Positive Results from Pivotal Trial of Better Therapeutics’ Investigational BT-001 Prescription Digital Therapy for Type 2 Diabetes Published in Diabetes Care
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
“When we saw the complete results from this trial at both the 90- and 180-day endpoints, we were encouraged by the real and tangible potential of using our investigational, digitally-delivered CBT to help people with type 2 diabetes gain more control over their condition,” said Dr.
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
“When it comes to cardiometabolic diseases like type 2 diabetes, available treatments have been focused on improving biomarkers alone, like glucose, rather than helping to address the underlying behaviors which lead to the onset and inevitable progression of disease,” said Dr.
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 (CBT). 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.
About the Better Therapeutics CBT Platform
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.
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Certain statements made in this press release are "forward-looking statements" within the meaning of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements in this press release include, but are not limited to, statements regarding the results of the completed trial of BT-001 in patients with type 2 diabetes, Better Therapeutics’ plans and expectations regarding FDA submissions and the potential for marketing authorizations, expectations related to the potential benefits of BT-001 and CBT and their potential treatment applications, Better Therapeutics’ plans regarding the research and advancement of its product candidates for additional treatments and expectations related to the interest of healthcare providers and payers in PDTs, among others. These forward-looking statements are based on the current expectations of the management of
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