Better Therapeutics, Inc. announced it has completed the enrollment of 1,000 participants across two studies as part of its ongoing clinical program to evaluate the long-term effectiveness of AspyreRxTM (formerly BT-001). AspyreRx received FDA authorization in July 2023 as the first PDT to deliver Cognitive Behavioral Therapy (CBT) to treat adults with type 2 diabetes (T2D). Better Therapeutics' ongoing clinical studies are designed to assess the long-term effectiveness of AspyreRx in diverse populations, as measured by change in HbA1c, and safety, as measured by severity and frequency of adverse events.

The impact on medication use and healthcare utilization one year after beginning treatment with AspyreRx will also be evaluated, along with an advanced understanding of patient engagement patterns in a real-world setting. In addition, these studies intend to inform the durability of this digital therapeutic intervention. Participants have been enrolled across Colorado Prevention Center (CPC), affiliated with the University of Colorado Anschutz Medical Campus, the Durham Veterans Association (VA) Health Care System, Ascension DePaul, and Mass General Brigham (MGB).

All enrolled participants have been randomized and on-boarded onto AspyreRx or a control app. Depending on adequate power, Better Therapeutics plans to share initial 6-month data by the end of 2023. This initial readout is expected to be followed by additional data releases in 2024.