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Position Statement

Standards of Medical Care in Diabetes—2007

D
AMERICAN DIABETES ASSOCIATION iabetes is a chronic illness that re-
quires continuing medical care and
patient self-management education
CONTENTS 2. Dyslipidemia/lipid manage- to prevent acute complications and to re-
ment duce the risk of long-term complications.
I. CLASSIFICATION AND DIAGNOSIS, Diabetes care is complex and requires that
3. Antiplatelet agents
p. S4
A. Classification
4. Smoking cessation many issues, beyond glycemic control, be
B. Diagnosis 5. C o r o n a r y h e a r t d i s e a s e addressed. A large body of evidence exists
screening and treatment that supports a range of interventions to
II. SCREENING FOR DIABETES, p. S5 B. Nephropathy screening and improve diabetes outcomes.
III. DETECTION AND DIAGNOSIS OF treatment These standards of care are intended
GESTATIONAL DIABETES MELLITUS, C. Retinopathy screening and to provide clinicians, patients, research-
p. S7 treatment ers, payors, and other interested individ-
D. Neuropathy uals with the components of diabetes
IV. PREVENTION/DELAY OF TYPE 2 E. Foot care
DIABETES, p. S7 care, treatment goals, and tools to evalu-
VII. DIABETES CARE IN SPECIFIC POPU- ate the quality of care. While individual
V. DIABETES CARE, p. S8 LATIONS, p. S24 preferences, comorbidities, and other pa-
A. Initial evaluation A. Children and adolescents tient factors may require modification of
B. Management B. Preconception care goals, targets that are desirable for most
C. Glycemic control
1. Assessment of glycemic control
C. Older individuals patients with diabetes are provided.
a. Self-monitoring of blood These standards are not intended to pre-
VIII. D I A B E T E S C A R E I N S P E C I F I C
glucose clude more extensive evaluation and
SETTINGS, p. S27
b. A1C A. Diabetes care in the hospital
management of the patient by other spe-
2. Glycemic goals B. Diabetes care in the school and day cialists as needed. For more detailed in-
3. Approach to treatment care setting formation, refer to refs. 1–3.
D. Medical nutrition therapy C. Diabetes care at diabetes camps The recommendations included are
E. Diabetes self-management education diagnostic and therapeutic actions that
D. Diabetes care at correctional
F. Physical activity are known or believed to favorably affect
institutions
G. Psychosocial assessment and care health outcomes of patients with diabetes.
E. Emergency and disaster prepared-
H. Referral for diabetes management
I. Intercurrent illness ness A grading system (Table 1), developed by
J. Hypoglycemia the American Diabetes Association (ADA)
IX. HYPOGLYCEMIA AND EMPLOY-
K. Immunization and modeled after existing methods, was
MENT/LICENSURE, p. S33
utilized to clarify and codify the evidence
X. THIRD-PARTY REIMBURSEMENT that forms the basis for the recommenda-
VI. PREVENTION AND MANAGEMENT FOR DIABETES CARE, SELF- tions. The level of evidence that supports
OF DIABETES COMPLICATIONS, MANAGEMENT EDUCATION, AND each recommendation is listed after each
p. S15 SUPPLIES, p. S33
A. Cardiovascular disease
recommendation using the letters A, B, C,
1. Hypertension/blood pressure XI. STRATEGIES FOR IMPROVING DIA- or E.
control BETES CARE, p. S33
I. CLASSIFICATION AND
● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
DIAGNOSIS
The recommendations in this article are based on the evidence reviewed in the following publication:
Standards of care for diabetes (Technical Review). Diabetes Care 17:1514 –1522, 1994.
Originally approved 1988. Most recent review/revision, October 2006.
A. Classification
Abbreviations: ABI, ankle-brachial index; AMI, acute myocardial infarction; ARB, angiotensin receptor In 1997, ADA issued new diagnostic and
blocker; CAD, coronary artery disease; CBG, capillary blood glucose; CHD, coronary heart disease; CHF, classification criteria (4); in 2003, modi-
congestive heart failure; CKD, chronic kidney disease; CMS, Centers for Medicare and Medicaid Services; fications were made regarding the diagno-
CSII, continuous subcutaneous insulin infusion; CVD, cardiovascular disease; DCCB, dihydropyridine sis of impaired fasting glucose (IFG) (5).
calcium channel blocker; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis;
DMMP, diabetes medical management plan; DPN, distal symmetric polyneuropathy; DPP, Diabetes Preven- The classification of diabetes includes
tion Program; DRI, dietary reference intake; DRS, Diabetic Retinopathy Study; DSME, diabetes self- four clinical classes:
management education; DSMT, diabetes self-management training; ECG, electrocardiogram; ESRD, end-
stage renal disease; ETDRS, Early Treatment Diabetic Retinopathy Study; FDA, Food and Drug
Administration; FPG, fasting plasma glucose; GDM, gestational diabetes mellitus; GFR, glomerular filtration
● Type 1 diabetes (results from ␤-cell de-
rate; HRC, high-risk characteristic; ICU, intensive care unit; IFG, impaired fasting glucose; IGT, impaired struction, usually leading to absolute
glucose tolerance; MNT, medical nutrition therapy; NDEP, National Diabetes Education Program; NPDR, insulin deficiency)
nonproliferative diabetic retinopathy; OGTT, oral glucose tolerance test; PAD, peripheral arterial disease; ● Type 2 diabetes (results from a progres-
PDR, proliferative diabetic retinopathy; PPG, postprandial plasma glucose; RDA, recommended dietary sive insulin secretory defect on the
allowance; SMBG, self-monitoring of blood glucose; TZD, thiazolidinedione; UKPDS, U.K. Prospective
Diabetes Study. background of insulin resistance)
DOI: 10.2337/dc07-S004 ● Other specific types of diabetes due to
© 2007 by the American Diabetes Association. other causes, e.g., genetic defects in

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Position Statement

Table 1—ADA evidence grading system for clinical practice recommendations in practice. Because of ease of use, accept-
ability to patients, and lower cost, the
Level of FPG is the preferred diagnostic test. It
evidence Description should be noted that the vast majority of
people who meet diagnostic criteria for
A Clear evidence from well-conducted, generalizable, randomized controlled diabetes by OGTT, but not by FPG, will
trials that are adequately powered, including: have an A1C value ⬍7.0%. The use of the
● Evidence from a well-conducted multicenter trial A1C for the diagnosis of diabetes is not
● Evidence from a meta-analysis that incorporated quality ratings in the recommended at this time.
analysis Hyperglycemia not sufficient to meet
● Compelling nonexperimental evidence, i.e., “all or none” rule the diagnostic criteria for diabetes is cate-
developed by Center for Evidence Based Medicine at Oxford gorized as either IFG or impaired glucose
Supportive evidence from well-conducted randomized controlled trials tolerance (IGT), depending on whether it
that are adequately powered, including: is identified through an FPG or an OGTT:
● Evidence from a well-conducted trial at one or more institutions
● Evidence from a meta-analysis that incorporated quality ratings in the ● IFG ⫽ FPG 100 mg/dl (5.6 mmol/l) to
analysis 125 mg/dl (6.9 mmol/l)
B Supportive evidence from well-conducted cohort studies ● IGT ⫽ 2-h plasma glucose 140 mg/dl
● Evidence from a well-conducted prospective cohort study or registry (7.8 mmol/l) to 199 mg/dl (11.0
● Evidence from a well-conducted meta-analysis of cohort studies mmol/l)
Supportive evidence from a well-conducted case-control study
C Supportive evidence from poorly controlled or uncontrolled studies Recently, IFG and IGT have been offi-
● Evidence from randomized clinical trials with one or more major or cially termed “pre-diabetes.” Both catego-
three or more minor methodological flaws that could invalidate the ries, IFG and IGT, are risk factors for
results future diabetes and cardiovascular dis-
● Evidence from observational studies with high potential for bias (such ease (CVD).
as case series with comparison to historical controls) In the absence of unequivocal hyper-
● Evidence from case series or case reports glycemia, these criteria should be con-
Conflicting evidence with the weight of evidence supporting the firmed by repeat testing on a different
recommendation day. The OGTT is not recommended for
E Expert consensus or clinical experience routine clinical use but may be required
in the evaluation of patients with IFG (see
␤-cell function, genetic defects in insu- ● Use of the A1C for the diagnosis of di- text) or when diabetes is still suspected
lin action, diseases of the exocrine pan- abetes is not recommended at this time. despite a normal FPG, as with the post-
creas (such as cystic fibrosis), and drug (E) partum evaluation of women with GDM.
or chemical induced (such as in the
treatment of AIDS or after organ trans- Criteria for the diagnosis of diabetes in II. SCREENING FOR
plantation) nonpregnant adults are shown in Table 2. DIABETES
● Gestational diabetes mellitus (GDM) Three ways to diagnose diabetes are avail-
(diagnosed during pregnancy) able, and each must be confirmed on a Recommendations
subsequent day unless unequivocal ● Screening to detect pre-diabetes (IFG
Some patients cannot be clearly classified symptoms of hyperglycemia are present. or IGT) and diabetes should be consid-
as type 1 or type 2 diabetes. Clinical pre- Although the 75-g oral glucose tolerance ered in individuals ⱖ45 years of age,
sentation and disease progression vary test (OGTT) is more sensitive and mod- particularly in those with a BMI ⱖ25
considerably in both types of diabetes. estly more specific than fasting plasma kg/m2. Screening should also be con-
Occasionally, patients who otherwise glucose (FPG) to diagnose diabetes, it is sidered for people who are ⬍45 years of
have type 2 diabetes may present with ke- poorly reproducible and rarely performed age and are overweight if they have an-
toacidosis. Similarly, patients with type 1
may have a late onset and slow (but re- Table 2—Criteria for the diagnosis of diabetes
lentless) progression of disease despite
having features of autoimmune disease. 1. Symptoms of diabetes and a casual plasma glucose ⱖ200 mg/dl (11.1 mmol/l).
Such difficulties in diagnosis may occur in Casual is defined as any time of day without regard to time since last meal. The
children, adolescents, and adults. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained
true diagnosis may become more obvious weight loss.
over time. OR
2. FPG ⱖ126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at
B. Diagnosis least 8 h.
OR
Recommendations 3. 2-h plasma glucose ⱖ200 mg/dl (11.1 mmol/l) during an OGTT. The test
● The FPG is the preferred test to diag- should be performed as described by the World Health Organization, using a
nose diabetes in children and nonpreg- glucose load containing the equivalent of 75-g anhydrous glucose dissolved in
nant adults. (E) water.

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Standards of Medical Care

Table 3—Criteria for testing for diabetes in asymptomatic adult individuals of diabetes and CVD. It should be noted
1. Testing for diabetes should be considered in all individuals at age 45 years and above, that the two tests do not necessarily detect
particularly in those with a BMI ⱖ25 kg/m2*, and, if normal, should be repeated at the same individuals (7). It is important to
3-year intervals. recognize that although the efficacy of in-
2. Testing should be considered at a younger age or be carried out more frequently in terventions for primary prevention of
individuals who are overweight (BMI ⱖ25 kg/m2*) and have additional risk factors: type 2 diabetes have been demonstrated
● are habitually physically inactive among individuals with IGT (8 –10), such
● have a first-degree relative with diabetes data among individuals with IFG (who do
● are members of a high-risk ethnic population (e.g., African American, Latino, not also have IGT) are not available. The
Native American, Asian American, Pacific Islander) FPG test is more convenient to patients,
● have delivered a baby weighing ⬎9 lb or have been diagnosed with GDM more reproducible, less costly, and easier
● are hypertensive (ⱖ140/90 mmHg) to administer than the 2-h OGTT (4,5).
● have an HDL cholesterol level ⬍35 mg/dl (0.90 mmol/l) and/or a triglyceride level Therefore, the recommended initial
⬎250 mg/dl (2.82 mmol/l) screening test for nonpregnant adults is
● have PCOS the FPG. An OGTT may be considered in
● on previous testing, had IGT or IFG patients with IFG to better define the risk
● have other clinical conditions associated with insulin resistance (e.g., PCOS or of diabetes.
acanthosis nigricans) The incidence of type 2 diabetes in
● have a history of vascular disease adolescents has increased dramatically in
the last decade. Consistent with screening
*May not be correct for all ethnic groups. PCOS, polycystic ovary syndrome.
recommendations for adults, only chil-
dren and youth at increased risk for the
other risk factor for diabetes (Table 3). cannot be recommended at this time as a presence or the development of type 2
Repeat testing should be carried out at means to identify individuals at risk. Rea- diabetes should be tested (11) (Table 4).
3-year intervals. (E) sons for this include the following: 1) cut- The effectiveness of screening may
● Screen for pre-diabetes and diabetes in off values for some of the immune marker also depend on the setting in which it is
high-risk, asymptomatic, undiagnosed assays have not been completely estab- performed. In general, community
adults and children within the health lished in clinical settings; 2) there is no screening outside a health care setting
care setting. (E) consensus as to what action should be may be less effective because of the failure
● To screen for diabetes/pre-diabetes, ei- taken when a positive autoantibody test of people with a positive screening test to
ther an FPG test or 2-h OGTT (75-g result is obtained; and 3) because the in- seek and obtain appropriate follow-up
glucose load) or both are appropriate. cidence of type 1 diabetes is low, testing of testing and care or, conversely, to ensure
(B) healthy children will identify only a very appropriate repeat testing for individuals
● An OGTT may be considered in pa- small number (⬍0.5%) who at that mo- who screen negative. That is, screening
tients with IFG to better define the risk ment may be “pre-diabetic.” Clinical stud- outside of clinical settings may yield ab-
of diabetes. (E) ies are being conducted to test various
methods of preventing type 1 diabetes in
There is a major distinction between di- high-risk individuals (e.g., siblings of Table 4—Testing for type 2 diabetes in chil-
agnostic testing and screening. Both uti- type 1 diabetic patients). These studies dren
lize the same clinical tests, which should may uncover an effective means of pre- Criteria
be done within the context of the health venting type 1 diabetes, in which case tar- ● Overweight (BMI ⬎85th percentile for
care setting. When an individual exhibits geted screening may be appropriate in the age and sex, weight for height ⬎85th
symptoms or signs of the disease, diag- future. percentile, or weight ⬎120% of ideal for
nostic tests are performed, and such tests height)
do not represent screening. The purpose Type 2 diabetes Plus any two of the following risk factors:
of screening is to identify asymptomatic Type 2 diabetes is frequently not diag- ● Family history of type 2 diabetes in first-
individuals who are likely to have diabe- nosed until complications appear, and or second-degree relative
tes or pre-diabetes. Separate diagnostic approximately one-third of all people ● Race/ethnicity (Native American, African
tests using standard criteria are required with diabetes may be undiagnosed. Indi- American, Latino, Asian American,
after positive screening tests to establish a viduals at high risk should be screened for Pacific Islander)
definitive diagnosis as described above. diabetes and pre-diabetes. Criteria for ● Signs of insulin resistance or conditions
testing for diabetes in asymptomatic, un- associated with insulin resistance
Type 1 diabetes diagnosed adults are listed in Table 3. The (acanthosis nigricans, hypertension,
Generally, people with type 1 diabetes effectiveness of early diagnosis through dyslipidemia, or PCOS)
present with acute symptoms of diabetes screening of asymptomatic individuals ● Maternal history of diabetes or GDM
and markedly elevated blood glucose lev- has not been determined (6). Age of initiation: age 10 years or at onset of
els. Because of the acute onset of symp- Screening should be carried out puberty, if puberty occurs at a younger age
toms, most cases of type 1 diabetes are within the health care setting. Either an Frequency: every 2 years
detected soon after symptoms develop. FPG test or 2-h OGTT (75-g glucose load) Test: FPG preferred
Widespread clinical testing of asymptom- is appropriate. The 2-h OGTT identifies Clinical judgment should be used to test for diabetes
atic individuals for the presence of auto- people with IGT, and thus, more people in high-risk patients who do not meet these criteria.
antibodies related to type 1 diabetes are at increased risk for the development PCOS, polycystic ovary syndrome.

S6 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

normal tests that are never discussed with ● One-step approach: perform a diagnos- many benefits of modest weight loss
a primary care provider, low compliance tic 100-g OGTT and participating in regular physical ac-
with treatment recommendations, and a ● Two-step approach: perform an initial tivity. (A)
very uncertain impact on long-term screening by measuring the plasma or ● Patients with IGT should be given
health. Community screening may also be serum glucose concentration 1 h after a counseling on weight loss as well as in-
poorly targeted, i.e., it may fail to reach 50-g oral glucose load (glucose chal- struction for increasing physical activ-
the groups most at risk and inappropri- lenge test) and perform a diagnostic ity. (A) (Reimbursement for such
ately test those at low risk (the worried 100-g OGTT on that subset of women counseling is encouraged.)
well) or even those already diagnosed exceeding the glucose threshold value ● Patients with IFG should be given
(12,13). on the glucose challenge test. When the counseling on weight loss as well as in-
On the basis of expert opinion, two-step approach is used, a glucose struction for increasing physical activ-
screening should be considered by health threshold value ⱖ140 mg/dl identifies ity. (E) (Reimbursement for such
care providers at 3-year intervals begin- ⬃80% of women with GDM, and the counseling is encouraged.)
ning at age 45, particularly in those with yield is further increased to 90% by us- ● Follow-up counseling appears to be im-
BMI ⱖ25 kg/m2. The rationale for this ing a cutoff of ⱖ130 mg/dl. portant for success. (B)
interval is that false negatives will be re- ● Monitoring for the development of
peated before substantial time elapses, Diagnostic criteria for the 100-g OGTT diabetes in those with pre-diabetes
and there is little likelihood of an individ- are as follows: ⱖ95 mg/dl fasting, ⱖ180 should be performed every 1–2 years. (E)
ual developing any of the complications mg/dl at 1 h, ⱖ155 mg/dl at 2 h, and ● Close attention should be given to, and
of diabetes to a significant degree within 3 ⱖ140 mg/dl at 3 h. Two or more of the appropriate treatment given for, other
years of a negative screening test result. plasma glucose values must be met or ex- CVD risk factors (e.g., tobacco use, hy-
Testing should be considered at a younger ceeded for a positive diagnosis. The test pertension, dyslipidemia). (A)
age or be carried out more frequently in should be done in the morning after an ● Because of possible side effects and
individuals who are overweight and have overnight fast of 8 –14 h. The diagnosis cost, there is insufficient evidence to
one or more of the other risk factors for can be made using a 2-h, 75-g glucose support the use of drug therapy. (E)
type 2 diabetes. tolerance test, but that test is not as well
validated for detection of at-risk infants or Many studies have shown that individuals
mothers as the 3-h, 100-g OGTT. at high risk for developing diabetes (those
III. DETECTION AND Low-risk status requires no glucose with IFG, IGT, or both) can be given a
DIAGNOSIS OF GDM testing, but this category is limited to wide variety of interventions that signifi-
those women meeting all of the following cantly delay, and sometimes prevent, the
Recommendations characteristics: onset of diabetes (8 –10,15–18). An in-
● Screen for diabetes in pregnancy using tensive lifestyle modification program has
risk factor analysis and, if appropriate, ● Age ⬍25 years been shown to be very effective (⬃58%
use of an OGTT. (C) ● Weight normal before pregnancy reduction after 3 years). Use of the phar-
● Women with GDM should be screened
● Member of an ethnic group with a low macologic agents metformin, acarbose,
for diabetes 6 –12 weeks postpartum prevalence of diabetes orlistat, and rosiglitazone has also been
and should be followed up with subse- ● No known diabetes in first-degree rela- shown to decrease incident diabetes to
quent screening for the development of tives various degrees. Of note, however, each
diabetes or pre-diabetes. (E) ● No history of abnormal glucose toler- of these drugs may cause side effects of
ance varying severity in a small number of in-
Risk assessment for GDM should be un- ● No history of poor obstetric outcome dividuals.
dertaken at the first prenatal visit. Women
with clinical characteristics consistent Because women with a history of GDM Lifestyle modification
with a high risk for GDM (e.g., those with have an increased subsequent risk for di- In well-controlled studies that included a
marked obesity, personal history of GDM abetes, they should be screened for diabe- lifestyle intervention arm, substantial ef-
or delivery of a previous large-for- tes 6 –12 weeks postpartum and should forts were necessary to achieve only mod-
gestation-age infant, glycosuria, polycys- be followed up with subsequent screen- est changes in weight and exercise, but
tic ovary syndrome, or a strong family ing for the development of diabetes or those changes were sufficient to achieve
history of diabetes) should undergo glu- pre-diabetes. For information on the Na- an important reduction in the incidence
cose testing as soon as possible (14). An tional Diabetes Education Program of diabetes. In the DPP lifestyle group, a
FPG ⱖ126 mg/dl or a casual plasma glu- (NDEP) campaign to prevent type 2 dia- low-fat (⬍25% fat) intake was recom-
cose ⱖ200 mg/dl meets the threshold for betes in women with GDM, go to www. mended; if reducing fat did not produce
the diagnosis of diabetes and needs to be ndep.nih.gov/diabetes/pubs/Never weight loss to goal, calorie restriction was
confirmed on a subsequent day as soon as TooEarly_Tipsheet.pdf. also recommended. Participants weigh-
possible unless unequivocal symptoms of ing 120 –174 lb (54 –78 kg) at baseline
hyperglycemia are present. High-risk IV. PREVENTION/DELAY were instructed to follow a 1,200 kcal/day
women not found to have GDM at the OF TYPE 2 DIABETES diet (33 g fat), those 175–219 lb (79 –99
initial screening and average-risk women kg) were instructed to follow a 1,500 kcal/
should be tested between 24 and 28 Recommendations day diet (42 g fat), those 220 –249 lb
weeks of gestation. Testing should follow ● Individuals at high risk for developing (100 –113 kg) were instructed to follow
one of two approaches: diabetes need to become aware of the an 1,800 kcal/day diet (50 g fat), and

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Standards of Medical Care

those ⬎250 lb (114 kg) were instructed to Table 5—Components of the comprehensive diabetes evaluation
follow a 2,000 kcal/day diet (55 g fat). On Medical history
average, 50% of the lifestyle group ● Age and characteristics of onset of diabetes (e.g., DKA, routine laboratory evaluation)
achieved the goal of ⱖ7% weight reduc- ● Prior A1C records
tion and 74% maintained at least 150 ● Eating patterns, nutritional status, and weight history; growth and development in
min/week of moderately intense activity children and adolescents
(8). In the Finnish Diabetes Prevention ● Diabetes education history
Study, weight loss averaged 9.2 lb at 1 ● Review of previous treatment programs
year, 7.7 lb after 2 years, and 4.6 lb after 5 ● Current treatment of diabetes, including medications, meal plan, and results of glucose
years (9); “moderate exercise,” such as monitoring and patient’s use of data
brisk walking, for 30 min/day was sug- ● Exercise history
gested. In the Finnish study, there was a ● DKA frequency, severity, and cause
direct relationship between adherence ● Hypoglycemic episodes
with the lifestyle intervention and the re- ● Any severe hypoglycemia: frequency, severity, and cause
duced incidence of diabetes. ● History of diabetes-related complications
● Microvascular: eye, kidney, nerve
● Macrovascular: cardiac, CVD, PAD
Lifestyle or medication? ● Other: sexual dysfunction, gastroparesis
Many factors must be considered when Physical examination
undertaking the effort to modify the ● Blood pressure determination, including orthostatic measurements when indicated
course of glucose intolerance. Lifestyle ● Fundoscopic examination
modification may have other beneficial ef- ● Thyroid palpation
fects (e.g., reduced CVD), but is often ● Skin examination (for acanthosis nigricans and insulin injection sites)
very difficult to sustain, and its cost- ● Neurological/foot examination examination
effectiveness is questionable if the regi- ● Inspection
men is similar to what was employed in ● Palpation of DP and PT pulses
clinical trials. Even so, lifestyle interven- ● Presence/absence of patellar and Achilles reflexes
tion still may be cost-effective compared ● Determination of proprioception, vibration, and monofilament sensation
with some pharmacologic treatments. Laboratory evaluation
Drug therapy can be very costly (except ● A1C
for metformin, which is a generic drug), ● Fasting lipid profile, including total LDL and HDL cholesterol and triglycerides
and side effects can range from mild/ ● Liver function tests
moderate discomfort to serious cardio- ● Test for microalbuminuria
vascular events. Finally, whether diabetes ● Serum creatinine and calculated GFR
prevention efforts can, over the long term, ● Thyroid-stimulating hormone
influence the development of micro- or ● Screen for celiac disease in type 1 diabetes and as indicated in type 2 diabetes
macrovascular events is unknown. It is Referrals
possible that at least microvascular com- ● Eye exam, if indicated
plications will be delayed or diminished, ● Family planning for women of reproductive age
since they are more closely related to hy- ● MNT
perglycemia. ● Diabetes educator if not provided by physician or practice staff
In light of the above, health care pro- DP, dorsalis pedis; PT, posterior tibial; PAD, peripheral arterial disease.
fessionals should first actively counsel pa-
tients to maintain normal weight and V. DIABETES CARE health care team to ensure optimal man-
exercise regularly (even before glucose in- agement of the patient with diabetes.
tolerance occurs). Because of potential
A. Initial evaluation
side effects and cost, there is insufficient B. Management
evidence to support the use of drug ther- A complete medical evaluation should be
performed to classify the patient, detect People with diabetes should receive med-
apy as a substitute for, or routinely used in ical care from a physician-coordinated
addition to, lifestyle modification to pre- the presence or absence of diabetes com-
team. Such teams may include, but are
vent diabetes. Public health messages, plications, assist in formulating a manage-
not limited to, physicians, nurse practitio-
health care professionals, and health care ment plan, and provide a basis for
ners, physician’s assistants, nurses, dieti-
systems should all encourage behavior continuing care. If the diagnosis of diabe- tians, pharmacists, and mental health
changes to achieve a healthy lifestyle. Fur- tes has already been made, the evaluation professionals with expertise and a special
ther research is necessary to understand should review the previous treatment and interest in diabetes. It is essential in this
how to better facilitate effective and effi- the past and present degrees of glycemic collaborative and integrated team ap-
cient programs for the primary preven- control. Laboratory tests appropriate to proach that individuals with diabetes as-
tion of type 2 diabetes. the evaluation of each patient’s general sume an active role in their care.
An ADA consensus statement offering medical condition should be performed. The management plan should be for-
more comprehensive guidance on diabe- A focus on the components of compre- mulated as an individualized therapeutic
tes prevention will be published in 2007. hensive care (Table 5) will assist the alliance among the patient and family, the

S8 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

physician, and other members of the of SMBG can be useful in preventing hy- lows for timely decisions on therapy
health care team. Any plan should recog- poglycemia and adjusting medications, changes, when needed. (E)
nize diabetes self-management education MNT, and physical activity.
(DSME) as an integral component of care. The frequency and timing of SMBG By performing an A1C test, health provid-
In developing the plan, consideration should be dictated by the particular needs ers can measure a patient’s average glyce-
should be given to the patient’s age, and goals of the patients. Daily SMBG is mia over the preceding 2–3 months (22)
school or work schedule and conditions, especially important for patients treated and, thus, assess treatment efficacy. A1C
physical activity, eating patterns, social with insulin to monitor for and prevent testing should be performed routinely in
situation and personality, cultural factors, asymptomatic hypoglycemia and hyper- all patients with diabetes, first to docu-
and presence of complications of diabetes glycemia. For most patients with type 1 ment the degree of glycemic control at
or other medical conditions. A variety of diabetes and pregnant women taking in- initial assessment and then as part of con-
strategies and techniques should be used sulin, SMBG is recommended three or tinuing care. Since the A1C test reflects
to provide adequate education and devel- more times daily. The optimal frequency mean glycemia over the preceding 2–3
opment of problem-solving skills in the and timing of SMBG for patients with type months, measurement approximately ev-
various aspects of diabetes management. 2 diabetes on oral agent therapy is not ery 3 months is required to determine
Implementation of the management plan known but should be sufficient to facili- whether a patient’s metabolic control has
requires that each aspect is understood tate reaching glucose goals. A recent been reached and maintained within the
and agreed on by the patient and the care meta-analysis of SMBG in non–insulin- target range. Thus, regular performance
providers and that the goals and treat- treated patients with type 2 diabetes con- of the A1C test permits detection of de-
ment plan are reasonable. cluded that some regimen of monitoring partures from the target (Table 6) in a
was associated with a reduction in A1C of timely fashion. For any individual patient,
C. Glycemic control ⬃0.4%. However, many of the studies in the frequency of A1C testing should be
1. Assessment of glycemic control. this analysis also included patient educa- dependent on the clinical situation, the
Techniques are available for health pro- tion with diet and exercise counseling treatment regimen used, and the judg-
viders and patients to assess the effective- and, in some cases, pharmacologic inter- ment of the clinician.
ness of the management plan on glycemic vention, making it very difficult to assess The A1C test is subject to certain lim-
control. the contribution of SMBG alone to im- itations. Conditions that affect erythro-
proved control (21). Patients with type 2 cyte turnover (hemolysis, blood loss) and
a. Self-monitoring of blood glucose diabetes on insulin typically need to per- hemoglobin variants must be considered,
form SMBG more frequently than those particularly when the A1C result does not
Recommendations not using insulin. When adding to or correlate with the patient’s clinical situa-
● Clinical trials using insulin that have modifying therapy, type 1 and type 2 di- tion (22). The availability of the A1C re-
demonstrated the value of tight glyce- abetic patients should test more often sult at the time that the patient is seen
mic control have used self-monitoring than usual. The role of SMBG in stable (point-of-care testing) has been reported
of blood glucose (SMBG) as an integral diet–treated patients with type 2 diabetes to result in the frequency of intensifica-
part of the management strategy. (A) is not known. tion of therapy and improvement in gly-
● SMBG should be carried out three or Because the accuracy of SMBG is in- cemic control (23,24).
more times daily for patients using mul- strument and user dependent (22), it is Glycemic control is best judged by
tiple insulin injections. (A) important for health care providers to the combination of the results of the pa-
● For patients using less frequent insulin evaluate each patient’s monitoring tech- tient’s SMBG testing (as performed) and
injections or oral agents or medical nu- nique, both initially and at regular inter- the current A1C result. The A1C should
trition therapy (MNT) alone, SMBG is vals thereafter. In addition, optimal use of be used not only to assess the patient’s
useful in achieving glycemic goals. (E) SMBG requires proper interpretation of control over the preceding 2–3 months,
● To achieve postprandial glucose tar- the data. Patients should be taught how to but also as a check on the accuracy of the
gets, postprandial SMBG may be appro- use the data to adjust food intake, exer- meter (or the patient’s self-reported re-
priate. (E) cise, or pharmacological therapy to sults) and the adequacy of the SMBG test-
● Instruct the patient in SMBG and rou- achieve specific glycemic goals. Health ing schedule. Table 7 contains the
tinely evaluate the patient’s technique professionals should evaluate at regular correlation between A1C levels and mean
and ability to use data to adjust therapy. intervals the patient’s ability to use SMBG plasma glucose levels based on data from
(E) data to guide treatment. the Diabetes Control and Complications
Trial (DCCT) (25).
The ADA’s consensus statements on b. A1C
SMBG provide a comprehensive review of 2. Glycemic goals
the subject (19,20). Major clinical trials Recommendations
assessing the impact of glycemic control ● Perform the A1C test at least two times Recommendations
on diabetes complications have included a year in patients who are meeting treat- ● Lowering A1C has been associated with
SMBG as part of multifactorial interven- ment goals (and who have stable glyce- a reduction of microvascular and neu-
tions, suggesting that SMBG is a compo- mic control). (E) ropathic complications of diabetes (A)
nent of effective therapy. SMBG allows ● Perform the A1C test quarterly in pa- and possibly macrovascular disease (B).
patients to evaluate their individual re- tients whose therapy has changed or ● The A1C goal for patients in general is an
sponse to therapy and assess whether gly- who are not meeting glycemic goals. (E) A1C goal of ⬍7%. (B)
cemic targets are being achieved. Results ● Use of point-of-care testing for A1C al- ● The A1C goal for the individual patient is

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S9


Standards of Medical Care

Table 6—Summary of recommendations for adults with diabetes Recommended glycemic goals for
Glycemic control nonpregnant individuals are shown in Ta-
A1C ⬍7.0%* ble 6. A major limitation to the available
Preprandial capillary plasma glucose 90–130 mg/dl (5.0–7.2 mmol/l) data is that they do not identify the opti-
Peak postprandial capillary plasma glucose† ⬍180 mg/dl (⬍10.0 mmol/l) mum level of control for particular pa-
Blood pressure ⬍130/80 mmHg tients, as there are individual differences
Lipids‡ in the risks of hypoglycemia, weight gain,
LDL ⬍100 mg/dl (⬍2.6 mmol/l) and other adverse effects. Furthermore,
Triglycerides ⬍150 mg/dl (⬍1.7 mmol/l) with multifactorial interventions, it is un-
HDL ⬎40 mg/dl (⬎1.0 mmol/l)§ clear how different components (e.g., ed-
Key concepts in setting glycemic goals: ucational interventions, glycemic targets,
● A1C is the primary target for glycemic control lifestyle changes, pharmacological
● Goals should be individualized agents) contribute to the reduction of
● Certain populations (children, pregnant women, and complications. There are no clinical trial
elderly) require special considerations data available for the effects of glycemic
● More stringent glycemic goals (i.e., a normal A1C, ⬍6%) control in patients with advanced compli-
may further reduce complications at the cost of increased cations, the elderly (ⱖ65 years of age), or
risk of hypoglycemia young children (⬍13 years of age). Less
● Less intensive glycemic goals may be indicated in patients stringent treatment goals may be appro-
with severe or frequent hypoglycemia priate for patients with limited life expect-
● Postprandial glucose may be targeted if A1C goals are not ancies, in the very young or older adults,
met despite reaching preprandial glucose goals and in individuals with comorbid condi-
tions. Severe or frequent hypoglycemia is
*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 an indication for the modification of treat-
diabetes. ‡Current NCEP/ATP III guidelines suggest that in patients with triglycerides ⱖ200 mg/dl, the ment regimens, including setting higher
“non-HDL cholesterol” (total cholesterol minus HDL) be utilized. The goal is ⱕ130 mg/dl (121). §For glycemic goals.
women, it has been suggested that the HDL goal be increased by 10 mg/dl. More stringent goals (i.e., a normal
A1C, ⬍6%) should be considered in in-
an A1C as close to normal (⬍6%) as mal as possible (representing normal dividual patients based on epidemiologi-
possible without significant hypoglyce- fasting and postprandial glucose concen- cal analyses suggesting that there is no
mia. (E) trations) in the absence of hypoglycemia. lower limit of A1C at which further low-
● Less stringent treatment goals may be However, this goal is difficult to achieve ering does not reduce the risk of compli-
appropriate for patients with a history with present therapies (26). Prospective, cations, at the risk of increased
of severe hypoglycemia, patients with randomized, clinical trials in type 1 dia- hypoglycemia (particularly in those with
limited life expectancies, very young betes such as the DCCT (27,28) have type 1 diabetes). However, the absolute
children or older adults, and individu- shown that improved glycemic control is risks and benefits of lower targets are un-
als with comorbid conditions. (E) associated with sustained decreased rates known. The risks and benefits of an A1C
● Aggressive glycemic management with of microvascular (retinopathy and ne- goal of ⬍6% are currently being tested in
insulin may reduce morbidity in patients phropathy), macrovascular, and neuro- an ongoing study (ACCORD [Action to
with severe acute illness, periopera- pathic complications (28 –31). Control Cardiovascular Risk in Diabetes])
tively, following myocardial infarction, In type 2 diabetes, the U.K. Prospec- of type 2 diabetes.
and in pregnancy. (B) Elevated postchallenge (2-h OGTT)
tive Diabetes Study (UKPDS) demon-
glucose values have been associated with
s t r a t e d s i g n i fi c a n t r e d u c t i o n s i n
Glycemic control is fundamental to the increased cardiovascular risk indepen-
microvascular and neuropathic complica-
management of diabetes. The goal of ther- dent of FPG in some epidemiological
tions with intensive therapy (32–34). The studies. Postprandial plasma glucose
apy is to achieve an A1C as close to nor-
potential of intensive glycemic control to (PPG) levels ⬎140 mg/dl are unusual in
reduce CVD in type 2 diabetes is sup- nondiabetic individuals, although large
Table 7—Correlation between A1C level and ported by epidemiological studies (32–
mean plasma glucose levels on multiple test- evening meals can be followed by plasma
34) and a recent meta-analysis (35), but glucose values up to 180 mg/dl. There are
ing over 2–3 months (25) this potential benefit on CVD events has now pharmacological agents that primar-
not been demonstrated in a randomized ily modify PPG and thereby reduce A1C
Mean plasma glucose clinical trial. in parallel. Thus, in individuals who have
A1C (%) mg/dl mmol/l In each of these large randomized premeal glucose values within target but
prospective clinical trials, treatment regi- are not meeting A1C targets, monitoring
6 135 7.5 mens that reduced average A1C to ⬃7% PPG 1–2 h after the start of the meal and
7 170 9.5 (⬃1% above the upper limits of normal) treatment aimed at reducing PPG values
8 205 11.5 were associated with fewer long-term mi- ⬍180 mg/dl may lower A1C. However, it
9 240 13.5 crovascular complications; however, in- should be noted that the effect of these
10 275 15.5 tensive control was found to increase the approaches on micro- or macrovascular
11 310 17.5 risk of severe hypoglycemia and weight complications has not been studied (36).
12 345 19.5 gain (31,34). As regards goals for glycemic control

S10 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

Figure 1—Algorithm for the


metabolic management of type 2
diabetes. Reinforce lifestyle in-
tervention at every visit. *Check
A1C every 3 months until ⬍7%
and then at least every 6 months.
⫹Although three oral agents
can be used, initiation and inten-
sification of insulin therapy is
preferred based on effectiveness
and expense. #See Fig. 1 in ref.
39 for initiation and adjustment
of insulin.

for women with GDM, recommendations all patients with type 1 diabetes. An algo- lifestyle change should be the primary
from the Fourth International Workshop- rithm for adjusting premeal insulin doses approach to weight loss. (A)
Conference on Gestational Diabetes sug- to correct for blood glucose values outside ● Physical activity and behavior modifi-
gest lowering maternal capillary blood of target ranges is appropriate for most cation are important components of
glucose concentrations to ⱕ95 mg/dl (5.3 patients with type 1 diabetes and insulin- weight loss programs and are most
mmol/l) fasting, ⱕ140 mg/dl (7.8 treated type 2 diabetes. There are excel- helpful in maintenance of weight loss.
mmol/l) at 1 h, and/or ⱕ120 mg/dl (6.7 lent reviews available that guide the (B)
mmol/l) at 2 h after the meal (37). For initiation and management of insulin
further information on GDM, refer to the therapy to achieve desired glycemic goals Fat intake
ADA position statement (14). For infor- (40,41). ● Saturated fat intake should be ⬍7% of
mation on glycemic control during preg- total calories. (A)
nancy in women with preexisting D. MNT (42) ● Intake of trans fat should be minimized.
diabetes, refer to ref. 38. (E)
3. Approach to treatment. A consensus Recommendations
statement from the ADA and the Euro- Carbohydrate intake
pean Association for the Study of Diabetes Diabetes and obesity management ● Monitoring carbohydrate, whether by
on the approach to management of hyper- ● Individuals who have pre-diabetes or carbohydrate counting, exchanges, or
glycemia in individuals with type 2 diabe- diabetes should receive individualized experience-based estimation, remains a
tes has recently been published (39). MNT as needed to achieve treatment key strategy in achieving glycemic con-
Early intervention with metformin in goals, preferably provided by a regis- trol. (A)
combination with lifestyle changes (MNT tered dietitian familiar with the compo- ● For individuals with diabetes, the use of
and exercise) with continuing, timely nents of diabetes MNT. (B) the glycemic index and glycemic load
augmentation therapy with additional ● MNT should be covered by insurance may provide a modest additional bene-
agents (including early initiation of insu- and other payors. (E) fit for glycemic control over that ob-
lin therapy) as a means of achieving and ● In overweight and obese insulin- served when total carbohydrate is
maintaining recommended levels of gly- resistant individuals, modest weight considered alone. (B)
cemic control (i.e., A1C ⬍7% for most loss has been shown to reduce insulin ● There is not sufficient evidence to rec-
patients) are highlights of this approach. resistance. Thus, weight loss is recom- ommend use of glycemic index or gly-
See Fig. 1 for metabolic management of mended for all overweight or obese in- cemic load for prevention of diabetes,
type 2 diabetes. dividuals who have or are at risk for although foods high in fiber are encour-
Early initiation of insulin would be a diabetes. (A) aged. (E)
safer approach for individuals presenting ● Structured programs that emphasize ● Low-carbohydrate diets (restricting to-
with weight loss, more severe symptoms, lifestyle changes, including education, tal carbohydrate to ⬍130 g/day) are not
and glucose values ⬎250 –300 mg/dl. reduced energy and fat (⬃30% of total recommended in the treatment of over-
Insulin therapy, consisting of inter- energy) intake, regular physical activ- weight/obesity. The long-term effects of
mediate- or long-acting basal insulin in ity, and regular participant contact, can these diets are unknown, and although
combination with premeal rapid- or produce long-term weight loss on the such diets produce short-term weight
short-acting insulin is recommended for order of 5–7% of starting weight. Thus, loss, maintenance of weight loss is sim-

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S11


Standards of Medical Care

ilar to that from low-fat diets and the tion, the DRIs may be helpful. The DRI individual needs and preferences (45),
impact on CVD risk profile is uncertain. report recommends that to meet the and that addressed psychosocial issues
(B) body’s daily nutritional needs while min- (45,46,50).
imizing risk for chronic diseases, adults
Other nutrition recommendations (in general, not specifically those with di- The national standards for DSME
● Sugar alcohols and nonnutritive sweet- abetes) should consume 45– 65% of total ADA-recognized DSME programs have
eners are safe when consumed within energy from carbohydrate, 20 –35% from staff that includes at least a registered
the acceptable daily intake levels estab- fat, and 10 –35% from protein (44). The nurse and a registered dietitian; these staff
lished by the Food and Drug Adminis- best mix of carbohydrate, protein, and fat must be certified diabetes educators or
tration (FDA). (A) appears to vary depending on individual have recent experience in diabetes educa-
● If adults with diabetes choose to use circumstances. tion and management. The curriculum of
alcohol, daily intake should be limited ADA-recognized DSME programs must
to a moderate amount (one drink per E. DSME cover all areas of diabetes management,
day or less for adult women and two with the assessed needs of the individual
drinks per day or less for adult men). Recommendations determining which areas are addressed.
(E) ● People with diabetes should receive All ADA-recognized DSME programs uti-
● Routine supplementation with antioxi- DSME according to national standards lize a process of continuous quality im-
dants, such as vitamins E and C and when their diabetes is diagnosed and as provement to evaluate the effectiveness of
carotene, is not advised because of lack needed thereafter. (B) the DSME provided and to identify op-
of evidence of efficacy and concern re- ● DSME should be provided by health portunities for improvement.
lated to long-term safety. (A) care providers who are qualified to
● Benefit from chromium supplementa- provide that DSME based on their pro- Reimbursement for DSME
tion in people with diabetes or obesity fessional training and continuing educa- DSME is reimbursed as part of the Medi-
has not been conclusively demon- tion. (E) care program as overseen by the Centers
strated and, therefore, cannot be rec- ● DSME should address psychosocial is-
for Medicare and Medicaid Services
ommended. (E) sues, since emotional well-being is (CMS) (www.cms.hhs.gov/DiabetesSelf
strongly associated with positive diabe- Management).
MNT is an integral component of diabetes tes outcomes. (C)
prevention, management, and self- ● DSME should be reimbursed by third-
management education. In addition to its party payors. (E) F. Physical activity
role in preventing and controlling diabe-
tes, ADA recognizes the importance of DSME is an essential element of diabetes Recommendations
nutrition as an essential component of an care (45–51), and National Standards for ● To improve glycemic control, assist
overall healthy lifestyle. These recom- DSME are based on evidence for its ben- with weight maintenance, and reduce
mendations are based on principles of efits. Education helps people with diabe- risk of CVD, at least 150 min/week of
good nutrition for the overall population tes initiate effective self-care when they moderate-intensity aerobic physical ac-
from the 2005 Dietary Guidelines (43) are first diagnosed. Ongoing DSME also tivity (50 –70% of maximum heart rate)
and the recommended dietary allowances helps people with diabetes maintain effec- and/or at least 90 min/week of vigorous
(RDAs) from the Institute of Medicine of tive self-management as their diabetes aerobic exercise (⬎70% of maximum
the National Academies of Sciences (44). presents new challenges and treatment heart rate) is recommended. The phys-
A review of the evidence regarding nutri- advances become available. DSME helps ical activity should be distributed over
tion in preventing and controlling diabe- patients optimize metabolic control, pre- at least 3 days/week and with no more
tes and its complications for the above vent and manage complications, and than two 2 consecutive days without
nutrition recommendations and addi- maximize quality of life, in a cost-effective physical activity. (A)
tional nutrition-related recommenda- manner. ● In the absence of contraindications,
tions can be found elsewhere in this people with type 2 diabetes should be
document. Achieving nutrition-related Evidence for the benefits of DSME encouraged to perform resistance exer-
goals requires a coordinated team effort Since the 1990s, there has been a shift cise three times a week, targeting all
that includes the active involvement of from a didactic approach with DSME fo- major muscle groups, progressing to
the person with pre-diabetes or diabetes. cusing on providing information to a three sets of 8 –10 repetitions at a
Because of the complexity of nutrition is- skill-based approach that focuses on weight that cannot be lifted more than
sues, it is recommended that a registered helping those with diabetes make in- 8 –10 times. (A)
dietitian who is knowledgeable and formed self-management choices. Several
skilled in implementing nutrition therapy studies have found that DSME is associ- Indications for graded exercise test
into diabetes management and education ated with improved diabetes knowledge with electrocardiogram monitoring
be the team member who provides MNT. (46), improved self-care behavior (46), ● A graded exercise test with electrocar-
However, it is essential that all team mem- improved clinical outcomes such as lower diogram (ECG) monitoring should be
bers are knowledgeable about nutrition A1C (47,48,50,51), lower self-reported seriously considered before undertak-
therapy and are supportive of the person weight (46), and improved quality of life ing aerobic physical activity with inten-
with diabetes. (49). Better outcomes were reported for sity exceeding the demands of everyday
For those individuals seeking guid- DSME that were longer and included fol- living (more intense than brisk walk-
ance regarding macronutrient distribu- low-up support (46), that were tailored to ing) in previously sedentary diabetic

S12 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

individuals whose 10-year risk of a cor- meta-analysis of the interrelationships Exercise in the presence of
onary event is likely to be ⱖ10%. (E) among exercise intensity, exercise vol- nonoptimal glycemic control
ume, change in cardiorespiratory fitness, Hyperglycemia. When people with type
ADA technical reviews on exercise in pa- and change in A1C. This meta-analysis 1 diabetes are deprived of insulin for
tients with diabetes have summarized the provides support for higher-intensity aer- 12– 48 h and are ketotic, exercise can
value of exercise in the diabetes manage- obic exercise in people with type 2 diabe- worsen hyperglycemia and ketosis (63).
ment plan (52,53). Regular exercise has tes as a means of improving A1C. These Vigorous activity should probably be
been shown to improve blood glucose results would provide support for en- avoided in the presence of ketosis. How-
control, reduce cardiovascular risk fac- couraging type 2 diabetic individuals who ever, provided the patient feels well and
tors, contribute to weight loss, and im- are already exercising at moderate inten- urine and/or blood ketones are negative,
prove well-being. Furthermore, regular sity to consider increasing the intensity of it is not necessary to postpone exercise
exercise may prevent type 2 diabetes in their exercise in order to obtain additional based simply on hyperglycemia.
high-risk individuals (8 –10). benefits in both aerobic fitness and glyce- Hypoglycemia. In individuals taking in-
mic control. sulin and/or insulin secretagogues, phys-
Definitions ical activity can cause hypoglycemia if
The following definitions are based on medication dose or carbohydrate con-
those outlined in Physical Activity and Frequency of exercise sumption is not altered. Hypoglycemia is
Health, the 1996 report of the Surgeon The U.S. Surgeon General’s report (54) rare in diabetic individuals who are not
General (54). Physical activity is defined recommended that most people accumu- treated with insulin or insulin secreta-
as bodily movement produced by the late ⱖ30 min of moderate-intensity activ- gogues. Added carbohydrate should be
contraction of skeletal muscle that re- ity on most, ideally all, days of the week. ingested if preexercise glucose levels are
quires energy expenditure in excess of The American College of Sports Medicine ⬍100 mg/dl (5.6 mmol/l) (64). Supple-
resting energy expenditure. Exercise is a now recommends including resistance mentary carbohydrate is generally not
subset of physical activity: planned, struc- training in fitness programs for adults necessary for individuals treated only
tured, and repetitive bodily movement with type 2 diabetes (57). Resistance ex- with diet, metformin, ␣-glucosidase in-
performed to improve or maintain one or ercise improves insulin sensitivity to hibitors, and/or TZDs without insulin or a
more component of physical fitness. Aer- about the same extent as aerobic exercise secretagogue (65).
obic exercise consists of rhythmic, re-
(58). Two clinical trials published in 2002
peated, and continuous movements of the Exercise in the presence of specific
provided strong evidence for the value of
same large muscle groups for at least 10 long-term complications of diabetes
resistance training in type 2 diabetes
min at a time. Examples include walking, Retinopathy. In the presence of prolif-
(59,60).
bicycling, jogging, swimming, water aer- erative diabetic retinopathy (PDR) or se-
obics, and many sports. Resistance exer- vere non-PDR (NPDR), vigorous aerobic
cise consists of activities that use mus- or resistance exercise may be contraindi-
Evaluation of the diabetic patient
cular strength to move a weight or work cated because of the risk of triggering vit-
before recommending an exercise
against a resistive load. Examples include reous hemorrhage or retinal detachment
weight lifting and exercises using weight program (66).
machines. Before beginning a program of physical Peripheral neuropathy. Decreased pain
activity more vigorous than brisk walk- sensation in the extremities results in in-
Effects of structured exercise ing, people with diabetes should be as- creased risk of skin breakdown and infec-
interventions on glycemic control sessed for conditions that might be tion and of Charcot joint destruction.
and body weight in type 2 diabetes associated with increased likelihood of Therefore, in the presence of severe pe-
Boulé et al. (55) undertook a systematic CVD or that might contraindicate certain ripheral neuropathy, it may be best to en-
review and meta-analysis on the effects of types of exercise or predispose to injury, courage non–weight-bearing activities
structured exercise interventions in clini- such as uncontrolled hypertension, se- such as swimming, bicycling, or arm ex-
cal trials of duration ⱖ8 weeks on A1C vere autonomic neuropathy, severe pe- ercises (67,68).
and body mass in people with type 2 di- ripheral neuropathy, and preproliferative Autonomic neuropathy. Autonomic
abetes. Twelve aerobic training studies or proliferative retinopathy or macular neuropathy can increase the risk of exer-
and two resistance training studies were edema. The patient’s age and previous cise-induced injury by decreasing cardiac
included (totaling 504 subjects), and the physical activity level should be consid- responsiveness to exercise, postural hy-
results were pooled using standard meta- ered. potension, impaired thermoregulation
analytic statistical methods. Postinterven- A recent systematic review for the due to impaired skin blood flow and
tion A1C was significantly lower in U.S. Preventive Services Task Force came sweating, impaired night vision due to
exercise than control groups. Metaregres- to the conclusion that stress tests should impaired papillary reaction, impaired
sion confirmed that the beneficial effect of usually not be recommended to detect thirst increasing risk of dehydration, and
exercise on A1C was independent of any ischemia in asymptomatic individuals at gastroparesis with unpredictable food de-
effect on body weight. Therefore, struc- low CAD risk (⬍10% risk of a cardiac livery (67). Autonomic neuropathy is also
tured exercise programs had a statistically event over 10 years) because the risks of strongly associated with CVD in people
and clinically significant beneficial effect subsequent invasive testing triggered by with diabetes (69,70). People with dia-
on glycemic control, and this effect was false-positive tests outweighed the ex- betic autonomic neuropathy should defi-
not mediated primarily by weight loss. pected benefits from detection of previ- nitely undergo cardiac investigation
Boulé et al. (56) later undertook a ously unsuspected ischemia (61,62). before beginning physical activity more

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S13


Standards of Medical Care

intense than that to which they are accus- Psychosocial screening should in- dition that requires immediate medical
tomed. clude but is not limited to attitudes about care to prevent complications and death;
Microalbuminuria and nephropathy. the illness, expectations for medical man- the possibility of DKA should always be
Physical activity can acutely increase uri- agement and outcomes, affect/mood, gen- considered (83). Marked hyperglycemia
nary protein excretion. There is no evi- eral and diabetes-related quality of life, requires temporary adjustment of the
dence from clinical trials or cohort studies resources (financial, social, and emo- treatment program and, if accompanied
demonstrating that vigorous exercise in- tional) (76), and psychiatric history by ketosis, frequent interaction with the
creases the rate of progression of diabetic (77,80,81). Particular attention needs to diabetes care team. The patient treated
kidney disease. There may be no need for be paid to gross noncompliance with with oral glucose-lowering agents or
any specific exercise restrictions for peo- medical regimen (due to self or others) MNT alone may temporarily require insu-
ple with diabetic kidney disease (71). (81), depression with the possibility of lin. Adequate fluid and caloric intake
self-harm (73,74), indications of an eat- must be assured. Infection or dehydration
G. Psychosocial assessment and care ing disorder (82) or a problem that ap- is more likely to necessitate hospitaliza-
pears to be organic in origin, and tion of the person with diabetes than the
Recommendations cognitive functioning that significantly person without diabetes. The hospitalized
● Preliminary assessment of psychologi- impairs judgment (74). In these cases, im- patient should be treated by a physician
cal and social status should be included mediate referral for further evaluation by with expertise in the management of dia-
as part of the medical management of a mental health specialist familiar with di- betes, and recent studies suggest that
diabetes. (E) abetes management should occur. Behav- achieving very stringent glycemic control
● Psychosocial screening should include ioral assessment of management skills is may reduce mortality in the immediate
but is not limited to attitudes about the also recommended. postmyocardial infarction period (84).
illness, expectations for medical man- It is preferable to incorporate psycho- Aggressive glycemic management with
agement and outcomes, affect/mood, logical treatment into routine care rather insulin may reduce morbidity in patients
general and diabetes-related quality of than waiting for identification of a specific with severe acute illness (85).
life, resources (financial, social, and problem or deterioration in psychological For further information on manage-
emotional), and psychiatric history. (E) status (79). Screening tools can facilitate ment of patients in the hospital with DKA
● Screening for psychosocial problems this goal, and although the clinician may or nonketotic hyperosmolar state, refer to
such as depression, eating disorders, not feel qualified to treat psychological the ADA position statement (83).
and cognitive impairment is needed problems, utilizing the patient-provider
when adherence to the medical regi- relationship as a foundation for further J. Hypoglycemia
men is poor. (E) treatment can increase the likelihood that
● It is preferable to incorporate psycho- the patient will accept referral for other Recommendations
logical treatment into routine care services. It is important to establish that ● Glucose (15–20 g) is the preferred
rather than wait for identification of a emotional well-being is part of diabetes treatment for hypoglycemia, although
specific problem or deterioration in management (80). any form of carbohydrate that contains
psychological status. (E) glucose may be used, and treatment ef-
H. Referral for diabetes management fects should be apparent in 15 min. (A)
Psychological and social state can impact For a variety of reasons, some people with ● Treatment effects on hypoglycemia
the patient’s ability to carry out diabetes diabetes and their health care providers may only be temporarily corrected.
care tasks (72–77). As a result, health sta- do not achieve the desired goals of treat- Therefore, plasma glucose should be
tus may be compromised. Family conflict ment (Table 6). Intensification of the retested in ⬃15 min, as additional
around diabetes care tasks is also com- treatment regimen is suggested and in- treatment may be necessary. (B)
mon and may interfere with treatment cludes identification (or assessment) of ● Glucagon should be prescribed for all
outcomes (78). There are opportunities barriers to adherence, culturally appro- patients at significant risk of severe hy-
for the clinician to assess psychosocial priate and enhanced DSME, comanage- poglycemia and does not require a
status in a timely and efficient manner ment with a diabetes team, change in health care professional for its adminis-
so that referral for appropriate services pharmacological therapy, initiation of or tration. (E)
can be accomplished (79). increase in SMBG, more frequent contact
Key opportunities for screening of with the patient, and referral to an endo- Hypoglycemia, especially in insulin-
psychosocial status occur at diagnosis, crinologist. treated patients, is the leading limiting
during regularly scheduled management factor in the glycemic management of
visits, during hospitalizations, at discov- I. Intercurrent illness type 1 and type 2 diabetes (86). Treat-
ery of complications, or at the discretion The stress of illness, trauma, and/or sur- ment of hypoglycemia (plasma glucose
of the clinician when problems in glucose gery frequently aggravates glycemic con- ⬍70 mg/dl) requires ingestion of glucose-
control, quality of life, or adherence are trol and may precipitate diabetic or carbohydrate-containing foods. The
identified (80). Patients are likely to ex- ketoacidosis (DKA) or nonketotic hyper- acute glycemic response correlates better
hibit psychological vulnerability at diag- osmolar state. Any condition leading to with the glucose content than with the
nosis and when their medical status deterioration in glycemic control necessi- carbohydrate content of the food. Al-
changes, i.e., the end of the honeymoon tates more frequent monitoring of blood though pure glucose may be the preferred
period, when the need for intensified glucose and urine or blood ketones. A treatment, any form of carbohydrate that
treatment is evident, and when complica- vomiting illness accompanied by ketosis contains glucose will raise blood glucose.
tions are discovered (75,77). may indicate DKA, a life-threatening con- Adding protein to carbohydrate does not

S14 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

affect the glycemic response and does not able that can greatly reduce the risk of Goals
prevent subsequent hypoglycemia. Add- serious complications from these diseases ● Patients with diabetes should be treated
ing fat, however, may retard and then (88,89). There is sufficient evidence to to a systolic blood pressure ⬍130
prolong the acute glycemic response (87). support that people with diabetes have mmHg. (C)
Rare situations of severe hypoglyce- appropriate serologic and clinical re- ● Patients with diabetes should be treated
mia (where the individual requires the as- sponses to these vaccinations. The Centers to a diastolic blood pressure ⬍80
sistance of another person and cannot be for Disease Control and Prevention’s Advi- mmHg. (B)
treated with oral carbohydrate) should be sory Committee on Immunization Practices
treated using emergency glucagon kits, recommends influenza and pneumococcal
which require a prescription. Those in vaccines for all individuals ⬎65 years of Treatment
● Patients with hypertension (systolic
close contact with, or having custodial age, as well as for all individuals of any age
care of, people with diabetes, such as fam- with diabetes. blood pressure ⱖ140 or diastolic blood
ily members, roommates, school person- For a complete discussion on the pre- pressure ⱖ90 mmHg) should receive
nel, child care providers, correctional vention of influenza and pneumococcal drug therapy in addition to lifestyle and
institution staff, and coworkers, should disease in people with diabetes, consult behavioral therapy. (A)
● Multiple drug therapy (two or more
be instructed in use of such kits. An indi- the technical review and position state-
vidual does not need to be a health care ment on this subject (90,91). agents at proper doses) is generally re-
professional to safely administer gluca- quired to achieve blood pressure tar-
gon. Care should be taken to ensure that gets. (B)
● Patients with a systolic blood pressure
unexpired glucagon kits are available.
VI. PREVENTION AND of 130 –139 mmHg or a diastolic blood
K. Immunization MANAGEMENT OF pressure of 80 – 89 mmHg should be
DIABETES COMPLICATIONS given lifestyle and behavioral therapy
Recommendations alone for a maximum of 3 months and
● Annually provide an influenza vaccine
A. CVD then, if targets are not achieved, in ad-
to all diabetic patients ⱖ6 months of CVD is the major cause of mortality for dition, be treated with pharmacological
age. (C) individuals with diabetes. It is also a ma- agents that block the renin-angiotensin
● Provide at least one lifetime pneumo-
jor contributor to morbidity and direct system. (E)
coccal vaccine for adults with diabetes. and indirect costs of diabetes. Type 2 di- ● Initial drug therapy for those with a

A one-time revaccination is recom- abetes is an independent risk factor for blood pressure ⬎140/90 mmHg
mended for individuals ⬎64 years of macrovascular disease, and its common should be with a drug class demon-
age previously immunized when they coexisting conditions (e.g., hypertension strated to reduce CVD events in pa-
were ⬍65 years of age if the vaccine was and dyslipidemia) are also risk factors. tients with diabetes (ACE inhibitors,
administered ⬎5 years ago. Other indi- Studies have shown the efficacy of re- angiotensin receptor blockers [ARBs],
cations for repeat vaccination include ducing cardiovascular risk factors in pre- ␤-blockers, diuretics, and calcium
nephrotic syndrome, chronic renal dis- venting or slowing CVD. Evidence is channel blockers). (A)
ease, and other immunocompromised summarized in the following sections and ● All patients with diabetes and hyper-

states, such as after transplantation. (C) reviewed in detail in the ADA technical tension should be treated with a regi-
reviews on hypertension (92), dyslipide- men that includes either an ACE
Influenza and pneumonia are common, mia (93), aspirin therapy (131), and inhibitor or an ARB. If one class is not
preventable infectious diseases associated smoking cessation (94) and the consen- tolerated, the other should be substi-
with high mortality and morbidity in the sus statement on CHD in people with di- tuted. If needed to achieve blood pres-
elderly and in people with chronic dis- abetes (95). Emphasis should be placed sure targets, a thiazide diuretic should
eases. There are limited studies reporting on reducing cardiovascular risk factors, be added. (E)
the morbidity and mortality of influenza when possible, and clinicians should be ● If ACE inhibitors, ARBs, or diuretics are
and pneumococcal pneumonia specifi- alert for signs and symptoms of athero- used, monitor renal function and se-
cally in people with diabetes. Observa- sclerosis. rum potassium levels. (E)
tional studies of patients with a variety of ● In patients with type 1 diabetes, with
chronic illnesses, including diabetes, 1. Hypertension/blood pressure hypertension and any degree of albu-
show that these conditions are associated control minuria, ACE inhibitors have been
with an increase in hospitalizations for in- shown to delay the progression of ne-
fluenza and its complications. Based on a phropathy. (A)
Recommendations ● In patients with type 2 diabetes, hy-
case-control series, influenza vaccine has
been shown to reduce diabetes-related pertension, and microalbuminuria,
hospital admission by as much as 79% Screening and diagnosis ACE inhibitors and ARBs have been
during flu epidemics (88). People with di- ● Blood pressure should be measured at shown to delay the progression to
abetes may be at increased risk of the bac- every routine diabetes visit. Patients macroalbuminuria. (A)
teremic form of pneumococcal infection found to have systolic blood pressure ● In those with type 2 diabetes, hyper-
and have been reported to have a high risk ⱖ130 mmHg or diastolic blood pres- tension, macroalbuminuria, and re-
of nosocomial bacteremia, which has a sure ⱖ80 mmHg should have blood nal insufficiency, ARBs have been
mortality rate as high as 50%. pressure confirmed on a separate day. shown to delay the progression of ne-
Safe and effective vaccines are avail- (C) phropathy. (A)

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S15


Standards of Medical Care
● In pregnant patients with diabetes and
chronic hypertension, blood pressure trol. Their effects on cardiovascular mmHg, however, mandates that immedi-
target goals of 110 –129/65–79 mmHg events have not been well measured. ate pharmacological therapy be initiated.
are suggested in the interest of long- Lowering of blood pressure with reg- Patients with hypertension should be
term maternal health and minimizing imens based on antihypertensive drugs, seen as often as needed until the recom-
impaired fetal growth. ACE inhibitors including ACE inhibitors, ARBs, ␤-block- mended blood pressure goal is obtained
and ARBs are contraindicated during ers, diuretics, and calcium channel block- and then seen as necessary (96). In these
pregnancy. (E) ers, has been shown to be effective in patients, other cardiovascular risk factors,
● In elderly hypertensive patients, blood lowering cardiovascular events. Several including obesity, hyperlipidemia, smok-
pressure should be lowered gradually studies suggest that ACE inhibitors may ing, presence of microalbuminuria (as-
to avoid complications. (E) be superior to dihydropyridine calcium sessed before initiation of treatment), and
● Patients not achieving target blood channel blockers (DCCBs) in reducing glycemic control, should be carefully as-
pressure despite multiple drug therapy cardiovascular events (103,104). Addi- sessed and treated. Many patients will re-
should be referred to a physician expe- tionally, in people with diabetic nephrop- quire three or more drugs to reach target
rienced in the care of patients with hy- athy, ARBs may be superior to DCCBs for goals.
pertension. (E) reducing heart failure but not overall car- During pregnancy in diabetic women
● Orthostatic measurement of blood diovascular events (105). Conversely, in
with chronic hypertension, target blood
pressure should be performed in peo- the recently completed INVEST (Interna-
pressure goals of systolic blood pressure
ple with diabetes and hypertension tional Verapamil-Trandolapril Study) of
110 –129 mmHg and diastolic blood
when clinically indicated. (E) ⬎22,000 people with CAD and hyper-
tension, the non-DCCB verapamil dem- pressure 65–79 mmHg are reasonable, as
onstrated a similar reduction in cardio- they may contribute to long-term mater-
Hypertension (blood pressure ⱖ140/90 vascular mortality to a ␤-blocker. nal health. Lower blood pressure levels
mmHg) is a common comorbidity of dia- Moreover, this relationship held true in may be associated with impaired fetal
betes, affecting the majority of people the diabetic subgroup (106). growth. During pregnancy, treatment
with diabetes, depending on type of dia- ACE inhibitors have been shown to with ACE inhibitors and ARBs is contra-
betes, age, obesity, and ethnicity. Hyper- improve cardiovascular outcomes in indicated, since they are likely to cause
tension is also a major risk factor for CVD high– cardiovascular risk patients with or fetal damage. Antihypertensive drugs
and microvascular complications such as without hypertension (107,108). In pa- known to be effective and safe in preg-
retinopathy and nephropathy. In type 1 tients with congestive heart failure (CHF), nancy include methyldopa, labetalol, dil-
diabetes, hypertension is often the result the addition of ARBs to either ACE inhib- tiazem, clonidine, and prazosin. Chronic
of underlying nephropathy. In type 2 di- itors or other therapies reduces the risk of diuretic use during pregnancy has been
abetes, hypertension may be present as cardiovascular death or hospitalization associated with restricted maternal
part of the metabolic syndrome (i.e., obe- for heart failure (109 –111). In one study, plasma volume, which might reduce
sity, hyperglycemia, and dyslipidemia), an ARB was superior to a ␤-blocker as a uteroplacental perfusion.
which is accompanied by high rates of therapy to improve cardiovascular out-
CVD. comes in a subset of diabetic patients with
Randomized clinical trials have dem- hypertension and left ventricular hyper-
onstrated the benefit (reduction of CHD trophy (112). The compelling effect of 2. Dyslipidemia/lipid management
events, stroke, and nephropathy) of low- ACE inhibitors or ARBs in patients with
ering blood pressure to ⬍140 mmHg albuminuria or renal insufficiency pro-
systolic and ⬍80 mmHg diastolic in indi- vides additional rationale for use of these Recommendations
viduals with diabetes (96 –99). Epidemi- agents (see section VI, B below).
ologic analyses show that blood pressure The ALLHAT (Antihypertensive and
⬎115/75 mmHg are associated with in- Lipid-Lowering Treatment to Prevent Screening
creased cardiovascular event rates and Heart Attack Trial), a large randomized ● In adult patients, test for lipid disorders
mortality in individuals with diabetes trial of different initial blood pressure at least annually and more often if
(96,100,101). Therefore, a target blood pharmacological therapies, found no needed to achieve goals. In adults with
pressure goal of ⬍130/80 mmHg is rea- large differences in initial therapy with low-risk lipid values (LDL ⬍100 mg/dl,
sonable if it can be safely achieved. chlorthalidone, amlodipine, or lisinopril. HDL ⬎50 mg/dl, and triglycerides
Although there are no well-controlled Diuretics appeared slightly more effective ⬍150 mg/dl), lipid assessments may be
studies of diet and exercise in the treat- than other agents, particularly for reduc- repeated every 2 years. (E)
ment of hypertension in individuals with ing heart failure (113). The ␣-blocker arm
diabetes, reducing sodium intake and of the ALLHAT was terminated after in-
body weight (when indicated); increasing terim analysis showed that doxazosin was
consumption of fruits, vegetables, and substantially less effective in reducing Treatment recommendations and
low-fat dairy products; avoiding excessive CHF than diuretic therapy (114). goals
alcohol consumption; and increasing ac- Before beginning treatment, patients ● Lifestyle modification focusing on the
tivity levels have been shown to be effec- with elevated blood pressure should have reduction of saturated fat, trans fat, and
tive in reducing blood pressure in their blood pressure reexamined within 1 cholesterol intake; weight loss (if indi-
nondiabetic individuals (102). These month to confirm the presence of hyper- cated); and increased physical activity
nonpharmacological strategies may also tension. Systolic blood pressure ⱖ160 has been shown to improve the lipid
positively affect glycemia and lipid con- mmHg or diastolic blood pressure ⱖ100 profile in patients with diabetes. (A)

S16 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

● In individuals without overt CVD increased physical activity, weight loss, ther events. The risk of side effects with
● The primary goal is an LDL ⬍100 and smoking cessation, should allow high doses of statins is significantly out-
mg/dl (2.6 mmol/l). (A) some patients to reach these lipid levels. weighed by the benefits of such therapy in
● For those over the age of 40 years, Nutrition intervention should be tailored these high-risk patients. Therefore, a re-
statin therapy to achieve an LDL re- according to each patient’s age, type of duction in LDL to a goal of ⬍70 mg/dl is
duction of 30 – 40% regardless of diabetes, pharmacological treatment, an option in very-high-risk patients with
baseline LDL levels is recommended. lipid levels, and other medical conditions overt CVD (122). The combination of st-
(A) and should focus on the reduction of sat- atins with other lipid-lowering drugs
● For those under the age of 40 years urated fat, cholesterol, and trans unsatur- such as ezetimibe may allow achievement
but at increased risk due to other car- ated fat intake. Glycemic control can also of the LDL goal with a lower dose of a
diovascular risk factors who do not beneficially modify plasma lipid levels. statin in such patients (128), but no data
achieve lipid goals with lifestyle mod- Particularly in patients with very high are available as to whether such combina-
ifications alone, the addition of phar- triglycerides and poor glycemic control, tion therapy is more effective than a statin
macological therapy is appropriate. glucose lowering may be necessary to alone in preventing cardiovascular
(C) control hypertriglyceridemia. Pharmaco- events.
● In individuals with overt CVD logical treatment is indicated if there is an Relatively little data are available on
● All patients should be treated with a inadequate response to lifestyle modifica- lipid-lowering therapy in subjects with
statin to achieve an LDL reduction of tions and improved glucose control. type 1 diabetes. In the Heart Protection
30 – 40%. (A) However, in patients with clinical CVD Study, ⬃600 patients with type 1 diabetes
● A lower LDL cholesterol goal of ⬍70 and LDL ⬎100 mg/dl, pharmacological had a proportionately similar, but not sta-
mg/dl (1.8 mmol/l), using a high dose therapy should be initiated at the same tistically significant, reduction in risk
of a statin, is an option. (B) time that lifestyle intervention is started. compared with patients with type 2 dia-
● Lower triglycerides to ⬍150 mg/dl (1.7 In patients with diabetes aged ⬍40 years, betes. Although the data are not defini-
mmol/l) and raise HDL cholesterol to similar consideration for LDL-lowering tive, consideration should be given for
⬎40 mg/dl (1.0 mmol/l). In women, an therapy should be given if they have in- similar lipid-lowering therapy in type 1
HDL goal 10 mg/dl higher (⬎50 mg/dl) creased cardiovascular risk (e.g., addi- diabetic patients as in type 2 diabetic pa-
should be considered. (C) tional cardiovascular risk factors or long

tients, particularly if they have other car-
Lowering triglycerides and increasing duration of diabetes). Very little clinical
diovascular risk factors or features of the
HDL cholesterol with a fibrate is asso- trial data exist for patients in this age-
metabolic syndrome.
ciated with a reduction in cardiovascu- group.
lar events in patients with clinical CVD, If the HDL is ⬍40 mg/dl and the LDL
The first priority of pharmacological
low HDL, and near-normal levels of between 100 and 129 mg/dl, a fibric acid
therapy is to lower LDL cholesterol to a
derivative or niacin might be used. Niacin
LDL. (A) target goal of ⬍100 mg/dl (2.60 mmol/l)
● Combination therapy using statins and is the most effective drug for raising HDL
or therapy to achieve a reduction in LDL
other lipid-lowering agents may be nec- of 30 – 40%. For LDL lowering, statins are but can significantly increase blood glu-
essary to achieve lipid targets but has the drugs of choice. Other drugs that cose at high doses. More recent studies
not been evaluated in outcomes studies lower LDL include nicotinic acid, demonstrate that at modest doses (750 –
for either CVD event reduction or ezetimbe, bile acid sequestrants, and fe- 2,000 mg/day), significant benefits to
safety. (E) nofibrate (121,122). LDL, HDL, and triglyceride levels are ac-
● Statin therapy is contraindicated in The Heart Protection Study (118) companied by only modest changes in
pregnancy. (E) demonstrated that in individuals with di- glucose that are generally amenable to ad-
abetes over the age of 40 years with a total justment of diabetes therapy (129,130).
Patients with type 2 diabetes have an in- cholesterol ⬎135 mg/dl, LDL reduction Combination therapy, with a statin
creased prevalence of lipid abnormalities, of ⬃30% from baseline with the statin and a fibrate or statin and niacin, may be
which contributes to higher rates of CVD. simvastatin was associated with an ⬃25% efficacious for patients needing treatment
Lipid management aimed at lowering reduction in the first event rate for major for all three lipid fractions, but this com-
LDL cholesterol, raising HDL cholesterol, coronary artery events independent of bination is associated with an increased
and lowering triglycerides has been baseline LDL, preexisting vascular dis- risk for abnormal transaminase levels,
shown to reduce macrovascular disease ease, type or duration of diabetes, or ade- myositis, or rhabdomyolysis. The risk of
and mortality in patients with type 2 dia- quacy of glycemic control. Similarly, in rhabdomyolysis seems to be lower when
betes, particularly in those who have had the CARDS (Coronary Artery Diabetes statins are combined with fenofibrate
prior cardiovascular events. In studies us- Study) (124), patients with type 2 diabe- than gemfibrozil. There is also a risk of a
ing HMG (hydroxymethylglutaryl)-CoA tes randomized to 10 mg atorvastatin rise in plasma creatinine, particularly
reductase inhibitors (statins), patients daily had a significant reduction in car- with fenofibrate. It is important to note
with diabetes achieved significant reduc- diovascular events including stroke. that clinical trials with fibrates and niacin
tions in coronary and cerebrovascular Recent clinical trials in high-risk pa- have demonstrated benefits in patients
events (115–118). In two studies using tients, such as those with acute coronary who were not being treated with statins
the fibric acid derivative gemfibrozil, re- syndromes or previous cardiovascular and that there are no data available on
ductions in cardiovascular end points events (125–127), have demonstrated reduction of events with such combina-
were also achieved (119,120). that more aggressive therapy with high tions. The risks may be greater in patients
Target lipid levels are shown in Table doses of statins to achieve an LDL of ⬍70 who are treated with combinations of
6. Lifestyle intervention, including MNT, mg/dl led to a significant reduction in fur- these drugs with high doses of statins.

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S17


Standards of Medical Care

3. Antiplatelet agents patients with and without a history of of tobacco use is important as a means of
CVD, males and females, and patients preventing smoking or encouraging ces-
Recommendations with hypertension. sation. Special considerations should in-
● Use aspirin therapy (75–162 mg/day) Dosages used in most clinical trials clude assessment of level of nicotine
as a secondary prevention strategy in ranged from 75 to 325 mg/day. There is dependence, which is associated with dif-
those with diabetes with a history of no evidence to support any specific dose, ficulty in quitting and relapse.
CVD. (A) but using the lowest possible dosage may
● Use aspirin therapy (75–162 mg/day) help reduce side effects. There is no evi- 5. CHD screening and treatment
as a primary prevention strategy in dence for a specific age at which to start
those with: aspirin, but at ages ⬍30 years, aspirin has Recommendations
● Type 2 diabetes at increased cardio- not been studied. ● In patients ⬎55 years of age, with or
vascular risk, including those who Clopidogrel has been demonstrated without hypertension but with another
are ⬎40 years of age or who have to reduce CVD rates in diabetic individu- cardiovascular risk factor (history of
additional risk factors (family history als (135). Adjunctive therapy in very- CVD, dyslipidemia, microalbuminuria,
of CVD, hypertension, smoking, dys- high-risk patients or as alternative or smoking), an ACE inhibitor (if not
lipidemia, or albuminuria). (A) therapy in aspirin-intolerant patients contraindicated) should be considered
● Type 1 diabetes at increased cardio- should be considered. to reduce the risk of cardiovascular
vascular risk, including those who events. (A)
are ⬎40 years of age or who have ad- 4. Smoking cessation ● In patients with a prior myocardial in-
ditional risk factors (family history of farction or in patients undergoing ma-
CVD, hypertension, smoking, dyslip- Recommendations jor surgery, ␤-blockers, in addition,
idemia, or albuminuria). (C) ● Advise all patients not to smoke. (A) should be considered to reduce mortal-
● Consider aspirin therapy in people be- ● Include smoking cessation counseling ity. (A)
tween the age of 30 and 40 years, par- and other forms of treatment as a rou- ● In asymptomatic patients, consider a
ticularly in the presence of other tine component of diabetes care. (B) risk factor evaluation to stratify patients
cardiovascular risk factors. (E) by 10-year risk and treat risk factors
● Aspirin therapy should not be recom- Issues of smoking in diabetes are re- accordingly. (B)
mended for patients under the age of 21 viewed in detail in the ADA technical re- ● In patients with treated CHF, met-
years because of the increased risk of view (94) and position statement (136) formin use is contraindicated. TZDs are
Reye’s syndrome associated with aspi- on smoking cessation. A large body of ev- associated with fluid retention, and
rin use in this population. People ⬍30 idence from epidemiological, case- their use can be complicated by the de-
years have not been studied. (E) control, and cohort studies provides velopment of CHF. Caution in pre-
● Combination therapy using other anti- convincing documentation of the causal scribing TZDs in the setting of known
platelet agents such as clopidrogel in link between cigarette smoking and CHF or other heart diseases, as well as
addition to aspirin should be used in health risks. Cigarette smoking contrib- in patients with preexisting edema or
patients with severe and progressive utes to one of every five deaths in the U.S. concurrent insulin therapy, is required.
CVD. (C) and is the most important modifiable (C)
● Other antiplatelet agents may be a rea- cause of premature death. Much of the
sonable alternative for high-risk pa- prior work documenting the impact of CHD screening and treatment are re-
tients with aspirin allergy, with smoking on health did not separately dis- viewed in detail in the ADA consensus
bleeding tendency, who are receiving cuss results on subsets of individuals with statement on CHD in people with diabe-
anticoagulant therapy, with recent gas- diabetes, suggesting that the identified tes (95). To identify the presence of CHD
trointestinal bleeding, and with clini- risks are at least equivalent to those found in diabetic patients without clear or sug-
cally active hepatic disease who are not in the general population. Other studies gestive symptoms of CAD, a risk factor–
candidates for aspirin therapy. (E) of individuals with diabetes consistently based approach to the initial diagnostic
found a heightened risk of morbidity and evaluation and subsequent follow-up is
The use of aspirin in diabetes is reviewed premature death associated with the de- recommended. However, a recent study
in detail in the ADA technical review velopment of macrovascular complica- concluded that using current guidelines
(131) and position statement (132) on as- tions among smokers. Smoking is also fails to detect a significant percentage of
pirin therapy. Aspirin has been recom- related to the premature development of patients with silent ischemia (69).
mended as a primary (133,134) and microvascular complications of diabetes At least annually, cardiovascular risk
secondary therapy to prevent cardiovas- and may have a role in the development of factors should be assessed. These risk fac-
cular events in diabetic and nondiabetic type 2 diabetes. tors include dyslipidemia, hypertension,
individuals. One large meta-analysis and A number of large randomized clini- smoking, a positive family history of pre-
several clinical trials demonstrate the effi- cal trials have demonstrated the efficacy mature coronary disease, and the pres-
cacy of using aspirin as a preventive mea- and cost-effectiveness of counseling in ence of micro- or macroalbuminuria.
sure for cardiovascular events, including changing smoking behavior. Such stud- Abnormal risk factors should be treated as
stroke and myocardial infarction. Many ies, combined with others specific to in- described elsewhere in these guidelines.
trials have shown an ⬃30% decrease in dividuals with diabetes, suggest that Patients at increased CHD risk should
myocardial infarction and a 20% decrease smoking cessation counseling is effective receive aspirin and may warrant an ACE
in stroke in a wide range of patients, in- in reducing tobacco use (137,138). inhibitor.
cluding young and middle-aged patients, The routine and thorough assessment Candidates for a diagnostic cardiac

S18 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

stress test include those with 1) typical or testing. Currently, stress nuclear perfu- ● In patients with type 1 diabetes, with
atypical cardiac symptoms and 2) an ab- sion and stress echocardiography are hypertension and any degree of albu-
normal resting ECG. The screening of valuable next-level diagnostic proce- minuria, ACE inhibitors have been
asymptomatic patients remains contro- dures. A consultation with a cardiologist shown to delay the progression of ne-
versial. is recommended regarding further work- phropathy. (A)
Studies have demonstrated that a sig- up. ● In patients with type 2 diabetes, hy-
nificant percentage of patients with diabe- When identified, the optimal thera- pertension, and microalbuminuria,
tes who have no symptoms of CAD have peutic approach to the diabetic patient ACE inhibitors and ARBs have been
abnormal stress tests, either by ECG or with silent myocardial ischemia is un- shown to delay the progression to
echo and nuclear perfusion imaging. known. Certainly if major CAD is identi- macroalbuminuria. (A)
Some of these patients, though clearly not fied, aggressive intervention appears ● In patients with type 2 diabetes, hy-
all, have significant coronary stenoses if warranted. If minor stenoses are detected, pertension, macroalbuminuria, and
they proceed to angiography. It has also however, it is unknown whether there is renal insufficiency (serum creatinine
been demonstrated that patients with si- any benefit to further invasive evaluation ⬎1.5 mg/dl), ARBs have been shown
lent myocardial ischemia have a poorer and/or therapy. There are no well- to delay the progression of nephrop-
prognosis than those with normal stress conducted prospective trials with ade- athy. (A)
tests. Their risk is further accentuated if quate control groups to shed light on this ● If one class is not tolerated, the other
cardiac autonomic neuropathy coexists. subject. Accordingly, there are no evi- should be substituted. (E)
Candidates for a screening cardiac stress dence-based guidelines for screening the ● Reduction of protein intake to 0.8 –1.0
test include those with 1) a history of pe- asymptomatic diabetic patient for CAD. g 䡠 kg body wt⫺1 䡠 day⫺1 in individuals
ripheral or carotid occlusive disease and with diabetes and the earlier stages of
2) sedentary lifestyle, age ⬎35 years, and B. Nephropathy screening and CKD and to 0.8 g 䡠 kg body wt⫺1 䡠
plans to begin a vigorous exercise pro- treatment day⫺1 in the later stages of CKD may
gram. There are no data to suggest that improve measures of renal function
patients who start to increase their phys- (urine albumin excretion rate, GFR)
Recommendations and is recommended (B)
ical activity by walking or similar exercise
increase their risk of a CVD event and ● To slow the progression of nephropa-
therefore are unlikely to need a stress test. General recommendations thy, the use of DCCBs as initial therapy
● To reduce the risk and/or slow the pro- is not more effective than placebo.
It has previously been proposed to
screen those with two or more additional gression of nephropathy, optimize glu- Their use in nephropathy should be re-
cardiac risk factors. However, this likely cose control. (A) stricted to additional therapy to further
● To reduce the risk and/or slow the pro- lower blood pressure in patients al-
includes the vast majority of patients with
type 2 diabetes (given that the risk factors gression of nephropathy, optimize ready treated with ACE inhibitors or
frequently cluster). The DIAD (Detection blood pressure control. (A) ARBs. (B)
of Silent Myocardial Ischemia in Asymp- ● In the setting of albuminuria or ne-
tomatic Diabetic Subjects) study sug- Screening phropathy, in patients unable to toler-
gested that conventional cardiac risk ● Perform an annual test for the presence ate ACE inhibitors and/or ARBs,
factors did not help to identify those pa- of microalbuminuria in type 1 diabetic consider the use of non-DCCBs,
tients with abnormal perfusion imaging patients with diabetes duration of ⱖ5 ␤-blockers, or diuretics for the manage-
(69). years and in all type 2 diabetic patients, ment of blood pressure. Use of non-
Current evidence suggests that non- starting at diagnosis and during preg- DCCBs may reduce albuminuria in
invasive tests can improve assessment of nancy. (E) diabetic patients, including during
future CHD risk. There is, however, no ● Serum creatinine should be measured pregnancy. (E)
current evidence that such testing in at least annually for the estimation of ● If ACE inhibitors, ARBs, or diuretics are
asymptomatic patients with risk factors glomerular filtration rate (GFR) in all used, monitor serum potassium levels
improves outcomes or leads to better uti- adults with diabetes regardless of the for the development of hyperkalemia.
lization of treatments (62). degree of urine albumin excretion. The (B)
Approximately 1 in 5 will have an ab- serum creatinine alone should not be ● Continued surveillance of microalbu-
normal test, and ⬃1 in 15 will have a ma- used as a measure of kidney function minuria/proteinuria to assess both re-
jor abnormality. More information is but instead used to estimate GFR and sponse to therapy and progression of
needed concerning prognosis, and the stage the level of chronic kidney disease disease is recommended. (E)
value of early intervention (invasive or (CKD). (E) ● Consider referral to a physician experi-
noninvasive) before widespread screen- enced in the care of diabetic renal dis-
ing is recommended. All patients irre- Treatment ease when the estimated GFR has fallen
spective of their CAD status should have ● In the treatment of both micro- and to ⬍60 ml/min per 1.73 m2 or if diffi-
aggressive risk factor modification, in- macroalbuminuria, either ACE inhibi- culties occur in the management of hy-
cluding control of glucose, lipids, and tors or ARBs should be used except dur- pertension or hyperkalemia. (B)
blood pressure and prophylactic aspirin ing pregnancy. (A)
therapy. ● While there are no adequate head-to- Diabetic nephropathy occurs in 20 – 40%
Patients with abnormal exercise ECG head comparisons of ACE inhibitors of patients with diabetes and is the single
and patients unable to perform an exer- and ARBs, there is clinical trial support leading cause of end-stage renal disease
cise ECG require additional or alternative for each of the following statements: (ESRD). Persistent albuminuria in the

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S19


Standards of Medical Care

Table 8—Definitions of abnormalities in albumin excretion spot urine for albumin only, whether by
immunoassay or by using a dipstick test
Category Spot collection (␮g/mg creatinine) specific for microalbumin, without simul-
taneously measuring urine creatinine, is
Normal ⬍30 less expensive than the recommended
Microalbuminuria 30–299 methods but is susceptible to false-
Macro (clinical)-albuminuria ⱖ300 negative and -positive determinations as a
Because of variability in urinary albumin excretion, two of three specimens collected within a 3- to 6-month result of variation in urine concentration
period should be abnormal before considering a patient to have crossed one of these diagnostic thresholds. due to hydration and other factors.
Exercise within 24 h, infection, fever, CHF, marked hyperglycemia, and marked hypertension may elevate
urinary albumin excretion over baseline values.
At least two of three tests measured
within a 6-month period should show el-
evated levels before a patient is designated
range of 30 –299 mg/24 h (microalbu- of nephropathy, the use of DCCBs as ini- as having microalbuminuria. Abnormali-
minuria) has been shown to be the earliest tial therapy is not more effective than pla- ties of albumin excretion are defined in
stage of diabetic nephropathy in type 1 cebo. Their use in nephropathy should be Table 8.
diabetes and a marker for development of restricted to additional therapy to further Screening for microalbuminuria is in-
nephropathy in type 2 diabetes. Mi- lower blood pressure in patients already dicated in pregnancies complicated by di-
croalbuminuria is also a well-established treated with ACE inhibitors or ARBs abetes, since microalbuminuria in the
marker of increased CVD risk (139,140). (105). In the setting of albuminuria or ne- absence of urinary tract infection is a
Patients with microalbuminuria who phropathy, in patients unable to tolerate strong predictor of superimposed pre-
progress to macroalbuminuria (ⱖ300 ACE inhibitors and/or ARBs, consider the eclampsia. In the presence of macroalbu-
mg/24 h) are likely to progress to ESRD use of non-DCCBs, ␤-blockers, or diuretics minuria or urine dipstick proteinuria,
over a period of years (141,142). Over the for the management of blood pressure estimation of GFR by serum creatinine
past several years, a number of interven- (106,151). (see below) or 24-h urine creatinine clear-
tions have been demonstrated to reduce Studies in patients with varying stages ance is indicated to stage the patient’s re-
the risk and slow the progression of renal of nephropathy have shown that protein nal disease, and other tests may be
disease. restriction helps slow the progression of necessary to diagnose preeclampsia.
Intensive diabetes management with albuminuria, GFR decline, and occur- Information on presence of urine al-
the goal of achieving near normoglycemia rence of ESRD (152–154). Protein restric- bumin excretion in addition to level of
has been shown in large prospective ran- tion should be considered particularly in GFR may be used to stage CKD according
domized studies to delay the onset of mi- patients whose nephropathy seems to be to the National Kidney Foundation. The
croalbuminuria and the progression of progressing despite optimal glucose and current National Kidney Foundation clas-
micro- to macroalbuminuria in patients blood pressure control and use of ACE sification (Table 9) is primarily based on
with type 1 (143,144) and type 2 (32,33) inhibitor and/or ARBs (155). GFR levels and therefore differs from
diabetes. The UKPDS provided strong ev- Screening for microalbuminuria can some earlier staging systems used by oth-
idence that control of blood pressure can be performed by three methods: 1) mea- ers, in which staging is based primarily on
reduce the development of nephropathy surement of the albumin-to-creatinine ra- urinary albumin excretion (158). Studies
(97). In addition, large prospective ran- tio in a random spot collection (preferred have found decreased GFR in the absence
domized studies in patients with type 1 method); 2) 24-h collection with creati- of increase urine albumin excretion in a
diabetes have demonstrated that achieve- nine, allowing the simultaneous measure- substantial percentage of adults with dia-
ment of lower levels of systolic blood ment of creatinine clearance; and 3) timed betes (159,160). Thus, these studies dem-
pressure (⬍140 mmHg) resulting from (e.g., 4-h or overnight) collection. onstrate that significant decline in GFR
treatment using ACE inhibitors provides a The analysis of a spot sample for the may be noted in adults with type 1 and
selective benefit over other antihyperten- albumin-to-creatinine ratio is strongly type 2 diabetes in the absence of increased
sive drug classes in delaying the progres- recommended by most authorities urine albumin excretion. It is now clear
sion from micro- to macroalbuminuria (156,157). The other two alternatives that stage 3 or higher CKD (GFR ⬍60
and can slow the decline in GFR in pa- (24-h collection and a timed specimen) ml/min per 1.73 m2) occurs in the ab-
tients with macroalbuminuria (145– are rarely necessary. Measurement of a sence of urine albumin excretion in a sub-
147).
In addition, ACE inhibitors have been
shown to reduce severe CVD (i.e., myo- Table 9—Stages of CKD
cardial infarction, stroke, death), thus fur-
ther supporting the use of these agents in
GFR (ml/min per 1.73
patients with microalbuminuria (107).
Stage Description m2 body surface area)
ARBs have also been shown to reduce the
rate of progression from micro- to mac- 1 Kidney damage* with normal or increased GFR ⱖ90
roalbuminuria as well as ESRD in patients 2 Kidney damage* with mildly decreased GFR 60–89
with type 2 diabetes (148 –150). Some ev- 3 Moderately decreased GFR 30–59
idence suggests that ARBs have a smaller 4 Severely decreased GFR 15–29
magnitude of rise in potassium compared 5 Kidney failure ⬍15 or dialysis
with ACE inhibitors in people with ne- *Kidney damage defined as abnormalities on pathologic, urine, blood, or imaging tests. Adapted from ref.
phropathy (106). To slow the progression 157a.

S20 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

stantial proportion of adults with Screening (27,32,33). In addition to glycemic con-


diabetes. Screening this population for in- ● Adults and adolescents with type 1 di- trol, several other factors seem to increase
creased urine albumin excretion alone, abetes should have an initial dilated the risk of retinopathy. The presence of
therefore, will miss a considerable num- and comprehensive eye examination by nephropathy is associated with retinopa-
ber of CKD cases (158). an ophthalmologist or optometrist thy. High blood pressure is an established
Serum creatinine should be measured within 3–5 years after the onset of dia- risk factor for the development of macular
at least annually for the estimation of GFR betes. (B) edema and is associated with the presence
in all adults with diabetes regardless of the ● Patients with type 2 diabetes should of PDR. Lowering blood pressure, as dem-
degree of urine albumin excretion. Serum have an initial dilated and comprehen- onstrated by the UKPDS, has been shown
creatinine alone should not be used as a sive eye examination by an ophthalmol- to decrease the progression of retinopa-
measure of kidney function, but used to ogist or optometrist shortly after the thy. Several case series and a controlled
estimate GFR and stage the level of CKD. diagnosis of diabetes. (B) prospective study suggest that pregnancy
The GFR can be easily estimated using ● Subsequent examinations for type 1 in type 1 diabetic patients may aggravate
formulae like the Cockroft-Gault formula and type 2 diabetic patients should be retinopathy (164). During pregnancy and
or a newer prediction formula developed repeated annually by an ophthalmolo- 1 year postpartum, retinopathy may be
by Levey et al. (161) using data collected gist or optometrist. Less frequent exams transiently aggravated; laser photocoagu-
from the MDRD (Modification of Diet and (every 2–3 years) may be considered in lation surgery can minimize this risk
Renal Disease) study. Estimated GFR can the setting of a normal eye exam. Exam- (165).
easily be calculated by going to www. inations will be required more fre- Patients with type 1 diabetes should
kidney.org/professionals/kdoqi/gfr_ quently if retinopathy is progressing. have an initial dilated and comprehensive
calculator.cfm. (B) eye examination by an ophthalmologist or
The role of annual microalbumuria ● Women who are planning pregnancy optometrist within 5 years after the onset
assessment is less clear after diagnosis of or who have become pregnant should of diabetes. Patients with type 2 diabetes
microalbuminuria and institution of ACE have a comprehensive eye examination should have an initial dilated and com-
inhibitor or ARB therapy and blood pres- and should be counseled on the risk of prehensive eye examination by an oph-
sure control. Most experts, however, rec- development and/or progression of di- thalmologist or optometrist shortly after
ommend continued surveillance to assess abetic retinopathy. Eye examination the diagnosis of diabetes. Subsequent ex-
both response to therapy and progression should occur in the first trimester with aminations for type 1 and type 2 diabetic
of disease. Some experts suggest that re- close follow-up throughout pregnancy patients should be repeated annually by
ducing urine microalbuminuria to the and for 1 year postpartum. This guide- an ophthalmologist or optometrist who is
normal or near-normal range, if possible, line does not apply to women who de- knowledgeable and experienced in diag-
may improve renal and cardiovascular velop GDM because such individuals nosing the presence of diabetic retinopa-
prognosis. This approach has not been are not at increased risk for diabetic ret- thy and is aware of its management. Less
formally evaluated in prospective trials. inopathy. (B) frequent exams (every 2–3 years) may be
Consider referral to a physician expe- considered with the advice of an eye care
rienced in the care of diabetic renal dis- Treatment professional in the setting of a normal eye
ease either when the GFR has fallen to ● Laser therapy can reduce the risk of vi- exam (166 –168). Examinations will be
⬍60 ml/min per 1.73 m2 or if difficulties sion loss in patients with high-risk required more frequently if retinopathy is
occur in the management of hypertension characteristics (HRCs). (A) progressing.
or hyperkalemia. It is suggested that con- ● Promptly refer patients with any level of Examinations can also be done by the
sultation with a nephrologist be obtained macular edema, severe NPDR, or any taking of retinal photographs (with or
when the GFR is ⬍30 ml/min per 1.73 PDR to an ophthalmologist who is without dilation of the pupil) and having
m2. Early referral of such patients has knowledgeable and experienced in the these read by experienced experts in this
been found to reduce cost and improve management and treatment of diabetic field. In-person exams are still necessary
quality of care and keep people off dialysis retinopathy. (A) when the photos are unacceptable and for
longer (162,163). follow-up of abnormalities detected. This
Diabetic retinopathy is a highly specific technology has it greatest potential in ar-
C. Retinopathy screening and vascular complication of both type 1 and eas where qualified eye care professionals
treatment type 2 diabetes. The prevalence of reti- are not available. Results of eye examina-
nopathy is strongly related to the duration tions should be documented and transmit-
Recommendations of diabetes. Diabetic retinopathy is esti- ted to the referring health care professional.
mated to be the most frequent cause of One of the main motivations for
General recommendations new cases of blindness among adults aged screening for diabetic retinopathy is the
● Optimal glycemic control can substan- 20 –74 years. Glaucoma, cataracts, and established efficacy of laser photocoagu-
tially reduce the risk and progression of other disorders of the eye may occur ear- lation surgery in preventing visual loss.
diabetic retinopathy. (A) lier in people with diabetes and should Two large National Institutes of Health–
● Optimal blood pressure control can re- also be evaluated. sponsored trials, the Diabetic Retinopa-
duce the risk and progression of dia- Intensive diabetes management with thy Study (DRS) and the Early Treatment
betic retinopathy. (A) the goal of achieving near normoglycemia Diabetic Retinopathy Study (ETDRS),
● Aspirin therapy does not prevent reti- has been shown in large prospective ran- provide the strongest support for the ther-
nopathy or increase the risks of hemor- domized studies to prevent and/or delay apeutic benefit of photocoagulation
rhage. (A) the onset of diabetic retinopathy surgery.

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S21


Standards of Medical Care

The DRS tested whether scatter (pan- diagnosis and at least annually thereaf- manifestations of DPN and autonomic
retinal) photocoagulation surgery could ter, using simple clinical tests. (A) neuropathy.
reduce the risk of vision loss from PDR. ● Electrophysiological testing is rarely
Severe visual loss (i.e., best acuity of ever needed, except in situations where
5/200 or worse) was seen in 15.9% of un- the clinical features are atypical. (E) Diagnosis of neuropathy
treated vs. 6.4% of treated eyes. The ben- ● Once the diagnosis of DPN is estab- Patients with diabetes should be screened
efit was greatest among patients whose lished, special foot care is appropriate annually for DPN using tests such as pin-
baseline evaluation revealed HRCs for insensate feet to decrease the risk of prick sensation, temperature and vibra-
(chiefly disc neovascularization or vitre- amputation. (B) tion perception (using a 128-Hz tuning
ous hemorrhage with any retinal neovas- ● Simple inspection of insensate feet fork), and 10-g monofilament pressure
cularization). Of control eyes with HRCs, should be performed at 3- to 6-month sensation at the distal plantar aspect of
26% progressed to severe visual loss vs. intervals. An abnormality should trig- both great toes and ankle reflexes. Com-
11% of treated eyes. Given the risk of a ger referral for special footwear, pre- binations of more than one test have
modest loss of visual acuity and of con- ventive specialist, or podiatric care. (B) ⬎87% sensitivity in detecting DPN. Loss
traction of visual field from panretinal la- ● Screening for autonomic neuropathy of 10-g monofilament perception and re-
ser surgery, such therapy has been should be instituted at diagnosis of type duced vibration perception predict foot
primarily recommended for eyes ap- 2 diabetes and 5 years after the diagno- ulcers. A minimum of one clinical test
proaching or reaching HRCs. sis of type 1 diabetes. Special electro- should be carried out annually, and the
The ETDRS established the benefit of physiological testing for autonomic use of two tests will increase diagnostic
focal laser photocoagulation surgery in neuropathy is rarely needed and may ability.
eyes with macular edema, particularly not affect management and outcomes. Focal and multifocal neuropathy as-
those with clinically significant macular (E) sessment requires clinical examination in
edema. In patients with clinically signifi- ● Education of patients about self-care of the area related to the neurological symp-
cant macular edema after 2 years, 20% of the feet and referral for special shoes/ toms.
untreated eyes had a doubling of the vi- inserts are vital components of patient
sual angle (e.g., 20/50 to 20/100) com- management. (B)
pared with 8% of treated eyes. Other ● A wide variety of medications is recom- Diabetic autonomic neuropathy
results from the ETDRS indicate that, pro- mended for the relief of specific symp- (173)
vided careful follow-up can be main- toms related to autonomic neuropathy The symptoms of autonomic dysfunction
tained, scatter photocoagulation surgery and are recommended, as they improve should be elicited carefully during the
is not recommended for eyes with mild or the quality of life of the patient. (E) history and review of systems, particu-
moderate NPDR. When retinopathy is larly since many of these symptoms are
more severe, scatter photocoagulation potentially treatable. Major clinical man-
surgery should be considered, and usu- The diabetic neuropathies are heteroge- ifestations of diabetic autonomic neurop-
ally should not be delayed, if the eye has neous with diverse clinical manifesta- athy include resting tachycardia, exercise
reached the high-risk proliferative stage. tions. They may be focal or diffuse. Most intolerance, orthostatic hypotension,
In older-onset patients with severe NPDR common among the neuropathies are constipation, gastroparesis, erectile dys-
or less-than-high-risk PDR, the risk of se- chronic sensorimotor DPN and auto- function, sudomotor dysfunction, im-
vere visual loss and vitrectomy is reduced nomic neuropathy. Although DPN is a paired neurovascular function, “brittle
⬃50% by laser photocoagulation surgery diagnosis of exclusion, complex investi- diabetes,” and hypoglycemic autonomic
at these earlier stages. gations to exclude other conditions are failure.
Laser photocoagulation surgery in rarely needed. Cardiovascular autonomic neuropa-
both the DRS and the ETDRS was benefi- The early recognition and appropri- thy is the most studied and clinically im-
cial in reducing the risk of further visual ate management of neuropathy in the pa- portant form of diabetic autonomic
loss, but generally not beneficial in revers- tient with diabetes is important for a neuropathy. Cardiac autonomic neurop-
ing already diminished acuity. This pre- number of reasons: 1) nondiabetic neu- athy may be indicated by resting tachycar-
ventive effect and the fact that patients ropathies may be present in patients with dia (⬎100 bpm), orthostasis (a fall in
with PDR or macular edema may be diabetes and may be treatable; 2) a num- systolic blood pressure ⬎20 mmHg upon
asymptomatic provide strong support for ber of treatment options exist for symp- standing), or other disturbances in auto-
a screening program to detect diabetic ret- tomatic diabetic neuropathy; 3) up to nomic nervous system function involving
inopathy. 50% of DPN may be asymptomatic and the skin, pupils, or gastrointestinal and
For a detailed review of the evidence patients are at risk of insensate injury to genitourinary systems.
and further discussion, see the ADA’s their feet; 4) autonomic neuropathy may Gastrointestinal disturbances (e.g.,
technical review and position statement involve every system in the body; and 5) esophageal enteropathy, gastroparesis,
on this subject (169,170). cardiovascular autonomic neuropathy constipation, diarrhea, fecal inconti-
causes substantial morbidity and mortal- nence) are common, and any section of
D. Neuropathy screening and ity. Specific treatment for the underlying the gastrointestinal tract may be affected.
treatment (171,172) nerve damage is currently not available, Gastroparesis should be suspected in in-
other than improved glycemic control, dividuals with erratic glucose control.
Recommendations which may slow progression but rarely Upper-gastrointestinal symptoms should
● All patients should be screened for dis- reverses neuronal loss. Effective symp- lead to consideration of all possible
tal symmetric polyneuropathy (DPN) at tomatic treatments are available for the causes, including autonomic dysfunction.

S22 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

Evaluation of solid-phase gastric empty- Table 10—Table of drugs to treat symptomatic DPN
ing using double-isotope scintigraphy
may be done if symptoms are suggestive, Class Examples Typical doses*
but test results often correlate poorly with
symptoms. Barium studies or referral for Tricyclic drugs Amitriptyline 10–75 mg at bedtime
endoscopy may be required to rule out Nortriptyline 25–75 mg at bedtime
structural abnormalities. Constipation is Imipramine 25–75 mg at bedtime
Anticonvulsants Gabapentin 300–1,200 mg t.i.d.
the most common lower-gastrointestinal
Carbamazepine 200–400 mg t.i.d.
symptom but can alternate with episodes
Pregabalin 100 mg t.i.d.
of diarrhea. Endoscopy may be required
5-hydroxytryptamine and Duloxitine 60–120 mg daily
to rule out other causes.
norepinephrine uptake
Diabetic autonomic neuropathy is inhibitor
also associated with genitourinary tract Substance P inhibitor Capsaicin cream 0.025–0.075% applied t.i.d.-q.i.d.
disturbances, including bladder and/or
*Dose response may vary; initial doses need to be low and titrated up.
sexual dysfunction. Evaluation of bladder
dysfunction should be performed for
individuals with diabetes who have recur-
rent urinary tract infections, pyelonephri- E. Foot care retinal, or renal complications. The fol-
tis, incontinence, or a palpable bladder. lowing foot-related risk conditions are as-
In men, diabetic autonomic neuropathy Recommendations sociated with an increased risk of
may cause loss of penile erection and/or ● Perform a comprehensive foot exami- amputation:
retrograde ejaculation. nation and provide foot self-care edu-
cation annually on patients with ● Peripheral neuropathy with loss of pro-
diabetes to identify risk factors predic- tective sensation
tive of ulcers and amputations. (B) ● Altered biomechanics (in the presence
Symptomatic treatments ● The foot examination can be accom- of neuropathy)
plished in a primary care setting and ● Evidence of increased pressure (ery-
should include the use of a monofila- thema, hemorrhage under a callus)
DPN ment, tuning fork, palpation, and a vi- ● Bony deformity
The first step in management of patients sual examination. (B) ● Peripheral vascular disease (decreased
with DPN should be to aim for stable and ● A multidisciplinary approach is recom- or absent pedal pulses)
optimal glycemic control. Although con- mended for individuals with foot ulcers ● A history of ulcers or amputation
trolled trial evidence is lacking, several and high-risk feet, especially those with ● Severe nail pathology
observational studies suggest that neuro- a history of prior ulcer or amputation.
pathic symptoms improve not only with (B) All individuals with diabetes should re-
optimization of control, but also with the ● Refer patients who smoke or with prior ceive an annual foot examination to iden-
avoidance of extreme blood glucose fluc- lower-extremity complications to foot tify high-risk foot conditions. This
tuations. Most patients will require phar- care specialists for ongoing preventive examination should include assessment
macological treatment for painful care and life-long surveillance. (C) of protective sensation, foot structure and
● Initial screening for peripheral arterial biomechanics, vascular status, and skin
symptoms: many agents have efficacy
confirmed in published randomized con- disease (PAD) should include a history integrity. People with one or more high-
trolled trials, though none are specifically for claudication and an assessment of risk foot condition should be evaluated
licensed for the management of painful- the pedal pulses. Consider obtaining an more frequently for the development of
DPN. See Table 10 for examples of agents ankle-brachial index (ABI), as many pa- additional risk factors. People with neu-
tients with PAD are asymptomatic. (C) ropathy should have a visual inspection of
to treat DPN pain. ● Refer patients with significant claudica- their feet at every visit with a health care
tion or a positive ABI for further vascu- professional. Evaluation of neurological
lar assessment and consider exercise, status in the low-risk foot should include
Treatment of autonomic neuropathy
medications, and surgical options. (C) a quantitative somatosensory threshold
A wide variety of agents are used to treat test, using the Semmes-Weinstein 5.07
the symptoms of autonomic neuropathy, Amputation and foot ulceration are the (10-g) monofilament. The skin should be
including metoclopramide for gastropa- most common consequences of diabetic assessed for integrity, especially between
resis and several medications for bladder neuropathy and major causes of morbid- the toes and under the metatarsal heads.
and erectile dysfunction. These treat- ity and disability in people with diabetes. The presence of erythema, warmth, or
ments are frequently used to provide Early recognition and management of in- callus formation may indicate areas of tis-
symptomatic relief to patients. Although dependent risk factors can prevent or de- sue damage with impending breakdown.
they do not change the underlying pathol- lay adverse outcomes. Bony deformities, limitation in joint mo-
ogy and natural history of the disease pro- The risk of ulcers or amputations is bility, and problems with gait and balance
cess, their use is recommended due to the increased in people who have had diabe- should be assessed.
impact they may have on the quality of life tes ⬎10 years, are male, have poor glu- People with neuropathy or evidence
of the patient. cose control, or have cardiovascular, of increased plantar pressure may be ad-

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S23


Standards of Medical Care

equately managed with well-fitted walk- wound care, see the ADA’s consensus chological, and emotional maturity. MNT
ing shoes or athletic shoes. Patients statement on diabetic foot wound care should be provided at diagnosis, and at
should be educated on the implications of (177). least annually thereafter, by an individual
sensory loss and the ways to substitute experienced with the nutritional needs of
other sensory modalities (hand palpation, VII. DIABETES CARE IN the growing child and the behavioral is-
visual inspection) for surveillance of early SPECIFIC POPULATIONS sues that have an impact on adolescent
problems. People with evidence of in- diets.
creased plantar pressure (e.g., erythema, A. Children and adolescents a. Glycemic control. While current
warmth, callus, or measured pressure) standards for diabetes management re-
should use footwear that cushions and re- 1. Type 1 diabetes flect the need to maintain glucose control
distributes the pressure. Callus can be de- Although approximately three-quarters as near to normal as safely possible, spe-
brided with a scalpel by a foot care of all cases of type 1 diabetes are diag- cial consideration must be given to the
specialist or other health professional nosed in individuals ⬍18 years of age, unique risks of hypoglycemia in young
with experience and training in foot care. historically ADA recommendations for children. Glycemic goals need to be mod-
People with bony deformities (e.g., ham- management of type 1 diabetes have per- ified to take into account the fact that
mertoes, prominent metatarsal heads, tained most directly to adults with type 1 most children ⬍6 or 7 years of age have a
bunions) may need extra-wide shoes or diabetes. Because children are not simply form of “hypoglycemic unawareness,” in
depth shoes. People with extreme bony “small adults,” it is appropriate to con- that counterregulatory mechanisms are
deformities (e.g., Charcot foot) who can- sider the unique aspects of care and man- immature, and young children lack the
not be accommodated with commercial agement of children and adolescents with cognitive capacity to recognize and re-
therapeutic footwear may need custom- type 1 diabetes. Children with diabetes spond to hypoglycemic symptoms, plac-
molded shoes. differ from adults in many respects, in- ing them at greater risk for hypoglycemia
Initial screening for PAD should in- cluding insulin sensitivity related to sex- and its sequelae. In addition, extensive
clude a history for claudication and an ual maturity, physical growth, ability to evidence indicates that near normaliza-
assessment of the pedal pulses. Consider provide self-care, and unique neurologic tion of blood glucose levels is seldom at-
obtaining an ABI, as many patients with vulnerability to hypoglycemia. Attention tainable in children and adolescents after
PAD are asymptomatic. Refer patients to such issues as family dynamics, devel- the honeymoon (remission) period. The
with significant or a positive ABI for fur- opmental stages, and physiologic differ- A1C level achieved in the “intensive” ad-
ther vascular assessment and consider ex- ences related to sexual maturity all are olescent cohort of the DCCT group was
ercise, medications, and surgical options essential in developing and implementing ⬎1% higher than that achieved for older
(174). an optimal diabetes regimen. Although patients and current ADA recommenda-
Patients with diabetes and high-risk current recommendations for children tions for patients in general (179). How-
foot conditions should be educated re- and adolescents are less likely to be based ever, the increased frequency of use of
garding their risk factors and appropriate on evidence derived from rigorous re- basal bolus regimens (including insulin
management. Patients at risk should un- search because of current and historical pumps) in youth from infancy through
derstand the implications of the loss of restraints placed on conducting research adolescence has been associated with
protective sensation, the importance of in children, expert opinion and a review more children reaching ADA blood glu-
foot monitoring on a daily basis, the of available and relevant experimental cose targets (180,181).
proper care of the foot, including nail and data are summarized in a recent ADA In selecting glycemic goals, the bene-
skin care, and the selection of appropriate statement (178). The following represents fits of achieving a lower A1C must be
footwear. The patient’s understanding of a summary of recommendations and weighed against the unique risks of hypo-
these issues and their physical ability to guidelines pertaining specifically to the glycemia and the disadvantages of target-
conduct proper foot surveillance and care care and management of children and ad- ing a higher, though more achievable,
should be assessed. Patients with visual olescents that are included in that docu- goal that may not promote optimal long-
difficulties, physical constraints prevent- ment. term health outcomes. Age-specific glyce-
ing movement, or cognitive problems that Ideally, the care of a child or adoles- mic and A1C goals are presented in Table
impair their ability to assess the condition cent with type 1 diabetes should be pro- 11.
of the foot and to institute appropriate vided by a multidisciplinary team of b. Screening and management of
responses will need other people, such as specialists trained in the care of children chronic complications in children and
family members, to assist in their care. with pediatric diabetes, although this may adolescents with type 1 diabetes.
Patients at low risk may benefit from ed- not always be possible. At the very least,
ucation on foot care and footwear. education of the child and family should i. Nephropathy
For a detailed review of the evidence be provided by health care providers
and further discussion, see the ADA’s trained and experienced in childhood di- Recommendations
technical review and position statement abetes and sensitive to the challenges ● Annual screening for microalbumin-
on this subject (175,176). posed by diabetes in this age-group. At uria should be initiated once the child is
Problems involving the feet, espe- the time of initial diagnosis, it is essential 10 years of age and has had diabetes for
cially ulcers and wound care, may require that diabetes education be provided in a 5 years. Screening may be done with a
care by a podiatrist, orthopedic surgeon, timely fashion, with the expectation that random spot urine sample analyzed for
or rehabilitation specialist experienced in the balance between adult supervision microalbumin-to-creatinine ratio. (E)
the management of individuals with dia- and self-care should be defined by, and ● Confirmed, persistently elevated mi-
betes. For a complete discussion on will evolve according to, physical, psy- croalbumin levels should be treated

S24 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

Table 11—Plasma blood glucose and A1C goals for type 1 diabetes by age-group

Plasma blood glucose


goal range (mg/dl)
Before Bedtime/
Values by age (years) meals overnight A1C Rationale
Toddlers and preschoolers (0–6) 100–180 110–200 ⬍8.5% (but ⬎7.5%) High risk and vulnerability to
hypoglycemia
School age (6–12) 90–180 100–180 ⬍8% Risks of hypoglycemia and relatively low
risk of complications prior to puberty
Adolescents and young adults (13–19) 90–130 90–150 ⬍7.5% ● Risk of severe hypoglycemia
● Developmental and psychological
issues
● A lower goal (⬍7.0%) is reasonable if
it can be achieved without excessive
hypoglycemia

Key concepts in setting glycemic goals:


● Goals should be individualized and lower goals may be reasonable based on benefit-risk assessment.
● Blood glucose goals should be higher than those listed above in children with frequent hypoglycemia or hypoglycemia unawareness.
● Postprandial blood glucose values should be measured when there is a disparity between preprandial blood glucose values and A1C levels.

with an ACE inhibitor, titrated to nor- percentile measured on at least 3 separate Treatment
malization of microalbumin excretion days. Normal blood pressure levels for ● Treatment should be based on fasting
(if possible). (E) age, sex, and height and appropriate lipid levels (mainly LDL) obtained after
methods for determinations are available glucose control is established. (E)
ii. Hypertension online at www.nhlbi.nih.gov/health/prof/ ● Initial therapy should consist of optimi-
heart/hbp/hbp_ped.pdf. zation of glucose control and MNT
Recommendations aimed at a decrease in the amount of
● Treatment of high-normal blood pres- iii. Dyslipidemia saturated fat in the diet. (E)
sure (systolic or diastolic blood pres- ● The addition of a pharmacologic lipid-
sure consistently above the 90th Recommendations lowering agents is recommended for
percentile for age, sex, and height) Screening LDL ⬎160 mg/dl (4.1 mmol/l), and is
should include dietary intervention ● Prepubertal children: a fasting lipid also recommended in patients who
and exercise, aimed at weight control profile should be performed on all chil- have LDL cholesterol values of 130 –
and increased physical activity, if ap- dren ⬎2 years of age at the time of di- 159 mg/dl (3.4 – 4.1 mmol/l) based on
propriate. If target blood pressure is not agnosis (after glucose control has been the patient’s CVD risk profile, after fail-
reached within 3– 6 months of lifestyle established) if there is a family history ure of MNT and lifestyle changes. (E)
intervention, pharmacologic treatment of hypercholesterolemia (total choles- ● The goal of therapy is an LDL value
should be initiated. (E) terol ⬎240 mg/dl), if there is a history ⬍100 mg/dl (2.6 mmol/l). (E)
● Pharmacologic treatment of hyperten- of a cardiovascular event before age 55
sion (systolic or diastolic blood pres- years, or if family history is unknown. If iv. Retinopathy
sure consistently above the 95th family history is not of concern, then
percentile for age, sex, and height or the first lipid screening should be per- Recommendations
consistently greater than 130/80 formed at puberty (⬎12 years). If val- ● The first ophthalmologic examination
mmHg, if 95% exceeds that value) ues are within the accepted risk levels should be obtained once the child is
should be initiated as soon as the diag- (LDL ⬍100 mg/dl [2.6 mmol/l]), a lipid ⱖ10 years of age and has had diabetes
nosis is confirmed. (E) profile should be repeated every 5 for 3–5 years. (E)
● ACE inhibitors should be considered years. (E) ● After the initial examination, annual
for the initial treatment of hyperten- ● Pubertal children (⬎12 years of age): a routine follow-up is generally recom-
sion. (E) fasting lipid profile should be per- mended. Less frequent examinations
formed at the time of diagnosis (after may be acceptable on the advice of an
Hypertension in childhood is defined as glucose control has been established). eye care professional. (E)
an average systolic or diastolic blood pres- If values fall within the accepted risk
sure ⱖ95th percentile for age, sex, and levels (LDL ⬍100 mg/dl [2.6 mmol/l]), Although retinopathy most commonly
height percentile measured on at least the measurement should be repeated occurs after the onset of puberty and after
three separate days. “High-normal” blood every 5 years. (E) 5–10 years of diabetes duration, it has
pressure is defined as an average systolic ● If lipids are abnormal, annual monitor- been reported in prepubertal children
or diastolic blood pressure ⱖ90th but ing is recommended in both age- and with diabetes duration of only 1–2
⬍95th percentile for age, sex, and height groups. (E) years. Referrals should be made to eye

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S25


Standards of Medical Care

care professionals with expertise in dia- treatment of hypoglycemia. In most cases statins are pregnancy category X and
betic retinopathy, an understanding of it is imperative that blood glucose testing should be discontinued before concep-
the risk for retinopathy in the pediatric be performed at the school or day care tion if possible. Based on recent re-
population, and experience in counseling setting before lunch and when signs or search, ACE inhibitors also should be
the pediatric patient and family on the symptoms of abnormal blood glucose lev- discontinued before conception
importance of early prevention/ els are present. Many children may re- (187a). ARBs are category C in the first
intervention. quire support for insulin administration trimester (maternal benefit may out-
by either injection or continuous subcu- weigh fetal risk in certain situations),
v. Celiac disease taneous insulin infusion (CSII) before but category D in later pregnancy, and
lunch (and often also before breakfast) at should generally be discontinued be-
school or in day care. For further discus- fore pregnancy. Among the oral antidi-
Recommendations sion, see the ADA position statement abetic agents, metformin and acarbose
● Children with positive antibodies
(184) and the report from the NDEP are classified as category B and all oth-
should be referred to a gastroenterolo- (185). ers as category C; potential risks and
gist for evaluation. (E) benefits of oral antidiabetic agents in
● Children with confirmed celiac disease
2. Type 2 diabetes the preconception period must be care-
should have consultation with a dieti- Finally, the incidence of type 2 diabetes in fully weighed, recognizing that suffi-
tian and placed on a gluten-free diet. adolescents has been shown to be increas- cient data are not available to establish
(E) ing, especially in ethnic minority popula- the safety of these agents in pregnancy.
● Patients with type 1 diabetes who are or
tions (186,187). Distinction between type They should generally be discontinued
who become symptomatic for celiac 1 and type 2 diabetes in children can be in pregnancy. (E)
disease should be screened, using tTG difficult, since autoantigens and ketosis
antibodies, or anti-EMA, with docu- may be present in a substantial number of Major congenital malformations remain
mentation of normal serum IgA levels. patients with otherwise straightforward the leading cause of mortality and serious
(E) type 2 diabetes (including obesity and ac- morbidity in infants of mothers with type
anthosis nigricans). Such a distinction at 1 and type 2 diabetes. Observational stud-
Celiac disease is an immune-mediated the time of diagnosis is critical since treat- ies indicate that the risk of malformations
disorder that occurs with increased fre- ment regimens, educational approaches, increases continuously with increasing
quency in patients with type 1 diabetes and dietary counsel will differ markedly maternal glycemia during the first 6 – 8
(1–16% of individuals compared with between the two diagnoses. It is recom- weeks of gestation, as defined by first-
0.3–1% in the general population) mended that screening for the comorbidi- trimester A1C concentrations. There is no
(182,183). Symptoms of celiac disease in- ties and complications of diabetes, threshold for A1C values above which the
clude diarrhea, weight loss or poor weight including fasting lipid profile, and urine risk begins or below which it disappears.
gain, growth failure, abdominal pain, for microalbumin, be obtained at the time However, malformation rates above the
chronic fatigue, malnutrition due to mal- of diagnosis of type 2 diabetes. An oph- 1–2% background rate seen in nondia-
absorption, and other gastrointestinal thalmologic examination should be con- betic pregnancies appear to be limited to
problems. sidered. The ADA consensus statement pregnancies in which first-trimester A1C
c. Other issues. A major issue deserving (11) provides guidance on the preven- concentrations are ⬎1% above the nor-
emphasis in this age-group is that of “ad- tion, screening, and treatment of type 2 mal range for a nondiabetic pregnant
herence.” No matter how sound the med- diabetes, as well as its comorbidities, in woman.
ical regimen, it can only be as good as the young people. Preconception care of diabetes ap-
ability of the family and/or individual to pears to reduce the risk of congenital mal-
implement it. Family involvement in dia- B. Preconception care formations. Five nonrandomized studies
betes remains an important component of have compared rates of major malforma-
optimal diabetes management through- Recommendations tions in infants between women who par-
out childhood and into adolescence. ● A1C levels should be normal or as close ticipated in preconception diabetes care
Health care providers who care for chil- to normal as possible (⬍1% above the programs and women who initiated in-
dren and adolescents, therefore, must be upper limits of normal) in an individual tensive diabetes management after they
capable of evaluating the behavioral, patient before conception is attempted. were already pregnant. The preconcep-
emotional, and psychosocial factors that (B) tion care programs were multidisci-
interfere with implementation and then ● All women with diabetes and child- plinary and designed to train patients in
must work with the individual and family bearing potential should be educated diabetes self-management with diet, in-
to resolve problems that occur and/or to about the need for good glucose control tensified insulin therapy, and SMBG.
modify goals as appropriate. before pregnancy. They should partici- Goals were set to achieve normal blood
Since a sizable portion of a child’s day pate in family planning. (E) glucose concentrations, and ⬎80% of
is spent in school, close communication ● Women with diabetes who are contem- subjects achieved normal A1C concentra-
with school or day care personnel is es- plating pregnancy should be evaluated tions before they became pregnant (188 –
sential for optimal diabetes management. and, if indicated, treated for diabetic 192). In all five studies, the incidence of
Information should be supplied to school retinopathy, nephropathy, neuropathy, major congenital malformations in
personnel, so that they may be made and CVD. (E) women who participated in preconcep-
aware of the diagnosis of diabetes in the ● Among the drugs commonly used in tion care (range 1.0 –1.7% of infants) was
student and of the signs, symptoms, and the treatment of patients with diabetes, much lower than the incidence in women

S26 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

who did not participate (range 1.4 – cussion of this area, and specific guide- therapy, although as diabetic patients
10.9% of infants). One limitation of these lines and language from it have been have such an elevated risk for CVD, ag-
studies is that participation in preconcep- incorporated below. Unfortunately, there gressive management of lipids and aspirin
tion care was self-selected by patients are no long-term studies in individuals use when not contraindicated are reason-
rather than randomized. Thus, it is im- ⬎65 years of age demonstrating the ben- able interventions.
possible to be certain that the lower mal- efits of tight glycemic control, blood pres- As noted above, for patients with ad-
formation rates resulted fully from sure, and lipid control. Older individuals vanced diabetes complications, life-
improved diabetes care. Nonetheless, the with diabetes have higher rates of prema- limiting comorbid illness, or cognitive or
overwhelming evidence supports the ture death, functional disability, and co- functional impairment, it is reasonable to
concept that malformations can be re- existing illnesses such as hypertension, set less intensive glycemic target goals.
duced or prevented by careful manage- CHD, and stroke than those without dia- These patients are less likely to benefit
ment of diabetes before pregnancy. betes. Older adults with diabetes are also from reducing the risk of microvascular
Planned pregnancies greatly facilitate at greater risk than other older adults for complications and more likely to suffer
preconception diabetes care. Unfortu- several common geriatric syndromes, serious adverse effects from hypoglyce-
nately, nearly two-thirds of pregnancies such as polypharmacy, depression, cogni- mia. Patients with poorly controlled
in women with diabetes are unplanned, tive impairment, urinary incontinence, diabetes may be subject to acute compli-
leading to a persistent excess of malfor- injurious falls, and persistent pain. cations of diabetes, including hyperglyce-
mations in infants of diabetic mothers. To The care of older adults with diabetes mic hyperosmolar coma. Older patients
minimize the occurrence of these devas- is complicated by their clinical and func- can be treated with the same drug regi-
tating malformations, standard care for all tional heterogeneity. Some older individ- mens as younger patients, but special care
women with diabetes who have child- uals developed diabetes in middle age and is required in prescribing and monitoring
bearing potential should include 1) edu- face years of comorbidity; others who are drug therapy. Metformin is often contra-
cation about the risk of malformations newly diagnosed may have had years of indicated because of renal insufficiency or
associated with unplanned pregnancies undiagnosed comorbidity or few compli- heart failure. Sulfonylureas and other in-
and poor metabolic control and 2) use of cations from the disease. Some older sulin secretagogues can cause hypoglyce-
effective contraception at all times, unless adults with diabetes are frail and have mia. Insulin can also cause hypoglycemia
the patient is in good metabolic control other underlying chronic conditions, as well as require good visual and motor
and actively trying to conceive. substantial diabetes-related comorbidity, skills and cognitive ability of the patient
Women contemplating pregnancy or limited physical or cognitive function- or a caregiver. TZDs should not be used in
need to be seen frequently by a multidis- ing, but other older individuals with dia- patients with CHF (New York Heart As-
ciplinary team experienced in the man- betes have little comorbidity and are sociation class III and IV). Drugs should
agement of diabetes before and during active. Life expectancies are also highly be started at the lowest dose and titrated
pregnancy. Teams may vary but should variable for this population. Clinicians up gradually until targets are reached or
include a diabetologist, an internist or a caring for older adults with diabetes must side effects develop. As with blood pres-
family physician, an obstetrician, a diabe- take this heterogeneity into consideration sure and lipid management, the potential
tes educator, a dietitian, a social worker, when setting and prioritizing treatment benefits must always be weighed against
and other specialists as necessary. The goals. potential risks.
goals of preconception care are to 1) inte- All this having been said, patients
grate the patient into the management of who can be expected to live long enough VIII. DIABETES CARE IN
her diabetes, 2) achieve the lowest A1C to reap the benefits of long-term intensive SPECIFIC SETTINGS
test results possible without excessive hy- diabetes management (⬃10 years) and
poglycemia, 3) assure effective contracep- who are active, cognitively intact, and A. Diabetes care in the hospital
tion until stable and acceptable glycemia willing to undertake the responsibility of
is achieved, and 4) identify, evaluate, and self-management should be encouraged Recommendations
treat long-term diabetic complications to do so and be treated using the stated ● All patients with diabetes admitted to
such as retinopathy, nephropathy, neu- goals for younger adults with diabetes. the hospital should be identified in the
ropathy, hypertension, and CAD. There is good evidence from middle- medical record as having diabetes. (E)
For further discussion, see the ADA’s aged and older adults suggesting that ● All patients with diabetes should have
technical review (193) and position state- multidisciplinary interventions that pro- an order for blood glucose monitoring,
ment (194) on this subject. vide education on medication use, moni- with results available to all members of
toring, and recognizing hypo- and the health care team. (E)
C. Older individuals hyperglycemia can significantly improve ● Goals for blood glucose levels:
Diabetes is an important health condition glycemic control. Although control of hy- ● Critically ill patients: blood glucose
for the aging population; at least 20% of perglycemia is important, in older indi- levels should be kept as close to 110
patients over the age of 65 years have di- viduals with diabetes, greater reductions mg/dl (6.1 mmol/l) as possible and
abetes. The number of older individuals in morbidity and mortality may result generally ⬍180 mg/dl (10 mmol/l).
with diabetes can be expected to grow from control of all cardiovascular risk fac- These patients will usually require in-
rapidly in the coming decades. A recent tors rather than from tight glycemic con- travenous insulin. (B)
publication (195) contains evidence- trol alone. There is strong evidence from ● Non– critically ill patients: premeal
based guidelines produced in conjunc- clinical trials of the value of treating hy- blood glucose levels should be kept
tion with the American Geriatric Society. pertension in the elderly. There is less ev- as close to 90 –130 mg/dl (5.0 –7.2
This document contains an excellent dis- idence for lipid-lowering and aspirin mmol/l; midpoint of range 110 mg/

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S27


Standards of Medical Care

dl) as possible given the clinical situ- ● Medical history of diabetes: diabetes When admissions on general medi-
ation and postprandial blood glucose has been previously diagnosed and ac- cine and surgery units were studied, pa-
levels ⬍180 mg/dl. Insulin should be knowledged by the patient’s treating tients with new hyperglycemia had
used as necessary. (E) physician. significantly increased inhospital mortal-
● Due to concerns regarding the risk of ● Unrecognized diabetes: hyperglycemia ity, as did patients with known diabetes.
hypoglycemia, some institutions may (fasting blood glucose 126 mg/dl or In addition, length of stay was higher for
consider these blood glucose levels to random blood glucose 200 mg/dl) oc- the new hyperglycemic group, and both
be overly aggressive for initial targets. curring during hospitalization and con- the patients with new hyperglycemia and
Through quality improvement, gly- firmed as diabetes after hospitalization those with known diabetes were more
cemic goals should systematically be by standard diagnostic criteria but un- likely to require intensive care unit (ICU)
reduced to the recommended levels. recognized as diabetes by the treating care and transitional or nursing home
(E) physician during hospitalization. care. Better outcomes were demonstrated
● Hospital-related hyperglycemia: hyper- in patients with fasting and admission
● Scheduled prandial insulin doses glycemia (fasting blood glucose 126 blood glucose ⬍126 mg/dl (7 mmol/l)
should be given in relation to meals and mg/dl or random blood glucose ⱖ200 and all random blood glucose levels
should be adjusted according to point- mg/dl) occurring during the hospital- ⬍200 mg/dl (11.1 mmol/l) (202).
of-care glucose levels. The traditional ization that reverts to normal after hos- b. CVD and critical care. The relation-
sliding-scale insulin regimens are inef- pital discharge. ship of blood glucose levels and mortality
fective as monotherapy and are not rec- in the setting of acute myocardial infarc-
ommended. (C) tion (AMI) has been reported. A meta-
The prevalence of diabetes in hospitalized
● Using correction dose or “supplemen- analysis of 15 previously published
adult patients is not precisely known. In
tal” insulin to correct premeal hyper- the year 2000, 12.4% of hospital dis- studies compared in-hospital mortality
glycemia in addition to scheduled charges in the U.S. listed diabetes as a di- and CHF in both hyper- and normoglyce-
prandial and basal insulin is recom- agnosis. The prevalence of diabetes in mic patients with and without diabetes. In
mended. (C) hospitalized adults is conservatively esti- subjects without known diabetes whose
● A plan for treating hypoglycemia admission blood glucose was 109.8 mg/dl
mated at 12–25%, depending on the thor-
should be established for each patient. oughness used in identifying patients. (6.1 mmol/l), the relative risk for in-
Episodes of hypoglycemia in the hospi- Patients presenting to hospitals may have hospital mortality was increased signifi-
tal should be tracked. (E) diabetes, unrecognized diabetes, or hos- cantly. When diabetes was present and
● All patients with diabetes admitted to admission glucose 180 mg/dl (10 mmol/
pital-related hyperglycemia. Using the
the hospital should have an A1C ob- A1C test may be a valuable case-finding l), risk of death was moderately increased
tained for discharge planning if the re- tool for identifying diabetes in hospital- compared with patients who had diabetes
sult of testing in the previous 2–3 ized patients. In the year 2003, there were but no hyperglycemia on admission
months is not available. (E) 5.1 million hospitalizations for diabetes (203). In another study (204), admission
● A diabetes education plan including as any-listed diagnosis. By way of compar- blood glucose values were analyzed in
“survival skills education” and fol- ison, in 1980 there were 2.2 million hos- consecutive patients with AMI. Analysis
low-up should be developed for each pitalizations for those having diabetes revealed an independent association of
patient. (E) (200). admission blood glucose and mortality.
● Patients with hyperglycemia in the hos- A rapidly growing body of literature The 1-year mortality rate was significantly
pital who do not have a diagnosis of supports targeted glucose control in the lower in subjects with admission plasma
diabetes should have appropriate plans hospital setting with potential for im- glucose ⬍100.8 mg/dl (5.6 mmol/l) than
for follow-up testing and care docu- proved mortality, morbidity, and health in those with plasma glucose 199.8 mg/dl
mented at discharge. (E) care economic outcomes. Hyperglycemia (11 mmol/l).
in the hospital may result from stress, de- It is important to note that these stud-
compensation of type 1 diabetes, type 2 ies focused more on admission blood glu-
The management of diabetes in the hos- cose as a predictor of outcomes rather
diabetes, or other forms of diabetes
pital is extensively reviewed in an ADA than inpatient diabetes or glycemic man-
and/or may be iatrogenic due to admin-
technical review by Clement et al. (196). agement per se. Higher admission plasma
istration or withholding of pharmaco-
This review forms the basis for these logic agents, including glucocorticoids, glucose levels in patients with a prior his-
guidelines. In addition, the American As- vasopressors, etc. Distinction between tory of diabetes could reflect the degree of
sociation of Clinical Endocrinologists decompensated diabetes and stress hy- glycemic control experienced in the out-
held a conference on this topic (197), and perglycemia is often not made. patient setting, thus linking attention to
the recommendations from this meeting outpatient glycemic control to outcomes
(198) were also carefully reviewed and in the inpatient population. In patients
discussed in the formulation of the guide- 1. Blood glucose targets without a prior history of diabetes, this
lines that follow. The management of di- a. General medicine and surgery. Ob- could represent case finding of patients
abetes in the hospital is generally servational studies suggest an association previously undiagnosed with diabetes
considered secondary in importance between hyperglycemia and increased who have the disease, an unmasking of
compared with the condition that mortality. General medical and surgical risk in a population at high risk for diabe-
prompted admission (199). patients with a blood glucose value(s) tes, or possibly more severe illness at ad-
Patients with hyperglycemia fall into ⬎220 mg/dl (12.2 mmol/l) have higher mission.
three categories: infection rates (201). In the first DIGAMI (Diabetes and In-

S28 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

sulin-Glucose Infusion in Acute Myocar- 2. Treatment options hyperglycemia. Therefore, they would
dial Infarction) study (84,205), insulin- a. Noninsulin glucose-lowering agents. not be appropriate for patients not eating
glucose infusion followed by No large studies have investigated the po- (NPO) or with reduced caloric consump-
subcutaneous insulin treatment in dia- tential roles of various oral agents on out- tion. Furthermore, it would generally be
betic patients with AMI was examined. comes in hospitalized patients with inappropriate to initiate these drugs in the
Intensive subcutaneous insulin therapy diabetes. While the various classes of oral inpatient setting due to all of the differ-
for ⱖ3 months improved long-term sur- agents are commonly used in the outpa- ences in normal food intake, in addition
vival (84). Mean blood glucose in the in- tient setting with good response, their use to the fact that both of these agents result
tensive insulin intervention arm was in the inpatient setting presents some spe- in nausea as the most common side effect.
172.8 mg/dl (9.6 mmol/l) (compared cific issues. In general, these agents should be initi-
with 210.6 mg/dl [11.7 mmol/l] in the ated when the patient is not ill in the out-
“conventional” group). The broad range i. Sulfonylureas and meglitinides. The long patient setting.
of blood glucose levels within each arm action and predisposition to hypoglyce- In summary, each of the major classes
limits the ability to define specific blood mia in patients not consuming their of oral agents has significant limitations
glucose target thresholds. normal nutrition serve as relative contra- for inpatient use. Additionally, they pro-
Finally, two more recent studies indications to routine use of sulfonylureas vide little flexibility or opportunity for ti-
(206,207) using an insulin-glucose infu- in the hospital for many patients (214). tration in a setting where acute changes
sion did not show a reduction in mortality Sulfonylureas do not generally allow demand these characteristics. Therefore,
in the intervention groups. However, in rapid dose adjustment to meet the chang- insulin, when used properly, may have
both of these studies, blood glucose levels ing inpatient needs. Sulfonylureas also many advantages in the hospital setting.
were positively correlated with mortality. vary in duration of action between indi- b. Insulin. The inpatient insulin regi-
c. Cardiac surgery. Attainment of tar- viduals and likely vary in the frequency men must be matched or tailored to the
geted glucose control in the setting of car- with which they induce hypoglycemia. specific clinical circumstance of the indi-
diac surgery is associated with reduced While the two available meglitinides, re- vidual patient. A recent meta-analysis
mortality and risk of deep sternal wound paglinide and neteglinide, theoretically concluded that insulin therapy in criti-
infections in cardiac surgery patients with would produce less hypoglycemia than cally ill patients had a beneficial effect on
diabetes (208,209) and supports the con- sulfonylureas, lack of clinical trial data for short-term mortality in different clinical
cept that perioperative hyperglycemia is these agents would preclude their use. settings (218).
an independent predictor of infection in
ii. Metformin. The major limitation to met- i. Subcutaneous insulin therapy. Subcutane-
patients with diabetes (210), with the
formin use in the hospital is a number of ous insulin therapy may be used to attain
lowest mortality in patients with blood
specific contraindications to its use, many
glucose ⬍150 mg/dl (8.3 mmol/l) (211). glucose control in most hospitalized pa-
of which occur in the hospital. All of these tients with diabetes. The components of
d. Critical care. A mixed group of pa-
contraindications relate to lactic acidosis, the daily insulin dose requirement can be
tients with and without diabetes admitted
to a surgical ICU were randomized to re- a potentially fatal complication of met- met by a variety of insulins, depending on
ceive intensive insulin therapy (target formin therapy. The most common risk the particular hospital situation. Subcuta-
blood glucose 80 –110 mg/dl [4.4 – 6.1 factors for lactic acidosis in metformin- neous insulin therapy is subdivided into
mmol/l]). The mean blood glucose of 103 treated patients are cardiac disease, in- programmed or scheduled insulin and
mg/dl (5.7 mmol/l) had reduced mortality cluding CHF, hypoperfusion, renal supplemental or correction-dose insulin.
during the ICU stay and decreased overall insufficiency, old age, and chronic pul- Correction-dose insulin therapy is an im-
in-hospital mortality (85). Hospital and monary disease (215). Recent evidence portant adjunct to scheduled insulin,
ICU survival were linearly associated with continues to indicate lactic acidosis is a both as a dose-finding strategy and as a
ICU glucose levels, with the highest sur- rare complication (216), despite the rela- supplement when rapid changes in insu-
vival rates occurring in patients achieving tive frequency of risk factors (217). How- lin requirements lead to hyperglycemia. If
an average blood glucose ⬍110 mg/dl ever, in the hospital, where the risk for correction doses are frequently required,
(6.1 mmol/l) (212). hypoxia, hypoperfusion, and renal insuf- it is recommended that the appropriate
The same group subsequently stud- ficiency is much higher, it still seems pru- scheduled insulin doses be increased the
ied a similar population of patients in a dent to avoid the use of metformin in following day to accommodate the in-
medical ICU (213). As in the SICU (Sur- most patients. creased insulin needs (219). There are no
gical Intensive Care Unit) study, one iii. TZDs. TZDs are not suitable for initia- studies comparing human regular insulin
group received intensive insulin therapy tion in the hospital because of their de- with rapid-acting analogs for use as cor-
[mean blood glucose 110 mg/dl (6.1 layed onset of effect. In addition, they do rection-dose insulin. However, due to the
mmol/l)] while the other received con- increase intravascular volume, a particu- longer duration with human regular insu-
ventional therapy [mean blood glucose lar problem in those predisposed to CHF lin, there is a greater risk of “insulin stack-
161 mg/dl (8.9 mmol/l). The group re- and potentially a problem for patients ing” when the usual next blood glucose
ceiving the intensive therapy had reduced with hemodynamic changes related to ad- measurement is performed 4 – 6 h later.
morbidity but not mortality among all pa- mission diagnoses (e.g., acute coronary The traditional sliding-scale insulin
tients in the MICU. However, death was ischemia) or interventions common in regimens, usually consisting of regular in-
reduced for those patients who were hospitalized patients. sulin without any intermediate or long-
treated for longer than 3 days. These pa- acting insulins, have been shown to be
tients could not be identified before ther- iv. Pramlintide and exenatide. These drugs ineffective when used as monotherapy in
apy. work mainly by reducing postprandial patients with an established insulin re-

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S29


Standards of Medical Care

quirement (219 –221). Problems cited For those who will require subcutaneous for hypoglycemia are present, even
with sliding-scale insulin regimens are insulin, it is necessary to administer among patients who are neither “brittle”
that the sliding-scale regimen prescribed short- or rapid-acting insulin subcutane- nor tightly controlled. Patients who do
on admission is likely to be used through- ously 1–2 h before discontinuation of the not have diabetes may experience hypo-
out the hospital stay without modification intravenous insulin infusion. An interme- glycemia in the hospital, in association
(219). Second, sliding-scale insulin ther- diate- or long-acting insulin must be in- with factors such as altered nutritional
apy treats hyperglycemia after it has al- jected 2–3 h before discontinuing the state, heart failure, renal or liver disease,
ready occurred, instead of preventing the insulin infusion. In transitioning from in- malignancy, infection, or sepsis (222). Pa-
occurrence of hyperglycemia. This “reac- travenous insulin infusion to subcutane- tients having diabetes may develop hypo-
tive” approach can lead to rapid changes ous therapy, the caregiver may order glycemia in association with the same
in blood glucose levels, exacerbating both subcutaneous insulin with appropriate conditions (223). Additional triggering
hyper- and hypoglycemia. duration of action to be administered as a events leading to iatrogenic hypoglycemia
single dose or repeatedly to maintain include sudden reduction of corticoste-
ii. Intravenous insulin infusion. The only basal effect until the time of day when the roid dose, altered ability of the patient
method of insulin delivery specifically de- choice of insulin or analog preferred for to self-report symptoms, reduction of
veloped for use in the hospital is contin- basal effect normally would be provided. oral intake, emesis, new NPO status,
uous intravenous infusion, using regular reduction of rate of administration of
crystalline insulin. There is no advantage 3. Self-management in the hospital intravenous dextrose, and unexpected in-
to using insulin lispro or aspart in an in- Self-management in the hospital may be terruption of enteral feedings or paren-
travenous insulin infusion. The medical appropriate for competent adult patients teral nutrition. Altered consciousness
literature supports the use of intravenous who have a stable level of consciousness from anesthesia may also alter typical hy-
insulin infusion in preference to the sub- and reasonably stable known daily insulin poglycemic symptoms.
cutaneous route of insulin administration requirements and successfully conduct Despite the preventable nature of
for several clinical indications among self-management of diabetes at home, many inpatient episodes of hypoglyce-
nonpregnant adults. These include DKA have physical skills appropriate to suc- mia, institutions are more likely to have
and nonketotic hyperosmolar state; gen- cessfully self-administer insulin, perform nursing protocols for the treatment of hy-
eral preoperative, intraoperative, and SMBG, and have adequate oral intake. poglycemia than for its prevention.
postoperative care; the postoperative pe- Appropriate patients are those already
riod following heart surgery; following proficient in carbohydrate counting, use 5. Diabetes care providers
organ transplantation; with cardiogenic of multiple daily injections of insulin or Diabetes management may be effectively
shock; exacerbated hyperglycemia during insulin pump therapy, and sick-day man- offered by primary care physicians or hos-
high-dose glucocorticoid therapy; pa- agement. The patient and physician in pitalists, but involvement of appropri-
tients who are NPO or in critical care ill- consultation with nursing staff must agree ately trained specialists or specialty teams
ness in general; and as a dose-finding that patient self-management is appropri- may reduce length of stay, improve glyce-
strategy in anticipation of initiation or ate under the conditions of hospitaliza- mic control, and improve outcomes
reinitiation of subcutaneous insulin ther- tion. For patients who are selected for (224 –227). In the care of diabetes, imple-
apy in type 1 or type 2 diabetes. self-management in the hospital, it is im- mentation of standardized order sets for
Many institutions use insulin infusion portant that basal and bolus doses of in- scheduled and correction-dose insulin
algorithms that can be implemented by sulin with results of bedside glucose may reduce reliance on sliding-scale man-
nursing staff. Algorithms should incorpo- monitoring be recorded as part of the pa- agement. A team approach is needed to
rate the concept that maintenance re- tient’s hospital medical record. establish hospital pathways. To imple-
quirements differ between patients and While many institutions allow pa- ment intravenous infusion of insulin for
change over the course of treatment. Al- tients on an insulin pump to continue the majority of patients having prolonged
though numerous algorithms have been these devices in the hospital, others ex- NPO status, hospitals will need multidis-
published, there have been no head-to- press concern regarding use of a device ciplinary support for using insulin infu-
head comparisons, and thus no single al- that nurses are unfamiliar with, particu- sion therapy outside of critical care units
gorithm can be recommended for an larly in patients who are not able to man- or will need to develop protocols for sub-
individual hospital. Ideally, intravenous age their own pump therapy. If a patient is cutaneous insulin therapy that achieve
insulin algorithms should consider both too ill to self-manage either multiple daily similar glycemic goals (228).
the current and previous glucose level, injections or CSII, then appropriate sub-
the rate of change of plasma glucose, and cutaneous doses can be calculated on the 6. DSME
the current IV insulin infusion rate. For all basis of their basal and bolus insulin doses Teaching diabetes self-management to
algorithms, frequent bedside glucose test- during hospitalization with adjustments patients in hospitals is a difficult and chal-
ing is required but the ideal frequency is for changes in nutritional or metabolic lenging task. Patients are hospitalized be-
not known. status. cause they are ill, are under increased
stress related to their hospitalization and
iii. Transition from intravenous to subcuta- 4. Preventing hypoglycemia diagnosis, and are in an environment that
neous insulin therapy. There are no specific Hypoglycemia, especially in insulin- is not conducive to learning. Ideally, peo-
clinical trials examining how to best tran- treated patients, is the leading limiting ple with diabetes should be taught at a
sition from intravenous to subcutaneous factor in the glycemic management of time and place conducive to learning: as
insulin or which patients with type 2 di- type 1 and type 2 diabetes (86). In the an outpatient in a nationally recognized
abetes may be transitioned to oral agents. hospital, multiple additional risk factors program of diabetes education classes.

S30 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

For the hospitalized patient, diabetes Bedside blood glucose testing is usu- spite legal protections, children in the
“survival skills” education is generally ally performed with portable glucose de- school and day care setting still face dis-
considered a feasible approach. Patients vices that are identical or similar to crimination. Parents and the health care
are taught sufficient information to enable devices for home SMBG. Ability to track team should provide school systems and
them to go home safely. Those newly di- the occurrence of hypo- and hyperglyce- day care providers with the information
agnosed with diabetes or who are new to mia is necessary. necessary by developing an individual-
insulin and or blood glucose monitoring ized DMMP, including information nec-
need to be instructed before discharge to 9. Continuous blood glucose essary for children with diabetes to
help ensure safe care upon returning monitoring participate fully and safely in the school/
home. Those patients hospitalized be- The introduction of real-time blood glu- day care experience. Appropriate diabetes
cause of a crisis related to diabetes man- cose monitoring as a tool for outpatient care in the school and day care setting is
agement or poor care at home need diabetes management has potential bene- necessary for the child’s immediate safety,
education to hopefully prevent subse- fit for the inpatient population (230). long-term well-being, and optimal aca-
quent episodes of hospitalization. However, at this time, data are lacking demic performance.
examining this new technology in the An adequate number of school per-
7. MNT acutely ill patient population. Until more sonnel should be trained in the necessary
Even though hospital diets continue to be studies are published, it is premature to diabetes procedures (e.g., blood glucose
ordered by calorie levels based on the use continuous blood glucose monitoring monitoring and insulin and glucagon ad-
“ADA diet,” it has been recommended except in a research setting. ministration) and in the appropriate re-
that the term “ADA diet” no longer be sponse to high and low blood glucose
used (229). Since 1994, the ADA has not B. Diabetes care in the school and levels. This will ensure that at least one
endorsed any single meal plan or speci- day care setting (184) adult is present to perform these proce-
fied percentages of macronutrients. Cur- dures in a timely manner while the stu-
rent nutrition recommendations advise Recommendations dent is at school, on field trips, and during
individualization based on treatment ● An individualized diabetes medical extracurricular activities or other school-
goals, physiologic parameters, and medi- management plan (DMMP) should be sponsored events. These school person-
cation usage. developed by the parent/guardian and nel need not be health care professionals.
Because of the complexity of nutrition the student’s diabetes health care team. The student with diabetes should
issues, it is recommended that a registered (E) have immediate access to diabetes sup-
dietitian, knowledgeable and skilled in ● A 504 plan should be developed and plies at all times, with supervision as
MNT, serve as the team member who pro- implemented by the family, school needed. A student with diabetes should
vides MNT. The dietitian is responsible nurse, and diabetes health care team. be able to obtain a blood glucose level and
for integrating information about the pa- (E) respond to the results as quickly and con-
tient’s clinical condition, eating, and life- ● An adequate number of school person- veniently as possible, minimizing the
style habits and for establishing treatment nel should be trained in the necessary need for missing instruction in the class-
goals in order to determine a realistic plan diabetes procedures (including moni- room. Accordingly, a student who is ca-
for nutrition therapy (229). toring of blood glucose levels and ad- pable of doing so should be permitted to
ministration of insulin and glucagon) monitor his or her blood glucose level and
8. Bedside blood glucose monitoring and in the appropriate response to high take appropriate action to treat hypogly-
Implementing intensive diabetes therapy and low blood glucose levels. These cemia in the classroom or designated area
in the hospital setting requires frequent school personnel need not be health adjacent to the classroom or anywhere the
and accurate blood glucose data. This care professionals. (E) student is in conjunction with a school
measure is analogous to an additional “vi- ● The student with diabetes should have activity. The student’s desire for privacy
tal sign” for hospitalized patients with di- immediate access to diabetes supplies during testing should also be accommo-
abetes. Bedside glucose monitoring using at all times, with supervision as needed. dated.
capillary blood has advantages over labo- (E)
ratory venous glucose testing because the ● The student should be permitted to C. Diabetes care at diabetes camps
results can be obtained rapidly at the monitor his or her blood glucose level, (231)
“point of care,” where therapeutic deci- as developmentally appropriate and de-
sions are made. For this reason, the terms termined by the family and diabetes Recommendations
bedside and point-of-care glucose moni- health care team with input by the ● Each camper should have a standard-
toring are used interchangeably. school nurse, and take appropriate ac- ized medical form completed by his/her
For patients who are eating, com- tion to treat hypoglycemia in the class- family and the physician managing the
monly recommended testing frequencies room or anywhere the student is in diabetes. (E)
are premeal and at bedtime. For patients conjunction with a school activity if in- ● It is imperative that the medical staff is
not eating, testing every 4 – 6 h is usually dicated in the student’s DMMP. (E) led by someone with expertise in man-
sufficient for determining correction in- aging type 1 and type 2 diabetes and
sulin doses. Patients controlled with con- There are ⬃206,000 individuals ⬍20 includes a nursing staff (including dia-
tinuous intravenous insulin typically years of age with diabetes in the U.S., betes educators and diabetes clinical
require hourly blood glucose testing until most of whom attend school and/or some nurse specialists) and registered dieti-
the blood glucose levels are stable, then type of day care and need knowledgeable tians with expertise in diabetes. (E)
every 2 h. staff to provide a safe environment. De- ● All camp staff, including medical, nurs-

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S31


Standards of Medical Care

ing, nutrition, and volunteer, should prompt treatment of medical emergen- care and facilitate entry into commu-
undergo background testing to ensure cies. It is imperative that the medical staff nity diabetes care. (E)
appropriateness in working with chil- is led by someone with expertise in man-
dren. (E) aging type 1 and type 2 diabetes. Nursing At any given time, ⬎2 million people are
staff should include diabetes educators incarcerated in prisons and jails in the
The concept of specialized residential and and diabetes clinical nurse specialists. U.S. It is estimated that nearly 80,000 of
day camps for children with diabetes has Registered dietitians with expertise in di- these inmates have diabetes. In addition,
become widespread throughout the U.S. abetes should also have input into the de- many more people with diabetes pass
and many other parts of the world. The sign of the menu and the education through the corrections system in a given
mission of camps specialized for children program. All camp staff, including medi- year.
and youth with diabetes is to allow for a cal, nursing, nutrition, and volunteer, People with diabetes in correctional
camping experience in a safe environ- should undergo background testing to facilities should receive care that meets
ment. An equally important goal is to en- ensure appropriateness in working with national standards. Correctional institu-
able children with diabetes to meet and children. tions have unique circumstances that
share their experiences with one another need to be considered so that all standards
while they learn to be more personally D. Diabetes management in of care may be achieved. Correctional in-
responsible for their disease. For this to correctional institutions (232) stitutions should have written policies
occur, a skilled medical and camping staff and procedures for the management of
must be available to ensure optimal safety Recommendations diabetes and for training of medical and
and an integrated camping/educational ● Patients with a diagnosis of diabetes correctional staff in diabetes care prac-
experience. should have a complete medical history tices.
The diabetes camping experience is and undergo an intake physical exami- Reception screening should empha-
short term and is most often associated nation by a licensed health professional size patient safety. In particular, rapid
with increased physical activity relative to in a timely manner. (E) identification of all insulin-treated indi-
that experienced while at home. Thus, ● Insulin-treated patients should have a viduals with diabetes is essential in order
goals of glycemic control are more related capillary blood glucose (CBG) determi- to identify those at highest risk for hypo-
to the avoidance of extremes in blood glu- nation within 1–2 h of arrival. (E) and hyperglycemia and DKA. All insulin-
cose levels than to the optimization of in- ● Medications and MNT should be con- treated patients should have a CBG deter-
tensive glycemic control while away at tinued without interruption upon entry mination within 1–2 h of arrival. Patients
camp. into the correctional environment. (E) with a diagnosis of diabetes should have a
Each camper should have a standard- ● Correctional staff should be trained in complete medical history and physical ex-
ized medical form completed by his/her the recognition, treatment, and appro- amination by a licensed health care pro-
family and the physician managing the di- priate referral for hypo- and hypergly- vider with prescriptive authority in a
abetes that details the camper’s past med- cemia. (E) timely manner. It is essential that medica-
ical history, immunization record, and ● Train staff to recognize symptoms and tion and MNT be continued without in-
diabetes regimen. The home insulin dos- signs of serious metabolic decompensa- terruption upon entry into the
age should be recorded for each camper, tion and to immediately refer the pa- correctional system, as a hiatus in either
including number and timing of injec- tient for appropriate medical care. (E) medication or appropriate nutrition may
tions or basal and bolus dosages given by ● Institutions should implement a policy lead to either severe hypo- or hyperglyce-
CSII and type(s) of insulin used. requiring staff to notify a physician of mia.
During camp, a daily record of the all CBG results outside of a specified All patients must have access to
camper’s progress should be made. All range, as determined by the treating prompt treatment of hypo- and hypergly-
blood glucose levels and insulin dosages physician. (E) cemia. Correctional staff should be
should be recorded. To ensure safety and ● Identify patients with type 1 diabetes trained in the recognition and treatment
optimal diabetes management, multiple who are at high risk for DKA. (E) of hypo- and hyperglycemia, and appro-
blood glucose determinations should be ● In the correctional setting, policies and priate staff should be trained to adminis-
made throughout each 24-h period: be- procedures need to be developed and ter glucagon. Institutions should
fore meals, at bedtime, after or during implemented to enable CBG monitor- implement a policy requiring staff to no-
prolonged and strenuous activity, and in ing to occur at the frequency necessi- tify a physician of all CBG results outside
the middle of the night when indicated for tated by the individual patient’s of a specified range, as determined by the
prior hypoglycemia. If major alterations glycemic control and diabetes regimen. treating physician.
of a camper’s regimen appear to be indi- (E) Correctional institutions should have
cated, it is important to discuss this with ● Include diabetes in correctional staff systems in place to ensure that insulin ad-
the camper and the family in addition to education programs. (E) ministration and meals are coordinated to
the child’s local physician. The record of ● For all interinstitutional transfers, com- prevent hypo- and hyperglycemia, taking
what transpired during camp should be plete a medical transfer summary to be into consideration the transport of resi-
discussed with the family when the transferred with the patient. (E) dents off site and the possibility of emer-
camper is picked up. ● Diabetes supplies and medication gency schedule changes.
A formal relationship with a nearby should accompany the patient during Monitoring of CBG is a strategy that
medical facility should be secured for transfer. (E) allows caregivers and people with diabe-
each camp so that camp medical staff have ● Begin discharge planning with ade- tes to evaluate diabetes management reg-
the ability to refer to this facility for quate lead time to insure continuity of imens. The frequency of monitoring will

S32 DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007


Position Statement

vary by patients’ glycemic control and di- he/she is otherwise qualified. Despite the laries, prior authorization, and related
abetes regimens. Policies and procedures significant medical and technological ad- provisions, such as competitive bidding,
should be implemented to ensure that the vances made in managing diabetes, dis- can manage provider practices as well as
health care staff has adequate knowledge crimination in employment and licensure costs to the potential benefit of payors and
and skills to direct the management and against people with diabetes still occurs. patients. However, any controls should
education of individuals with diabetes. This discrimination is often based on ap- ensure that all classes of antidiabetic
Patients in jails may be housed for a prehension that the person with diabetes agents with unique mechanisms of action
short period of time before being trans- may present a safety risk to the employer and all classes of equipment and supplies
ferred or released, and it is not unusual for or the public, a fear sometimes based on designed for use with such equipment are
patients in prison to be transferred within misinformation or lack of up-to-date available to facilitate achieving glycemic
the system several times during their in- knowledge about diabetes. Perhaps the goals and to reduce the risk of complica-
carceration. Transferring a patient with greatest concern is that hypoglycemia will tions. To reach diabetes treatment goals,
diabetes from one correctional facility to cause sudden unexpected incapacitation. practitioners should have access to all
another requires a coordinated effort as However, most people with diabetes can classes of antidiabetic medications,
does planning for discharge. manage their condition in such a manner equipment, and supplies without undue
that there is minimal risk of incapacita- controls. Without appropriate safe-
E. Emergency and disaster tion from hypoglycemia. guards, these controls could constitute an
preparedness Because the effects of diabetes are obstruction of effective care.
People with diabetes should always be unique to each individual, it is inappro- Medicare and many other third-party
prepared for emergencies whether natural priate to consider all people with diabetes payors cover DSME (diabetes self-
or otherwise, affecting the nation/state or the same. People with diabetes should be management training [DSMT]) and MNT.
just them and their families. Such pre- individually considered for employment The qualified beneficiary, who meets the di-
paredness will lessen the impact an emer- based on the requirements of the specific agnostic criteria and medical necessity, can
gency may have on their condition. It is job. Factors to be weighed in this decision receive an initial benefit of 10 h of DSMT
recommended that people with diabetes include the individual’s medical condi- and 3 h of MNT with a potential total of 13 h
keep a waterproof and insulated disaster tion, treatment regimen (MNT, oral glu- of initial education as long as the services are
kit ready with items critically important cose-lowering agent, and/or insulin), and not provided on the same date. However,
to their self-management. These include medical history, particularly in regard to not all Medicare beneficiaries with a diag-
glucose testing strips, lancets, and a glu- the occurrence of incapacitating hypogly- nosis of diabetes will qualify for both MNT
cose-testing meter; medications including cemic episodes. and DSMT benefits. More information on
insulin in a cool bag; syringes; glucose Medicare policy, including follow-up
tabs or gels; antibiotic ointments/creams X. THIRD-PARTY benefits, is available at www.diabetes.org/
for external use; and glucagon emergency REIMBURSEMENT FOR for-health-professionals-and-scientists/
kits. In addition, it may be important to DIABETES CARE, SELF- recognition.jsp. Or visit CMS websites:
carry a list of contacts for national organi- MANAGEMENT DSME, www.cms.hhs.gov/DiabetesSelf
zations, such as the ADA, through their EDUCATION, AND Management; and diabetes MNT, www.
help lines or the Internet, and photo- SUPPLIES (233) cms.hhs.gov/MedicalNutritionTherapy
copies of relevant medical information, reimbursement.
particularly medication lists, and recent Recommendations
lab tests/procedures if available. If possi- ● Patients and practitioners should have XI. STRATEGIES FOR
ble, prescription numbers should be access to all classes of antidiabetic med- IMPROVING DIABETES
noted, since many chain pharmacies ications, equipment, and supplies with- CARE
throughout the country may be able to out undue controls. (E) The implementation of the standards of
refill medications based on the prescrip- ● MNT and DSME should be covered by care for diabetes has been suboptimal in
tion number alone. This disaster kit insurance and other payors. (E) most clinical settings. A recent report (26)
should be reviewed and replenished at indicated that only 37% of adults with
least twice yearly. To achieve optimal glucose control, the diagnosed diabetes achieved an A1C of
person with diabetes must be able to ac- ⬍7%, only 36% had a blood pressure
IX. HYPOGLYCEMIA AND cess health care providers who have ex- ⬍130/80 mmHg, and just 48% had a cho-
EMPLOYMENT/LICENSURE pertise in the field of diabetes. Treatments lesterol ⬍200 mg/dl. Most distressing was
and therapies that improve glycemic con- that only 7.3% of diabetes subjects
Recommendations trol and reduce the complications of dia- achieved all three treatment goals.
● People with diabetes should be individ- betes will also significantly reduce health While numerous interventions to im-
ually considered for employment based care costs. Access to the integral compo- prove adherence to the recommended
on the requirements of the specific job nents of diabetes care, such as health care standards have been implemented, the
and the individual’s medical condition, visits, diabetes supplies and medications, challenge of providing uniformly effective
treatment regimen, and medical his- and self-management education, is essen- diabetes care has thus far defied a simple
tory. (E) tial. All medications and supplies, such as solution. A major contributor to subopti-
syringes, strips, and meters, related to the mal care is a delivery system that too often
Any person with diabetes, whether insu- daily care of diabetes must also be reim- is fragmented, lacks clinical information
lin treated or non–insulin treated, should bursed by third-party payors. capabilities, often duplicates services, and
be eligible for any employment for which It is recognized that the use of formu- is poorly designed for the delivery of

DIABETES CARE, VOLUME 30, SUPPLEMENT 1, JANUARY 2007 S33


Standards of Medical Care

chronic care. The Institute of Medicine have been successful at improving ad-
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Position Statement

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