1. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
- Author
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Breton, Marc, Kanapka, Lauren, Beck, Roy, Ekhlaspour, Laya, Forlenza, Gregory, Cengiz, Eda, Schoelwer, Melissa, Ruedy, Katrina, Jost, Emily, Carria, Lori, Emory, Emma, Hsu, Liana, Oliveri, Mary, Kollman, Craig, Dokken, Betsy, Weinzimer, Stuart, DeBoer, Mark, Buckingham, Bruce, Cherñavvsky, Daniel, Wadwa, R. Paul, Research Group, iDCL Trial, Renard, Eric, University of Virginia [Charlottesville], Jaeb Center for Health Research, Stanford University, Barbara Davis Center for Childhood Diabetes (BDC), University of Colorado Anschutz [Aurora], Yale University School of Medicine, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), and Université de Montpellier (UM)
- Subjects
medicine.medical_specialty ,MESH: Hypoglycemia ,MEDLINE ,Insulin delivery ,MESH: Insulin ,030204 cardiovascular system & hematology ,Artificial pancreas ,law.invention ,03 medical and health sciences ,MESH: Insulin Infusion Systems ,MESH: Diabetic Ketoacidosis ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Diabetes mellitus ,MESH: Child ,MESH: Hypoglycemic Agents ,medicine ,030212 general & internal medicine ,Glycemic ,MESH: Adolescent ,Type 1 diabetes ,MESH: Humans ,business.industry ,MESH: Injections, Subcutaneous ,General Medicine ,medicine.disease ,MESH: Male ,3. Good health ,MESH: Glycated Hemoglobin A ,medicine.anatomical_structure ,MESH: Infusion Pumps, Implantable ,MESH: Blood Glucose ,Pancreas ,business ,MESH: Diabetes Mellitus, Type 1 ,MESH: Female ,MESH: Pancreas, Artificial ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
International audience; Background: A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes.Methods: In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.Results: A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P
- Published
- 2020