title: Screening for diabetes and pre-diabetes with proposed A1C-based diagnostic criteria.
abstract: 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).
  
  
  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.
authors.affiliation: Atlanta VA Medical Center, Decatur, Georgia, USA. deolson@emory.edu
authors.forename: Darin E
authors.initials: DE
authors.lastname: Olson
authors.forename: Mary K
authors.initials: MK
authors.lastname: Rhee
authors.forename: Kirsten
authors.initials: K
authors.lastname: Herrick
authors.forename: David C
authors.initials: DC
authors.lastname: Ziemer
authors.forename: Jennifer G
authors.initials: JG
authors.lastname: Twombly
authors.forename: Lawrence S
authors.initials: LS
authors.lastname: Phillips
mesh_terms: D003920:Diabetes Mellitus / Q000175:diagnosis* / Q000378:metabolism; D005260:Female; D005951:Glucose Tolerance Test; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011236:Prediabetic State / Q000175:diagnosis* / Q000378:metabolism
chemical_list: D006442:Glycated Hemoglobin