Elvira Isganaitis1, Dan Raghinaru2, Louise Ambler-Osborn1, Jordan E Pinsker3, Bruce A Buckingham4, R Paul Wadwa5, Laya Ekhlaspour4, Yogish C Kudva6, Carol J Levy7, Gregory P Forlenza5, Roy W Beck2, Craig Kollman2, John W Lum2, Sue A Brown8, Lori M Laffel1. 1. Research Division, Department of Pediatrics, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA. 2. Jaeb Center for Health Research, Tampa, Florida, USA. 3. Sansum Diabetes Research Institute, Santa Barbara, CA, USA. 4. Pediatric Endocrinology and Diabetes, Stanford Children's Health, Stanford, California, USA. 5. Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA. 6. Division of Endocrinology, Diabetes, Metabolism, Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA. 7. Department of Medicine, Endocrinology, Diabetes and Bone Diseases, Mount Sinai Diabetes Center, New York, New York, USA. 8. Endocrinology and Metabolism Division, Department of Medicine, Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.
Abstract
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).
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).
Entities:
Keywords:
Adolescents; Closed-loop control insulin delivery; Time in range; Young adult
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