PREDICTS Trial Meets Primary and Secondary Endpoints,
Demonstrates Omada’s Program Delivers Meaningful Clinical Outcomes
San Francisco, CA (November 3, 2020) — Outcomes of the Preventing Diabetes with Digital Health and Coaching for Translation and Scalability (“PREDICTS”) Randomized Controlled Trial (“RCT”) presented at ObesityWeek® Interactive demonstrate Omada Health’s Digital Diabetes Prevention Program (d-DPP) achieved a statistically significant and clinically meaningful improvement in Hemoglobin A1c reduction and weight loss over a 12-month period.
The PREDICTS trial randomized 599 individuals with prediabetes to the Omada d-DPP or a single session diabetes prevention class. The Omada group received weekly sessions, lifestyle coaching, virtual peer support and behavior tracking tools for 12 months. The primary and secondary endpoints of the study were to detect changes in HbA1c and body weight at 12 months. Jeffrey Katula, PhD, Associate Professor of Health and Exercise Science at Wake Forest University and the study’s co-Principal Investigator, presented the PREDICTS outcomes. The study endpoints of the trial were met and the intention-to-treat analysis revealed the following:
- Omada participants on average reduced Hemoglobin A1c (HbA1c) by 0.23% at 12 months, a significantly greater reduction than the 0.15% seen in the comparison group (p-value<0.01);
- Fifty-eight percent of Omada participants reduced their HbA1c to the normal range one year after beginning the program, versus 48% of the comparison group (p-value<0.04);
- Omada participants achieved an average weight loss of 5.4% one year after enrollment, compared to 2% weight loss in the comparison group (p-value<.01);
- Forty-four percent of Omada participants achieved weight loss of 5% or greater, versus 21% of comparison group participants (p-value<.01);
- Among Omada participants in the study, age 65 and older:
- Average HbA1c reduction was 0.28% at one year, significantly greater than the 0.14% reduction in the comparison group (p-value<.05); and
- Average weight loss at 12 months was 6.1%, significantly greater than the 2.1% weight loss seen in the comparison group (p-value<.05).
“To our knowledge, this is the largest RCT to test a digital diabetes prevention program,” added Dr. Katula. “The results clearly demonstrate the clinical effectiveness of the Omada program, and compare quite favorably to other studies of digital approaches to diabetes prevention. Our results should certainly inform policy decisions regarding the rapidly changing world of digital preventive health at a time when remote delivery of services is essential.”
“The PREDICTS data definitively prove that the Omada Digital Diabetes Prevention Program achieves clinically meaningful outcomes,” said Dr. Cynthia Castro Sweet, Senior Director of Clinical Research for Omada. “We gave our program the most difficult test - a randomized controlled trial - and the results speak for themselves. I couldn’t be more proud of Omada for sponsoring a study with this degree of scientific rigor and integrity.”
“To be taken seriously as a health care provider, digital companies must prove using gold standard methods that their services deliver clinically meaningful outcomes,”said Omada CEO and Co-Founder Sean Duffy, “We are proud to be the first, and only, company in our space to invest in a trial of this magnitude that shows sustained, meaningful outcomes.”
The PREDICTS study population was recruited from the greater Omaha region of Nebraska via the University of Nebraska Medical Center (UNMC). The UNMC team, led by co-Principal Investigator Dr. Paul Estabrooks, conducted all data collection, while scientists with Dr. Katula’s Wake Forest team conducted the evaluation and analysis. All study participants were 19 years of age or older, with confirmed HbA1c values indicative of prediabetes. The average age of the study population was 55 years old, with 26% of the total population over the age of 65. Intention-to-treat analyses were performed on all study endpoints, using data from all participants enrolled in the study.
About Omada Health
Omada Health is a digital care provider that empowers people to achieve their health goals through sustainable behavioral change. Working with health plans, employers, and health systems, the company delivers personalized interventions for individuals dealing with chronic conditions, musculoskeletal issues, anxiety, and depression. Combining data-powered human coaching, connected devices, and curriculum tailored to an individual’s specific conditions and circumstances, Omada has enrolled more than 400,000 participants across all 50 states. Omada partners include Cigna, Kaiser Permanente, Blue Cross Blue Shield Minnesota, and other leading health plans.