A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes

Autor: 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
Přispěvatelé: 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), Université de Montpellier (UM)
Jazyk: angličtina
Rok vydání: 2020
Předmět:
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
Zdroj: New England Journal of Medicine
New England Journal of Medicine, Massachusetts Medical Society, 2020, 383 (9), pp.836-845. ⟨10.1056/NEJMoa2004736⟩
ISSN: 0028-4793
1533-4406
DOI: 10.1056/NEJMoa2004736⟩
Popis: 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
Databáze: OpenAIRE