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Letters |

Glycosylated Hemoglobin as a Diagnostic Test for Type 2 Diabetes Mellitus

Mayer B. Davidson, MD; David L. Schriger, MD; Anne L. Peters, MD; Brett Lorber, MPH
JAMA. 2000;283(5):605-607. doi:10.1001/jama.283.5.601.
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To the Editor: In our article1 we advised against diagnosing diabetes mellitus in individuals with normal or only slightly elevated HbA1C levels. However, we take issue with several points raised in the editorial by Dr Vinicor2 that accompanied our article.

We agree with Vinicor that there will be both false-positive and false-negative results using our alternative approach to the diagnosis of diabetes. Regarding false-positives, Vinicor cites the 2.8% prevalence of increased HbA1C levels in NHANES III subjects with normal FPG concentrations. However, by definition, 2.5% of a normal population will have values 2 SDs above the normal range. Only 0.1% had an HbA1C level exceeding 1% above the upper limit of normal. This level was selected as diagnostic because 4 studies showed almost no development or progression of retinopathy or microalbuminuria over 6 to 10 years in patients with either type 13,4 or type 25,6 diabetes with lower values. If our alternative approach to the diagnosis of diabetes had been used to characterize the NHANES III population, neither false-positive nor false-negative diagnoses would have occurred because HbA1C levels would not have been measured in subjects with normal FPG values or those of 7.8 mmol/L (140 mg/dL) or more.

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