Omada Health Launches “PREDICTS” Clinical Trial
Digital Therapeutics Leader launches largest-ever Randomized Control Trial of Virtual Diabetes Prevention with researchers from University of Nebraska Medical Center and Wake Forest
San Francisco, CA (January 29, 2018) -- Building on nine peer-reviewed publications to date, and continuing to raise the bar for clinical evidence generation in digital health, Omada Health today announced the largest-ever randomized controlled trial of diabetes prevention with a virtual program. Collaborating with leading researchers from Wake Forest University and the University of Nebraska Medical Center (UNMC), the PREDICTS (“Preventing Diabetes With Digital Health and Coaching for Translation and Scalability”) trial will include approximately 500 participants with verified clinical eligibility for Omada’s CDC-recognized diabetes prevention program.
Participants will be recruited at UNMC, then randomly assigned to either the Omada Program or UNMC’s current clinical practice. During the trial, UNMC will lead data collection and study the implementation process, while researchers at Wake Forest will be responsible for data system management, quality operational reports, evaluation, and analysis. Omada will run the experimental arm of the trial and provide engagement and outcome data for analysis.
In addition to tracking weight loss and reduction in A1c blood sugar levels, the PREDICTS trial also will track the impact of the Omada program on participants’ quality of life, stress levels, and healthcare utilization, among other measures. This will be the first time many of these measures are tracked in a randomized controlled trial of a digitally-delivered DPP.
“Our goal at Omada has been to continually set new standards for what the industry should expect when it comes to the effectiveness of digital healthcare interventions,” said Omada co-founder and CEO Sean Duffy. “The PREDICTS trial is the next step in that evolution -- it will track a range of healthcare and other outcomes, while establishing the highest level of clinical evidence for the effectiveness of a digitally-delivered intensive behavioral counseling program.”
Omada’s Clinical Research Director Cynthia Castro Sweet, PhD, who is leading the trial from the company end, added “Omada holds itself to rigorous scientific standards because it’s what is right for our customers, participants, and the field of digital health. Even with the research to date in published literature, there is still some debate about the efficacy of virtual programs; the outcomes of the PREDICTS trial should help resolve these concerns and move policy towards accepting digital DPP as a proven, evidence-based and effective means to reduce risk for costly chronic diseases.”
Leading the PREDICTS trial will be academic experts with deep experience in diabetes prevention, including:
- Paul A. Estabrooks, PhD, the Harold M. Maurer Distinguished Chair for Health Promotion in the Social and Behavioral Health Department at the University of Nebraska Medical Center. Dr. Estabrooks has led a number of large trials examining how diabetes prevention and weight management interventions can be implemented and taken to scale in community and clinical settings.
- Jeffrey Katula, Associate Professor in the Department of Health and Exercise Science at Wake Forest University. Dr. Katula led the “Healthy Living to Prevent Diabetes” (HELP PD) project at Wake Forest, intended to translate clinical literature on DPP into community practice.
“I’ve been working in the diabetes prevention community for years,” said Dr. Katula. “The goal has always been to find ways to translate the academic work on this intervention into clinical and community practice while maintaining outcomes and data integrity. The PREDICTS trial will move the field ahead in our ability to do that.”
Dr. Estabrooks added, “What’s really exciting about this clinical trial is that we also are studying how best to integrate effective, scalable preventive services, especially digitally-enabled ones, into typical clinical practice. In fact, we’ll be able to shed some light on strategies that will really speed the translation of high-quality, research-tested diabetes prevention interventions into sustained clinical practice.”
