A smartphone-based app designed to deliver cognitive-behavioral therapy (CBT) to adults with Type 2 diabetes has received marketing approval as a class II medical device from the US Food and Drug Administration (FDA), 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 to December 2023.
The FDA approval focused on trial data, which included 669 US adults with poorly controlled Type 2 diabetes. Results showed that after 90 days, people using the app had an average incremental reduction in HbA1c of 0.39 percentage points compared with control patients who did not use the app.
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. 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 anti-diabetes medications.
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