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 - 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 -