SAN FRANCISCO – Omada Health has announced the largest-ever randomized controlled trial of diabetes prevention using a virtual program.
In collaboration with researchers from Wake Forest University and the University of Nebraska Medical Center, the PREDICTS (Preventing Diabetes With Digital Health and Coaching for Translation and Scalability) trial will include some 500 participants with verified clinical eligibility for Omada’s Centers for Disease Control-recognized diabetes prevention program.
“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 health care interventions,” said Sean Duffy, co-founder and CEO of Omada Health, in a statement. “The PREDICTS trial is the next step in that evolution—it will track a range of health care and other outcomes, while establishing the highest level of clinical evidence for the effectiveness of a digitally-delivered intensive behavioral counseling 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 blood sugar levels, the PREDICTS trial will track the impact of the Omada program on quality of life, stress levels and health care utilization. This will be the first time many of these measures are tracked in a randomized controlled trial of a digitally delivered DPP, said Duffy.
“Even with the research to date in published literature, there is still some debate about the efficacy of virtual programs,” said Cynthia Castro Sweet, clinical research director at Omada Health, in a statement. “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.”