8/11/23, 11:21 Diagnosis and Classification of Diabetes Mellitus: New Criteria | AAFP

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Diagnosis and Classification of Diabetes Mellitus: New

Criteria
JENNIFER MAYFIELD, M.D., M.P.H.

info Am Fam Physician. 1998;58(6):1355-1362

local_library See editorials on page 1290. (https://www.aafp.org/afp/1998/1015/p1290)
share See related patient information handout on diabetes mellitus
(https://www.aafp.org/afp/1998/1015/p1369.html), written by the author of this article.

New recommendations for the classification and diagnosis of diabetes mellitus include the
preferred use of the terms “type 1” and “type 2” instead of “IDDM” and “NIDDM” to designate the
two major types of diabetes mellitus; simplification of the diagnostic criteria for diabetes
mellitus to two abnormal fasting plasma determinations; and a lower cutoff for fasting plasma
glucose (126 mg per dL [7 mmol per L] or higher) to confirm the diagnosis of diabetes mellitus.
These changes provide an easier and more reliable means of diagnosing persons at risk of
complications from hyperglycemia. Currently, only one half of the people who have diabetes
mellitus have been diagnosed. Screening for diabetes mellitus should begin at 45 years of age
and should be repeated every three years in persons without risk factors, and should begin
earlier and be repeated more often in those with risk factors. Risk factors include obesity, first-
degree relatives with diabetes mellitus, hypertension, hypertriglyceridemia or previous evidence
of impaired glucose homeostasis. Earlier detection of diabetes mellitus may lead to tighter
control of blood glucose levels and a reduction in the severity of complications associated with
this disease.

Diabetes mellitus is a group of metabolic disorders with one common manifestation:

hyperglycemia. Chronic hyperglycemia causes damage to the eyes, kidneys, nerves, heart and
blood vessels. The etiology and pathophysiology leading to the hyperglycemia, however, are

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markedly different among patients with diabetes mellitus, dictating different prevention strategies,
diagnostic screening methods and treatments. The adverse impact of hyperglycemia and the
rationale for aggressive treatment have recently been reviewed.1
In June 1997, an international expert committee released a report with new recommendations for
the classification and diagnosis of diabetes mellitus.2 These new recommendations were the result
of more than two years of collaboration among experts from the American Diabetes Association
and the World Health Organization (WHO). The use of classification systems and standardized
diagnostic criteria facilitates a common language among patients, physicians, other health care
professionals and scientists.

Previous Classification

In 1979, the National Diabetes Data Group produced a consensus document standardizing the
nomenclature and definitions for diabetes mellitus.3 This document was endorsed one year later by
WHO.4,5 The two major types of diabetes mellitus were given names descriptive of their clinical
presentation: “insulin-dependent diabetes mellitus” (IDDM) and “non–insulin-dependent diabetes
mellitus” (NIDDM). However, as treatment recommendations evolved, correct classification of the
type of diabetes mellitus became confusing. For example, it was difficult to correctly classify
persons with NIDDM who were being treated with insulin. This confusion led to the incorrect
classification of a large number of patients with diabetes mellitus, complicating epidemiologic
evaluation and clinical management. The discovery of other types of diabetes with specific
pathophysiology that did not fit into this classification system further complicated the situation.
These difficulties, along with new insights into the mechanisms of diabetes mellitus, provided a
major impetus for the development of a new classification system.

The National Diabetes Data Group also established the oral glucose tolerance test (using a glucose
load of 75 g) as the preferred diagnostic test for diabetes mellitus.3 However, this test has poor
reproducibility, lacks physiologic relevance and is a weaker indicator of long-term complications
compared with other measures of hyperglycemia.6 Furthermore, many high-risk patients are
unwilling to undergo this time-consuming test on a repeat basis. The new diagnostic criteria also
address this issue.

Changes in the Classification System

The new classification system identifies four types of diabetes mellitus: type 1, type 2, “other
specific types” and gestational diabetes. Arabic numerals are specifically used in the new system to
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minimize the occasional confusion of type “II” as the number “11.” Each of the types of diabetes
mellitus identified extends across a clinical continuum of hyperglycemia and insulin requirements.
Type 1 diabetes mellitus (formerly called type I, IDDM or juvenile diabetes) is characterized by beta
cell destruction caused by an autoimmune process, usually leading to absolute insulin deficiency.2,7
The onset is usually acute, developing over a period of a few days to weeks. Over 95 percent of
persons with type 1 diabetes mellitus develop the disease before the age of 25, with an equal
incidence in both sexes and an increased prevalence in the white population. A family history of
type 1 diabetes mellitus, gluten enteropathy (celiac disease) or other endocrine disease is often
found. Most of these patients have the “immune-mediated form” of type 1 diabetes mellitus with
islet cell antibodies and often have other autoimmune disorders such as Hashimoto's thyroiditis,
Addison's disease, vitiligo or pernicious anemia. A few patients, usually those of African or Asian
origin, have no antibodies but have a similar clinical presentation; consequently, they are included in
this classification and their disease is called the “idiopathic form” of type 1 diabetes mellitus.2,7

Type 2 diabetes mellitus (formerly called NIDDM, type II or adult-onset) is characterized by insulin
resistance in peripheral tissue and an insulin secretory defect of the beta cell.2,7 This is the most
common form of diabetes mellitus and is highly associated with a family history of diabetes, older
age, obesity and lack of exercise. It is more common in women, especially women with a history of
gestational diabetes, and in blacks, Hispanics and Native Americans. Insulin resistance and
hyperinsulinemia eventually lead to impaired glucose tolerance. Defective beta cells become
exhausted, further fueling the cycle of glucose intolerance and hyperglycemia. The etiology of type
2 diabetes mellitus is multifactorial and probably genetically based, but it also has strong
behavioral components.

Types of diabetes mellitus of various known etiologies are grouped together to form the
classification called “other specific types.” This group includes persons with genetic defects of beta-
cell function (this type of diabetes was formerly called MODY or maturity-onset diabetes in youth)
or with defects of insulin action; persons with diseases of the exocrine pancreas, such as
pancreatitis or cystic fibrosis; persons with dysfunction associated with other endocrinopathies
(e.g., acromegaly); and persons with pancreatic dysfunction caused by drugs, chemicals or
infections.2,7 The etiologic classifications of diabetes mellitus are listed in Table 1.2

TABLE 1

Etiologic Classifications of Diabetes Mellitus

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The definition and diagnosis of gestational diabetes mellitus was not altered in these new
recommendations.2 Gestational diabetes mellitus is an operational classification (rather than a
pathophysiologic condition) identifying women who develop diabetes mellitus during gestation.7
(Women with diabetes mellitus before pregnancy are said to have “pregestational diabetes” and are
not included in this group.) Women who develop type 1 diabetes mellitus during pregnancy and
women with undiagnosed asymptomatic type 2 diabetes mellitus that is discovered during
pregnancy are classified with gestational diabetes mellitus. However, most women classified with
gestational diabetes mellitus have normal glucose homeostasis during the first half of the
pregnancy and develop a relative insulin deficiency during the last half of the pregnancy, leading to
hyperglycemia. The hyperglycemia resolves in most women after delivery but places them at
increased risk of developing type 2 diabetes mellitus later in life.

New Diagnostic Criteria for Diabetes Mellitus

The new diagnostic criteria for diabetes mellitus have been greatly simplified (Table 2).2

TABLE 2

Criteria for the Diagnosis of Diabetes Mellitus and Impaired Glucose

Homeostasis

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original print version of this publication.

The oral glucose tolerance test previously recommended by the National Diabetes Data Group has
been replaced with the recommendation that the diagnosis of diabetes mellitus be based on two
fasting plasma glucose levels of 126 mg per dL (7.0 mmol per L) or higher. Other options for
diagnosis include two two-hour postprandial plasma glucose (2hrPPG) readings of 200 mg per dL
(11.1 mmol per L) or higher after a glucose load of 75 g (essentially, the criterion recommended by
WHO) or two casual glucose readings of 200 mg per dL (11.1 mmol per L) or higher. Measurement
of the fasting plasma glucose level is the preferred diagnostic test, but any combination of two
abnormal test results can be used. Fasting plasma glucose was selected as the primary diagnostic
test because it predicts adverse outcomes (e.g., retinopathy) as well as the 2hrPPG test but is
much more reproducible than the oral glucose tolerance test or the 2hrPPG test and easier to
perform in a clinical setting.

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The choice of the new cutoff point for fasting plasma glucose levels is based on strong evidence
from a number of populations linking the risk of various complications to the glycemic status of the
patient. Figure 1 shows the risk of diabetic retinopathy based on the glycemic status of 40- to 74-
year-old participants in the National Health and Nutritional Epidemiologic Survey (NHANES III).2
The risk of retinopathy greatly increases when the patient's fasting plasma glucose level is higher
than 109 to 116 mg per dL (6.05 to 6.45 mmol per L) or when the result of a 2hrPPG test is higher
than 150 to 180 mg per dL (8.3 to 10.0 mmol per L). However, the committee decided to maintain
the cutoff point for the 2hrPPG test at 200 mg per dL (11.1 mmol per L) because so much literature
has already been published using this criterion. They selected a cutoff point for fasting plasma
glucose of 126 mg per dL (7.0 mmol per L) or higher. This point corresponded best with the 2hrPPG
level of 200 mg per dL (11.1 mmol per L). The risk of other complications also increases
dramatically at the same cutoff points.

FIGURE 1.

Prevalence of retinopathy by deciles of the distribution of FPG, 2hrPPG and HbAlc in 40- to 74-year-old
participants in the National Health and Nutritional Epidemiologic Survey (NHANES III). The x-axis labels indicate
the lower limit of each decile group. (FPG = fasting plasma glucose; 2hrPG = two-hour postprandial plasma
glucose; HbA1c = glycosylated hemoglobin)

A normal fasting plasma glucose level is less than 110 mg per dL (6.1 mmol per L) and normal
2hrPPG levels are less than 140 mg per dL (7.75 mmol per L). Blood glucose levels above the
normal level but below the criterion established for diabetes mellitus indicate impaired glucose
homeostasis. Persons with fasting plasma glucose levels ranging from 110 to 126 mg per dL (6.1

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to 7.0 mmol per L) are said to have impaired fasting glucose, while those with a 2hrPPG level
between 140 mg per dL (7.75 mmol per L) and 200 mg per dL (11.1 mmol per L) are said to have
impaired glucose tolerance. Both impaired fasting glucose and impaired glucose tolerance are
associated with an increased risk of developing type 2 diabetes mellitus. Lifestyle changes, such as
weight loss and exercise, are warranted in these patients.
The committee chose not to address the current controversies surrounding the diagnosis of
gestational diabetes mellitus and did not alter the diagnostic criteria in this area. Screening for
gestational diabetes mellitus is generally accomplished with administration of a 50-g glucose load
one hour before determining a plasma glucose level. A positive screen (defined as a plasma
glucose level of 140 mg per dL [7.75 mmol per L] or higher) should prompt a diagnostic test: fasting
plasma glucose levels should be measured after a 100-g glucose load at baseline and at one, two
and three hours after the glucose load. Two of the four values must be abnormal (105 mg per dL
[5.8 mmol per L] or higher; 190 mg per dL [10.5 mmol per L] or higher; 165 mg per dL [9.15 mmol
per L] or higher; and 145 mg per dL [8.05 mmol per L] or higher) for a patient to be diagnosed with
gestational diabetes mellitus. The WHO criteria use a glucose load of 75 g with a test two hours
after the glucose load, using the same criterion for the diagnosis of gestational diabetes mellitus.

Glycated Hemoglobin

Measurements of glycated hemoglobin have commonly been used to monitor the glycemic control
of persons already diagnosed with diabetes mellitus. Measurements of this hemoglobin, also called
glycosylated hemoglobin, glycohemoglobin, hemoglobin A1c or hemoglobin A1, aid in the evaluation
of the stable linkage of glucose to minor hemoglobin components. There is currently no agreement
on standardization, so a variety of measurement methods and normal ranges are being used.

Some experts argue that a glycated hemoglobin test could be used for the diagnosis of diabetes
mellitus.8,9 Glycated hemoglobin levels are as highly correlated to adverse clinical outcomes (e.g.,
retinopathy) as are fasting plasma glucose or postprandial plasma glucose levels and are as
reproducible as fasting plasma glucose levels. The major advantage of measuring glycated
hemoglobin is that the specimen can be collected without regard to when the patient last ate.

The expert committee, however, did not include glycated hemoglobin measurement in the
recommendations for international standards for the diagnosis of diabetes mellitus.2 They noted
the lack of standardization and normal ranges among the various tests, making it difficult to dictate
a standard cutoff point. The test for measuring glycated hemoglobin is not widely available in
developing countries; consequently, it was not favored for use as an international criterion. There is

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also some overlap in the levels of glycated hemoglobin in patients with diabetes mellitus and those
without it.
Although it was not specifically recommended by the National Diabetes Data Group as a diagnostic
test for diabetes mellitus, glycated hemoglobin may, in some cases, be used to diagnose diabetes
mellitus. The diagnosis of diabetes mellitus is made in the following fashion.8,9 A glycated
hemoglobin level of 1 percent above the reference laboratory's upper range of normal is consistent
with diabetes mellitus and has a specificity of 98 percent.8 People with normal glycated
hemoglobin levels (i.e., within the laboratory's published normal range) either do not have diabetes
mellitus or have well-controlled diabetes mellitus (i.e., a false-negative test). However, incorrectly
diagnosing these persons as normal would not alter their treatment because exercise and diet are
adequately controlling their blood glucose levels. People who are not diagnosed with diabetes
mellitus and who have near-normal glycated hemoglobin levels (less than 1 percent above the
normal range) may be advised of the high probability that they have diabetes mellitus and may be
offered the same treatment as a person with mild diabetes mellitus (i.e., dietary and exercise
counseling), followed by repeat testing of glycated hemoglobin several months later. This method
of screening and counseling high-risk persons is easier for many patients and clinicians because
the blood specimen can be drawn at the time of the patient visit.

Impact of the New Diagnostic Criteria

Physicians may be concerned that the new diagnostic criteria for diabetes mellitus, including the
lower cutoff for fasting plasma glucose levels, may greatly increase the number of people who are
diagnosed with diabetes mellitus in their practices. Concerns about overdiagnosis include the harm
created by anxiety, the risks and costs of unnecessary treatment, and possible insurance
discrimination, especially if the condition that is being diagnosed is relatively benign or if no
effective treatment is available. On the other hand, underdiagnosing a condition is harmful if early
treatment can make a difference in patient outcome, especially if the treatment is relatively benign
and inexpensive.

It is true that a rigorous screening program will increase the number of persons who are diagnosed
with diabetes mellitus. However, currently one half of the people who have diabetes mellitus
according to the old criteria have not been diagnosed and may remain undiagnosed for up to 10
years.10 People who are asymptomatic and undiagnosed continue to develop the complications of
diabetes mellitus.1

Screening Recommendations
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The expert committee provided guidelines governing the selection of patients to be tested for
diabetes and the frequency of that testing (Table 3).2 Testing should be considered for all persons
who are 45 years or older and should be repeated at three-year intervals.

TABLE 3

Recommendations for Diabetes Screening of Asymptomatic Persons

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original print version of this publication.

Testing should be considered at a younger age and be performed more frequently in persons who
are obese (120 percent of desirable body weight or greater or a body mass index of 27 kg per m2 or
greater); who have a first-degree relative with diabetes mellitus; who are black, Hispanic or Native
American; who have delivered a baby weighing more than 4,032 g (9 lb), or who were diagnosed
with gestational diabetes mellitus during pregnancy; are hypertensive; or have a high-density
lipoprotein level of 35 mg per dL (0.90 mmol per L) or lower and/or a triglyceride level of 250 mg per
dL (2.83 mmol per L) or higher. In addition, any patient with impaired glucohomeostasis should be
reevaluated on a more frequent basis.

The expert committee recommended that screening for gestational diabetes mellitus be reserved
for use in women who meet one or more of the following criteria: 25 years of age or older, obese
(defined as more than 120 percent above their desirable body weight), a family history of a first-
degree relative with diabetes mellitus, and belong to a high-risk ethnic population.

Final Comment

The changes recommended by the expert committee for the diagnosis of diabetes mellitus should
prove beneficial to patients. Measurement of fasting plasma glucose levels should be more
acceptable to patients than the oral glucose tolerance test and can be readily incorporated with
fasting lipid determinations. Identifying asymptomatic persons earlier in the disease process will
allow earlier institution of lifestyle changes and medical therapy that may decrease the
complications of hyperglycemia. The National Diabetes Data Group emphasizes that these
changes in diagnostic criteria have not changed the treatment goals in patients with diabetes
mellitus. These goals include maintaining a fasting plasma glucose level of less than 120 mg per
dL (6.65 mmol per L) and a glucose hemoglobin measurement of less than 7.0 percent.

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Author Information
JENNIFER MAYFIELD, M.D., M.P.H., is associate professor of family medicine at Bowen Research
Center, Indiana University, Indianapolis. She received a medical degree from Loma Linda (Calif.)
School of Medicine and completed a residency in family medicine at the University of Minnesota
Medical School, Minneapolis. Dr. Mayfield has served as chair of the Council on Foot Care for the
American Diabetes Association for the past two years and was previously the epidemiologist for
the Indian Health Service Diabetes Program.

Address correspondence to Jennifer Mayfield, M.D., M.P.H., Bowen Research Center, Department of
Family Practice, Indiana University, 1110 West Michigan St., Long Hospital Room 200, Indianapolis, IN
46202. Reprints are not available from the author.

Reference(s)
1. Susman JL, Helseth LD. Reducing the complications of type II diabetes: a patient-centered
approach. Am Fam Physician. 1997;56:471-80.

2. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus.
Diabetes Care. 1997;20:1183-97.

3. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance.
National Diabetes Data Group. Diabetes. 1979;28:1039-57.

4. WHO Expert Committee on Diabetes Mellitus: second report. World Health Organ Tech Rep Ser.
1980;646:1-80.

5. Diabetes mellitus: Report of a WHO Study Group. World Health Organ Tech Rep Ser. 1985;727:1-
113.

6. McCance DR, Hanson RL, Pettitt DJ, Bennett PH, Hadden DR, Knowler WC. Diagnosing diabetes
mellitus: do we need new criteria?. Diabetologia. 1997;40:247-55.

7. National Diabetes Data Group. Diabetes in America. 2d ed. Bethesda, Md.: National Institutes of
Health, National Institute of Diabetes and Digestive and Kidney Diseases, 1995; NIH publication no.
95-1468.

8. McCance DR, Hanson RL, Charles MA, Jacobsson LT, Pettitt DJ, Bennett PH, et al. Which test for
diagnosing diabetes?. Diabetes Care. 1995;18:1042-4.

9. Davidson MB, Peters AL, Schriger DL. An alternative approach to the diagnosis of diabetes with a
review of the literature. Diabetes Care. 1995;8:1065-71.
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8/11/23, 11:21 Diagnosis and Classification of Diabetes Mellitus: New Criteria | AAFP

10. Harris MI, Hadden WC, Knowler WC, Bennett PH. Prevalence of diabetes and impaired glucose
tolerance and plasma glucose levels in U.S. population aged 20–74 yr. Diabetes. 1987;36:523-34.

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