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

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. +12 more·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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  • The iDCL Trial and its continuation with young children ages 2 to 6 years old completed several clinical protocols, three of which were published in the New England Journal of Medicine.

    “This large-scale study and its continuation with young children ages 2 to 6 years old completed several clinical protocols, three of which were published in the New England Journal of Medicine.[132][133][134]”

    From Developing the UVA/Padova Type 1 Diabetes Simulator: Modeling, Validation, Refinements, and Utility (2023) · cites this paper as [133]

    The Trial Conduct and Oversight and Trial Design and Patients sections document one pediatric clinical trial published in the New England Journal of Medicine. The paper studied children aged 6 to 13; it does not establish a continuation involving children aged 2 to 6 or that three protocols were published in the journal. (LLM, conf=0.85)

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  • Hybrid Closed Loop systems that might decrease the risk of DKA were not standard features of CSII treatment at the time of study inclusion.

    “Hybrid Closed Loop systems that might decrease the risk of DKA were not standard features of CSII treatment at the time of study inclusion. 22 , 23 , 26”

    From Insulin pump therapy is associated with higher rates of mild diabetic ketoacidosis compared to injection therapy: A 2‐year Swedish national survey of children and adolescents with type 1 diabetes (2022) · cites this paper as [22]

    The Trial Design and Patients section describes closed-loop control as a separate assigned treatment; control patients used their existing pumps or pumps with a predictive low-glucose suspend feature. This supports the distinction between closed-loop control and the pump treatment used in this trial, but does not establish what was standard in CSII treatment at the citing study’s inclusion date. The Adverse Events section reports no DKA in either group, so this trial cannot show a reduction in DKA risk. (LLM, conf=0.83)

    Experimental — accuracy not yet measured

  • The NEJM publications reported pivotal trials of the commercial descendant of DiAs, Control-IQ by Tandem Diabetes Care, in age groups 14 years old and older, 6 to 13 years old, and 2 to 6 years old.

    “These prestigious publications reported pivotal trials of the commercial descendant of DiAs-a new AID system (Control-IQ by Tandem Diabetes Care)-in different age groups: 14 years old and older, 132 6 to 13 years old, 133 and 2 to 6 years old.134”

    From Developing the UVA/Padova Type 1 Diabetes Simulator: Modeling, Validation, Refinements, and Utility (2023) · cites this paper as [133]

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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
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 · 2019: 1
FWCI
49.97
Type
journal article
Language
en
Open access
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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