TY - JOUR
T1 - Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults
T2 - Outcomes from the International Diabetes Closed-Loop Trial
AU - Isganaitis, Elvira
AU - Raghinaru, Dan
AU - Ambler-Osborn, Louise
AU - Pinsker, Jordan E.
AU - Buckingham, Bruce A.
AU - Wadwa, R. Paul
AU - Ekhlaspour, Laya
AU - Kudva, Yogish C.
AU - Levy, Carol J.
AU - Forlenza, Gregory P.
AU - Beck, Roy W.
AU - Kollman, Craig
AU - Lum, John W.
AU - Brown, Sue A.
AU - Laffel, Lori M.
N1 - Funding Information:
E.I. reports grant support from NICHD R21HD091974, NIDDK (P30DK057521 and UC4DK108483), the Harold Hamm Foundation, and the Peabody Foundation. NIH/ NIDDK Grant UC4 108483. The University of Virginia Strategic Investment Fund Project #88 provided institutional and regulatory support. Tandem Diabetes Care provided the experimental closed-loop systems used in the trial, system-related supplies including the Dexcom CGM and Roche glucometer, and technical expertise. Tandem Diabetes Care was not involved in data analysis and was provided a copy of the article for review before publication.
Funding Information:
D.R. has no disclosures to report. L.A.-O. has received consulting fees from Dexcom. J.E.P. reports receiving grant support, provided to his institution, consulting fees, and speaker fees from Tandem Diabetes Care, grant support, provided to his institution, and advisory board fees from Medtronic, grant support, provided to his institution, and consulting fees from Eli Lilly, grant support and supplies, provided to his institution, from Insulet, and supplies, provided to his institution, from Dexcom. B.A.B. has received research funding from Tandem, Insulet Corp., Medtronic, Beta Bionics, Lilly, Convatec, and Dexcom. He has served on advisory boards for Medtronic, Novo Nordisk, and Convatec. R.P.W. reports receiving grant support and supplies, provided to his institution, from Tandem Diabetes Care, Dex-com, Beta Bionics, Eli Lilly, and MannKind and has served as a consultant/speaker for Eli Lilly and Tandem Diabetes Care. L.E. serves as a consultant for Tandem Diabetes Care. Y.C.K. received product support from Dexcom and Roche Diabetes and has consulted for Novo Nordisk. C.J.L. reports receiving advisory board fees from Sanofi, and grant support, paid to her institution, from Dexcom, Tandem Diabetes Care, Insulet, Abbott Diabetes, Senseonics, and Lexicon Pharmaceuticals. G.P.F. conducts research supported by Medtronic, Dexcom, Abbott, Tandem, Insulet, Beta Bionics, and Lilly and has been a consultant/speaker for Medtronic, Dexcom, Abbott, Tandem, Insulet, Beta Bionics, and Lilly. R.W.B. reports receiving consulting fees, paid to his institution, from Insulet, Bigfoot Biomedical, vTv Therapeutics, and Eli Lilly, grant support and supplies, provided to his institution, from Tandem and Dexcom, and supplies from Ascenia and Roche. C.K. has received consulting fees, paid to his institution, from Bigfoot Biomedical and grant support and supplies, provided to his institution, from Tandem and Dexcom. J.W.L. reports receiving consulting fees, paid to his institution, from Animas Corporation, Bigfoot Biomedical, Tandem Diabetes Care, and Eli Lilly. S.A.B. reports receiving grant support and supplies, provided to her institution, from Tandem Diabetes Care, In-sulet, and Tolerion, and supplies, provided to her institution, from Dexcom and Roche Diagnostics. L.M.L. has received consulting fees from Johnson & Johnson, Sanofi, Novo-Nordisk, Roche, Dexcom, Insulet, Boehringer Ingelheim, ConvaTec, Medtronic, Lifescan, Laxmi, and Insulogic.
Publisher Copyright:
© Copyright 2021, Mary Ann Liebert, Inc., publishers 2021.
PY - 2021/5
Y1 - 2021/5
N2 - Objective: To assess the efficacy and safety of closed-loop control (CLC) insulin delivery system in adolescents and young adults with type 1 diabetes. Research Design and Methods: Prespecified subanalysis of outcomes in adolescents and young adults aged 14-24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial. Participants were randomly assigned 2:1 to CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM) and followed for 6 months. Results: Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1%. All 63 completed the trial. Time in range (TIR) increased by 13% with CLC versus decreasing by 1% with SAP (adjusted treatment group difference = +13% [+3.1 h/day]; 95% confidence interval [CI] 9-16, P < 0.001), which largely reflected a reduction in time >180 mg/dL (adjusted difference -12% [-2.9 h/day], P < 0.001). Time <70 mg/dL decreased by 1.6% with CLC versus 0.3% with SAP (adjusted difference -0.7% [-10 min/day], 95% CI -1.0% to -0.2%, P = 0.002). CLC use averaged 89% of the time for 6 months. The mean adjusted difference in HbA1c after 6 months was 0.30% in CLC versus SAP (95% CI -0.67 to +0.08, P = 0.13). There was one diabetic ketoacidosis episode in the CLC group. Conclusions: CLC use for 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group. The clinical trial was registered with ClinicalTrials.gov (NCT03563313).
AB - Objective: To assess the efficacy and safety of closed-loop control (CLC) insulin delivery system in adolescents and young adults with type 1 diabetes. Research Design and Methods: Prespecified subanalysis of outcomes in adolescents and young adults aged 14-24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial. Participants were randomly assigned 2:1 to CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM) and followed for 6 months. Results: Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1%. All 63 completed the trial. Time in range (TIR) increased by 13% with CLC versus decreasing by 1% with SAP (adjusted treatment group difference = +13% [+3.1 h/day]; 95% confidence interval [CI] 9-16, P < 0.001), which largely reflected a reduction in time >180 mg/dL (adjusted difference -12% [-2.9 h/day], P < 0.001). Time <70 mg/dL decreased by 1.6% with CLC versus 0.3% with SAP (adjusted difference -0.7% [-10 min/day], 95% CI -1.0% to -0.2%, P = 0.002). CLC use averaged 89% of the time for 6 months. The mean adjusted difference in HbA1c after 6 months was 0.30% in CLC versus SAP (95% CI -0.67 to +0.08, P = 0.13). There was one diabetic ketoacidosis episode in the CLC group. Conclusions: CLC use for 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group. The clinical trial was registered with ClinicalTrials.gov (NCT03563313).
KW - Adolescents
KW - Closed-loop control insulin delivery
KW - Time in range
KW - Young adult
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U2 - 10.1089/dia.2020.0572
DO - 10.1089/dia.2020.0572
M3 - Article
C2 - 33216667
AN - SCOPUS:85099216886
SN - 1520-9156
VL - 23
SP - 342
EP - 349
JO - Diabetes Technology and Therapeutics
JF - Diabetes Technology and Therapeutics
IS - 5
ER -