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Randomized Controlled Trial Multicenter Study Comparative Study
Day and night home closed-loop insulin delivery in adults with type 1 diabetes: three-center randomized crossover study.
- Lalantha Leelarathna, Sibylle Dellweg, Julia K Mader, Janet M Allen, Carsten Benesch, Werner Doll, Martin Ellmerer, Sara Hartnell, Lutz Heinemann, Harald Kojzar, Lucy Michalewski, Marianna Nodale, Hood Thabit, Malgorzata E Wilinska, Thomas R Pieber, Sabine Arnolds, Mark L Evans, Roman Hovorka, and AP@home Consortium.
- Wellcome Trust-Medical Research Clinical Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.Department of Diabetes and Endocrinology, Addenbrooke's Hospital, Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, U.K.
- Diabetes Care. 2014 Jul 1;37(7):1931-7.
ObjectiveTo evaluate the feasibility of day and night closed-loop insulin delivery in adults with type 1 diabetes under free-living conditions.Research Design And MethodsSeventeen adults with type 1 diabetes on insulin pump therapy (means ± SD age 34 ± 9 years, HbA1c 7.6 ± 0.8%, and duration of diabetes 19 ± 9 years) participated in an open-label multinational three-center crossover study. In a random order, participants underwent two 8-day periods (first day at the clinical research facility followed by 7 days at home) of sensor-augmented insulin pump therapy (SAP) or automated closed-loop insulin delivery. The primary end point was the time when sensor glucose was in target range between 3.9 and 10.0 mmol/L during the 7-day home phase.ResultsDuring the home phase, the percentage of time when glucose was in target range was significantly higher during closed-loop compared with SAP (median 75% [interquartile range 61-79] vs. 62% [53-70], P = 0.005). Mean glucose (8.1 vs. 8.8 mmol/L, P = 0.027) and time spent above target (P = 0.013) were lower during closed loop, while time spent below target was comparable (P = 0.339). Increased time in target was observed during both daytime (P = 0.017) and nighttime (P = 0.013).ConclusionsCompared with SAP, 1 week of closed-loop insulin delivery at home reduces mean glucose and increases time in target without increasing the risk of hypoglycemia in adults with relatively well-controlled type 1 diabetes.© 2014 by the American Diabetes Association.
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