Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop Trial
Elvira Isganaitis, Dan Raghinaru, Louise Ambler-Osborn, Jordan E. Pinsker, Bruce A. Buckingham, R. Paul Wadwa, Laya Ekhlaspour, Yogish C. Kudva, Carol J. Levy, Gregory P. Forlenza, Roy W. Beck, Craig Kollman, John W. Lum, Sue A. Brown, Lori M. Laffel, Boris Kovatchev, Stacey Anderson, Emma Emory, Mary Voelmle, Katie Conshafter, Kim Morris, Mary Oliveri, Linda Gondor-Fredrick, Harry Mitchell, Kayla Calvo, Christian Wakeman, Marc Breton, Emily Flint, Kenny Kim, Lindsay Roethke, Mei Mei Church, Camille André, Molly Piper, David Lam, Grenye O’Malley, Camilla Levister, Selassie Ogyaadu, Jessica Lovett, Vinaya Simha, Vikash Dadlani, Shelly McCrady-Spitzer, Corey Reid, Kanchan Kumari, Gregory P. Forlenza, G. Todd Alonso, Robert H. Slover, Emily Jost, Laurel H. Messer, Cari Berget, Lindsey Towers, Alex Rossick-Solis, Tali Jacobson, Marissa Town, Ideen Tabatabai, Jordan Keller, Evalina Salas, Francis J. Doyle, Eyal Dassau, Samantha Passman, Tiffany Campos, Carlos Murphy, Nandan Patibandla, Sarah Borgman, Guillermo Arreaza-Rubín, Neal Green, Boris Kovatchev, Sue A. Brown, Stacey Anderson, Marc Breton, Lori Laffel, Jordan Pinsker, Carol J. Levy, R. Paul Wadwa, Bruce A. Buckingham, Francis Doyle, Eric Renard, Claudio Cobelli, Yves Reznik, Guillermo Arreaza-Rubín, John Lum, Roy W. Beck, Robert Janicek, Deanna Gabrielson, Steven H. Belle, Jessica R. Castle, Jennifer Green, Laurent Legault, Steven M. Willi, Carol Wysham, Thomas Eggerman
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).