Randomized, Controlled Trial of a Digital Behavioral Therapeutic Application to Improve Glycemic Control in Adults With Type 2 Diabetes

OBJECTIVE: To evaluate the efficacy and safety of a digital therapeutic application (app) delivering cognitive behavioral therapy (CBT) designed to improve glycemic control in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: Adults with type 2 diabetes and an HbA(1c) of 7 to <11% were randomly assigned to receive access to a digital therapeutic app delivering CBT (BT-001) or a control app, both on top of standard of care management. CBT is an established form of psychological treatment that endeavors to identify and change unhelpful thinking patterns. The primary study end point was treatment group difference in mean HbA(1c) change from baseline to 90 days. RESULTS: Among 669 randomly assigned subjects who completed app onboarding, the mean age was 58 years, BMI 35 kg/m(2), 54% were female, 28% Black, and 16% Latino. Baseline HbA(1c) was 8.2 and 8.1% in the BT-001 and control groups, respectively. After 90 days of app access, change in HbA(1c) was −0.28% (95% CI −0.41, −0.15) in the BT-001 group and +0.11% (95% CI −0.02, 0.23) in the control group (treatment group difference 0.39%; P < 0.0001). HbA(1c) reduction paralleled exposure to the therapeutic intervention, assessed as the number of modules completed on the app (P for trend <0.0001). No adverse events in either group were attributed to app use and no adverse device effects reported. CONCLUSIONS: Patients randomly assigned to the BT-001 arm relative to the control arm had significantly lower HbA(1c) at 90 days. The digital therapeutic may provide a scalable treatment option for patients with type 2 diabetes.