CBT device for type 2 diabetes receives OK to market
The FDA recently authorized marketing of a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy (CBT) to adult patients with type 2 diabetes.
BT-001, a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy (CBT) to adult patients with type 2 diabetes, received marketing authorization from the FDA on July 11. According to an FDA press release, BT-001 provides CBT to help patients who are under the care of a clinician better adhere to behaviors that help manage diabetes, and it should be used adjunctively with standard care.
A trial of the device randomized 669 patients with type 2 diabetes to it or a control app. From baseline HbA1c levels of 8.2% and 8.1%, respectively, study participants saw changes of −0.28% (95% CI −0.41% to −0.15%) versus 0.11% (95% CI, −0.02% to 0.23%) after 90 days, according to results published by Diabetes Care in October 2022.