Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT Trial.
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2025-08
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Background
The prevalence of type 2 diabetes continues to rise in the United States and worldwide. Although novel pharmacotherapies have shown benefits, not all patients have access to these medications and of those who do, some are unable to tolerate treatment. Behavior change is long known to be foundational for patients with cardiometabolic disease due to its direct positive impact on health outcomes. Cognitive behavioral therapy delivered by a digital therapeutic has the potential to address access to behavioral therapy for patients with type 2 diabetes.Methods
The BRIGHT (Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy) Trial (NCT05266625) is a randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that AspyreRx improves glycemic control and cardiometabolic measures in patients with type 2 diabetes compared with a control application added to usual care across a broad range of patients in a real-world setting. The current study objectives are to evaluate the efficacy and safety of AspyreRx at 90 and 180 days compared with a control group and to assess the long-term effectiveness, safety, and impact on health care and medication use over long-term follow up.Conclusions
The AspyreRx digital therapeutic is a Food and Drug Administration approved therapy for patients with type 2 diabetes. Although its efficacy for lowering hemoglobin A1C at 90 days was demonstrated, opportunities remain to better understand the long-term effects and the effectiveness and safety in a broader and more diverse real-world environment. BRIGHT is designed to evaluate these questions using a virtual, decentralized, model and include a diverse site mix designed to better understand real-world effectiveness and generalizability.Type
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Canonico, Mario Enrico, Judith Hsia, Frederick A Masoudi, Hayden B Bosworth, Stacy Greene, Bryan C Batch, Natia Hamilton, Thiago B de Araujo, et al. (2025). Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT Trial. Journal of the American Heart Association, 14(15). p. e038737. 10.1161/jaha.124.038737 Retrieved from https://hdl.handle.net/10161/33906.
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Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy
Bryan Courtney Batch
Type 2 Diabetes, Obesity/Overweight, Behavior change, Non-pharmacologic intervention, Health disparities
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