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Cited by 191Diabetes Management and ResearchDiabetes Management and EducationDiabetes and associated disorders

Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes

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Wadwa, R. Paul, Reed, Zachariah W., Buckingham, Bruce A., DeBoer, Mark D., Ekhlaspour, Laya, Forlenza, Gregory P., Schoelwer, Melissa, Lum, John +3 more·2023·New England Journal of Medicine
DOI 10.1056/nejmoa2210834PMC PMC10082994
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Abstract

BACKGROUND: Closed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety of initiating a closed-loop system virtually are unclear. METHODS: In this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least 2 years of age but younger than 6 years of age who had type 1 diabetes to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor. 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. Secondary outcomes included the percentage of time that the glucose level was above 250 mg per deciliter or below 70 mg per deciliter, the mean glucose level, the glycated hemoglobin level, and safety outcomes. RESULTS: A total of 102 children underwent randomization (68 to the closed-loop group and 34 to the standard-care group); the glycated hemoglobin levels at baseline ranged from 5.2 to 11.5%. Initiation of the closed-loop system was virtual in 55 patients (81%). The mean (±SD) percentage of time that the glucose level was within the target range increased from 56.7±18.0% at baseline to 69.3±11.1% during the 13-week follow-up period in the closed-loop group and from 54.9±14.7% to 55.9±12.6% in the standard-care group (mean adjusted difference, 12.4 percentage points [equivalent to approximately 3 hours per day]; 95% confidence interval, 9.5 to 15.3; P<0.001). We observed similar treatment effects (favoring the closed-loop system) on the percentage of time that the glucose level was above 250 mg per deciliter, on the mean glucose level, and on the glycated hemoglobin level, with no significant between-group difference in the percentage of time that the glucose level was below 70 mg per deciliter. There were two cases of severe hypoglycemia in the closed-loop group and one case in the standard-care group. One case of diabetic ketoacidosis occurred in the closed-loop group. CONCLUSIONS: In this trial involving young children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with a closed-loop system than with standard care. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; PEDAP ClinicalTrials.gov number, NCT04796779.).

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  • 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 [134]

    The Trial Design and Patients section identifies this as a Control-IQ trial in children aged at least 2 but younger than 6, supporting the citation’s role in identifying the youngest age-group trial. It does not establish that Control-IQ descended from DiAs, and its eligibility criteria excluded children who were already 6 years old. The older age groups are attached to other citations in the citing sentence. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • 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 [134]

  • Improvements with AID systems have been especially notable in vulnerable populations, such as young children and pregnant women with type 1 diabetes.

    “Improvements have been especially notable in vulnerable populations, such as young children 103 and pregnant women with type 1 diabetes.104”

    From The future of type 1 diabetes therapy (2025) · cites this paper as [103]

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Authors
Wadwa, R. P., Reed, Z. W., Buckingham, B. A., DeBoer, M. D., Ekhlaspour, L., Forlenza, G. P., Schoelwer, M., Lum, J., Kollman, C., Beck, R. W., & Breton, M. D.
Affiliations
University of California, San Francisco (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2023-03-16
Volume
388
Issue
11
Pages
991-1001
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2210834
PMC
PMC10082994
OpenAlex
W4324305901
Cited by
191
References
14
Citations by year
2026: 51 · 2025: 58 · 2024: 48 · 2023: 34
FWCI
39.18
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)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
National Institute of Diabetes and Digestive and Kidney Diseases (U01DK127551)
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, insulin pump, continuous glucose monitoring, glycemic control, children, HbA1c, hypoglycemia, diabetic ketoacidosis, insulin delivery, HbA1c variability
MeSH terms
Blood Glucose, Child, Child, Preschool, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Blood Glucose Self-Monitoring

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