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.
Level 3 - non-randomized controlled study
Open-label, non-randomized controlled trial with a concurrent control group.
PubMed 31231311 · doi:10.3389/fendo.2019.00348
What was done
An open-label, non-randomized controlled trial evaluated 349 adults with type 2 diabetes assigned to either a digitally monitored continuous care intervention (CCI) providing nutritional ketosis support (n = 262) or usual care (UC, n = 87). Primary outcomes assessed at 2 years were program retention, glycemic control, and weight change. Secondary outcomes included body composition, bone mineral density, liver, cardiovascular, kidney, thyroid, and inflammatory markers, as well as diabetes medication usage.
What was found
In intent-to-treat analyses at 2 years, the CCI group demonstrated statistically significant improvements (all reported p < 0.00012) in HbA1c, fasting glucose, fasting insulin, weight, systolic and diastolic blood pressure, triglycerides, alanine transaminase, and HDL-C. Spine bone mineral density in the CCI group was unchanged. Overall non-metformin diabetes medication use fell from 55.7% to 26.8% in the CCI group, including a 62% reduction in insulin and complete elimination (100% reduction) of sulfonylureas. Diabetes reversal occurred in 53.5% and remission in 17.6% of CCI participants. The UC group showed no significant improvements in these parameters or medication use.
Why it matters
This study shows that a digitally supported nutritional ketosis intervention can sustain improvements in glycemic markers and body weight for up to two years while dramatically reducing reliance on diabetes medications.
Limits
The non-randomized, open-label design introduces substantial risk of self-selection and confounding bias between the intervention and usual care cohorts. The abstract reports percentage reductions and p-values but lacks absolute baseline and 2-year mean values for primary metabolic endpoints.
Cited by
- supports Virta Health has demonstrated the reversal of type 2 diabetes using dietary intervention alone in clinical trials.