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Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial.


Type

Article

Change log

Authors

Elleri, Daniela 
Thabit, Hood 
Allen, Janet M 
Leelarathna, Lalantha 

Abstract

OBJECTIVE: To evaluate feasibility, safety, and efficacy of overnight closed-loop insulin delivery in free-living youth with type 1 diabetes. RESEARCH DESIGN AND METHODS: Overnight closed loop was evaluated at home by 16 pump-treated adolescents with type 1 diabetes aged 12-18 years. Over a 3-week period, overnight insulin delivery was directed by a closed-loop system, and on another 3-week period sensor-augmented therapy was applied. The order of interventions was random. The primary end point was time when adjusted sensor glucose was between 3.9 and 8.0 mmol/L from 2300 to 0700 h. RESULTS: Closed loop was constantly applied over at least 4 h on 269 nights (80%); sensor data were collected over at least 4 h on 282 control nights (84%). Closed loop increased time spent with glucose in target by a median 15% (interquartile range -9 to 43; P < 0.001). Mean overnight glucose was reduced by a mean 14 (SD 58) mg/dL (P < 0.001). Time when glucose was <70 mg/dL was low in both groups, but nights with glucose <63 mg/dL for at least 20 min were less frequent during closed loop (10 vs. 17%; P = 0.01). Despite lower total daily insulin doses by a median 2.3 (interquartile range -4.7 to 9.3) units (P = 0.009), overall 24-h glucose was reduced by a mean 9 (SD 41) mg/dL (P = 0.006) during closed loop. CONCLUSIONS: Unsupervised home use of overnight closed loop in adolescents with type 1 diabetes is safe and feasible. Glucose control was improved during the day and night with fewer episodes of nocturnal hypoglycemia.

Description

Keywords

Adolescent, Blood Glucose, Child, Circadian Rhythm, Cross-Over Studies, Diabetes Mellitus, Type 1, Feasibility Studies, Female, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Time Factors, Treatment Outcome

Journal Title

Diabetes Care

Conference Name

Journal ISSN

0149-5992
1935-5548

Volume Title

37

Publisher

American Diabetes Association
Sponsorship
Diabetes UK (None)
TCC (None)
TCC (None)
Cambridge University Hospitals NHS Foundation Trust (CUH) (Roman Hovorka)
National Institute of Diabetes and Digestive and Kidney Diseases (R01DK085621)
Medical Research Council (G0600717)
Juvenile Diabetes Research Foundation Ltd (JDRF) (22-2007-1801)
Juvenile Diabetes Research Foundation Ltd (JDRF) (22-2006-1113)
Juvenile Diabetes Research Foundation (22-2009-801)
Diabetes UK (None)
Supported by Juvenile Diabetes Research Foundation (#22-2006-1113, #22-2007-1801, #22-2009-801, #22-2009-802), Diabetes UK (BDA07/0003549), National Institute of Diabetes and Digestive and Kidney Diseases (1R01DK085621), Medical Research Council Centre for Obesity and Related metabolic Diseases, and National Institute for Health Research Cambridge Biomedical Research Centre. Abbott Diabetes Care supplied continuous glucose delivery devices and sensors and modified devices to facilitate real-time connectivity.