New top-line data presented by Omada Health and researchers from the University of Nebraska Medical Center and Wake Forest University suggest that the chronic condition-management company's digital diabetes-prevention program can deliver clinically meaningful blood sugar reduction and weight loss over 12 months.

The PREDICTS randomized controlled trial was first announced in 2018, and enrolled nearly 600 adults with confirmed prediabetes living in Nebraska's greater Omaha region, according to an abstract presented this week at the Obesity Society's ObesityWeek virtual conference and additional information relayed by the company through a press release.

Omada and its research partners say that this now represents the largest and longest such trial conducted on a digital diabetes prevention program to date – although a representative of the company told MobiHealthNews that plans to eventually publish the Omada-funded study's full data in a peer-reviewed journal are still "pending." 

“To be taken seriously as a health care provider, digital companies must prove using gold standard methods that their services deliver clinically meaningful outcomes,” Sean Duffy, Omada CEO and cofounder, said in a statement. “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.”

TOP-LINE DATA

Eighty-one percent of the 599 individuals enrolled and randomized to receive completed the full trial.

Twelve-month average HbA1c reduction was significantly greater among those who received Omada's digital program (-0.23% versus -0.15%, p < .01), as was the 12-month average reduction in body weight (-5.4% vs. -2.0%, p < .01).

The researchers saw similar trends when measuring the proportion of participants in each study group with clinically meaningful reductions: 58% versus 48% for HbA1c (p < .04), and 44% versus 21% for body weight (p < .01).

While the average age of study participants was 55 years, 26% of the study population was over the age of 65. According to the company, the digital program continued to show benefits within this high-risk group as well – average HbA1c dropped -0.28% after 12 months in the intervention group compared to -0.14% in the comparison group (p < .05), while average 12-month weight loss was -6.1% versus -2.1% (p < .05).

“The results clearly demonstrate the clinical effectiveness of the Omada program, and compare quite favorably to other studies of digital approaches to diabetes prevention," Jeffrey Katula, associate professor at Wake Forest University and co-principal investigator of the study, said in a statement provided by Omada. "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.”

HOW IT WAS DONE

The researchers enrolled participants aged 19 years or older with documented prediabetic HbA1c values through the University of Nebraska Medical Center, which headed up recruitment and data collection for the 12-month trial. Outside of age and geographic location, no demographic information regarding the study population was included in the abstract or press release.

The PREDICTS study's primary and secondary endpoints were HbA1c and body-weight reduction, and were accompanied by an intention-to-treat analysis conducted by the Wake Forest University team.

The intervention was enrollment into Omada's Digital Diabetes Prevention Program, which includes weekly sessions, lifestyle coaching, peer support and behavior tracking, all delivered through the digital platform. The comparison group, meanwhile, received a small-group, single-session diabetes prevention class.

At the time of launch, Omada said that that the trial would also be monitoring uptake characteristics, such as patients' quality of life, healthcare utilization and the study staff's perceptions of implementation. Those information were not included in today's releases.

THE LARGER TREND

Outcomes of the PREDICTS study come just a couple months after Omada shared early data on its diabetes management program collect through Evidation Health's research platform. This effort – which is slated to be published in full later this year – monitored 195 participants with Type 2 diabetes between November 2019 and July 2020, and saw reductions in average HbA1c from baseline.

Earlier in the year also saw the full publication of a study suggesting that a modified version of the digital diabetes-prevention program had some level of impact on low-income patients, more than half of whom were Hispanic/Latino. While those enrolled achieved weight loss at six and 12 months, HbA1c levels generally remained stagnant through the full course of the study.

Beyond Omada, other digital health names providing CDC-recognized digital diabetes prevention programs include Livongo, Welldoc and Lark Health.