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

Background: This study assessed the safety and performance of the Omnipod((R)) 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 <70mg/dL and hyperglycemia 250mg/dL. Glycemic responses for 4h 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 (meanstandard deviation): age 35.4 +/- 14.1 years, diabetes duration 16.5 +/- 9.3 years, HbA1c 7.7 +/- 0.9%, and total daily dose 0.58 +/- 0.19U/kg. Outcomes for the 54-h HCL period were mean glucose 153 +/- 15mg/dL, percentage time <70mg/dL [median (interquartile range)]: 0.0% (0.0-1.2%), 70-180mg/dL: 76.1%+/- 8.0%, and 250mg/dL: 4.5%+/- 3.6%. After both the 100% and 130% boluses, postprandial percentage time <70mg/dL was 0.0% (0.0-0.0%) (P=0.50). After the 100% and missed boluses, postprandial percentage time 250mg/dL was 0.2%+/- 0.6% and 10.3%+/- 16.5%, respectively (P=0.06). Postprandial percentages time 250 mg/dL and <70mg/dL were similar with standard or extended boluses for a high-fat meal. Conclusions: The Omnipod personalized MPC algorithm performed well and was safe during day and night use in response to overestimated, missed, and extended meal boluses in adults with type 1 diabetes.