Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes
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. In this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least...
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| Published in | The New England journal of medicine Vol. 388; no. 11; pp. 991 - 1001 |
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| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Massachusetts Medical Society
16.03.2023
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0028-4793 1533-4406 1533-4406 |
| DOI | 10.1056/NEJMoa2210834 |
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| Abstract | 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.
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.
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.
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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| AbstractList | In children 2 to younger than 6 years of age with type 1 diabetes, a closed-loop control system was associated with a greater percentage of time in the target glycemic range than standard care. AbstractBackgroundClosed-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.MethodsIn 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.ResultsA 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.ConclusionsIn 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.) 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.BACKGROUNDClosed-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.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.METHODSIn 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.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.RESULTSA 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.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.).CONCLUSIONSIn 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.). 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. 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. 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. 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.). |
| Author | DeBoer, Mark D. Schoelwer, Melissa Breton, Marc D. Ekhlaspour, Laya Reed, Zachariah W. Forlenza, Gregory P. Kollman, Craig Buckingham, Bruce A. Lum, John Beck, Roy W. Wadwa, R. Paul |
| Author_xml | – sequence: 1 givenname: R. Paul orcidid: 0000-0002-4139-2122 surname: Wadwa fullname: Wadwa, R. Paul organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) – sequence: 2 givenname: Zachariah W. surname: Reed fullname: Reed, Zachariah W. organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) – sequence: 3 givenname: Bruce A. surname: Buckingham fullname: Buckingham, Bruce A. organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) – sequence: 4 givenname: Mark D. surname: DeBoer fullname: DeBoer, Mark D. organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) – sequence: 5 givenname: Laya surname: Ekhlaspour fullname: Ekhlaspour, Laya organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) – sequence: 6 givenname: Gregory P. surname: Forlenza fullname: Forlenza, Gregory P. organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) – sequence: 7 givenname: Melissa surname: Schoelwer fullname: Schoelwer, Melissa organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) – sequence: 8 givenname: John surname: Lum fullname: Lum, John organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) – sequence: 9 givenname: Craig surname: Kollman fullname: Kollman, Craig organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) – sequence: 10 givenname: Roy W. surname: Beck fullname: Beck, Roy W. organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) – sequence: 11 givenname: Marc D. surname: Breton fullname: Breton, Marc D. organization: From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) — both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.) |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/36920756$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Buckingham, Bruce Ekhlaspour, Laya Beck, Roy Conschafter, Katie Arreaza-Rubín, Guillermo Wysham, Carol Hiser, Shannon Berget, Cari Belle, Steven H Oliveri, Mary Janicek, Robert Krauthause, Katie Strayer, Heidi Eggerman, Thomas Hellmann, Amanda Slover, Robert Cullipher, Dillon Lange, Samantha Stamates-Roerty, Tracey Morales, Amanda Norlander, Lisa Suh, Bailey Kingman, Ryan Forlenza, Gregory Green, Neal Breton, Marc Hood, Korey Lum, John Towers, Lindsey Castle, Jessica Sullivan, Katie DeBoer, Mark Green, Jennifer Karami, Angela Escobar, Estella Messer, Laurel Jost, Emily Boranian, Emily Morgan, Marci Emory, Emma Wadwa, R Paul Schoelwer, Melissa Reed, Zachariah Davis, Julie Murphy, Carlos Willi, Steven M Cobry, Erin Gabrielson, Deanna Schneider-Utaka, Aika Kollman, Craig Legault, Laurent Geiser, Luke Van Kirk, Gena |
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| Copyright | Copyright © 2023 Massachusetts Medical Society. All rights reserved. Copyright © 2023 Massachusetts Medical Society. |
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| DOI | 10.1056/NEJMoa2210834 |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Feature-3 content type line 23 ObjectType-Undefined-2 Drs. Wadwa, Beck, and Breton contributed equally to this article. A full list of the Pediatric Artificial Pancreas (PEDAP) Trial Study Group members is provided in the Supplementary Appendix, available at NEJM.org. |
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| References | Nathan, DM, Genuth, S, Lachin, J (r10) 1993; 329 Ekhlaspour, L, Schoelwer, MJ, Forlenza, GP (r5) 2021; 23 Brown, SA, Kovatchev, BP, Raghinaru, D (r4) 2019; 381 Sherr, JL, Bode, BW, Forlenza, GP (r2) 2022; 45 Breton, MD, Kanapka, LG, Beck, RW (r3) 2020; 383 Beck, RW, Bocchino, LE, Lum, JW (r8) 2021; 23 Battelino, T, Danne, T, Bergenstal, RM (r9) 2019; 42 Ware, J, Allen, JM, Boughton, CK (r11) 2022; 386 Ly, TT, Breton, MD, Keith-Hynes, P (r7) 2014; 37 (r14) 2022; 387 Forlenza, GP, Ekhlaspour, L, DiMeglio, LA (r12) 2022; 23 Lee, JM, Carlson, E, Albanese-O’Neill, A (r6) 2021; 23 Kanapka, LG, Lum, JW, Beck, RW (r13) 2022; 24 Foster, NC, Beck, RW, Miller, KM (r1) 2019; 21 e_1_3_4_3_2 e_1_3_4_2_2 e_1_3_4_9_2 e_1_3_4_8_2 e_1_3_4_7_2 e_1_3_4_6_2 e_1_3_4_5_2 e_1_3_4_4_2 e_1_3_4_11_2 e_1_3_4_12_2 e_1_3_4_10_2 e_1_3_4_15_2 e_1_3_4_13_2 e_1_3_4_14_2 37285541 - N Engl J Med. 2023 Jun 8;388(23):2206. doi: 10.1056/NEJMc2304389. 37285540 - N Engl J Med. 2023 Jun 8;388(23):2205-2206. doi: 10.1056/NEJMc2304389. 37285542 - N Engl J Med. 2023 Jun 8;388(23):2206-2207. doi: 10.1056/NEJMc2304389. |
| References_xml | – volume: 387 start-page: 1161 year: 2022 end-page: 1172 ident: r14 article-title: Multicenter, randomized trial of a bionic pancreas in type 1 diabetes. publication-title: N Engl J Med – volume: 381 start-page: 1707 year: 2019 end-page: 1717 ident: r4 article-title: Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. publication-title: N Engl J Med – volume: 23 start-page: 384 year: 2021 end-page: 391 ident: r5 article-title: Safety and performance of the Tandem t:slim X2 with Control-IQ automated insulin delivery system in toddlers and preschoolers. publication-title: Diabetes Technol Ther – volume: 383 start-page: 836 year: 2020 end-page: 845 ident: r3 article-title: A randomized trial of closed-loop control in children with type 1 diabetes. publication-title: N Engl J Med – volume: 23 start-page: 642 year: 2021 end-page: 651 ident: r6 article-title: Adoption of telemedicine for type 1 diabetes care during the COVID-19 pandemic. publication-title: Diabetes Technol Ther – volume: 23 start-page: 324 year: 2022 end-page: 329 ident: r12 article-title: Glycemic outcomes of children 2–6years of age with type 1 diabetes during the pediatric MiniMed 670G system trial. publication-title: Pediatr Diabetes – volume: 45 start-page: 1907 year: 2022 end-page: 1910 ident: r2 article-title: Safety and glycemic outcomes with a tubeless automated insulin delivery system in very young children with type 1 diabetes: a single-arm multicenter clinical trial. publication-title: Diabetes Care – volume: 37 start-page: 2310 year: 2014 end-page: 2316 ident: r7 article-title: Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp. publication-title: Diabetes Care – volume: 329 start-page: 977 year: 1993 end-page: 986 ident: r10 article-title: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. publication-title: N Engl J Med – volume: 24 start-page: 396 year: 2022 end-page: 402 ident: r13 article-title: Insulin pump infusion set failures associated with prolonged hyperglycemia: frequency and relationship to age and type of infusion set during 22,741 infusion set wears. publication-title: Diabetes Technol Ther – volume: 23 start-page: 537 year: 2021 end-page: 545 ident: r8 article-title: An evaluation of two capillary sample collection kits for laboratory measurement of HbA1c. publication-title: Diabetes Technol Ther – volume: 386 start-page: 209 year: 2022 end-page: 219 ident: r11 article-title: Randomized trial of closed-loop control in very young children with type 1 diabetes. publication-title: N Engl J Med – volume: 21 start-page: 66 year: 2019 end-page: 72 ident: r1 article-title: State of type 1 diabetes management and outcomes from the T1D Exchange in 2016–2018. publication-title: Diabetes Technol Ther – volume: 42 start-page: 1593 year: 2019 end-page: 1603 ident: r9 article-title: Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. publication-title: Diabetes Care – ident: e_1_3_4_15_2 doi: 10.1056/NEJMoa2205225 – ident: e_1_3_4_4_2 doi: 10.1056/NEJMoa2004736 – ident: e_1_3_4_6_2 doi: 10.1089/dia.2020.0507 – ident: e_1_3_4_14_2 doi: 10.1089/dia.2021.0548 – ident: e_1_3_4_5_2 doi: 10.1056/NEJMoa1907863 – ident: e_1_3_4_11_2 doi: 10.1056/NEJM199309303291401 – ident: e_1_3_4_7_2 doi: 10.1089/dia.2021.0080 – ident: e_1_3_4_9_2 doi: 10.1089/dia.2021.0023 – ident: e_1_3_4_12_2 doi: 10.1056/NEJMoa2111673 – ident: e_1_3_4_8_2 doi: 10.2337/dc14-0147 – ident: e_1_3_4_2_2 doi: 10.1089/dia.2018.0384 – ident: e_1_3_4_3_2 doi: 10.2337/dc21-2359 – ident: e_1_3_4_13_2 doi: 10.1111/pedi.13312 – ident: e_1_3_4_10_2 doi: 10.2337/dci19-0028 – reference: 37285540 - N Engl J Med. 2023 Jun 8;388(23):2205-2206. doi: 10.1056/NEJMc2304389. – reference: 37285542 - N Engl J Med. 2023 Jun 8;388(23):2206-2207. doi: 10.1056/NEJMc2304389. – reference: 37285541 - N Engl J Med. 2023 Jun 8;388(23):2206. doi: 10.1056/NEJMc2304389. |
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| Snippet | In children 2 to younger than 6 years of age with type 1 diabetes, a closed-loop control system was associated with a greater percentage of time in the target... 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... AbstractBackgroundClosed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety... |
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| SubjectTerms | Adolescent Medicine Age groups Algorithms Automation Blood Glucose - analysis Blood Glucose Self-Monitoring Child Child, Preschool Childhood Diseases Children Clinical Medicine Clinical Medicine General Closed loop systems Coronaviruses COVID-19 Diabetes Diabetes mellitus (insulin dependent) Diabetes Mellitus, Type 1 - blood Diabetes Mellitus, Type 1 - drug therapy Diabetic ketoacidosis Endocrinology FDA approval Glucose Glucose monitoring Glycated Hemoglobin - analysis Hemoglobin Humans Hyperglycemia Hypoglycemia Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Infusion pumps Insulin Insulin - administration & dosage Insulin - adverse effects Insulin - therapeutic use Insulin Infusion Systems - adverse effects Ketoacidosis Kidney diseases Outpatient-Based Clinical Medicine Pediatrics Pediatrics General Software Statistical analysis Teenagers |
| SubjectTermsDisplay | Adolescent Medicine Childhood Diseases Clinical Medicine Clinical Medicine General Diabetes Endocrinology Outpatient-Based Clinical Medicine Pediatrics Pediatrics General |
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| Title | Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes |
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