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

Screening for Diabetes


AMERICAN DIABETES ASSOCIATION

D
iabetes mellitus is a group of meta- itive autoantibody test result is obtained; frequently in women with prior GDM or
bolic diseases characterized by hy- and 3) because the incidence of type 1 polycystic ovary syndrome and in indi-
perglycemia resulting from defects diabetes is low, testing of healthy children viduals with hypertension, dyslipidemia,
in insulin secretion, insulin action, or will identify only a very small number impaired glucose tolerance (IGT), or im-
both. Type 2 diabetes, the most prevalent (0.5%) who at that moment may be paired fasting glucose (IFG).
form of the disease, is often asymptomatic prediabetic. Clinical studies are being
in its early stages and can remain undiag- conducted to test various methods of pre-
nosed for many years. venting type 1 diabetes in high-risk indi- PRINCIPLES TO ASSESS THE
The chronic hyperglycemia of diabe- viduals (e.g., siblings of type 1 diabetic VALUE OF SCREENING FOR
tes is associated with long-term dysfunc- patients). These studies may uncover an TYPE 2 DIABETES There is a
tion, damage, and failure of various effective means of preventing type 1 dia- major distinction between diagnostic test-
organs, especially the eyes, kidneys, betes, in which case targeted screening ing and screening. When an individual
nerves, heart, and blood vessels. Individ- may be appropriate in the future. exhibits symptoms or signs of the disease,
uals with undiagnosed type 2 diabetes are For information on screening for diagnostic tests are performed, and such
also at significantly higher risk for stroke, GDM, refer to the American Diabetes Asso- tests do not represent screening. The pur-
coronary heart disease, and peripheral ciations position statement Gestational pose of screening is to identify asymptom-
vascular disease than the nondiabetic Diabetes Mellitus. atic individuals who are likely to have
population. They also have a greater like- diabetes. Separate diagnostic tests using
lihood of having dyslipidemia, hyperten- DIABETES PREVALENCE AND standard criteria are required after posi-
sion, and obesity. Because early detection RISK FACTORS The estimated tive screening tests to establish a definitive
and prompt treatment may reduce the prevalence of diabetes among adults was diagnosis.
burden of diabetes and its complications, 7.4% in 1995; this is expected to rise to Generally, screening in asymptomatic
screening for diabetes may be appropriate 9% in 2025. However, specific popula- populations is appropriate when seven
under certain circumstances. This posi- tion subgroups have a much higher prev- conditions are met: 1) the disease repre-
tion statement provides recommenda- alence of the disease than the population sents an important health problem that
tions for diabetes screenings performed in as a whole. These subgroups have certain imposes a significant burden on the pop-
physicians offices and in other health care attributes or risk factors that either di- ulation; 2) the natural history of the
settings. rectly cause diabetes or are associated disease is understood; 3) there is a recog-
This position statement does not ad- with it. nizable preclinical (asymptomatic) stage
dress screening for type 1 diabetes or ges- The correlation of a risk factor(s) with during which the disease can be diag-
tational diabetes mellitus (GDM). Because development of diabetes is never 100%. nosed; 4) tests are available that can detect
of the acute onset of symptoms, most However, the greater the number of risk the preclinical stage of the disease, and
cases of type 1 diabetes are detected soon factors present in an individual, the the tests are acceptable and reliable; 5)
after symptoms develop. Widespread greater the chance of that individual de- treatment after early detection yields ben-
clinical testing of asymptomatic individu- veloping or having diabetes. Conversely, efits superior to those obtained when
als for the presence of autoantibodies the chance of an asymptomatic individual treatment is delayed; 6) the costs of case
related to type 1 diabetes cannot be rec- without any risk factors having or devel- finding and treatment are reasonable and
ommended at this time as a means to oping diabetes is relatively low. are balanced in relation to health expen-
identify persons at risk. Reasons for this The risk of developing type 2 diabetes ditures as a whole, and facilities and re-
include the following: 1) cutoff values for increases with age, obesity, and lack of sources are available to treat newly
some of the immune marker assays have physical activity. Type 2 diabetes is more diagnosed cases; and 7) screening will be
not been completely established in clini- common in individuals with a family his- a systematic ongoing process and not
cal settings; 2) there is no consensus as to tory of the disease and in members of cer- merely an isolated one-time effort.
what action should be taken when a pos- tain racial/ethnic groups. It occurs more For diabetes, conditions 1 4 are met.
Conditions 57 have not been met en-
The recommendations in this paper are based on the evidence reviewed in the following publication: tirely because there are no randomized
Screening for type 2 diabetes (Technical Review). Diabetes Care 23:15631580, 2000. clinical trials documenting the effective-
The paper was peer-reviewed, modified, and approved by the Professional Practice Committee and the ness of screening programs in decreasing
Executive Committee, October 2000.
Abbreviations: DPP, Diabetes Prevention Program; FPG, fasting plasma glucose; GDM, gestational dia-
mortality and morbidity from diabetes,
betes mellitus; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; OGTT, oral glucose tolerance and some controversy exists regarding the
test. cost-effectiveness of screening and

DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 S21


Position Statement

Table 1Major risk factors for type 2 diabetes significant degree within 3 years of a neg-
ative screening test result. Testing should
Family history of diabetes (i.e., parents or siblings with diabetes) be considered at a younger age or be car-
Overweight (BMI 25 kg/m2) ried out more frequently in individuals
Habitual physical inactivity with one or more of the risk factors shown
Race/ethnicity (e.g., African-Americans, Hispanic-Americans, Native Americans, Asian- in Table 1.
Americans, and Pacific Islanders) Patients presenting to health care pro-
Previously identified IFG or IGT viders with symptoms of marked hyper-
Hypertension (140/90 mmHg in adults) glycemia, including polyuria, polydipsia,
HDL cholesterol 35 mg/dl (0.90 mmol/l) and/or a triglyceride level 250 mg/dl weight loss (sometimes with polyphagia)
(2.82 mmol/l) and blurred vision, should receive diag-
History of GDM or delivery of a baby weighing 9 lbs nostic testing for diabetes, as should those
Polycystic ovary syndrome with potential complications of diabetes
or with any other clinical presentation in
which diabetes is included in the differ-
whether screening as currently carried normal tests that are never discussed with ential diagnosis. Such diagnostic testing,
out is a systematic and ongoing process. a primary care provider, low compliance however, does not constitute screening.
Randomized clinical trials would be with treatment recommendations, and a The incidence of type 2 diabetes in
the best means to evaluate the benefits very uncertain impact on long-term children and adolescents has been shown
and risks of diabetes screening and early health. Community screening may also be to be increasing. Consistent with screen-
treatment. However, rigorous studies that poorly targeted, i.e., it may fail to reach ing recommendations for adults, only
apply currently available treatments to a the groups most at risk and inappropri- children and youth at substantial risk for
screened group but not to a control group ately test those at low risk (the worried the presence or the development of type 2
have not been done and are unlikely to be well) or even those already diagnosed. diabetes should be tested. Although there
performed soon because of feasibility, are insufficient data to make definite rec-
ethical concerns, and costs. Thus, while it GENERAL RECOMMENDATIONS ommendations, the American Diabetes
is well established that treating diabetes FOR THE EVALUATION OF Association consensus statement titled
diagnosed through standard clinical prac- HIGH-RISK INDIVIDUALS Type 2 Diabetes in Children and Adoles-
tice is effective in reducing diabetic mi- Based on the lack of data from prospective cents recommends that overweight (de-
crovascular complications, it is unknown studies on the benefits of screening and fined as BMI 85th percentile for age and
whether the additional years of treatment the relatively low cost-effectiveness of sex, weight for height 85th percentile,
that might be received by individuals di- screening suggested by existing studies, or weight 120% of ideal [50th percen-
agnosed through screening would result the decision to test for diabetes should tile] for height) youths with any two of the
in clinically important improvements in ultimately be based on clinical judgment risk factors listed below be screened. Test-
diabetes-related outcomes. A large clini- and patient preference. ing should be done every 2 years starting
cal trial, the Diabetes Prevention Program On the basis of expert opinion, eval- at age 10 years or at the onset of puberty if
(DPP), is underway in the U.S. It is de- uation of the general population should it occurs at a younger age. Testing may be
signed to answer the question of whether be considered by their health care pro- considered in other high-risk patients
treatment with lifestyle interventions or vider at 3-year intervals beginning at age who display any of the following charac-
metformin for patients with IGT or IFG 45. The rationale for this interval is that teristics:
detected through a screening program false negatives will be repeated before
will reduce the incidence of type 2 diabe- substantial time elapses, and there is little Have a family history of type 2 diabetes
tes. If the DPP demonstrates a reduction likelihood of an individual developing in first- and second-degree relatives;
in the incidence of type 2 diabetes as a any of the complications of diabetes to a Belong to a certain race/ethnic group
result of one or more of the interventions,
then more widespread screening for these
conditions, which would incidentally de- Table 2Criteria for the diagnosis of diabetes
tect many cases of asymptomatic diabetes,
may be justified. Normoglycemia IFG or IGT Diabetes*
The effectiveness of screening may
also depend on the setting in which it FPG 110 mg/dl FPG 110 and 126 mg/dl (IFG) FPG 126 mg/dl
2-h PG 140 mg/dl 2-h PG 140 and 200 mg/dl (IGT) 2-h PG 200 mg/dl
is performed. In general, community
Symptoms of diabetes and
screening outside a health care setting
casual plasma glucose
may be less effective because of the failure
concentration 200
of people with a positive screening test to
mg/dl
seek and obtain appropriate follow-up
testing and care or, conversely, to ensure *A diagnosis of diabetes must be confirmed, on a subsequent day, by measurement of FPG, 2-h PG, or
random plasma glucose (if symptoms are present). The FPG test is greatly preferred because of ease of
appropriate repeat testing for individuals administration, convenience, acceptability to patients, and lower cost. Fasting is defined as no caloric intake
who screen negative. That is, screening for at least 8 h. This test requires the use of a glucose load containing the equivalent of 75 g anhydrous
outside of clinical settings may yield ab- glucose dissolved in water. 2-h PG, 2-h postload glucose.

S22 DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002


Position Statement

Table 3Summary of major recommendations venous samples with enzymatic assay


techniques, and the above-mentioned
Evidence values are based on the use of such meth-
Recommendations grading* ods. The A1C test values remain a valu-
able tool for monitoring glycemia, but it is
Evaluation for type 2 diabetes should be performed within the health care setting. E not currently recommended for the
Patients should be screened at 3-year intervals beginning at age 45; testing should screening or diagnosis of diabetes. Pencil
be considered at an earlier age or be carried out more frequently if diabetes risk and paper tests, such as the American Di-
factors are present. abetes Associations risk test, may be use-
Diabetes risk factors include a family history of diabetes; overweight defined as BMI B ful for educational purposes but do not
25 kg/m2; habitual physical inactivity; belonging to a high-risk ethnic or racial perform well as stand-alone tests. Capil-
group; previously identified IFG or IGT; hypertension; dyslipidemia; history of lary blood glucose testing using a reflec-
GDM or delivery of a baby weighing 9 lbs; and polycystic ovary syndrome. tance blood glucose meter has also been
The FPG is the recommended screening test. The OGTT may be necessary for the C used but because of the imprecision of
diagnosis of diabetes when the FPG is normal. The FPG is preferred for screenings this method, it is better used for self-
because it is faster and easier to perform, more convenient, acceptable to patients, monitoring rather than as a screening tool.
and less expensive.
Diagnostic testing should be performed in any clinical situation in which such E OTHER CONSIDERATIONS In
testing is warranted; health care providers should not consider whether a person screening for disease, it is crucial that an
meets screening criteria in such cases. interpretation of the screening test results
Screening outside of health care settings, or community screening, has not been E be provided to the patient and that fol-
shown to be beneficial and may result in some harm; this type of screening is not low-up evaluation and treatment are
recommended. made available. Also, it is important to
*Scientific evidence was ranked based on the American Diabetes Associations grading system. The highest consider that certain drugs, including
ranking (A) was assigned when there is supportive evidence from well-conducted generalizable randomized glucocorticoids and nicotinic acid, may
controlled trials that are adequately powered, including evidence from a meta-analysis that incorporated
quality ratings in the analysis. An intermediate ranking (B) was given to supportive evidence from well-
produce hyperglycemia.
conducted cohort studies, registries, or case-control studies. A lower rank (C) was assigned to evidence from
uncontrolled or poorly controlled studies or when there is conflicting evidence with the weight of the COMMUNITY
evidence supporting the recommendation. Expert consensus (E) is indicated, as appropriate. For a detailed SCREENING Although there is
description of this grading system, refer to Diabetes Care 25 (Suppl. 1):S1, 2002. ample scientific evidence showing that
certain risk factors predispose individuals
(Native Americans, African-Americans, diabetes. Fasting is defined as no con- to development of diabetes (Table 1),
Hispanic Americans, Asians/South sumption of food or beverage other than there is insufficient evidence to conclude
Pacific Islanders); water for at least 8 h before testing. that community screening is a cost-
Have signs of insulin resistance or Nondiabetic individuals with an FPG effective approach to reduce the morbid-
conditions associated with insulin re- 110 mg/dl (6.1 mmol/l) but 126 ity and mortality associated with diabetes
sistance (acanthosis nigricans, hyper- mg/dl (7.0 mmol/l) are considered to have in presumably healthy individuals. While
tension, dyslipidemia, polycystic ovary IFG, and those with 2-h values in the community screening programs may pro-
syndrome). OGTT 140 mg/dl (7.8 mmol/l) but vide a means to enhance public awareness
200 mg/dl (11.1 mmol/l) are defined as of the seriousness of diabetes and its com-
TESTS The best screening test for di- having IGT. Both IFG and IGT are risk plications, other less costly approaches
abetes, the fasting plasma glucose (FPG), factors for future diabetes. Normoglyce- may be more appropriate, particularly be-
is also a component of diagnostic testing. mia is defined as plasma glucose levels cause the potential risks are poorly de-
The FPG test and the 75-g oral glucose 110 mg/dl (6.1 mmol/l) in the FPG test fined. Thus, based on the lack of scientific
tolerance test (OGTT) are both suitable and a 2-h postload value 140 mg/dl evidence, community screening for dia-
tests for diabetes; however, the FPG test is (7.8 mmol/l) in the OGTT. betes, even in high-risk populations, is
preferred in clinical settings because it is If necessary, plasma glucose testing not recommended.
easier and faster to perform, more conve- may be performed on individuals who
nient and acceptable to patients, and less have taken food or drink shortly before CONCLUSION Diabetes is fre-
expensive. An FPG 126 mg/dl (7.0 testing. Such tests are referred to as casual quently not diagnosed until complica-
mmol/l) is an indication for retesting, plasma glucose measurements and are tions appear, and approximately one-
which should be repeated on a different given without regard to time of last meal. third of all people with diabetes may be
day to confirm a diagnosis. If the FPG is A casual plasma glucose level 200 mg/dl undiagnosed. Although the burden of di-
126 mg/dl (7.0 mmol/l) and there is a (11.1 mmol/l) with symptoms of diabetes abetes is well known, the natural history
high suspicion for diabetes, an OGTT is considered diagnostic of diabetes. A is well characterized, and there is good
should be performed. A 2-h postload confirmatory FPG test or OGTT should be evidence for benefit from treating cases
value in the OGTT 200 mg/dl (11.1 completed on a different day if the clinical diagnosed through usual clinical care,
mmol/l) is a positive test for diabetes and condition of the patient permits. there are no randomized trials demon-
should be confirmed on an alternate day. Laboratory measurement of plasma strating the benefits of early diagnosis
Table 2 presents the diagnostic criteria for glucose concentration is performed on through screening of asymptomatic indi-

DIABETES CARE, VOLUME 25, SUPPLEMENT 1, JANUARY 2002 S23


Position Statement

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and methods for a clinical trial in the pre- tus: a randomized prospective 6-year study.
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