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FDA Authorizes First Digital Therapy App for Type 2 Diabetes Management

Published: 8/14/23 2:10 pm
By Eliza Skoler

A woman uses an app on her phoneAspyreRx is a new behavioral therapy app that helps adults manage type 2 diabetes. It's the first digital prescription service to offer cognitive behavioral therapy through a smartphone.

Cognitive behavioral therapy (CBT) is a common psychological treatment that helps people improve their mental health. It may be especially beneficial for people with diabetes, who deal with added stressors of living with a chronic condition like health anxiety, depression, and diabetes distress.

AspyreRx, a behavioral therapy app recently authorized by the FDA, is the first treatment of its kind to provide CBT to people with diabetes through a smartphone. Used as a supplementary treatment to regular diabetes care, AspyreRx has been shown to improve both mental and physical well-being.

What is AspyreRx and how does it work?

Better Therapeutics’ AspyreRx is a prescription-only, digital therapy app designed to help adults with type 2 diabetes learn and sustain lifestyle changes that help balance glucose levels and boost mood. 

The app uses behavioral learning modules and skill-based exercises to target psychological, behavioral, and cognitive factors that can make type 2 diabetes difficult to manage. For example, the program addresses concepts and beliefs about diabetes, food types, and exercise. 

Healthcare professionals may prescribe AspyreRx to support self-directed diabetes management between clinic visits. People can use the app at their own pace and can access CBT lessons at any time via a smartphone. The goal of CBT is to rework patterns and pathways in the brain to make positive, long-term behavioral changes possible. 

Traditionally in CBT, people work one-on-one with a therapist. Of course, in-person treatments have their benefits, but depending on your health insurance and personal circumstances, therapies like CBT can be expensive, time-consuming, and hard to stick with.

Using AspyreRx, the user can work at their own pace. It works by creating a CBT-based treatment plan based on information the user provides about their diabetes beliefs and behaviors, such as nutrition, exercise, glucose levels, blood pressure readings, and more. 

What the research says about AspyreRx

The app was tested in a randomized, controlled trial of adults with type 2 diabetes who had A1C levels between 7-11%. The study group included participants who were 28% Black, 4% Asian, 14% Latino, and 61% white subjects. Roughly 55% were women, 40% of subjects did not have a college degree, and the median annual household income was $68,000.  

Participants were randomly assigned AspyreRx or a control app, alongside their standard diabetes care. The main findings from the study showed:

  • People using AspyreRx had significantly lower A1C levels after 90 days – a 0.28 percent decrease in A1C compared to a 0.11 percent increase in the control group. 

  • The reduction in A1C lasted between days 90 and 180. At day 180, half of AspyreRx participants saw a meaningful improvement in A1C with a reduction of 0.4% or more, with a 1.3% average decrease among these individuals. This indicates that digital therapy may have played a role in helping people maintain stable blood sugar levels over time.

  • The more people used the app and completed learning modules, the more their A1C lowered.

  • People using AspyreRx also saw improvements in fasting glucose levels, blood pressure, weight, mood, and quality of life compared to the control group. 

  • While the results of the study are promising, further research in diverse groups is needed to get a clearer picture of how effective digital CBT therapy is for diabetes management, especially among populations with limited access to care.

Overall, the results indicate the important role that mental health care plays in diabetes treatment and that CBT delivered digitally may be an effective tool for clinical change.

What does this mean for diabetes care?

Digital CBT makes mental health care much more accessible to people with type 2 diabetes, teaching behavioral and psychological strategies to better manage blood sugar levels (in conjunction with diabetes medications) from the comfort of home. 

“Trying to simulate personalized, one-on-one therapy with an app is an ambitious and daunting task,” said Adam Brown, mental health professional and author of “Bright Spots & Landmines.” 

“That said, if it helps people and is affordable and scalable, that is a lovely thing,” he added. “Going to therapy can be transformative, yet we know not everyone can access a mental health professional.”

Type 2 diabetes is considered a progressive condition, meaning that over time without proper treatment, A1C levels increase and overall health declines. While not the be-all-end-all for diabetes treatment, this new mode of CBT opens a window for people to understand and address the deeper factors that may affect their diabetes management. 

This tool may also help people make (and sustain) behavioral changes that can improve overall health and well-being in the long term. If you’re interested in AspyreRx, talk to a healthcare professional – the app is expected to become available later this year. 

Learn more about diabetes and mental health resources here: 

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About the authors

Eliza Skoler joined The diaTribe Foundation in 2019, after graduating cum laude from Carleton College with a degree in Biology. Her undergraduate studies focused on human biology and neuroscience, and... Read the full bio »