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Clinical Trial
. 2022 Aug;45(8):850-856.
doi: 10.1002/clc.23853. Epub 2022 Jul 1.

Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale, design, and baseline characteristics of a randomized, controlled trial

Mario Enrico Canonico  1   2 , Judith Hsia  1   2 , Nicole L Guthrie  3 , Martha Simmons  3 , Prapti Mehta  3 , Paul Lupinacci  3 , Kate Edwards  3 , Kara Mosesso  3 , Michelle Gearhart  3 , Aleksandar Skuban  3 , Marc P Bonaca  1   2 , Mark A Berman  3
Affiliations
Clinical Trial

Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale, design, and baseline characteristics of a randomized, controlled trial

Mario Enrico Canonico et al. Clin Cardiol. 2022 Aug.

Abstract

Background: The prevalence of type 2 diabetes (T2D) continues to rise in the United States and worldwide. Cognitive behavioral therapy (CBT) has been shown to improve glycemic control in patients with T2D, but broad implementation has been limited by inherent access and resource constraints. Digital therapeutics have the potential to overcome these obstacles.

Hypothesis: To describe the rationale and design of a trial evaluating the efficacy and safety of a digital therapeutic providing CBT to improve glycemic control in adults with T2D.

Methods: This randomized, controlled, multicenter, Phase 3 trial evaluates the hypothesis that BT-001, an investigational digital therapeutic intended to help patients with T2D improve their glycemic control, on top of standard of care therapy, will lower hemoglobin A1c (HbA1c) compared to a control app across a broad range of patients in a real-world setting. The study is designed to provide evidence to support FDA review of this device as a digital therapeutic. The intervention is provided within the digital application (app) and includes no person-to-person coaching. The primary endpoint is the difference in HbA1c change from baseline to 90 days for BT-001-allocated subjects compared with those assigned to the control app. Safety assessment includes adverse events and adverse device effects. The study incorporates pragmatic features including entirely remote conduct with at-home visits for physical measures and blood sample collection.

Conclusions: This randomized, controlled trial evaluates a cognitive behavioral intervention delivered via smartphone app which has the potential to provide a scalable treatment option for patients with T2D.

Keywords: behavior change; digital therapeutics; type 2 diabetes.

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Conflict of interest statement

N. L. Guthrie, M. Simmons, P. Mehta, P. Lupinacci, K. Edwards, K. Mosesso, M. Gearhart, A. Skuban, and M. P. Bonaca are employees of Better Therapeutics and own stock in the company. Drs. M. E. Canonico, M. P. Bonaca, and J. Hsia receive salary support from CPC, a nonprofit academic research organization affiliated with the University of Colorado, that receives research grant/consulting funding from: Abbott, Agios, Alexion Pharma, Alnylam, Amgen, Angionetics, ARCA Biopharma, Array, AstraZeneca, Atentiv, Audentes, Bayer, Better Therapeutics, Brigham and Women's Hospital, Bristol‐Myers Squibb, Cardiol Therapeutics, CellResearch, Cook Medical, Cook, CSL Behring, Eidos Therapeutics, EP Trading Co., Esperion Therapeutics, EverlyWell, Faraday, Fortress Biotech, HDL Therapeutics, Heartflow, Hummingbird Bioscience, Insmed, Janssen, Kowa Research, Lexicon, Merck, Medtronic, Moderna, Novate Medical, NovoNordisk, Pfizer, PhaseBio, PPD Development, Prairie Education and Research, Prothena Biosciences, Regeneron, Regio Biosciences, Sanifit Therapeutics, Sanofi, Smith and Nephew, Stealth BioTherapeutics, University of Colorado, University of Pittsburgh, Worldwide Clinical Trials, Wraser, Yale Cardiovascular Research Group. Dr. J. Hsia also reports owning AstraZeneca stock and Dr. M. P. Bonaca reports salary support from an AHA SFRN under award numbers 18SFRN3390085 (BWH‐DH SFRN Center) and 18SFRN33960262 (BWH‐DH Clinical Project). Dr. Bonaca also reports stock in Medtronic and Pfizer and consulting fees from Audentes.

Figures

Figure 1
Figure 1
Study schema. BL, baseline; BMI, body mass index; DM, diabetes mellitus; HbA1c, hemoglobin A1c.
See this image and copyright information in PMC

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