5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study.
Level 3 - non-randomized controlled study
Non-randomized, open-label cohort extension study
PubMed 39433217 · doi:10.1016/j.diabres.2024.111898
What was done
Participants with type 2 diabetes initially enrolled in a 2-year, open-label, non-randomized study comparing a telemedicine-delivered continuous care intervention (CCI) for a very low-carbohydrate diet with nutritional ketosis against usual care. At 2 years, 194 of 262 CCI participants were approached for a 3-year extension; 169 consented and 122 completed the 5-year follow-up. Primary outcomes were changes in diabetes status (remission and HbA1c < 6.5% on no glucose-lowering medication or metformin only) assessed via McNemar's test, along with linear mixed-effects modeling of body mass, glycemia, and cardiometabolic markers from baseline to 5 years.
What was found
Among the 122 five-year completers: - Diabetes remission was achieved by 20.0% (n = 24), with sustained remission observed over 3 years in 15.8% (n = 19) and over 4 years in 12.5% (n = 15). - Reversal to HbA1c < 6.5% without medication or with metformin only occurred in 32.5% (n = 39). - Significant sustained changes from baseline included body mass (-7.6%), HbA1c (-0.3%), triglycerides (-18.4%), and HDL-C (+17.4%), alongside improvements in inflammatory markers. - No significant changes were observed in LDL-C or total cholesterol.
Why it matters
This study provides evidence that a continuous remote care model using nutritional ketosis can support multi-year retention and sustain diabetes remission and cardiometabolic improvements for up to five years in a subset of patients.
Limits
The study was non-randomized and open-label. Data at 5 years represent a completer cohort analysis (122 of the original 262 CCI participants, reflecting substantial attrition and self-selection bias), and the abstract provides no 5-year comparative outcome data for the usual care group.
Cited by
- supports Virta Health has demonstrated the reversal of type 2 diabetes using dietary intervention alone in clinical trials.