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

Summary

This is the largest published study of sustained nutritional ketosis as a T2D management strategy. The Virta Health study enrolled 349 adults with type-2 diabetes — 262 in the continuous care intervention (CCI, an app-mediated remote-care program with macronutrient guidance toward sustained nutritional ketosis) and 87 in usual care. The design was open-label and non-randomized (participants self-selected into the intervention), so it sits below DiRECT's RCT evidence in the hierarchy — but the sample is larger and the duration is longer. At one year, the intervention group's HbA1c fell from 7.6 to 6.3 percent (the threshold for diabetes remission), mean weight loss was 13.8 kg, and 94 percent of insulin users reduced or eliminated insulin therapy. Sulfonylureas were discontinued completely in the CCI group. Secondary markers improved across the board: HOMA-IR dropped 55 percent, hsCRP dropped 39 percent, triglycerides dropped 24 percent, HDL-C rose 18 percent. The usual-care arm showed no meaningful change on any of these endpoints.