Prescription Digital Behavioral Therapeutic for Type 2 Diabetes Wins FDA Marketing Clearance

The US Food and Drug Administration this week authorized marketing for AspyreRx™, the first prescription-only digital therapeutic (PDT) treatment indicated to provide cognitive behavioral therapy (CBT) to patients aged ≥18 years with type 2 diabetes (T2D).¹

The AspyreRx software program, delivered through an app on an individual's smartphone, is intended to serve as an adjunct to standard of care for patients with T2D under the care of health care professional. Marketing authorization was awarded to Better Therapeutics, Inc,¹ and the company expects commercial launch of the device in the final quarter of 2023.

Clinicians prescribe the program in increments of 90 days during which the proprietary CBT is delivered in a weekly step-by-step sequence that includes therapy, skills building, and goal setting and tracking. Each step expands on the one prior to reinforce the links between cognitive and behavioral change and improvements in glycemic control.¹ CBT is a well-established form of psychological treatment that helps individuals identify and change maladaptive thought patterns.

Phase 3 data

The FDA's marketing authorization was based on data from a phase 3 randomized clinical trial (ClinicalTrials.gov Identifier: NCT04886388) that enrolled 669 adults with T2D and HbA1c of 7% to <11%.² Mean age was 58 years and half the cohort (54%) were women. Mean baseline HbA1c was approximately 8.0%. Participants were randomly assigned to receive AspyreRx or a control app and all received standard of care. The trial's primary endpoint was mean change in HbA1c from baseline to 90 days.²

Findings at 90 days, according to the study, published in the journal Diabetes Care, showed that HbA1c was significantly lower among participants assigned the AspyreRx app (-0.28%; 95% C, -0.41 to -0.15) compared with those using the control app (+0.11%; 95% CI, -0.02 to 0.23), with the treatment group difference calculated at 0.39% (P<.001).² The investigators also reported a clear dose-response relationship between engagement with the digital therapeutic (number of modules completed) and reductions in HbA1c (P_trend<.001).² At a follow-up at 180 days of use, 1 in 2 participants using the AspyreRx app experienced a mean reduction in HbA1c of 1.3%, according to the study.²

Cardiometabolic measures at the 90-day point also were improved in the AspyreRx arm including reduced fasting plasma glucose, systolic blood pressure, and weight. Participants reported improved mood and quality of life as well. Compared with the control group, medication use was lower in the treatment group and the latter reported fewer diabetes-related risks. Adverse events reported during the study were not attributed to the app.²

At 90 days in the phase 3 study, 94% of participants were using the PDT; at 180 days, 81% were still engaged.

According to Better Therapeutics, the FDA review was through the agency's de novo pathway and this week's authorization creates a new class of diabetes digital behavioral therapeutic devices.

“This regulatory milestone signals a promising future where technology, psychology, and medicine converge to address for the first time the behavioral causes of disease for the 37 million patients living with T2D in the US,” said Frank Karbe, Better Therapeutics chief executive officer. Karbe adds that the de novo authorization provides opportunities to expand the PDT platform to related cardiometabolic diseases.

References

1. Better Therapeutics receives FDA authorization for AspyreRx™ to treat adults with type 2 diabetes. Better Therapeutics. News release. July 10, 2023. Accessed July 14, 2023. https://www.businesswire.com/news/home/20230710624673/en/Better-Therapeutics-Receives-FDA-Authorization-for-AspyreRx%E2%84%A2-to-Treat-Adults-with-Type-2-Diabetes.

2. Hsia J, Guthrie NL, Lupinacci P, et al. Randomized, controlled trial of a digital behavioral therapeutic application to improve glycemic control in adults with type 2 diabetes. Diabetes Care. 2022;45(12): 2976–2981. doi:10.2337/dc22-1099