Question / Intervention Goal / Objectives
Virta Health offers a continuous remote care intervention to people living with type 2 diabetes. Participants adhere to a carbohydrate-restricted nutritional protocol, and, via a mobile app, receive daily monitoring and supervision by a health coach as well as a board-certified physician. The interaction with the program – daily or more often in the early stages – ensures that medical management is continuous, and as participants’ metabolism changes, the physicians quickly deprescribe medications.
Two non-randomized clinical trials were reviewed: Hallberg et al, Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study, Diabetes Therapy (2018) 9:583 – 612; and Athinarayanan et al, Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial, Frontiers in Endocrinology (2019) 10:348. These studies focused upon changes in various laboratory tests, ranging from weight and blood glucose to blood cholesterol and liver enzymes.
Participants were recruited and voluntarily enrolled in the Virta Health program or the comparison group, which consisted of patients referred to a diabetes education program by their physician. Patients’ data were assigned to their original group, even if they dropped out. Both groups had lab values assessed at baseline, at one year and at two years. Intent-to-treat analyses with methods for handling missing data, as well as completers analyses, were performed. Statistical adjustments were made to account for differences between the two groups’ baseline characteristics.
Findings / Metric/ Outcome/ Savings
The table below lists selected measures and the amount of improvement that program participants achieved. Data is not shown for the Usual Care comparison group because no significant change was observed.
The statistical methods used in both studies sought to adjust for baseline differences between Virta Health program participants and usual care participants, but the groups may vary in ways that cannot be measured.