Medical researchers at two universities are spearheading a clinical trial to test the effectiveness of virtual tools to prevent diabetes.
Launched by the University of Nebraska Medical Center and Wake Forest University in partnership with Omada Health, the study will be the largest single-blind, randomized controlled trial of a digital diabetes program.
Known as PREDICTS (“Preventing Diabetes With Digital Health and Coaching for Translation and Scalability”), the 500-person study will compare the use of online support groups and digital tools used through Omada’s program against a two-hour class hosted by UNMC where participants develop a personal action plan. Wake Forest researchers will be responsible for data systems management, evaluation and analysis.
Participants will be able to access the virtual portions of the program through a laptop, smartphone or tablet and link wearable devices to integrate activity data.
“We're excited about this clinical trial and the ability to study how best to integrate effective, scalable preventive services, especially digitally-enabled ones, into typical clinical practice,” Paul Estabrooks, Ph.D., the study’s co-investigator and chair of health promotion, social and behavioral health at UNMC said in an announcement. “In fact, we'll be able to shed some light on strategies that will speed the translation of high-quality, research-tested diabetes prevention interventions into sustained clinical practice.”
Previous smaller-scale studies have underscored the benefits of technology in preventing and managing diabetes. One startup—Virta Health—has set a goal to reverse Type 2 diabetes in 100 million people by 2025, and earlier this month UnitedHealth launched an initiative that uses wearables and personalized coaching to help Medicare Advantage members manage diabetes.
For Omada, the study offers an opportunity validate a virtual diabetes program that it believes can make a substantial impact on diabetes treatment and prevention. Omada’s Clinical Research Director Cynthia Castro Sweet, Ph.D., said the study will help resolve the lingering debate over the efficacy of of diabetes prevention programs and shift existing policies toward accepting digital interventions as a proven approach.
In November, the Centers for Medicare & Medicaid Services finalized policies to implement the Medicare Diabetes Prevention Program in 2018, allowing Medicare beneficiaries to access evidence-based prevention services. The rule includes a performance-based payment structure, with weight loss as a key indicator of success.