Abstract
OBJECTIVE: Assess the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention on improving glycemic control among African American (AA) adults with poorly controlled type 2 diabetes (T2DM). METHODS: Data from 200 AAs ≥ 21 years of age with T2DM (hemoglobin A1c (HbA1c) ≥ 8%) from the southeastern U.S. were randomized to TIDES or usual care. Participants in TIDES received a home telemonitoring device for daily uploads of blood glucose readings and 12 weeks of telephone-delivered diabetes education and skills training. The primary outcome was HbA1c at 12-months in the intent-to-treat (ITT) population. Participants were assessed at baseline, 3, 6, 9, and 12 months. Baseline adjusted random intercept models evaluated the reduction in HbA1c for TIDES compared to usual care. Per protocol samples and baseline adjusted marginal models were used as sensitivity analyses. RESULTS: Approximately 66.5% of the sample was women; 88.5% were < 70 years of age; and 85.3% had an annual household income < $50,000. The study maintained a 90% retention rate at 12-months. HbA1c at 3 months was marginally statistically significantly lower compared to usual care (p = 0.06); however, at 12-months, there was no statistically significant difference (p = 0.668). Per protocol samples and marginal models showed similar results. CONCLUSIONS: Results found a more immediate drop in HbA1c during the intervention period compared to usual care, but no significant difference at 12-months. Possible co-interventions occurring in the primary care clinic at the time of the study and low intensity booster sessions may explain results and have implications for future diabetes multicomponent trials.