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

Abstract

IntroductionCarbohydrate restriction markedly improves glycemic control in patients with type 2 diabetes (T2D) but necessitates prompt medication changes. Therefore, we assessed the effectiveness and safety of a novel care model providing continuous remote care with medication management based on biometric feedback combined with the metabolic approach of nutritional ketosis for T2D management.MethodsWe conducted an open-label, non-randomized, controlled, before-and-after 1-year study of this continuous care intervention (CCI) and usual care (UC). Primary outcomes were glycosylated hemoglobin (HbA1c), weight, and medication use. Secondary outcomes included fasting serum glucose and insulin, HOMA-IR, blood lipids and lipoproteins, liver and kidney function markers, and high-sensitivity C-reactive protein (hsCRP).Results349 adults with T2D enrolled: CCI: n = 262 [mean (SD); 54 (8) years, 116.5 (25.9) kg, 40.4 (8.8) kg m2, 92% obese, 88% prescribed T2D medication]; UC: n = 87 (52 (10) years, 105.6 (22.15) kg, 36.72 (7.26) kg m2, 82% obese, 87% prescribed T2D medication]. 218 participants (83%) remained enrolled in the CCI at 1 year. Intention-to-treat analysis of the CCI (mean ± SE) revealed HbA1c declined from 59.6 ± 1.0 to 45.2 ± 0.8 mmol mol−1 (7.6 ± 0.09% to 6.3 ± 0.07%, P < 1.0 × 10−16), weight declined 13.8 ± 0.71 kg (P < 1.0 × 10−16), and T2D medication prescription other than metformin declined from 56.9 ± 3.1% to 29.7 ± 3.0% (P < 1.0 × 10−16). Insulin therapy was reduced or eliminated in 94% of users; sulfonylureas were entirely eliminated in the CCI. No adverse events were attributed to the CCI. Additional CCI 1-year effects were HOMA-IR − 55% (P = 3.2 × 10−5), hsCRP − 39% (P < 1.0 × 10−16), triglycerides − 24% (P < 1.0 × 10−16), HDL-cholesterol + 18% (P < 1.0 × 10−16), and LDL-cholesterol + 10% (P = 5.1 × 10−5); serum creatinine and liver enzymes (ALT, AST, and ALP) declined (P ≤ 0.0001), and apolipoprotein B was unchanged (P = 0.37). UC participants had no significant changes in biomarkers or T2D medication prescription at 1 year.ConclusionsThese results demonstrate that a novel metabolic and continuous remote care model can support adults with T2D to safely improve HbA1c, weight, and other biomarkers while reducing diabetes medication use.ClinicalTrials.gov IdentifierNCT02519309.FundingVirta Health Corp.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0373-9) contains supplementary material, which is available to authorized users.

An evidence‐based approach to developing low‐carbohydrate diets for type 2 diabetes management: A systematic review of interventions and methods

“…Of these, all 13 studies set initial CHO amount to <50 g/d before increasing or decreasing CHO intake. For example, Hallberg et al 2018 commenced participants on a CHO intake <30 g/d before personalizing the prescriptions according to the goal of achieving nutritional ketosis (beta hydroxybutyrate level of 0.5‐3.0 mmol/L).…”

“…Eleven studies (11/21) did not intentionally reduce or minimize saturated fat but recommended a variety of fat from whole food sources (including fatty cuts of meat, oily fish, full‐fat cheese, cream, coconut oil, olive oil, nuts, seeds and avocado). One study specifically reported providing advice on adequate intakes of omega‐3 and omega‐6 polyunsaturated fats …”

Very low‐energy and low‐energy formula diets: Effects on weight loss, obesity co‐morbidities and type 2 diabetes remission – an update on the evidence for their use in clinical practice

“…More recently, a non‐randomised, controlled study using a novel remote care model, which included a well‐formulated ketogenic diet compared with usual care, showed the ketogenic diet achieved T2D remission in 25% of participants compared with no cases in the usual care group (Hallberg et al . ). Similar to the results of the Look AHEAD trial, remission rates reduced over time in both studies (Esposito et al .…”

Health 2.0 2018

“…Regarding unpublished data, Mr Inkinen revealed that new results were just received internally; although no exact numbers or outcomes were divulged, he did share that the company now treats patients in 49 of the 50 states in the US. Previously published 1‐year results from Virta demonstrated 60% type 2 diabetes reversal, 1.3% HbA1c reduction (baseline 7.6%), 12% weight loss (approximately 14 kg), and significant improvement in 22 of 26 cardiovascular risk factors at 1 year …”