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HbA_1c Measurement Improves the Detection of Type 2 Diabetes in High-Risk Individuals With Nondiagnostic Levels of Fasting Plasma Glucose

The Early Diabetes Intervention Program (EDIP)

¹ Medicine and
² Pediatrics, Division of Endocrinology and Metabolism, and the
³ Department of Medicine, Division of Biostatistics, Indiana University, Indianapolis, Indiana
⁴ Division of Diabetes, Endocrinology, and Metabolism, Department of Medicine, Washington University, St. Louis, Missouri
⁵ Section of Endocrinology, Department of Medicine, Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, Indiana

OBJECTIVE—Whereas new diagnostic criteria based on a fasting plasma glucose (FPG) of >126 mg/dl (7.8 mmol/l) have improved the detection of diabetes, multiple reports indicate that many people with diabetes diagnosed by 2-h oral glucose tolerance test (OGTT) glucose measurements of 11.1 mmol/l (200 mg/dl) would remain undiagnosed based on this FPG criteria. Thus, improved methods to detect diabetes are particularly needed for high-risk individuals. We evaluated whether the combination of FPG and HbA_1c measurements enhanced detection of diabetes in those individuals at risk for diabetes with nondiagnostic or minimally elevated FPG.

RESEARCH DESIGN AND METHODS—We analyzed FPG, OGTT, and HbA_1c data from 244 subjects screened for participation in the Early Diabetes Intervention Program (EDIP).

RESULTS—Of 244 high-risk subjects studied by FPG measurements and OGTT, 24% of the individuals with FPG levels of 5.5–6.0 mmol/l (100–109 mg/dl) had OGTT-diagnosed diabetes, and nearly 50% of the individuals with FPG levels of 6.1–6.9 mmol/l (110–125 mg/dl) had OGTT-diagnosed diabetes. In the subjects with OGTT-diagnosed diabetes and FPG levels between 5.5 and 8.0 mmol/l, detection of an elevated HbA_1c (>6.1% or mean + 2 SDs) led to a substantial improvement in diagnostic sensitivity over the FPG threshold of 7.0 mmol/l (61 vs. 45%, respectively, P = 0.002). Concordant FPG levels 7.0 mmol/l (currently recommended for diagnosis) occurred in only 19% of our cohort with type 2 diabetes.

CONCLUSIONS—Diagnostic criteria based on FPG criteria are relatively insensitive in the detection of early type 2 diabetes in at-risk subjects. HbA_1c measurement improves the sensitivity of screening in high-risk individuals.

Abbreviations: ADA, American Diabetes Association • EDIP, Early Diabetes Intervention Program • FPG, fasting plasma glucose • IFG, impaired fasting glucose • OGTT, oral glucose tolerance test

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