Hybrid Closed-Loop Insulin Delivery in Type 1 Diabetes during Supervised Outpatient Conditions

Benyamin Grosman*, Jacob Ilany, Anirban Roy, Natalie Kurtz, Di Wu, Neha Parikh, Gayane Voskanyan, Noa Konvalina, Chrystaleni Mylonas, Rebecca Gottlieb, Francine Kaufman, Ohad Cohen

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

36 Scopus citations

Abstract

Background: Efficacy and safety of the Medtronic Hybrid Closed-Loop (HCL) system were tested in subjects with type 1 diabetes in a supervised outpatient setting. Methods: The HCL system is a prototype research platform that includes a sensor-augmented insulin pump in communication with a control algorithm housed on an Android-based cellular device. Nine subjects with type 1 diabetes (5 female, mean age 53.3 years, mean A1C 7.2%) underwent 9 studies totaling 571 hours of closed-loop control using either default or personalized parameters. The system required meal announcements with estimates of carbohydrate (CHO) intake that were based on metabolic kitchen quantification (MK), dietician estimates (D), or subject estimates (Control). Postprandial glycemia was compared for MK, D, and Control meals. Results: The overall sensor glucose mean was 145 ± 43, the overall percentage time in the range 70-180 mg/dL was 80%, the overall percentage time <70 mg/dL was 0.79%. Compared to intervals of default parameter use (225 hours), intervals of personalized parameter use (346 hours), sensor glucose mean was 158 ± 49 and 137 ± 37 mg/dL (P <.001), respectively, and included more time in range (87% vs 68%) and less time below range (0.54% vs 1.18%). Most subjects underestimated the CHO content of meals, but postprandial glycemia was not significantly different between MK and matched Control meals (P =.16) or between D and matched Control meals (P =.76). There were no episodes of severe hypoglycemia. Conclusions: The HCL system was efficacious and safe during this study. Personally adapted HCL parameters were associated with more time in range and less time below range than default parameters. Accurate estimates of meal CHO did not contribute to improved postprandial glycemia.

Original languageEnglish
Pages (from-to)708-713
Number of pages6
JournalJournal of diabetes science and technology
Volume10
Issue number3
DOIs
StatePublished - 1 May 2016
Externally publishedYes

Funding

FundersFunder number
Juvenile Diabetes Research Foundation United States of America1-SRA-2014-240-M-R

    Keywords

    • artificial pancreas
    • diabetes
    • human trials
    • insulin pump therapy

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