A smartphone app designed to deliver cognitive-behavioral therapy (CBT) to adults with type 2 diabetes was launched in the US on October 16 to patients who have received a prescription for the app from a healthcare provider.
The app, AspyreRx (formerly known as BT-001) received marketing approval from the US Food and Drug Administration in July 2023 and is the first mobile-phone app available that provides CBT to adults with type 2 diabetes.
Better Therapeutics, the company that developed and is marketing the CBT app, said in a news release that a prescription will allow a patient to download and use the app for 90 days. Further product information explains that patients can refill their prescription once for an additional 90 days of use. 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.
The company previously announced that the list price for the app (for each 90-day fill) will be $750. Better Therapeutics also said they have been working with medical insurance companies to try to arrange third-party coverage for all, or part of, the app’s cost. The company said that during the early stage of this launch, when insurance coverage may not yet be available, the company will give patients a discount from the list price.
An Average 0.39% Drop in A1c, Linked to Use Frequency
Evidence for the app’s safety and efficacy came from 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 from baseline in A1c of 0.39 percentage point compared with a control group of 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, 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.
Analyses from the trial showed that during 180 days of app availability, people who used the app fewer than 10 times had an average reduction from baseline in their A1c of less than 0.1 percentage point.
Among those who used the app 10-20 times (a subgroup comprising roughly one third of the people randomized to app use), average A1c reduction increased to about 0.4 percentage point, and among those who used the app more than 20 times, also one third of the intervention group, the average A1c reduction from baseline was about 0.6 percentage point.
“In my view, the app is ready for clinical use,” said Judith Hsia, MD, a cardiologist and professor of medicine at the University of Colorado in Aurora, who served as co–lead investigator for the BT-001 study. Among the attractions of the app are the potentially durable effects of CBT that may persist beyond the period of app availability and a “favorable” safety profile, said Hsia in an interview in 2022.
The BT-001 trial was sponsored by Better Therapeutics. Hsia has received salary support from CPC, a nonprofit academic research organization affiliated with the University of Colorado that receives or has received research grant and consulting funding from Better Therapeutics and from numerous other companies. Hsia also owns stock in AstraZeneca.
Mitchel L. Zoler is a reporter with Medscape and MDedge based in the Philadelphia region. @mitchelzoler
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