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Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents with Type 1 Diabetes: A Free-Living, Randomized Clinical Trial

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Peer-reviewed

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Article

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Authors

Allen, Janet Macdonald 
Wilinska, Malgorzata E  ORCID logo  https://orcid.org/0000-0003-2739-1753
Thabit, Hood 
Stewart, Zoë 

Abstract

OBJECTIVE: To evaluate feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions without remote monitoring or supervision. RESEARCH DESIGN AND METHODS: In an open-label, randomized, free-living, crossover study design, 12 adolescents receiving insulin pump therapy (mean [±SD] age 15.4 ± 2.6 years; HbA1c 8.3 ± 0.9%; duration of diabetes 8.2 ± 3.4 years) underwent two 7-day periods of sensor-augmented insulin pump therapy or hybrid closed-loop insulin delivery without supervision or remote monitoring. During the closed-loop insulin delivery, a model predictive algorithm automatically directed insulin delivery between meals and overnight; prandial boluses were administered by participants using a bolus calculator. RESULTS: The proportion of time when the sensor glucose level was in the target range (3.9-10 mmol/L) was increased during closed-loop insulin delivery compared with sensor-augmented pump therapy (72 vs. 53%, P < 0.001; primary end point), the mean glucose concentration was lowered (8.7 vs. 10.1 mmol/L, P = 0.028), and the time spent above the target level was reduced (P = 0.005) without changing the total daily insulin amount (P = 0.55). The time spent in the hypoglycemic range was low and comparable between interventions. CONCLUSIONS: Unsupervised day-and-night hybrid closed-loop insulin delivery at home is feasible and safe in young people with type 1 diabetes. Compared with sensor-augmented insulin pump therapy, closed-loop insulin delivery may improve glucose control without increasing the risk of hypoglycemia in adolescents with suboptimally controlled type 1 diabetes.

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Journal Title

Diabetes Care

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Journal ISSN

Volume Title

39

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Sponsorship
MRC (G0600717)
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (R01DK085621)
Juvenile Diabetes Research Foundation Ltd (JDRF) (2-SRA-2014-256-M-R)
Cambridge University Hospitals NHS Foundation Trust (CUH) (Roman Hovorka)
Department of Health (via National Institute for Health Research (NIHR)) (EME 14/23/09)