Screening for Diabetes and Pre-Diabetes With Proposed A1C-Based Diagnostic Criteria

OBJECTIVE An International Expert Committee (IEC) and the American Diabetes Association (ADA) proposed diagnostic criteria for diabetes and pre-diabetes based on A1C levels. We hypothesized that screening for diabetes and pre-diabetes with A1C measurements would differ from using oral glucose tolerance tests (OGTT). RESEARCH DESIGN AND METHODS We compared pre-diabetes, dysglycemia (diabetes or pre-diabetes), and diabetes identified by the proposed criteria (A1C ≥ 6.5% for diabetes and 6.0-6.4% [IEC] or 5.7-6.4% [ADA] for high risk/pre-diabetes) with standard OGTT diagnoses in three datasets. Non-Hispanic white or black adults without known diabetes who had A1C and 75-g OGTT measurements were included from the prospective Screening for Impaired Glucose Tolerance study (n = 1,581), and from the National Health and Nutrition Examination Survey (NHANES) III (n = 2014), and NHANES 2005-2006 (n = 1,111). RESULTS OGTTs revealed pre-diabetes in 35.8% and diabetes in 5.2% of combined study subjects. A1C provided receiver operating characteristic (ROC) curve areas for diabetes of 0.79-0.83, but ROC curve areas were ≤ 0.70 for dysglycemia or pre-diabetes. The proposed criteria missed 70% of individuals with diabetes, 71-84% with dysglycemia, and 82-94% with pre-diabetes. Compared with the IEC criteria, the ADA criteria for pre-diabetes resulted in fewer false-negative and more false-positive result. There were also racial differences, with false-positive results being more common in black subjects and false-negative results being more common in white subjects. With use of NHANES 2005-2006 data, ∼5.9 million non-Hispanic U.S. adults with unrecognized diabetes and 43-52 million with pre-diabetes would be missed by screening with A1C. CONCLUSIONS The proposed A1C diagnostic criteria are insensitive and racially discrepant for screening, missing most Americans with undiagnosed diabetes and pre-diabetes.