5 October 2022 - - US-based prescription digital therapeutics company Better Therapeutics, Inc. (NASDAQ: BTTX) has is highlighting the publication of positive 90 day results from its pivotal trial for BT-001, a potentially first-of-its-kind digital therapeutic platform that is designed to use CBT to treat type 2 diabetes in patients 18 years and older, in the American Diabetes Association -produced, peer reviewed journal Diabetes Care, the company said.

The article published in the latest edition of Diabetes Care details data from the first 90 days of the pivotal trial, which looked at a group of adults with T2D receiving the current standard of care randomized to BT-001 or a control group.

This trial was the largest randomized, controlled study conducted to date looking at use of digitally delivered CBT to improve glycemic control in T2D.

Patients using BT-001 saw A1c lowered on average by 0.4% compared to the control group after 90 days, with a greater reduction among patients who completed more modules of the therapy.

The article concludes that "delivery of a cognitive behavioral intervention via smartphone app can provide a scalable option for improving glycemic control."

In addition to publication in Diabetes Care, the pivotal trial results were recently presented on October 1, 2022 by Dr. Marc Bonaca, Professor of Medicine at the University of Colorado School of Medicine and Executive director of CPC Clinical Research as part of the Society for Vascular Medicine's Annual Scientific Sessions.

The results featured in Diabetes Care as well as the topline 180-day results announced earlier this summer helped support the recent submission of a de novo classification request for BT-001 to the US Food and Drug Administration, which, if authorized, would make BT-001 the first prescription digital therapeutic delivering CBT available for adults with T2D.

The pivotal trial data showed that patients using BT-001 saw encouraging improvement over the current standard of care, with significant and durable A1c reductions at both 90 and 180 days. Exploratory data revealed cardiometabolic improvements as well as lower medication utilization compared to the control group.

BT-001 is Better Therapeutics' investigational prescription digital therapy for the treatment of T2D. The investigational therapy is delivered via software that provides a tailored experience to patients designed to help them address the underlying causes of T2D by making meaningful, sustainable behavioral changes.

The BT-001 investigational therapy is rooted in the well-studied, gold standard of behavioral modification therapies, cognitive behavioral therapy.

While in-person CBT has been used for T2D and other cardiometabolic conditions before, until now the approach has not been scalable due to the need to deliver the therapy via a therapist.

If authorized by FDA, BT-001 would be the first validated, prescription solution for delivering this therapeutic approach to T2D patients at scale, from their digital devices.

Better Therapeutics' investigational digital therapeutic platform is designed to deliver a novel form of CBT to help people with cardiometabolic diseases potentially improve key measures related to T2D, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, hypertension, hyperlipidemia and other cardiometabolic conditions.

By adapting the principles and mechanisms of CBT, the digital therapeutic platform is designed to address and modify the cognitive patterns that affect eating habits and other behavioral factors associated with cardiometabolic diseases.

Better Therapeutics is a prescription digital therapeutics company developing a novel form of cognitive behavioral therapy to address the root causes of cardiometabolic diseases.

The company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for type 2 diabetes, heart disease and other conditions.