A speaker reported that using a smartphone app and cognitive behavioral therapy, patients with type 2 diabetes were able to reduce HbA1c with less medication and insulation intensification than controls.
“Cardiometabolic diseases, and at its core, type 2 diabetes, are largely behavioral-acquired diseases and they’re related to unhelpful behaviors. But when we drive to what are the core, root causes of these behavioral choices, they have to do with thoughts and beliefs that lead to unhelpful behaviors and then unhelpful food choices, eating, exercise or behaviors and then type 2 diabetes,” Marc P. Bonaca, MD, MPH, FAHA, FACC, executive director of CPC Clinical Research, professor of cardiology and vascular medicine and director of vascular research at the University of Colorado School of Medicine, said during a press conference.
“There’s actually a well-established mechanism called cognitive behavioral therapy. It’s been around for very long time, shown to be efficacious for many different conditions, addictions, pain management and others as well as type 2 diabetes,” Bonaca said. “The main issue though with cognitive behavioral therapy is not scalable. It’s hard. You need a therapist, you need to drive into an institution and so on. The notion here is can you develop a digital therapeutic [that] provides cognitive behavioral therapy for patients with type 2 diabetes to reverse a root cause?”
The pivotal trial of the BT-001 mobile app (Better Therapeutics) was a randomized, controlled trial with 669 diabetes patients enrolled at 12 sites (mean age: 58 years; mean BMI, 35 kg/m2; 56% women; 55% white). In addition to receiving standard diabetes care, participants were randomly assigned to the intervention app or a control app.
Participants in the cognitive behavioral therapy app were required to complete at least one weekly lesson aimed at skill enhancement and behavior modification.
Change in mean HbA1c after 90 days was the primary efficacy outcome. The important security result was unfavorable occasions. Changes in HbA1c and adverse events at 180 days were secondary outcomes.
“Compared to a control app, cognitive behavioral therapy delivered with a digital mobile app or digital therapeutic not only lowered HbA1c, but it did so requiring less intensification of antihyperglycemic therapy, less requirement of insulin intensification, and significantly and persistently reduced HbA1c,” Bonaca said.