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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