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A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
Open accessAbstract
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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“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]
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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. 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]
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“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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Battelino, T., Danne, T., Bergenstal, R. M., Amiel, S. A., Beck, R., Biester, T., Bosi, E., Buckingham, B. A., Cefalu, W. T., Close, K. L., et al. (2019) · Diabetes Care · doi:10.2337/dci19-0028 · Cited by 4,237
Self-citationState of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016–2018
Foster, N. C., Beck, R. W., Miller, K. M., Clements, M. A., Rickels, M. R., DiMeglio, L. A., Maahs, D. M., Tamborlane, W. V., Bergenstal, R., Smith, E., et al. (2019) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2018.0384 · Cited by 1,907
Self-citationSix-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes
Brown, S. A., Kovatchev, B. P., Raghinaru, D., Lum, J. W., Buckingham, B. A., Kudva, Y. C., Laffel, L. M., Levy, C. J., Pinsker, J. E., Wadwa, R. P., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1907863 · Cited by 1,030
Self-citationOutpatient Glycemic Control with a Bionic Pancreas in Type 1 Diabetes
Russell, S. J., El-Khatib, F. H., Sinha, M., Magyar, K. L., McKeon, K., Goergen, L. G., BALLIRO, C. A., HILLARD, M. A., Nathan, D. M., & Damiano, E. R. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1314474 · Cited by 617
Home Use of an Artificial Beta Cell in Type 1 Diabetes
Thabit, H., Tauschmann, M., Allen, J. M., Leelarathna, L., Hartnell, S., Wilinska, M. E., Acerini, C. L., Dellweg, S., Benesch, C., Heinemann, L., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1509351 · Cited by 450
Self-citationHovorka, R., Allen, J. M., Elleri, D., Chassin, L. J., Harris, J. R., Xing, D., Kollman, C., Hovorka, T., Larsen, A. M. F., Nodale, M., et al. (2010) · The Lancet · doi:10.1016/s0140-6736(09)61998-x · Cited by 448
Self-citationNocturnal Glucose Control with an Artificial Pancreas at a Diabetes Camp
Phillip, M., Battelino, T., Atlas, E., Kordonouri, O., Bratina, N., Miller, S., Biester, T., Stefanija, M. A., Muller, I., Nimri, R., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1206881 · Cited by 431
13. Children and Adolescents: Standards of Medical Care in Diabetes−2020
American Diabetes Association (2019) · Diabetes Care · doi:10.2337/dc20-s013 · Cited by 287
Forlenza, G. P., Li, Z., Buckingham, B. A., Pinsker, J. E., Cengiz, E., Wadwa, R. P., Ekhlaspour, L., Church, M. M., Weinzimer, S. A., Jost, E., et al. (2018) · Diabetes Care · doi:10.2337/dc18-0771 · Cited by 246
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Phillip, M., Nimri, R., Bergenstal, R. M., Barnard-Kelly, K., Danne, T., Hovorka, R., Kovatchev, B. P., Messer, L. H., Parkin, C. G., Ambler-Osborn, L., et al. (2023) · Endocrine Reviews · doi:10.1210/endrev/bnac022 · Cited by 443
Self-citation14. Children and Adolescents: Standards of Medical Care in Diabetes—2022
(2021) · Diabetes Care · doi:10.2337/dc22-s014 · Cited by 385
Bergenstal, R. M., Nimri, R., Beck, R. W., Criego, A., Laffel, L., Schatz, D., Battelino, T., Danne, T., Weinzimer, S. A., Sibayan, J., et al. (2021) · The Lancet · doi:10.1016/s0140-6736(20)32514-9 · Cited by 344
Self-citationGrunberger, G., Sherr, J., Allende, M., Blevins, T., Bode, B., Handelsman, Y., Hellman, R., Lajara, R., Roberts, V. L., Rodbard, D., et al. (2021) · Endocrine Practice · doi:10.1016/j.eprac.2021.04.008 · Cited by 288
Brown, S. A., Forlenza, G. P., Bode, B. W., Pinsker, J. E., Levy, C. J., Criego, A. B., Hansen, D. W., Hirsch, I. B., Carlson, A. L., Bergenstal, R. M., et al. (2021) · Diabetes Care · doi:10.2337/dc21-0172 · Cited by 286
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Metadata
- 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
- 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
- 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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