Diabetes mellitus is a chronic illness that requires continuing medical care and ongoing
patient self-management education and support to prevent acute complications and to
reduce the risk of long-term complications. Diabetes care is complex and requires
that many issues, beyond glycemic control, be addressed. A large body of evidence
exists that supports a range of interventions to improve diabetes outcomes.
These standards of care are intended to provide clinicians, patients, researchers,
payers, and other interested individuals with the components of diabetes care, general
treatment goals, and tools to evaluate the quality of care. While individual preferences,
comorbidities, and other patient factors may require modification of goals, targets
that are desirable for most patients with diabetes are provided. Specifically titled
sections of the standards address children with diabetes, pregnant women, and people
with prediabetes. These standards are not intended to preclude clinical judgment or
more extensive evaluation and management of the patient by other specialists as needed.
For more detailed information about management of diabetes, refer to references 1–3.
The recommendations included are screening, diagnostic, and therapeutic actions that
are known or believed to favorably affect health outcomes of patients with diabetes.
A large number of these interventions have been shown to be cost-effective (4). A
grading system (Table 1), developed by the American Diabetes Association (ADA) and
modeled after existing methods, was utilized to clarify and codify the evidence that
forms the basis for the recommendations. The level of evidence that supports each
recommendation is listed after each recommendation using the letters A, B, C, or E.
Table 1
ADA evidence grading system for clinical practice recommendations
Level of evidence
Description
A
Clear evidence from well-conducted, generalizable, RCTs that are adequately powered,
including:
Evidence from a well-conducted multicenter trial
Evidence from a meta-analysis that incorporated quality ratings in the analysis
Compelling nonexperimental evidence, i.e., “all or none” rule developed by Center
for Evidence Based Medicine at Oxford
Supportive evidence from well-conducted randomized controlled trials that are adequately
powered, including:
Evidence from a well-conducted trial at one or more institutions
Evidence from a meta-analysis that incorporated quality ratings in the analysis
B
Supportive evidence from well-conducted cohort studies
Evidence from a well-conducted prospective cohort study or registry
Evidence from a well-conducted meta-analysis of cohort studies
Supportive evidence from a well-conducted case-control study
C
Supportive evidence from poorly controlled or uncontrolled studies
Evidence from RCTs with one or more major or three or more minor methodological flaws
that could invalidate the results
Evidence from observational studies with high potential for bias (such as case series
with comparison with historical controls)
Evidence from case series or case reports
Conflicting evidence with the weight of evidence supporting the recommendation
E
Expert consensus or clinical experience
These standards of care are revised annually by the ADA's multidisciplinary Professional
Practice Committee, incorporating new evidence. For the current revision, committee
members systematically searched Medline for human studies related to each subsection
and published since 1 January 2010. Recommendations (bulleted at the beginning of
each subsection and also listed in the “Executive Summary: Standards of Medical Care
in Diabetes—2012”) were revised based on new evidence or, in some cases, to clarify
the prior recommendation or match the strength of the wording to the strength of the
evidence. A table linking the changes in recommendations to new evidence can be reviewed
at http://professional.diabetes.org/CPR_Search.aspx. Subsequently, as is the case
for all Position Statements, the standards of care were reviewed and approved by the
Executive Committee of ADA's Board of Directors, which includes health care professionals,
scientists, and lay people.
Feedback from the larger clinical community was valuable for the 2012 revision of
the standards. Readers who wish to comment on the “Standards of Medical Care in Diabetes—2012”
are invited to do so at http://professional.diabetes.org/CPR_Search.aspx.
Members of the Professional Practice Committee disclose all potential financial conflicts
of interest with industry. These disclosures were discussed at the onset of the standards
revision meeting. Members of the committee, their employer, and their disclosed conflicts
of interest are listed in the “Professional Practice Committee Members” table (see
pg. S109). The American Diabetes Association funds development of the standards and
all its position statements out of its general revenues and does not utilize industry
support for these purposes.
I. CLASSIFICATION AND DIAGNOSIS
A. Classification
The classification of diabetes includes four clinical classes:
Type 1 diabetes (results from β-cell destruction, usually leading to absolute insulin
deficiency)
Type 2 diabetes (results from a progressive insulin secretory defect on the background
of insulin resistance)
Other specific types of diabetes due to other causes, e.g., genetic defects in β-cell
function, genetic defects in insulin action, diseases of the exocrine pancreas (such
as cystic fibrosis), and drug- or chemical-induced (such as in the treatment of HIV/AIDS
or after organ transplantation)
Gestational diabetes mellitus (GDM) (diabetes diagnosed during pregnancy that is not
clearly overt diabetes)
Some patients cannot be clearly classified as having type 1 or type 2 diabetes. Clinical
presentation and disease progression vary considerably in both types of diabetes.
Occasionally, patients who otherwise have type 2 diabetes may present with ketoacidosis.
Similarly, patients with type 1 may have a late onset and slow (but relentless) progression
of disease despite having features of autoimmune disease. Such difficulties in diagnosis
may occur in children, adolescents, and adults. The true diagnosis may become more
obvious over time.
B. Diagnosis of diabetes
Recommendations.
For decades, the diagnosis of diabetes was based on plasma glucose criteria, either
the fasting plasma glucose (FPG) or the 2-h value in the 75-g oral glucose tolerance
test (OGTT) (5).
In 2009, an International Expert Committee that included representatives of the American
Diabetes Association (ADA), the International Diabetes Federation (IDF), and the European
Association for the Study of Diabetes (EASD) recommended the use of the A1C test to
diagnose diabetes, with a threshold of ≥6.5% (6), and ADA adopted this criterion in
2010 (5). The diagnostic test should be performed using a method that is certified
by the National Glycohemoglobin Standardization Program (NGSP) and standardized or
traceable to the Diabetes Control and Complications Trial (DCCT) reference assay.
Point-of-care A1C assays, for which proficiency testing is not mandated, are not sufficiently
accurate at this time to use for diagnostic purposes.
Epidemiologic datasets show a similar relationship between A1C and risk of retinopathy
as has been shown for the corresponding FPG and 2-h PG thresholds. The A1C has several
advantages to the FPG and OGTT, including greater convenience (since fasting is not
required), evidence to suggest greater preanalytical stability, and less day-to-day
perturbations during periods of stress and illness. These advantages must be balanced
by greater cost, the limited availability of A1C testing in certain regions of the
developing world, and the incomplete correlation between A1C and average glucose in
certain individuals. In addition, HbA1c levels may vary with patients’ race/ethnicity
(7,8). Some have posited that glycation rates differ by race (with, for example, African
Americans having higher rates of glycation), but this is controversial. A recent epidemiologic
study found that, when matched for FPG, African Americans (with and without diabetes)
indeed had higher A1C than whites, but also had higher levels of fructosamine and
glycated albumin and lower levels of 1,5-anhydroglucitol, suggesting that their glycemic
burden (particularly postprandially) may be higher (9). Epidemiologic studies forming
the framework for recommending use of the A1C to diagnose diabetes have all been in
adult populations. Whether the cut point would be the same to diagnose children with
type 2 diabetes is an area of uncertainty (10). A1C inaccurately reflects glycemia
with certain anemias and hemoglobinopathies. For patients with an abnormal hemoglobin
but normal red cell turnover, such as sickle cell trait, an A1C assay without interference
from abnormal hemoglobins should be used (an updated list is available at www.ngsp.org/npsp.org/interf.asp).
For conditions with abnormal red cell turnover, such as pregnancy, recent blood loss
or transfusion, or some anemias, the diagnosis of diabetes must employ glucose criteria
exclusively.
The established glucose criteria for the diagnosis of diabetes (FPG and 2-h PG) remain
valid as well (Table 2). Just as there is less than 100% concordance between the FPG
and 2-h PG tests, there is not perfect concordance between A1C and either glucose-based
test. Analyses of National Health and Nutrition Examination Survey (NHANES) data indicate
that, assuming universal screening of the undiagnosed, the A1C cut point of ≥6.5%
identifies one-third fewer cases of undiagnosed diabetes than a fasting glucose cut
point of ≥126 mg/dL (7.0 mmol/L) (11). However, in practice, a large portion of the
diabetic population remains unaware of their condition. Thus, the lower sensitivity
of A1C at the designated cut point may well be offset by the test's greater practicality,
and wider application of a more convenient test (A1C) may actually increase the number
of diagnoses made.
Table 2
Criteria for the diagnosis of diabetes
As with most diagnostic tests, a test result diagnostic of diabetes should be repeated
to rule out laboratory error, unless the diagnosis is clear on clinical grounds, such
as a patient with a hyperglycemic crisis or classic symptoms of hyperglycemia and
a random plasma glucose ≥200 mg/dL. It is preferable that the same test be repeated
for confirmation, since there will be a greater likelihood of concurrence in this
case. For example, if the A1C is 7.0% and a repeat result is 6.8%, the diagnosis of
diabetes is confirmed. However, if two different tests (such as A1C and FPG) are both
above the diagnostic thresholds, the diagnosis of diabetes is also confirmed.
On the other hand, if two different tests are available in an individual and the results
are discordant, the test whose result is above the diagnostic cut point should be
repeated, and the diagnosis is made on the basis of the confirmed test. That is, if
a patient meets the diabetes criterion of the A1C (two results ≥6.5%) but not the
FPG (<126 mg/dL or 7.0 mmol/L), or vice versa, that person should be considered to
have diabetes.
Since there is preanalytic and analytic variability of all the tests, it is also possible
that when a test whose result was above the diagnostic threshold is repeated, the
second value will be below the diagnostic cut point. This is least likely for A1C,
somewhat more likely for FPG, and most likely for the 2-h PG. Barring a laboratory
error, such patients are likely to have test results near the margins of the threshold
for a diagnosis. The health care professional might opt to follow the patient closely
and repeat the testing in 3–6 months. The current diagnostic criteria for diabetes
are summarized in Table 2.
C. Categories of increased risk for diabetes (prediabetes)
In 1997 and 2003, The Expert Committee on Diagnosis and Classification of Diabetes
Mellitus (12,13) recognized an intermediate group of individuals whose glucose levels,
although not meeting criteria for diabetes, are nevertheless too high to be considered
normal. These persons were defined as having impaired fasting glucose (IFG) (FPG levels
100 mg/dL [5.6 mmol/L] to 125 mg/dL [6.9 mmol/L]), or impaired glucose tolerance (IGT)
(2-h values in the OGTT of 140 mg/dL [7.8 mmol/L] to 199 mg/dL [11.0 mmol/L]). It
should be noted that the World Health Organization (WHO) and a number of other diabetes
organizations define the cutoff for IFG at 110 mg/dL (6.1 mmol/L).
Individuals with IFG and/or IGT have been referred to as having prediabetes, indicating
the relatively high risk for the future development of diabetes. IFG and IGT should
not be viewed as clinical entities in their own right but rather risk factors for
diabetes as well as cardiovascular disease (CVD). IFG and IGT are associated with
obesity (especially abdominal or visceral obesity), dyslipidemia with high triglycerides
and/or low HDL cholesterol, and hypertension.
As is the case with the glucose measures, several prospective studies that used A1C
to predict the progression to diabetes demonstrated a strong, continuous association
between A1C and subsequent diabetes. In a systematic review of 44,203 individuals
from 16 cohort studies with a follow-up interval averaging 5.6 years (range 2.8-12
years), those with an A1C between 5.5 and 6.0% had a substantially increased risk
of diabetes with 5-year incidences ranging from 9–25%. An A1C range of 6.0 to 6.5%
had a 5-year risk of developing diabetes between 25 to 50% and relative risk 20 times
higher compared with an A1C of 5.0% (14). In a community-based study of black and
white adults without diabetes, baseline A1C was a stronger predictor of subsequent
diabetes and cardiovascular events than fasting glucose (15). Other analyses suggest
that an A1C of 5.7% is associated with diabetes risk similar to that of the high-risk
participants in the Diabetes Prevention Program (DPP).
Hence, it is reasonable to consider an A1C range of 5.7 to 6.4% as identifying individuals
with high risk for future diabetes, a state that may be referred to as prediabetes
(5). As is the case for individuals found to have IFG and IGT, individuals with an
A1C of 5.7–6.4% should be informed of their increased risk for diabetes as well as
CVD and counseled about effective strategies to lower their risks (see section IV.
PREVENTION/DELAY OF TYPE 2 DIABETES). As with glucose measurements, the continuum
of risk is curvilinear, so that as A1C rises the risk of diabetes rises disproportionately
(14). Accordingly, interventions should be most intensive and follow-up should be
particularly vigilant for those with A1Cs >6.0%, who should be considered to be at
very high risk. Table 3 summarizes the categories of increased risk for diabetes.
Table 3
Categories of increased risk for diabetes (prediabetes)*
II. TESTING FOR DIABETES IN ASYMPTOMATIC PATIENTS
Recommendations.
Testing to detect type 2 diabetes and assess risk for future diabetes in asymptomatic
people should be considered in adults of any age who are overweight or obese (BMI
≥25 kg/m2) and who have one or more additional risk factors for diabetes (Table 4).
In those without these risk factors, testing should begin at age 45 years. (B)
If tests are normal, repeat testing at least at 3-year intervals is reasonable. (E)
To test for diabetes or to assess risk of future diabetes, the A1C, FPG, or 2-h 75-g
OGTT are appropriate. (B)
In those identified with increased risk for future diabetes, identify and, if appropriate,
treat other CVD risk factors. (B)
Table 4
Criteria for testing for diabetes in asymptomatic adult individuals
1. Testing should be considered in all adults who are overweight (BMI ≥25 kg/m2
*) and who have one or more additional risk factors:
physical inactivity
first-degree relative with diabetes
high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American,
Pacific Islander)
women who delivered a baby weighing >9 lb or who were diagnosed with GDM
hypertension (blood pressure ≥140/90 mmHg or on therapy for hypertension)
HDL cholesterol level <35 mg/dL (0.90 mmol/L) and/or a triglyceride level >250 mg/dL
(2.82 mmol/L)
women with PCOS
A1C ≥5.7%, IGT, or IFG on previous testing
other clinical conditions associated with insulin resistance (e.g., severe obesity,
acanthosis nigricans)
history of CVD
2. In the absence of the above criteria, testing for diabetes should begin at age
45 years
3. If results are normal, testing should be repeated at least at 3-year intervals,
with consideration of more-frequent testing depending on initial results (e.g., those
with prediabetes should be tested yearly) and risk status.
*
At-risk BMI may be lower in some ethnic groups. PCOS, polycystic ovary syndrome.
For many illnesses, there is a major distinction between screening and diagnostic
testing. However, for diabetes, the same tests would be used for “screening” as for
diagnosis. Diabetes may be identified anywhere along a spectrum of clinical scenarios
ranging from a seemingly low-risk individual who happens to have glucose testing,
to a higher-risk individual whom the provider tests because of high suspicion of diabetes,
to the symptomatic patient. The discussion herein is primarily framed as testing for
diabetes in those without symptoms. The same assays used for testing for diabetes
will also detect individuals with prediabetes.
A. Testing for type 2 diabetes and risk of future diabetes in adults
Prediabetes and diabetes meet established criteria for conditions in which early detection
is appropriate. Both conditions are common, increasing in prevalence, and impose significant
public health burdens. There is a long presymptomatic phase before the diagnosis of
type 2 diabetes is usually made. Relatively simple tests are available to detect preclinical
disease. Additionally, the duration of glycemic burden is a strong predictor of adverse
outcomes, and effective interventions exist to prevent progression of prediabetes
to diabetes (see section IV. PREVENTION/DELAY OF TYPE 2 DIABETES) and to reduce risk
of complications of diabetes (see section V.I. PREVENTION AND MANAGEMENT OF DIABETES
COMPLICATIONS).
Type 2 diabetes is frequently not diagnosed until complications appear, and approximately
one-fourth of all people with diabetes in the U.S. may be undiagnosed. The effectiveness
of early identification of prediabetes and diabetes through mass testing of asymptomatic
individuals has not been proven definitively, and rigorous trials to provide such
proof are unlikely to occur. In a large randomized controlled trial (RCT) in Europe,
general practice patients between the ages of 40 and 69 years were screened for diabetes
and then randomized by practice to routine care of diabetes or intensive treatment
of multiple risk factors. After 5.3 years of follow-up, CVD risk factors were modestly
but significantly more improved with intensive treatment. Incidence of first CVD event
and mortality rates were not significantly different between groups (16). This study
would seem to add support for early treatment of screen-detected diabetes, as risk
factor control was excellent even in the routine treatment arm and both groups had
lower event rates than predicted. The absence of a control unscreened arm limits the
ability to definitely prove that screening impacts outcomes. Mathematical modeling
studies suggest that screening independent of risk factors beginning at age 30 or
age 45 years is highly cost-effective (<$11,000 per quality-adjusted life-year gained)
(17).
Recommendations for testing for diabetes in asymptomatic, undiagnosed adults are listed
in Table 4. Testing should be considered in adults of any age with BMI ≥25 kg/m2 and
one or more of the known risk factors for diabetes. There is compelling evidence that
lower BMI cut points suggest diabetes risk in some racial and ethnic groups. In a
large multiethnic cohort study, for an equivalent incidence rate of diabetes conferred
by a BMI of 30 kg/m2 in whites, the BMI cutoff value was 24 kg/m2 in South Asians,
25 kg/m2 in Chinese, and 26 kg/m2 African Americans (18).Disparities in screening
rates, not explainable by insurance status, are highlighted by evidence that despite
much higher prevalence of type 2 diabetes, non-Caucasians in an insured population
are no more likely than Caucasians to be screened for diabetes (19). Because age is
a major risk factor for diabetes, testing of those without other risk factors should
begin no later than age 45 years.
Either A1C, FPG, or the 2-h OGTT is appropriate for testing. It should be noted that
the tests do not necessarily detect diabetes in the same individuals. The efficacy
of interventions for primary prevention of type 2 diabetes (20–26) has primarily been
demonstrated among individuals with IGT, not for individuals with isolated IFG or
for individuals with specific A1C levels.
The appropriate interval between tests is not known (27). The rationale for the 3-year
interval is that false negatives will be repeated before substantial time elapses,
and there is little likelihood that an individual will develop significant complications
of diabetes within 3 years of a negative test result. In the modeling study, repeat
screening every 3 or 5 years was cost-effective (17).
Because of the need for follow-up and discussion of abnormal results, testing should
be carried out within the health care setting. Community screening outside a health
care setting is not recommended because people with positive tests may not seek, or
have access to, appropriate follow-up testing and care. Conversely, there may be failure
to ensure appropriate repeat testing for individuals who test negative. Community
screening may also be poorly targeted, i.e., it may fail to reach the groups most
at risk and inappropriately test those at low risk (the worried well) or even those
already diagnosed.
B. Testing for type 2 diabetes in children
The incidence of type 2 diabetes in adolescents has increased dramatically in the
last decade, especially in minority populations (28), although the disease remains
rare in the general pediatric population (29). Consistent with recommendations for
adults, children and youth at increased risk for the presence or the development of
type 2 diabetes should be tested within the healthcare setting (30). The recommendations
of the ADA consensus statement on Type 2 Diabetes in Children and Youth, with some
modifications, are summarized in Table 5 (30).
Table 5
Testing for type 2 diabetes in asymptomatic children
Criteria
Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile,
or weight >120% of ideal for height
Plus any two of the following risk factors:
Family history of type 2 diabetes in first- or second-degree relative
Race/ethnicity (Native American, African American, Latino, Asian American, Pacific
Islander)
Signs of insulin resistance or conditions associated with insulin resistance (acanthosis
nigricans, hypertension, dyslipidemia, PCOS, or birth weight small for gestational
age birthweight)
Maternal history of diabetes or GDM during the child's gestation
Age of initiation: 10 years or at onset of puberty, if puberty occurs at a younger
age
Frequency: every 3 years
PCOS, polycystic ovary syndrome
C. Screening for type 1 diabetes
Generally, people with type 1 diabetes present with acute symptoms of diabetes and
markedly elevated blood glucose levels, and most cases are diagnosed soon after the
onset of hyperglycemia. However, evidence from type 1 prevention studies suggests
that measurement of islet autoantibodies identifies individuals who are at risk for
developing type 1 diabetes. Such testing may be appropriate in high-risk individuals,
such as those with prior transient hyperglycemia or those who have relatives with
type 1 diabetes, in the context of clinical research studies (see, e.g., http://www2.diabetestrialnet.org).
Widespread clinical testing of asymptomatic low-risk individuals cannot currently
be recommended, as it would identify very few individuals in the general population
who are at risk. Individuals who screen positive should be counseled about their risk
of developing diabetes. Clinical studies are being conducted to test various methods
of preventing type 1 diabetes, or reversing early type 1 diabetes, in those with evidence
of autoimmunity.
III. DETECTION AND DIAGNOSIS OF GESTATIONAL DIABETES MELLITUS (GDM)
Recommendations.
Screen for undiagnosed type 2 diabetes at the first prenatal visit in those with risk
factors, using standard diagnostic criteria. (B)
In pregnant women not previously known to have diabetes, screen for GDM at 24–28 weeks’
gestation, using a 75-g 2-h OGTT and the diagnostic cut points in Table 6. (B)
Screen women with GDM for persistent diabetes at 6–12 weeks’ postpartum, using a test
other than A1C. (E)
Women with a history of GDM should have lifelong screening for the development of
diabetes or prediabetes at least every 3 years. (B)
Women with a history of GDM found to have prediabetes should receive lifestyle interventions
or metformin to prevent diabetes. (A)