title: Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents With Type 1 Diabetes: A Free-Living, Randomized Clinical Trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, U.K. Department of Paediatrics, University of Cambridge, Cambridge, U.K.
authors.forename: Martin
authors.initials: M
authors.lastname: Tauschmann
authors.affiliation: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, U.K. Department of Paediatrics, University of Cambridge, Cambridge, U.K.
authors.forename: Janet M
authors.initials: JM
authors.lastname: Allen
authors.affiliation: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, U.K. Department of Paediatrics, University of Cambridge, Cambridge, U.K.
authors.forename: Malgorzata E
authors.initials: ME
authors.lastname: Wilinska
authors.affiliation: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
authors.forename: Hood
authors.initials: H
authors.lastname: Thabit
authors.affiliation: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
authors.forename: Zoë
authors.initials: Z
authors.lastname: Stewart
authors.affiliation: The Jaeb Center for Health Research, Tampa, FL.
authors.forename: Peiyao
authors.initials: P
authors.lastname: Cheng
authors.affiliation: The Jaeb Center for Health Research, Tampa, FL.
authors.forename: Craig
authors.initials: C
authors.lastname: Kollman
authors.affiliation: Department of Paediatrics, University of Cambridge, Cambridge, U.K.
authors.forename: Carlo L
authors.initials: CL
authors.lastname: Acerini
authors.affiliation: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, U.K. Department of Paediatrics, University of Cambridge, Cambridge, U.K.
authors.forename: David B
authors.initials: DB
authors.lastname: Dunger
authors.affiliation: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, U.K. Department of Paediatrics, University of Cambridge, Cambridge, U.K. rh347@cam.ac.uk.
authors.forename: Roman
authors.initials: R
authors.lastname: Hovorka
mesh_terms: D000293:Adolescent; D000465:Algorithms; D001786:Blood Glucose / Q000378:metabolism; D002648:Child; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006946:Hyperinsulinism / Q000175:diagnosis; D007003:Hypoglycemia / Q000188:drug therapy; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D008297:Male; D011446:Prospective Studies; D012306:Risk
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin