Standards of Medical Care in Diabetes A D · Standards of Medical Care in Diabetes AMERICAN...

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Standards of Medical Care in Diabetes AMERICAN DIABETES ASSOCIATION CONTENTS I. CLASSIFICATION AND DIAGNOSIS A. Classification B. Diagnosis II. SCREENING FOR DIABETES III. DETECTION AND DIAGNOSIS OF GESTATIONAL DIABETES MELLITUS (GDM) IV. PREVENTION/DELAY OF TYPE 2 DIABETES V. DIABETES CARE A. Initial evaluation B. Management C. Glycemic control 1. Assessment of glycemic control a. Self-monitoring of blood glucose b. A1C 2. Glycemic goals D. Medical nutrition therapy E. Physical activity F. Psychosocial assessment and care G. Referral for diabetes manage- ment H. Intercurrent illness I. Immunization VI. PREVENTION AND MANAGE- MENT OF DIABETES COMPLI- CATIONS A. Cardiovascular disease 1. Hypertension/blood pres- sure control 2. Dyslipidemia/lipid man- agement 3. Anti-platelet agents 4. Smoking cessation 5. Coronary heart disease screening and treatment B. Nephropathy screening and treatment C. Retinopathy screening and treatment D. Foot care VII. DIABETES CARE IN SPECIFIC POPULATIONS A. Children and adolescents B. Preconception care C. Older individuals VIII. DIABETES CARE IN SPECIFIC SETTINGS A. Diabetes care in the hospital B. Diabetes care in the school and day care setting C. Diabetes care at diabetes camps D. Diabetes care at correctional institutions IX. HYPOGLYCEMIA AND EMPLOY- MENT/LICENSURE X. THIRD-PARTY REIMBURSE- MENT FOR DIABETES CARE, SELF-MANAGEMENT EDUCA- TION, AND SUPPLIES XI. STRATEGIES FOR IMPROVING DIABETES CARE 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 individ- uals with the components of diabetes care, treatment goals, and tools to evalu- ate the quality of care. While individual preferences, comorbidities, and other pa- tient factors may require modification of goals, targets that are desirable for most patients with diabetes are provided. These standards are not intended to pre- clude more extensive evaluation and management of the patient by other spe- cialists as needed. For more detailed in- formation, refer to Bode (Ed.): Medical Management of Type 1 Diabetes (1), Burant (Ed): Medical Management of Type 2 Dia- betes (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. I. CLASSIFICATION AND DIAGNOSIS A. 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: ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● Originally approved 1988. Most recent review/revision, October 2004. Abbreviations: ABI, ankle-brachial index; AMI, acute myocardial infarction; ARB, angiotensin receptor blocker; CAD, coronary artery disease; CBG, capillary blood glucose; CHD, coronary heart disease; CHF, congestive heart failure; CSII, continuous subcutaneous insulin injection; CVD, cardiovascular disease; DCCB, dihydropyridine calcium channel blocker; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis; DPP, Diabetes Prevention Program; DSME, diabetes self-management education; DRS, Diabetic Retinopathy Study; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; ESRD, end-stage renal disease; ETDRS, Early Treatment Diabetic Retinopathy Study; FPG, fasting plasma glucose; GCT, glucose challenge test; GDM, gestational diabetes mellitus; GFR, glomerular filtration rate; HRC, high-risk characteristic; ICU, intensive care unit; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; MNT, medical nutrition therapy; NPDR, nonproliferative diabetic retinopathy; OGTT, oral glu- cose tolerance test; PAD, peripheral arterial disease; PDR, proliferative diabetic retinopathy; PPG, postpran- dial plasma glucose; SMBG, self-monitoring of blood glucose; UKPDS, U.K. Prospective Diabetes Study. © 2005 by the American Diabetes Association. P O S I T I O N S T A T E M E N T S4 DIABETES CARE, VOLUME 28, SUPPLEMENT 1, JANUARY 2005

Transcript of Standards of Medical Care in Diabetes A D · Standards of Medical Care in Diabetes AMERICAN...

Page 1: Standards of Medical Care in Diabetes A D · Standards of Medical Care in Diabetes AMERICAN DIABETES ASSOCIATION CONTENTS I. CLASSIFICATIONANDDIAGNOSIS A. Classification B. Diagnosis

Standards of Medical Care in DiabetesAMERICAN DIABETES ASSOCIATION

CONTENTS

I. CLASSIFICATIONANDDIAGNOSISA. ClassificationB. Diagnosis

II. SCREENING FOR DIABETES

III. DETECTION AND DIAGNOSISOF GESTATIONAL DIABETESMELLITUS (GDM)

IV. PREVENTION/DELAY OF TYPE 2DIABETES

V. DIABETES CAREA. Initial evaluationB. ManagementC. Glycemic control

1. Assessment of glycemiccontrola. Self-monitoring of

blood glucoseb. A1C

2. Glycemic goalsD. Medical nutrition therapyE. Physical activityF. Psychosocial assessment and careG. Referral for diabetes manage-

mentH. Intercurrent illnessI. Immunization

VI. PREVENTION AND MANAGE-MENT OF DIABETES COMPLI-CATIONSA. Cardiovascular disease

1. Hypertension/blood pres-sure control

2. Dyslipidemia/lipid man-agement

3. Anti-platelet agents4. Smoking cessation5. Coronary heart disease

screening and treatmentB. Nephropathy screening and

treatmentC. Retinopathy screening and

treatmentD. Foot care

VII. DIABETES CARE IN SPECIFICPOPULATIONSA. Children and adolescentsB. Preconception careC. Older individuals

VIII. DIABETES CARE IN SPECIFICSETTINGSA. Diabetes care in the hospitalB. Diabetes care in the school and

day care settingC. Diabetes care at diabetes campsD. Diabetes care at correctional

institutions

IX. HYPOGLYCEMIA AND EMPLOY-MENT/LICENSURE

X. THIRD-PARTY REIMBURSE-MENT FOR DIABETES CARE,SELF-MANAGEMENT EDUCA-TION, AND SUPPLIES

XI. STRATEGIES FOR IMPROVINGDIABETES CARE

D iabetes is a chronic illness that re-quires continuing medical care andpatient self-management education

to prevent acute complications and to re-duce the risk of long-term complications.Diabetes care is complex and requires 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 intendedto provide clinicians, patients, research-ers, payors, and other interested individ-uals with the components of diabetescare, treatment goals, and tools to evalu-ate the quality of care. While individualpreferences, comorbidities, and other pa-tient factors may require modification ofgoals, targets that are desirable for mostpatients with diabetes are provided.These standards are not intended to pre-clude more extensive evaluation andmanagement of the patient by other spe-cialists as needed. For more detailed in-formation, refer to Bode (Ed.): MedicalManagement of Type 1 Diabetes (1), Burant(Ed): Medical Management of Type 2 Dia-betes (2), and Klingensmith (Ed): IntensiveDiabetes Management (3).

The recommendations included arediagnostic and therapeutic actions 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.

I. CLASSIFICATION ANDDIAGNOSIS

A. ClassificationIn 1997, the ADA issued new diagnosticand classification criteria (4); in 2003,modifications were made regarding thediagnosis of impaired fasting glucose(IFG) (5). The classification of diabetesincludes four clinical classes:

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Originally approved 1988. Most recent review/revision, October 2004.Abbreviations: ABI, ankle-brachial index; AMI, acute myocardial infarction; ARB, angiotensin receptor

blocker; CAD, coronary artery disease; CBG, capillary blood glucose; CHD, coronary heart disease; CHF,congestive heart failure; CSII, continuous subcutaneous insulin injection; CVD, cardiovascular disease;DCCB, dihydropyridine calcium channel blocker; DCCT, Diabetes Control and Complications Trial; DKA,diabetic ketoacidosis; DPP, Diabetes Prevention Program; DSME, diabetes self-management education; DRS,Diabetic Retinopathy Study; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; ESRD,end-stage renal disease; ETDRS, Early Treatment Diabetic Retinopathy Study; FPG, fasting plasma glucose;GCT, glucose challenge test; GDM, gestational diabetes mellitus; GFR, glomerular filtration rate; HRC,high-risk characteristic; ICU, intensive care unit; IFG, impaired fasting glucose; IGT, impaired glucosetolerance; MNT, medical nutrition therapy; NPDR, nonproliferative diabetic retinopathy; OGTT, oral glu-cose tolerance test; PAD, peripheral arterial disease; PDR, proliferative diabetic retinopathy; PPG, postpran-dial plasma glucose; SMBG, self-monitoring of blood glucose; UKPDS, U.K. Prospective Diabetes Study.

© 2005 by the American Diabetes Association.

P O S I T I O N S T A T E M E N T

S4 DIABETES CARE, VOLUME 28, SUPPLEMENT 1, JANUARY 2005

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● Type 1 diabetes (results from �-cell de-struction, usually leading to absoluteinsulin deficiency).

● Type 2 diabetes (results from a progres-sive insulin secretory defect on thebackground of insulin resistance).

● Other specific types of diabetes (due toother causes, e.g., genetic defects in�-cell function, genetic defects in insu-lin action, diseases of the exocrine pan-creas, and drug or chemical induced).

● Gestational diabetes mellitus (GDM)(diagnosed during pregnancy).

B. DiagnosisCriteria for the diagnosis of diabetes innonpregnant adults are shown in Table 2.Three ways to diagnose diabetes are avail-able, and each must be confirmed on asubsequent day unless unequivocalsymptoms of hyperglycemia are present.Although the 75-g oral glucose tolerancetest (OGTT) is more sensitive and mod-estly more specific than fasting plasmaglucose (FPG) to diagnose diabetes, it ispoorly reproducible and rarely performedin practice. Because of ease of use, accept-ability to patients, and lower cost, the

FPG is the preferred diagnostic test. Itshould be noted that the vast majority ofpeople who meet diagnostic criteria fordiabetes by OGTT, but not by FPG, willhave an A1C value �7.0%. The use of theA1C for the diagnosis of diabetes is notrecommended at this time.

Hyperglycemia not sufficient to meetthe diagnostic criteria for diabetes is cate-gorized as either IFG or impaired glucose

tolerance (IGT), depending on whether itis identified through a 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, IFG and IGT have been offi-cially termed “pre-diabetes.” Both catego-ries, IFG and IGT, are risk factors forfuture diabetes and cardiovascular dis-ease (CVD).

Recommendations● The FPG is the preferred test to diag-

nose diabetes in children and nonpreg-nant adults. (E)

● The use of the A1C for the diagnosis ofdiabetes is not recommended at thistime. (E)

II. SCREENING FORDIABETESThere is a major distinction between di-agnostic testing and screening. When anindividual exhibits symptoms or signs ofthe disease, diagnostic tests are per-formed, and such tests do not representscreening. The purpose of screening is toidentify asymptomatic individuals whoare likely to have diabetes. Separate diag-nostic tests using standard criteria are re-quired after positive screening tests toestablish a definitive diagnosis as de-scribed above.

Type 1 diabetesGenerally, people with type 1 diabetespresent with acute symptoms of diabetesand markedly elevated blood glucose lev-

Table 1—ADA evidence grading system for clinical practice recommendations

Level ofevidence Description

A Clear evidence from well-conducted, generalizable, randomized controlled trialsthat 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 meta-analysis of cohort studies

Supportive 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 threeor more minor methodological flaws that could invalidate 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 reportsConflicting evidence with the weight of evidence supporting the

recommendationE Expert consensus or clinical experience

Table 2—Criteria for the diagnosis of diabetes

1. Symptoms of diabetes and a casual plasma glucose �200 mg/dl (11.1 mmol/l).Casual is defined as any time of day without regard to time since last meal. Theclassic symptoms of diabetes include polyuria, polydipsia, and unexplainedweight loss.

OR2. FPG �126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8

h.OR

3. 2-h plasma glucose �200 mg/dl (11.1 mmol/l) during an OGTT. The test should beperformed as described by the World Health Organization, using a glucose loadcontaining the equivalent of 75-g anhydrous glucose dissolved in water.

In the absence of unequivocal hyperglycemia, these criteria should be confirmed by repeat testing on adifferent day. The OGTT is not recommended for routine clinical use, but may be required in the evaluationof patients with IFG (see text) or when diabetes is still suspected despite a normal FPG as with the postpartumevaluation of women with GDM.

Position Statement

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els. Because of the acute onset of symp-toms, most cases of type 1 diabetes aredetected soon after symptoms develop.Widespread clinical testing of asymptom-atic individuals for the presence of auto-antibodies related to type 1 diabetescannot be recommended at this time as ameans to identify individuals at risk. Rea-sons for this include the following: 1) cut-off values for some of the immune markerassays have not been completely estab-lished in clinical settings; 2) there is noconsensus as to what action should betaken when a positive autoantibody testresult is obtained; and 3) because the in-cidence of type 1 diabetes is low, testing ofhealthy children will identify only a verysmall number (�0.5%) who at that mo-ment may be “pre-diabetic.” Clinical stud-ies are being conducted to test variousmethods of preventing type 1 diabetes inhigh-risk individuals (e.g., siblings oftype 1 diabetic patients). These studiesmay uncover an effective means of pre-venting type 1 diabetes, in which case tar-geted screening may be appropriate in thefuture.

Type 2 diabetesType 2 diabetes is frequently not diag-nosed until complications appear, andapproximately one-third of all peoplewith diabetes may be undiagnosed. Indi-viduals at high risk should be screened fordiabetes and pre-diabetes. Criteria fortesting for diabetes in asymptomatic, un-diagnosed adults are listed in Table 3. The

effectiveness of early diagnosis throughscreening of asymptomatic individualshas not been determined (6).

Screening should be carried outwithin the health care setting. Either anFPG test or 2-h OGTT (75-g glucose load)is appropriate. The 2-h OGTT identifiespeople with IGT, and thus more peoplewho at increased risk for the developmentof diabetes and CVD. It should be notedthat the two tests do not necessarily detectthe same individuals (7). The FPG test ismore convenient to patients, more repro-ducible, less costly, and easier to admin-ister than the 2-h OGTT (4,5). Therefore,the recommended initial screening testfor nonpregnant adults is the FPG.

The incidence of type 2 diabetes inchildren and adolescents has increaseddramatically in the last decade. Consis-tent with screening recommendations foradults, only children and youth at in-creased risk for the presence or the devel-opment of type 2 diabetes should betested (8) (Table 4).

The effectiveness of screening mayalso depend on the setting in which it isperformed. In general, communityscreening, outside a health care setting,may be less effective because of the failureof people with a positive screening test toseek and obtain appropriate follow-uptesting and care or, conversely, to ensureappropriate repeat testing for individualswho screen negative. That is, screeningoutside of clinical settings may yield ab-normal tests that are never discussed with

a primary care provider, low compliancewith treatment recommendations, and avery uncertain impact on long-termhealth. Community screening may also bepoorly targeted, i.e., it may fail to reachthe groups most at risk and inappropri-ately test those at low risk (the worriedwell) or even those already diagnosed(9,10).

On the basis of expert opinion,screening should be considered by healthcare providers at 3-year intervals begin-ning at age 45 years, particularly in thosewith BMI �25 kg/m2. The rationale forthis interval is that false negatives will berepeated before substantial time elapses,and there is little likelihood of an individ-ual developing any of the complicationsof diabetes to a significant degree within 3years of a negative screening test result.Testing should be considered at a youngerage or be carried out more frequently inindividuals who are overweight and haveone or more of the other risk factors fortype 2 diabetes.

Recommendations● Screening to detect pre-diabetes (IFG

or IGT) and diabetes should be consid-ered in individuals �45 years of age,particularly in those with a BMI �25kg/m2. Screening should also be con-

Table 3—Criteria for testing for diabetes in asymptomatic adult individuals

1. Testing for diabetes should be considered in all individuals at age 45 years andabove, particularly in those with a BMI �25 kg/m2* and, if normal, should berepeated at 3-year intervals.

2. Testing should be considered at a younger age or be carried out more frequently inindividuals who are overweight (BMI �25 kg/m2*) and have additional riskfactors, as follows:

● are habitually physically inactive● have a first-degree relative with diabetes● are members of a high-risk ethnic population (e.g., African American, Latino,

Native American, Asian American, Pacific 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 (acanthosis

nigricans)● have a history of vascular disease

*May not be correct for all ethnic groups. PCOS, polycystic ovary syndrome.

Table 4—Testing for type 2 diabetes in chil-dren

Criteria:● Overweight (BMI �85th percentile for

age and sex, weight for height �85thpercentile, or weight �120% of ideal forheight)

Plus● Any two of the following risk factors:● Family history of type 2 diabetes in first-

or second-degree relative● Race/ethnicity (Native American, African

American, Latino, Asian American,Pacific Islander)

● Signs of insulin resistance or conditionsassociated with insulin resistance(acanthosis nigricans, hypertension,dyslipidemia, or PCOS)

Age of initiation: age 10 years or at onset ofpuberty, if puberty occurs at a youngerage

Frequency: every 2 yearsTest: FPG preferred

Clinical judgment should be used to test for for di-abetes in high-risk patients who do not meet thesecriteria. PCOS, polycystic ovary syndrome.

Standards of Medical Care

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sidered for people who are �45 years ofage and are overweight if they have an-other risk factor for diabetes (Table 3).Repeat testing should be carried out at3-year intervals. (E)

● Screen for pre-diabetes and diabetes inhigh-risk, asymptomatic, undiagnosedadults and children within the healthcare setting. (E)

● Either an FPG test or 2-h OGTT (75-gglucose load) is appropriate (B)

● The FPG is the preferred test to screenfor pre-diabetes and diabetes. TheOGTT may also be used to screen forpre-diabetes or diabetes in high-riskadults. (E)

III. DETECTION ANDDIAGNOSIS OFGESTATIONAL DIABETESMELLITUS (GDM)Risk assessment for GDM should be un-dertaken at the first prenatal visit. Womenwith clinical characteristics consistentwith a high risk for GDM (those withmarked obesity, personal history of GDM,glycosuria, or a strong family history ofdiabetes) should undergo glucose testingas soon as possible (11). An FPG �126mg/dl or a casual plasma glucose �200mg/dl meets the threshold for the diagno-sis of diabetes and needs to be confirmedon a subsequent day unless unequivocalsymptoms of hyperglycemia are present.High-risk women not found to have GDMat the initial screening and average-riskwomen should be tested between 24 and28 weeks of gestation. Testing should fol-low one of two approaches:

● One-step approach: perform a diagnos-tic 100-g OGTT

● Two-step approach: perform an initialscreening by measuring the plasma orserum glucose concentration 1 h after a50-g oral glucose load (glucose chal-lenge test [GCT]) and perform a diag-nostic 100-g OGTT on that subset ofwomen exceeding the glucose thresh-old value on the GCT. When the two-step approach is used, a glucosethreshold value �140 mg/dl identifies�80% of women with GDM, and theyield is further increased to 90% by us-ing a cutoff of �130 mg/dl.

Diagnostic criteria for the 100-g OGTTare as follows: �95 mg/dl fasting, �180mg/dl at 1 h, �155 mg/dl at 2 h, and�140 mg/dl at 3 h. Two or more of the

plasma glucose values must be met or ex-ceeded for a positive diagnosis. The testshould be done in the morning after anovernight fast of 8–14 h. The diagnosiscan be made using a 75-g glucose load,but that test is not as well validated fordetection of at-risk infants or mothers asthe 100-g OGTT.

Low-risk status requires no glucosetesting, but this category is limited tothose women meeting all of the followingcharacteristics:

● Age �25 years.● Weight normal before pregnancy.● Member of an ethnic group with a low

prevalence of GDM.● No known diabetes in first-degree rela-

tives.● No history of abnormal glucose toler-

ance.● No history of poor obstetric outcome.

Recommendations● Screen for diabetes in pregnancy using

risk factor analysis and, if appropriate,use of an OGTT. (C)

● Women with gestational diabetesshould be screened for diabetes 6weeks postpartum and should be fol-lowed up with subsequent screeningfor the development of diabetes or pre-diabetes. (E)

IV. PREVENTION/DELAYOF TYPE 2 DIABETESStudies have been initiated in the last de-cade to determine the feasibility and ben-efit of various strategies to prevent ordelay the onset of type 2 diabetes. Fivewell-designed randomized controlled tri-als have been reported (12–16). The strat-egies shown to be effective in preventingdiabetes relied on lifestyle modification orglucose-lowering drugs that have beenapproved for treating diabetes.

In the Finnish study (12), middle-aged obese subjects with IGT were ran-domized to receive either brief diet andexercise counseling (control group) or in-tensive individualized instruction onweight reduction, food intake, and guid-ance on increasing physical activity (in-tervention group). After an averagefollow-up of 3.2 years, there was a 58%relative reduction in the incidence of dia-betes in the intervention group comparedwith the control subjects.

In the Diabetes Prevention Program(DPP) (13), enrolled subjects were

slightly younger and more obese but hadnearly identical glucose intolerance com-pared with subjects in the Finnish study.About 45% of the participants were fromminority groups (e.g., African American,Hispanic), and 20% were �60 years ofage. Subjects were randomized to one ofthree intervention groups, which in-cluded the intensive nutrition and exer-cise counseling (“lifestyle”) group oreither of two masked medication treat-ment groups: the biguanide metformingroup or the placebo group. The latterinterventions were combined with stan-dard diet and exercise recommendations.After an average follow-up of 2.8 years, a58% relative reduction in the progressionto diabetes was observed in the lifestylegroup, and a 31% relative reduction in theprogression of diabetes was observed inthe metformin group compared with con-trol subjects. On average, 50% of the life-style group achieved the goal of �7%weight reduction, and 74% maintained atleast 150 min/week of moderately intenseactivity.

In the Da Qing Study (16), men andwomen from health care clinics in the cityof Da Qing, China, were screened withOGTT, and those with IGT were random-ized by clinic to a control group or to oneof three active treatment groups: dietonly, exercise only, or diet plus exercise.Subjects were reexamined biannually,and after an average of 6 years follow-upthe diet, exercise, and diet-plus-exerciseinterventions were associated with 31,46, and 42% reductions in risk of devel-oping type 2 diabetes, respectively.

Two other studies, each using a dif-ferent class of glucose-lowering agent,have shown a reduction in progression todiabetes with pharmacological interven-tion. In the Troglitazone in Prevention ofDiabetes (TRIPOD) study (14), Hispanicwomen with previous GDM were ran-domized to receive either placebo or tro-glitazone (a drug now withdrawn fromcommercial sale in the U.S. but belongingto the thiazolidinedione class). After a me-dian follow-up of 30 months, troglitazonetreatment was associated with a 56% rel-ative reduction in progression to diabetes.In the STOP-NIDDM trial (15), partici-pants with IGT were randomized in adouble-blind fashion to receive either the�-glucosidase inhibitor acarbose or a pla-cebo. After a mean follow-up of 3.3 years,a 25% relative risk reduction in progres-sion to diabetes, based on one OGTT, was

Position Statement

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observed in the acarbose-treated groupcompared with the placebo group. If thisdiagnosis was confirmed by a secondOGTT, a 36% relative risk reduction wasobserved in the acarbose group comparedwith the placebo group.

Our knowledge of the early stages ofhyperglycemia that portend the diagnosisof diabetes, and the recent success of ma-jor intervention trials, clearly show thatindividuals at high risk can be identifiedand diabetes delayed, if not prevented.The cost-effectiveness of interventionstrategies is unclear, but the huge burdenresulting from the complications of diabe-tes and the potential ancillary benefits ofsome of the interventions suggest that aneffort to prevent diabetes is worthwhile.

Lifestyle modificationIn well-controlled studies that included alifestyle intervention arm, substantial ef-forts were necessary to achieve only mod-est changes in weight and exercise, butthose changes were sufficient to achievean important reduction in the incidenceof diabetes. In the Finnish Diabetes Pre-vention Study, weight loss averaged 9.2 lbat 1 year, 7.7 lb after 2 years, and 4.6 lbafter 5 years (12); “moderate exercise,”such as brisk walking, for 30 min/day wassuggested. In the Finnish study, there wasa direct relationship between adherencewith the lifestyle intervention and the re-duced incidence of diabetes.

In the DPP (13), the lifestyle grouplost �12 lb at 2 years and 9 lb at 3 years(mean weight loss for the study durationwas �12 lb or 6% of initial body weight).In both of these studies, most of the par-ticipants were obese (BMI �30 kg/m2).

A low-fat (�25% fat) intake was rec-ommended; if reducing fat did not pro-duce weight loss to goal, calorierestriction was also recommended. Par-ticipants weighing 120–174 lb (54–78kg) at baseline were instructed to follow a1,200-kcal/day diet (33 g fat); partici-pants weighing 175–219 lb (79–99 kg)were instructed to follow a 1,500-kcal/day diet (42 g fat); those 220 –249 lb(100–113 kg) were instructed to followan 1,800-kcal/day diet (50 g fat); andthose �250 lb (114 kg) were instructed tofollow a 2000-kcal/day diet (55 g fat).

Pharmacological interventionsThree diabetes prevention trials usedpharmacological therapy, and all have re-ported a significant lowering of the inci-

dence of diabetes. The biguanidemetformin reduced the risk of diabetes by31% in the DPP (13), the �-glucosidaseinhibitor acarbose reduced the risk by32% in the STOP-NIDDM trial (15), andthe thiazolidinedione troglitazone re-duced the risk by 56% in the TRIPODstudy (14).

In the DPP, metformin was about halfas effective as diet and exercise in delayingthe onset of diabetes overall, but it wasnearly ineffective in older individuals(�60 years of age) or in those who wereless overweight (BMI �30 kg/m2). Con-versely, metformin was as effective as life-style modification in individuals aged24–44 years or in those with a BMI �35kg/m2. Thus, the population of people inwhom treatment with metformin hasequal benefit to that of a lifestyle interven-tion is only a small subset of those who arelikely to have pre-diabetes (IFG or IGT).

There are also data to suggest thatblockade of the rennin-angiotensin sys-tem (17) may lower the risk of developingdiabetes, but more studies are necessarybefore these drugs can be recommendedfor preventing diabetes.

Lifestyle or medication?The DPP is the only study in which a com-parison of the two was made, and lifestylemodification was nearly twice as effectivein preventing diabetes (58 vs. 31% rela-tive reductions, respectively). The greaterbenefit of weight loss and physical activitystrongly suggests that lifestyle modifica-tion should be the first choice to preventor delay diabetes. Modest weight loss (5–10% of body weight) and modest physicalactivity (30 min daily) are the recom-mended goals. Because this interventionnot only has been shown to prevent ordelay diabetes, but also has a variety ofother benefits, health care providersshould urge all overweight or sedentaryindividuals to adopt these changes, andsuch recommendations should be madeat every opportunity.

When all factors are considered, thereis insufficient evidence to support the useof drug therapy as a substitute for, or rou-tinely used in addition to, lifestyle modi-fication to prevent diabetes. Public healthmessages, health care professionals, andhealth care systems should all encouragebehavior changes to achieve a healthy life-style. Further research is necessary to un-derstand better how to facilitate effective

and efficient programs for the primaryprevention of type 2 diabetes.

Recommendations● Individuals at high risk for developing

diabetes need to become aware of thebenefits of modest weight loss and par-ticipating in regular physical activity.(A)

● Patients with IGT should be givencounseling on weight loss as well as in-struction for increasing physical activ-ity. (A)

● Patients with IFG should be givencounseling on weight loss as well as in-struction for increasing physical activ-ity. (E)

● Follow-up counseling appears impor-tant for success. (B)

● Monitoring for the development of di-abetes should be performed every 1–2years. (E)

● Close attention should be given to, andappropriate treatment given for, otherCVD risk factors (e.g., tobacco use, hy-pertension, dyslipidemia). (A)

● Drug therapy should not be routinelyused to prevent diabetes until more in-formation is known about its cost-effectiveness. (E)

V. DIABETES CARE

A. Initial evaluationA complete medical evaluation should beperformed to classify the patient, detectthe presence or absence of diabetes com-plications, assist in formulating a manage-ment plan, and provide a basis forcontinuing care. If the diagnosis of diabe-tes has already been made, the evaluationshould review the previous treatment andthe past and present degrees of glycemiccontrol. Laboratory tests appropriate tothe evaluation of each patient’s generalmedical condition should be performed.A focus on the components of compre-hensive care (Table 5) will assist thehealth care team to ensure optimal man-agement of the patient with diabetes.

B. ManagementPeople with diabetes should receive med-ical care from a physician-coordinatedteam. Such teams may include, but arenot limited to, physicians, nurse practitio-ners, physician’s assistants, nurses, dieti-tians, pharmacists, and mental healthprofessionals with expertise and a specialinterest in diabetes. It is essential in this

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collaborative and integrated team ap-proach that individuals with diabetes as-sume an active role in their care.

The management plan should be for-mulated as an individualized therapeutic

alliance among the patient and family, thephysician, and other members of thehealth care team. Any plan should recog-nize diabetes self-management education(DSME) as an integral component of care.

In developing the plan, considerationshould be given to the patient’s age,school or work schedule and conditions,physical activity, eating patterns, socialsituation and personality, cultural factors,

Table 5—Components of the comprehensive diabetes evaluation

Medical history● Symptoms, results of laboratory tests, and special examination results related to the diagnosis of diabetes● Prior A1C records● Eating patterns, nutritional status, and weight history; growth and development in children and adolescents● Details of previous treatment programs, including nutrition and diabetes self-management education, attitudes, and health beliefs● Current treatment of diabetes, including medications, meal plan, and results of glucose monitoring and patients’ use of data● Exercise history● Frequency, severity, and cause of acute complications such as ketoacidosis and hypoglycemia● Prior or current infections, particularly skin, foot, dental, and genitourinary infections● Symptoms and treatment of chronic eye; kidney; nerve; genitourinary (including sexual), bladder, and gastrointestinal function (including

symptoms of celiac disease in type 1 diabetic patients); heart; peripheral vascular; foot; and cerebrovascular complications associated 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 influence the management of diabetes● Tobacco, alcohol, and/or controlled substance use● Contraception and reproductive and sexual history

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

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

Referrals● Eye exam, if indicated● Family planning for women of reproductive age● MNT, as indicated● Diabetes educator, if not provided by physician or practice staff● Behavioral specialist, as indicated● Foot specialist, as indicated● Other specialties and services as appropriate

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and presence of complications of diabetesor other medical conditions. A variety ofstrategies and techniques should be usedto provide adequate education and devel-opment of problem-solving skills in thevarious aspects of diabetes management.Implementation of the management planrequires that each aspect is understoodand agreed on by the patient and the careproviders and that the goals and treat-ment plan are reasonable.

C. Glycemic control1. Assessment of glycemic control.Techniques are available for health pro-viders and patients to assess the effective-ness of the management plan on glycemiccontrol.

a. Self-monitoring of blood glucose. TheADA’s consensus statements on self-monitoring of blood glucose (SMBG) pro-vide a comprehensive review of thesubject (18,19). Major clinical trials as-sessing the impact of glycemic control ondiabetes complications have includedSMBG as part of multifactorial interven-

tions, suggesting that SMBG is a compo-nent of effective therapy. SMBG allowspatients to evaluate their individual re-sponse to therapy and assess whether gly-cemic targets are being achieved. Resultsof SMBG can be useful in preventing hy-poglycemia and adjusting medications,medical nutrition therapy (MNT), andphysical activity.

The frequency and timing of SMBGshould be dictated by the particular needsand goals of the patients. Daily SMBG isespecially important for patients treatedwith insulin to monitor for and preventasymptomatic hypoglycemia and hyper-glycemia. For most patients with type 1diabetes and pregnant women taking in-sulin, SMBG is recommended three ormore times daily. The optimal frequencyand timing of SMBG for patients with type2 diabetes on oral agent therapy is notknown but should be sufficient to facili-tate reaching glucose goals. Patients withtype 2 diabetes on insulin typically needto perform SMBG more frequently thanthose not using insulin. When adding to

or modifying therapy, type 1 and type 2diabetic patients should test more oftenthan usual. The role of SMBG in stablediet-treated patients with type 2 diabetesis not known.

Because the accuracy of SMBG is in-strument- and user-dependent (20), it isimportant for health care providers toevaluate each patient’s monitoring tech-nique, both initially and at regular inter-vals thereafter. In addition, optimal use ofSMBG requires proper interpretation ofthe data. Patients should be taught how touse the data to adjust food intake, exer-cise, or pharmacological therapy toachieve specific glycemic goals. Healthprofessionals should evaluate at regularintervals the patient’s ability to use SMBGdata to guide treatment.

Recommendations● Clinical trials using insulin that have

demonstrated the value of tight glyce-mic control have used SMBG as an in-tegral part of the management strategy.(A)

● SMBG should be carried out three ormore times daily for patients using mul-tiple insulin injections. (A)

● For patients using less frequent insulininjections or oral agents or MNT alone,SMBG is useful in achieving glycemicgoals. (E)

● To achieve postprandial glucose tar-gets, postprandial SMBG may be appro-priate. (E)

● Instruct the patient in SMBG and rou-tinely evaluate the patient’s techniqueand ability to use data to adjust therapy.(E)

b. A1C. By performing an A1C test,health providers can measure a patient’saverage glycemia over the preceding 2–3months (20) and, thus, assess treatmentefficacy. A1C testing should be performedroutinely in all patients with diabetes, firstto document the degree of glycemic con-trol at initial assessment and then as partof continuing care. Since the A1C test re-flects mean glycemia over the preceding2–3 months, measurement approxi-mately every 3 months is required to de-termine whether a patient’s metaboliccontrol has been reached and maintainedwithin the target range. Thus, regular per-formance of the A1C test permits detec-tion of departures from the target (Table6) in a timely fashion. For any individualpatient, the frequency of A1C testing

Table 6—Summary of recommendations for adults with diabetes

Glycemic controlA1C �7.0%*Preprandial capillary plasma glucose 90–130 mg/dl (5.0–7.2 mmol/l)Peak postprandial capillary plasma glucose† �180 mg/dl (�10.0 mmol/l)Blood pressure �130/80 mmHg

Lipids‡LDL �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:● A1C is the primary target for glycemic control● Goals should be individualized● Certain populations (children, pregnant

women, and elderly) require specialconsiderations

● Less intensive glycemic goals may beindicated in patients with severe or frequenthypoglycemia

● More stringent glycemic goals (i.e. a normalA1C, �6%) may further reducecomplications at the cost of increased risk ofhypoglycemia (particularly in those with type1 diabetes)

● Postprandial glucose may be targeted if A1Cgoals are not met despite reachingpreprandial glucose goals

*Referenced to a nondiabetic range of 4.0–6.0% using a DCCT-based assay. †Postprandial glucose mea-surements should be made 1–2 h after the beginning of the meal, generally peak levels in patients withdiabetes. ‡Current NCEP/ATP III guidelines suggest that in patients with triglycerides �200 mg/dl, the“non-HDL cholesterol” (total cholesterol minus HDL) be used. The goal is �130 mg/dl (31). §For women,it has been suggested that the HDL goal be increased by 10 mg/dl.

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should be dependent on the clinical situ-ation, the treatment regimen used, andthe judgment of the clinician.

Glycemic control is best judged bythe combination of the results of the pa-tient’s SMBG testing (as performed) andthe current A1C result. The A1C shouldbe used not only to assess the patient’scontrol over the preceding 2–3 monthsbut also as a check on the accuracy of themeter (or the patient’s self-reported re-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 Diabetes Control and ComplicationsTrial (DCCT) (21).

Recommendations● Perform the A1C test at least two times

a year in patients who are meeting treat-ment goals (and who have stable glyce-mic control). (E)

● Perform the A1C test quarterly in pa-tients whose therapy has changed orwho are not meeting glycemic goals. (E)

2. Glycemic goals. Glycemic control isfundamental to the management of diabe-tes. Prospective randomized clinical trialssuch as the DCCT (22) and the U.K. Pro-spective Diabetes Study (UKPDS) (23,24)have shown that improved glycemic con-trol is associated with sustained decreasedrates of retinopathy, nephropathy, andneuropathy (25). In these trials, treatmentregimens that reduced average A1C to�7% (�1% above the upper limits ofnormal) were associated with fewer long-term microvascular complications; how-ever, intensive control was found toincrease the risk of severe hypoglycemiaand weight gain (26,27). The potential ofintensive glycemic control to reduce CVD

is supported by epidemiological studies(22–27) and a recent meta-analysis (28),but this potential benefit on CVD eventshas not yet been demonstrated in a ran-domized clinical trial.

Recommended glycemic 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,and other adverse effects. Furthermore,with multifactorial interventions, it is un-clear how different components (e.g., ed-ucational interventions, glycemic targets,lifestyle changes, and pharmacologicalagents) contribute to the reduction ofcomplications. There are no clinical trialdata available for the effects of glycemiccontrol 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 modification of treat-ment regimens, including setting higherglycemic goals.

More stringent goals (i.e., a normalA1C, �6%) can be considered in individ-ual patients based on epidemiologicalanalyses that suggest that there is no lowerlimit of A1C at which further loweringdoes not reduce the risk of complications,at the risk of increased hypoglycemia(particularly in those with type 1 diabe-tes). However, the absolute risks and ben-efits of lower targets are unknown. Therisks and benefits of an A1C goal of �6%are currently being tested in an ongoingstudy (ACCORD [Action to Control Car-diovascular Risk in Diabetes]) in type 2diabetes.

Elevated postchallenge (2-h OGTT)glucose values have been associated withincreased cardiovascular risk indepen-dent of FPG in some epidemiologicalstudies. Postprandial plasma glucose(PPG) levels �140 mg/dl are unusual innondiabetic individuals, although largeevening 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 1–2 h after thestart of the meal and treatment aimed atreducing PPG values �180 mg/dl maylower A1C. However, it should be notedthat the effect of these approaches on mi-cro- or macrovascular complications hasnot been studied (29).

For information on glycemic controlfor women with GDM, refer to the ADAposition statement “Gestational DiabetesMellitus” (11). For information on glyce-mic control during pregnancy in womenwith preexisting diabetes, refer to MedicalManagement of Pregnancy Complicated byDiabetes (3rd ed.) (30).

Recommendations● Lowering A1C has been associated with

a reduction of microvascular and neu-ropathic complications of diabetes. (A)

● Develop or adjust the managementplan to achieve normal or near-normalglycemia with an A1C goal of �7%. (B)

● More stringent goals (i.e., a normalA1C, �6%) can be considered in indi-vidual patients and in pregnancy. (B)

● A lower A1C is associated with a lowerrisk of myocardial infarction and car-diovascular death. (B)

● Aggressive glycemic management withinsulin may reduce morbidity in pa-tients with severe acute illness, peri-operatively, following myocardialinfarction and in pregnancy. (B)

● Less stringent treatment goals may beappropriate for patients with a historyof severe hypoglycemia, patients withlimited life expectancies, very youngchildren or older adults, and individu-als with comorbid conditions. (E)

D. MNTMNT is an integral component of diabetesmanagement and DSME. A review of theevidence and detailed information can befound in the ADA technical review andposition statement in this area (32,33).People with diabetes should receive indi-vidualized MNT as needed to achievetreatment goals, preferably provided by aregistered dietitian familiar with the com-ponents of diabetes MNT. Goals of MNTthat apply to all individuals with diabetesare as follows:

● Attain and maintain recommendedmetabolic outcomes, including glucoseand A1C levels, LDL cholesterol, HDLcholesterol, triglyceride levels, bloodpressure, and body weight (Table 6).

Table 7—Correlation between A1C level andmean plasma glucose levels on multiple test-ing over 2–3 months (21)

A1C (%)

Mean plasma glucose

mg/dl mmol/l

6 135 7.57 170 9.58 205 11.59 240 13.510 275 15.511 310 17.512 345 19.5

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● Prevent and treat the chronic complica-tions and comorbidities of diabetes.Modify nutrient intake and lifestyle asappropriate for the prevention andtreatment of obesity, dyslipidemiaCVD, hypertension, and nephropathy.

● Improve health through healthy foodchoices and physical activity.

● Address individual nutritional needs,taking into consideration personal andcultural preferences and lifestyle, whilerespecting the individual’s wishes andwillingness to change.

Goals of MNT that apply to specific sit-uations include the following:

● For youth with type 1 diabetes (34),provide adequate energy to ensure nor-mal growth and development; integrateinsulin regimens into usual eating andphysical activity habits.

● For youth with type 2 diabetes, who areoften overweight/obese, facilitate ap-propriate changes in eating and physi-cal activity habits.

● For pregnant and lactating women,provide adequate energy and nutrientsneeded for optimal outcomes. In preg-nancy, counting and recording carbo-hydrate intake contributes to optimalglycemic control.

● For older adults, provide for the nutri-tional and psychosocial needs of an ag-ing individual.

● For individuals treated with insulin orinsulin secretagogues, provide self-management education for treatment(and prevention) of hypoglycemia,acute illnesses, and exercise-relatedblood glucose problems.

● For individuals at risk for diabetes, de-crease risk by encouraging physical ac-tivity and promoting foods choices thatfacilitate moderate weight loss or atleast prevent weight gain.

Achieving nutrition-related goals requiresa coordinated team effort that includesthe person with diabetes. Because of thecomplexity of nutrition issues, it is recom-mended that a registered dietitian, knowl-edgeable and skilled in implementingnutrition therapy into diabetes manage-ment and education, is the team memberwho provides MNT. However, it is essen-tial that all team members are knowledge-able about nutrition therapy and aresupportive of the person with diabeteswho needs to make lifestyle changes.

MNT involves a nutrition assessmentto evaluate the patient’s food intake, met-abolic status, lifestyle and readiness tomake changes, goal setting, dietary in-struction, and evaluation. To facilitateadherence, the plan should be individu-alized and take into account cultural, life-style, and financial considerations.Monitoring of glucose and A1C, lipids,blood pressure, and renal status is essen-tial to evaluate nutrition-related out-comes. If goals are not met (Table 6),changes must be made in the overall dia-betes care and management plan.Dietary carbohydrate (35). Regulationof blood glucose to achieve near normallevels is a primary goal in the manage-ment of diabetes, and thus, dietary tech-niques that limit hyperglycemia followinga meal are important in limiting the com-plications of diabetes. Both the amount(grams) of carbohydrate as well as thetype of carbohydrate in a food influenceblood glucose level. The total amount ofcarbohydrate consumed is a strong pre-dictor of glycemic response, and thus,monitoring total grams of carbohydrate,whether by use of exchanges or carbohy-drate counting, remains a key strategy inachieving glycemic control. A recent anal-ysis of the randomized, controlled trialsthat have examined the efficacy of the gly-cemic index (a measure of the effect oftype of carbohydrate) on overall bloodglucose control indicates that the use ofthis technique can provide an additionalbenefit over that observed when total car-bohydrate is considered alone.

Low carbohydrate diets are not rec-ommended in the management of diabe-tes. Although dietary carbohydrate is themajor contributor to postprandial glucoseconcentration, it is an important source ofenergy, water soluble vitamins and min-erals, and fiber. Thus, in agreement withthe National Academy of Sciences-Foodand Nutrition Board, a recommendedrange of carbohydrate intake is 45–65%of total calories. In addition, because thebrain and central nervous system have anabsolute requirement for glucose as an en-ergy source, restricting total carbohydrateto �130 g/day is not recommended.Weight management (36). Overweightand obesity are strongly linked to the de-velopment of type 2 diabetes and cancomplicate its management. Obesity isalso an independent risk factor for hyper-tension and dyslipidemia as well as CVD,which is the major cause of death in those

with diabetes. Moderate weight loss im-proves glycemic control, reduces CVDrisk, and can prevent the development oftype 2 diabetes in those with pre-diabetes.Therefore, weight loss is an importanttherapeutic strategy in all overweight orobese individuals who have type 2 diabe-tes or are at risk for developing diabetes.The primary approach for achievingweight loss, in the vast majority of cases, istherapeutic lifestyle change, which in-cludes a reduction in energy intake and anincrease in physical activity. A moderatedecrease in caloric balance (500–1,000kcal/day) will result in a slow but progres-sive weight loss (1–2 lb/week). For mostpatients, weight loss diets should supplyat least 1,000–1,200 kcal/day for womenand 1,200–1,600 kcal/day for men.

Physical activity is an important com-ponent of a comprehensive weight man-agement program. Regular, moderateintensity, physical activity enhances long-term weight maintenance. Regular activ-ity also improves insulin sensitivity,glycemic control, and selected risk factorsfor CVD (i.e., hypertension and dyslipi-demia), and increased aerobic fitness de-creases the risk of coronary heart disease(CHD). Initial physical activity recom-mendations should be modest, based onthe patient’s willingness and ability, grad-ually increasing the duration and fre-quency to 30 – 45 min of moderateaerobic activity 3–5 days per week, whenpossible. Greater activity levels of at least1 h/day of moderate (walking) or 30 min/day of vigorous (jogging) activity may beneeded to achieve successful long-termweight loss.

Recommendations● People with diabetes should receive in-

dividualized MNT as needed to achievetreatment goals, preferably provided bya registered dietitian familiar with thecomponents of diabetes MNT. (B)

● Both the amount (grams) of carbohy-drate as well as the type of carbohydratein a food influence blood glucose level.Monitoring total grams of carbohy-drate, whether by use of exchanges orcarbohydrate counting, remains a keystrategy in achieving glycemic control.The use of the glycemic index/glycemicload can provide an additional benefitover that observed when total carbohy-drate is considered alone. (B)

● Low carbohydrate diets (restricting to-tal carbohydrate to �130 g/day) are not

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recommended in the management ofdiabetes. (E)

● Weight loss is recommended for alloverweight (BMI 25.0–29.9 kg/m2) orobese (BMI �30.0 kg/m2) adults, whohave, or who are at risk for developing,type 2 diabetes. (E)

● The primary approach for achievingweight loss is therapeutic lifestylechange, which includes a reduction inenergy intake and/or an increase inphysical activity. A moderate decreasein caloric balance (500 –1,000 kcal/day) will result in a slow but progres-sive weight loss (1–2 lb/week). Formost patients, weight loss diets shouldsupply at least 1,000–1,200 kcal/dayfor women and 1,200–1,600 kcal/dayfor men. (E)

● Initial physical activity recommenda-tions should be modest, based on thepatient’s willingness and ability, gradu-ally increasing the duration and fre-quency to 30 – 45 min of moderateaerobic activity 3–5 days per week,when possible. Greater activity levels ofat least 1 h/day of moderate (walking)or 30 min/day of vigorous (jogging) ac-tivity may be needed to achieve suc-cessful long-term weight loss. (E)

E. Physical activityADA technical reviews on exercise in pa-tients with diabetes have summarized thevalue of exercise in the diabetes manage-ment plan (37,38). Regular exercise hasbeen shown to improve blood glucosecontrol, reduce cardiovascular risk fac-tors, contribute to weight loss, and im-prove well-being. Furthermore, regularexercise may prevent type 2 diabetes inhigh-risk individuals (12,13,16) .

Before beginning a physical activityprogram, the patient with diabetes shouldhave a detailed medical evaluation withappropriate diagnostic studies. This ex-amination should screen for the presenceof macro- and microvascular complica-tions that may be worsened by the phys-ical activity program (see next sectionregarding CHD screening). Identificationof areas of concern will allow the design ofan individualized physical activity planthat can minimize risk to the patient.

All levels of physical activity, includ-ing leisure activities, recreational sports,and competitive 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-sulin therapy and MNT) to allow safeparticipation is an important manage-ment strategy.

Recommendations● A regular physical activity program,

adapted to the presence of complica-tions, is recommended for all patientswith diabetes who are capable of partic-ipating. (B)

F. Psychosocial assessment and carePsychological and social state can impactthe patient’s ability to carry out diabetescare tasks (39–44). As a result, health sta-tus may be compromised. Family conflictaround diabetes care tasks is also com-mon and may interfere with treatmentoutcomes (45). There are opportunitiesfor the clinician to assess psychosocial sta-tus in a timely and efficient manner sothat referral for appropriate services canbe accomplished (46).

Key opportunities for screening ofpsychosocial status occur at diagnosis,during regularly scheduled managementvisits, during hospitalizations, at discov-ery of complications, or at the discretionof the clinician when problems in glucosecontrol, quality of life, or adherence areidentified (47). Patients are likely to ex-hibit psychological vulnerability at diag-nosis and when their medical statuschanges: the end of the honeymoon pe-riod, when the need for intensified treat-ment is evident and when complicationsare discovered (42,44).

Psychosocial screening should in-clude but is not limited to: attitudes aboutthe illness, expectations for medical man-agement and outcomes, affect/mood, gen-eral and diabetes related quality of life,resources (financial, social, and emo-tional), (43) and psychiatric history(44,47,48). Particular attention needs tobe paid to gross noncompliance withmedical regimen (due to self or others)(39,48), depression with the possibility ofself-harm (40,41), indications of an eat-ing disorder (49) or a problem that ap-pears to be organic in origin, andcognitive functioning that significantlyimpairs judgment (41). In these cases, im-mediate referral for further evaluation bya mental health specialist familiar with di-abetes management should occur. Behav-ioral assessment of management skills isalso recommended.

It is preferable to incorporate psycho-

logical treatment into routine care ratherthan waiting for identification of a specificproblem or deterioration in psychologicalstatus (46). Screening tools can facilitatethis goal, and although the clinician maynot feel qualified to treat psychologicalproblems, utilizing the patient-providerrelationship as a foundation for furthertreatment can increase the likelihood thatthe patient will accept referral for otherservices. It is important to establish thatemotional wellbeing is part of diabetesmanagement (47).

Recommendations● Preliminary assessment of psychologi-

cal and social status should be includedas part of the medical management ofdiabetes. (E)

● Psychosocial screening should includebut is not limited to: attitudes about theillness, expectations for medical man-agement and outcomes, affect/mood,general and diabetes related quality oflife, resources (financial, social, andemotional) and psychiatric history. (E)

● Screening for psychosocial problemssuch as depression, eating disorders,and cognitive impairment is neededwhen adherence to the medical regi-men is poor. (E)

● It is preferable to incorporate psycho-logical treatment into routine carerather than to wait for identification of aspecific problem or deterioration inpsychological status. (E)

G. Referral for diabetes managementFor a variety of reasons, some people withdiabetes and their health care providersdo not achieve the desired goals of treat-ment (Table 6). Intensification of thetreatment regimen is suggested and in-cludes identification (or assessment) ofbarriers to adherence, culturally appro-priate and enhanced DSME, comanage-ment with a diabetes team, change inpharmacological therapy, initiation of orincrease in SMBG, more frequent contactwith the patient, and referral to an endo-crinologist.

H. Intercurrent illnessThe stress of illness, trauma, and/or sur-gery frequently aggravates glycemic con-trol and may precipitate diabeticketoacidosis (DKA) or nonketotic hyper-osmolar state. Any condition leading todeterioration in glycemic control necessi-tates more frequent monitoring of blood

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glucose and urine or blood ketones. Avomiting illness accompanied by ketosismay indicate DKA, a life-threatening con-dition that requires immediate medicalcare to prevent complications and death;the possibility of DKA should always beconsidered (50). Marked hyperglycemiarequires temporary adjustment of thetreatment program and, if accompaniedby ketosis, frequent interaction with thediabetes care team. The patient treatedwith oral glucose-lowering agents orMNT alone may temporarily require insu-lin. Adequate fluid and caloric intakemust be assured. Infection or dehydrationis more likely to necessitate hospitaliza-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, and recent studies suggest thatachieving very stringent glycemic controlmay reduce mortality in the immediatepostmyocardial infarction period (51).Aggressive glycemic management withinsulin may reduce morbidity in patientswith severe acute illness (52).

For information on management ofpatients in the hospital with DKA or non-ketotic hyperosmolar state, refer to theADA position statement titled “Hypergly-cemic Crises in Diabetes” (50).

I. ImmunizationInfluenza and pneumonia are common,preventable infectious diseases associatedwith high mortality and morbidity in theelderly and in people with chronic dis-eases. There are limited studies reportingthe morbidity and mortality of influenzaand pneumococcal pneumonia, specifi-cally in people with diabetes. Observa-tional studies of patients with a variety ofchronic illnesses, including diabetes,show that these conditions are associatedwith an increase in hospitalizations for in-fluenza and its complications. Based on acase-control series, influenza vaccine hasbeen shown to reduce diabetes-relatedhospital admission by as much as 79%during flu epidemics (53). People with di-abetes may be at increased risk of the bac-teremic form of pneumococcal infectionand have been reported to have a high riskof nosocomial bacteremia, which has amortality rate as high as 50%.

Safe and effective vaccines are avail-able that can greatly reduce the risk ofserious complications from these diseases(54,55). There is sufficient evidence to

support that people with diabetes haveappropriate serologic and clinical re-sponses to these vaccinations. The Cen-ters for Disease Control’s AdvisoryCommittee on Immunization Practicesrecommends influenza and pneumococ-cal vaccines for all individuals �65 yearsof age as well as for all individuals of anyage with diabetes.

For a complete discussion on the pre-vention of influenza and pneumococcaldisease in people with diabetes, consultthe technical review and position state-ment on this subject (56,57).

Recommendations● Annually provide an influenza vaccine

to all diabetic patients 6 months of ageor older. (C)

● Provide at least one lifetime pneumo-coccal vaccine for adults with diabetes.A one-time revaccination is recom-mended for individuals �64 years ofage previously immunized when theywere �65 years of age if the vaccine wasadministered �5 years ago. Other indi-cations for repeat vaccination includenephrotic syndrome, chronic renal dis-ease, and other immunocompromisedstates, such as after transplantation. (C)

VI. PREVENTION ANDMANAGEMENT OFDIABETES COMPLICATIONS

A. CVDCVD is the major cause of mortality forindividuals with diabetes. It is also a ma-jor contributor to morbidity and directand indirect costs of diabetes. Type 2 di-abetes is an independent risk factor formacrovascular disease, and its commoncoexisting conditions (e.g., hypertensionand dyslipidemia) are also risk factors.

Studies have shown the efficacy of re-ducing cardiovascular risk factors in pre-venting or slowing CVD. Evidence issummarized in the following sections andreviewed in detail in the ADA technicalreviews on hypertension (58), dyslipide-mia (59), aspirin therapy (60), and smok-ing cessation (61) and the consensusstatement on CHD in people with diabe-tes (62). Emphasis should be placed onreducing cardiovascular risk factors,when possible, and clinicians should bealert for signs and symptoms of athero-sclerosis.

1. Hypertension/blood pressure con-trol. Hypertension (HTN) (blood pres-sure �140/90 mmHg) is a commoncomorbidity of diabetes, affecting the ma-jority of people with diabetes, dependingon type of diabetes, age, obesity, and eth-nicity. HTN is also a major risk factor forCVD and microvascular complicationssuch as retinopathy and nephropathy. Intype 1 diabetes, HTN is often the result ofunderlying nephropathy. In type 2 diabe-tes, HTN may be present as part of themetabolic syndrome (i.e., obesity, hyper-glycemia, and dyslipidemia) that is ac-companied by high rates of CVD.

Randomized clinical trials have dem-onstrated the benefit (reduction of CHDevents, stroke, and nephropathy) of low-ering blood pressure to �130 mmHg sys-tolic and �80 mmHg diastolic inindividuals with diabetes (63–66). Epi-demiologic analyses show that bloodpressure �115/75 mmHg is associatedwith increased cardiovascular event ratesand mortality in individuals with diabetes(63,67,68). Therefore, a target bloodpressure goal of �130/80 mmHg is rea-sonable if it can be safely achieved.

Although there are no well-controlledstudies of diet and exercise in the treat-ment of HTN in individuals with diabetes,reducing sodium intake and body weight(when indicated); increasing consump-tion of fruits, vegetables, and low-fat dairyproducts; avoiding excessive alcohol con-sumption; and increasing activity levelshave been shown to be effective in reduc-ing blood pressure in nondiabetic indi-viduals (69). These nonpharmacologicalstrategies may also positively affect glyce-mia and lipid control. Their effects on car-diovascular events have not been wellmeasured.

Lowering of blood pressure with reg-imens based on antihypertensive drugs,including ACE inhibitors, angiotensin re-ceptor blockers (ARBs), �-blockers, di-uretics, and calcium channel 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 (70,71). Additionally, in peo-ple with diabetic nephropathy indicatethat ARBs may be superior to DCCBs forreducing cardiovascular events (72).Conversely, in the recently completed In-ternational Verapamil Study (INVEST) of�22,000 people with coronary artery dis-

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ease (CAD) and hypertension, the non-DCCB, verapamil, demonstrated a similarreduction in cardiovascular mortality to a�-blocker. Moreover, this relationshipheld true in the diabetic subgroup (73).

ACE inhibitors have been shown toimprove cardiovascular outcomes inhigh-cardiovascular-risk patients with orwithout HTN (74,75). In patients withcongestive heart failure (CHF), ACE in-hibitors are associated with better out-comes when compared with ARBs. In onestudy an ARB was superior to a �-blockeras a therapy to improve cardiovascularoutcomes in a subset of diabetic patientswith HTN and left ventricular hypertro-phy (76). The compelling effect of ACEinhibitors or ARBs in patients with albu-minuria or renal insufficiency provide ad-ditional rationale for use of these agents(see section VI B. below).

The ALLHAT (Antihypertensive andLipid-Lowering Treatment to PreventHeart Attack Trial), a large randomizedtrial of different initial blood pressurepharmacological therapies, found nolarge differences between initial therapywith a chlorthalidone, amlodipine, andlisinopril. Diuretics appeared slightlymore effective than other agents, particu-larly for reducing heart failure (77). The�-blocker arm of the ALLHAT was termi-nated after interim analysis showed thatdoxazosin was substantially less effectivein reducing CHF than diuretic therapy(78).

Before beginning treatment, patientswith elevated blood pressures shouldhave their blood pressure reexaminedwithin 1 month to confirm the presence ofHTN. Systolic blood pressure �160mmHg or diastolic blood pressure �100mmHg, however, mandates that immedi-ate pharmacological therapy be initiated.Patients with HTN should be seen as oftenas needed until the recommended bloodpressure goal is obtained and then seen asnecessary (63). In these patients, othercardiovascular risk factors, includingobesity, hyperlipidemia, smoking, pres-ence of microalbuminuria (assessed be-fore initiation of treatment), and glycemiccontrol, should be carefully assessed andtreated. Many patients will require threeor more drugs to reach target goals.

During pregnancy in diabetic womenwith chronic HTN, target blood pressuregoals of systolic blood pressure 110–129mmHg and diastolic blood pressure65–79 mmHg are reasonable as they may

contribute to long-term maternal health.Lower blood pressure levels may be asso-ciated with impaired fetal growth. Duringpregnancy treatment with ACE inhibitorsand ARBs is contraindicated, since theyare likely to cause fetal damage. Antihy-pertensive drugs known to be effectiveand safe in pregnancy include methyl-dopa, labetalol, diltiazem, clonidine, andprazosin. Chronic diuretic use duringpregnancy has been associated with re-stricted maternal plasma volume, whichmight reduce uteroplacental perfusion.

RecommendationsScreening and diagnosis● Blood pressure should be measured at

every routine diabetes visit. Patientsfound to have systolic blood pressure�130 mmHg or diastolic blood pres-sure �80 mmHg should have bloodpressure confirmed on a separate day.(C)

Goals● Patients with diabetes should be treated

to a systolic blood pressure �130mmHg. (C)

● Patients with diabetes should be treatedto a diastolic blood pressure �80mmHg. (B)

Treatment● Patients with hypertension (systolic

blood pressure �140 mmHg or dia-stolic blood pressure �90 mmHg)should receive drug therapy in additionto lifestyle and behavioral therapy. (A)

● Multiple drug therapy (two or moreagents at proper doses) is generally re-quired to achieve blood pressure tar-gets. (B)

● Patients with a systolic blood pressureof 130–139 mmHg or a diastolic bloodpressure of 80–89 mmHg should begiven lifestyle and behavioral 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 drug therapy should be with adrug class demonstrated to reduce CVDevents in patients with diabetes (ACEinhibitors, ARBs, �-blockers, diuretics,and calcium channel blockers). (A)

● All patients with diabetes and hyper-tension should be treated with a regi-men that includes either an ACEinhibitor or an ARB. If one class is not

tolerated, the other should be substi-tuted. If needed to achieve blood pres-sure targets, a thiazide diuretic shouldbe added. (E)

● If ACE inhibitors, ARBs, or diuretics areused, monitor renal function and se-rum potassium levels. (E)

● While there are no adequate head-to-head comparisons of ACE inhibitorsand ARBs, there is clinical trial supportfor each of the following statements:● In patients with type 1 diabetes, with

hypertension and any degree of albu-minuria, ACE inhibitors have beenshown to delay the progression of ne-phropathy. (A)

● In patients with type 2 diabetes, hy-pertension, and microalbuminuria,ACE inhibitors and ARBs have beenshown to delay the progression tomacroalbuminuria. (A)

● In those with type 2 diabetes, hyper-tension, macroalbuminuria, and re-nal insufficiency, ARBs have beenshown to delay the progression of ne-phropathy. (A)

● In pregnant patients with diabetes andchronic hypertension, blood pressuretarget goals of 110–129/65–79 mmHgare suggested in the interest of long-term maternal health and minimizingimpaired fetal growth. ACE inhibitorsand ARBs are contraindicated duringpregnancy. (E)

● In elderly hypertensive patients, bloodpressure should be lowered graduallyto avoid complications. (E)

● Patients not achieving target bloodpressure despite multiple drug therapyshould be referred to a physician expe-rienced in the care of patients with hy-pertension. (E)

● Orthostatic measurement of bloodpressure should be performed in peo-ple with diabetes and hypertensionwhen clinically indicated. (E)

2. Dyslipidemia/lipid management.Patients with type 2 diabetes have an in-creased prevalence of lipid abnormalitiesthat contributes to higher rates of CVD.Lipid management aimed at loweringLDL cholesterol, raising HDL cholesterol,and lowering triglycerides has beenshown to reduce macrovascular diseaseand mortality in patients with type 2 dia-betes, particularly those who have hadprior cardiovascular events. In studies us-ing HMG (hydroxymethylglutaryl) CoAreductase inhibitors (statins), patients

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with diabetes achieved significant reduc-tions in coronary and cerebrovascularevents (79–82). In two studies using thefibric acid derivative gemfibrozil, reduc-tions in cardiovascular end points werealso achieved (83,84).

Target lipid levels are shown in Table6. Lifestyle intervention including MNT,increased physical activity, weight loss,and smoking cessation should allow somepatients to reach these lipid levels. Nutri-tion intervention should be tailored ac-cording to each patient’s age, type ofdiabetes, pharmacological treatment,lipid levels, and other medical conditionsand should focus on the reduction of sat-urated fat, cholesterol, and transunsat-urated fat intake. Glycemic control canalso beneficially modify plasma lipid lev-els. Particularly in patients with very hightriglycerides and poor glycemic control,glucose lowering maybe necessary to con-trol hypertriglyceridemia. Pharmacologi-cal treatment is indicated if there is aninadequate response to lifestyle modifica-tions and improved glucose control.However, in patients with clinical CVDand LDL �100 mg/dl, pharmacologicaltherapy should be initiated at the sametime that lifestyle intervention is started.In patients with diabetes aged �40 yearssimilar consideration for LDL loweringtherapy should be given if they have in-creased cardiovascular risk (e.g., addi-tional cardiovascular risk factors or longduration of diabetes). Very little clinicaltrial data exists in patients in this age-group.

The first priority of pharmacologicaltherapy is to lower LDL cholesterol to atarget goal of �100 mg/dl (2.60 mmol/l)or therapy to achieve a reduction in LDLof 30–40%. For LDL lowering, statins arethe drugs of choice. Other drugs thatlower LDL include nicotinic acid,ezetimbe, bile acid sequestrants, and fe-nofibrate (31,85).

The Heart Protection Study (82) dem-onstrated that in people with diabetesover the age of 40 years with a total cho-lesterol �135 mg/dl, LDL reduction of�30% from baseline with the statin sim-vastatin was associated with an �25% re-duction in the first event rate for majorcoronary artery events independent ofbaseline LDL, preexisting vascular dis-ease, type or duration of diabetes, or ade-quacy of glycemic control. Similarly in theCollaborative Atorvastatin Diabetes Study(CARDS) study (86), patients with type 2

diabetes randomized to atorvastatin 10mg daily had a significant reduction incardiovascular events including stroke.

Recent clinical trials in high-risk pa-tients, such as those with acute coronarysyndromes or previous cardiovascularevents (87–89), have demonstrated thatmore aggressive therapy with high dosesof statins to achieve an LDL of �70 mg/dlled to a significant reduction in furtherevents. The risk of side effects with highdoses of statins is significantly out-weighed by the benefits of such therapy inthese high-risk patients. Therefore a re-duction in LDL to a goal of �70 mg/dl isan option in very-high-risk patients withovert CVD (85).

Relatively little data are available onlipid lowering therapy in subjects withtype 1 diabetes. In the Heart ProtectionStudy �600 patients with type 1 diabeteshad a proportionately similar, but not sta-tistically significant, reduction in risk asin the patients with type 2 diabetes. Al-though the data are not definitive, consid-eration should be given to similar lipid-lowering therapy in patients with type 1diabetes as in type 2 diabetes, particularlyif they have other cardiovascular riskfactors or features of the metabolicsyndrome.

If the HDL is �40 mg/dl and the LDLis between 100 and 129 mg/dl, a fibricacid derivative or niacin might be used.Niacin is the most effective drug for rais-ing HDL but can significantly increaseblood glucose at high doses. More recentstudies demonstrate that at modest doses(750–2,000 mg/day), significant benefitwith regards to LDL, HDL, and triglycer-ide levels are accompanied by only mod-est changes in glucose that are generallyamenable to adjustment of diabetes ther-apy (90,91).

Combination therapy, with a statinand a fibrate or statin and niacin, may beefficacious for patients needing treatmentfor all three lipid fractions, but this com-bination is associated with an increasedrisk for abnormal transaminase levels,myositis, or rhabdomyolysis. The risk ofrhabdomyolysis seems to be lower whenstatins are combined with fenofibratethan gemfibrozil. There is also a risk of arise in plasma creatinine, particularlywith fenofibrate. It is important to notethat clinical trials with fibrates and niacinhave demonstrated benefits in patientswho were not on treatment with statinsand that there is no data available on re-

duction of events with such combina-tions. The risks may be greater in patientswho are treated with combinations ofthese drugs with high doses of statins.

RecommendationsScreening● In adult patients, test for lipid disorders

at least annually and more often ifneeded to achieve goals. In adults withlow-risk lipid values (LDL �100 mg/dl,HDL �50 mg/dl, and triglycerides�150 mg/dl), lipid assessments may berepeated every 2 years. (E)

Treatment recommendations and goals● Lifestyle modification focusing on the

reduction of saturated fat and choles-terol intake, weight loss (if indicated),and increased physical activity has beenshown to improve the lipid profile inpatients with diabetes. (A)

● In individuals with diabetes over theage of 40 years with a total cholesterol�135 mg/dl, without overt CVD, statintherapy to achieve an LDL reduction of30 �40% regardless of baseline LDLlevels is recommended. The primary goalis an LDL �100 mg/dl (2.6 mmol/l). (A)

● For individuals with diabetes aged �40years without overt CVD, but at in-creased risk (due to other cardiovascu-lar risk factors or long duration ofdiabetes), who do not achieve lipidgoals with lifestyle modifications alone,the addition of pharmacological ther-apy is appropriate and the primary goalis an LDL cholesterol �100 mg/dl (2.6mmol/l). (C)

● People with diabetes and overt CVD areat very high risk for further events andshould be treated with a statin. (A)

● A lower LDL cholesterol goal of �70mg/dl (1.8 mmol/l), using a high doseof a statin, is an option in these high riskpatients with diabetes and overt CVD.(B)

● Lower triglycerides to �150 mg/dl (1.7mmol/l) and raise HDL cholesterol to�40 mg/dl (1.15 mmol/l). In women,an HDL goal 10 mg/dl higher (�50 mg/dl) should be considered. (C)

● Lowering triglycerides and increasingHDL cholesterol with a fibrate is asso-ciated with a reduction in cardiovascu-lar events in patients with clinical CVD,low HDL, and near-normal levels ofLDL. (A)

● Combination therapy employing st-atins and fibrates or niacin may be nec-

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essary to achieve lipid targets but hasnot been evaluated in outcomes studiesfor either CVD event reduction orsafety. (E)

● Statin therapy is contraindicated inpregnancy. (E)

3. Anti-platelet agents. The use of aspi-rin in diabetes is reviewed in detail in theADA technical review (60) and positionstatement (92) on aspirin therapy. Aspirinhas been recommended as a primary(93,94) and secondary therapy to preventcardiovascular events in diabetic andnondiabetic individuals. One large meta-analysis and several clinical trials demon-strate the efficacy of using aspirin as apreventive measure for cardiovascularevents, including stroke and myocardialinfarction. Many trials have shown an�30% decrease in myocardial infarctionand a 20% decrease in stroke in a widerange of patients, including young andmiddle-aged patients, patients with andwithout a history of CVD, males and fe-males, and patients with hypertension.

Dosages used in most clinical trialsranged from 75 to 325 mg/day. There isno evidence to support any specific dose,but using the lowest possible dosage mayhelp reduce side effects. There is no evi-dence for a specific age at which to startaspirin, but at ages �30 years, aspirin hasnot been studied.

Clopidogrel has been demonstratedto reduce CVD rates in diabetic individu-als (95). Adjunctive therapy in very high-risk patients or as alternative therapy inaspirin-intolerant patients should beconsidered.

Recommendations● Use aspirin therapy (75–162 mg/day)

as a secondary prevention strategy inthose with diabetes with a history ofmyocardial infarction, vascular bypassprocedure, stroke or transient ischemicattack, peripheral vascular disease,claudication, and/or angina. (A)

● Use aspirin therapy (75–162 mg/day)as a primary prevention strategy inthose with type 2 diabetes at increasedcardiovascular risk, including thosewho are �40 years of age or who haveadditional risk factors (family history ofCVD, hypertension, smoking, dyslipi-demia, or albuminuria). (A)

● Use aspirin therapy (75–162 mg/day)as a primary prevention strategy inthose with type 1 diabetes at increased

cardiovascular risk, including thosewho are �40 years of age or who haveadditional risk factors (family history ofCVD, hypertension, smoking, dyslipi-demia, or albuminuria). (C)

● People with aspirin allergy, bleedingtendency, receiving anticoagulant ther-apy, recent gastrointestinal bleeding,and clinically active hepatic disease arenot candidates for aspirin therapy.Other anti-platelet agents may be a rea-sonable alternative for patients withhigh risk. (E)

● Aspirin therapy should not be recom-mended for patients under the age of 21years because of the increased risk ofReye’s syndrome associated with aspi-rin use in this population. People underthe age of 30 years have not been stud-ied. (E)

4. Smoking cessation. Issues of smok-ing in diabetes are reviewed in detail inthe ADA technical review (61) and posi-tion statement (96) on smoking cessation.A large body of evidence from epidemio-logical, case-control, and cohort studiesprovides convincing documentation ofthe causal link between cigarette smokingand health risks. Cigarette smoking con-tributes to one of every five deaths in theU.S. and is the most important modifiablecause of premature death. Much of theprior work documenting the impact ofsmoking on health did not separately dis-cuss results on subsets of individuals withdiabetes, suggesting that the identifiedrisks are at least equivalent to those foundin the general population. Other studiesof individuals with diabetes consistentlyfound a heightened risk of morbidity andpremature death associated with the de-velopment of macrovascular complica-tions among smokers. Smoking is alsorelated to the premature development ofmicrovascular complications of diabetesand may have a role in the development oftype 2 diabetes.

A number of large randomized clini-cal trials have demonstrated the efficacyand cost-effectiveness of counseling inchanging smoking behavior. Such stud-ies, combined with others specific to in-dividuals with diabetes, suggest thatsmoking cessation counseling is effectivein reducing tobacco use (97,98).

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-ficulty in quitting and relapse.

Recommendations● Advise all patients not to smoke. (A)● Include smoking cessation counseling

and other forms of treatment as a rou-tine component of diabetes care. (B)

5. CHD screening and treatment. CHDscreening and treatment are reviewed indetail in the ADA consensus statement onCHD in people with diabetes (62). Toidentify the presence of CHD in diabeticpatients without clear or suggestive symp-toms of CAD, a risk factor-based ap-proach to the initial diagnostic evaluationand subsequent follow-up is recom-mended. A recent study concluded thatusing current guidelines fails to detect asignificant percentage of patients with si-lent ischemia (99).

At least annually, cardiovascular riskfactors should be assessed. These risk fac-tors include dyslipidemia, hypertension,smoking, a positive family history of pre-mature coronary disease, and the pres-ence of micro- or macroalbuminuria.Abnormal risk factors should be treated asdescribed elsewhere in these guidelines.Patients at increased CHD risk shouldreceive aspirin and may warrant an ACEinhibitor.

Candidates for a diagnostic cardiacstress 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 or carotid occlusive disease; 2)sedentary lifestyle, age �35 years, andplans to begin a vigorous exercise pro-gram; and 3) two or more of the risk fac-tors noted above.

Current evidence suggests that non-invasive tests can improve assessment offuture CHD risk. There is, however, nocurrent evidence that such testing inasymptomatic patients with risk factorsimproves outcomes or leads to better uti-lization of treatments (100).

Patients with abnormal exercise ECGand patients unable to perform an exer-cise ECG require additional or alternativetesting. Currently, stress nuclear perfu-sion and stress echocardiography arevaluable next-level diagnostic proce-dures. A consultation with a cardiolo-

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gist is recommended regarding furtherwork-up.

Recommendations● In patients �55 years of age, with or

without hypertension but with anothercardiovascular risk factor (history ofCVD, dyslipidemia, microalbuminuria,or smoking), an ACE inhibitor (if notcontraindicated) should be consideredto reduce the risk of cardiovascularevents. (A)

● In patients with a prior myocardial in-farction or in patients undergoing ma-jor surgery, �-blockers, in addition,should be considered to reduce mortal-ity. (A)

● Refer patients with signs and symptomsof CVD or with positive noninvasivetest for CAD to a cardiologist for furtherevaluation. (E)

● In asymptomatic patients consider arisk factor evaluation to stratify patientsby 10-year risk and treat risk factorsaccordingly. (B)

● In asymptomatic patients considerscreening for CAD based on the criteriaoutlined above. Such screening mightinclude stress ECG and/or stress echo-cardiography and/or perfusion imag-ing. (E)

● In patients with treated CHF, met-formin use is contraindicated. The thia-zolidinediones are associated with fluidretention, and their use can be compli-cated by the development of CHF. Cau-tion in prescribing thiazolidinedionesin the setting of known CHF or otherheart diseases as well as in patients withpreexisting edema or concurrent insu-lin therapy is required. (C)

B. Nephropathy screening andtreatmentDiabetic nephropathy occurs in 20–40%of patients with diabetes and is the singleleading cause of end-stage renal disease(ESRD). Persistent albuminuria in therange of 30–299 mg/24 h (microalbu-minuria) has been shown to be the earlieststage of diabetic nephropathy in type 1diabetes and a marker for development ofnephropathy in type 2 diabetes. Mi-croalbuminuria is also a well-establishedmarker of increased CVD risk (101,102).

Patients with microalbuminuria whoprogress to macroalbuminuria (�300mg/24 h) are likely to progress to ESRDover a period of years (103,104). 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-croalbuminuria and the progression ofmicro- to macroalbuminuria in patientswith type 1 (105,106) and type 2 diabetes(23,24). The UKPDS provided strong ev-idence that control of blood pressure canreduce the development of nephropathy(64). In addition, large prospective ran-domized studies in patients with type 1diabetes have demonstrated that achieve-ment of lower levels of systolic bloodpressure (�140 mmHg) achieved withtreatment using ACE inhibitors provides aselective benefit over other antihyperten-sive drug classes in delaying the progres-sion from micro- to macroalbuminuriaand can slow the decline in glomerularfiltration rate (GFR) in patients with mac-roalbuminuria (64,107–109) .

In addition, ACE inhibitors have beenshown to reduce severe CVD (i.e., myo-cardial infarction, stroke, and death), thusfurther supporting the use of these agentsin patients with microalbuminuria (74).ARBs have also been shown to reduce therate of progression from micro- to mac-roalbuminuria as well as ESRD in patientswith type 2 diabetes (110–112). Some ev-idence suggests that ARBs have a smallermagnitude of rise in potassium comparedwith ACE inhibitors in people with ne-phropathy (73). With regard to slowingthe progression of nephropathy, the useof DCCBs as initial therapy is not moreeffective than placebo. Their use in ne-phropathy should be restricted to addi-tional therapy to further lower bloodpressure in patients already treated withACE inhibitors or ARBs (72). In the set-ting of albuminuria or nephropathy, inpatients unable to tolerate ACE inhibitorsand/or ARBs, consider the use of non-DCCBs, �-blockers, or diuretics for themanagement of blood pressure (73,113).

A meta-analysis of several small stud-ies has shown that protein restriction maybe of benefit in some patients whose ne-phropathy seems to be progressing de-spite optimal glucose and blood pressurecontrol (114).

Screening for microalbuminuria canbe performed by three methods: 1) mea-surement of the albumin-to-creatinine ra-tio in a random, spot collection (preferred

method); 2) 24-h collection with creati-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-creatinine ratio is stronglyrecommended by most authorities(115,116). The other two alternatives(24-h collection and a timed specimen)are rarely necessary. Measurement of aspot urine for albumin only, whether byimmunoassay or by using a dipstick testspecific for microalbumin, without simul-taneously measuring urine creatinine isless expensive than the recommendedmethods but is susceptible to false-negative and false-positive determina-tions as a result of variation in urineconcentration due to hydration and otherfactors.

At least two of three tests measuredwithin a 6-month period should show el-evated levels before a patient is designatedas having microalbuminuria. Abnormali-ties of albumin excretion are defined inTable 8.

Screening for microalbuminuria is in-dicated in pregnancies complicated by di-abetes, since microalbuminuria in theabsence of urinary tract infection is astrong predictor of superimposed pre-eclampsia. In the presence of macroalbu-minuria or urine dipstick proteinuria,estimation of GFR by serum creatinine or24-h urine creatinine clearance is indi-cated to stage the patient’s renal disease,and other tests may be necessary to diag-nose preeclampsia.

Physicians may use the Levey modifica-tion of the Cockcroft and Gault equation tocalculate estimated GFR (eGFR) from se-rum creatinine and to stage the patient’s re-

Table 8—Definitions of abnormalities in al-bumin excretion

CategorySpot collection (�g/

mg creatinine)

Normal �30Microalbuminuria 30–299Macro (clinical)-

albuminuria300

Because of variability in urinary albumin excretion,two of three specimens collected within a 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,CHF, marked hyperglycemia, and marked hyper-tension may elevate urinary albumin excretion overbaseline values.

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nal disease (117). The eGFR can easily becalculated by accessing http://www.kidney.org/kls/professionals/gfr_calculator.cfm.

The role of 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. Some experts suggest that re-ducing urine microalbuminuria to thenormal or near-normal range, if possible,may improve renal and cardiovascularprognosis. This approach has not beenformally evaluated in prospective trials.

Consider referral to a physician expe-rienced in the care of diabetic renal dis-ease either when the GFR has fallen to�60 ml � min�1 � 1.73 m�2 or if difficul-ties occur in the management of hyper-tension or hyperkalemia. It is suggestedthat consultation with a nephrologist beobtained when the GFR is �30 ml �min�1 � 1.73 m�2. Early referral of suchpatients has been found to reduce costand improve quality of care and keep peo-ple off dialysis longer (118). For a com-plete discussion on the treatment ofnephropathy, see the ADA position state-ment “Diabetic Nephropathy” (119)

RecommendationsGeneral recommendations● To 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-gression of nephropathy, optimizeblood pressure control. (A)

Screening● Perform an annual test for the presence

of microalbuminuria in type 1 diabeticpatients with diabetes duration of �5years and in all type 2 diabetic patients,starting at diagnosis and during preg-nancy. (E)

Treatment● In the treatment of both micro- and

macroalbuminuria, either ACE inhibi-tors or ARBs should be used except dur-ing pregnancy. (A)

● While there are no adequate head-to-head comparisons of ACE inhibitorsand ARBs, there is clinical trial supportfor each of the following statements:● In patients with type 1 diabetes, with

hypertension and any degree of albu-

minuria, ACE inhibitors have beenshown to delay the progression of ne-phropathy. (A)

● In patients with type 2 diabetes, hy-pertension, and microalbuminuria,ACE inhibitors and ARBs have beenshown to delay the progression tomacroalbuminuria. (A)

● In patients with type 2 diabetes, hy-pertension, macroalbuminuria, andrenal insufficiency (serum creatinine�1.5 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, initiateprotein restriction to �0.8 g � kg�1

body wt�1 � day�1 (�10% of daily cal-ories), the current adult-recommendeddietary allowance for protein. Furtherrestriction may be useful in slowing thedecline of GFR in selected patients. (B)

● With regards to slowing the progres-sion of nephropathy, the use of DCCBsas initial therapy is not more effectivethan placebo. Their use in nephropathyshould be restricted to additional ther-apy to further lower blood pressure inpatients already treated with ACE in-hibitors or ARBs. (B)

● In the setting of albuminuria or 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. Use of non-DCCBs may reduce albuminuria indiabetic patients, including duringpregnancy. (E)

● If ACE inhibitors, ARBs, or diuretics areused, monitor serum potassium levels forthe development of hyperkalemia. (B)

● Consider referral to a physician experi-enced in the care of diabetic renal dis-ease when the eGFR has fallen to �60ml � min�1 � 1.73 m�2 or if difficultiesoccur in the management of hyperten-sion or hyperkalemia. (B)

C. Retinopathy screening andtreatmentDiabetic retinopathy is a highly specificvascular complication of both type 1 andtype 2 diabetes. The prevalence of reti-nopathy is strongly related to the durationof diabetes. Diabetic retinopathy is esti-mated to be the most frequent cause ofnew cases of blindness among adults aged20–74 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 (22–24).In addition to glycemic control, severalother factors seem to increase the risk ofretinopathy. The presence of nephropa-thy is associated with retinopathy. 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 blood pressure, as demon-strated by the UKPDS, has been shown todecrease the progression of retinopathy.Several case series and a controlled pro-spective study suggest that pregnancyin type 1 diabetic patients may aggra-vate retinopathy (119a). During pregnancyand 1-year postpartum, retinopathy may betransiently aggravated; laser photocoagula-tion surgery can minimize this risk (120).

Patients with type 1 diabetes shouldhave an initial dilated and comprehensiveeye examination by an ophthalmologist oroptometrist within 5 years after the onsetof diabetes. Patients with type 2 diabetesshould have an initial dilated and com-prehensive eye examination by an oph-thalmologist or optometrist shortly afterthe diagnosis of diabetes. Subsequent ex-aminations for type 1 and type 2 diabeticpatients should be repeated annually byan ophthalmologist or optometrist who isknowledgeable and experienced in diag-nosing the presence of diabetic retinopa-thy and is aware of its management. Lessfrequent exams (every 2–3 years) may beconsidered with the advice of an eye careprofessional in the setting of a normal eyeexam (121–123). Examinations will berequired more frequently if retinopathy isprogressing.

One of the main motivations forscreening for diabetic retinopathy is theestablished efficacy of laser photocoagu-lation surgery in preventing visual loss.Two large National Institutes of Health–sponsored trials, the Diabetic Retinopa-thy Study (DRS) and the Early TreatmentDiabetic Retinopathy Study (ETDRS),provide the strongest support for thetherapeutic benefit of photocoagulationsurgery

The DRS tested whether scatter (pan-retinal) photocoagulation surgery couldreduce the risk of vision loss from PDR.Severe visual loss (i.e., best acuity of5/200 or worse) was seen in 15.9% of un-

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treated versus 6.4% of treated eyes. Thebenefit was greatest among patientswhose baseline evaluation revealed high-risk characteristics (HRCs) (chiefly discneovascularization or vitreous hemor-rhage with any retinal neovasculariza-tion). Of control eyes with HRCs, 26%progressed to severe visual loss versus11% of treated eyes. Given the risk of amodest loss of visual acuity and of con-traction of visual field from panretinal la-ser surgery, such therapy has beenprimarily recommended for eyes ap-proaching or reaching HRCs.

The ETDRS established the benefit offocal laser photocoagulation surgery ineyes with macular edema, particularlythose with clinically significant macularedema. In patients with clinically signifi-cant macular edema after 2 years, 20% ofuntreated eyes had a doubling of the vi-sual angle (e.g., 20/50 to 20/100) com-pared with 8% of treated eyes. Otherresults from the ETDRS indicate that, pro-vided careful follow-up can be main-tained, scatter photocoagulation surgeryis not recommended for eyes with mild ormoderate non-PDR (NPDR). When reti-nopathy is more severe, scatter photoco-agulation surgery should be considered,and usually should not be delayed, if theeye has reached the high-risk proliferativestage. In older-onset patients with severeNPDR or less than high-risk PDR, the riskof severe visual loss and vitrectomy is re-duced �50% by laser photocoagulationsurgery at these earlier stages.

Laser photocoagulation surgery inboth the DRS and the ETDRS was benefi-cial in reducing the risk of further visualloss but generally not beneficial in revers-ing already diminished acuity. This pre-ventive effect and the fact that patientswith PDR or macular edema may beasymptomatic provide strong support fora screening program to detect diabeticretinopathy.

For a detailed review of the evidenceand further discussion, see the ADA tech-nical review and position statement onthis subject (119a,124,125).

RecommendationsGeneral recommendations● Optimal glycemic control can substan-

tially reduce the risk and progression ofdiabetic retinopathy. (A)

● Optimal blood pressure control can re-duce the risk and progression of dia-betic retinopathy. (A)

● Aspirin therapy does not prevent reti-nopathy or increase the risks of hemor-rhage. (A)

Screening● Adults with type 1 diabetes should have

an initial dilated and comprehensiveeye examination by an ophthalmologistor optometrist within 5 years after theonset of diabetes. (B)

● Patients with type 2 diabetes shouldhave an initial dilated and comprehen-sive eye examination by an ophthalmol-ogist or optometrist shortly after thediagnosis of diabetes. (B)

● Subsequent examinations for type 1and 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 2–3 years) may be consid-ered with the advice of an eye care pro-fessional in the setting of a normal eyeexam. Examinations will be requiredmore frequently if retinopathy is pro-gressing. (B)

● When planning pregnancy, womenwith preexisting diabetes should have acomprehensive eye examination andshould be counseled on the risk of de-velopment and/or progression of dia-betic retinopathy. Women withdiabetes who become pregnant shouldhave a comprehensive eye examinationin the first trimester and close fol-low-up throughout pregnancy and for1-year postpartum. This guideline doesnot apply to women who develop GDMbecause such individuals are not at in-creased risk for diabetic retinopathy.(B)

Treatment● Laser therapy can reduce the risk of vi-

sion loss in patients with HRCs. (A)● Promptly refer patients with any level of

macular edema, severe NPDR, or anyPDR to an ophthalmologist who isknowledgeable and experienced in themanagement and treatment of diabeticretinopathy. (A)

D. Foot careAmputation and foot ulceration are themost common consequences of diabeticneuropathy 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.

The risk of ulcers or amputationsis increased in people who have had di-abetes �10 years, are male, have poorglucose control, or have cardiovascular,retinal, or renal complications. The fol-lowing foot-related risk conditionsare associated with an increased risk ofamputation:

● Peripheral neuropathy with loss of pro-tective sensation.

● Altered biomechanics (in the presenceof neuropathy).

● Evidence of increased pressure (ery-thema, hemorrhage under a callus).

● Bony deformity.● Peripheral vascular disease (decreased

or absent pedal pulses).● A history of ulcers or amputation.● Severe nail pathology.

All individuals with diabetes should re-ceive an annual foot examination to iden-tify high-risk foot conditions. Thisexamination should include assessmentof protective sensation, foot structure andbiomechanics, vascular status, and skinintegrity. People with one or more high-risk foot conditions should be evaluatedmore frequently for the development ofadditional risk factors. People with neu-ropathy should have a visual inspection oftheir feet at every visit with a health careprofessional. Evaluation of neurologicalstatus in the low-risk foot should includea quantitative somatosensory thresholdtest, using the Semmes-Weinstein 5.07(10 g) monofilament. The skin should beassessed for integrity, especially betweenthe toes and under the metatarsal heads.The presence of 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.

People with neuropathy or evidenceof increased plantar pressure may be ad-equately managed with well-fitted walk-ing shoes or athletic shoes. Patientsshould be educated on the implications ofsensory loss and the ways to substituteother sensory modalities (hand palpation,visual inspection) for surveillance of earlyproblems. People with evidence of in-creased plantar pressure (e.g., erythema,warmth, callus, or measured pressure)should use footwear that cushions and re-

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distributes the pressure. Callus can be de-brided with a scalpel by a foot carespecialist or other health professionalwith experience and training in foot care.People with bony deformities (e.g., ham-mertoes, prominent metatarsal heads,and bunions) may need extra-wide shoesor depth shoes. People with extreme bonydeformities (e.g., Charcot foot) that can-not be accommodated with commercialtherapeutic footwear may need custom-molded shoes.

Initial screening for peripheral arte-rial disease (PAD) should include a his-tory for claudication and an assessment ofthe pedal pulses. Consider obtaining anankle-brachial index (ABI), as many pa-tients with PAD are asymptomatic. Referpatients with significant or a positive ABIfor further vascular assessment and con-sider exercise, medications, and surgicaloptions (126).

Patients with diabetes and high-riskfoot conditions should be educated re-garding their risk factors and appropriatemanagement. Patients at risk should un-derstand the implications of the loss ofprotective sensation, the importance offoot monitoring on a daily basis, theproper care of the foot, including nail andskin care, and the selection of appropriatefootwear. The patient’s understanding ofthese issues and their physical ability toconduct proper foot surveillance and careshould be assessed. Patients with visualdifficulties, physical constraints prevent-ing movement, or cognitive problems thatimpair their ability to assess the conditionof the foot and to institute appropriateresponses will need other people, such asfamily members, to assist in their care.Patients at low risk may benefit from ed-ucation on foot care and footwear.

For a detailed review of the evidenceand further discussion, see the ADA tech-nical review and position statement in thisarea (127,128).

Problems involving the feet, espe-cially ulcers and wound care, may requirecare by a podiatrist, orthopedic surgeon,or rehabilitation specialist experienced inthe management of individuals with dia-betes. For a complete discussion onwound care, see the ADA consensus state-ment on diabetic foot wound care (129).

Recommendations● A multidisciplinary approach is recom-

mended for persons with foot ulcersand high-risk feet, especially those with

a history of prior ulcer or amputation.(A)

● The foot examination can be accom-plished in a primary care setting andshould include the use of a Semmes-Weinstein monofilament, tuning fork,palpation, and a visual examination. (B)

● Educate all patients, especially thosewith risk factors, including smoking, orprior lower-extremity complications,about the risk and prevention of 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 screening for PAD should in-clude a history for claudication and anassessment of the pedal pulses. Con-sider obtaining an ABI, as many pa-tients with PAD are asymptomatic. (C)

● Refer patients with significant claudica-tion or a positive ABI for further vascu-lar assessment and consider exercise,medications, and surgical options. (C)

● Perform a comprehensive foot exami-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)

VII. DIABETES CARE INSPECIFIC POPULATIONS

A. Children and adolescents1. Type 1 diabetes. Although approxi-mately three-quarters of all cases of type 1diabetes are diagnosed in individualsyounger than 18 years of age, historically,ADA recommendations for managementof type 1 diabetes have pertained mostdirectly to adults with type 1 diabetes. Be-cause children are not simply “smalladults,” it is appropriate to consider theunique aspects of care and managementof children and adolescents with type 1diabetes. Children with diabetes differfrom adults in many respects, includinginsulin sensitivity related to sexual matu-rity, physical growth, ability to provideself-care, and unique neurologic vulnera-bility to hypoglycemia. Attention to suchissues as family dynamics, developmentalstages, and physiologic differences relatedto sexual maturity all are essential in de-veloping and implementing an optimaldiabetes regimen. Although current rec-ommendations for children and adoles-cents are less likely to be based on

evidence derived from rigorous researchbecause of current and historical re-straints placed on conducting research inchildren, expert opinion and a review ofavailable and relevant experimental dataare summarized in a recent ADA State-ment “Care of Children and Adolescentswith Type 1 Diabetes” (34). The followingrepresents a summary of recommenda-tions and guidelines pertaining specifi-cally to the care and management ofchildren and adolescents that are in-cluded in that document.

Ideally, the care of a child or adoles-cent with type 1 diabetes should be pro-vided by a multidisciplinary team ofspecialists trained in the care of childrenwith pediatric diabetes, although this maynot always be possible. At the very least,education of the child and family shouldbe provided by health care providerstrained and experienced in childhood di-abetes and sensitive to the challengesposed by diabetes in this age-group. Atthe time of initial diagnosis, it is essentialthat diabetes education be provided in atimely fashion, with the expectation thatthe balance between adult supervisionand self-care should be defined by andwill evolve according to physical, psycho-logic, and emotional maturity. MNTshould be provided at diagnosis, and atleast annually thereafter, by an individualexperienced with the nutritional needs ofthe growing child and the behavioral is-sues that have an impact on adolescentdiets.

a. Glycemic control. While currentstandards for diabetes management re-flect the need to maintain glucose controlas near to normal as safely possible, spe-cial consideration must be given to theunique risks of hypoglycemia in youngchildren. Glycemic goals need to be mod-ified to take into account the fact thatmost children younger than 6 or 7 years ofage have a form of “hypoglycemic un-awareness,” in that counterregulatorymechanisms are immature, and youngchildren lack the cognitive capacity torecognize and respond to hypoglycemicsymptoms, placing them at greater riskfor hypoglycemia and its sequelae. In ad-dition, extensive evidence indicates thatnear-normalization of blood glucose lev-els is seldom attainable in children andadolescents after the honeymoon (remis-sion) period. The A1C level achieved inthe “intensive” adolescent cohort of theDCCT group was �1% higher than that

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achieved for older patients and currentADA recommendations for patients ingeneral (130).

In selecting glycemic goals, the bene-fits of achieving a lower A1C must beweighed against the unique risks of hypo-glycemia and the disadvantages of target-ing a higher, although more achievablegoal that may not promote optimal long-term health outcomes. Age-specific glyce-mic and A1C goals are presented inTable 9.

b. Screening and management of chroniccomplications in children and adolescentswith type 1 diabetesi. Nephropathy

Recommendations● Annual screening for microalbumin-

uria should be initiated once the child is10 years of age and has had diabetes for5 years. Screening may be done with arandom spot urine sample analyzed formicroalbumin-to-creatinine ratio. (E)

● Confirmed, persistently elevated mi-croalbumin levels should be treatedwith an ACE inhibitor, titrated to nor-malization of microalbumin excretion(if possible). (E)

ii. HypertensionHypertension in childhood is defined asan average systolic or diastolic blood pres-sure �95th percentile for age, sex, andheight percentile measured on at least 3separate days. “High-normal” blood pres-sure is defined as an average systolic ordiastolic blood pressure �90th but

�95th percentile for age, sex, and heightpercentile measured on at least 3 separatedays. Normal blood pressure levels forage, sex, and height and appropriatemethods for determinations are availableonline at: www.nhlbi.nih.gov/health/prof/heart/hbp/hbp_ped.pdf.

Recommendations● Treatment of high-normal blood pres-

sure (systolic or diastolic blood pres-sure consistently above the 90thpercentile for age, sex, and height)should include dietary interventionand exercise, aimed at weight controland increased physical activity, if ap-propriate. If target blood pressure is notreached within 3–6 months of lifestyleintervention, pharmacologic treatmentshould be initiated. (E)

● Pharmacologic treatment of hyperten-sion (systolic or diastolic blood pres-sure consistently above the 95thpercentile for age, sex, and height, orconsistently �130/80, if 95% exceedsthat value) should be initiated as soonas the diagnosis is confirmed. (E)

● ACE inhibitors should be consideredfor the initial treatment of hyperten-sion. (E)

iii. Dyslipidemia

RecommendationsScreening● Prepubertal children: a fasting lipid

profile should be performed on all chil-dren �2 years of age at the time of di-

agnosis (after glucose control has beenestablished) if there is a family historyof hypercholesterolemia (total choles-terol �240 mg/dl) or a history of a car-diovascular event before age 55 years,or if family history is unknown. If fam-ily history is not of concern, then thefirst lipid screening should be per-formed at puberty (�12 years). If val-ues fall are within the accepted risklevels (LDL �100 mg/dl; 2.6 mmol/l), alipid profile should be repeated every 5years. (E)

● Pubertal children (�12 years old): afasting lipid profile should be per-formed at the time of diagnosis (afterglucose control has been established).If values fall within the accepted risklevels (LDL �100 mg/dl; 2.6 mmol/l),the measurement should be repeatedevery 5 years. (E)

● If lipids are abnormal, annual monitor-ing is recommended in both age-groups. (E)

Treatment● Treatment should be based on fasting

lipid levels (mainly LDL) obtained afterglucose control is established. (E)

● Initial therapy should consist of optimi-zation of glucose control and MNTaimed at a decrease in the amount ofsaturated fat in the diet. (E)

● The addition of pharmacologic lipid-lowering agents is recommended forLDL �160 mg/dl (4.1 mmol/l) and isalso recommended in patients whohave LDL cholesterol values 130–159

Table 9—Plasma blood glucose and A1C goals for type 1 diabetes by age group

Plasma blood glucose goal range(mg/dl)

Values by age (years) Before meals Bedtime/overnight A1C (%) Rationale

Toddlers and preschoolers(�6)

100–180 110–200 �8.5 (but � 7.5%) ● High risk and vulnerability tohypoglycemia

School age (6–12) 90–180 100–180 �8% ● Risks of hypoglycemia and relatively lowrisk of complications prior to puberty

Adolescents and young adults(13–19)

90–130 90–150 �7.5%* ● Risk of hypoglycemia● Developmental and psychological issues

Key concepts in setting glycemic goals:● Goals should be individualized and lower goals may be reasonable based on benefit:

risk assessment● Blood glucose goals should be higher than those listed above in children with frequent

hypoglycemia or hypoglycemia unawareness● Postprandial blood glucose values should be measured when there is a disparity between

preprandial blood glucose values and A1C levels

*A lower goal (�7.0%) is reasonable if it can be achieved without excessive hypoglycemia

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mg/dl (3.4–4.1 mmol/l) based on thepatient’s CVD risk profile, after failureof MNT and lifestyle changes. (E)

● The goal of therapy is an LDL value�100 mg/dl (2.6 mmol/l). (E)

iv. RetinopathyAlthough retinopathy most commonlyoccurs after the onset of puberty and after5–10 years of diabetes duration, it hasbeen reported in prepubertal childrenand with diabetes duration of only 1–2years. Referrals should be made to eyecare professionals with expertise in dia-betic retinopathy, an understanding ofthe risk for retinopathy in the pediatricpopulation, as well as experience in coun-seling the pediatric patient and family onthe importance of early prevention/intervention.

Recommendations● The first ophthalmologic examination

should be obtained once the child is 10years of age or older and has had diabe-tes for 3–5 years. (E)

● After the initial examination, annualroutine follow-up is generally recom-mended. Less frequent examinationsmay be acceptable on the advice of aneye care professional. (E)

c. Other issues. A major issue deserv-ing emphasis in this age-group is that of“adherence.” No matter how sound themedical regimen, it can only be as good asthe ability of the family and/or individualto implement it. Family involvement indiabetes remains an important compo-nent of optimal diabetes managementthroughout childhood and into adoles-cence. Health care providers who care forchildren and adolescents, therefore, mustbe capable of evaluating the behavioral,emotional, and psychosocial factors thatinterfere with implementation and thenmust work with the individual and familyto resolve problems that occur and/or tomodify goals as appropriate.

Since a sizable portion of a child’s dayis spent in school, close communicationwith school or day care personnel is es-sential for optimal diabetes management.Information should be supplied to schoolpersonnel, so that they may be madeaware of the diagnosis of diabetes in thestudent and of the signs, symptoms, andtreatment of hypoglycemia. In most casesit is imperative that blood glucose testingbe performed at the school or day care

setting before lunch and when signs orsymptoms of abnormal blood glucose lev-els are present. Many children may re-quire support for insulin administrationby either injection or continuous subcu-taneous insulin injection (CSII) beforelunch (and often also before breakfast) atschool or in day care. For further discus-sion, see the ADA position statement “TheCare of Children With Diabetes in theSchool and Day Care Setting” (131) andthe National Diabetes Education Program(NDEP) publication “Helping the Studentwith Diabetes Succeed: A Guide for SchoolPersonnel” (National Diabetes EducationProgram, 2003, www.ndep.nih.gov).2. Type 2 diabetes. Finally, the inci-dence of type 2 diabetes in children andadolescents has been shown to be increas-ing, especially in ethnic minority popula-tions (132,133). Distinction between type1 and type 2 diabetes in children can bedifficult, since autoantigens and ketosismay be present in a substantial number ofpatients with otherwise straightforwardtype 2 diabetes (including obesity and ac-anthosis nigricans). Such a distinction atthe time of diagnosis is critical since treat-ment regimens, educational approaches,and dietary counsel will differ markedlybetween the two diagnoses. The ADAconsensus statement “Type 2 Diabetes inChildren and Adolescents” (8) providesguidance to the prevention, screening,and treatment of type 2 diabetes, as wellas its comorbidities in young people.

B. Preconception careMajor congenital malformations remainthe 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 continuously with increasingmaternal glycemia during the first 6–8weeks of gestation, as defined by first-trimester A1C concentrations. There is nothreshold for A1C values above which therisk begins or below which it disappears.However, malformation rates above the1–2% background rate seen in nondia-betic pregnancies appear to be limited topregnancies in which first trimester A1Cconcentrations are �1% above the nor-mal range.

Preconception care of 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-

ticipated in preconception diabetes careprograms and women who initiated in-tensive diabetes management after theywere already pregnant. The preconcep-tion care programs were multidisci-plinary and designed to train patients indiabetes self-management with diet, in-tensified insulin therapy, and SMBG.Goals were set to achieve normal bloodglucose concentrations, and �80% ofsubjects achieved normal A1C concentra-tions before they became pregnant (134–138). In all five studies, the incidence ofmajor congenital malformations inwomen who participated in preconcep-tion care (range 1.0–1.7% of infants) wasmuch lower than the incidence in womenwho did not participate (range 1.4 –10.9% of infants). One limitation of thesestudies is that participation in preconcep-tion care was self-selected by patientsrather than randomized. Thus, it is im-possible to be certain that the lower mal-formation rates resulted fully fromimproved diabetes care. Nonetheless, theoverwhelming evidence supports theconcept that malformations can be re-duced or prevented by careful manage-ment of diabetes before pregnancy.

Planned pregnancies greatly facilitatepreconception diabetes care. Unfortu-nately, nearly two-thirds of pregnanciesin women with diabetes are unplanned,leading to a persistent excess of malfor-mations in infants of diabetic mothers. Tominimize the occurrence of these devas-tating malformations, standard care for allwomen with diabetes who have child-bearing potential should include 1) edu-cation about the risk of malformationsassociated with unplanned pregnanciesand poor metabolic control and 2) use ofeffective contraception at all times, unlessthe patient is in good metabolic controland actively trying to conceive.

Women contemplating pregnancyneed to be seen frequently by a multidis-ciplinary team experienced in the man-agement of diabetes before and duringpregnancy. Teams may vary but shouldinclude a diabetologist, an internist or afamily physician, an obstetrician, a diabe-tes educator, a dietitian, a social worker,and other specialists as necessary. Thegoals of preconception care are to 1) inte-grate the patient into the management ofher diabetes, 2) achieve the lowest A1Ctest results possible without excessive hy-poglycemia, 3) assure effective contracep-tion until stable and acceptable glycemia

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is achieved, and 4) identify, evaluate, andtreat long-term diabetic complicationssuch as retinopathy, nephropathy, neu-ropathy, hypertension, and CAD.

For further discussion, see the ADAtechnical review and position statementon this subject (139,140).

Recommendations● A1C levels should be normal or as close

to normal as possible (�1% above theupper limits of normal) in an individualpatient before conception is attempted.(B)

● All women with diabetes and child-bearing potential should be educatedabout 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 evaluatedand, if indicated, treated for diabeticretinopathy, nephropathy, neuropathy,and CVD. (E)

● Among the drugs commonly used inthe treatment of patients with diabetes,statins are pregnancy category X andshould be discontinued before concep-tion if possible. ACE inhibitors andARBs are category C in the first trimes-ter (maternal benefit may outweigh fe-tal risk in certain situations) butcategory D in later pregnancy andshould generally be discontinued be-fore pregnancy. Among the oral antidi-abetic agents, metformin and acarboseare classified as category B and all oth-ers as category C; potential risks andbenefits of oral antidiabetic agents inthe preconception period must be care-fully weighed, recognizing that suffi-cient data are not available to establishthe safety of these agents in pregnancy.They should generally be discontinuedin pregnancy. (E)

C. Older individualsDiabetes 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 individualswith diabetes can be expected to growrapidly over the coming decades. A recentpublication, “Guidelines for Improvingthe Care of the Older Person with Diabe-tes,” (141) contains evidence-basedguidelines produced in conjunction withthe American Geriatric Society. This doc-ument contains an excellent discussion ofthis area, and specific guidelines and lan-

guage from it have been incorporated be-low. Unfortunately, there are no long-term studies in individuals �65 years ofage demonstrating the benefits of tightglycemic control, blood pressure, andlipid control. Older individuals with dia-betes have higher rates of prematuredeath, functional disability, and coexist-ing illnesses such as hypertension CHD,and stroke than those without diabetes.Older adults with diabetes are also atgreater risk than other older adults forseveral common geriatric syndromes,such as polypharmacy, depression, cogni-tive impairment, urinary incontinence,injurious falls, and persistent pain.

The care of older adults with diabetesis complicated by their clinical and func-tional heterogeneity. Some older individ-uals developed diabetes in middle age andface years of comorbidity; others who arenewly diagnosed may have had years ofundiagnosed comorbidity or few compli-cations from the disease. Some olderadults with diabetes are frail and haveother underlying chronic conditions,substantial diabetes-related comorbidity,or limited physical or cognitive function-ing, but other older adults with diabeteshave little comorbidity and are active. Lifeexpectancies are also highly variable forthis population. Clinicians caring forolder adults with diabetes must take thisheterogeneity into consideration whensetting and prioritizing treatment goals.

All this having been said, patientswho can be expected to live long enoughto reap the benefits of long-term intensivediabetes management (�10 years) andwho are active, cognitively intact, andwilling to undertake the responsibility ofself-management should be encouragedto do so and be treated using the statedgoals for younger adults with diabetes.

There is good evidence from middle-aged and older adults suggesting thatmultidisciplinary interventions that pro-vide education on medication use, moni-toring, and recognizing hypo- andhyperglycemia can significantly improveglycemic control. Although control of hy-perglycemia is important, in older indi-viduals with diabetes, greater reductionsin morbidity and mortality may resultfrom control of all cardiovascular risk fac-tors rather than from tight glycemic con-trol alone. There is strong evidence fromclinical trials of the value of treating hy-pertension in the elderly. There is less ev-idence for lipid-lowering and aspirin

therapy, although as diabetic patientshave such an elevated risk for CVD, ag-gressive management of lipids and aspirinuse when not contraindicated are reason-able interventions.

As noted above, for patients with ad-vanced diabetes complications, life-limiting comorbid illness, or cognitive orfunctional impairment, it is reasonable toset less intensive glycemic target goals.These patients are less likely to benefitfrom reducing the risk of microvascularcomplications and more likely to sufferserious adverse effects from hypogly-cemia. Patients with poorly controlleddiabetes may be subject to acute compli-cations of diabetes, including hyperglyce-mic hyperosmolar coma. Older patientscan be treated with the same drug regi-mens as younger patients, but special careis required in prescribing and monitoringdrug therapy. Metformin is often contra-indicated because of renal insufficiency orheart failure. Sulfonylureas and other in-sulin secretagogues can cause hypoglyce-mia. Insulin can also cause hypoglycemiaas well as require good visual and motorskills and cognitive ability of the patientor a caregiver. Thiazolidinediones shouldnot be used in patients with CHF (NewYork Heart Association [NYHA] Class IIIand IV). Drugs should be started at thelowest 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-efits must always be weighed against po-tential risks.

VIII. DIABETES CARE INSPECIFIC SETTINGS

A. Diabetes care in the hospitalThe management of diabetes in the hos-pital is extensively reviewed in the ADATechnical Review, “Management of dia-betes and hyperglycemia in hospitals” byClement et al. (142). This review formsthe basis for these guidelines. In addition,the American Association of Clinical En-docrinologists held a conference on thistopic (143), and the recommendationsfrom this meeting (144) were also care-fully reviewed and discussed in the for-mulation of the guidelines, which follow.The management of diabetes in the hos-pital is generally considered secondary inimportance compared with the conditionthat prompted admission.

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Patients with hyperglycemia fall intothree categories:● Medical history of diabetes: diabetes

has been previously diagnosed and ac-knowledged by the patient’s treatingphysician.

● Unrecognized diabetes: hyperglycemia(fasting blood glucose 126 mg/dl orrandom blood glucose 200 mg/dl) oc-curring during hospitalization and con-firmed as diabetes after hospitalizationby standard diagnostic criteria, but un-recognized as diabetes by the treatingphysician during hospitalization.

● Hospital-related hyperglycemia: hyper-glycemia (fasting blood glucose 126mg/dl or random blood glucose 200mg/dl) occurring during the hospital-ization that reverts to normal after hos-pital discharge.

The prevalence of diabetes in hospitalizedadult patients is not precisely known. Inthe year 2000, 12.4% of hospital dis-charges in the U.S. listed diabetes as a di-agnosis. The prevalence of diabetes inhospitalized adults is conservatively esti-mated at 12–25%, depending on the thor-oughness used in identifying patients.Patients presenting to hospitals may haveunrecognized diabetes or hospital-relatedhyperglycemia. Using the A1C test maybe a valuable case-finding tool for identi-fying diabetes in hospitalized patients.

A rapidly growing body of literaturesupports targeted glucose control in thehospital setting with potential for im-proved mortality, morbidity, and healthcare economic outcomes. Hyperglycemiain the hospital may result from stress, de-compensation of type 1 diabetes, type 2diabetes, or other forms of diabetesand/or may be iatrogenic due to admin-istration or withholding of pharmaco-logic agents, including glucocorticoids,vasopressors, etc. Distinction betweendecompensated diabetes and stress hy-perglycemia is often not made.1. Blood glucose targets

a. General medicine and surgery. Ob-servational studies suggest an associationbetween hyperglycemia and increasedmortality. General medical and surgicalpatients with a blood glucose value(s)�220 mg/dl (12.2 mmol/l) have higherinfection rates (145).

When admissions on general medi-cine and surgery units were studied, pa-tients with new hyperglycemia hadsignificantly increased in-hospital mortal-

ity than patients with known diabetes. Inaddition, length of stay was higher for thenew hyperglycemia group, and both thepatients with new hyperglycemia andthose with known diabetes were morelikely to require intensive care unit (ICU)care and transitional or nursing homecare. Better outcomes were demonstratedin patients with fasting and admissionblood glucose �126 mg/dl (7 mmol/l)and all random blood glucose levels�200 mg/dl (11.1 mmol/l) (146).

b. CVD and critical care. The relation-ship of blood glucose levels and mortalityin the setting of acute myocardial infarc-tion (AMI) has been reported. A meta-analysis 15 previously published studiescomparing in-hospital mortality and CHFin both hyper- and normoglycemic pa-tients with and without diabetes. In sub-jects without known diabetes whoseadmission blood glucose was 109.8 mg/dl(6.1 mmol/l), the relative risk for in-hospital mortality was increased signifi-cantly. When diabetes was present andadmission glucose was 180 mg/dl (10mmol/l), risk of death was moderately in-creased compared with patients who haddiabetes but no hyperglycemia on admis-sion (147). In another study (148), ad-mission blood glucose values wereanalyzed in consecutive patients withAMI. Analysis revealed an independentassociation of admission blood glucoseand mortality. The 1-year mortality ratewas significantly lower in subjects withadmission plasma glucose �100.8 mg/dl(5.6 mmol/l) than in those with plasmaglucose 199.8 mg/dl (11 mmol/l). Finally,in the first Diabetes and Insulin-GlucoseInfusion in Acute Myocardial Infarction(DIGAMI) study, (51,149) insulin-glucose infusion followed by subcutane-ous insulin treatment in diabetic patientswith AMI was examined. Intensive subcu-taneous insulin therapy for 3 or moremonths improved long-term survival(51). Mean blood glucose in the intensiveinsulin intervention arm was 172.8 mg/dl(9.6 mmol/l) (vs. 210.6 mg/dl [11.7mmol/l] in the “conventional” group).The broad range of blood glucose levelswithin each arm limits the ability to definespecific blood glucose target thresholds.

c. Cardiac surgery. Attainment of tar-geted glucose control in the setting of car-diac surgery is associated with reducedmortality and risk of deep sternal woundinfections in cardiac surgery patients withdiabetes (150,151) and supports the con-

cept that perioperative hyperglycemia isan independent predictor of infection inpatients with diabetes (152), with thelowest mortality in patients with bloodglucose �150 mg/dl (8.3 mmol/l)(150,153).

d. Critical care. A mixed group of pa-tients with and without diabetes admittedto a surgical ICU were randomized to re-ceive intensive insulin therapy (targetblood glucose 80–110 mg/dl [4.4–6.1])The mean blood glucose of 103 mg/dl(5.7 mmol/l) had reduced mortality dur-ing the ICU stay and decreased overall inhospital mortality (52). Subsequent anal-ysis demonstrated that for each 20 mg/dl(1.1 mmol/l), glucose was elevated �100mg/dl (5.5 mmol/l), and the risk of ICUdeath increased. Hospital and ICU sur-vival were linearly associated with ICUglucose levels, with the highest survivalrates occurring in patients achieving anaverage blood glucose �110 mg/dl(6.1 mmol/l).

e. Acute neurological disorders. Hyper-glycemia is associated with worsened out-comes in patients with acute stroke andhead injury, as evidenced by the largenumber of observational studies in the lit-erature (154–156) A meta-analysis iden-tified an admission blood glucose �110mg/dl (6.1 mmol/l) for increased mortal-ity for acute stroke (157).2. Treatment options

a. Oral diabetes agents. No large stud-ies have investigated the potential roles ofvarious oral agents on outcomes in hospi-talized patients with diabetes. While thevarious classes of oral agents are com-monly used in the outpatient setting withgood response, their use in the inpatientsetting presents some specific issues.

● Sulfonylureas and meglitinides—Thelong action and predisposition to hypo-glycemia in patients not consumingtheir normal nutrition serve as relativecontraindications to routine use of sul-fonylureas in the hospital for many pa-tients (158). Sulfonylureas do notgenerally allow rapid dose adjustmentto meet the changing inpatient needs.Sulfonylureas also vary in duration ofaction between individuals and likelyvary in the frequency with which theyinduce hypoglycemia While the twoavailable meglitinides, repaglinide andneteglinide, theoretically would pro-duce less hypoglycemia than sulfonyl-

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ureas, lack of clinical trial data for theseagents would preclude their use.

● Metformin—The major limitation tometformin use in the hospital is a num-ber of specific contraindications to itsuse, many of which occur in the hospi-tal. All of these contraindications relateto lactic acidosis, a potentially fatalcomplication of metformin therapy.The most common risk factors for lacticacidosis in metformin-treated patientsare cardiac disease, including CHF, hy-poperfusion, renal insufficiency, oldage, and chronic pulmonary disease(159). Recent evidence continues to in-dicate that lactic acidosis is a rare com-plication, despite the relative frequencyof risk factors (160). However, in thehospital, where the risk for hypoxia,hypoperfusion, and renal insufficiencyis much higher, it still seems prudent toavoid the use of metformin in mostpatients.

● Thiazolidinediones—Thiazolidine-diones are not suitable for initiation in thehospital because of their delayed onset ofeffect. In addition, they do increase intra-vascular volume, a particular problem inthose predisposed to CHF and poten-tially a problem for patients with hemo-dynamic changes related to admissiondiagnoses (e.g., acute coronary ischemia)or interventions common in hospitalizedpatients.

In summary, each of the major classesof oral agents has significant limitationsfor inpatient use. Additionally, they pro-vide little flexibility or opportunity for ti-tration in a setting where acute changesdemand these characteristics. Therefore,insulin, when used properly, may havemany advantages in the hospital setting.

b. Insulin. The inpatient insulin regi-men must be matched or tailored to thespecific clinical circumstance of the indi-vidual patient. A recent meta-analysisconcluded that insulin therapy in criti-cally ill patients had a beneficial effect onshort-term mortality in different clinicalsettings (161).

● Subcutaneous insulin therapy—Subcutaneous insulin therapy may beused to attain glucose control in mosthospitalized patients with diabetes. Thecomponents of the daily insulin doserequirement can be met by a variety oftypes of insulin, depending on the par-ticular hospital situation. Subcutane-

ous insulin therapy is subdivided intoprogrammed or scheduled insulin andsupplemental or correction-dose insu-lin. Correction-dose insulin therapy isan important adjunct to scheduled in-sulin, both as a dose-finding strategyand as a supplement when rapidchanges in insulin requirements lead tohyperglycemia. If correction doses arefrequently required, it is recommendedthat the appropriate scheduled insulindoses be increased the following day(162) to accommodate the increasedinsulin needs. There are no studiescomparing human regular insulin withrapid-acting analogues for use as cor-rection-dose insulin. However, due tothe longer duration with human regularinsulin, there is a greater risk of “insulinstacking” when the usual next bloodglucose measurement is performed4–6 h later.

The traditional sliding scale insulinregimens, usually consisting of regular in-sulin without any intermediate or long-acting insulin, have been shown to beineffective (162–164). Problems citedwith sliding scale insulin regimens arethat the sliding scale regimen prescribedon admission is likely to be used through-out the hospital stay without modifica-tion (162). Second, sliding scale insulintherapy treats hyperglycemia after it hasalready occurred, rather than prevent-ing the occurrence of hyperglycemia.This “reactive” approach can lead torapid changes in blood glucose levels,exacerbating both hyperglycemia andhypoglycemia.

● Intravenous insulin infusion—Theonly method of insulin delivery specif-ically developed for use in the hospitalis continuous intravenous infusion, us-ing regular crystalline insulin. There isno advantage to using insulin lispro oraspart in an intravenous insulin infu-sion. The medical literature supportsthe use of intravenous insulin infusionin preference to the subcutaneous routeof insulin administration for severalclinical indications in nonpregnantadults, including DKA and nonketotichyperosmolar state; general preopera-tive, intraoperative, and postoperativecare ; the postoperat ive per iodfollowing heart surgery organ trans-plantation or cardiogenic shock andpossibly stroke exacerbated hypergly-

cemia during high-dose glucocorticoidtherapy; patients who are not eating(NPO); critical care illness; and as adose-finding strategy, anticipatory toinitiation or reinitiation of subcutane-ous insulin therapy in type 1 or type 2diabetes. Many institutions use insulininfusion algorithms that can be imple-mented by nursing staff. Algorithmsshould incorporate the concept thatmaintenance requirements differ be-tween patients and change over thecourse of treatment. Although numer-ous algorithms have been published,there have been no head-to-head com-parisons, and thus no single algorithmcan be recommended for an individualhospital. Ideally, intravenous insulinalgorithms should consider both theglucose level and its rate of change. Forall algorithms, frequent bedside glu-cose testing is required, but the idealfrequency is not known.

● Transition from intravenous to subcu-taneous insulin therapy—There are nospecific clinical trials examining how tobest transition from intravenous to sub-cutaneous insulin or which patientswith type 2 diabetes may be transi-tioned to oral agents. For those whowill require subcutaneous insulin, it isnecessary to administer short- or rapid-acting insulin subcutaneously 1–2 hbefore discontinuation of the intrave-nous insulin infusion. An intermediateor long-acting insulin must be injected2–3 h before discontinuing the insulininfusion. In transitioning from intrave-nous insulin infusion to subcutaneoustherapy, the caregiver may order sub-cutaneous insulin with appropriate du-ration of action to be administered as asingle dose or repeatedly to maintainbasal effect until the time of day whenthe choice of insulin or analog pre-ferred for basal effect normally wouldbe provided.

3. Self-management in the hospital.Self-management in the hospital may beappropriate for competent adult patientswho have a stable level of consciousnessand reasonably stable known daily insulinrequirements, successfully conduct self-management of diabetes at home, havephysical skills appropriate to successfullyself-administer insulin and performSMBG, and have adequate oral intake.Appropriate patients are those already

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proficient in carbohydrate counting, useof multiple daily injections of insulin orinsulin pump therapy, and sick-day man-agement. The patient and physician inconsultation with nursing staff mustagree that patient self-management isappropriate under the conditions ofhospitalization.4. Preventing hypoglycemia. Hypogly-cemia, especially in insulin-treated pa-tients, is the leading limiting factor in theglycemic management of type 1 and type2 diabetes (165). In the hospital, multipleadditional risk factors for hypoglycemiaare present, even among patients who areneither “brittle” nor tightly controlled. Pa-tients who do not have diabetes may ex-perience hypoglycemia in the hospital, inassociation with factors such as alterednutritional state, heart failure, renal orliver disease, malignancy, infection, orsepsis (166). Patients having diabetes maydevelop hypoglycemia in association withthe same conditions (167). Additionaltriggering events leading to iatrogenic hy-poglycemia include sudden reduction ofcorticosteroid dose, altered ability of thepatient to self-report symptoms, reduc-tion of oral intake, emesis, new NPO sta-tus, reduction of rate of administration ofintravenous dextrose, and unexpected in-terruption of enteral feedings or paren-teral nutrition. Altered consciousnessfrom anesthesia may also alter typicalhypoglycemic symptoms.

Despite the preventable nature ofmany inpatient episodes of hypoglyce-mia, institutions are more likely to havenursing protocols for the treatment of hy-poglycemia than for its prevention5. Diabetes care providers. Diabetesmanagement may be offered effectively byprimary care physicians or hospitalists,but involvement of appropriately trainedspecialists or specialty teams may reducelength of stay, improve glycemic control,and improve outcomes (168–171). In thecare of diabetes, implementation of stan-dardized order sets for scheduled and cor-rection-dose insulin may reduce relianceon sliding scale management. A team ap-proach is needed to establish hospitalpathways. To implement intravenous in-fusion of insulin for the majority of pa-tients having prolonged NPO status,hospitals will need multidisciplinary sup-port for using insulin infusion therapyoutside of critical care units.6. DSME. Teaching diabetes self-management to patients in hospitals is a

difficult and challenging task. Patients arehospitalized because they are ill, underincreased stress related to their hospital-ization and diagnosis, and in an environ-ment that is not conducive to learning.Ideally, people with diabetes should betaught at a time and place conducive tolearning: as an outpatient in a nationallyrecognized program of diabetes educa-tion classes.

For the hospitalized patient, diabetes“survival skills” education is generallyconsidered a feasible approach. Patientsare taught sufficient information to enablethem to go home safely. Those newly di-agnosed with diabetes or who are new toinsulin and or blood glucose monitoringneed to be instructed before discharge tohelp ensure safe care upon returninghome. Those patients hospitalized be-cause of a crisis related to diabetes man-agement or poor care at home neededucation to hopefully prevent subse-quent episodes of hospitalization.7. MNT. Even though hospital dietscontinue to be ordered by calorie levelsbased on the “ADA diet,” it has been rec-ommended that the term “ADA diet” nolonger be used (172). Since 1994, theADA has not endorsed any single mealplan or specified percentages of macronu-trients. Current nutrition recommenda-tions advise individualization based ontreatment goals, physiologic parameters,and medication usage.

Because of the complexity of nutritionissues, it is recommended that a registereddietitian, knowledgeable and skilled inMNT, serve as the team member who pro-vides MNT. The dietitian is responsiblefor integrating information about the pa-tient’s clinical condition, eating, and life-style habits and for establishing treatmentgoals in order to determine a realistic planfor nutrition therapy (172).8. Bedside blood glucose monitoring.Implementing intensive diabetes therapyin the hospital setting requires frequentand accurate blood glucose data. Thismeasure is analogous to an additional “vi-tal sign” for hospitalized patients with di-abetes. Bedside glucose monitoring usingcapillary blood has advantages over labo-ratory venous glucose testing because theresults can be obtained rapidly at the“point of care,” where therapeutic deci-sions are made. For this reason, the termsbedside and point-of-care glucose moni-toring are used interchangeably.

For patients who are eating, com-

monly recommended testing frequenciesare premeal and at bedtime. For patientsnot eating, testing every 4–6 h is usuallysufficient for determining correction in-sulin doses. Patients controlled with con-tinuous intravenous insulin typicallyrequire hourly blood glucose testing untilthe blood glucose levels are stable, thenevery 2 h.

Bedside blood glucose testing is usu-ally performed with portable glucose de-vices that are identical or similar todevices for home SMBG.

Recommendations● All patients with diabetes admitted to

the hospital should be identified in themedical record as having diabetes. (E)

● All patients with diabetes should havean order for blood glucose monitoring,with results available to all members ofthe health care team. (E)

● Goals for blood glucose levels:● Critically ill patients: blood glucose

levels should be kept as close to 110mg/dl (6.1 mmol/l) as possible andgenerally �180 mg/dl (10.0 mmol/l).These patients will usually require IVinsulin. (B)

● Noncritically ill patients: premealblood glucose should be kept as closeto 90–130 mg/dl (5.0–7.2 mmol/l)(midpoint of range: 110 mg/dl) aspossible given the clinical situationand a postprandial blood glucoselevel �180 mg/dl. Insulin should beused as necessary. (E)

● Scheduled prandial insulin dosesshould be given in relation to meals andshould be adjusted according to pointof care glucose levels. The traditionalsliding scale insulin regimens are inef-fective and are not recommended. (C)

● A plan for treating hypoglycemiashould be established for each patient.Episodes of hypoglycemia in the hospi-tal should be tracked. (E)

● All patients with diabetes admitted tothe hospital should have an A1C ob-tained for discharge planning if the re-sult of testing in the previous 2–3months is not available. (E)

● A diabetes education plan including“survival skills education” and fol-low-up should be developed for eachpatient. (E)

● Patients with hyperglycemia in the hos-pital who do not have a diagnosis ofdiabetes should have appropriate plans

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for follow-up testing and care docu-mented at discharge. (E)

B. Diabetes care in the school andday care setting (131)There are about 206,000 individuals �20years of age with diabetes in the U.S.,most of whom attend school and/or sometype of day care and need knowledgeablestaff to provide a safe environment. De-spite legal protections, children in theschool and day care setting still face dis-crimination. Parents and the health careteam should provide school systems andday care providers with the informationnecessary by developing an individual-ized “Diabetes Medical ManagementPlan” including information necessary forchildren with diabetes to participate fullyand safely in the school/day care experi-ence. Appropriate diabetes care in theschool and day care setting is necessaryfor the child’s immediate safety, long-term well being, and optimal academicperformance.

An adequate number of school per-sonnel should be trained in the necessarydiabetes procedures (e.g., blood glucosemonitoring and insulin and glucagon ad-ministration) and in the appropriate re-sponse to high and low blood glucoselevels. This will ensure that at least oneadult is present to perform these proce-dures in a timely manner while the stu-dent is at school, on field trips, and duringextracurricular activities or other school-sponsored events. These school person-nel need not be health care professionals.

The student with diabetes shouldhave immediate access to diabetes sup-plies at all times, with supervision asneeded. A student with diabetes shouldbe able to obtain a blood glucose level andrespond to the results as quickly and con-veniently as possible, minimizing theneed for missing instruction in the class-room. Accordingly, a student who is ca-pable of doing so should be permitted tomonitor his or her blood glucose level andtake appropriate action to treat hypogly-cemia in the classroom or anywhere thestudent is in conjunction with a schoolactivity. The student’s desire for privacyduring testing and should also be accom-modated.

Recommendations● An individualized Diabetes Medical

Management Plan should be developed

by the parent/guardian and the stu-dent’s diabetes health care team. (E)

● An adequate number of school person-nel should be trained in the necessarydiabetes procedures and in the appro-priate response to high and low bloodglucose levels. These school personnelneed not be health care professionals.(E)

● The student with diabetes should haveimmediate access to diabetes suppliesat all times, with supervision as needed.(E)

● The student should be permitted tomonitor his or her blood glucose leveland take appropriate action to treat hy-poglycemia in the classroom or any-where the student is in conjunctionwith a school activity if indicated in thestudent’s Diabetes Medical Manage-ment Plan. (E)

C. Diabetes care at diabetes camps(173)The concept of specialized residential andday camps for children with diabetes hasbecome widespread throughout the U.S.and many other parts of the world. Themission of camps specialized for childrenand youth with diabetes is to allow for acamping experience in a safe environ-ment. An equally important goal is to en-able children with diabetes to meet andshare their experiences with one anotherwhile they learn to be more personallyresponsible for their disease. For this tooccur, a skilled medical and camping staffmust be available to ensure optimal safetyand an integrated camping/educationalexperience.

The diabetes camping experience isshort term and is most often associatedwith increased physical activity relative tothat experienced while at home. Thus,goals of glycemic control are more relatedto the avoidance of extremes in blood glu-cose levels than to the optimization of in-tensive glycemic control while away atcamp.

Each camper should have a standard-ized medical form completed by his/herfamily and the physician managing the di-abetes that details the camper’s past med-ical history, immunization record, anddiabetes regimen. The home insulin dos-age should be recorded for each camper,including number and timing of injec-tions or basal and bolus dosages given byCSII and type(s) of insulin used.

During camp, a daily record of the

camper’s progress should be made. Allblood glucose levels and insulin dosagesshould be recorded. To ensure safety andoptimal diabetes management, multipleblood glucose determinations should bemade throughout each 24-h period: be-fore meals, at bedtime, after or duringprolonged and strenuous activity, and inthe middle of the night when indicated forprior hypoglycemia. If major alterationsof a camper’s regimen appear to be indi-cated, it is important to discuss this withthe camper and the family in addition tothe child’s local physician. The record ofwhat transpired during camp should bediscussed with the family when thecamper is picked up.

A formal relationship with a nearbymedical facility should be secured foreach camp so that camp medical staff havethe ability to refer to this facility forprompt treatment of medical emergen-cies. It is imperative that the medical staffis led by someone with expertise in man-aging type 1 and type 2 diabetes. Nursingstaff should include diabetes educatorsand diabetes clinical nurse specialists.Registered dietitians with expertise in di-abetes should also have input into the de-sign of the menu and the educationprogram. All camp staff, including medi-cal, nursing, nutrition, and volunteer,should undergo background testing toensure appropriateness in working withchildren.

Recommendations● Each camper should have a standard-

ized medical form completed by his/herfamily and the physician managing thediabetes. (E)

● It is imperative that the medical staff isled by someone with expertise in man-aging type 1 and type 2 diabetes, a nurs-ing staff (including diabetes educatorsand diabetes clinical nurse specialists),and registered dietitians with expertisein diabetes. (E)

● All camp staff, including medical, nurs-ing, nutrition, and volunteer, shouldundergo background testing to ensureappropriateness in working with chil-dren. (E)

D. Diabetes care in correctionalinstitutions (174)At any given time, over 2 million peopleare incarcerated in prisons and jails in theU.S. It is estimated that nearly 80,000 ofthese inmates have diabetes. In addition,

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many more people with diabetes passthrough the corrections system in a givenyear.

People with diabetes in correctionalfacilities should receive care that meetsnational standards. Correctional institu-tions have unique circumstances thatneed to be considered so that all standardsof care may be achieved. Correctional in-stitutions should have written policiesand procedures for the management ofdiabetes and for training of medicaland correctional staff in diabetes carepractices.

Reception screening should empha-size patient safety. In particular, rapididentification of all insulin-treated indi-viduals with diabetes is essential in orderto identify those at highest risk for hypo-and hyperglycemia and DKA. All insulin-treated patients should have a capillaryblood glucose (CBG) determinationwithin 1–2 h of arrival. Patients with adiagnosis of diabetes should have a com-plete medical history and physical exam-ination by a licensed health care providerwith prescriptive authority in a timelymanner. It is essential that medicationand MNT be continued without interrup-tion upon entry into the correctional sys-tem, as a hiatus in either medication orappropriate nutrition may lead to eithersevere hypo- or hyperglycemia.

All patients must have access toprompt treatment of hypo- and hypergly-cemia. Correctional staff should betrained in the recognition and treatmentof hypo- and hyperglycemia, and ap-propriate staff should be trained to ad-minister glucagon. Institutions shouldimplement a policy requiring staff to no-tify a physician of all CBG results outsideof a specified range, as determined by thetreating physician.

Correctional institutions should havesystems in place to ensure that insulin ad-ministration and meals are coordinated toprevent hypo- and hyperglycemia, takinginto consideration the transport of pa-tients off-site and the possibility of emer-gency schedule changes.

Monitoring of CBG is a strategy thatallows caregivers and people with diabe-tes to evaluate diabetes management reg-imens. The frequency of monitoring willvary by patients’ glycemic control and di-abetes regimens. Policies and proceduresshould be implemented to ensure that thehealth care staff has adequate knowledge

and skills to direct the management andeducation of individuals with diabetes.

Patients in jails may be housed for ashort period of time before being trans-ferred or released, and it is not unusual forpatients in prison to be transferred withinthe system several times during their in-carceration. Transferring a patient withdiabetes from one correctional facility toanother requires a coordinated effort asdoes planning for discharge.

Recommendations● Patients with a diagnosis of diabetes

should have a complete medical historyand undergo an intake physical exami-nation by a licensed health professionalin a timely manner. (E)

● Insulin-treated patients should have aCBG determination within 1–2 h of ar-rival. (E)

● Medications and MNT should be con-tinued without interruption upon entryinto the correctional environment. (E)

● Correctional staff should be trained inthe recognition, treatment, and appro-priate referral for hypo- and hypergly-cemia. (E)

● Train staff to recognize symptoms andsigns of serious metabolic decompensa-tion and to immediately refer the pa-tient for appropriate medical care. (E)

● Institutions should implement a policyrequiring staff to notify a physician ofall CBG results outside of a specifiedrange, as determined by the treatingphysician. (E)

● Identify patients with type 1 diabeteswho are at high risk for DKA. (E)

● In the correctional setting, policies andprocedures need to be developed andimplemented to enable CBG monitor-ing to occur at the frequency necessitat-ed by the individual patient’s glycemiccontrol and diabetes regimen. (E)

● Include diabetes in correctional staffeducation programs. (E)

● For all interinstitutional transfers, com-plete a medical transfer summary to betransferred with the patient. (E)

● Diabetes supplies and medicationshould accompany the patient duringtransfer. (E)

● Begin discharge planning with ade-quate lead time to insure continuity ofcare and facilitate entry into commu-nity diabetes care. (E)

IX. HYPOGLYCEMIA ANDEMPLOYMENT/LICENSURE(175)Any person with diabetes, whether insu-lin treated or noninsulin treated, shouldbe eligible for any employment for whichhe/she is otherwise qualified. Despite thesignificant medical and technological ad-vances made in managing diabetes, dis-crimination in employment and licensureagainst people with diabetes still occurs.This discrimination is often based on ap-prehension that the person with diabetesmay present a safety risk to the employeror to the public—a fear sometimes basedon misinformation or lack of up-to-dateknowledge about diabetes. Perhaps thegreatest concern is that hypoglycemia willcause sudden unexpected incapacitation.However, most people with diabetes canmanage their condition in such a mannerthat there is minimal risk of incapacita-tion from hypoglycemia.

Because the effects of diabetes areunique to each individual, it is inappro-priate to consider all people with diabetesthe same. People with diabetes should beindividually considered for employmentbased on the requirements of the specificjob. Factors to be weighed in this decisioninclude the individual’s medical condi-tion, treatment regimen (MNT, oral glu-cose-lowering agent, and/or insulin), andmedical history, particularly in regard tothe occurrence of incapacitating hypogly-cemic episodes.

Recommendation● People with diabetes should be individ-

ually considered for employment basedon the requirements of the specific joband the individual’s medical condition,treatment regimen, and medical his-tory. (E)

X. THIRD-PARTYREIMBURSEMENT FORDIABETES CARE, SELF-MANAGEMENTEDUCATION, ANDSUPPLIES (176)To achieve optimal glucose control, theperson with diabetes must be able to ac-cess health care providers who have ex-pertise in the field of diabetes. Treatmentsand therapies that improve glycemic con-trol and reduce the complications of dia-betes will also significantly reduce healthcare costs. Access to the integral compo-nents of diabetes care, such as health care

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visits, diabetes supplies and medications,and self-management education, is essen-tial. All medications and supplies, such assyringes, strips, and meters, related to thedaily care of diabetes must also be reim-bursed by third-party payers.

It is recognized that the use of formu-laries, prior authorization, and relatedprovisions, such as competitive bidding,can manage provider practices as well ascosts to the potential benefit of payors andpatients. However, any controls shouldensure that all classes of antidiabeticagents with unique mechanisms of actionand all classes of equipment and suppliesdesigned for use with such equipment areavailable to facilitate achieving glycemicgoals and to reduce the risk of complica-tions. To reach diabetes treatment goals,practitioners should have access to allclasses of antidiabetic medications,equipment, and supplies without unduecontrols. Without appropriate safe-guards, these controls could constitute anobstruction of effective care.

Medicare and many other third-partypayors cover DSMT and MNT. The qual-ified beneficiary, who meets the diagnos-tic criteria and medical necessity, canreceive an initial benefit of 10 h of DSMTand 3 h of MNT with a potential total of13 h of initial education, as long as theservices are not provided on the samedate. However, not all Medicare benefi-ciaries with a diagnosis of diabetes willqualify for both MNT and DSMT benefits.For more information on Medicare policyincluding follow-up benefits, go to thefollowing link: http://www.diabetes.org/for-health-professionals-and-scientists/recognition/dsmt-mntfaqs.jsp.

Recommendations● Patients and practitioners should have

access to all classes of antidiabetic med-ications, equipment, and supplies with-out undue controls. (E)

● MNT and DSME should be covered byinsurance and other payors. (E)

XI. STRATEGIES FORIMPROVING DIABETESCAREThe implementation of the standards ofcare for diabetes has been suboptimal inmost clinical settings. A recent report(177) indicated that only 37% of adultswith diagnosed diabetes achieved an A1Cof �7%, only 36% had a blood pressure�130/80 and just 48% had a cholesterol

level �200 mg/dl. Most distressing wasthat only 7.3% of diabetes subjectsachieved all three treatment goals.

While numerous interventions to im-prove adherence to the recommendedstandards have been implemented, thechallenge of providing uniformly effectivediabetes care has thus far defied a simplesolution. A major contributor to subopti-mal care is a delivery system that too oftenis fragmented, lacks clinical informationcapabilities, often duplicates services, andis poorly designed for the delivery ofchronic care. The Institute of Medicine(IOM) has called for changes so that de-livery systems provide care that is evi-dence based, patient centered, andsystems oriented and takes advantage ofinformation technologies that foster con-tinuous quality improvement. Collabora-tive, multidisciplinary teams should bebest suited to provide such care for peoplewith chronic conditions like diabetes andto empower patients’ performance of ap-propriate self-management. Alterations inreimbursement that reward the provisionof quality care as defined by the attain-ment of quality measures developed bysuch activities as the ADA/NCQA Diabe-tes Provider Recognition Program willalso be required to achieve desired out-come goals.

The NDEP recently launched a newonline resource to help health care profes-sionals better organize their diabetes care.The www.betterdiabetescare.nih.govwebsite should help users design and im-plement more effective health care deliv-ery systems for those with diabetes.

In recent years, numerous health careorganizations, ranging from large healthcare systems such as the U.S. Veteran’sAdministration to small private practices,have implemented strategies to improvediabetes care. Successful programs havepublished results showing improvementin important outcomes such as A1C mea-surements and blood pressure and lipiddeterminations as well as process mea-sures such as provision of eye exams. Suc-cessful interventions have been focused atthe level of health care professionals, de-livery systems, and patients. Features ofsuccessful programs reported in the liter-ature include:

● Improving health care professional ed-ucation regarding the standards of carethrough formal and informal educationprograms.

● Delivery of DSME, which has beenshown to increase adherence to stan-dard of care.

● Adoption of practice guidelines, withparticipation of health care profession-als in the process. Guidelines should bereadily accessible at the point of service,such as on patient charts, in examiningrooms, in “wallet or pocket cards,” onPDAs, or on office computer systems.Guidelines should begin with a sum-mary of their major recommendationsinstructing health care professionalswhat to do and how to do it.

● Use of checklists that mirror guidelineshave been successful at improving ad-herence to standards of care.

● System changes, such as provision ofautomated reminders to health careprofessionals and patients, reporting ofprocess and outcome data to providers,and especially identification of patientsat risk because of failure to achieve tar-get values or a lack of reported values.

● Quality improvement programs com-bining Continuous Quality Improve-ment (CQI) or other cycles of analysisand intervention with provider perfor-mance data.

● Practice changes, such as clustering ofdedicated diabetes visits into specifictimes within a primary care practiceschedule and/or visits with multiplehealth care professionals on a single dayand group visits.

● Tracking systems either with an elec-tronic medical record or patient regis-try have been helpful at increasingadherence to standards of care by pro-spectively identifying those requiringassessments and/or treatment modifi-cations. They likely could have greaterefficacy if they suggested specific ther-apeutic interventions to be consideredfor a particular patient at a particularpoint in time (Diabetes Care 26: 942–943, 2003).

● A variety of nonautomated systemssuch as mailing reminders to patients,chart stickers, and flow sheets havebeen useful to prompt both providersand patients.

● Availability of case or (preferably) caremanagement services, usually by anurse. Nurses, pharmacists, and othernonphysician health care professionalsusing detailed algorithms working un-der the supervision of physiciansand/or nurse education calls have alsobeen helpful. Similarly dietitians using

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MNT guidelines have been demon-strated to improve glycemic control.

● Availability and involvement of expertconsultants, such as endocrinologistsand diabetes educators.

Evidence suggests that these individ-ual initiatives work best when provided ascomponents of a multifactorial interven-tion. Therefore, it is difficult to assess thecontribution of each component; how-ever, it is clear that optimal diabetesmanagement requires an organized,systematic approach and involvementof a coordinated team of health careprofessionals.

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