293-OR: Flexible Insulin Therapy: Untethered Insulin Regimen Using Insulin Degludec and Continuous Subcutaneous Insulin Infusion (CSII) in Avidly Exercising Patients with T1D: FIT Untethered Study

Abstract

Athletes with T1D using CSII routinely remove their pump for prolonged periods, predisposing to hyperglycemia and ketosis. We examined the safety and efficacy of an “Untethered” approach - evenly splitting basal insulin between adjusted CSII and a daily injection of insulin degludec. This randomized cross-over study explored glycemic outcomes following in-clinic, fasted exercise (90-minute moderate- and 30-minute high-intensity). After a 1-week run-in, subjects were randomized to Usual CSII or Untethered CSII, for 5-week periods including a week of optimization, and then crossed over. Nineteen patients (age 34 ± 10 (mean ± SD), T1D duration 16 ± 11 years; mean A1C 7.1 ± 0.5) have completed both periods. In the 6 hours following moderate exercise, the Untethered arm showed improved mean glucose and spent 61% more time in range relative to the Usual arm (p Disclosure R. Aronson: Research Support; Self; AstraZeneca, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Senseonics. A. Li: None. R.E. Brown: None. S. McGaugh: None. L. Yavelberg: None. M. Riddell: Advisory Panel; Self; Xeris Pharmaceuticals, Inc. Research Support; Self; Dexcom, Inc. Speaker9s Bureau; Self; Insulet Corporation, Medtronic MiniMed, Inc. Stock/Shareholder; Self; Zucara Therapeutics Inc. Funding Novo Nordisk