Cited by 455Diabetes Management and ResearchDiabetes Management and EducationDiabetes and associated disorders

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

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Breton, Marc D., Kanapka, Lauren G., Beck, Roy W., Ekhlaspour, Laya, Forlenza, Gregory P., Cengiz, Eda, Schoelwer, Melissa, Ruedy, Katrina J., Jost, Emily, Carria, Lori, Emory, Emma, Hsu, Liana J., Oliveri, Mary, Kollman, Craig C., Dokken, Betsy B., Weinzimer, Stuart A., DeBoer, Mark D., Buckingham, Bruce A., Cherñavvsky, Daniel, Wadwa, R. Paul·2020·New England Journal of Medicine

DOI 10.1056/nejmoa2004736PMC PMC7920146

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Abstract

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<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group. CONCLUSIONS: In this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.).

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Authors: Breton, M. D., Kanapka, L. G., Beck, R. W., Ekhlaspour, L., Forlenza, G. P., Cengiz, E., Schoelwer, M., Ruedy, K. J., Jost, E., Carria, L., Emory, E., Hsu, L. J., Oliveri, M., Kollman, C. C., Dokken, B. B., Weinzimer, S. A., DeBoer, M. D., Buckingham, B. A., Cherñavvsky, D., & Wadwa, R. P.
Affiliations: Stanford Medicine (US)
Yale University (US)
ORCID: Breton, Marc D.
Kanapka, Lauren G.
Beck, Roy W.
Ekhlaspour, Laya
Forlenza, Gregory P.
Cengiz, Eda
Schoelwer, Melissa
Jost, Emily
Oliveri, Mary
Kollman, Craig C.
Weinzimer, Stuart A.
DeBoer, Mark D.
Buckingham, Bruce A.
Cherñavvsky, Daniel
Wadwa, R. Paul
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2020-08-27
Volume: 383
Issue: 9
Pages: 836-845
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa2004736
PMC: PMC7920146
OpenAlex: W3080244655
Semantic Scholar: b2dc01402e937edd688a968cc993faf797fe24ad
Cited by: 455
References: 24
Citations by year: 2026: 54 · 2025: 68 · 2024: 65 · 2023: 84 · 2022: 88 · 2021: 78 · 2020: 15
FWCI: 49.97
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
HAL (submittedVersion)
Funders: Tandem Diabetes
National Institute of Diabetes and Digestive and Kidney Diseases
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords: type 1 diabetes, children, artificial pancreas, sensor-augmented pump, glycemic control, continuous glucose monitoring, hypoglycemia, HbA1c, diabetes technology, diabetic ketoacidosis, glycemic variability
MeSH terms: Adolescent, Blood Glucose, Child, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Injections, Subcutaneous, Insulin, Insulin Infusion Systems, Male, Infusion Pumps, Implantable, Diabetic Ketoacidosis, Pancreas, Artificial

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

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