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 years, HbA1c 7.7?±?0.9%, and total daily dose 0.58?±?0.19?U/kg. Outcomes for the 54-h HCL period were mean glucose 153?±?15?mg/dL, percentage time <70?mg/dL [median (interquartile range)]: 0.0% (0.0-1.2%), 70-180?mg/dL: 76.1%?±?8.0%, and ?250?mg/dL: 4.5%?±?3.6%. After both the 100% and 130% boluses, postprandial percentage time <70?mg/dL was 0.0% (0.0-0.0%) (P?=?0.50). After the 100% and missed boluses, postprandial percentage time ?250?mg/dL was 0.2%?±?0.6% and 10.3%?±?16.5%, respectively (P?=?0.06). Postprandial percentages time ?250 mg/dL and <70?mg/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.

SUBMITTER: Buckingham BA 

PROVIDER: S-EPMC6114075 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature