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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 (HbA 1c ), 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 m 2 , 92% obese, 88% prescribed T2D medication]; UC: n  = 87 (52 (10) years, 105.6 (22.15) kg, 36.72 (7.26) kg m 2 , 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 HbA 1c 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 HbA 1c , weight, and other biomarkers while reducing diabetes medication use. ClinicalTrials.gov Identifier NCT02519309. Funding Virta Health Corp. 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.

Background: Type 2 diabetes (T2D) has long been identified as an incurable chronic disease based on traditional means of treatment. Research now exists that suggests reversal is possible through other means that have only recently been embraced in the guidelines. This narrative review examines the evidence for T2D reversal using each of the three methods, including advantages and limitations for each. Methods: A literature search was performed, and a total of 99 original articles containing information pertaining to diabetes reversal or remission were included. Results: Evidence exists that T2D reversal is achievable using bariatric surgery, low-calorie diets (LCD), or carbohydrate restriction (LC). Bariatric surgery has been recommended for the treatment of T2D since 2016 by an international diabetes consensus group. Both the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) now recommend a LC eating pattern and support the short-term use of LCD for weight loss. However, only T2D treatment, not reversal, is discussed in their guidelines. Conclusion: Given the state of evidence for T2D reversal, healthcare providers need to be educated on reversal options so they can actively engage in counseling patients who may desire this approach to their disease.

Due to a baseline diagnosis of type 2 diabetes, all patients in the Hallberg study, even after reversal of DM, are at high risk for developing diabetes in the future. [...]metformin was continued in these patients as an adjunct that is well-known to decrease the risk for developing diabetes [9]. [...]all conflicts of interest were fully declared for this paper in accordance to guidelines. Numao, S.; Kawano, H.; Endo, N.; Yamada, Y.; Konishi, M.; Takahashi, M.; Sakamoto, S. Short-term low carbohydrate/high-fat diet intake increases postprandial plasma glucose and glucagon-like peptide-1 levels during an oral glucose tolerance test in healthy men.

The presentation of Table 1 and ESM 1 have been published incorrectly. Corrected units have been provided for LDL-C values. The corrected Table 1 in text is given below and ESM Table 1 is available online. Table 1. Baseline characteristics of the recruited sample, completers, and participants with missing data by treatment arm All Completers with data Dropout or missing data Completers–dropouts N Mean (SD) or ± SE N Mean (SD) or ± SE N Mean (SD) or ± SE Mean ± SE Age (years) CCI-all educationa 262 53.75 (8.35) 218 54.09 (8.35) 44 52.09 (8.25) 2.0 ± 1.37 Usual carea 87 52.33 (9.52) 78 51.71 (9.62) 9 57.78 (6.85) − 6.07 ± 2.53* CCI-all vs. usual careb 1.42 ± 1.14 2.38 ± 1.23* − 5.69 ± 2.6* Female (%) CCI-all educationa 262 66.79 ± 2.91 218 65.14 ± 3.23 44 75.0 ± 6.53 − 9.86 ± 7.28 Usual carea 87 58.62 ± 5.28 78 60.26 ± 5.54 9 44.44 ± 16.56 15.81 ± 17.47 CCI-all vs. usual careb 8.17 ± 6.03 4.88 ± 6.41 30.56 ± 17.8 African American (%) CCI-all educationa 262 6.87 ± 1.56 218 5.96 ± 1.6 44 11.36 ± 4.78 − 5.4 ± 5.05 Usual carea 87 0.0 ± 0.0 78 0.0 ± 0.0 9 0.0 ± 0.0 0.0 ± 0.0 CCI-all vs. usual careb 6.87 ± 1.56§ 5.96 ± 1.6‡ 11.36 ± 4.78* Years with type 2 diabetes CCI-all educationa 261 8.44 (7.22) 217 8.4 (7.28) 44 8.61 (6.97) − 0.21 ± 1.16 Usual carea 71 7.85 (7.32) 71 7.85 (7.32) Not collected CCI-all vs. usual careb 0.59 (0.9) 0.56 ± 1.0 Beta-hydroxybutyrate (mmol L−1) CCI-all educationa 248 0.17 (0.15) 186 0.17 (0.15) 62 0.19 (0.16) − 0.02 ± 0.02 Usual carea 79 0.15 (0.13) 59 0.14 (0.12) 20 0.17 (0.15) − 0.03 ± 0.03 CCI-all vs. usual careb 0.02 ± 0.02 0.02 ± 0.02 0.02 ± 0.04 Hemoglobin A1c (mmol mol−1) CCI-all educationa 262 59.55 (16.4) 204 58.35 (15.3) 58 63.49 (19.57) − 28.66 ± 2.73 Usual carea 87 59.99 (19.24) 72 61.08 (19.89) 15 54.52 (14.87) − 16.97 ± 4.48 CCI-all vs. usual careb − 0.44 ± 2.3 − 2.73 ± 2.62 8.96 ± 4.59* Hemoglobin A1c (%) CCI-all educationa 262 7.60 (1.50) 204 7.49 (1.4) 58 7.96 (1.79) − 0.47 ± 0.25 Usual carea 87 7.64 (1.76) 72 7.74 (1.82) 15 7.14 (1.36) 0.60 ± 0.41 CCI-all vs. usual careb − 0.04 ± 0.21 − 0.25 ± 0.24 0.82 ± 0.42* Fasting glucose (mmol L−1) CCI-all educationa 258 8.92 (3.41) 202 8.8 (3.28) 56 9.36 (3.83) − 0.55 ± 0.56 Usual carea 86 8.67 (4.03) 71 8.71 (3.96) 15 8.5 (4.5) 0.21 ± 1.25 CCI-all vs. usual careb 0.25 ± 0.48 0.1 ± 0.52 0.86 ± 1.27 Insulin all (pmol L−1) CCI-all educationa 248 198.35 (165.85) 186 197.65 (167.17) 62 200.5 (163.21) − 2.85 ± 24.1 Usual carea 79 202.17 (172.58) 59 206.68 (187.93) 20 188.77 (119.18) 17.99 ± 36.18 CCI-all vs. usual careb − 3.82 ± 22.09 − 9.1 ± 27.36 11.74 ± 33.75 C-peptide (nmol L−1) CCI-all educationa 247 1.45 (0.71) 185 1.47 (0.72) 62 1.39 (0.69) 0.07 ± 0.1 Usual carea 79 1.38 (0.82) 59 1.35 (0.82) 20 1.49 (0.84) − 0.14 ± 0.22 CCI-all vs. usual careb 0.07 ± 0.1 0.12 ± 0.12 − 0.09 ± 0.21 HOMA-IR (insulin derived), all CCI-all educationa 244 11.8 (13.14) 179 11.19 (12.75) 65 13.48 (14.12) − 2.3 ± 1.99 Usual carea 78 10.64 (9.12) 56 11.31 (10.05) 22 8.94 (6.03) 2.36 ± 1.86 CCI-all vs. usual careb 1.16 ± 1.33 − 0.12 ± 1.65 4.54 ± 2.17 HOMA-IR (C-peptide derived) CCI-all educationa 244 11.52 (7.15) 170 11.44 (6.26) 69 11.72 (9.04) − 0.28 ± 1.19 Usual carea 72 11.16 (7.26) 47 10.56 (7.70) 25 12.29 (6.33) − 1.73 ± 1.69 CCI-all vs. usual careb 0.36 ± 0.97 0.88 ± 1.22 − 0.56 ± 1.67 Weight-clinic (kg) CCI-all educationa 257 116.51 (25.94) 184 115.42 (24.62) 73 119.25 (29.01) − 3.83 ± 3.85 Usual carea 83 105.63 (22.15) 69 106.79 (22.18) 14 99.94 (21.86) 6.84 ± 6.42 CCI-all vs. usual careb 10.87 ± 2.92§ 8.63 ± 3.23† 19.3 ± 6.76† BMI (kg m−2) CCI-all educationa 257 40.43 (8.81) 184 39.87 (7.88) 73 41.82 (10.75) − 1.94 ± 1.39 Usual carea 83 36.72 (7.26) 69 37.14 (7.62) 14 34.66 (4.8) 2.48 ± 1.58 CCI-all vs. usual careb 3.7 ± 0.97‡ 2.73 ± 1.09† 7.15 ± 1.8§ Systolic blood pressure (mmHg) CCI-all educationa 260 131.94 (14.09) 187 132.51 (14.54) 73 130.47 (12.84) 2.05 ± 1.84 Usual carea 79 129.8 (13.61) 67 128.72 (12.65) 12 135.83 (17.49) − 7.12 ± 5.28 CCI-all vs. usual careb 2.14 ± 1.76 3.8 ± 1.88* − 5.37 ± 5.27 Diastolic blood pressure (mmHg) CCI-all educationa 260 82.09 (8.25) 187 81.59 (8.05) 73 83.37 (8.67) − 1.78 ± 1.17 Usual carea 79 82.0 (8.93) 67 81.1 (8.07) 12 87.0 (11.95) − 5.9 ± 3.59 CCI-all vs. usual careb 0.09 ± 1.13 0.49 ± 1.15 − 3.63 ± 3.6 Total cholesterol (mmol L−1) CCI-all educationa 247 4.76 (1.07) 186 4.68 (1.03) 61 4.99 (1.15) − 0.31 ± 0.17 Usual carea 79 4.76 (1.19) 59 4.72 (1.26) 20 4.88 (0.93) − 0.16 ± 0.27 CCI-all vs. usual careb − 0.0 ± 0.15 − 0.04 ± 0.18 0.11 ± 0.26 LDL-cholesterol (mmol L−1) CCI-all educationa 232 2.66 (0.85) 172 2.59 (0.84) 60 2.84 (0.86) − 0.24 ± 0.13 Usual carea 70 2.63 (0.94) 48 2.60 (0.98) 22 2.69 (0.85) − 0.09 ± 0.23 CCI-all vs. usual careb 0.03 ± 0.13 − 0.01 ± 0.16 0.14 ± 0.21 Apo B (g L−1) CCI-all educationa 248 1.05 (0.29) 186 1.03 (0.28) 62 1.1 (0.31) − 0.06 ± 0.04 Usual carea 79 1.07 (0.28) 59 1.06 (0.3) 20 1.11 (0.24) − 0.05 ± 0.07 CCI-all vs. usual careb − 0.02 ± 0.04 − 0.02 ± 0.04 − 0.01 ± 0.07 HDL-C (mmol L−1) CCI-all educationa 247 1.09 (0.35) 186 1.1 (0.36) 61 1.08 (0.32) 0.02 ± 0.05 Usual carea 79 0.97 (0.29) 59 0.96 (0.29) 20 1.02 (0.29) − 0.06 ± 0.08 CCI-all vs. usual careb 0.12 ± 0.04† 0.14 ± 0.05† 0.06 ± 0.08 Triglycerides (mmol L−1) CCI-all educationa 247 2.23 (1.62) 186 2.27 (1.73) 61 2.11 (1.25) 0.15 ± 0.2 Usual carea 79 3.2 (4.53) 59 3.36 (5.17) 20 2.72 (1.56) 0.64 ± 0.76 CCI-all vs. usual careb − 0.97 ± 0.52* − 1.09 ± 0.68 − 0.61 ± 0.38* Total/HDL-cholesterol CCI-all educationa 247 4.72 (1.7) 186 4.65 (1.72) 61 4.93 (1.65) − 0.28 ± 0.25 Usual carea 79 5.37 (2.42) 59 5.44 (2.63) 20 5.17 (1.72) 0.27 ± 0.52 CCI-all vs. usual careb − 0.65 ± 0.29* − 0.79 ± 0.36* − 0.24 ± 0.44 hsC-reactive protein (nmol L−1) CCI-all educationa 249 81.33 (138.0) 193 85.62 (153.05) 56 66.76 (62.1) 18.86 ± 13.81 Usual carea 85 84.67 (82.1) 70 86.95 (86.95) 15 73.81 (73.81) 13.14 ± 19.14 CCI-all vs. usual careb − 3.24 ± 12.48 − 1.33 ± 15.05 − 7.05 ± 18.19 ALT (µkat L−1) CCI-all educationa 257 0.51 (0.38) 201 0.52 (0.41) 56 0.47 (0.27) 0.05 ± 0.05 Usual carea 86 0.46 (0.33) 71 0.45 (0.34) 15 0.51 (0.29) − 0.05 ± 0.09 CCI-all vs. usual careb 0.05 ± 0.04 0.07 ± 0.05 − 0.04 ± 0.08 AST (µkat L−1) CCI-all educationa 257 0.4 (0.25) 201 0.41 (0.28) 56 0.36 (0.15) 0.04 ± 0.03 Usual carea 86 0.4 (0.32) 71 0.39 (0.35) 15 0.42 (0.16) − 0.03 ± 0.06 CCI-all vs. usual careb − 0.0 ± 0.04 0.01 ± 0.05 − 0.06 ± 0.05 Alkaline phosphatase (µkat L−1) CCI-all educationa 256 1.24 (0.37) 200 1.24 (0.37) 56 1.23 (0.36) 0.01 ± 0.05 Usual carea 86 1.29 (0.44) 71 1.31 (0.45) 15 1.22 (0.38) 0.09 ± 0.11 CCI-all vs. usual careb − 0.05 ± 0.05 − 0.07 ± 0.06 0.01 ± 0.11 Serum creatinine (µmol L−1) CCI-all educationa 258 77.79 (21.22) 202 77.79 (20.33) 56 81.33 (24.75) − 3.54 ± 3.54 Usual carea 86 80.44 (22.1) 71 78.68 (20.33) 15 86.63 (25.64) − 7.07 ± 7.07 CCI-all vs. usual careb − 1.77 ± 2.65 − 1.77 ± 2.65 − 5.3 ± 7.07 BUN (mmol L−1) CCI-all educationa 258 6.03 (2.34) 202 6.06 (2.15) 56 5.9 (2.96) 0.16 ± 0.42 Usual carea 86 5.73 (2.23) 71 5.59 (1.86) 15 6.38 (3.52) − 0.79 ± 0.94 CCI-all vs. usual careb 0.3 ± 0.28 0.47 ± 0.27 − 0.47 ± 0.99 eGFR (mL s−1 m−2) CCI-all educationa 258 1.34 (0.23) 202 1.35 (0.22) 56 1.33 (0.25) 0.02 ± 0.04 Usual carea 86 1.32 (0.23) 71 1.34 (0.22) 15 1.26 (0.28) 0.08 ± 0.08 CCI-all vs. usual careb 0.02 ± 0.03 0.02 ± 0.03 0.03 ± 0.08 Anion gap (mmol L−1) CCI-all educationa 257 6.83 (1.67) 201 6.79 (1.7) 56 6.98 (1.53) − 0.19 ± 0.24 Usual carea 86 6.93 (1.82) 71 6.92 (1.82) 15 7.0 (1.89) − 0.08 ± 0.53 CCI-all vs. usual careb − 0.1 ± 0.22 −