The report is a product of the VA/HSR&D Evidence Synthesis Program.
Evidence Brief: Virtual Diet Programs for Diabetes
One in four Veterans has some form of diabetes, which is twice the rate seen in the general U.S. population. Type 2 diabetes is the most common form of diabetes and is thought to be primarily caused by excess weight. While there is widespread consensus that maintaining a healthy diet is a key part of diabetes management, there is no consensus on the ideal diet for diabetes. In recent years, the ketogenic diet has become an increasingly popular option for people looking to lose weight, including those with type 2 diabetes; however, there is a lack of data on its long-term effects and harms. Virtual tools can help patients with diabetes with the burdensome process of tracking information related to their health, including diet. One such virtual diabetes program – Virta Health – is an online platform that delivers a suite of services related to diabetes management, including nutrition and behavioral counseling focused on the ketogenic diet, as well as education, coaching, and management of medications (i.e., titration of medications based on biomarker tracking).
The ketogenic diet is a low carbohydrate, high-fat diet, where approximately 70% of an individual’s calories come from fat, 20% from protein, and 10% or less from carbohydrates.
In 2019, VA initiated a pilot project in which 400 Veterans with type 2 diabetes were given access to the Virta Health program. On its website, Virta claims that 84% of Veteran patients on the Virta treatment for 90 days achieved glycemic outcomes below the diabetes threshold or at least a one point drop in HbA1c. However, data from Virta’s VA pilot project have not been published in a peer-reviewed journal, so this claim cannot be verified.
This evidence brief sought to evaluate the effectiveness and harms of Virta Health and other virtual diet programs for type 2 diabetes that include a coaching component. Investigators with VA’s Evidence Synthesis Program (ESP) Coordinating Center in Portland, OR searched the literature, including MEDLINE, CINAHL, and the Cochrane Central Register of Controlled Trials, from January 2015 through April 2020. Among 622 potentially relevant citations, investigators included 15 studies (9 randomized controlled trials, 1 non-randomized controlled trial, 3 single-arm longitudinal studies, and 2 pre-post studies) that evaluated 14 virtual diabetes diet programs with a coaching component. These virtual programs are: ANODE, Better Therapeutics, DiabMemory + Nutrinaunt, GlycoLeap, Low Carb Program, My Dietitian, Noom Coach, Our Path (Second Nature), TeLiPro, u-Healthcare, Virta Health, and three unnamed programs.
Summary of Findings
Although the single, non-randomized controlled study of Virta had important limitations, overall findings suggest that for some patients (i.e., those who are severely obese, interested in an intensive diabetes management program, and willing to adhere to the ketogenic diet), participation in Virta Health is associated with clinically meaningful improvements in diabetes outcomes including weight and HbA1c at 10 weeks. Some participants also stopped taking medications and reversed their diabetes. These outcomes were maintained for up to two years in patients who continued to participate in the intervention. Three other programs (TeLiPro, Low Carb Program, and Better Therapeutics), all of which delivered a named diet (meal replacement, low carb, plant-based), were associated with a clinically significant improvement in two diabetes outcomes (lowering HbA1c >.5%, weight loss >5%, and/or diabetes medication cessation) between three months and one year after initiation. Participants in two of these programs (TeLiPro and Low Carb Program) maintained improvements for one year (in TeLiPro the intervention ended at 12 weeks, and in the Low Carb Program the intervention continued for a year).
Although benefits were more limited, six other virtual diet programs (u-Healthcare, Our Path, GlycoLeap, Noom Coach, and two unnamed programs) were associated with a clinically meaningful improvement in one diabetes-related outcome (either lowering HbA1c >.5% or weight loss > 5%). In the Noom Coach study, more people reversed diabetes (i.e., reduced HbA1c below the 6.5% diagnostic threshold) in the intervention group than the control group.
Data on harms were sparse. Only studies of Virta Health, Better Therapeutics, and Noom Coach reported that no severe or serious treatment-related harms occurred.
Due to limitations in study designs, investigators could not determine whether outcomes were driven by the remote care interventions or by the diets. Additionally, because studies enrolled participants who were interested in intensive diabetes management programs and met other study eligibility criteria, findings may not apply to the wider, unselected Veteran population.
Implications for VA
As Veterans’ preferences for the type of diet they follow are likely to vary, a practical solution to improving diabetes care should include testing a variety of diet options if the individual’s particular diet is not the critical component of the intervention. This type of evaluation could inform how Virta Health and other virtual diabetes programs might be adapted to meet the needs of a variety of Veterans with type 2 diabetes.
Research Gaps/Future Research
As health systems like VA begin to implement virtual diabetes programs, evaluations should emphasize creation of appropriate control arms; ensuring comparable long-term follow-up data; and attention to possible harms. Since evidence isn’t clear which features of programs are most critical, a health system also might wish to compare virtual programs delivering different types of diets.
Veazie S, Vela K, Helfand M. Evidence Brief: Virtual Diet Programs for Diabetes. VA ESP Project #09-199; 2020.
To view the full report, go to http://www.hsrd.research.va.gov/publications/esp/publications/esp/virtual-diet-brief.cfm
ESP is currently soliciting review topics from the broader VA community. Nominations will be accepted electronically using the online Topic Submission Form. If your topic is selected for a synthesis, you will be contacted by an ESP Center to refine the questions and determine a timeline for the report.
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