Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control
Erin Cobry, Lauren Kanapka, Eda Cengiz, Lori Carria, Laya Ekhlaspour, Bruce A. Buckingham, Korey K. Hood, Liana Hsu, Laurel H. Messer, Melissa J. Schoelwer, Emma Emory, Katrina J. Ruedy, Roy W. Beck, R. Paul Wadwa, Linda Gonder‐Frederick, Marc D. Breton, Mark D. DeBoer, Daniel R. Cherñavvsky, J. Robic, Mary Voelmle, Katie Conschafter, Kimberly Morris, Charlotte L. Barnett, Kelly Carr, Jacob Hellmann, Matthew Kime, Mary Oliveri, Gregory P. Forlenza, G. Todd Alonso, Robert Slover, Emily Jost, Cari Berget, Lindsey Towers, Samantha Lange, David M. Maahs, Rayhan Lal, Lisa Norlander, Marissa Town, Christine Weir, Kerren Smith, Deanna Shinksy, J. Roberto Viana, Stuart A. Weinzimer, Kate Weyman, Melinda Zgorski, Sarah Borgman, Jessica Rusnak, Craig Kollman, Carlos Murphy, Guillermo Arreza-Rubin, Neal Green, Boris Kovatchev, Sue A. Brown, Stacey M. Anderson, Marc D. Breton, Lori M. Laffel, Jordan Pinsker, Carol Levy, Yogish C. Kudva, Francis J. Doyle, Éric Renard, Claudio Cobelli, Yves Reznik, Guillermo Arreza-Rubin, John Lum, Robert Janicek, Deanna Gabrielson
Abstract
Introduction: Hybrid closed-loop systems increase time-in-range (TIR) and reduce glycemic variability. Person-reported outcomes (PROs) are essential to assess the utility of new devices and their impact on quality of life. This article focuses on the PROs for pediatric participants (ages 6–13 years) with type 1 diabetes (T1D) and their parents during a trial using the Tandem Control-IQ system, which was shown to increase TIR and improve other glycemic metrics. Research Design and Methods: One hundred and one children 6 to 13 years old with T1D were randomly assigned to closed-loop control (CLC) or sensor-augmented pump (SAP) in a 16-week randomized clinical trial with extension to 28 weeks during which the SAP group crossed over to CLC. Health-related quality of life and treatment satisfaction measures were obtained from children and their parents at baseline, 16 weeks, and 28 weeks. Results: Neither the children in the CLC group nor their parents had statistically significant changes in PRO outcomes compared with the SAP group at the end of the 16-week randomized controlled trial and the 28-week extension. Parents in the CLC group reported nonsignificant improvements in some PRO scores when compared with the SAP group at 16 weeks, which were sustained at 28 weeks. Sleep scores for parents improved from “poor sleep quality” to “adequate sleep quality” between baseline and 16 weeks, however, the change in scores was not statistically different between groups. Conclusions: Children with T1D who used the Control-IQ system did not experience increased burden compared with those using SAP based on person-reported outcomes from the children and their parents. Clinical Trials Registration: NCT03844789