A smartphone-based app designed to deliver cognitive behavioral therapy (CBT) to adults with type 2 diabetes received marketing approval as a class II medical device from the US Food and Drug Administration (FDA) on July 10, becoming the first digital behavioral therapeutic device for people with diabetes to receive this designation for US patients.
Better Therapeutics representatives said that the app, formerly known as BT-001, will be called AspyreRX, with US sales planned to launch in October-December 2023.
The app will be available to patients exclusively by prescription, with a planned 90-day use duration and an option for a second 90-day prescription. A company official said the price per prescription will be about $500-800 although this is not yet finalized. The app is intended for use in concert with the conventional pillars of glycemic control in people with type 2 diabetes: lifestyle modification and treatment with antidiabetes medications.
Senior staff members of Better Therapeutics acknowledged the critical need for an education program, which they will now launch for clinicians, payers, and patients to get across the message of the potential benefit and safety associated with using the CBT app. Their initial marketing will target patients with type 2 diabetes and poorly controlled A1c levels in five to six US regions with high numbers of these patients. The company will also attempt to make the app available through the US Department of Veterans Affairs health system and try to secure coverage by Medicare and commercial health-insurance providers.
Approval Based on Pivotal Trial Results
The FDA approval focused on data collected in the BT-001 randomized, controlled trial, which included 669 US adults with poorly controlled type 2 diabetes. Results, published in 2022 in Diabetes Care, showed that after 90 days, people using the app had an average incremental reduction in A1c of 0.39 percentage points compared with control patients who didn’t use the app, the primary endpoint. Use of the app also appeared safe.
Subsequent meeting presentations of study findings, as reported by Medscape Medical News, showed that A1c-lowering linked with app use was durable during continued use for a total of 180 days, that the effectiveness of the app in helping to lower A1c levels was “dose-dependent” relative to the number of lessons a person completed, and that using the app significantly linked with a reduced need for intensified glycemic control through added medications.
Another finding of the extended-use phase of the study was that 81% of patients assigned to the app-using group continued to regularly use the app after 180 days, a level of durable engagement by patients that “exceeded our expectations,” said Diane Gomez-Thinnes, chief commercial officer of Better Therapeutics, during a press conference.
The company plans to tweak the app prior to its launch based on additional analyses of results from the pivotal study to further improve patient engagement and app ease of use. The company is also planning to expand the range of smartphones that can support the app, although about 90%-95% of US smartphones have this capability.
Better Therapeutics is also actively developing and testing other modifications to the basic CBT app to make it usable by people with other cardiometabolic disorders such as hypertension, obesity, and fatty liver disease.
The BT-001 study was funded by Better Therapeutics.
Mitchel L. Zoler is a reporter for Medscape and MDedge based in the Philadelphia area. @mitchelzoler
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