Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin Delivery

The study is a 3-period randomized crossover trial, each with a structured afternoon exercise session following a standard lunch meal. 9 participants completed Phase 1 sessions which included (1) TI for meal bolus with pump in sleep mode, (2) RAA for meal bolus with pump in sleep mode, and (3) RAA for meal bolus with pump in standard mode with transition to exercise mode one hour before start of exercise. 21 participants will complete the Phase 2 sessions which will include: (1) TI for meal bolus with pump in exercies mode, (2) TI for meal air bolus (i.e., the infusion set is disconnected from the pump and the TI bolus and carbohydrates are reported in the system but no pump insulin is administered) with pump in exercise mode, and (3) RAA for meal bolus with pump in exercise mode. The study is being done to compare the efficacy and safety of TI versus RAA given as bolus for meal prior to initiating aerobic exercise in adults ≥18 to ≤ 65 years of age with T1D using Control-IQ. All participants will complete 3 exercise sessions, with the order determined through randomization. Participants who complete Phase 1 may also participate in Phase 2 if they choose to.