso benecially modify plasma lipid lev-els. Particularly in patients with very hightriglyceridesandpoorglycemiccontrol,glucose lowering maybe necessary to con-trol hypertriglyceridemia.Pharmacological treatment is indi-cated if there is an inadequate response tolifestyle modications and improved glu-cosecontrol. However, inpatientswithclinical CVDand LDL 100 mg/dl, phar-macological therapy should be initiated atthe same time that lifestyle intervention isstarted.The rst priority of pharmacologicaltherapyistolowerLDLcholesteroltoatarget goal of 100 mg/dl (2.60 mmol/l).For LDL lowering, statins are the drugs ofchoice (61).TheHeartProtectionStudydemon-strated that in people with diabetes overtheageof 40withatotal cholesterol135mg/dl, LDLreductionof 30%from baseline with the statin, simvastatinwas associated with an 25% reductionin the rst event rate for major coronaryarteryevents independent of baselineLDL, preexisting vascular disease, type orduration of diabetes, or adequacy of gly-cemic control (58). Therefore, in patientsover the age of 40, statin therapy shouldbe routinely considered. In patients withLDL130mg/dl, initial therapywithboth lifestyle intervention and a statin isindicated. In patients with LDL between100 mg/dl (2.60 mmol/l) and 129 mg/dl(3.30mmol/l), a varietyof treatmentstrategies areavailable, includingmoreaggressive nutrition intervention or phar-macological treatment with a statin. If theHDLis40mg/dl andtheLDLisbe-tween100and129mg/dl, abricacidderivative or niacin might be used.Niacin is the most effective drug forraising HDL but can signicantly increaseblood glucose at a high dose. More recentstudies demonstrate that at modest doses(7502,000mg/day), signicantbenetwith regards to LDL, HDL, and triglycer-idelevels areaccompaniedbymodestchanges in glucose that are generally ame-nabletoadjustmentofdiabetestherapy(62,63).Combinationtherapy, withastatinand a brate or statin and niacin, may beefcacious for patients needing treatmentfor all three lipid fractions, but this com-binationisassociatedwithanincreasedriskfor abnormal transaminaselevels,myositis, or rhabdomyolysis. The risk ofrhabdomyolysis seems to be lower whenstatins are combinedwithfenobratethan gembrozil.In children and adolescentswith dia-betes, LDL cholesterol should be loweredto 100 mg/dl (2.60 mmol/l) using dietand medications based on LDL level andother cardiovascular risk factors in addi-tion to diabetes (64,65).RecommendationsScreeningIn adult patients, test for lipid disordersat least annuallyandmore oftenifneeded to achieve goals. In adults withlow-risk lipid values (LDL 100 mg/dl,HDL50mg/dl, andtriglycerides150 mg/dl), repeat lipid assessmentsevery 2 years. (E)In children 2 years of age, perform alipid prole after diagnosis of diabetesand when glucose control has been es-tablished. Type 1 diabetes: Begin prior to pu-berty, if positivefamilyhistoryofCVD(or if familyhistoryis un-known), andat puberty, if familyhistory is known and is negative. Type 2 diabetes: Begin at diagnosis,regardless of pubertal status. If lipidvalues areconsideredlowrisk, repeat lipidproleevery25years based on CVD risk status.Treatment recommendations andgoalsLifestylemodicationfocusingonthereductionofsaturatedfatandcholes-terol intake, weight loss, increasedphysical activity, andsmokingcessa-tionhasbeenshowntoimprovethelipidproleinpatientswithdiabetes.(A)Patients who do not achieve lipid goalswithlifestyle modications requirepharmacological therapy. (A)Lower LDL cholesterol to 100 mg/dl(2.6mmol/l) as theprimarygoal oftherapy for adults. (B)Lowering LDL cholesterol with a statinis associated with a reduction in cardio-vascular events. (A)In people with diabetes over the age of40 with a total cholesterol 135 mg/dl,statin therapy to achieve an LDL reduc-tionof 30%regardless of baselineLDL levels may be appropriate. (A)In children and adolescents with diabe-tes, LDL cholesterol should be loweredto100mg/dl (2.60mmol/l) usingdiet aswell asmedicationsbasedonLDL level and other cardiovascular riskfactors in addition to diabetes. (E)Lower triglycerides to 150 mg/dl (1.7mmol/l)andraiseHDLcholesterol to40 mg/dl (1.15 mmol/l). In women,anHDLgoal10mg/dlhighermaybeappropriate. (C)LoweringtriglyceridesandincreasingHDL cholesterol with a brate are asso-ciated with a reduction in cardiovascu-lar events in patients with clinical CVD,lowHDLandnear-normal levels ofLDL. (A)Combinationtherapyemployingst-atins and brates or niacin may be nec-essary to achieve lipid targets, but havenot been evaluated in outcomes studiesfor either event reduction or safety. (E)Standards of Medical CareDIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S23C. Anti-platelet agents in diabetesThe use of aspirin in diabetes is reviewedin detail in the ADA technical review (37)andpositionstatement (66) onaspirintherapy. Aspirin has been recommendedas aprimary(66a,66b) andsecondarytherapy to prevent cardiovascular eventsindiabeticandnondiabeticindividuals.One large meta-analysis and several clin-ical trials demonstrate the efcacy of us-ingaspirinasapreventivemeasureforcardiovascular events, includingstrokeandmyocardial infarction. Manytrialshave shown an 30% decrease in myo-cardial infarction and a 20% decrease instroke in a wide range of patients, includ-ing young and middle-aged patients, pa-tients with and without a history of CVD,males and females, and patients with hy-pertension.Dosagesusedinmost clinical trialsranged from 75 to 325 mg/day. There isno evidence to support any specic dose,but using the lowest possible dosage mayhelp reduce side effects. There is no evi-dence for a specic age at which to startaspirin, but at ages below30 years, aspirinhas not been studied.Clopidogrel hasbeendemonstratedto reduce CVD rates in diabetic individu-als (67). Adjunctive therapy in very high-riskpatientsorasalternativetherapyinaspirin-intolerant patients should be con-sidered.RecommendationUseaspirintherapy(75162mg/day)asasecondarypreventionstrategyinthosewithdiabeteswithahistoryofmyocardial infarction, vascular bypassprocedure, stroke or transient ischemicattack, peripheral vascular disease,claudication, and/or angina. (A)Useaspirintherapy(75162mg/day)as a primarypreventionstrategyinthose with type 2 diabetes at increasedcardiovascular risk, includingthosewhoareover40yearsof ageorwhohave additional risk factors (family his-toryof CVD, hypertension, smoking,dyslipidemia, albuminuria). (A)Useaspirintherapy(75162mg/day)as a primarypreventionstrategyinthose with type 1 diabetes at increasedcardiovascular risk, includingthosewhoareover40yearsof ageorwhohave additional risk factors (family his-toryof CVD, hypertension, smoking,dyslipidemia, albuminuria). (C)Peoplewithaspirinallergy, bleedingtendency, receiving anticoagulant ther-apy, recent gastrointestinal bleeding,and clinically active hepatic disease arenot candidates for aspirintherapy.Other antiplatelet agents may be a rea-sonablealternativefor patients withhigh risk. (E)Aspirin therapy should not be recom-mended for patients under the age of 21yearsbecauseoftheincreasedriskofReyes syndrome associated with aspi-rin use in this population. People underthe age of 30 have not been studied. (E)D. Smoking cessationIssues of smokingindiabetes are re-viewed in detail in the ADA technical re-view (38) and position statement (68) onsmokingcessation. Alargebodyofevi-dence fromepidemiological, case-control, andcohort studies providesconvincingdocumentationofthecausallinkbetweencigarette smoking andhealthrisks. Cigarettesmokingcontrib-utes to one of every ve deaths in the U.S.andis themost important modiablecauseof prematuredeath. Muchof theprior workdocumentingtheimpact ofsmoking on health did not separately dis-cuss results on subsets of individuals withdiabetes, suggestingthat theidentiedrisks are at least equivalent to those foundin the general population. Other studiesofindividualswithdiabetesconsistentlyfound a heightened risk of morbidity andpremature death associated with the de-velopment of macrovascular complica-tions amongsmokers. Smokingis alsorelated to the premature development ofmicrovascularcomplicationsof diabetesand may have a role in the development oftype 2 diabetes.A number of large randomized clini-caltrialshavedemonstratedtheefcacyandcost-effectiveness of counselinginchangingsmokingbehavior. Suchstud-ies, combined with others specic to in-dividuals withdiabetes, suggest thatsmoking cessation counseling is effectivein reducing tobacco use (69,70).The routine and thorough assessmentof tobacco use is important as a means ofpreventing smoking or encouraging ces-sation. Special considerations should in-clude assessment of level of nicotinedependence, which is associated with dif-culty in quitting and relapse.RecommendationsAdvise all patients not to smoke. (A)Includesmokingcessationcounselingand other forms of treatment as a rou-tine component of diabetes care. (B)E. CHD screening and treatmentCHDscreeningandtreatment are re-viewedindetail intheADAconsensusstatement on CHD in people with diabe-tes (39). To identify the presence of CHDin diabetic patients without clear or sug-gestive symptoms of coronary artery dis-ease (CAD), a risk factorbased approachtotheinitial diagnosticevaluationandsubsequent follow-upisrecommended.At least annually, cardiovascular risk fac-tors should be assessed. These risk factorsinclude dyslipidemia, hypertension,smoking, a positive family history of pre-maturecoronarydisease, andthepres-ence of micro- or macroalbuminuria.Abnormal risk factors should be treated asdescribedelsewhereintheseguidelines.Patients at increased CHD risk should re-ceive aspirin and may warrant an ACE in-hibitor.Candidates for adiagnosticcardiacstress test include those with 1) typical oratypical cardiac symptoms and 2) an ab-normal resting electrocardiogram (ECG).Candidates for a screening cardiac stresstest include those with 1) a history of pe-ripheral orcarotidocclusivedisease; 2)sedentarylifestyle, age35years, andplanstobeginavigorousexercisepro-gram; and 3) two or more of the risk fac-tors noted above.Currentevidencesuggeststhatnon-invasive tests can improve assessment offutureCHDrisk. Thereis, however, nocurrent evidence that suchtestinginasymptomaticpatientswithriskfactorsimproves outcomes or leads to better uti-lization of treatments.Patients with abnormal exercise ECGand patients unable to perform an exer-cise ECG require additional or alternativetesting. Currently, stressnuclear perfu-sionandstress echocardiographyarevaluable next-level diagnostic proce-dures. A consultation with a cardiologistis recommended regarding further work-up.RecommendationsPerformexercise stress testing inasymptomaticdiabeticpatientsbasedon the criteria outlined above. Considera risk factorbased strategy for the di-agnosis of CADthat might includePosition StatementS24 DIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004stress ECGand/or stress echocardiogra-phy and/or perfusion imaging. (E)Refer patients with signs and symptomsof CVDor withpositivenoninvasivetest for CADto a cardiologist for furtherevaluation. (E)Inpatients withtreatedcongestiveheart failure, metformin use is contra-indicated. Thethiazolidinediones areassociatedwithuidretention, andtheir use can be complicated by the de-velopmentofcongestiveheartfailure.Caution in prescribing thiazolidinedio-nes in the setting of known congestiveheart failure or other heart diseases aswell as inpatients withpreexistingedema or concurrent insulin therapy isrequired. (E)Inpatients55yearsofage, withorwithout hypertension but with anothercardiovascular riskfactor (historyofCVD, dyslipidemia, microalbuminuria,smoking), an ACE inhibitor (if not con-traindicated)shouldbeconsideredtoreduce the risk of cardiovascularevents. (A)In patients with a prior myocardial in-farction or in patients undergoing ma-jor surgery, -blockers, inaddition,should be considered to reduce mortal-ity. (A)II. Nephropathy screening andtreatmentDiabetic nephropathy occurs in 2040%of patients with diabetes and is the singleleadingcauseof end-stagerenal disease(ESRD). Persistent albuminuriaintherangeof 30299mg/24h(microalbu-minuria) has been shown to be the earlieststageof diabeticnephropathyintype1diabetes and a marker for development ofnephropathy intype 2diabetes. Mi-croalbuminuria is also a well-establishedmarker of increased CVD risk (71).Patients with microalbuminuria whoprogress tomacroalbuminuria (300mg/24 h) are likely to progress to ESRDover a period of years (72,73). Over thepast several years, a number of interven-tions have been demonstrated to reducethe risk and slow the progression of renaldisease.Intensive diabetes management withthe goal of achieving near normoglycemiahas been shown in large prospective ran-domized studies to delay the onset of mi-croalbuminuriaandtheprogressionofmicro-tomacroalbuminuriainpatientswith type 1 (74,75) and type 2 diabetes(16). TheUKPDSprovidedstrongevi-dence that control of blood pressure canreduce the development of nephropathy(41).Inaddition,largeprospectiveran-domizedstudiesinpatientswithtype1diabetes have demonstrated that achieve-ment of lower levels of systolicbloodpressure(140mmHg) achievedwithtreatment using ACEinhibitors provides aselective benet over other antihyperten-sive drug classes in delaying the progres-sionfrommicro- tomacroalbuminuriaandcanslowthedeclineinglomerularltration rate (GFR) in patients with mac-roalbuminuria (41,7678).In addition, ACE inhibitors have beenshown to reduce severe CVD (i.e., myo-cardial infarction, stroke, death), thus fur-ther supporting the use of these agents inpatients withmicroalbuminuria (50).ARBs have also been shown to reduce therateofprogressionfrommicro-tomac-roalbuminuria as well as ESRDin patientswith type 2 diabetes (7981). Some evi-dence suggests that ARBs have a smallermagnitude of rise in potassium comparedwithACEinhibitorsinpeoplewithne-phropathy (82). With regards to slowingthe progression of nephropathy, the useofDCCBsasinitialtherapyisnotmoreeffectivethanplacebo. Theiruseinne-phropathyshouldberestrictedtoaddi-tional therapytofurther lower bloodpressure in patients already treated withACE inhibitors or ARBs (49). In the set-tingof albuminuriaornephropathy, inpatients unable to tolerate ACE inhibitorsand/or ARBs, consider theuseof non-DCCBs, -blockers, ordiureticsforthemanagement of blood pressure (83,84).A meta-analysis of several small stud-ies has shown that protein restriction maybe of benet in some patients whose ne-phropathyseemstobeprogressingde-spite optimal glucose and blood pressurecontrol (85).Screeningformicroalbuminuriacanbe performed by three methods: 1) mea-surement of the albumin-to-creatinine ra-tio in a random, spot collection (preferredmethod);2)24-hcollectionwithcreati-nine, allowing the simultaneous measure-ment of creatinine clearance; and 3) timed(e.g., 4-h or overnight) collection.The analysis of a spot sample for thealbumin-to-creatinineratiois stronglyrecommended by most authorities(86,87). The other two alternatives (24-hcollectionanda timedspecimen) arerarelynecessary.Measurementofaspoturine microalbumin by immunoassay orbyusingadipsticktestspecicformi-croalbumin without simultaneously mea-suringurinecreatinineislessexpensivethantherecommendedmethods, butissusceptibletofalse-negativeandfalse-positive determinations as a result of vari-ationinurine concentrationdue tohydration and other factors.Atleasttwoofthreetestsmeasuredwithin a 6-month period should show el-evated levels before a patient is designatedas having microalbuminuria. Abnormali-tiesofalbuminexcretionaredenedinTable 8.Physicians may use the Levey modi-cation of the Cockcroft and Gault equa-tiontocalculateestimatedGFR(eGFR)fromserumcreatinineandtostagethepatients renal disease (87,88). The eGFRcan easily be calculated by going to www.ki dney. org/professi onal s/dogi /gfr_calculator.cfm.Theroleof annual microalbumuriaassessment is less clear after diagnosis ofmicroalbuminuria and institution of ACEinhibitor or ARB therapy and blood pres-sure control. Most experts, however, rec-ommend continued surveillance to assessboth response to therapy and progressionof disease. Manyexperts suggest thatmanaging urine microalbuminuria to re-duceit tothenormal or near-normalrange may improve renal and cardiovas-cular prognosis; this approachhas notbeenformallyevaluatedinprospectivetrials.Consider referral to a physician expe-rienced in the care of diabetic renal dis-easeeitherwhentheGFRhasfallento60 ml min1 1.73 m2or if difcul-tiesoccurinthemanagementofhyper-Table 8Denitions of abnormalities in al-bumin excretionCategorySpot collection(g/mg creatinine)Normal 30Microalbuminuria 30299Macro (clinical)albuminuria300Because of variability in urinary albumin excretion,twoof three specimens collectedwithina 3- to6-month period should be abnormal before consid-ering a patient to have crossed one of these diagnos-tic thresholds. Exercise within 24 h, infection, fever,congestive heart failure, marked hyperglycemia, andmarked hypertension may elevate urinary albuminexcretion over baseline values.Standards of Medical CareDIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S25tensionorhyperkalemia.Itissuggestedthat consultation with a nephrologist beobtainedwhenthe GFRis 30ml min1 1.73 m2. Early referral of suchpatientshasbeenfoundtoreducecostand improve quality of care and keep peo-ple off dialysis longer (89). For a completediscussion on the treatment of nephropa-thy, see the ADAs position statement Di-abetic Nephropathy (90).RecommendationsGeneral recommendationsTo reduce the risk and/or slow the pro-gression of nephropathy, optimize glu-cose control. (A)To reduce the risk and/or slow the pro-gressionof nephropathy, optimizeblood pressure control. (A)ScreeningPerform an annual test for the presenceof microalbuminuria in type 1 diabeticpatientswithdiabetesdurationof5years and in all type 2 diabetic patients,starting at diagnosis. (E)TreatmentInthetreatment of bothmicro- andmacroalbuminuria,eitherACEinhibi-tors or ARBs should be used. (A)Whiletherearenoadequatehead-to-headcomparisons of ACEinhibitorsand ARBs, there is clinical trial supportfor each of the following statements:In patients with type 1 diabetes, withhypertension and any degree of albu-minuria, ACEinhibitorshavebeenshowntodelaytheprogressionofnephropathy. (A) In patients with type 2 diabetes, hy-pertension, andmicroalbuminuria,ACE inhibitors and ARBs have beenshowntodelaytheprogressiontomacroalbuminuria. (A)In patients with type 2 diabetes, hy-pertension, macroalbuminuria, andrenal insufciency (serum creatinine1.5 mg/dl), ARBs have been shownto delay the progression of nephrop-athy. (A) If one class is not tolerated, the othershould be substituted. (E)With presence of nephropathy, initiateproteinrestrictionto0.8g kg1body wt1 day1(10% of daily cal-ories), the current adult-recommendeddietaryallowanceforprotein.Furtherrestriction may be useful in slowing thedecline of GFR in selected patients. (B)Withregardstoslowingtheprogres-sion of nephropathy, the use of DCCBsasinitialtherapyisnotmoreeffectivethan placebo. Their use in nephropathyshould be restricted to additional ther-apy to further lower blood pressure inpatientsalreadytreatedwithACEin-hibitors or ARBs. (B)Inthesettingof albuminuriaor ne-phropathy, in patients unable to toler-ate ACE inhibitors and/or ARBs,consider the use of non-DCCBs,-blockers, or diuretics for the manage-ment of blood pressure. (E)If ACE inhibitors, ARBs, or diuretics areused, monitor serum potassium levelsforthedevelopmentofhyperkalemia.(B)Consider referral to a physician experi-enced in the care of diabetic renal dis-ease when the eGFR has fallen to 60ml min1 1.73 m2or if difcultiesoccur in the management of hyperten-sion or hyperkalemia. (B)III. Diabetic retinopathy screeningand treatmentDiabeticretinopathyisahighlyspecicvascular complication of both type 1 andtype2diabetes. Theprevalenceof reti-nopathy is strongly related to the durationofdiabetes. Diabeticretinopathyisesti-matedtobethemostfrequentcauseofnewcases of blindness among adults aged2074 years.Intensive diabetes management withthe goal of achieving near normoglycemiahas been shown in large prospective ran-domized studies to prevent and/or delaythe onset of diabetic retinopathy (15,16).Inadditiontoglycemiccontrol, severalother factors seem to increase the risk ofretinopathy. Thepresenceofnephropa-thyisassociatedwithretinopathy.Highblood pressure is an established risk fac-tor for the development of macular edemaand is associated with the presence of pro-liferative diabetic retinopathy (PDR).Lowering bloodpressure, as demon-strated by the UKPDS, has been shown todecreasetheprogressionofretinopathy.Several case series and a controlled pro-spective study suggest that pregnancy intype 1 diabetic patients may aggravate ret-inopathy(91). Duringpregnancyand1year postpartum, retinopathymaybetransiently aggravated; laser photocoagu-lation surgery can minimize this risk (92).Patients with type 1 diabetes shouldhave an initial dilated and comprehensiveeye examination by an ophthalmologist oroptometrist within 35 years after the on-set of diabetes. Patients with type 2 diabe-tes shouldhaveaninitial dilatedandcomprehensiveeyeexaminationbyanophthalmologist or optometrist shortlyafter thediagnosis of diabetes. Subse-quent examinations for type 1 and type 2diabetic patients should be repeated an-nually by an ophthalmologist or optome-t r i s t who i s knowl edgeabl e andexperienced in diagnosing the presence ofdiabeticretinopathyandisawareof itsmanagement. Less frequent exams (every23years)maybeconsideredwiththeadvice of an eye care professional in thesetting of a normal eye exam(9395). Ex-aminations will berequiredmorefre-quently if retinopathy is progressing.One of the mainmotivations forscreeningfordiabeticretinopathyistheestablished efcacy of laser photocoagu-lationsurgeryinpreventingvisual loss.Two large National Institutes of Healthsponsoredtrials, theDiabeticRetinopa-thy Study (DRS) (96100) and the EarlyTreatment DiabeticRetinopathyStudy(ETDRS), providethestrongestsupportfor the therapeutic benet of photocoag-ulation surgery (101107).The DRS tested whether scatter (pan-retinal) photocoagulationsurgerycouldreduce the risk of vision loss from PDR.Severe visual loss (i.e., best acuityof5/200 or worse) was seen in 15.9%of un-treated vs. 6.4% of treated eyes. The ben-et wasgreatest amongpatientswhosebaseline evaluationrevealedhigh-riskcharacteristics(HRCs)(chieydiscneo-vascularizationor vitreous hemorrhagewithanyretinal neovascularization). Ofcontrol eyes with HRCs, 26% progressedtoseverevisual lossvs. 11%of treatedeyes.Giventheriskofamodestlossofvisual acuity and of contraction of visualeldfrompanretinallasersurgery,suchtherapy has been primarily recommendedfor eyes approaching or reaching HRCs.The ETDRS established the benet offocal laser photocoagulationsurgeryineyes withmacular edema, particularlythosewithclinicallysignicant macularedema. In patients with clinically signi-cant macular edema after 2 years, 20% ofuntreated eyes had a doubling of the vi-sual angle(e.g., 20/50to20/100)com-Position StatementS26 DIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004paredwith8%of treatedeyes. Otherresults fromthe ETDRS indicate that, pro-videdcareful follow-upcanbe main-tained, scatterphotocoagulationsurgeryis not recommended for eyes with mild ormoderatenonproliferativediabeticreti-nopathy(NPDR). Whenretinopathyismore severe, scatter photocoagulationsurgeryshouldbeconsidered,andusu-ally should not be delayed, if the eye hasreached the high-risk proliferative stage.In older-onset patients with severe NPDRor less than high-risk PDR, the risk of se-vere visual loss and vitrectomy is reduced50% by laser photocoagulation surgeryat these earlier stages.Laser photocoagulationsurgeryinboth the DRS and the ETDRS was bene-cial in reducing the risk of further visualloss, but generally not benecial in revers-ing already diminished acuity. This pre-ventiveeffect andthefact that patientswithPDRor macular edema maybeasymptomatic provide strong support fora screening programto detect diabetic ret-inopathy.For a detailed review of the evidenceandfurther discussion, seetheADAstechnical reviewandpositionstatementon this subject (91,108,109).RecommendationsGeneral recommendationsOptimal glycemic control can substan-tially reduce the risk and progression ofdiabetic retinopathy. (A)Optimal blood pressure control can re-ducetheriskandprogressionof dia-betic retinopathy. (A)Aspirin therapy does not prevent reti-nopathy or increase the risks of hemor-rhage. (A)ScreeningAdults and adolescents with type 1 di-abetes shouldhaveaninitial dilatedand comprehensive eye examination byanophthalmologist or optometristwithin 35 years after the onset of dia-betes. (B)Patients withtype2diabetes shouldhave an initial dilated and comprehen-sive eye examination by an ophthalmol-ogist or optometrist shortlyafter thediagnosis of diabetes. (B)Subsequent examinations for type1and type 2 diabetic patients should berepeated annually by an ophthalmolo-gist or optometrist who is knowledge-able and experienced in diagnosing thepresence of diabetic retinopathy and isaware of its management. Less frequentexams (every 23 years) may be consid-ered with the advice of an eye care pro-fessional in the setting of a normal eyeexam. Examinations will berequiredmorefrequentlyifretinopathyispro-gressing. (B)Whenplanningpregnancy, womenwith preexisting diabetes should have acomprehensiveeyeexaminationandshould be counseled on the risk of de-velopment and/orprogressionof dia-beti c reti nopathy. Women wi thdiabetes who become pregnant shouldhave a comprehensive eye examinationinthe rst trimester andclose fol-low-up throughout pregnancy and for1 year postpartum. This guideline doesnot apply to women who develop GDMbecause such individuals are not at in-creasedriskfor diabeticretinopathy.(B)TreatmentLaser therapy can reduce the risk of vi-sion loss in patients with HRCs. (A)Promptly refer patients with any level ofmacularedema, severeNPDR, oranyPDRtoanophthalmologist whoisknowledgeable and experienced in themanagement and treatment of diabeticretinopathy. (A)IV. Foot careAmputationandfoot ulcerationarethemostcommonconsequencesofdiabeticneuropathy and major causes of morbid-ity and disability in people with diabetes.Early recognition and management of in-dependent risk factors can prevent or de-lay adverse outcomes.Theriskofulcersoramputationsisincreased in people who have had diabe-tes10years,aremale,havepoorglu-cose control, or have cardiovascular,retinal, orrenal complications. Thefol-lowing foot-related risk conditions are as-sociated with an increased risk ofamputation:Peripheral neuropathy with loss of pro-tective sensation.Altered biomechanics (in the presenceof neuropathy).Evidenceof increasedpressure(ery-thema, hemorrhage under a callus).Bony deformity.Peripheralvasculardisease(decreasedor absent pedal pulses).A history of ulcers or amputation.Severe nail pathology.All individualswithdiabetesshouldre-ceive an annual foot examination to iden-tify high-risk foot conditions. Thisexaminationshouldincludeassessmentof protective sensation, foot structure andbiomechanics, vascularstatus, andskinintegrity. People with one or more high-risk foot conditions should be evaluatedmorefrequentlyforthedevelopmentofadditional risk factors. People with neu-ropathy should have a visual inspection oftheir feet at every visit with a health careprofessional. Evaluationof neurologicalstatus in the low-risk foot should includeaquantitativesomatosensorythresholdtest, usingtheSemmes-Weinstein5.07(10-g) monolament. The skin should beassessed for integrity, especially betweenthe toes and under the metatarsal heads.Thepresenceof erythema, warmth, orcallus formation may indicate areas of tis-sue damage with impending breakdown.Bony deformities, limitation in joint mo-bility, and problems with gait and balanceshould be assessed.Peoplewithneuropathyorevidenceof increased plantar pressure may be ad-equately managed with well-tted walk-ing shoes or athletic shoes. Patientsshould be educated on the implications ofsensorylossandthewaystosubstituteother sensory modalities (hand palpation,visual inspection) for surveillance of earlyproblems. Peoplewithevidenceof in-creased plantar pressure (e.g., erythema,warmth, callus, or measuredpressure)should use footwear that cushions and re-distributes the pressure. Callus can be de-bridedwitha scalpel by a foot carespecialist or other healthprofessionalwith experience and training in foot care.People with bony deformities (e.g., ham-mertoes, prominent metatarsal heads,bunions)mayneedextra-wideshoesordepthshoes. Peoplewithextremebonydeformities (e.g., Charcot foot) that can-not beaccommodatedwithcommercialtherapeuticfootwearmayneedcustom-molded shoes.Initial screeningforperipheral arte-rialdisease(PAD)shouldincludeahis-tory for claudication and an assessment ofthepedalpulses.Considerobtaininganankle-brachialindex(ABI),asmanypa-tients with PAD are asymptomatic. ReferStandards of Medical CareDIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S27patients with signicant or a positive ABIfor further vascular assessment and con-sider exercise, medications, and surgicaloptions (110).Patientswithdiabetesandhigh-riskfoot conditionsshouldbeeducatedre-garding their risk factors and appropriatemanagement. Patients at risk should un-derstandtheimplicationsof thelossofprotectivesensation, theimportanceoffoot monitoringona dailybasis, theproper care of the foot, including nail andskin care, and the selection of appropriatefootwear. The patients understanding oftheseissuesandtheirphysicalabilitytoconduct proper foot surveillance and careshouldbeassessed. Patientswithvisualdifculties, physical constraints prevent-ing movement, or cognitive problems thatimpair their ability to assess the conditionof thefoot andtoinstituteappropriateresponses will need other people, such asfamilymembers, toassist intheircare.Patients at low risk may benet from ed-ucation on foot care and footwear.For a detailed review of the evidenceandfurther discussion, seetheADAstechnical reviewandpositionstatementin this area (111,112).Problems involvingthefeet, espe-cially ulcers and wound care, may requirecare by a podiatrist, orthopedic surgeon,or rehabilitation specialist experienced inthe management of persons with diabetes.For a complete discussion on wound care,see the ADAs consensus statement on di-abetic foot wound care (113).RecommendationsA multidisciplinary approach is recom-mendedfor persons withfoot ulcersand high-risk feet, especially those witha history of prior ulcer or amputation.(A)Thefoot examinationcanbeaccom-plishedinaprimarycaresettingandshouldincludetheuseof aSemmes-Weinsteinmonolament,tuningfork,palpation, and a visual examination. (B)Educateall patients, especiallythosewith risk factors, including smoking, orprior lower-extremitycomplications,abouttheriskandpreventionof footproblems and reinforce self-care behav-ior. (B)Refer high-risk patients to foot care spe-cialists for ongoing preventive care andlife-long surveillance. (C)Initial screeningfor PADshouldin-clude a history for claudication and anassessment of thepedal pulses. Con-sider obtaininganABI, as manypa-tients with PAD are asymptomatic. (C)Refer patients with signicant claudica-tion or a positive ABI for further vascu-lar assessment andconsider exercise,medications, and surgical options. (C)Performacomprehensivefootexami-nation annually on patients with diabe-tes to identify risk factors predictive ofulcers and amputations. Perform a vi-sual inspection of patients feet at eachroutine visit. (E)PREVENTIVE CAREI. Preconception careMajor congenital malformationsremainthe leading cause of mortality and seriousmorbidity in infants of mothers with type1 and type 2 diabetes. Observational stud-ies indicate that the risk of malformationsincreases continuouslywithincreasingmaternal glycemiaduringtherst 68weeks of gestation, as dened by rst tri-mesterA1Cconcentrations.Thereisnothreshold for A1Cvalues above which therisk begins or below which it disappears.However, malformationratesabovethe12%backgroundrateseeninnondia-betic pregnancies appear to be limited topregnancies in which rst trimester A1Cconcentrationsare1%abovethenor-mal range.Preconceptioncareof diabetes ap-pears to reduce the risk of congenital mal-formations. Five nonrandomized studieshave compared rates of major malforma-tions in infants between women who par-ticipatedinpreconceptiondiabetescareprogramsandwomenwhoinitiatedin-tensivediabetesmanagement after theywerealreadypregnant. Thepreconcep-tioncare programs were multidisci-plinary and designed to train patients indiabetesself-management withdiet, in-tensiedinsulintherapy, andSMBG.Goalsweresettoachievenormal bloodglucoseconcentrations, and80%ofsubjects achieved normal A1C concentra-tions before they became pregnant (114118). In all ve studies, the incidence ofmajor congenital malformations inwomenwhoparticipatedinpreconcep-tion care (range 1.01.7% of infants) wasmuch lower than the incidence in womenwhodidnot participate (range 1.410.9% of infants). One limitation of thesestudies is that participation in preconcep-tioncarewas self-selectedbypatientsratherthanrandomized. Thus, itisim-possible to be certain that the lower mal-formation rates resulted fully fromimproved diabetes care. Nonetheless, theoverwhelming evidence supports theconcept that malformations canbere-ducedorpreventedbycareful manage-ment of diabetes before pregnancy.Planned pregnancies greatly facilitatepreconceptiondiabetes care. Unfortu-nately, nearlytwo-thirdsof pregnanciesinwomenwithdiabetesareunplanned,leadingtoapersistentexcessofmalfor-mations in infants of diabetic mothers. Tominimize the occurrence of these devas-tating malformations, standard care for allwomenwithdiabetes whohavechild-bearing potential should include 1) edu-cationabout theriskof malformationsassociatedwithunplannedpregnanciesand poor metabolic control and 2) use ofeffective contraception at all times, unlessthepatientisingoodmetaboliccontroland actively trying to conceive.Womencontemplatingpregnancyneed to be seen frequently by a multidis-ciplinaryteamexperiencedintheman-agement of diabetes beforeandduringpregnancy. Teamsmayvarybutshouldinclude a diabetologist, an internist or afamily physician, an obstetrician, a diabe-tes educator, a dietitian, a social worker,andother specialists as necessary. Thegoals of preconception care are to 1) inte-grate the patient into the management ofherdiabetes,2)achievethelowestA1Ctest results possible without excessive hy-poglycemia, 3) assure effective contracep-tion until stable and acceptable glycemiais achieved, and 4) identify, evaluate, andtreat long-termdiabeticcomplicationssuchasretinopathy, nephropathy, neu-ropathy, hypertension, and CAD.For further discussion, see the ADAstechnical reviewandpositionstatementon this subject (119,120).RecommendationsA1Clevels should be normal or as closeto normal as possible (1% above theupper limits of normal) in an individualpatient before conception is attempted.(B)All womenwithdiabetes andchild-bearingpotential shouldbeeducatedabout the need for good glucose controlbefore pregnancy. They should partici-pate in family planning. (E)Women with diabetes who are contem-plating pregnancy should be evaluatedPosition StatementS28 DIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004and, if indicated, treatedfor diabeticretinopathy, nephropathy, neuropathy,and CVD. (E)Amongthedrugscommonlyusedinthe treatment of patients with diabetes,statinsarepregnancycategoryXandshould be discontinued before concep-tionif possible. ACEinhibitors andARBs are category C in the rst trimes-ter (maternal benet may outweigh fe-tal riskincertainsituations), butcategoryDinlater pregnancy, andshouldgenerallybediscontinuedbe-fore pregnancy. Among the oral antidi-abetic agents, metformin and acarboseare classied as category B and all oth-ersascategoryC; potential risksandbenetsof oral antidiabeticagentsinthe preconception period must be care-fullyweighed, recognizingthat suf-cient data are not available to establishthe safety of these agents in pregnancy.They should generally be discontinuedin pregnancy. (E)II. ImmunizationInuenzaandpneumoniaarecommon,preventable infectious diseases associatedwith high mortality and morbidity in theelderlyandinpeoplewithchronicdis-eases. There are limited studies reportingthe morbidity and mortality of inuenzaandpneumococcal pneumoniaspeci-callyinpeoplewithdiabetes. Observa-tional studies of patients with a variety ofchronic illnesses, including diabetes,show that these conditions are associatedwith an increase in hospitalizations for in-uenza and its complications. Based on acase-control series, inuenza vaccine hasbeenshowntoreducediabetes-relatedhospital admissionbyasmuchas79%during u epidemics (121). People withdiabetesmaybeatincreasedriskofthebacteremic form of pneumococcal infec-tionandhavebeenreportedtohaveahighriskof nosocomial bacteremia,which has a mortality rate as high as 50%.Safe and effective vaccines are avail-ablethat cangreatlyreducetheriskofserious complications from these diseases(122,123). There is sufcient evidence tosupport that peoplewithdiabeteshaveappropriate serologic andclinical re-sponsestothesevaccinations.TheCen-ters for Disease Control s AdvisoryCommitteeonImmunizationPracticesrecommendsinuenzaandpneumococ-cal vaccines for all persons over 65 yearsof age as well as for all persons of any agewith diabetes.For a complete discussion on the pre-ventionof inuenzaandpneumococcaldiseaseinpeoplewithdiabetes, consultthetechnical reviewandpositionstate-ment on this subject (124,125).RecommendationsAnnually provide an inuenza vaccineto all diabetic patients 6 months of ageor older. (C)Provideatleastonelifetimepneumo-coccal vaccine for adults with diabetes.Aone-time revaccinationis recom-mendedforindividuals64yearsofagepreviouslyimmunizedwhentheywere 65 years of age if the vaccine wasadministered 5 years ago. Other indi-cationsforrepeat vaccinationincludenephrotic syndrome, chronic renal dis-ease,andotherimmunocompromisedstates, such as after transplantation. (C)SPECIAL CONSIDERATIONSI. Care of older adults with diabetesDiabetes is an important health conditionfor the aging population; at least 20% ofpatients over the age of 65 years have di-abetes. The number of older persons withdiabetes can be expected to grow rapidlyover the coming decades. A recent publi-cation, Guidelines for improving the careoftheolderpersonwithdiabetes,con-tains evidence-basedguidelines pro-duced in conjunction with the AmericanGeriatric Society. This document containsanexcellentdiscussionofthisarea,andspecicguidelinesandlanguagefromithave been incorporated below (126). Un-fortunately, there are no long-term stud-ies inpersons over 65years of agedemonstrating the benets of tight glyce-miccontrol, bloodpressure, andlipidcontrol. Older persons with diabetes havehigher rates of prematuredeath, func-tionaldisability,andcoexistingillnessessuchashypertension, CHD, andstrokethan those without diabetes. Older adultswith diabetes are also at greater risk thanotherolderpersonsforseveralcommongeriatricsyndromes, suchas polyphar-macy, depression, cognitive impairment,urinary incontinence, injurious falls, andpersistent pain.The care of older adults with diabetesis complicated by their clinical and func-tional heterogeneity. Some older personsdeveloped diabetes in middle age and faceyears of comorbidity; others whoarenewlydiagnosedmayhavehadyearsofundiagnosed comorbidity or few compli-cations fromthe disease. Some olderadults withdiabetes arefrail andhaveother underlying chronic conditions,substantial diabetes-related comorbidity,or limited physical or cognitive function-ing, but other older persons with diabeteshave little comorbidity and are active. Lifeexpectanciesarealsohighlyvariableforthis population. Clinicians caringforolder adults with diabetes must take thisheterogeneityintoconsiderationwhensetting and prioritizing treatment goals.All this havingbeensaid, patientswho can be expected to live long enoughto reap the benets of long-termintensivediabetes management (10years) andwhoareactive, cognitivelyintact, andwilling to undertake the responsibility ofself-management shouldbeencouragedto do so and be treated using the statedgoals for younger adults with diabetes.There is good evidence from middle-agedandolder adults suggestingthatmultidisciplinaryinterventionsthatpro-vide education on medication use, moni-toring, and recognizing hypo- andhyperglycemia can signicantly improveglycemic control. Although control of hy-perglycemiaisimportant, inolder per-sons with diabetes, greater reductions inmorbidity and mortality may result fromcontrol ofall cardiovascularriskfactorsratherthanfromtight glycemiccontrolalone. There is strong evidence from clin-icaltrialsofthevalueoftreatinghyper-tensioninthe elderly. There is lessevidencefor lipid-loweringandaspirintherapy, althoughas diabeticpatientshavesuchanelevatedriskforCVD,ag-gressive management of lipids and aspirinuse when not contraindicated are reason-able interventions.As noted above, for patients with ad-vanceddiabetes complications, life-limiting comorbid illness, or cognitive orfunctional impairment, it is reasonable toset lessintensiveglycemictarget goals.Thesepatientsarelesslikelytobenetfromreducingtheriskofmicrovascularcomplicationsandmorelikelytosufferseriousadverseeffectsfromhypoglyce-mia. Patients with poorly controlled dia-bet es may be subj ect t o acut ecomplications of diabetes, including hy-perglycemichyperosmolar coma. Olderpatients can be treated with the same drugregimens as younger patients, but specialStandards of Medical CareDIABETES CARE,VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S29care is required in prescribing and moni-toringdrugtherapy. Metforminisoftencontraindicatedbecauseofrenalinsuf-ciency or heart failure. Sulfonylureas andother insulin secretagogues can cause hy-poglycemia. Insulin can also cause hypo-glycemiaaswell asrequiregoodvisualand motor skills and cognitive ability ofthe patient or a caregiver. Thiazo-lidinedionesshouldnot beusedinpa-tients with congestive heart failure (NewYork Heart Association [NYHA] Class IIIandIV). Drugsshouldbestartedatthelowest dose and titrated up gradually un-til targets are reached or side effects de-velop. As well as regards blood pressureand lipid management, the potential ben-ets must always be weighed against po-tential risks.II. Children and adolescentsApproximately three-quarters of all newlydiagnosed cases of type 1 diabetes occurinindividualsyoungerthan18yearsofage. Care of this group requires integra-tionof diabetes management withthecomplicatedphysical andemotionalgrowthneeds of children, adolescents,and their families.Diabetes care for children of this age-group should be provided by a team thatcan deal with these special medical, edu-cational, nutritional, andbehavioral is-sues.Atthetimeofinitial diagnosis, itisextremely important to establish the goalsof care and to begin diabetes self-management education. Armeduca-tional base should be provided so that theindividual andfamilycanbecomein-creasingly independent in the self-management of diabetes. Glycemic goalsmay need to be modied to take into ac-count the fact that most children youngerthan6or7yearsofagehaveaformofhypoglycemic unawareness, in that theylackthecognitivecapacitytorecognizeand respond to hypoglycemic symptomsand may be at greater risk for the sequelaeof hypoglycemia.Intercurrent illnesses aremorefre-quent in young children. Sick-day man-agementrules, includingassessmentforketosis with every illness, must be estab-lished and taught to prevent severe hyper-gl ycemi a and DKA t hat requi reshospitalizationandmayleadtoseveremorbidityandevendeath(24). MNTshouldbeprovidedatdiagnosis,andatleast annually thereafter, by an individualexperienced with the nutritional needs ofthe growing child and the behavioral is-suesthathaveanimpactonadolescentdiets. Caution must be exercised to avoidoveraggressivedietarymanipulationintheveryyoung. Assessment of lifestyleneeds should be accompanied by possiblemodications of thediabetes regimen.For example, an adolescent who requiresmoreexibilitymight beswitchedtoabasal/bolus insulinprogramwithpre-prandial rapidlyactinginsulinadminis-trationor continuous subcutaneousinsulin injection (CSII).A major issue deserving emphasis inthis age-group is that of adherence. Nomatter howsound the medical regimen, itcan only be as good as the ability of thefamily and/or individual to implement it.Familyinvolvementindiabetesremainsan important component of optimal dia-betes management throughout childhoodand into adolescence. Health care provid-ers who care for children and adolescents,therefore,mustbecapableofevaluatingthe behavioral, emotional, and psychoso-cial factors that interfere with implemen-tationandthenmust workwiththeindividual and family to resolve problemsthat occur and/or to modify goals as ap-propriate.Theincidenceof type2diabetesinchildren and adolescents has been shownto be increasing, especially in ethnic mi-noritypopulations(127,128). Althoughthere are insufcient data to make deniterecommendations, a recent ADA consen-susstatement providesguidancetotheprevention, screening, andtreatment oftype 2 diabetes in young people. The idealgoal of treatment is normalizationofblood glucose and A1C values. Accuratediagnosis and classication of diabetes iscrucial in determining appropriate treat-ment for these patients. Medical manage-ment should include MNT, exercise, andlifestyle interventions, but drug therapy,including insulininmany cases, isrequired. Successful control of comor-bidities, such as hypertension and hyper-lipidemia,isalsoimportant.Forfurtherdiscussion, see the ADA consensus state-mentType2DiabetesinChildrenandAdolescents (13).Informationshouldbesuppliedtotheschool or daycaresettingsothatschool personnel are aware of the diagno-sisofdiabetesinthestudentandofthesigns, symptoms, and treatment of hypo-glycemia. Itisdesirablethatbloodglu-cose testing be performed at the school ordaycaresettingbeforelunchandwhensigns or symptoms of abnormal bloodglucose levels are present. Many childrenmay require support for insulin adminis-tration by either injection or CSII beforelunch at school or in day care.For further discussion, see the ADAsposition statement The Care of ChildrenWith Diabetes in the School and Day CareSetting (129) and the NDEP publicationHelping the Student with Diabetes Succeed:A Guide for School Personnel (National Di-abetes EducationProgram, 2003


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