Incidence of Type 2 Diabetes in Pre-Diabetic Japanese Individuals Categorized by HbA1c Levels: A Historical Cohort Study

Objective 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 HbA(1c) levels. Methods A historical cohort study using electronic medical record data obtained between January 2008 and December 2013. A total of 52,781 individuals with HbA(1c) < 6.5% were assigned to one of six groups categorized by baseline HbA(1c) 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. Results 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 HbA(1c) 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 HbA(1c) <= 5.5% group to the other groups). After adjustment for confounding factors, the hazard ratios compared with the HbA(1c) <= 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 HbA(1c) groups (p < 0.0001). Conclusion By fractionating baseline HbA(1c) levels into narrower HbA(1c) range groups, accuracy of estimating the incidence of type 2 diabetes in subsequent years was increased. The risk of developing diabetes increased with increasing HbA(1c) levels, especially with the HbA(1c) level >= 6.2% in the first follow-up year.