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.
The effects of a continuous care intervention (CCI) for the management of Type 2 Diabetes.
Studies on long-term sustainability of low-carbohydrate approaches to treat diabetes are limited. We previously reported the effectiveness of a novel digitally-monitored continuous care intervention (CCI) including nutritional ketosis in improving weight, glycemic outcomes, lipid, and liver marker changes at 1 year. Here, we assess the effects of the CCI at 2 years. An open label, non-randomized, controlled study with 262 and 87 participants with T2D were enrolled in the CCI and usual care (UC) groups, respectively. Primary outcomes were retention, glycemic control, and weight changes at 2 years. Secondary outcomes included changes in body composition, liver, cardiovascular, kidney, thyroid and inflammatory markers, diabetes medication use and disease status. Reductions from baseline to 2 years in the CCI group resulting from intent-to-treat analyses included: HbA1c, fasting glucose, fasting insulin, weight, systolic blood pressure, diastolic blood pressure, triglycerides, and liver alanine transaminase, and HDL-C increased. Spine bone mineral density in the CCI group was unchanged. Use of any glycemic control medication (excluding metformin) among CCI participants declined (from 55.7 to 26.8%) including insulin (-62%) and sulfonylureas (-100%). The UC group had no changes in these parameters (except uric acid and anion gap) or diabetes medication use. There was also resolution of diabetes (reversal, 53.5%; remission, 17.6%) in the CCI group but not in UC. All the reported improvements had p < 0.00012. The CCI group sustained long-term beneficial effects on multiple clinical markers of diabetes and cardio metabolic health at 2 years while utilizing less medication. The intervention was also effective in the resolution of diabetes and visceral obesity with no adverse effect on bone health. Clinical Trial Registration: Clinicaltrials.gov NCT02519309.
At 2 years, the CCI, including remote medical management with instruction in nutritional ketosis, was associated with improvements in blood glucose, insulin, HbA1c, weight, blood pressure, triglyceride, liver function and inflammation and reduced dependence upon medication. These long-term benefits were achieved concurrent with reduced prevalence of metabolic syndrome and visceral adiposity. The CCI had no adverse effect on bone mineral density. The CCI group also had a higher prevalence of diabetes reversal and remission compared to the UC group following a standard diabetes care program. These results provide evidence that sustained improvement in diabetes status can be achieved through the continuous remote monitoring and accountability mechanisms provided by this multi-component CCI including recommendations for low carbohydrate nutrition.