Incidence of type 2 diabetes in pre-diabetic Japanese individuals categorized by HbA1c levels: a historical cohort study.

Reported incidence of type 2 diabetes estimated at the pre-diabetic stage differs widely (2.3-18.1% per year). Because clinicians need to know the risk of incident diabetes after a diagnosis of pre-diabetes, our objective was to estimate precise incidence of diabetes using baseline HbA1c levels.A historical cohort study using electronic medical record data obtained between January 2008 and December 2013. A total of 52,781 individuals with HbA1c < 6.5% were assigned to one of six groups categorized by baseline HbA1c level: ≤ 5.5% (n=34,616), 5.6-5.7% (n=9,388), 5.8-5.9% (n=4,664), 6.0-6.1% (n= 2,338), 6.2-6.3% (n=1,257), and 6.4% (n=518). Participants were tracked until a subsequent diagnosis of diabetes or end of follow-up during a period of 5 years.During the follow-up period (mean 3.7 years), 4,369 participants developed diabetes. The incidence of diabetes in the first year was 0.7, 1.5, 2.9, 9.2, 30.4, and 44.0% in the six HbA1c groups, respectively. At five years the incidence was 3.6, 8.9, 13.8, 27.5, 51.6, and 67.8%, respectively (p < 0.0001 comparing the HbA1c ≤5.5% group to the other groups). After adjustment for confounding factors, the hazard ratios compared with the HbA1c ≤5.5% group were significantly elevated: 2.3 (95%CI 2.0-2.5), 3.4 (95%CI 2.9-3.7), 8.8 (95%CI 8.0-10.1), 26.3 (95%CI 23.3-30.1), and 48.7 (95%CI 40.8-58.1) in the five HbA1c groups (p < 0.0001).By fractionating baseline HbA1c levels into narrower HbA1c range groups, accuracy of estimating the incidence of type 2 diabetes in subsequent years was increased. The risk of developing diabetes increased with increasing HbA1c levels, especially with the HbA1c level ≥ 6.2% in the first follow-up year.