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.

Abstract

OBJECTIVEStudies on long-term sustainability of low-carbohydrate approaches to treat diabetes are limited. We aim to assess the effects of a continuous care intervention (CCI) on retention, glycemic control, weight, body composition, cardiovascular, liver, kidney, thyroid, inflammatory markers, diabetes medication usage and disease outcomes at 2 years in adults with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODSAn open label, non-randomized, controlled study with 262 and 87 participants with T2D were enrolled in the CCI and usual care (UC) groups, respectively. RESULTSSignificant changes from baseline to 2 years in the CCI group included: HbA1c (-12% from 7.7{+/-}0.1%); fasting glucose (-18% from 163.67{+/-}3.90 mg/dL); fasting insulin (-42% from 27.73{+/-}1.26 pmol L-1); weight (-10% from 114.56{+/-}0.60 kg); systolic blood pressure (-4% from 131.7{+/-}0.9 mmHg); diastolic blood pressure (-4% from 81.8{+/-}0.5 mmHg); triglycerides (-22% from 197.2{+/-}9.1 mg/dL); HDL-C (+19% from 41.8{+/-}0.9 mg/dL), and liver alanine transaminase (-21% from 29.16{+/-}0.97 U/L). Spine bone mineral density in the CCI group was unchanged. Glycemic control medication use (excluding metformin) among CCI participants declined (from 56.9% to 26.8%, P=1.3x10-11) including prescribed insulin (-62%) and sulfonylureas (-100%). The UC group had no significant changes in these parameters (except uric acid and anion gap) or diabetes medication use. There was also significant resolution of diabetes (reversal, 53.5%; remission, 17.6%) in the CCI group but not in UC. All the reported improvements had p-values <0.00012. CONCLUSIONSThe CCI sustained long-term beneficial effects on multiple clinical markers of diabetes and cardiometabolic 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. TRIAL REGISTRATIONClinicaltrials.gov NCT02519309 DATA SHARINGThe complete data and statistical codes are available upon reasonable request. Conflicts of InterestsSJA, RNA, SJH, ALM, NHB, SDP and JPM are employed by Virta Health Corp and were offered stock options. SDP and JSV are founders of Virta Health Corp. WWC has no conflict of interest to declare. Financial supportVirta Health Corp. is the study sponsor. Author contributionsS.J.A, R.N.A, and J.P.M drafted the manuscript. S.J.A, R.N.A, A.L.M, N.H.B, and S.J.H participated in data acquisition and compiling. R.N.A and S.J.A analyzed the data. J.P.M, A.L.M, N.H.B, W.W.C, R.N.A, S.J.A, S.J.H, S.D.P and J.S.V edited the manuscript. All authors approved the final version of the manuscript. Abbreviations