A smartphone app that delivers cognitive behavioral therapy to adults with type 2 diabetes received US FDA marketing approval on July 10, with prescribing and sales slated to start later in 2023.
as a class II medical device from the US Food and Drug Administration 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 controlledlevels in five to six US regions with high numbers of these patients.
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