- A Nebraska hospital is recruiting 500 patients for a study on the effectiveness of a digital diabetes prevention program that includes mHealth interventions.
The University of Nebraska Medical Center will recruit patients for the project, to be run on Omada Health’s digital health platform and analyzed by Wake Forest University.
The PREDICTS (Preventing Diabetes With Digital Health and Coaching for Translation and Scalability) study will focus on weight loss and reduction in HbA1c blood sugar levels through the program, which includes an online support group, digital tracking tools, a weekly behavior change curriculum and health coaches who monitor each participant and reached out to offer virtual support and guidance when needed.
The program is modeled after the National Diabetes Prevention Program (NDPP), a Medicare-covered service beginning this April. The Centers for Medicare & Medicaid Services last year declined to include digital health models in the Medicare DPP because officials said the value of virtual coaching for weight loss hasn’t been proven.
CMS officials have said they will continue to gather evidence on the value of virtual coaching, and may include such a program in a Center for Medicare & Medicaid Innovation (CMMI) demonstration project.
Omada executives say the PREDICTS study builds on nine previous studies and is the largest to date. They’re hoping to convince CMS – and others – to find more value in virtual coaching platforms and mHealth tools.
“Even with the research to date in published literature, there is still some debate about the efficacy of virtual programs,” Cynthia Castro Sweet, PhD, Omada’s Clinical Research Director, said in a press release. “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.”
“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,” added Omada co-founder and CEO Sean Duffy, who’d argued for the inclusion of digital health programs in CMS reimbursement last year. “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.”
Along with weight loss and HbA1c levels, the 12-month study will track the program’s impact on participants’ quality of life, stress and use of healthcare services.
“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,” Dr. 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 and the project’s principal investigator, said in the press release. 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.”
Among the programs developed by Omada is one launched by Humana in 2015.
According to a study published in 2017 in The Journal of Aging and Health, an analysis of some 500 people in Humana’s Medicare Advantage program lost an average of 13 to 14 pounds during 2015; they also saw improvements in cholesterol levels, blood-glucose levels and even moods and self-care.
The study’s authors – a team of researchers from Omada Health and the Louisville, Ky.-based insurer – concluded that a digital health platform directed at overweight seniors could help cut more than $3 billion in Medicare expenditures over 10 years. Those savings would come from a reduction in healthcare services for chronic issues like diabetes, high blood pressure and heart issues.
“Diabetes and obesity are an epidemic among the senior population and, if left unchallenged, threaten to seriously impact quality of life,” Sweet, the study’s lead author, said in a press release. “The results of our research show we now have the tools to fight this epidemic.”