The 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 Control Trial

<p dir="ltr">Objective: To compare the efficacy of enabling ‘Activity feature’ 60-minutes (AF-60) or 30-minutes (AF-30) before prolonged exercise vs. 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 underwent a 70-minute treadmill session at 64-76% HRmax in a post-meal-absorptive state under each condition. Auto mode was resumed after exercise, and glycemia and insulin delivery metrics were examined in the 4-hour post-exercise period. Results: The percent of participants that 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 to 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±-33mg/dL, p=0.02) and AF-30 (-36±-34 mg/dL, p=0.01). In the post-exercise period, glycemia and insulin delivery were comparable. Conclusions: Enabling Activity feature either 60- or 30-minutes before exercise reduced insulin delivery and attenuated glucose drops relative to Auto mode, 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.</p>