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

Martin Tauschmann, Janet M Allen, Malgorzata E Wilinska, Hood Thabit, Zoë Stewart, Peiyao Cheng, Craig Kollman, Carlo L Acerini, David B Dunger, Roman Hovorka

Research output: Contribution to journalArticlepeer-review

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 and design 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.

Original languageEnglish
Pages (from-to)1168-1174
Number of pages7
JournalDiabetes Care
Volume39
Issue number7
DOIs
Publication statusPublished - 1 Jul 2016

Keywords

  • Adolescent
  • Algorithms
  • Blood Glucose/metabolism
  • Child
  • Cross-Over Studies
  • Diabetes Mellitus, Type 1/blood
  • Female
  • Humans
  • Hyperinsulinism/diagnosis
  • Hypoglycemia/drug therapy
  • Hypoglycemic Agents/administration & dosage
  • Insulin/administration & dosage
  • Insulin Infusion Systems
  • Male
  • Prospective Studies
  • Risk

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