FDA grants authorization for digital cognitive behavioral therapy for type 2 diabetes
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Key takeaways:
- The FDA cleared AspyreRx digital cognitive behavior therapy for adults with type 2 diabetes.
- In a randomized controlled trial, the intervention was associated with a 0.28% HbA1c reduction at 90 days.
The FDA granted marketing authorization for a digital cognitive behavioral therapy intervention for adults with type 2 diabetes, according to an industry press release.
As Healio previously reported, AspyreRx (Better Therapeutics Inc.) is a prescription-only digital treatment intervention that provides cognitive behavioral therapy through a smartphone application for people aged 18 years and older with type 2 diabetes. In a randomized controlled trial, adults using the intervention were asked to complete a behavioral module and one or more skill-based exercises each week. The modules addressed diabetes-related topics such as personal beliefs and barriers, beliefs about macronutrients and the importance of various food types, hedonic-related beliefs about pleasant or unpleasant sensations experienced by eating or exercising, and beliefs about exercising.
In the trial, adults who received the intervention had a 0.28% reduction in HbA1c at 90 days compared with a 0.11% increase in a control group receiving standard care and a control app (P < .0001). Researchers also observed a greater improvement in fasting blood glucose, lower systolic blood pressure, a reduction in body weight, improvements in mood and quality of life, less medication use and fewer diabetes-related risks in the treatment group compared with controls. Of the treatment group, 94% continued to use the intervention at 90 days and 81% were using the intervention at 180 days.
The findings from the trial were published in Diabetes Care.
"AspyreRx is a game-changer as we now have an evidence-based intervention to help clinicians and people living with type 2 diabetes address the underlying factors that contribute to disease progression and achieve treatment outcomes beyond glucose management alone,” David Kerr MBChB, DM, FRCP, FRCPE, director of digital health at the Diabetes Technology Society, said in a press release. "The cornerstone of modern diabetes care is helping to improve self-efficacy, and AspyreRx now provides a prescription tool for physicians that seamlessly integrates with existing disease management programs to help patients make and sustain meaningful changes to improve their overall health.”
AspyreRx was reviewed through the FDA’s De Novo pathway. It is expected to become commercially available in the fourth quarter of 2023, according to the release.
Reference:
Hsia J, et al. Diabetes Care. 2022;doi:10.2337/dc22-1099.
Perspective
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Nicole M. Bereolos, PhD, MPH, MSCP, CDCES, FADCES
Digital behavioral therapeutics has been a buzz word, especially since COVID and the need for behavioral health services escalated. Cognitive behavioral therapy has been empirically validated to help ease the challenges associated with living with diabetes.
This study utilized adults (mean age, 58 years) living with type 2 diabetes and provided them with an app that included 13 educational modules that are based in cognitive behavioral therapy techniques. There were no in-person services, and the modules were not individualized. It is unclear why a prescription is needed as it seems that many people would benefit from this information, especially if they live in a community that has little to no resources for people with diabetes. Since a prescription is required, insurance reimbursement is likely at some point.
Although digital apps have utility, there are numerous people who prefer the "human touch." This would be a nice app to augment individualized diabetes care and education, not replace. We know that there is a shortage of behavioral health specialists that are knowledgeable about diabetes, however, professional organizations have taken steps to try and increase the number of qualified individuals. Also, certified diabetes care & education specialists (previously known as certified diabetes educators) are also well-equipped to address the behavioral health needs of people with diabetes and their families.
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