Washington [US]: People with Type 2 diabetes who were given a smartphone app that personalized delivery cognitive behavior therapy (CBT) saw significantly greater reductions in their blood sugar and less need for higher doses of diabetes medication at six months compared to those who received standard diabetes care and a monitoring app alone, in a study presented at the American College of Cardiology Annual Scientific Session. Together with the World Congress of Cardiology.
A clear ‘dose effect’ was observed, with patients who completed the most CBT lessons seeing the greatest benefits.
“When studied in a large randomized controlled trial, individual-tailored digital CBT lowered blood sugar levels, while reducing the need for intensive medication use and improving blood pressure and body weight,” he said. Marc P. Bonaca, MD, MPH, professor. of medicine and director of vascular research at the University of Colorado School of Medicine in Aurora, Colorado, and the study’s principal investigator. Digital CBT also had a positive effect on patient-reported outcomes, including depression and quality-of-life scores over six months, he said.
This is one of the first digital therapies to demonstrate efficacy in lowering blood sugar in a rigorous randomized controlled trial and has the potential to become one of the first digital therapies prescribed for diabetes, Bonaca said.
Lifestyle modification is the cornerstone of diabetes management to reduce blood sugar levels and the long-term consequences of high blood sugar, which can include high blood pressure, heart disease and stroke, he said. . However, health care professionals have struggled to help patients make effective lifestyle changes, Bonaca said. For example, traditional individual CBT performed in a therapist’s office has been shown to be effective, but it is expensive and may not be covered by health insurance. Access to CBT is also limited by the availability of therapists and the need to travel to the therapist’s office.
“Much of diabetes stems from unhealthy behaviors (poor food choices, overeating, stress eating, not exercising) that are often rooted in thought patterns and coping with environmental stress that don’t help Bonaca said. “CBT has been shown to be effective in helping people develop the skills to recognize the unhelpful thoughts and beliefs that trigger their unhealthy behaviors and to establish healthier thought and behavior patterns.”
The trial enrolled 668 people with diabetes whose average age was 58 years and an average body mass index (BMI) of 35. A BMI of 30 or higher falls within the range of obesity. Fifty-six percent of registrants were women, 30 percent were black, and 15 percent were Latino. At the time of enrollment in the study, the participants were taking an average of two medications to control their blood sugar levels. Their mean hemoglobin A1c (HbA1c) level, a measure of average blood sugar levels over the past two to three months, was 8.1 percent. The threshold for a diagnosis of diabetes is greater than 6.5 percent. Participants had to have a smartphone.
“For this trial, we wanted to find out if a personalized, automated diabetes CBT program would be effective,” Bonaca said. “We wanted something that users could access on a smartphone that would provide benefits through lessons and skills and be individually tailored through a process of asking questions.”
Half of the participants were randomly assigned to the CBT app (BT-001) and the other half to a control app, which asked some questions but did not provide personalized lessons or skills. Those assigned to the CBT app were required to complete one lesson per week aimed at skill development and behavior change, but they 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 in standardized scales that measure patient-reported outcomes, such as depression and quality of life. Changes in the use of medications 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 0.4 percent reduction in HbA1c, 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 percent of patients in the control group had an increase in medical therapy compared to 14.4 percent in the BT-001 arm. Additionally, while more participants in the control group started taking insulin or increased their dose, more participants in the BT-001 group stopped insulin or were able to reduce 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 the participants completed. The more lessons they took, the greater the reductions in HbA1c they achieved. Participants older than 75 years did better than younger patients if they completed the same number of lessons.
The CBT program was not time consuming, he said, and users typically spent less than six minutes a day using the app.
Bonaca and his colleagues, as well as other groups, are conducting follow-up studies to learn more about the impacts of digital cognitive behavioral therapy in different delivery models and for longer exposures.
