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. 2018 Apr;9(2):583-612.
doi: 10.1007/s13300-018-0373-9. Epub 2018 Feb 7.

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

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Free PMC article

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

Sarah J Hallberg et al. Diabetes Ther. .
Free PMC article

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Abstract

Introduction: Carbohydrate 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.

Methods: We 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).

Results: 349 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.

Conclusions: These 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 identifier: NCT02519309.

Funding: Virta Health Corp.

Keywords: Beta-hydroxybutyrate; Carbohydrate restriction; HbA1c; Ketosis; Type 2 diabetes; Weight loss.

Plain Language Summary

Treatments for type 2 diabetes (T2D) have improved, yet T2D and being overweight are still significant public health concerns. Blood sugar in patients with T2D can improve quickly when patients eat significantly fewer dietary carbohydrates. However, this demands careful medicine management by doctors, and patients need support and frequent contact with health providers to sustain this way of living. The purpose of this study was to evaluate if a new care model with very low dietary carbohydrate intake and continuous supervision by a health coach and doctor could safely lower HbA1c, weight and need for medicines after 1 year in adults with T2D. 262 adults with T2D volunteered to participate in this continuous care intervention (CCI) along with 87 adults with T2D receiving usual care (UC) from their doctors and diabetes education program. After 1 year, patients in the CCI, on average, lowered HbA1c from 7.6 to 6.3%, lost 12% of their body weight, and reduced diabetes medicine use. 94% of patients who were prescribed insulin reduced or stopped their insulin use, and sulfonylureas were eliminated in all patients. Participants in the UC group had no changes to HbA1c, weight or diabetes medicine use over the year. These changes in CCI participants happened safely while dyslipidemia and markers of inflammation and liver function improved. This suggests the novel care model studied here using dietary carbohydrate restriction and continuous remote care can safely support adults with T2D to lower HbA1c, weight, and medicine use.

Figures

Fig. 1
Fig. 1
Change in HbA1c over the course of 1 year for CCI and UC groups. a Mean (95% CI) in HbA1c based on starting value at baseline and 1 year for completers in both groups. b Individual changes in HbA1c over 1 year for completers in both groups
Fig. 2
Fig. 2
Body weight change over the course of 1 year in CCI completers. a Mean (95% CI) change in body weight for completers over the course of 1 year. For each individual, weight on a given day was computed as the 3-day trailing mean (to reduce day-to-day variation). On dates where no weights were recorded during the 3-day time window for a given participant, the most recent 3-day mean preceding the date was used. b Histogram depicting individual body weight changes at 1 year
Fig. 3
Fig. 3
Medication changes over the course of 1 year in completers of the CCI and UC groups. a Proportion of completers prescribed diabetes medications other than metformin. b Mean ± SE prescribed dose among insulin users. c Frequency in change of medication dosage among prescribed users by diabetes medication class in both groups
Fig. 4
Fig. 4
Beta-hydroxybutyrate concentrations of CCI completers. Note: For each individual in the graph, the BHB concentration on a given day was computed as the 3-day trailing mean (to reduce day-to-day variation). On dates where no BHB concentrations were recorded during the 3-day time window for a given participant, the most recent 3-day mean preceding the date was used. Line graph depicts mean (95% CI) over time for BHB measured at home and reported via the app. Dots and error bars represent the mean ± SE from laboratory measured BHB at baseline, 70 days, and 1 year

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