• Julia Ware, Janet M Allen, Charlotte K Boughton, Malgorzata E Wilinska, Sara Hartnell, Ajay Thankamony, Carine de Beaufort, Ulrike Schierloh, Elke Fröhlich-Reiterer, Julia K Mader, Thomas M Kapellen, Birgit Rami-Merhar, Martin Tauschmann, Katrin Nagl, Sabine E Hofer, Fiona M Campbell, James Yong, Korey K Hood, Julia Lawton, Stephane Roze, Judy Sibayan, Laura E Bocchino, Craig Kollman, Roman Hovorka, and KidsAP Consortium.
• From the Wellcome Trust-Medical Research Council (MRC) Institute of Metabolic Science (J.W., J.M.A., C.K.B., M.E.W., R.H.) and the Department of Paediatrics (J.W., M.E.W., A.T., R.H.), University of Cambridge, and the Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust (S.H.), Cambridge, the Department of Paediatric Diabetes, Leeds Children's Hospital, Leeds (F.M.C., J.Y.), and Usher Institute, University of Edinburgh, Edinburgh (J.L.) - all in the United Kingdom; Diabetes and Endocrine Care Clinique Pédiatrique, Clinique Pédiatrique, Centre Hospitalier de Luxembourg, Luxembourg (C.B., U.S.); the Department of Pediatric Endocrinology, Universitair Ziekenhuis Brussel-Vrije Universiteit Brussel, Brussels (C.B.); the Department of Pediatric and Adolescent Medicine (E.F.-R.), and the Division of Endocrinology and Diabetology, Department of Internal Medicine (J.K.M.), Medical University of Graz, Graz, the Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (B.R.-M., M.T., K.N.), and the Department of Pediatrics I, Medical University of Innsbruck, Innsbruck (S.E.H.) - all in Austria; the Hospital for Children and Adolescents, University of Leipzig, Leipzig, and the Hospital for Children and Adolescents "am Nicolausholz," Bad Kösen - both in Germany (T.M.K.); the Division of Pediatric Endocrinology, Stanford University, Stanford, CA (K.K.H.); Vyoo Agency, Lyon, France (S.R.); and the Jaeb Center for Health Research, Tampa, FL (J.S., L.E.B., C.K.).
• N. Engl. J. Med. 2022 Jan 20; 386 (3): 209-219.

BackgroundThe possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear.MethodsIn this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, >180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level, <70 mg per deciliter). Safety was assessed.ResultsA total of 74 participants underwent randomization. The mean (±SD) age of the participants was 5.6±1.6 years, and the baseline glycated hemoglobin level was 7.3±0.7%. The percentage of time with the glucose level in the target range was 8.7 percentage points (95% confidence interval [CI], 7.4 to 9.9) higher during the closed-loop period than during the control period (P<0.001). The mean adjusted difference (closed-loop minus control) in the percentage of time spent in a hyperglycemic state was -8.5 percentage points (95% CI, -9.9 to -7.1), the difference in the glycated hemoglobin level was -0.4 percentage points (95% CI, -0.5 to -0.3), and the difference in the mean sensor glucose level was -12.3 mg per deciliter (95% CI, -14.8 to -9.8) (P<0.001 for all comparisons). The time spent in a hypoglycemic state was similar with the two treatments (P = 0.74). The median time spent in the closed-loop mode was 95% (interquartile range, 92 to 97) over the 16-week closed-loop period. One serious adverse event of severe hypoglycemia occurred during the closed-loop period. One serious adverse event that was deemed to be unrelated to treatment occurred.ConclusionsA hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in hypoglycemia. (Funded by the European Commission and others; ClinicalTrials.gov number, NCT03784027.).Copyright © 2022 Massachusetts Medical Society.

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