Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents With Type 1 Diabetes: A Free-Living, Randomized Clinical Trial.
American Diabetes Association
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Tauschmann, M., Allen, J., Wilinska, M., Thabit, H., Stewart, Z., Cheng, P., Kollman, C., et al. (2016). Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents With Type 1 Diabetes: A Free-Living, Randomized Clinical Trial.. Diabetes Care, 39 (7), 1168-1174. https://doi.org/10.2337/dc15-2078
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.
National Institute of Diabetes and Digestive and Kidney Diseases (1R01DK085621-01). Additional support for the Artificial Pancreas work by JDRF, National Institute for Health Research Cambridge Biomedical Research Centre and Wellcome Strategic Award (100574/Z/12/Z). Abbott Diabetes Care supplied discounted continuous glucose monitoring devices, sensors, and communication protocol to facilitate real-time connectivity. Diasend provided discounted platform for data upload.
Department of Health (via National Institute for Health Research (NIHR)) (EME 14/23/09)
Juvenile Diabetes Research Foundation Ltd (JDRF) (2-SRA-2014-256-M-R)
Cambridge University Hospitals NHS Foundation Trust (CUH) (Roman Hovorka)
National Institute of Diabetes and Digestive and Kidney Diseases (R01DK085621)
Medical Research Council (G0600717)
Wellcome Trust (100574/Z/12/Z)
External DOI: https://doi.org/10.2337/dc15-2078
This record's URL: https://www.repository.cam.ac.uk/handle/1810/253146