Overnight Closed-Loop Insulin Delivery in Young People With Type 1 Diabetes: A Free-Living,Randomized Clinical Trial |
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Authors: | Roman Hovorka Daniela Elleri Hood Thabit Janet M. Allen Lalantha Leelarathna Ranna El-Khairi Kavita Kumareswaran Karen Caldwell Peter Calhoun Craig Kollman Helen R. Murphy Carlo L. Acerini Malgorzata E. Wilinska Marianna Nodale David B. Dunger |
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Affiliation: | 1.Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, United Kingdom;2.Department of Paediatrics, University of Cambridge, Cambridge, United Kingdom;3.Department of Medicine, University of Cambridge, Cambridge, United Kingdom;4.The Jaeb Center for Health Research, Tampa, FL |
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Abstract: | OBJECTIVETo evaluate feasibility, safety, and efficacy of overnight closed-loop insulin delivery in free-living youth with type 1 diabetes.RESEARCH DESIGN AND METHODSOvernight 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.RESULTSClosed 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.CONCLUSIONSUnsupervised 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. |
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