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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 pos

SUBMITTER: Buckingham BA 

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

REPOSITORIES: biostudies-literature