The national Diabetes Prevention Program (nDPP) failed to translate the efficacy of the Diabetes Prevention Program (DPP) into real world effectiveness. We initiated a prevention program, previously publishing outcomes on 96 patients with prediabetes over two years with 75% retention. This single center observational trial examines the effectiveness of a very low carbohydrate intervention (VLCI) including nutritional ketosis delivered via a continuous remote care (CRC) model; here, we report sustainability and durability at 5 years. At completion of the 2-year trial, 58 of the original cohort (80%) renewed consent and 78% completed the 5 year follow-up. At baseline, all had prediabetes, with mean weight 109 kg and mean BMI 38.9 kg/m2. Using intention to treat analysis at 5 years, 22% regressed to normoglycemia, 13% progressed to diabetes, and 65% remained prediabetes. A1c remained unchanged (mean 5.9%) , and mean fasting glucose fell from 112 to 108 mg/dl (p=NS). Weight fell from 1 to 103 kg (p<0.001) , with insulin resistance falling from a HOMA-IR of 6.1 to 4.7 (p<0.05) . The nDPP utilizes 5% weight loss as a surrogate outcome for prevention. Forty-eight percent of the sample met that criteria at 5 years, with 19% achieving a 5-9.9% weight loss, 19% a 10-19.9% weight loss, and 10% with at least 20% weight loss. There was a 30% reduction in class 3 obesity (BMI ≥40) , contributing to a 2.7 fold increase in those now overweight (BMI 25-29.9). These results show that a VLCI delivered via CRC is sustainable in prediabetes, resulting in normalization of A1c without medication in over 20% with limited glycemic deterioration to the diabetes threshold. No other real world intervention has presented glycemic data on diabetes prevention, but only reported surrogate weight change as an outcome. Over 5 years, almost half of the cohort achieved that surrogate with significant population shifts to lower obesity classes. The promise of the DPP is met via telehealth-supported VLCI and is sustainable over the long term.
A.L.Mckenzie: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. S.Phinney: Employee; Virta Health Corp. S.Hallberg: Advisory Panel; Atkins Nutritionals Inc., Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. S.J.Athinarayanan: Employee; Virta Health Corp. M.Vantieghem: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. B.M.Volk: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. R.N.Adams: Employee; Virta Health Corp. C.G.P.Roberts: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. B.Fell: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. R.E.Ratner: Employee; Virta Health Corp. J.Volek: Advisory Panel; Abbott Diagnostics, Simply Good Foods, Stock/Shareholder; Virta Health Corp.