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

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. A supervised 54-h hybrid cl...

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Bibliographic Details
Published in:Diabetes technology & therapeutics Vol. 20; no. 9; p. 585
Main Authors: Buckingham, Bruce A, Christiansen, Mark P, Forlenza, Gregory P, Wadwa, R Paul, Peyser, Thomas A, Lee, Joon Bok, O'Connor, Jason, Dassau, Eyal, Huyett, Lauren M, Layne, Jennifer E, Ly, Trang T
Format: Journal Article
Language:English
Published: United States 01.09.2018
Subjects:
Adult
Algorithms
Blood Glucose
Diabetes Mellitus, Type 1 - drug therapy
Feeding Behavior
Female
Humans
Hypoglycemic Agents - administration & dosage
Insulin - administration & dosage
Male
Middle Aged
Pancreas, Artificial
Postprandial Period
Young Adult
Artificial pancreas
Omnipod
Automated insulin delivery
tubeless Insulin pump
Closed-loop
Postprandial
ISSN:1557-8593, 1557-8593
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Summary: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. 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. 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. 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.
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ISSN:1557-8593
1557-8593
DOI:10.1089/dia.2018.0138