Use of the Omnipod 5 Automated Insulin Delivery System Activity Feature Reduces Insulin Delivery and Attenuates the Drop in Glycemia Associated With Exercise in a Randomized Controlled Trial.

Objective: To compare the efficacy of enabling Activity feature 60 (AF-60) or 30 min (AF-30) before prolonged exercise versus the automated mode (Auto) in adults and adolescents with type 1 diabetes wearing the Omnipod 5 System.

Research Design And Methods: In this three-way crossover study, 38 participants (age 30 ± 15 years; BMI 24.7 ± 4.1 kg/m2; HbA1c 7.5% ± 0.9% [58 ± 11 mmol/mol]) from the extension phase of the pivotal trial of the Omnipod 5 System completed a 70-min treadmill session at 64-76% maximum heart rate in a postabsorptive state under each of the three conditions. Auto was resumed after exercise, and glycemia and insulin delivery metrics were examined in the 4-h postexercise period.

Results: The percentage of participants who developed hypoglycemia during exercise did not differ significantly between Auto (42%) and AF-60 (29%; P = 0.34) or AF-30 (24%; P = 0.14). However, AF-60 and AF-30 reduced insulin delivery compared with Auto in the hour before (P < 0.001) and during exercise (P < 0.001). There was also a favorable attenuation in glucose drop during exercise when comparing Auto (-57 ± -35 mg/dL) with AF-60 (-44 ± -33 mg/dL; P = 0.02) and AF-30 (-36 ± -34 mg/dL; P = 0.01). In the postexercise period, glycemia and insulin delivery were comparable.

Conclusions: Enabling the Activity feature either 60 or 30 min before exercise reduced insulin delivery and attenuated glucose drops relative to Auto, but hypoglycemia incidence was not different across the three conditions. These findings support the use of the Omnipod 5 System for exercise but highlight the importance of using additional strategies, such as earlier use of Activity feature and/or carbohydrate intake to further reduce hypoglycemia risk.