Woman injecting insulin, daily diabetes care during COVID-19
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A smartphone app that delivers personalized cognitive behavioral therapy (CBT) improved health for people with Type 2 diabetes. Subjects saw greater reduction in blood sugar and less need for higher doses of diabetes medications at six months compared with those who only received standard diabetes care and a control app. Patients completing more CBT lessons saw the greatest benefits.

The study, which involved Better Therapeutics’ BT-001 app, will be presented this week at the American College of Cardiology’s Annual Scientific Session.

“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 Marc P. Bonaca, MD, MPH, the study’s principal investigator and director of vascular research at the University of Colorado School of Medicine in Aurora, Colorado.

The authors say this is one of the first digital therapeutics to demonstrate efficacy for lowering blood sugar in a rigorous randomized controlled trial and has the potential to become one of the first prescription digital therapeutics for diabetes.

Lifestyle modification is the mainstay of diabetes management. The goal is to reduce elevated blood sugar levels, the long-term consequences of which can include high blood pressure, heart disease, and stroke. But health care professionals struggle to help patients achieve effective lifestyle change.

“Much of diabetes stems from unhealthy behaviors—making poor food choices, overeating, stress eating, not exercising—that are generally rooted in unhelpful patterns of thinking and modes of coping with environmental stresses,” Bonaca said. “CBT has been shown to be effective at helping people develop the skills to recognize the unhelpful thoughts and beliefs that trigger their unhealthy behaviors and to establish healthier patterns of thinking and behavior.”

The trial enrolled 668 people with diabetes whose average age was 58 years and average body mass index (BMI) was 35. A BMI of 30 or higher falls within the obesity range. Fifty-six percent of those enrolled were women, 30% were Black and 15% were Latino. Their median level of hemoglobin A1c (HbA1c) was 8.1%.

Half of the participants were randomly assigned to the CBT app (BT-001) and half to a control app, which asked some questions but did not provide tailored lessons or skills. Those assigned to the CBT app were asked to complete one lesson per week aimed at skill development and behavior change but could complete more lessons if they wished. The primary endpoint was the change in HbA1c levels at three and six months.

Secondary endpoints included changes on standardized scales measuring patient-reported outcomes such as depression and quality of life. Changes in the use of medication to control blood sugar levels was a prespecified exploratory endpoint (an endpoint included to explore a new hypothesis).

At three months, participants assigned to the app saw a reduction in HbA1c of 0.4%, which was statistically significant and similar in magnitude to what is achieved with most antihyperglycemic medications.

At six months, these participants maintained this reduction, which remained statistically significantly lower than the control group. At the end of the study, 24% of patients in the control group had an increase in medical therapy compared with 14.4% in the BT-001 arm. In addition, 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,” Bonaca said. “That is, the antihyperglycemic effect increased in direct proportion to the number of lessons participants completed.”

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