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

Standards of Medical Care in Diabetes

AMERICAN DIABETES ASSOCIATION estly more specific than fasting plasma
glucose (FPG) to diagnose diabetes, it is
poorly reproducible and rarely performed
in practice. Because of ease of use, accept-
ability to patients, and lower cost, the

D
iabetes is a chronic illness that re- each recommendation is listed after each
quires continuing medical care and recommendation using the letters A, B, C, FPG is the preferred screening and diag-
patient self-management education or E. nostic test. It should be noted that the vast
to prevent acute complications and to re- majority of people who meet diagnostic
duce the risk of long-term complications. CLASSIFICATION, criteria for diabetes by OGTT, but not by
Diabetes care is complex and requires that DIAGNOSIS, AND FPG, will have an A1C value ⬍7.0%. The
many issues, beyond glycemic control, be SCREENING use of the A1C for the diagnosis of diabe-
addressed. A large body of evidence exists tes is not recommended at this time.
that supports a range of interventions to Classification Hyperglycemia not sufficient to meet
improve diabetes outcomes. In 1997, the ADA issued new diagnostic the diagnostic criteria for diabetes is cate-
These standards of care are intended and classification criteria (4); in 2003, gorized as either IFG or impaired glucose
to provide clinicians, patients, research- modifications were made regarding the tolerance (IGT), depending on whether it
ers, payors, and other interested persons diagnosis of impaired fasting glucose is identified through FPG or an OGTT:
with the components of diabetes care, (IFG) (5). The classification of diabetes
treatment goals, and tools to evaluate the includes four clinical classes: ● IFG ⫽ FPG 100 mg/dl (5.6 mmol/l) to
quality of care. While individual prefer- 125 mg/dl (6.9 mmol/l)
ences, comorbidities, and other patient ● Type 1 diabetes (results from ␤-cell de- ● IGT ⫽ 2-h plasma glucose 140 mg/dl
factors may require modification of goals, struction, usually leading to absolute (7.8 mmol/l) to 199 mg/dl (11.0
targets that are desirable for most patients insulin deficiency). mmol/l)
with diabetes are provided. These stan- ● Type 2 diabetes (results from a progres-
dards are not intended to preclude more sive insulin secretory defect on the Recently, IFG and IGT have been offi-
extensive evaluation and management of background of insulin resistance). cially termed “pre-diabetes.” Both catego-
the patient by other specialists as needed. ● Other specific types of diabetes (due to ries, IFG and IGT, are risk factors for
For more detailed information, refer to other causes, e.g., genetic defects in future diabetes and cardiovascular dis-
Bode (Ed.): Medical Management of Type 1 ␤-cell function, genetic defects in insu- ease (CVD). Recent studies have shown
Diabetes (1), Zimmerman (Ed.): Medical lin action, diseases of the exocrine pan- that modest weight loss and regular phys-
Management of Type 2 Diabetes (2), and creas, drug or chemical induced). ical activity can reduce the rate of progres-
Klingensmith (Ed): Intensive Diabetes ● Gestational diabetes mellitus (GDM) sion of IGT to type 2 diabetes (6 – 8). Drug
Management (3). (diagnosed during pregnancy). therapy (metformin [8], acarbose [9], and
The recommendations included are orlistat [10] and troglitazone [no longer
diagnostic and therapeutic actions that Diagnosis clinically available] [11]) has been shown
are known or believed to favorably affect Criteria for the diagnosis of diabetes in to be effective in reducing progression to
health outcomes of patients with diabetes. nonpregnant adults are shown in Table 2. diabetes, though generally not as effec-
A grading system (Table 1), developed by Three ways to diagnose diabetes are avail- tively as intensive lifestyle interventions.
the American Diabetes Association (ADA) able, and each must be confirmed on a
and modeled after existing methods, was subsequent day unless unequivocal Screening
utilized to clarify and codify the evidence symptoms of hyperglycemia are present. Generally, people with type 1 diabetes
that forms the basis for the recommenda- Although the 75-g oral glucose tolerance present with acute symptoms of diabetes
tions. The level of evidence that supports test (OGTT) is more sensitive and mod- and markedly elevated blood glucose lev-
● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● els. Type 2 diabetes is frequently not di-
The recommendations in this paper are based on the evidence reviewed in the following publication: agnosed until complications appear, and
Standards of care for diabetes (Technical Review). Diabetes Care 17:1514 –1522, 1994. approximately one-third of all people
Originally approved 1988. Most recent review/revision, October 2003. with diabetes may be undiagnosed. Al-
Abbreviations: ABI, ankle-brachial index; ARB, angiotensin receptor blocker; CAD, coronary artery though the burden and natural history of
disease; CHD, coronary heart disease; CSII, continuous subcutaneous insulin injection; CVD, cardiovascular
disease; FPG, fasting plasma glucose; GCT, glucose challenge test; DCCB, dihydropyridine calcium channel
diabetes is well known and although there
blocker; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis; DRS, Diabetic is good evidence for benefit from treating
Retinopathy Study; ECG, electrocardiogram; eGFR, estimated GFR; ESRD, end-stage renal disease; ETDRS, cases diagnosed in the context of usual
Early Treatment Diabetic Retinopathy Study; GDM, gestational diabetes mellitus; GFR, glomerular filtration clinical care, there are no randomized tri-
rate; HRC, high-risk characteristic; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; MNT, als demonstrating the benefits of early
medical nutrition therapy; NPDR, nonproliferative diabetic retinopathy; OGTT, oral glucose tolerance test;
PAD, peripheral arterial disease; PDR, proliferative diabetic retinopathy; PPG, postprandidial plasma glu- diagnosis through screening of asymp-
cose; SMBG, self-monitoring of blood glucose; UKPDS, U.K. Prospective Diabetes Study. tomatic individuals (12). Nevertheless,
© 2004 by the American Diabetes Association. there is sufficient indirect evidence to jus-

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S15

Position Statement

Table 1—ADA evidence grading system for clinical practice recommendations

Level of
evidence Description
A Clear evidence from well-conducted, generalizable, randomized controlled trials that are adequately powered including:
● Evidence from a well-conducted multicenter trial
● Evidence from a meta-analysis that incorporated quality ratings in the analysis
● Compelling nonexperimental evidence, i.e., “all or none” rule developed by Center for Evidence Based Medicine at Oxford
Supportive evidence from well-conducted randomized controlled trials that are adequately powered including:
● Evidence from a well-conducted trial at one or more institutions
● Evidence from a meta-analysis that incorporated quality ratings in the analysis
B Supportive evidence from well-conducted cohort studies
● Evidence from a well-conducted prospective cohort study or registry
● Evidence from a well-conducted prospective cohort study
● Evidence from a well-conducted meta-analysis of cohort studies
Supportive evidence from a well-conducted case-control study
C Supportive evidence from poorly controlled or uncontrolled studies
● Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could
invalidate the results
● Evidence from observational studies with high potential for bias (such as
case series with comparison to historical controls)
● Evidence from case series or case reports
Conflicting evidence with the weight of evidence supporting the recommendation
E Expert consensus or clinical experience

tify opportunistic screening in a clinical with clinical characteristics consistent serum glucose concentration 1 h after a
setting of individuals at high risk. Criteria with a high risk for GDM (those with 50-g oral glucose load (glucose chal-
for testing for diabetes in asymptomatic, marked obesity, personal history of GDM, lenge test [GCT]) and perform a diag-
undiagnosed adults are listed in Table 3. glycosuria, or a strong family history of nostic 100-g OGTT on that subset of
The recommended screening test for non- diabetes) should undergo glucose testing women exceeding the glucose thresh-
pregnant adults is the FPG. The OGTT is as soon as possible (14). An FPG ⱖ126 old value on the GCT. When the two-
more sensitive for the diagnosis of diabe- mg/dl or a casual plasma glucose ⱖ200 step approach is used, a glucose
tes and pre-diabetes, but is impractical mg/dl meets the threshold for the diagno- threshold value ⱖ140 mg/dl identifies
and expensive as a screening procedure. sis of diabetes and needs to be confirmed ⬃80% of women with GDM, and the
The incidence of type 2 diabetes in on a subsequent day unless unequivocal yield is further increased to 90% by us-
children and adolescents has increased symptoms of hyperglycemia are present. ing a cutoff of ⱖ130 mg/dl.
dramatically in the last decade. Consis- High-risk women not found to have GDM ● Diagnostic criteria for the 100-g OGTT
tent with screening recommendations for at the initial screening and average-risk are as follows: ⱖ95 mg/dl fasting,
adults, only children and youth at in- women should be tested between 24 and ⱖ180 mg/dl at 1 h, ⱖ155 mg/dl at 2 h,
creased risk for the presence or the devel- 28 weeks of gestation. Testing should fol- and ⱖ140 mg/dl at 3 h. Two or more of
opment of type 2 diabetes should be low one of two approaches: the plasma glucose values must be met
tested (13) (Table 4). or exceeded for a positive diagnosis.
● One-step approach: perform a diagnos- The test should be done in the morning
Detection and diagnosis of GDM tic 100-g OGTT after an overnight fast of 8 –14 h. The
Risk assessment for GDM should be un- ● Two-step approach: perform an initial diagnosis can be made using a 75-g glu-
dertaken at the first prenatal visit. Women screening by measuring the plasma or cose load, but that test is not as well
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. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss.
OR
2. FPG 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h.
OR
3. 2-h PG 200 mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as described by the World Health Organization (4a),
using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water.
In the absence of unequivocal hyperglycemia, these criteria should be confirmed by repeat testing on a different day. The OGTT is not recommended for routine
clinical use, but may be required in the evaluation of patients with IFG (see text) or when diabetes is still suspected despite a normal FPG.

S16 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

 Standards of Medical Care

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 and above, particularly in those with a BMI 25 kg/m2*, and, if
normal, should be repeated at 3-year intervals.
2. Testing should be considered at a younger age or be carried out more frequently in individuals who are overweight (BMI 25 kg/m2*) and
have additional risk factors:
● 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 (e.g. PCOS or acanthosis nigricans)
● have a history of vascular disease
*May not be correct for all ethnic groups. PCOS, polycystic ovary syndrome.

validated for detection of at-risk infants strongly recommended and progres- MANAGEMENT
or mothers as the 100-g OGTT. sion of glycemic abnormalities followed People with diabetes should receive
● Low-risk status requires no glucose by screening at least yearly. (A) medical care from a physician-coordi-
testing, but this category is limited to ● Screen for diabetes in pregnancy using nated team. Such teams may include,
those women meeting all of the follow- risk factor analysis and screening tests but are not limited to, physicians,
ing characteristics: as noted; the OGTT is the preferred nurse practitioners, physician’s assis-
screening test in pregnancy. (E) tants, nurses, dietitians, pharmacists, and
• Age ⬍25 years. mental health professionals with exper-
• Weight normal before pregnancy. tise and a special interest in diabetes. It is
• Member of an ethnic group with a INITIAL EVALUATION essential in this collaborative and inte-
low prevalence of GDM. A complete medical evaluation should be grated team approach that individuals
• No known diabetes in first-degree performed to classify the patient, detect with diabetes assume an active role in
relatives.
the presence or absence of diabetes com- their care.
• No history of abnormal glucose tol-
plications, assist in formulating a manage- The management plan should be for-
erance.
• No history of poor obstetric out- ment plan, and provide a basis for mulated as an individualized therapeutic
come. continuing care. If the diagnosis of diabe- alliance among the patient and family, the
tes has already been made, the evaluation physician, and other members of the
Recommendations should review the previous treatment and health care team. Any plan should recog-
● The FPG is the preferred test to screen the past and present degrees of glycemic nize diabetes self-management education
for and diagnose diabetes in children control. Laboratory tests appropriate to as an integral component of care. In de-
and nonpregnant adults. (E) the evaluation of each patient’s general veloping the plan, consideration should
● Screen for diabetes in high-risk, asymp- medical condition should be performed. be given to the patient’s age, school or
tomatic, undiagnosed adults and chil- A focus on the components of compre- work schedule and conditions, physical
dren within the health care setting. (E) hensive care (Table 5) will assist the activity, eating patterns, social situation
● In those with pre-diabetes (IFG/IGT), health care team to ensure optimal man- and personality, cultural factors, and
lifestyle modification should be agement of the patient with diabetes. presence of complications of diabetes or

Table 4—Testing for type 2 diabetes in children

● Criteria
Overweight (BMI ⬎85th percentile for age and sex, weight for height ⬎85th percentile, or weight ⬎120% of ideal for height)
Plus
Any two of the following risk factors:
Family history of type 2 diabetes in first- or second-degree relative
Race/ethnicity (Native American, African American, Latino, Asian American, Pacific Islander)
Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, or PCOS)
● Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a younger age
● Frequency: every 2 years
● Test: FPG preferred
Clinical judgment should be used to test for diabetes in high-risk patients who do not meet these criteria. PCOS, polycystic ovary syndrome.

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S17

Position Statement

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 AIC records
● Eating patterns, nutritional status, and weight history; growth and development in children and adolescents
● Details of previous treatment programs, including nutrition and diabetes self-management education, attitudes, and health beliefs
● Current treatment of diabetes, including medications, meal plan, and results of glucose monitoring and patients’ use of data
● Exercise history
● Frequency, severity, and cause of acute complications such as ketoacidosis and hypoglycemia
● Prior or current infections, particularly skin, foot, dental, and genitourinary infections
● Symptoms and treatment of chronic eye; kidney; nerve; genitourinary (including sexual), bladder, and gastrointestinal function (including
symptoms of celiac disease in type 1 diabetic patients); heart; peripheral vascular; foot; and cerebrovascular complications associated with
diabetes
● Other medications that may affect blood glucose levels
● Risk factors for 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 (TSH) 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

other medical conditions. A variety of Implementation of the management plan Glycemic control
strategies and techniques should be used requires that each aspect is understood Glycemic control is fundamental to the
to provide adequate education and devel- and agreed on by the patient and the care management of diabetes. Prospective ran-
opment of problem-solving skills in the providers and that the goals and treat- domized clinical trials such as the Diabe-
various aspects of diabetes management. ment plan are reasonable. tes Control and Complications Trial

S18 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

 Standards of Medical Care

Table 6—Summary of recommendations for adults with diabetes increased cardiovascular risk indepen-
Glycemic control dent of FPG in some epidemiological
AIC ⬍7.0%* studies. Postprandial plasma glucose
Preprandial plasma glucose 90–130 mg/dl (5.0–7.2 mmol/l) (PPG) levels ⬎140 mg/dl are unusual in
Postprandial plasma glucose† ⬍180 mg/dl (⬍10.0 mmol/l) nondiabetic individuals, although large
Blood pressure ⬍130/80 mmHg evening meals can be followed by plasma
Lipids‡ glucose values up to 180 mg/dl. There are
LDL ⬍100 mg/dl (⬍2.6 mmol/l) now pharmacological agents that primar-
Triglycerides ⬍150 mg/dl (⬍1.7 mmol/l) ily modify PPG and thereby reduce A1C
HDL ⬎40 mg/dl (⬎1.1 mmol/l)§ in parallel. Thus, in individuals who have
Key concepts in setting glycemic goals: premeal glucose values within target but
● Goals should be individualized who are not meeting A1C targets, consid-
● Certain populations (children, pregnant women, eration of monitoring PPG 1–2 h after the
and elderly) require special considerations start of the meal and treatment aimed at
● Less intensive glycemic goals may be indicated reducing PPG values ⬍180 mg/dl may
in patients with severe or frequent lower A1C. However, it should be noted
hypoglycemia that the effect of these approaches on mi-
● More stringent glycemic goals (i.e. a normal cro- or macrovascular complications has
A1C, ⬍6%) may further reduce complications not been studied (22).
at the cost of increased risk of hypoglycemia For information on glycemic control
(particularly in those with type 1 diabetes) for women with GDM, refer to the ADA
● Postprandial glucose may be targeted if AIC position statement “Gestational Diabetes
goals are not met despite reaching preprandial Mellitus” (14). For information on glyce-
glucose goals mic control during pregnancy in women
with preexisting diabetes, refer to Medical
*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 with Management of Pregnancy Complicated by
diabetes. ‡Current NCEP/ATP III guidelines suggest that in patients with triglycerides 200 mg/dl, the Diabetes (3rd ed.) (23).
“non-HDL cholesterol” (total cholesterol minus HDL) be utilized. The goal is 130 mg/dl (61). §For women,
it has been suggested that the HDL goal be increased by 10 mg/dl. Referral for diabetes management
For a variety of reasons, some people with
diabetes and their health care providers
(DCCT) (15) and the U.K. Prospective Di- complications. There are no clinical trial do not achieve the desired goals of treat-
abetes Study (UKPDS) (16,17) have data available for the effects of glycemic ment (Table 6). In such instances, addi-
shown that improved glycemic control is control in patients with advanced compli- tional actions suggested include
associated with sustained decreased rates cations, the elderly (ⱖ65 years of age), or enhanced diabetes self-management edu-
of retinopathy, nephropathy, and neu- young children (⬍13 years of age). Less cation, comanagement with a diabetes
ropathy (18). In these trials, treatment stringent treatment goals may be appro- team, change in pharmacological therapy,
regimens that reduced average A1C to priate for patients with limited life expect- initiation of or increase in self-monitoring
⬃7% (⬃1% above the upper limits of ancies, in the very young or older adults, of blood glucose (SMBG), more frequent
normal) were associated with fewer long- and in individuals with comorbid condi- contact with the patient, and referral to an
term microvascular complications; how- tions. Severe or frequent hypoglycemia is endocrinologist.
ever, intensive control was found to an indication for the modification of treat-
increase the risk of severe hypoglycemia ment regimens, including setting higher Intercurrent illness
and weight gain (19,20). Epidemiological glycemic goals. The stress of illness frequently aggravates
studies support the potential of intensive More stringent goals (i.e., a normal glycemic control and necessitates more
glycemic control in the reduction of CVD A1C, ⬍6%) can be considered in individ- frequent monitoring of blood glucose and
(15–20). ual patients based on epidemiological urine or blood ketones. A vomiting illness
Recommended glycemic goals for analyses that suggest that there is no lower accompanied by ketosis may indicate di-
nonpregnant individuals are shown in Ta- limit of A1C at which further lowering abetic ketoacidosis (DKA), a life-
ble 6. A major limitation to the available does not reduce risk of complications, at threatening condition that requires
data are that they do not identify the op- the risk of increased hypoglycemia (par- immediate medical care to prevent com-
timum level of control for particular pa- ticularly in those with type 1 diabetes). plications and death; the possibility of
tients, as there are individual differences However, the absolute risks and benefits DKA should always be considered (24).
in the risks of hypoglycemia, weight gain, of lower targets are unknown. The risks Marked hyperglycemia requires tempo-
and other adverse effects. Furthermore, and benefits of an A1C goal of ⬍6% are rary adjustment of the treatment program
with multifactorial interventions, it is un- currently being tested in an ongoing study and, if accompanied by ketosis, frequent
clear how different components (e.g., ed- (ACCORD [Action to Control Cardiovas- interaction with the diabetes care team.
ucational interventions, glycemic targets, cular Risk in Diabetes]) in type 2 diabetes The patient treated with oral glucose-
lifestyle changes, and pharmacological (21). Elevated postchallenge (2-h OGTT) lowering agents or medical nutrition ther-
agents) contribute to the reduction of glucose values have been associated with apy (MNT) alone may temporarily require

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S19

Position Statement

insulin. Adequate fluid and caloric intake patients to evaluate their individual re- Table 7—Correlation between A1C level and
must be assured. Infection or dehydration sponse to therapy and assess whether gly- mean plasma glucose levels (30)
is more likely to necessitate hospitaliza- cemic targets are being achieved. Results
tion of the person with diabetes than the of SMBG can be useful in preventing hy- Mean plasma glucose
person without diabetes. The hospitalized poglycemia and adjusting medications,
patient should be treated by a physician MNT, and physical activity. AIC (%) mg/dl mmol/l
with expertise in the management of dia- The frequency and timing of SMBG 6 135 7.5
betes, and recent studies suggest that should be dictated by the particular needs 7 170 9.5
achieving very stringent glycemic control and goals of the patients. Daily SMBG is 8 205 11.5
may reduce mortality in the immediate especially important for patients treated 9 240 13.5
postmyocardial infarction period (25). with insulin to monitor for and prevent 10 275 15.5
Aggressive glycemic management with asymptomatic hypoglycemia. For most 11 310 17.5
insulin may reduce morbidity in patients patients with type 1 diabetes and preg- 12 345 19.5
with severe acute illness (26). nant women taking insulin, SMBG is rec-
For information on management of ommended three or more times daily. The
patients in the hospital, refer to the ADA optimal frequency and timing of SMBG months, measurement approximately ev-
position statement titled “Hyperglycemic for patients with type 2 diabetes is not ery 3 months is required to determine
Crises in Diabetes ” (24). known but should be sufficient to facili- whether a patient’s metabolic control has
tate reaching glucose goals. When adding been reached and maintained within the
Recommendations to or modifying therapy, type 1 and type 2 target range. Thus, regular performance
● Lowering A1C has been associated with diabetic patients should test more often of the A1C test permits detection of de-
a reduction of microvascular and neu- than usual. The role of SMBG in stable partures from the target (Table 6) in a
ropathic complications of diabetes. (A) diet-treated patients with type 2 diabetes timely fashion. For any individual patient,
● Develop or adjust the management is not known. the frequency of A1C testing should be
plan to achieve normal or near-normal Because the accuracy of SMBG is in- dependent on the clinical situation, the
glycemia with an A1C goal of ⬍7%. (B) strument- and user-dependent (29), it is treatment regimen used, and the judg-
● More stringent goals (i.e., a normal important for health care providers to ment of the clinician.
A1C, ⬍6%) can be considered in indi- evaluate each patient’s monitoring tech- Glycemic control is best judged by
vidual patients. (B) nique, both initially and at regular inter- the combination of the results of the pa-
● Lowering A1C may lower the risk of vals thereafter. In addition, optimal use of tient’s SMBG testing (as performed) and
myocardial infarction and cardiovascu- SMBG requires proper interpretation of the current A1C result. The A1C should
lar death. (B) the data. Patients should be taught how to be used not only to assess the patient’s
● Aggressive glycemic management with use the data to adjust food intake, exer- control over the preceding 2–3 months
insulin may reduce morbidity in pa- cise, or pharmacological therapy to but also as a check on the accuracy of the
tients with severe acute illness, periop- achieve specific glycemic goals. Health meter (or the patient’s self-reported re-
eratively and following myocardial professionals should evaluate at regular sults) and the adequacy of the SMBG test-
infarction. (B) intervals the patient’s ability to use SMBG ing schedule. Table 7 contains the
● Less stringent treatment goals may be data to guide treatment. correlation between A1C levels and mean
appropriate for patients with a history plasma glucose levels based on data from
of severe hypoglycemia, patients with Recommendations the DCCT (30).
limited life expectancies, very young ● SMBG is an integral component of dia-
children or older adults, and individu- betes therapy. (B) Recommendations
als with comorbid conditions. (E) ● Include SMBG in the management ● Perform the A1C test at least two times
plan. (E) a year in patients who are meeting treat-
ASSESSMENT OF GLYCEMIC ● Instruct the patient in SMBG and rou- ment goals (and who have stable glyce-
CONTROL tinely evaluate the patient’s technique mic control) and quarterly in patients
Techniques are available for health pro- and ability to use data to adjust therapy. whose therapy has changed or who are
viders and patients to assess the effective- (E) not meeting glycemic goals. (E)
ness of the management plan on glycemic
control. A1C MNT
By performing an A1C test, health provid- MNT is an integral component of diabetes
SMBG ers can measure a patient’s average glyce- management and diabetes self-manage-
The ADA’s consensus statements on mia over the preceding 2–3 months (29) ment education. A review of the evidence
SMBG provide a comprehensive review of and, thus, assess treatment efficacy. A1C and detailed information can be found in
the subject (27,28). Major clinical trials testing should be performed routinely in the ADA technical review and position
assessing the impact of glycemic control all patients with diabetes, first to docu- statement in this area (31,32). People
on diabetes complications have included ment the degree of glycemic control at with diabetes should receive individual-
SMBG as part of multifactorial interven- initial assessment and then as part of con- ized MNT as needed to achieve treatment
tions, suggesting that SMBG is a compo- tinuing care. Since the A1C test reflects goals, preferably provided by a registered
nent of effective therapy. SMBG allows mean glycemia over the preceding 2–3 dietitian familiar with the components of

S20 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

 Standards of Medical Care

diabetes MNT. Goals of MNT that apply ment and education, is the team member participation is an important manage-
to all persons with diabetes are as follows: who provides MNT. However, it is essen- ment strategy.
tial that all team members are knowledge-
● Attain and maintain recommended able about nutrition therapy and are Recommendations
metabolic outcomes, including glucose supportive of the person with diabetes ● A regular physical activity program,
and A1C levels; LDL cholesterol, HDL who needs to make lifestyle changes. adapted to the presence of complica-
cholesterol, and triglyceride levels; MNT involves a nutrition assessment tions, is recommended for all patients
blood pressure; and body weight (see to evaluate the patient’s food intake, met- with diabetes who are capable of partic-
Table 6). abolic status, lifestyle and readiness to ipating. (B)
● Prevent and treat the chronic complica- make changes, goal setting, dietary
tions and comorbidities of diabetes. instruction, and evaluation. To facilitate PREVENTION AND
Modify nutrient intake and lifestyle as adherence, the plan should be individu- MANAGEMENT OF
appropriate for the prevention and alized and take into account cultural, life- DIABETES COMPLICATIONS
treatment of obesity, dyslipidemia, style, and financial considerations.
CVD, hypertension, and nephropathy. Monitoring of glucose and A1C, lipids, I. CVD: management of risk factors
● Improve health through healthy food blood pressure, and renal status is essen- and screening for coronary artery
choices and physical activity. tial to evaluate nutrition-related out- disease
● Address individual nutritional needs, comes. If goals are not met (Table 6), CVD is the major cause of mortality for
taking into consideration personal and changes must be made in the overall dia- persons with diabetes. It is also a major
cultural preferences and lifestyle while betes care and management plan. contributor to morbidity and direct and
respecting the individual’s wishes and indirect costs of diabetes. Type 2 diabetes
willingness to change. Recommendations is an independent risk factor for macro-
● People with diabetes should receive in- vascular disease, and its common coexist-
Goals of MNT that apply to specific situ- dividualized MNT as needed to achieve ing conditions (e.g., hypertension and
ations include the following: treatment goals, preferably provided by dyslipidemia) are also risk factors.
a registered dietitian familiar with the Studies have shown the efficacy of re-
● For youth with type 1 diabetes, provide components of diabetes MNT. (B) ducing cardiovascular risk factors in pre-
adequate energy to ensure normal venting or slowing CVD. Evidence is
growth and development; integrate in- PHYSICAL ACTIVITY summarized in the following sections and
sulin regimens into usual eating and ADA technical reviews on exercise in pa- reviewed in detail in the ADA technical
physical activity habits. tients with diabetes have summarized the reviews on hypertension (35), dyslipide-
● For youth with type 2 diabetes, facilitate value of exercise in the diabetes manage- mia (36), aspirin therapy (37), and smok-
changes in eating and physical activity ment plan (33,34). Regular exercise has ing cessation (38) and in the consensus
habits that reduce insulin resistance and been shown to improve blood glucose statement on CHD in people with diabe-
improve metabolic status. control, reduce cardiovascular risk fac- tes (39). Emphasis should be placed on
● For pregnant and lactating women, tors, contribute to weight loss, and im- reducing cardiovascular risk factors,
provide adequate energy and nutrients prove well-being. Furthermore, regular when possible, and clinicians should be
needed for optimal outcomes. exercise may prevent type 2 diabetes in alert for signs and symptoms of athero-
● For older adults, provide for the nutri- high-risk individuals (6 – 8). sclerosis.
tional and psychosocial needs of an ag- Before beginning a physical activity
ing individual. program, the patient with diabetes should A. Blood pressure control
● For individuals treated with insulin or have a detailed medical evaluation with Hypertension (blood pressure ⱖ140/90
insulin secretagogues, provide self- appropriate diagnostic studies. This ex- mmHg) is a common comorbidity of dia-
management education for treatment amination should screen for the presence betes, affecting the majority of people
(and prevention) of hypoglycemia, of macro- and microvascular complica- with diabetes, depending on type of dia-
acute illnesses, and exercise-related tions that may be worsened by the phys- betes, age, obesity, and ethnicity. Hyper-
blood glucose problems. ical activity program (see next section tension is also a major risk factor for CVD
● For individuals at risk for diabetes, de- regarding coronary heart disease [CHD] and microvascular complications such as
crease risk by encouraging physical ac- screening). Identification of areas of con- retinopathy and nephropathy. In type 1
tivity and promoting foods choices that cern will allow the design of an individu- diabetes, hypertension is often the result
facilitate moderate weight loss or at alized physical activity plan that can of underlying nephropathy. In type 2 di-
least prevent weight gain. minimize risk to the patient. abetes, hypertension may be present as
All levels of physical activity, includ- part of the metabolic syndrome (i.e., obe-
Achieving nutrition-related goals requires ing leisure activities, recreational sports, sity, hyperglycemia, dyslipidemia) that is
a coordinated team effort that includes and competitive professional perfor- accompanied by high rates of CVD.
the person with diabetes. Because of the mance, can be performed by people with Randomized clinical trials have dem-
complexity of nutrition issues, it is recom- diabetes who do not have complications onstrated the benefit (reduction of CHD
mended that a registered dietitian, knowl- and have good glycemic control. The abil- events, stroke, and nephropathy) of low-
edgeable and skilled in implementing ity to adjust the therapeutic regimen (in- ering blood pressure to ⬍140 mmHg sys-
nutrition therapy into diabetes manage- sulin therapy and MNT) to allow safe tolic and ⬍80 mmHg diastolic in persons

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S21

Position Statement

with diabetes (40 – 43). Epidemiologic nale for use of these agents (see section II drug therapy in addition to lifestyle and
analyses show that blood pressures below). behavioral therapy. (A)
⬎115/75 mmHg are associated with in- The ALLHAT (Antihypertensive and ● Multiple drug therapy (two or more
creased cardiovascular event rates and Lipid-Lowering Treatment to Prevent agents at proper doses) is generally re-
mortality in persons with diabetes Heart Attack Trial), a large randomized quired to achieve blood pressure tar-
(40,44,45). Therefore, a target blood trial of different initial blood pressure gets. (B)
pressure goal of ⬍130/80 mmHg is rea- pharmacological therapies, found no ● Patients with a systolic blood pressure
sonable if it can be safely achieved. large differences between initial therapy of 130 –139 mmHg or a diastolic blood
Although there are no well-controlled with a chlorthalidone, amlodipine and lis- pressure of 80 – 89 mmHg should be
studies of diet and exercise in the treat- inopril. Diuretics appeared slightly more given lifestyle and behavioral therapy
ment of hypertension in persons with di- effective than other agents, particularly alone for a maximum of 3 months and
abetes, reducing sodium intake and body for reducing heart failure (53). The then, if targets are not achieved, in ad-
weight (when indicated), increasing con- ␣-blocker arm of the ALLHAT was termi- dition, be treated with pharmacological
sumption of fruits, vegetables, and low-fat nated after interim analysis showed that agents that block the renin-angiotensin
dairy products, avoiding excessive alco- doxazosin was substantially less effective system. (E)
hol consumption, and increasing activity in reducing congestive heart failure than ● Initial drug therapy for those with a
levels have been shown to be effective in diuretic therapy (54). blood pressure ⬎140/90 mmHg
reducing blood pressure in nondiabetic Before beginning treatment, patients should be with a drug class demon-
individuals (46a). These nonpharmaco- with elevated blood pressures should strated to reduce CVD events in pa-
logical strategies may also positively affect have their blood pressure reexamined tients with diabetes (ACE inhibitors,
glycemia and lipid control. Their effects within 1 month to confirm the presence of ARBs, ␤-blockers, diuretics, and cal-
on cardiovascular events have not been hypertension. A systolic blood pressure cium channel blockers). (A)
well measured. ⱖ160 mmHg or a diastolic blood pres- ● All patients with diabetes and hyper-
Lowering of blood pressure with reg- sure ⱖ100 mmHg, however, mandates tension should be treated with a regi-
imens based on antihypertensive drugs, that immediate pharmacological therapy men that includes either an ACE
including ACE inhibitors, angiotensin re- be initiated. Patients with hypertension inhibitor or ARB. If one class is not tol-
ceptor blockers (ARBs), ␤-blockers, di- should be seen as often as needed until erated, the other should be substituted.
uretics, and calcium channel blockers, the recommended blood pressure goal is If needed to achieve blood pressure tar-
has been shown to be effective in lowering obtained and then seen as necessary (40). gets, a thiazide diuretic should be
cardiovascular events. Several studies In these patients, other cardiovascular added. (E)
suggest that ACE inhibitors may be supe- risk factors, including obesity, hyperlip- ● If ACE inhibitors, ARBs, or diuretics are
rior to dihydropyridine calcium channel idemia, smoking, presence of microalbu- used, monitor renal function and se-
blockers (DCCBs) in reducing cardiovas- minuria (assessed before initiation of rum potassium levels. (E)
cular events (47,48). Additionally, recent treatment), and glycemic control, should ● While there are no adequate head-to-
data in people with diabetic nephropathy be carefully assessed and treated. Many head comparisons of ACE inhibitors
indicate that ARBs may be superior to DC- patients will require three or more drugs and ARBs, there is clinical trial support
CBs for reducing cardiovascular events to reach target goals. for each of the following statements:
(49). Conversely, in the recently com-
pleted International Verapamil Study Recommendations ● In patients with type 1 diabetes, with
(INVEST) of more than 22,000 people hypertension and any degree of albu-
with coronary artery disease and hyper- Screening and diagnosis minuria, ACE inhibitors have been
tension, the nondihydropyridine calcium ● Blood pressure should be measured at shown to delay the progression of ne-
channel blocker, verapamil, demon- every routine diabetes visit. Patients phropathy. (A)
strated a similar reduction in cardiovascu- found to have systolic blood pressure ● In patients with type 2 diabetes, hyper-
lar mortality to a ␤-blocker. Moreover, ⱖ130 or diastolic blood pressure ⱖ80 tension, and microalbuminuria, ACE
this relationship held true in the diabetic mmHg should have blood pressure inhibitors and ARBs have been shown
subgroup (49a). confirmed on a separate day. (C) to delay the progression to macroalbu-
ACE inhibitors have been shown to minuria. (A)
improve cardiovascular outcomes in Goals ● In those with type 2 diabetes, hyperten-
high-cardiovascular-risk patients with or ● Patients with diabetes should be treated sion, macroalbuminuria, and renal in-
without hypertension (50,51). In patients to a systolic blood pressure ⬍130 sufficiency, ARBs have been shown to
with congestive heart failure, ACE inhib- mmHg. (B) delay the progression of nephropathy.
itors are associated with better outcomes ● Patients with diabetes should be treated (A)
when compared with ARBs. ARBs also im- to a diastolic blood pressure ⬍80
prove cardiovascular outcomes in the mmHg. (B) ● In elderly hypertensive patients, blood
subset of patients with hypertension, dia- pressure should be lowered gradually
betes, and end-organ injury (52). The Treatment to avoid complications. (E)
compelling effect of ACE inhibitors or ● Patients with hypertension (systolic ● Patients not achieving target blood
ARBs in patients with albuminuria or re- blood pressure ⱖ140 or diastolic blood pressure despite multiple drug therapy
nal insufficiency provide additional ratio- pressure ⱖ90 mmHg) should receive should be referred to a physician expe-

S22 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

 Standards of Medical Care

rienced in the care of patients with hy- from baseline with the statin, simvastatin tablished.
pertension. (E) was associated with an ⬃25% reduction • Type 1 diabetes: Begin prior to pu-
● Orthostatic measurement of blood in the first event rate for major coronary berty, if positive family history of
pressure should be performed in peo- artery events independent of baseline CVD (or if family history is un-
ple with diabetes and hypertension LDL, preexisting vascular disease, type or known), and at puberty, if family
when clinically indicated. (E) duration of diabetes, or adequacy of gly- history is known and is negative.
cemic control (58). Therefore, in patients • Type 2 diabetes: Begin at diagnosis,
B. Lipid management over the age of 40, statin therapy should regardless of pubertal status.
Patients with type 2 diabetes have an in- be routinely considered. In patients with • If lipid values are considered low
creased prevalence of lipid abnormalities LDL ⬎130 mg/dl, initial therapy with risk, repeat lipid profile every 2–5
that contributes to higher rates of CVD. both lifestyle intervention and a statin is years based on CVD risk status.
Lipid management aimed at lowering indicated. In patients with LDL between
LDL cholesterol, raising HDL cholesterol, 100 mg/dl (2.60 mmol/l) and 129 mg/dl
and lowering triglycerides has been (3.30 mmol/l), a variety of treatment Treatment recommendations and
shown to reduce macrovascular disease strategies are available, including more goals
and mortality in patients with type 2 dia- aggressive nutrition intervention or phar- ● Lifestyle modification focusing on the
betes, particularly those who have had macological treatment with a statin. If the reduction of saturated fat and choles-
prior cardiovascular events. HDL is ⬍40 mg/dl and the LDL is be- terol intake, weight loss, increased
In studies using HMG (hydroxymeth- tween 100 and 129 mg/dl, a fibric acid physical activity, and smoking cessa-
ylglutaryl) CoA reductase inhibitors (st- derivative or niacin might be used. tion has been shown to improve the
atins), patients with diabetes achieved Niacin is the most effective drug for lipid profile in patients with diabetes.
significant reductions in coronary and ce- raising HDL but can significantly increase (A)
rebrovascular events (55–58). In two blood glucose at a high dose. More recent ● Patients who do not achieve lipid goals
studies using the fibric acid derivative studies demonstrate that at modest doses with lifestyle modifications require
gemfibrozil, reductions in cardiovascular (750 –2,000 mg/day), significant benefit
pharmacological therapy. (A)
end points were also achieved (59,60). with regards to LDL, HDL, and triglycer- ● Lower LDL cholesterol to ⬍100 mg/dl
Target lipid levels are shown in Table ide levels are accompanied by modest
6. Lifestyle intervention including MNT, changes in glucose that are generally ame- (2.6 mmol/l) as the primary goal of
increased physical activity, weight loss, nable to adjustment of diabetes therapy therapy for adults. (B)
● Lowering LDL cholesterol with a statin
and smoking cessation should allow some (62,63).
patients to reach these lipid levels. Nutri- Combination therapy, with a statin is associated with a reduction in cardio-
tion intervention should be tailored ac- and a fibrate or statin and niacin, may be vascular events. (A)
cording to each patient’s age, type of efficacious for patients needing treatment ● In people with diabetes over the age of

diabetes, pharmacological treatment, for all three lipid fractions, but this com- 40 with a total cholesterol ⱖ135 mg/dl,
lipid levels, and other medical conditions bination is associated with an increased statin therapy to achieve an LDL reduc-
and should focus on the reduction of sat- risk for abnormal transaminase levels, tion of ⬃30% regardless of baseline
urated fat, cholesterol, and transunsat- myositis, or rhabdomyolysis. The risk of LDL levels may be appropriate. (A)
urated fat intake. Glycemic control can rhabdomyolysis seems to be lower when ● In children and adolescents with diabe-
also beneficially modify plasma lipid lev- statins are combined with fenofibrate tes, LDL cholesterol should be lowered
els. Particularly in patients with very high than gemfibrozil. to ⬍100 mg/dl (2.60 mmol/l) using
triglycerides and poor glycemic control, In children and adolescentswith dia- diet as well as medications based on
glucose lowering maybe necessary to con- betes, LDL cholesterol should be lowered LDL level and other cardiovascular risk
trol hypertriglyceridemia. to ⬍100 mg/dl (2.60 mmol/l) using diet factors in addition to diabetes. (E)
Pharmacological treatment is indi- and medications based on LDL level and ● Lower triglycerides to ⬍150 mg/dl (1.7
cated if there is an inadequate response to other cardiovascular risk factors in addi- mmol/l) and raise HDL cholesterol to
lifestyle modifications and improved glu- tion to diabetes (64,65). ⬎40 mg/dl (1.15 mmol/l). In women,
cose control. However, in patients with an HDL goal 10 mg/dl higher may be
clinical CVD and LDL ⬎100 mg/dl, phar- Recommendations
appropriate. (C)
macological therapy should be initiated at ● Lowering triglycerides and increasing
the same time that lifestyle intervention is Screening
started. ● In adult patients, test for lipid disorders HDL cholesterol with a fibrate are asso-
The first priority of pharmacological at least annually and more often if ciated with a reduction in cardiovascu-
therapy is to lower LDL cholesterol to a needed to achieve goals. In adults with lar events in patients with clinical CVD,
target goal of ⬍100 mg/dl (2.60 mmol/l). low-risk lipid values (LDL ⬍100 mg/dl, low HDL and near-normal levels of
For LDL lowering, statins are the drugs of HDL ⬎50 mg/dl, and triglycerides LDL. (A)
choice (61). ⬍150 mg/dl), repeat lipid assessments ● Combination therapy employing st-

The Heart Protection Study demon- every 2 years. (E) atins and fibrates or niacin may be nec-
strated that in people with diabetes over ● In children ⬎2 years of age, perform a essary to achieve lipid targets, but have
the age of 40 with a total cholesterol lipid profile after diagnosis of diabetes not been evaluated in outcomes studies
⬎135 mg/dl, LDL reduction of ⬃30% and when glucose control has been es- for either event reduction or safety. (E)

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S23

Position Statement

C. Anti-platelet agents in diabetes tendency, receiving anticoagulant ther- ● Include smoking cessation counseling
The use of aspirin in diabetes is reviewed apy, recent gastrointestinal bleeding, and other forms of treatment as a rou-
in detail in the ADA technical review (37) and clinically active hepatic disease are tine component of diabetes care. (B)
and position statement (66) on aspirin not candidates for aspirin therapy.
therapy. Aspirin has been recommended Other antiplatelet agents may be a rea- E. CHD screening and treatment
as a primary (66a,66b) and secondary sonable alternative for patients with CHD screening and treatment are re-
therapy to prevent cardiovascular events high risk. (E) viewed in detail in the ADA consensus
in diabetic and nondiabetic individuals. ● Aspirin therapy should not be recom- statement on CHD in people with diabe-
One large meta-analysis and several clin- mended for patients under the age of 21 tes (39). To identify the presence of CHD
ical trials demonstrate the efficacy of us- years because of the increased risk of in diabetic patients without clear or sug-
ing aspirin as a preventive measure for Reye’s syndrome associated with aspi- gestive symptoms of coronary artery dis-
cardiovascular events, including stroke rin use in this population. People under ease (CAD), a risk factor– based approach
and myocardial infarction. Many trials the age of 30 have not been studied. (E) to the initial diagnostic evaluation and
have shown an ⬃30% decrease in myo- subsequent follow-up is recommended.
cardial infarction and a 20% decrease in D. Smoking cessation At least annually, cardiovascular risk fac-
stroke in a wide range of patients, includ- Issues of smoking in diabetes are re- tors should be assessed. These risk factors
ing young and middle-aged patients, pa- viewed in detail in the ADA technical re- include dyslipidemia, hypertension,
tients with and without a history of CVD, view (38) and position statement (68) on smoking, a positive family history of pre-
males and females, and patients with hy- smoking cessation. A large body of evi- mature coronary disease, and the pres-
pertension. dence from epidemiological, case- ence of micro- or macroalbuminuria.
Dosages used in most clinical trials control, and cohort studies provides Abnormal risk factors should be treated as
ranged from 75 to 325 mg/day. There is convincing documentation of the causal described elsewhere in these guidelines.
no evidence to support any specific dose, link between cigarette smoking and Patients at increased CHD risk should re-
but using the lowest possible dosage may health risks. Cigarette smoking contrib- ceive aspirin and may warrant an ACE in-
help reduce side effects. There is no evi- utes to one of every five deaths in the U.S. hibitor.
dence for a specific age at which to start and is the most important modifiable Candidates for a diagnostic cardiac
aspirin, but at ages below 30 years, aspirin cause of premature death. Much of the stress test include those with 1) typical or
has not been studied. prior work documenting the impact of atypical cardiac symptoms and 2) an ab-
Clopidogrel has been demonstrated smoking on health did not separately dis- normal resting electrocardiogram (ECG).
to reduce CVD rates in diabetic individu- cuss results on subsets of individuals with Candidates for a screening cardiac stress
als (67). Adjunctive therapy in very high- diabetes, suggesting that the identified test include those with 1) a history of pe-
risk patients or as alternative therapy in risks are at least equivalent to those found ripheral or carotid occlusive disease; 2)
aspirin-intolerant patients should be con- in the general population. Other studies sedentary lifestyle, age ⬎35 years, and
sidered. of individuals with diabetes consistently plans to begin a vigorous exercise pro-
found a heightened risk of morbidity and gram; and 3) two or more of the risk fac-
Recommendation premature death associated with the de- tors noted above.
● Use aspirin therapy (75–162 mg/day) velopment of macrovascular complica- Current evidence suggests that non-
as a secondary prevention strategy in tions among smokers. Smoking is also invasive tests can improve assessment of
those with diabetes with a history of related to the premature development of future CHD risk. There is, however, no
myocardial infarction, vascular bypass microvascular complications of diabetes current evidence that such testing in
procedure, stroke or transient ischemic and may have a role in the development of asymptomatic patients with risk factors
attack, peripheral vascular disease, type 2 diabetes. improves outcomes or leads to better uti-
claudication, and/or angina. (A) A number of large randomized clini- lization of treatments.
● Use aspirin therapy (75–162 mg/day) cal trials have demonstrated the efficacy Patients with abnormal exercise ECG
as a primary prevention strategy in and cost-effectiveness of counseling in and patients unable to perform an exer-
those with type 2 diabetes at increased changing smoking behavior. Such stud- cise ECG require additional or alternative
cardiovascular risk, including those ies, combined with others specific to in- testing. Currently, stress nuclear perfu-
who are over 40 years of age or who dividuals with diabetes, suggest that sion and stress echocardiography are
have additional risk factors (family his- smoking cessation counseling is effective valuable next-level diagnostic proce-
tory of CVD, hypertension, smoking, in reducing tobacco use (69,70). dures. A consultation with a cardiologist
dyslipidemia, albuminuria). (A) The routine and thorough assessment is recommended regarding further work-
● Use aspirin therapy (75–162 mg/day) of tobacco use is important as a means of up.
as a primary prevention strategy in preventing smoking or encouraging ces-
those with type 1 diabetes at increased sation. Special considerations should in-
cardiovascular risk, including those clude assessment of level of nicotine Recommendations
who are over 40 years of age or who dependence, which is associated with dif- ● Perform exercise stress testing in
have additional risk factors (family his- ficulty in quitting and relapse. asymptomatic diabetic patients based
tory of CVD, hypertension, smoking, on the criteria outlined above. Consider
dyslipidemia, albuminuria). (C) Recommendations a risk factor– based strategy for the di-
● People with aspirin allergy, bleeding ● Advise all patients not to smoke. (A) agnosis of CAD that might include

S24 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

 Standards of Medical Care

stress ECG and/or stress echocardiogra- (16). The UKPDS provided strong evi- Table 8—Definitions of abnormalities in al-
phy and/or perfusion imaging. (E) dence that control of blood pressure can bumin excretion
● Refer patients with signs and symptoms reduce the development of nephropathy
of CVD or with positive noninvasive (41). In addition, large prospective ran- Spot collection
test for CAD to a cardiologist for further domized studies in patients with type 1 Category (␮g/mg creatinine)
evaluation. (E) diabetes have demonstrated that achieve-
● In patients with treated congestive ment of lower levels of systolic blood Normal ⬍30
heart failure, metformin use is contra- pressure (⬍140 mmHg) achieved with Microalbuminuria 30–299
indicated. The thiazolidinediones are treatment using ACE inhibitors provides a Macro (clinical) 300
associated with fluid retention, and selective benefit over other antihyperten- albuminuria
their use can be complicated by the de- sive drug classes in delaying the progres- Because of variability in urinary albumin excretion,
velopment of congestive heart failure. sion from micro- to macroalbuminuria two of three specimens collected within a 3- to
6-month period should be abnormal before consid-
Caution in prescribing thiazolidinedio- and can slow the decline in glomerular ering a patient to have crossed one of these diagnos-
nes in the setting of known congestive filtration rate (GFR) in patients with mac- tic thresholds. Exercise within 24 h, infection, fever,
heart failure or other heart diseases as roalbuminuria (41,76 –78). congestive heart failure, marked hyperglycemia, and
well as in patients with preexisting In addition, ACE inhibitors have been marked hypertension may elevate urinary albumin
edema or concurrent insulin therapy is shown to reduce severe CVD (i.e., myo- excretion over baseline values.
required. (E) cardial infarction, stroke, death), thus fur-
● In patients ⬎55 years of age, with or ther supporting the use of these agents in urine microalbumin by immunoassay or
without hypertension but with another patients with microalbuminuria (50). by using a dipstick test specific for mi-
cardiovascular risk factor (history of ARBs have also been shown to reduce the croalbumin without simultaneously mea-
CVD, dyslipidemia, microalbuminuria, rate of progression from micro- to mac- suring urine creatinine is less expensive
smoking), an ACE inhibitor (if not con- roalbuminuria as well as ESRD in patients than the recommended methods, but is
traindicated) should be considered to with type 2 diabetes (79 – 81). Some evi- susceptible to false-negative and false-
reduce the risk of cardiovascular dence suggests that ARBs have a smaller positive determinations as a result of vari-
events. (A) magnitude of rise in potassium compared ation in urine concentration due to
● In patients with a prior myocardial in- with ACE inhibitors in people with ne- hydration and other factors.
farction or in patients undergoing ma- phropathy (82). With regards to slowing At least two of three tests measured
jor surgery, ␤-blockers, in addition, the progression of nephropathy, the use within a 6-month period should show el-
should be considered to reduce mortal- of DCCBs as initial therapy is not more evated levels before a patient is designated
ity. (A) effective than placebo. Their use in ne- as having microalbuminuria. Abnormali-
phropathy should be restricted to addi- ties of albumin excretion are defined in
II. Nephropathy screening and tional therapy to further lower blood Table 8.
treatment pressure in patients already treated with Physicians may use the Levey modifi-
Diabetic nephropathy occurs in 20 – 40% ACE inhibitors or ARBs (49). In the set- cation of the Cockcroft and Gault equa-
of patients with diabetes and is the single ting of albuminuria or nephropathy, in tion to calculate estimated GFR (eGFR)
leading cause of end-stage renal disease patients unable to tolerate ACE inhibitors from serum creatinine and to stage the
(ESRD). Persistent albuminuria in the and/or ARBs, consider the use of non- patient’s renal disease (87,88). The eGFR
range of 30 –299 mg/24 h (microalbu- DCCBs, ␤-blockers, or diuretics for the can easily be calculated by going to www.
minuria) has been shown to be the earliest management of blood pressure (83,84). kidney.org/professionals/dogi/gfr_
stage of diabetic nephropathy in type 1 A meta-analysis of several small stud- calculator.cfm.
diabetes and a marker for development of ies has shown that protein restriction may The role of annual microalbumuria
nephropathy in type 2 diabetes. Mi- be of benefit in some patients whose ne- assessment is less clear after diagnosis of
croalbuminuria is also a well-established phropathy seems to be progressing de- microalbuminuria and institution of ACE
marker of increased CVD risk (71). spite optimal glucose and blood pressure inhibitor or ARB therapy and blood pres-
Patients with microalbuminuria who control (85). sure control. Most experts, however, rec-
progress to macroalbuminuria (ⱖ300 Screening for microalbuminuria can ommend continued surveillance to assess
mg/24 h) are likely to progress to ESRD be performed by three methods: 1) mea- both response to therapy and progression
over a period of years (72,73). Over the surement of the albumin-to-creatinine ra- of disease. Many experts suggest that
past several years, a number of interven- tio in a random, spot collection (preferred managing urine microalbuminuria to re-
tions have been demonstrated to reduce method); 2) 24-h collection with creati- duce it to the normal or near-normal
the risk and slow the progression of renal nine, allowing the simultaneous measure- range may improve renal and cardiovas-
disease. ment of creatinine clearance; and 3) timed cular prognosis; this approach has not
Intensive diabetes management with (e.g., 4-h or overnight) collection. been formally evaluated in prospective
the goal of achieving near normoglycemia The analysis of a spot sample for the trials.
has been shown in large prospective ran- albumin-to-creatinine ratio is strongly Consider referral to a physician expe-
domized studies to delay the onset of mi- recommended by most authorities rienced in the care of diabetic renal dis-
croalbuminuria and the progression of (86,87). The other two alternatives (24-h ease either when the GFR has fallen to
micro- to macroalbuminuria in patients collection and a timed specimen) are ⬍60 ml 䡠 min⫺1 䡠 1.73 m⫺2 or if difficul-
with type 1 (74,75) and type 2 diabetes rarely necessary. Measurement of a spot ties occur in the management of hyper-

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S25

Position Statement

tension or hyperkalemia. It is suggested ories), the current adult-recommended transiently aggravated; laser photocoagu-
that consultation with a nephrologist be dietary allowance for protein. Further lation surgery can minimize this risk (92).
obtained when the GFR is ⬍30 ml 䡠 restriction may be useful in slowing the Patients with type 1 diabetes should
min⫺1 䡠 1.73 m⫺2. Early referral of such decline of GFR in selected patients. (B) have an initial dilated and comprehensive
patients has been found to reduce cost ● With regards to slowing the progres- eye examination by an ophthalmologist or
and improve quality of care and keep peo- sion of nephropathy, the use of DCCBs optometrist within 3–5 years after the on-
ple off dialysis longer (89). For a complete as initial therapy is not more effective set of diabetes. Patients with type 2 diabe-
discussion on the treatment of nephropa- than placebo. Their use in nephropathy tes should have an initial dilated and
thy, see the ADA’s position statement “Di- should be restricted to additional ther- comprehensive eye examination by an
abetic Nephropathy” (90). apy to further lower blood pressure in ophthalmologist or optometrist shortly
patients already treated with ACE in- after the diagnosis of diabetes. Subse-
Recommendations hibitors or ARBs. (B) quent examinations for type 1 and type 2
● In the setting of albuminuria or ne- diabetic patients should be repeated an-
General recommendations phropathy, in patients unable to toler- nually by an ophthalmologist or optome-
● To reduce the risk and/or slow the pro- ate ACE inhibitors and/or ARBs, trist who is knowledgeable and
gression of nephropathy, optimize glu- consider the use of non-DCCBs, experienced in diagnosing the presence of
cose control. (A) ␤-blockers, or diuretics for the manage- diabetic retinopathy and is aware of its
● To reduce the risk and/or slow the pro- ment of blood pressure. (E) management. Less frequent exams (every
gression of nephropathy, optimize ● If ACE inhibitors, ARBs, or diuretics are 2–3 years) may be considered with the
blood pressure control. (A) used, monitor serum potassium levels advice of an eye care professional in the
for the development of hyperkalemia. setting of a normal eye exam (93–95). Ex-
Screening (B) aminations will be required more fre-
● Perform an annual test for the presence ● Consider referral to a physician experi- quently if retinopathy is progressing.
of microalbuminuria in type 1 diabetic enced in the care of diabetic renal dis- One of the main motivations for
patients with diabetes duration of ⱖ5 ease when the eGFR has fallen to ⬍60 screening for diabetic retinopathy is the
years and in all type 2 diabetic patients, ml 䡠 min⫺1 䡠 1.73 m⫺2 or if difficulties established efficacy of laser photocoagu-
starting at diagnosis. (E) occur in the management of hyperten- lation surgery in preventing visual loss.
sion or hyperkalemia. (B) Two large National Institutes of Health–
Treatment sponsored trials, the Diabetic Retinopa-
● In the treatment of both micro- and III. Diabetic retinopathy screening thy Study (DRS) (96 –100) and the Early
macroalbuminuria, either ACE inhibi- and treatment Treatment Diabetic Retinopathy Study
tors or ARBs should be used. (A) Diabetic retinopathy is a highly specific (ETDRS), provide the strongest support
vascular complication of both type 1 and for the therapeutic benefit of photocoag-
● While there are no adequate head-to- type 2 diabetes. The prevalence of reti- ulation surgery (101–107).
head comparisons of ACE inhibitors nopathy is strongly related to the duration The DRS tested whether scatter (pan-
and ARBs, there is clinical trial support of diabetes. Diabetic retinopathy is esti- retinal) photocoagulation surgery could
for each of the following statements: mated to be the most frequent cause of reduce the risk of vision loss from PDR.
new cases of blindness among adults aged Severe visual loss (i.e., best acuity of
• In patients with type 1 diabetes, with 20 –74 years. 5/200 or worse) was seen in 15.9% of un-
hypertension and any degree of albu- Intensive diabetes management with treated vs. 6.4% of treated eyes. The ben-
minuria, ACE inhibitors have been the goal of achieving near normoglycemia efit was greatest among patients whose
shown to delay the progression of has been shown in large prospective ran- baseline evaluation revealed high-risk
nephropathy. (A) domized studies to prevent and/or delay characteristics (HRCs) (chiefly disc neo-
• In patients with type 2 diabetes, hy- the onset of diabetic retinopathy (15,16). vascularization or vitreous hemorrhage
pertension, and microalbuminuria, In addition to glycemic control, several with any retinal neovascularization). Of
ACE inhibitors and ARBs have been other factors seem to increase the risk of control eyes with HRCs, 26% progressed
shown to delay the progression to retinopathy. The presence of nephropa- to severe visual loss vs. 11% of treated
macroalbuminuria. (A) thy is associated with retinopathy. High eyes. Given the risk of a modest loss of
• In patients with type 2 diabetes, hy- blood pressure is an established risk fac- visual acuity and of contraction of visual
pertension, macroalbuminuria, and tor for the development of macular edema field from panretinal laser surgery, such
renal insufficiency (serum creatinine and is associated with the presence of pro- therapy has been primarily recommended
⬎1.5 mg/dl), ARBs have been shown liferative diabetic retinopathy (PDR). for eyes approaching or reaching HRCs.
to delay the progression of nephrop- Lowering blood pressure, as demon- The ETDRS established the benefit of
athy. (A) strated by the UKPDS, has been shown to focal laser photocoagulation surgery in
• If one class is not tolerated, the other decrease the progression of retinopathy. eyes with macular edema, particularly
should be substituted. (E) Several case series and a controlled pro- those with clinically significant macular
spective study suggest that pregnancy in edema. In patients with clinically signifi-
● With presence of nephropathy, initiate type 1 diabetic patients may aggravate ret- cant macular edema after 2 years, 20% of
protein restriction to ⱕ0.8 g 䡠 kg⫺1 inopathy (91). During pregnancy and 1 untreated eyes had a doubling of the vi-
body wt⫺1 䡠 day⫺1 (⬃10% of daily cal- year postpartum, retinopathy may be sual angle (e.g., 20/50 to 20/100) com-

S26 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

 Standards of Medical Care

pared with 8% of treated eyes. Other able and experienced in diagnosing the ● Peripheral vascular disease (decreased
results from the ETDRS indicate that, pro- presence of diabetic retinopathy and is or absent pedal pulses).
vided careful follow-up can be main- aware of its management. Less frequent ● A history of ulcers or amputation.
tained, scatter photocoagulation surgery exams (every 2–3 years) may be consid- ● Severe nail pathology.
is not recommended for eyes with mild or ered with the advice of an eye care pro-
moderate nonproliferative diabetic reti- fessional in the setting of a normal eye All individuals with diabetes should re-
nopathy (NPDR). When retinopathy is exam. Examinations will be required ceive an annual foot examination to iden-
more severe, scatter photocoagulation more frequently if retinopathy is pro- tify high-risk foot conditions. This
surgery should be considered, and usu- gressing. (B) examination should include assessment
ally should not be delayed, if the eye has ● When planning pregnancy, women of protective sensation, foot structure and
reached the high-risk proliferative stage. with preexisting diabetes should have a biomechanics, vascular status, and skin
In older-onset patients with severe NPDR comprehensive eye examination and integrity. People with one or more high-
or less than high-risk PDR, the risk of se- should be counseled on the risk of de- risk foot conditions should be evaluated
vere visual loss and vitrectomy is reduced velopment and/or progression of dia- more frequently for the development of
⬃50% by laser photocoagulation surgery betic retinopathy. Women with additional risk factors. People with neu-
at these earlier stages. diabetes who become pregnant should ropathy should have a visual inspection of
Laser photocoagulation surgery in have a comprehensive eye examination their feet at every visit with a health care
both the DRS and the ETDRS was benefi- in the first trimester and close fol- professional. Evaluation of neurological
cial in reducing the risk of further visual low-up throughout pregnancy and for status in the low-risk foot should include
loss, but generally not beneficial in revers- 1 year postpartum. This guideline does a quantitative somatosensory threshold
ing already diminished acuity. This pre- not apply to women who develop GDM test, using the Semmes-Weinstein 5.07
ventive effect and the fact that patients because such individuals are not at in- (10-g) monofilament. The skin should be
with PDR or macular edema may be creased risk for diabetic retinopathy. assessed for integrity, especially between
asymptomatic provide strong support for (B) the toes and under the metatarsal heads.
a screening program to detect diabetic ret- The presence of erythema, warmth, or
inopathy. Treatment callus formation may indicate areas of tis-
For a detailed review of the evidence ● Laser therapy can reduce the risk of vi- sue damage with impending breakdown.
and further discussion, see the ADA’s sion loss in patients with HRCs. (A) Bony deformities, limitation in joint mo-
technical review and position statement ● Promptly refer patients with any level of bility, and problems with gait and balance
on this subject (91,108,109). macular edema, severe NPDR, or any should be assessed.
PDR to an ophthalmologist who is People with neuropathy or evidence
Recommendations knowledgeable and experienced in the of increased plantar pressure may be ad-
management and treatment of diabetic equately managed with well-fitted walk-
General recommendations retinopathy. (A) ing shoes or athletic shoes. Patients
● Optimal glycemic control can substan- should be educated on the implications of
tially reduce the risk and progression of sensory loss and the ways to substitute
diabetic retinopathy. (A) IV. Foot care other sensory modalities (hand palpation,
● Optimal blood pressure control can re- Amputation and foot ulceration are the visual inspection) for surveillance of early
duce the risk and progression of dia- most common consequences of diabetic problems. People with evidence of in-
betic retinopathy. (A) neuropathy and major causes of morbid- creased plantar pressure (e.g., erythema,
● Aspirin therapy does not prevent reti- ity and disability in people with diabetes. warmth, callus, or measured pressure)
nopathy or increase the risks of hemor- Early recognition and management of in- should use footwear that cushions and re-
rhage. (A) dependent risk factors can prevent or de- distributes the pressure. Callus can be de-
lay adverse outcomes. brided with a scalpel by a foot care
Screening The risk of ulcers or amputations is specialist or other health professional
● Adults and adolescents with type 1 di- increased in people who have had diabe- with experience and training in foot care.
abetes should have an initial dilated tes ⬎10 years, are male, have poor glu- People with bony deformities (e.g., ham-
and comprehensive eye examination by cose control, or have cardiovascular, mertoes, prominent metatarsal heads,
an ophthalmologist or optometrist retinal, or renal complications. The fol- bunions) may need extra-wide shoes or
within 3–5 years after the onset of dia- lowing foot-related risk conditions are as- depth shoes. People with extreme bony
betes. (B) sociated with an increased risk of deformities (e.g., Charcot foot) that can-
● Patients with type 2 diabetes should amputation: not be accommodated with commercial
have an initial dilated and comprehen- therapeutic footwear may need custom-
sive eye examination by an ophthalmol- ● Peripheral neuropathy with loss of pro- molded shoes.
ogist or optometrist shortly after the tective sensation. Initial screening for peripheral arte-
diagnosis of diabetes. (B) ● Altered biomechanics (in the presence rial disease (PAD) should include a his-
● Subsequent examinations for type 1 of neuropathy). tory for claudication and an assessment of
and type 2 diabetic patients should be ● Evidence of increased pressure (ery- the pedal pulses. Consider obtaining an
repeated annually by an ophthalmolo- thema, hemorrhage under a callus). ankle-brachial index (ABI), as many pa-
gist or optometrist who is knowledge- ● Bony deformity. tients with PAD are asymptomatic. Refer

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S27

Position Statement

patients with significant or a positive ABI assessment of the pedal pulses. Con- rather than randomized. Thus, it is im-
for further vascular assessment and con- sider obtaining an ABI, as many pa- possible to be certain that the lower mal-
sider exercise, medications, and surgical tients with PAD are asymptomatic. (C) formation rates resulted fully from
options (110). ● Refer patients with significant claudica- improved diabetes care. Nonetheless, the
Patients with diabetes and high-risk tion or a positive ABI for further vascu- overwhelming evidence supports the
foot conditions should be educated re- lar assessment and consider exercise, concept that malformations can be re-
garding their risk factors and appropriate medications, and surgical options. (C) duced or prevented by careful manage-
management. Patients at risk should un- ● Perform a comprehensive foot exami- ment of diabetes before pregnancy.
derstand the implications of the loss of nation annually on patients with diabe- Planned pregnancies greatly facilitate
protective sensation, the importance of tes to identify risk factors predictive of preconception diabetes care. Unfortu-
foot monitoring on a daily basis, the ulcers and amputations. Perform a vi- nately, nearly two-thirds of pregnancies
proper care of the foot, including nail and sual inspection of patients’ feet at each in women with diabetes are unplanned,
skin care, and the selection of appropriate routine visit. (E) leading to a persistent excess of malfor-
footwear. The patient’s understanding of mations in infants of diabetic mothers. To
these issues and their physical ability to PREVENTIVE CARE minimize the occurrence of these devas-
conduct proper foot surveillance and care tating malformations, standard care for all
should be assessed. Patients with visual I. Preconception care women with diabetes who have child-
difficulties, physical constraints prevent- Major congenital malformations remain bearing potential should include 1) edu-
ing movement, or cognitive problems that the leading cause of mortality and serious cation about the risk of malformations
impair their ability to assess the condition morbidity in infants of mothers with type associated with unplanned pregnancies
of the foot and to institute appropriate 1 and type 2 diabetes. Observational stud- and poor metabolic control and 2) use of
responses will need other people, such as ies indicate that the risk of malformations effective contraception at all times, unless
family members, to assist in their care. increases continuously with increasing the patient is in good metabolic control
Patients at low risk may benefit from ed- maternal glycemia during the first 6 – 8 and actively trying to conceive.
ucation on foot care and footwear. weeks of gestation, as defined by first tri- Women contemplating pregnancy
For a detailed review of the evidence mester A1C concentrations. There is no need to be seen frequently by a multidis-
and further discussion, see the ADA’s threshold for A1C values above which the ciplinary team experienced in the man-
technical review and position statement risk begins or below which it disappears. agement of diabetes before and during
in this area (111,112). However, malformation rates above the pregnancy. Teams may vary but should
Problems involving the feet, espe- 1–2% background rate seen in nondia- include a diabetologist, an internist or a
cially ulcers and wound care, may require betic pregnancies appear to be limited to family physician, an obstetrician, a diabe-
care by a podiatrist, orthopedic surgeon, pregnancies in which first trimester A1C tes educator, a dietitian, a social worker,
or rehabilitation specialist experienced in concentrations are ⬎1% above the nor- and other specialists as necessary. The
the management of persons with diabetes. mal range. goals of preconception care are to 1) inte-
For a complete discussion on wound care, Preconception care of diabetes ap- grate the patient into the management of
see the ADA’s consensus statement on di- pears to reduce the risk of congenital mal- her diabetes, 2) achieve the lowest A1C
abetic foot wound care (113). formations. Five nonrandomized studies test results possible without excessive hy-
have compared rates of major malforma- poglycemia, 3) assure effective contracep-
Recommendations tions in infants between women who par- tion until stable and acceptable glycemia
● A multidisciplinary approach is recom- ticipated in preconception diabetes care is achieved, and 4) identify, evaluate, and
mended for persons with foot ulcers programs and women who initiated in- treat long-term diabetic complications
and high-risk feet, especially those with tensive diabetes management after they such as retinopathy, nephropathy, neu-
a history of prior ulcer or amputation. were already pregnant. The preconcep- ropathy, hypertension, and CAD.
(A) tion care programs were multidisci- For further discussion, see the ADA’s
● The foot examination can be accom- plinary and designed to train patients in technical review and position statement
plished in a primary care setting and diabetes self-management with diet, in- on this subject (119,120).
should include the use of a Semmes- tensified insulin therapy, and SMBG.
Weinstein monofilament, tuning fork, Goals were set to achieve normal blood Recommendations
palpation, and a visual examination. (B) glucose concentrations, and ⬎80% of ● A1C levels should be normal or as close
● Educate all patients, especially those subjects achieved normal A1C concentra- to normal as possible (⬍1% above the
with risk factors, including smoking, or tions before they became pregnant (114 – upper limits of normal) in an individual
prior lower-extremity complications, 118). In all five studies, the incidence of patient before conception is attempted.
about the risk and prevention of foot major congenital malformations in (B)
problems and reinforce self-care behav- women who participated in preconcep- ● All women with diabetes and child-
ior. (B) tion care (range 1.0 –1.7% of infants) was bearing potential should be educated
● Refer high-risk patients to foot care spe- much lower than the incidence in women about the need for good glucose control
cialists for ongoing preventive care and who did not participate (range 1.4 – before pregnancy. They should partici-
life-long surveillance. (C) 10.9% of infants). One limitation of these pate in family planning. (E)
● Initial screening for PAD should in- studies is that participation in preconcep- ● Women with diabetes who are contem-
clude a history for claudication and an tion care was self-selected by patients plating pregnancy should be evaluated

S28 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

 Standards of Medical Care

and, if indicated, treated for diabetic of age as well as for all persons of any age years of comorbidity; others who are
retinopathy, nephropathy, neuropathy, with diabetes. newly diagnosed may have had years of
and CVD. (E) For a complete discussion on the pre- undiagnosed comorbidity or few compli-
● Among the drugs commonly used in vention of influenza and pneumococcal cations from the disease. Some older
the treatment of patients with diabetes, disease in people with diabetes, consult adults with diabetes are frail and have
statins are pregnancy category X and the technical review and position state- other underlying chronic conditions,
should be discontinued before concep- ment on this subject (124,125). substantial diabetes-related comorbidity,
tion if possible. ACE inhibitors and or limited physical or cognitive function-
ARBs are category C in the first trimes- Recommendations ing, but other older persons with diabetes
ter (maternal benefit may outweigh fe- ● Annually provide an influenza vaccine have little comorbidity and are active. Life
tal risk in certain situations), but to all diabetic patients 6 months of age expectancies are also highly variable for
category D in later pregnancy, and or older. (C) this population. Clinicians caring for
should generally be discontinued be- ● Provide at least one lifetime pneumo- older adults with diabetes must take this
fore pregnancy. Among the oral antidi- coccal vaccine for adults with diabetes. heterogeneity into consideration when
abetic agents, metformin and acarbose A one-time revaccination is recom- setting and prioritizing treatment goals.
are classified as category B and all oth- mended for individuals ⬎64 years of All this having been said, patients
ers as category C; potential risks and age previously immunized when they who can be expected to live long enough
benefits of oral antidiabetic agents in were ⬍65 years of age if the vaccine was to reap the benefits of long-term intensive
the preconception period must be care- administered ⬎5 years ago. Other indi- diabetes management (⬃10 years) and
fully weighed, recognizing that suffi- cations for repeat vaccination include who are active, cognitively intact, and
cient data are not available to establish nephrotic syndrome, chronic renal dis- willing to undertake the responsibility of
the safety of these agents in pregnancy. ease, and other immunocompromised self-management should be encouraged
They should generally be discontinued states, such as after transplantation. (C) to do so and be treated using the stated
in pregnancy. (E) goals for younger adults with diabetes.
SPECIAL CONSIDERATIONS There is good evidence from middle-
aged and older adults suggesting that
II. Immunization I. Care of older adults with diabetes multidisciplinary interventions that pro-
Influenza and pneumonia are common, Diabetes is an important health condition vide education on medication use, moni-
preventable infectious diseases associated for the aging population; at least 20% of toring, and recognizing hypo- and
with high mortality and morbidity in the patients over the age of 65 years have di- hyperglycemia can significantly improve
elderly and in people with chronic dis- abetes. The number of older persons with glycemic control. Although control of hy-
eases. There are limited studies reporting diabetes can be expected to grow rapidly perglycemia is important, in older per-
the morbidity and mortality of influenza over the coming decades. A recent publi- sons with diabetes, greater reductions in
and pneumococcal pneumonia specifi- cation, “Guidelines for improving the care morbidity and mortality may result from
cally in people with diabetes. Observa- of the older person with diabetes,” con- control of all cardiovascular risk factors
tional studies of patients with a variety of tains evidence-based guidelines pro- rather than from tight glycemic control
chronic illnesses, including diabetes, duced in conjunction with the American alone. There is strong evidence from clin-
show that these conditions are associated Geriatric Society. This document contains ical trials of the value of treating hyper-
with an increase in hospitalizations for in- an excellent discussion of this area, and tension in the elderly. There is less
fluenza and its complications. Based on a specific guidelines and language from it evidence for lipid-lowering and aspirin
case-control series, influenza vaccine has have been incorporated below (126). Un- therapy, although as diabetic patients
been shown to reduce diabetes-related fortunately, there are no long-term stud- have such an elevated risk for CVD, ag-
hospital admission by as much as 79% ies in persons over 65 years of age gressive management of lipids and aspirin
during flu epidemics (121). People with demonstrating the benefits of tight glyce- use when not contraindicated are reason-
diabetes may be at increased risk of the mic control, blood pressure, and lipid able interventions.
bacteremic form of pneumococcal infec- control. Older persons with diabetes have As noted above, for patients with ad-
tion and have been reported to have a higher rates of premature death, func- vanced diabetes complications, life-
high risk of nosocomial bacteremia, tional disability, and coexisting illnesses limiting comorbid illness, or cognitive or
which has a mortality rate as high as 50%. such as hypertension, CHD, and stroke functional impairment, it is reasonable to
Safe and effective vaccines are avail- than those without diabetes. Older adults set less intensive glycemic target goals.
able that can greatly reduce the risk of with diabetes are also at greater risk than These patients are less likely to benefit
serious complications from these diseases other older persons for several common from reducing the risk of microvascular
(122,123). There is sufficient evidence to geriatric syndromes, such as polyphar- complications and more likely to suffer
support that people with diabetes have macy, depression, cognitive impairment, serious adverse effects from hypoglyce-
appropriate serologic and clinical re- urinary incontinence, injurious falls, and mia. Patients with poorly controlled dia-
sponses to these vaccinations. The Cen- persistent pain. betes may be subject to acute
ters for Disease Control’s Advisory The care of older adults with diabetes complications of diabetes, including hy-
Committee on Immunization Practices is complicated by their clinical and func- perglycemic hyperosmolar coma. Older
recommends influenza and pneumococ- tional heterogeneity. Some older persons patients can be treated with the same drug
cal vaccines for all persons over 65 years developed diabetes in middle age and face regimens as younger patients, but special

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S29

Position Statement

care is required in prescribing and moni- experienced with the nutritional needs of cose testing be performed at the school or
toring drug therapy. Metformin is often the growing child and the behavioral is- day care setting before lunch and when
contraindicated because of renal insuffi- sues that have an impact on adolescent signs or symptoms of abnormal blood
ciency or heart failure. Sulfonylureas and diets. Caution must be exercised to avoid glucose levels are present. Many children
other insulin secretagogues can cause hy- overaggressive dietary manipulation in may require support for insulin adminis-
poglycemia. Insulin can also cause hypo- the very young. Assessment of lifestyle tration by either injection or CSII before
glycemia as well as require good visual needs should be accompanied by possible lunch at school or in day care.
and motor skills and cognitive ability of modifications of the diabetes regimen. For further discussion, see the ADA’s
the patient or a caregiver. Thiazo- For example, an adolescent who requires position statement “The Care of Children
lidinediones should not be used in pa- more flexibility might be switched to a With Diabetes in the School and Day Care
tients with congestive heart failure (New basal/bolus insulin program with pre- Setting” (129) and the NDEP publication
York Heart Association [NYHA] Class III prandial rapidly acting insulin adminis- “Helping the Student with Diabetes Succeed:
and IV). Drugs should be started at the tration or continuous subcutaneous A Guide for School Personnel” (National Di-
lowest dose and titrated up gradually un- insulin injection (CSII). abetes Education Program, 2003, ww-
til targets are reached or side effects de- A major issue deserving emphasis in w.ndep.nih.gov).
velop. As well as regards blood pressure this age-group is that of “adherence.” No
and lipid management, the potential ben- matter how sound the medical regimen, it Strategies for improving diabetes
efits must always be weighed against po- can only be as good as the ability of the care
tential risks. family and/or individual to implement it. The implementation of the standards of
Family involvement in diabetes remains care for diabetes is suboptimal in the
II. Children and adolescents an important component of optimal dia- health care system. The challenge of pro-
Approximately three-quarters of all newly betes management throughout childhood viding effective diabetes care has thus far
diagnosed cases of type 1 diabetes occur and into adolescence. Health care provid- defied a simple solution, yet numerous
in individuals younger than 18 years of ers who care for children and adolescents, interventions have been implemented
age. Care of this group requires integra- therefore, must be capable of evaluating with strategies to improve adherence to
tion of diabetes management with the the behavioral, emotional, and psychoso- the recommended standards. Successful
complicated physical and emotional cial factors that interfere with implemen- programs have published results showing
growth needs of children, adolescents, tation and then must work with the improvement in important outcomes
and their families. individual and family to resolve problems such as A1C measurements as well as pro-
Diabetes care for children of this age- that occur and/or to modify goals as ap- cess measures such as provision of eye
group should be provided by a team that propriate. exams. The interventions have been fo-
can deal with these special medical, edu- The incidence of type 2 diabetes in cused at this level of providers, the sys-
cational, nutritional, and behavioral is- children and adolescents has been shown tem, and patients. Features of successful
sues. to be increasing, especially in ethnic mi- programs reported in the literature in-
At the time of initial diagnosis, it is nority populations (127,128). Although clude:
extremely important to establish the goals there are insufficient data to make definite
of care and to begin diabetes self- recommendations, a recent ADA consen- ● Improving provider education regard-
management education. A firm educa- sus statement provides guidance to the ing the standards of care through for-
tional base should be provided so that the prevention, screening, and treatment of mal and informal provider education
individual and family can become in- type 2 diabetes in young people. The ideal program.
creasingly independent in the self- goal of treatment is normalization of ● Adoption of practice guidelines, with
management of diabetes. Glycemic goals blood glucose and A1C values. Accurate participation of the providers in the
may need to be modified to take into ac- diagnosis and classification of diabetes is process. Guidelines should be readily
count the fact that most children younger crucial in determining appropriate treat- accessible at the point of service, such
than 6 or 7 years of age have a form of ment for these patients. Medical manage- as on patient charts, in examining
“hypoglycemic unawareness,” in that they ment should include MNT, exercise, and rooms, or on office computer systems.
lack the cognitive capacity to recognize lifestyle interventions, but drug therapy, ● Use of checklists that mirror guidelines
and respond to hypoglycemic symptoms including insulin in many cases, is have been successful at improving ad-
and may be at greater risk for the sequelae required. Successful control of comor- herence to standard of care.
of hypoglycemia. bidities, such as hypertension and hyper- ● Systems changes, such as provision of
Intercurrent illnesses are more fre- lipidemia, is also important. For further automated reminders to providers and
quent in young children. Sick-day man- discussion, see the ADA consensus state- patients, profiling or reporting of data
agement rules, including assessment for ment “Type 2 Diabetes in Children and to providers, and identification of pa-
ketosis with every illness, must be estab- Adolescents” (13). tients at risk because of abnormal target
lished and taught to prevent severe hyper- Information should be supplied to values or a lack of reported values.
glycemia and DKA that requires the school or day care setting so that ● Quality improvement programs com-
hospitalization and may lead to severe school personnel are aware of the diagno- bining CQI or other cycles of analysis
morbidity and even death (24). MNT sis of diabetes in the student and of the and intervention with provider perfor-
should be provided at diagnosis, and at signs, symptoms, and treatment of hypo- mance data.
least annually thereafter, by an individual glycemia. It is desirable that blood glu- ● Practice changes, such as clustering of

S30 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

 Standards of Medical Care

dedicated diabetes visits and group vis- patients, profiling or reporting of data HB, Liu PA, Jiang XG, Jiang YY, Wang JP,
its. to providers, and identification of pa- Zheng H, Zhang H, Bennett PH, Howard
● Tracking systems either with an elec- tients at risk because of abnormal target BV: Effects of diet and exercise in pre-
tronic medical record or patient regis- values or a lack of reported values. venting NIDDM in people with impaired
●
glucose tolerance: the DaQing IGT and
try have been helpful at increasing Practice changes, such as scheduling of Diabetes Study. Diabetes Care 20:537–
adherence to standards of care. dedicated diabetes visits and group vis- 544, 1997
● Delivery of diabetes self-management its. 8. The Diabetes Prevention Program Re-
education has been shown to increase ● Delivery of diabetes self-management search Group: Reduction in the inci-
adherence to standard of care. education. dence of type 2 diabetes with lifestyle
● Availability of case management ser- ● Availability of case management ser- intervention or metformin. N Engl J Med
vices, usually by a nurse. Nurses using vices, usually by a nurse. 346:393– 403, 2002
detailed protocols working under the ● Availability and involvement of expert 9. Chiasson JL, Josse RG, Gomis R,
supervision of physicians. Nurse edu- consultants, such as endocrinologists Hanefeld M, Karasik A, Laakso M: Acar-
cation calls have been helpful. and diabetes educators. bose for prevention of type 2 diabetes
● ●
mellitus: the STOP-NIDDM randomized
Availability and involvement of expert Because these interventions are gener- trial. Lancet 359:2072–2077, 2002
consultants, such as endocrinologists ally provided as components of a mul- 10. Sjostrom L, et al: XENDOS (Xenical in
and diabetes educators. tifactorial intervention, it is difficult to the prevention of diabetes in obese sub-
● Clustering patients with diabetes into assess the contribution of each compo- jects): a landmark study. Poster pre-
specific times within a primary care nent; however, it is clear that optimal sented at the International Congress on
practice schedule. diabetes management requires an orga- Obesity (ICO), San Paulo, Brazil, 2002
● Other nonautomated systems such as nized, systematic approach and in- 11. Buchanan TA, Xiang AH, Peters RK, Kjos
mailing reminders to patients, chart volvement of a health care team. SL, Marroquin A, Goico J, Ochoa C, Tan
stickers, and flow sheets have been use- ● Simple tools such as flow charts may be S, Berkowitz, Hodis HN, Azen SP: Pres-
ful to prompt both providers and pa- ervation of pancreatic ␤-cell function
useful in smaller practices.
and prevention of type 2 diabetes by
tients. pharmacological trewatment of insulin
resistance in high-risk hispanic women.
Because these interventions are generally References Diabetes 51:2796 –2803, 2002
provided as components of a multifacto- 1. Bode BW (Ed.): Medical Management of 12. Engelgau ME, Narayan KMV, Herman
rial intervention, it is difficult to assess the Type 1 Diabetes. 4th ed. Alexandria, VA, WH: Screening for type 2 diabetes
contribution of each component; how- American Diabetes Association, 2004 (Technical Review). Diabetes Care
ever, it is clear that optimal diabetes man- 2. Zimmerman BR (Ed.): Medical Manage- 23:1563–1580, 2000 [erratum appears
agement requires an organized, ment of Type 2 Diabetes. 4th ed. Alexan- in Diabetes Care 23:1868 –1869, 2000]
systematic approach and involvement of a dria, VA, American Diabetes 13. American Diabetes Association: Type 2
Association, 1998 diabetes in children and adolescents
health care team. Further research to
3. Kilingensmith G (Ed.): Intensive Diabetes (Consensus Statement). Diabetes Care
identify improved mechanisms to trans- Management. 3rd ed. Alexandria, VA, 23:381–389, 2000
late research into practice is necessary. American Diabetes Association, 2003 14. American Diabetes Association: Gesta-
Successful translation will require a mul- 4. The Expert Committee on the Diagnosis tional diabetes mellitus (Position State-
tidiscipline approach utilizing a variety of and Classification of Diabetes Mellitus: ment). Diabetes Care 27 (Suppl. 1):S88 –
behavioral and technological approaches. Report of the Expert Committee on the S90, 2004
In recent years, numerous health care Diagnosis and Classification of Diabetes 15. The Diabetes Control and Complica-
organizations, ranging from large health Mellitus. Diabetes Care 20:1183–1197, tions Trial Research Group: The effect of
care systems such as the U.S. Veteran’s 1997 intensive treatment of diabetes on the
Administration to small private practices, 4a. World Health Organization: Diabetes development and progression of long-
have implemented strategies to improve Mellitus: Report of a WHO Study Group. term complications in insulin-depen-
Geneva, World Health Org., 1985 dent diabetes mellitus. N Engl J Med 329:
diabetes care. Successful programs have (Tech. Rep. Ser., no. 727) 977–986, 1993
published results showing improvement 5. The Expert Committee on the Diagnosis 16. The UK Prospective Diabetes Study
in important outcomes such as A1C mea- and Classification of Diabetes Mellitus: Group: Intensive blood-glucose control
surements as well as process measures Follow-up report on the diagnosis of di- with sulphonylureas or insulin com-
such as provision of eye exams. Features abetes mellitus. Diabetes Care 26:3160 – pared with conventional treatment and
of successful programs reported in the lit- 3167, 2003 risk of complications in patients with
erature include: 6. Tuomilehto J, Lindstrom J, Eriksson JG, type 2 diabetes (UKPDS 33). Lancet 352:
Valle TT, Hamalainen H, Ilanne-Parikka 837– 853, 1998
● Adoption of practice guidelines, with P, Keinanen-Kiukaaniemi S, Laakso M, 17. The UK Prospective Diabetes Study
participation of the providers in the Louheranta A, Rastas M, Salminen V, Group: Effect of intensive blood-glucose
Uusitupa M: Prevention of type 2 diabe- control with metformin on complica-
process. Guidelines should be readily tes mellitus by changes in lifestyle tions in overweight patients with type 2
accessible at the point of service, such among subjects with impaired glucose diabetes (UKPDS 34). Lancet 352:854 –
as on patient charts, in examining tolerance. N Engl J Med 344:1343–1350, 865, 1998
rooms, or on office computer systems. 2001 18. The DCCT/EDIC Research Group: Reti-
● Systems changes, such as provision of 7. Pan XR, Li GW, Hu YH, Wang JX, Yang nopathy and nephropathy in patients
automated reminders to providers and WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao with type 1 diabetes four years after a

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S31

Position Statement

trial of intensive therapy. N Engl J Med mendations for the treatment and JS, Matthews DR, Cull CA, Wright AD,
342:381–389, 2000 prevention of diabetes and related com- Turner RC, Holman RR: Association of
19. Lawson ML, Gerstein HC, Tsui E, Zin- plications (Technical Review). Diabetes systolic blood pressure with macrovas-
man B: Effect of intensive therapy on Care 25:148 –198, 2002 cular and microvascular complications
early macrovascular disease in young in- 32. American Diabetes Association: Nutri- of type 2 diabetes (UKPDS 36): prospec-
dividuals with type 1 diabetes. Diabetes tion principles and recommendations in tive observational study. BMJ 321:412–
Care 22 (Suppl. 1):B35–B39, 1999 diabetes (Position Statement). Diabetes 419, 2000
20. Stratton IM, Adler AI, Neil HA, Mat- Care 27 (Suppl. 1):S36 –S46, 2004 44. Lewington S, Clarke R, Qizilbash N,
thews DR, Manley SE, Cull CA, Hadden 33. Schneider SH, Ruderman NB: Exercise Peto R, Collins R: Age-specific relevance
D, Turner RC, Holman RR: Association and NIDDM (Technical Review). Diabe- of usual blood pressure to vascular mor-
of glycaemia with macrovascular and tes Care 13:785–789, 1990 tality: a meta-analysis of individual data
microvascular complications of type 2 34. Wasserman DH, Zinman B: Exercise in for one million adults in 61 prospective
diabetes (UKPDS 35): prospective ob- individuals with IDDM (Technical Re- studies. Lancet 360:1903–1913, 2002
servational study. BMJ 321:405– 412, view). Diabetes Care 17:924 –937, 1994 45. Stamler J, Vaccaro O, Neaton JD, Went-
2000 35. Arauz-Pacheco C, Parrott MA, Raskin P: worth D: Diabetes, other risk factors,
21. www.accordtrial.org The treatment of hypertension in adult and 12-yr cardiovascular mortality for
22. American Diabetes Association: Post- patients with diabetes mellitus (Techni- men screened in the Multiple Risk Fac-
prandial blood glucose (Consensus cal Review). Diabetes Care 25:134 –147, tor Intervention Trial. Diabetes Care 16:
Statement). Diabetes Care 24:775–778, 2002 434 – 444, 1993
2001 36. Haffner SM: Management of dyslipide- 46. Appel LJ, Moore TJ, Obarzanek E,
23. Jovanovic L (Ed.): Medical Management mia in adults with diabetes (Technical Vollmer WM, Svetkey LP, Sacks FM,
of Pregnancy Complicated by Diabetes. 3rd Review). Diabetes Care 21:160 –178, Bray GA, Vogt TM, Cutler JA,
ed. Alexandria, VA, American Diabetes 1998 Windhauser MM, Lin PH, Karanja N: A
Association, 2000 37. Colwell JA: Aspirin therapy in diabetes clinical trial of the effects of dietary pat-
24. American Diabetes Association: Hyper- (Technical Review). Diabetes Care terns on blood pressure: DASH Collab-
glycemic crises in diabetes (Position 20:1767–1771, 1997 orative Research Group. N Engl J Med
Statement). Diabetes Care 27 (Suppl. 1): 38. Haire-Joshu D, Glasgow RE, Tibbs TL: 336:1117–1124, 1997
S94 –S102, 2004 Smoking and diabetes (Technical Re- 46a. Sacks FM, Svetkey LP, Vollmer WM, Ap-
25. Malmberg K, for the DIGAMI Study view). Diabetes Care 22:1887–1898, pel LJ, Bray GA, Harsha D, Obarzanek E,
Group: Prospective randomized study of 1999 Conlin PR, Miller ER 3rd, Simons-Mor-
intensive insulin treatment on long term 39. American Diabetes Association: Consen- ton DG, Karanja N, Lin PH, DASH-So-
survival after myocardial infarction in sus development conference on the di- dium Collaborative Research Group:
patients with diabetes. BMJ 314:512– agnosis of coronary heart disease in Effects on blood pressure of reduced so-
515, 1997 people with diabetes (Consensus State- dium and the Dietary Approaches to
26. Van den Berghe G, Wouters P, Weekers ment). Diabetes Care 21:1551–1559, Stop Hypertension (DASH) diet. N Engl J
F, Verwaest C, Bruyninckx F, Schetz M, 1998 Med 344:3–10, 2001
Vlasselaers D, Ferdinande P, Lauwers P, 40. Chobanian AV, Bakris GL, Black HR, 47. Tatti P, Paahron M, Byington RP, Di
Bouillon R: Intensive insulin therapy in Cushman WC, Green LA, Izzo JL Jr, Mauro P, Guarisco R, Strollo G, Strollo
critically ill patients. N Engl J Med 345: Jones DW, Materson BJ, Oparil S, F: Outcome results of Fosinopril Versus
1359 –1367, 2001 Wright JT Jr, Roccella EJ, the National Amlodipine Cardiovascular Events Ran-
27. American Diabetes Association: Self- Heart, Lung, and Blood Institute Joint domized Trial (FACET) in patients with
monitoring of blood glucose (Consensus National Committee on Prevention, De- hypertension and NIDDM. Diabetes Care
Statement). Diabetes Care 17:81– 86, tection, Evaluation, and Treatment of 21:597– 603, 1998
1994 High Blood Pressure, the National High 48. Estacio RO, Jeffers BW, Hiatt WR, Big-
28. American Diabetes Association: Self- Blood Pressure Education Program Co- gerstaff SL, Gifford N, Schrier RW: The
monitoring of blood glucose (Consensus ordinating Committee: The Seventh Re- effect of nisoldipine as compared with
Statement). Diabetes Care 10:93–99, port of the Joint National Committee on enalapril on cardiovascular outcomes in
1987 Prevention, Detection, Evaluation, and patients with non-insulin-dependent di-
29. Sacks DB, Bruns DE, Goldstein DE, Ma- Treatment of High Blood Pressure: the abetes and hypertension. N Engl J Med
cLaren NK, McDonald JM, Parrott M: JNC 7 report. JAMA 289:2560 –2572, 338:645– 654, 1998
Guidelines and recommendations for 2003 49. Berl T, Hunsicker LG, Lewis JB, Pfeffer
laboratory analysis in the diagnosis and 41. The UK Prospective Diabetes Study MA, Porush JG, Rouleau JL, Drury PL,
management of diabetes mellitus. Diabe- Group: Tight blood pressure control and Esmatjes E, Hricik D, Parikh CR, Raz I,
tes Care 25:750 –786, 2002 risk of macrovascular and microvascular Vanhille P, Wiegmann TB, Wolfe BM,
30. Rohlfing CL, Wiedmeyer HM, Little RR, complications in type 2 diabetes: UK- Locatelli F, Goldhaber SZ, Lewis EJ: Car-
England JD, Tennill A, Goldstein DE: PDS 38. BMJ 317:703–713, 1998 diovascular outcomes in the Irbesartan
Defining the relationship between 42. Hansson L, Zanchetti A, Carruthers SG, Diabetic Nephropathy Trial of patients
plasma glucose and HbA1c: analysis of Dahlof B, Elmfeldt D, Julius S, Menard J, with type 2 diabetes and overt nephrop-
glucose profiles and HbA1c in the Diabe- Rahn KH, Wedel H, Westerling S: Ef- athy. Ann Intern Med 138:542–549,
tes Contrrol and Complications Trial. fects of intensive blood-pressure lower- 2003
Diabetes Care 25:275–278, 2002 ing and low-dose aspirin on patients 49a. Pepine CJ, Handberg EM, Cooper-De-
31. Franz MJ, Bantle JP, Beebe CA, Brunzell with hypertension: principal results of Hoff RM, Marks R, Kowey P, Messerli
JD, Chiasson JL, Garg A, Holzmeister L, the Hypertension Optimal Treatment FH, Mancia G, Cangiano J, Garcia-Bar-
Hoogwerf BJ, Mayer-Davis E, Mooradian (HOT) randomized trial: HOT Study reto D, Keltai M, Erdine S, Bristol HA,
AD, Purnell JQ, Wheeler M: Evidence- Group. Lancet 351:1755–1762, 1998 Kolb HR, Bakris GL, Cohen JD, Parving
based nutrition principles and recom- 43. Adler AI, Stratton IM, Neil HA, Yudkin HH: A calcium antagonist vs a noncal-

S32 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

 Standards of Medical Care

cium antagonist hypertension treatment cular events and death with pravastatin childhood. Circulation 107:1562–1566,
strategy for patients with coronary artery in patients with coronary heart disease 2003
disease: the International Verapamil- and a broad range of initial cholesterol 66. American Diabetes Association: Aspirin
Transdolapril Study (INVEST): a ran- levels. N Engl J Med 339:1349 –1357, therapy in diabetes (Position Statement).
domized controlled trial. JAMA 290: 1998 Diabetes Care 27 (Suppl. 1):S72–S73,
2805–2816, 2003 58. The Heart Protection Study Collabora- 2004
50. The Heart Outcomes Prevention Evalu- tive Group: MRC/BHF Heart Protection 66a. Hayden M, Pignone M, Phillips C: Aspi-
ation (HOPE) Study Investigators: Ef- Study of cholesterol-lowering with sim- rin for the primary prevention of cardio-
fects of ramipril on cardiovascular and vastatin in 5963 people with diabetes: a vascular events: a summary of the
microvascular outcomes in people with randomised placebo-controlled trial. evidence for the U.S. Preventive Services
diabetes mellitus: results of the HOPE Lancet 361:2005–2016, 2003 Task Force. Ann Intern Med 136:161–
study and MICRO-HOPE study. Lancet 59. Frick MH, Elo O, Haapa K, Heinonen 171, 2002
355:253–259, 2000 OP, Heinsalmi P, Helo P, Huttunen JK, 66b. US Preventive Services Task Force: As-
51. The Progress Collaborative Group: Kaitaniemi P, Koskinen P, Manninen V: pirin for the primary prevention of car-
Randomized trial of a perindopril- Helsinki Heart Study: primary-preven- diovascular events: recommendation
based blood-pressure-lowering regi- tion trial with gemfibrozil in middle- and rationale. Ann Intern Med 136:157–
men among 6,105 individuals with aged men with dyslipidemia: safety of 160, 2002
previous stroke or transient ischaemic treatment, changes in risk factors, and 67. Bhatt DL, Marso SP, Hirsch AT, Ringleb
attack. Lancet 358:1033–1041, 2001 incidence of coronary heart disease. PA, Hacke W, Topol EJ: Amplified ben-
52. Lindholm LH, Ibsen H, Dahlof B, De- N Engl J Med 317:1237–1245, 1987 efit of clopidogrel versus aspirin in pa-
vereux RB, Beevers G, de Faire U, 60. Rubins HB, Robins SJ, Collins D, Fye CL, tientrs with diabetes mellitus. Am J
Fyhrquist F, Julius S, Kjeldsen SE, Kris- Anderson JW, Elam MB, Faas FH, Lin- Cardiol 90:625– 628, 2002
tiansson K, Lederballe-Pedersen O, Ni- ares E, Schaefer EJ, Schectman G, Wilt 68. American Diabetes Association: Smok-
eminen MS, Omvik P, Oparil S, Wedel TJ, Wittes J: Gemfibrozil for the second- ing and diabetes (Position Statement).
H, Aurup P, Edelman J, Snapinn S: Car- ary prevention of coronary heart disease Diabetes Care 27 (Suppl. 1):S74 –S75,
diovascular morbidity and mortality in in men with low levels of high-density 2004
patients with diabetes in the Losartan In- lipoprotein cholesterol: Veterans Affairs 69. US Preventive Services Task Force:
tervention For Endpoint reduction in High-Density Lipoprotein Cholesterol Counseling to prevent tobacco use. In
hypertension study (LIFE): a random- Intervention Trial Study Group. N Engl Guide to Clinical Preventive Services. 2nd
ized trial against atenolol. Lancet J Med 341:410 – 418, 1999 ed. Baltimore, MD, Williams & Wilkins,
359:1004 –1010, 2002 61. The National Cholesterol Education 1996, p. 597– 609
53. The ALLHAT Study Group: Major out- Program (NCEP) Expert Panel on Detec- 70. Fiore M, Bailey W, Cohen S: Smoking
comes in high-risk hypertensive patients tion, Evaluation and Treatment of High Cessation: Clinical Practice Guideline
randomized to angiotensin-converting Blood Cholesterol in Adults (Adult Number 18. Rockville, MD, U.S. Depart-
enzyme inhibitor or calcium channel Treatment Panel III): Executive sum- ment of Health and Human Services,
blocker vs diuretic: the Antihypertensive mary of the third report of the National Public Health Service, Agency for Health
and Lipid-Lowering Treatment to Pre- Cholesterol Education Program (NCEP) Care Policy and Research, 1996
vent Heart Attack Trial (ALLHAT). Expert Panel on Detection, Evaluation 71. Garg J, Bakris GL: Microalbuminuria:
JAMA 288:2981–2997, 2002 and Treatment of High Blood Choles- marker of vascular dysfunction, risk fac-
54. The ALLHAT Collaborative Research terol in Adults (Adult Treatment Panel tor for cardiovascular disease. J Vasc Med
Group: Major cardiovascular events in III). JAMA 285:2486 –2497, 2001 7:35– 43, 2002
hypertensive patients randomized to 62. Elam MB, Hunninghake DB, Davis KB, 72. Gall MA, Hougaard P, Borch-Johnsen K,
doxazosin vs chlorthalidone: the antihy- Garg R, Johnson C, Egan D, Kostis JB, Parving HH: Risk factors for develop-
pertensive and lipid-lowering treatment Sheps DS, Brinton EA: Effect of niacin on ment of incipient and overt diabetic ne-
to prevent heart attack trial (ALLHAT). lipid and lipoprotein levels and glycemic phropathy in patients with non-insulin
JAMA 283:1967–1975, 2000 control in patients with diabetes and pe- dependent diabetes mellitus: prospec-
55. Pyorala K, Pedersen TR, Kjeksus J, ripheral arterial disease. JAMA 284: tive, observational study. BMJ 314:783–
Faergeman O, Olsson AG, Thorgeirsson 1263–1270, 2000 788, 1997
G: Cholesterol lowering with simvasta- 63. Grundy SM, Vega GL, McGovern ME, 73. Ravid M, Lang R, Rachmani R, Lishner
tin improves prognosis of diabetic pa- Tulloch BR, Kendall DM, Fitz-Patrick D, M: Long-term renoprotective effect of
tients with coronary heart disease: a Ganda OP, Rosenson RS, Buse JB, Rob- angiotensin-converting enzyme inhibi-
subgroup analysis of the Scandinavian ertson DD, Sheehan JP: Efficacy, safety, tion in non-insulin-dependent diabetes
Simvastatin Study (4S). Diabetes Care and tolerability of once-daily niacin for mellitus: a 7-year follow-up study. Arch
20:614 – 620, 1997 the treatment of dyslipidemia associated Intern Med 156:286 –289, 1996
56. Sacks FM, Pfeffer MA, Moye LA, Rouleau with type 2 diabetes. Arch Intern Med 74. Reichard P, Nilsson B-Y, Rosenqvist U:
JL, Rutherford JD, Cole TG, Brown L, 162:1568 –1576, 2002 The effect of long-term intensified insu-
Warnica JW, Arnold JM, Wun CC, Davis 64. American Diabetes Association: Man- lin treatment on the development of mi-
BR, Braunwald E, for the Cholesterol agement of dyslipidemia in children and crovascular complications of diabetes
and Recurrent Events Trial Investigators: adolescents with diabetes (Consensus mellitus. N Engl J Med 329:304 –309,
The effect of pravastatin on coronary Statement). Diabetes Care 26:2194 – 1993
events after myocardial infarction I pa- 2197, 2003 75. The DCCT Research Group: Effect of in-
tients with average cholesterol levels. 65. Kavey RW, Daniels SR, Lauer RM, At- tensive therapy on the development and
N Engl J Med 335:1001–1009, 1996 kins DL, Hayman LL, Taubert K: Amer- progression of diabetic nephropathy in
57. The Long-Term Intervention with Prav- ican Heart Association guidelines for the Diabetes Control and Complications
astatin in Ischaemic Disease (LIPID) primary prevention of atherosclerotic Trial (DCCT). Kidney Int 47:1703–1720,
Study Group: Prevention of cardiovas- cardiovascular disease beginning in 1995

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S33

Position Statement

76. Lewis EJ, Hunsicker LG, Bain RP, Rohde tagonist (Atenolol) hypertension treat- fects of photocoagulation therapy. Am J
RD, for the Collaborative Study Group: ment strategy for patients with coronary Ophthalmol 81:383–396, 1976
The effect of angiotensin-converting-en- artery disease: the INternational VEra- 97. The Diabetic Retinopathy Study Re-
zyme inhibition on diabetic nephropa- pamil-Trandolapril STudy (INVEST). search Group: Four risk factors for se-
thy. N Engl J Med 329:1456 –1462, 1993 JAMA. In Press vere visual loss in diabetic retinopathy:
77. Laffel LMB, McGill JB, Gans DJ, the 85. Anderson S, Tarnow L, Rossing P, Han- the third report of the Diabetic Retinop-
North American Microalbuminuria sen BV, Parving HH: Renoprotective ef- athy Study. Arch Opthalmol 97:654 –
Study Group (NAMSG): The beneficial fects of angiotensin II receptor blockade 655, 1979
effect of angiotensin-converting enzyme in type 1 diabetic patients with diabetic 98. The Diabetic Retinopathy Study Re-
inhibition with captopril on diabetic ne- nephropathy. Kidney Int 57:601– 606, search Group: Design, methods, and
phropathy in normotensive IDDM pa- 2000 baseline results: DRS report no. 6. Invest
tients with microalbuminuria. Am J Med 86. Eknoyan G, Hostetter T, Bakris GL, He- Ophthalmol Vis Sci 21:149 –209, 1981
99:497–504, 1995 bert L, Levey AS, Parving HH, Steffes 99. The Diabetic Retinopathy Study Research
78. Bakris GL, Williams M, Dworkin L, El- MW, Toto R: Proteinuria and other Group: Photocoagulation treatment of
liott WJ, Epstein M, Toto R, Tuttle K, markers of chronic kidney disease: A po- proliferative diabetic retinopathy: clinical
Douglas J, Hsueh W, Sowers J: Preserv- sition statement of the national kidney application of Diabetic Retinopathy Study
ing renal function in adults with hyper- foundation (NKF) and the national insti- (DRS) findings: DRS report number 8.
tension and diabetes: a consensus tute of diabetes and digestive and kidney Opthalmology 88:583– 600, 1981
approach: National Kidney Foundation diseases (NIDDK). AmJ Kidney Dis 42: 100. The Diabetic Retinopathy Study
Hypertension and Diabetes Executive 617– 622, 2003 Research Group: Indications for photo-
Committees Working Group. Am J Kid- 87. K/DOQI Clinical Practice Guidelines for coagulation treatment of diabetic reti-
ney Dis 36:646 – 661, 2000 Chronic Kidney Disease: Evaluation, Clas- nopathy: DRS report no. 14. Int
79. Lewis EJ, Hunsicker LG, Clarke WR, sification, and Stratification. Kidney Dis- Opthalmol Clin 27:239 –253, 1987
Berl T, Pohl MA, Lewis JB, Ritz E, Atkins ease Outcome Quality Initiative. Am J 101. The Early Treatment Diabetic Retinopa-
RC, Rohde R, Raz I: Renoprotective ef- Kidney Dis 39 (Suppl. 2):SI–S246, 2002 thy Study Research Group: Photocoagu-
fect of the angiotensin-receptor antago- 88. Levey S, Bosch J, Lewis B, Greene T, Rog- lation for diabetic macular edema:
nist irbesartan in patients with ers N, Roth D: A more accurate method ETDRS report no. 1. Arch Opthalmol
nephropathy due to type 2 diabetes. to estimate glomerular filtration rate 103:1796 –1806, 1985
N Engl J Med 345:851– 860, 2001 from serum creatinine: a new prediction 102. The Early Treatment Diabetic Retinopa-
80. Brenner BM, Cooper ME, de Zeeuw D, equation: Modification of Diet in Renal
thy Study Research Group: Treatment
Keane WF, Mitch WE, Parving HH, Re- Disease Study Group. Ann Intern Med
techniques and clinical guidelines for
muzzi G, Snapinn SM, Zhang Z, Shahin- 130:461– 470, 1999
photocoagulation of diabetic macular
far S: Effects of losartan on renal and 89. Levinsky N: Specialist of evaluation in
edema: ETDRS report number 2. Opthal-
cardiovascular outcomes in patients chronic kidney disease: too little, too
mology 94:761–774, 1987
with type 2 diabetes and nephropathy. late. Ann Intern Med 137:542–543, 2002
103. The Early Treatment Diabetic Retinopa-
N Engl J Med 345:861– 869, 2001 90. American Diabetes Association: Ne-
81. Parving HH, Lehnert H, Brochner- phropathy in Diabetes (Position State- thy Study Research Group: Techniques
Mortensen J, Gomis R, Andersen S, ment). Diabetes Care 27 (Suppl. 1):S79 – for scatter and local photocoagulation
Arner P: The effect of irbesartan on the S83, 2004 treatment of diabetic retinopathy: ET-
development of diabetic nephropathy in 91. Aiello LP, Gardner TW, King GL, Blan- DRS report no. 3. Int Ophthalmol Clin 27:
patients with type 2 diabetes. N Engl kenship G, Cavallerano JD, Ferris FL, 254 –264, 1987
J Med 345:870 – 878, 2001 Klein R: Diabetic retinopathy (Technical 104. The Early Treatment Diabetic Retinopa-
82. Bakris GL, Siomos M, Richardson D, Review). Diabetes Care 21:143–156, thy Study Research Group: Photocoagu-
Janssen I, Bolton WK, Hebert L, Agarwal 1998 lation for diabetic macular edema:
R, Catanzaro D: ACE inhibition or an- 92. The Diabetes Control and Complica- ETDRS report no. 4. Int Opthalmol Clin
giotensin receptor blockade: impact on tions Trial Research Group: Effect of 27:265–272, 1987
potassium in renal failure: VAL-K Study pregnancy on microvascular complica- 105. The Early Treatment Diabetic Retinopa-
Group. Kidney Int 58:2084 –2092, 2000 tions in the Diabetes Control and Com- thy: Study design and baseline patient
83. Black HR, Elliott WJ, Grandits G, plications Trial. Diabetes Care 23:1084 – characteristics: ETDRS report number 7.
Grambsch P, Lucente T, White WB, 1091, 2000 Opthalmology 98:741–756, 1991
Neaton JD, Grimm Jr RH, Hansson L, 93. Vijan S, Hofer TP, Hayward RA: Cost- 106. The Early Treatment Diabetic Retinopa-
Lacourciere Y, Muller J, Sleight P, Weber utility analysis of screening intervals for thy Study Research Group: Effects of as-
MA, Williams G, Wittes J, Zanchetti A, diabetic retinopathy in patients with pirin treatment on diabetic retinopathy:
Anders RJ: Principal results of the Con- type 2 diabetes mellitus. JAMA 283: ETDRS report number 8. Opthalmology
trolled Onset Verapamil Investigation of 889 – 896, 2000 98 (Suppl.):757–765, 1991
Cardiovascular End Points (CON- 94. Klein R: Screening interval for retinopa- 107. The Early Treatment Diabetic Retinopa-
VINCE) trial. JAMA 289:2073–2082, thy in type 2 diabetes. Lancet 361:190 – thy Study Research Group: Early photo-
2003 191, 2003 coagulation for diabetic retinopathy:
84. Pepine CJ, Handberg EM, Cooper-De- 95. Younis N, Broadbent DM, Vora JP, Har- ETDRS report no. 9. Opthalmology 98:
Hoff RM, Marks R, Kowey P, Messerli ding SP: Incidence of sight-threatening 766 –785, 1991
FH, G Mancia, Cangiano J, Garcia-Bar- retinopathy in patients with type 2 dia- 108. American Diabetes Association: Reti-
reto D, Keltai M, Erdine S, Bristol HA, betes in the Liverpool Diabetic Eye nopathy in diabetes (Position State-
Kolb HR, Bakris GL, Cohen JD, Parving Study: a cohort study. Lancet 361:195– ment). Diabetes Care 27 (Suppl. 1):S84 –
HH, Erdine: Main outcomes from a ran- 200, 2003 S87, 2004
domized trial of a calcium antagonist 96. The Diabetic Retinopathy Study Re- 109. Ciulla TA, Amador AG, Zinman B: Dia-
(Verapamil-SR) versus a noncalcium an- search Group: Preliminary report on ef- betic retinopathy and diabetic macular

S34 DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004

 Standards of Medical Care

edema: pathophysiology, screening, and come. Obstet Gynecol 77:846 – 849, RR-08), 1997
novel therapies. Diabetes Care 26:2653– 1991 124. Smith SA, Poland GA: The use of influ-
2664, 2003 117. Tchobroutsky C, Vray MM, Altman JJ: enza and pneumococcal vaccines in peo-
110. American Diabetes Association: Periph- Risk/benefit ratio of changing late ob- ple with diabetes (Technical Review).
eral arterial disease in people with dia- stetrical strategies in the management of Diabetes Care 23:95–108, 2000
betes (Consensus Statement). Diabetes insulin-dependent diabetic pregnancies. 125. American Diabetes Association: Influ-
Care 26:3333–3342, 2003 Diabete Metab 17:287–294, 1991 enza and pneumococcal immunization
111. Mayfield JA, Reiber GE, Sanders LJ, 118. Willhoite MB, Bennert HW Jr, Palomaki in diabetes (Position Statement). Diabe-
Janisse D, Pogach LM: Preventive foot GE, Zaremba MM, Herman WH, Wil- tes Care 27 (Suppl. 1):S111–S113,
care in people with diabetes (Technical liams JR, Spear NH: The impact of pre- 2004
Review). Diabetes Care 21:2161–2177, conception counseling on pregnancy 126. The California Healthcare Foundation/
1998 outcomes. Diabetes Care 16:450 – 455, American Geriatric Society on Improv-
112. American Diabetes Association: Preven- 1993 ing Care for Elders with Diabetes:
tive foot care in diabetes (Position State- 119. Kitzmiller JL, Buchanan TA, Kjos S, Guidelines for improving the care of the
ment). Diabetes Care 27 (Suppl. 1):S63– Combs CA, Ratner R: Pre-conception older person with diabetes mellitus. Am J
S64, 2004 care of diabetes, congenital malforma- Geriatric Soc 51:S265–S280, 2003
113. American Diabetes Association: Consen- tions, and spontaneous abortions (Tech-
127. Fagot-Campagna A, Pettitt DJ, Engelgau
sus Development Conference on Dia- nical Review). Diabetes Care 19:514 –
MM, Burrows NR, Geiss LS, Valdez R,
betic Foot Wound Care (Consensus 541, 1996
Beckles GL, Saaddine J, Gregg EW, Wil-
Statement). Diabetes Care 22:1354 – 120. American Diabetes Association: Precon-
liamson DF, Narayan KM: DM2 among
1360, 1999 ception care of women with diabetes
114. Kitzmiller JL, Gavin LA, Gin GD, Jo- (Position Statement). Diabetes Care 27 North American children and adoles-
vanovic-Peterson L, Main EK, Zigrang (Suppl. 1):S76 –S78, 2004 cents: an epidemiologic review and a
WD: Preconception care of diabetes: gly- 121. Colquhoun AJ, Nicholson KG, Botha public health perspective. J Pediatr 136:
cemic control prevents excess congenital NT: Effectiveness of influenza vaccine in 664 – 672, 2000
malformations. JAMA 265:731–736, reducing hospital admissions in people 128. ahagan S, Silverstein J, the American
1991 with diabetes. Epidemiol Infect 119:335– Academy of Pediatrics Committee on
115. Goldman JA, Dicker D, Feldberg D, Ye- 341, 1997 Native American Child Health, the
shaya A, Samuel N, Karp M: Pregnancy 122. Centers for Disease Control and Preven- American Academy of Pediatrics Section
outcome in patients with insulin-depen- tion: Prevention and control of influen- on Endocrinology: Prevention and treat-
dent diabetes mellitus with preconcep- za: recommendations of the Advisory ment of type 2 diabetes mellitus in chil-
tion diabetic control: a comparative Committee on Immunization Practices dren, with special emphasis on
study. Am J Obstet Gynecol 155:293– (ACIP). MMWR 51 (no. RR-3), 2002 American Indian and Alaska Native chil-
297, 1986 123. Centers for Disease Control and Preven- dren. Pediatrics 112:e328, 2003
116. Rosenn B, Miodovnik M, Combs CA, tion: Prevention and control of pneumo- 129. American Diabetes Association: Diabe-
Khoury J, Siddiqi TA: Pre-conception coccal disease: recommendations of the tes care in the school and day care setting
management of insulin-dependent dia- Advisory Committee on Immunization (Position Statement). Diabetes Care 27
betes: improvement of pregnancy out- Practices (ACIP). MMWR 46 (no. (Suppl. 1):S122–S128, 2004

DIABETES CARE, VOLUME 27, SUPPLEMENT 1, JANUARY 2004 S35