ACC 2023. New study found cognitive behavioral therapy delivered via mobile app significantly reduced HbA1c and need for antihyperglycemic intensification compared to use of a control app.
Cognitive behavioral therapy (CBT) delivered via a digital mobile application significantly reduced HbA1c and need for antihyperglycemic intensification compared to use of a control app among patients with type 2 diabetes (T2D), according to a new study.
A clear “dose effect” was observed, with patients completing more CBT lessons seeing the greatest benefits, showed findings presented at the American College of Cardiology’s (ACC) 72nd Annual Scientific Session Together with the World Congress of Cardiology, being held March 4-6, 2023, in New Orleans.
“When studied in a large randomized controlled trial, digital CBT tailored to the individual reduced blood sugar levels, while also reducing the need for intensified medication use and improving blood pressure and body weight,” said principal investigator and presenting author Marc P. Bonaca, MD, MPH, professor of medicine and director of vascular research at the University of Colorado School of Medicine in Aurora, Colorado, in an ACC press release.
Also, digital CBT had a positive effect on patient-reported outcomes, including depression and quality of life scores over 6 months, added Bonaca. The CBT app—called BT-001—is one of the first digital therapeutics to demonstrate efficacy for lowering blood sugar in a rigorous randomized controlled trial and could become one of the first prescription digital therapeutics for diabetes, explained Bonaca.
Lifestyle modification is essential for patients with T2D to reduce their blood sugar levels and the long-term consequences of elevated blood sugar, including hypertension, cardiovascular disease, and stroke. It can be difficult, however, for clinicians to help patients achieve effective lifestyle change, said Bonaca. For instance, traditional one-on-one CBT delivered in a therapist’s office has been shown to be effective, but it is expensive and may not be covered by health insurance. Additionally, access to CBT is limited by the availability of therapists and the need to travel to the therapist’s office.
“For this trial, we wanted to know if a CBT program for diabetes that was automated and personalized would be effective,” said Bonaca. “We wanted something that users could access on a smartphone that would deliver benefit through lessons and skills and that would be individually tailored through a process of asking questions.”
Bonaca and colleagues enrolled 668 adults with HbA1c <7% whose mean age at baseline was 58 years, average body mass index was 35 kg/m2, and median HbA1c was 8.1%. Fifty-six percent of all participants were women, 30% were Black, and 15% were Latino, according to the study abstract. The mean number of antihyperglycemic medications at study enrollment was 2.
Researchers measured participants’ HbA1c levels at 90 and 180 days and half of the participants were randomly assigned to BT-001 or a control app. All patients received unrestricted guideline-directed medical therapy.
Adults in the BT-001 group were asked to complete 1 lesson per week aimed at skill development and behavior change but could complete more lessons if they desired. The primary endpoint was the change in HbA1c levels at 90 and 180 days. Secondary endpoints included changes on standardized scales measuring patient-reported outcomes such as depression and quality of life. Changes in the use of antihyperglycemic medication was a prespecified exploratory outcome, according to the abstract.
At 90 days, HbA1c among participants using BT-001 was reduced by 0.4% (p<.001) compared to those using the control app. Those using BT-001 maintained a HbA1c reduction of 0.3% (p<.01) at 180 days. At the end of the study, 24% of participants in the control group had an increase in medical therapy compared with 14.4% in the BT-001 group. Also, while more participants in the control group started insulin or increased their dose, more participants in the BT-001 group discontinued insulin or were able to lower their dose.
“We saw a clear dose effect with digital CBT,” said Bonaca. “That is, the antihyperglycemic effect increased in direct proportion to the number of lessons participants completed. The more lessons they did, the greater the reductions in HbA1c they achieved. Participants aged over 75 did as well as younger patients if they completed the same number of lessons.”
BT-001 was not time consuming, added Bonaca, with users typically spending less than 6 minutes a day using it. Bonaca and colleagues, as well as other research groups, are conducting follow-up studies to learn more about the impacts of digital CBT in different delivery models and for longer exposures.
Bonaca will present the study, “Digital Cognitive Behavioral Therapy Leads To Less Intensification Of Antihyperglycemic Medication In Patients With Type 2 Diabetes: Findings From The Pivotal, Randomized, Controlled Trial Of BT-001,” on Saturday, March 4, at 1:30 pm CT / 19:30 UTC in Poster Hall, Hall F.