New Diagnostic Criteria for Diabetes Mellitus

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

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TABLE 2
Criteria for the Diagnosis of Diabetes Mellitus and Impaired Glucose Homeostasis

Diabetes mellituspositive findings from any two of the following tests on different days:

Symptoms of diabetes mellitus* plus casual plasma glucose concentration 200 mg

per dL (11.1 mmol per L)

or

FPG 126 mg per dL (7.0 mmol per L)

or

2hrPPG 200 mg per dL (11.1 mmol per L) after a 75-g glucose load

Impaired glucose homeostasis

Impaired fasting glucose: FPG from 110 to <126 (6.1 to 7.0 mmol per L)

Impaired glucose tolerance: 2hrPPG from 140 to <200 (7.75 to <11.1 mmol per L)

Normal

FPG <110 mg per dL (6.1 mmol per L)

2hrPPG <140 mg per dL (7.75 mmol per L)

FPG = fasting plasma glucose; 2hrPPG = two-hour postprandial glucose.

*Symptoms include polyuria, polydipsia or unexplained weight loss.
Casual is defined as any time of day without regard to time since last meal.
Adapted with permission from Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes
Care 1997; 20:118397.

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.

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.

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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 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.