Digital Cognitive Behavioral Therapy Reduces Intensification of Antihyperglycemic Therapy in Patients with Type 2 Diabetes

ObjectiveWe evaluated the effect of cognitive behavioral therapy delivered via a novel digital therapeutic application (app), on antihyperglycemic medication use in adults with type 2 diabetes. MethodsTrial participants were randomized to receive access to BT-001 or a control app for 180 days.Antihyperglycemic medications were adjusted as needed consistent with standard of care, and all concomitant therapies were permitted.Change in antihyperglycemic medication from baseline to study exit was compared between treatment groups. ResultsAmong 668 randomized participants, the mean number of antihyperglycemic medications at baseline was 2+1 for both groups.The increase in number or dose of medications from baseline to study exit was greater in the control group compared with the BT-001 group (p for trend=0.0001).Use of glucagon-like peptide-1 receptor agonists was more frequent in the control group throughout the study.Participants in the control group more frequently initiated or increased their dose of insulin (control 3.8%, BT-001 1.5%) and less frequently discontinued or decreased their insulin dose (control 0.9%, BT-001 2.2%) during the treatment period (p=0.006). ConclusionsBT-001, the first prescription digital therapeutic authorized for treatment of type 2 diabetes, significantly reduced intensification of antihyperglycemic therapy compared to the control app and reduced insulin usage.