Representativeness of Participants in the ACCORD Trial Compared to Middle-aged and Older Adults Living with Diabetes in the United States.

BACKGROUND:We evaluated whether participants in the landmark Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial represent U.S. adults aged ≥40 with diabetes. METHODS:Using the nationally representative 2017-2020 pre-pandemic National Health and Nutrition Examination Survey (NHANES) data, we made operational definitions of ACCORD eligibility criteria. We calculated the percentage of individuals aged ≥40 with diabetes and HbA1c ≥6.0% or ≥7.5% who met operational ACCORD eligibility criteria. RESULTS:Applying survey sampling weights to 715 NHANES participants aged ≥40 with diabetes and HbA1c ≥6.0% (representing 29,717,406 individuals), 12% (95% confidence interval [CI]: 8-18%) met the operational ACCORD eligibility criteria. Restricting to HbA1c ≥7.5%, 39% (95% CI: 28-51%) of respondents met the ACCORD criteria. CONCLUSIONS:ACCORD represented a minority of U.S. middle-aged and older adults with diabetes. Given the differential risk profile between ACCORD participants and the general population with diabetes, extrapolating the trial findings may not be appropriate.