Performance of the Omnipod Personalized Model Predictive Control Algorithm with Meal Bolus Challenges in Adults with Type 1 Diabetes

Abstract Background: This study assessed the safety and performance of the Omnipod® personalized model predictive control (MPC) algorithm using an investigational device in adults with type 1 diabetes in response to overestimated and missed meal boluses and extended boluses for high-fat meals. Materials and Methods: A supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient open-loop run-in phase. Adults aged 18–65 years with type 1 diabetes and HbA1c 6.0%–10.0% were eligible. Primary endpoints were percentage time in hypoglycemia <70 mg/dL and hyperglycemia ≥250 mg/dL. Glycemic responses for 4 h to a 130% overestimated bolus and a missed meal bolus were compared with a 100% bolus for identical meals, respectively. The 12-h postprandial responses to a high-fat meal were compared using either a standard or extended bolus. Results: Twelve subjects participated in the study, with (mean ± standard deviation): age 35.4 ± 14.1 years, diabetes duration 16.5 ± 9.3 y...