THU254 VICTOR-Pilot Study Of A Virtual Dietary Intervention To Improve Diabetes And Cardiovascular Risk In Rural Communities - Primary Results

Abstract

Abstract Disclosure: C.C. Low Wang: Research Investigator; Self; Dexcom, Virta Health. R.O. Estacio: None. S. Coronel-Mockler: None. N. Flattery: None. A. McKenzie: Employee; Self; Virta Health. Stock Owner; Self; Virta Health. D. Harrison: Employee; Self; Virta Health. Stock Owner; Self; Virta Health. M.P. Bonaca: Consulting Fee; Self; Audentes. Research Investigator; Self; Abbott Laboratories, Agios Pharmaceuticals, Alexion Pharmaceuticals, Inc., Alnylam, Amgen Inc, Angionetics, Anthos Therapeutics, ARCA Biopharma Inc, Array, AstraZeneca, Atentiv, Better Therapeutics, Bayer, Inc., Bristol-Myers Squibb, Cardiol Therapeutics, CellResearch Corp, CSL Behring, Eidos Therapeutics, EP Trading Company, Esperion Therapeutics, EveryWell, Faraday Pharmaceuticals, Fortress Biotech, HeartFlow, Insmed, Jansen Pharmaceuticals, Lexicon Pharmaceuticals, Inc., Kowa Research, Merck & Co., Moderna, Novo Nordisk, Pfizer, Inc., PhaseBio, PPD Development, Prothena Biosciences, Regeneron Pharmaceuticals, Regio Biosciences, Sanifit Therapeutics, Sanofi, Stealth Biotherapeutics, Wraser, Cambrian Biopharma, Cook Regentech, EPG Communications, Epizon Pharma, Exicon Consulting, Medtronic, Silence Therapeutics, VarmX. Stock Owner; Self; Pfizer, Inc., Medtronic. Introduction: Individuals in rural communities face challenges accessing healthcare. Innovative strategies combining local Community Health Workers (CHW) and virtual digital solutions may be beneficial for improving type 2 diabetes (T2D) care and cardiovascular (CV) risk. Hypothesis: A virtually delivered digitally based intervention will improve glycemic control in individuals with diabetes in rural communities. Methods: The Virta Intervention in CommuniTies in cOloRado (VICTOR)-Pilot Study is designed to examine whether referral to the Virta Intervention (VINT) while integrated into the CHW program Colorado Heart Healthy Solutions (CHHS), a health education program designed to improve cardiovascular risk factors, is feasible, acceptable, and improves hemoglobin A1c (HbA1c). VINT is a low-carbohydrate approach to T2D treatment which is delivered through a continuous remote care platform via a smartphone application; patients receive care from a dedicated Health Coach and Medical Provider to boost efficacy and ensure safety. Adults with T2D age 18-79 yr in rural Colorado enrolled in CHHS and taking one or more antihyperglycemic medications for at least 3 months, with BMI >25 kg/m2, and HbA1c >7.5% were randomized to VINT + CHHS vs CHHS alone. The primary outcome is change in HbA1c from baseline to 3 months. Secondary outcomes include change in body weight, number of diabetes medications, and patient-reported outcomes. The Intervention arm undergoes VINT + CHHS for 6 months, then CHHS alone for 3 months. The Control arm starts with CHHS alone for 3 months, then VINT + CHHS for 3 months, and finally CHHS alone for 3 months. Both groups are assessed at baseline (0), 3, 6 and 9 months. Enrollment for the trial is complete, and the study is ongoing. Results: A total of 48 individuals are enrolled from 2 rural Colorado communities, 25 in the Intervention arm and 23 in the Control arm. Of these, 65% are female, mean age 59.4 years (range 36-77, SD 10.1), 92% white, 4% Hispanic, mean body mass index (BMI) 34.3 kg/m2 (range 25-62, SD 7.0), mean HbA1c 9.0% (range 7.5-14.1%, SD 1.3), mean weight 216.6 lb (range 148-364, SD 46.9), median number of diabetes medications: 2, with 36% of participants on insulin. The primary outcome of change in HbA1c from baseline to 3 months will be assessed in March 2023 and available for reporting at the 2023 Endocrine Society meeting. Conclusion: The VICTOR-Pilot study is evaluating the effect on HbA1c, medication burden, feasibility, and acceptability of a virtual digital dietary intervention to improve glycemic control and risk factor management in patients with type 2 diabetes living in rural communities. The trial has fully enrolled, and the primary end point as well as other key secondary endpoints will be reported. Presentation: Thursday, June 15, 2023