Real-World, Patient-Reported and Clinic Data from Individuals with Type 1 Diabetes Using the MiniMed 670G Hybrid Closed-Loop System
Stephanie N. DuBose, Colleen Bauza, Alandra Verdejo, Roy W. Beck, Richard M. Bergenstal, Jennifer L. Sherr, for the HYCLO Study Group, Carol J. Levy, Camilla Levister, David W. Lam, Grenye O’Malley, Selassie Ogyaadu, Jessica Lovett, Victoria Abram, Yogish C. Kudva, Shelly McCrady Spitzer, Corey Reid, Kanchan Kumari, Vikash Dadlani, Robin Goland, Sarah Pollak, Analía Álvarez, Eleanor Zagoren, Jennifer Deliard, Davida Kruger, Heather Hunter, Ana Smith, Heather Remtema, Paul Hiers, Anastasia Albanese-O’Neill, Michael J. Haller, Janey Adams, M Fernanda Greco, Anne L. Peters, Mark Harmel, Ruth S. Weinstock, Suzan Bzdick, Jane Bulger, Lynn Agonstini, Patricia Conboy, Sarah Doolittle, Grazia Aleppo, Anupam Bansal, Michael Thompson, Erek Arsiniega, Lisa Hubacz, Roshanak Monzavi, Jennifer Raymond, Daniel Brimberry, Alejandra Torres Sanchez, Jill H. Simmons, Kim Rainer, Faith Brendle, George E. Williams, Jennifer C. Kelley, Mark A. Clements, Ryan McDonough, Dara Watkins, Aliza Elrod, Barbara Seuferling, Heather P. Harding, Jennifer James, Steve Orlich, Vandana Raman, Carol M. Foster, Cassie Davis, Hillarie Slater, Zerina Ocanovic, Suzanne Kingery, Kupper A. Wintergerst, Sara E. Watson, Stephany Eubanks, Gwen Pierce, Heather Rush, Jenise C. Wong, Laura Dapkus, Jamie Wood, Ramon Adams, Gabe Blomquist, Lindsey Sterchi, Stephanie Welch, Diane Gouine, Sarah Racki, Juanita K. Hodax, Natalie Beauregard, Cisco Pascual, Cordelia Franklin, Kathleen E. Bethin, Indrajit Majumdar, Lucy D. Mastrandrea, Teresa Quattrin, Emily Tabaczynski, Amanda M. House
Abstract
Background: The purpose of this study was to collect 1 year of real-world data from individuals with type 1 diabetes (T1D) initiating the Medtronic 670G hybrid closed-loop insulin delivery system as part of usual care. We sought to expand current knowledge to understand how use of the system impacts patient-reported outcomes, in addition to clinical outcomes, for children and adults with T1D. Methods: Questionnaires were completed by the participant (and/or parent) before initiation of the 670G system (baseline) and at 6 weeks, 6 months, and 12 months from enrollment. Clinical data were obtained at routine clinical visits. Results: Of 132 participants who initiated Auto Mode, 80 completed the 12-month questionnaires while persisting with the system. Nearly all reported receiving adequate training on the 670G. Participant and parent-reported fear of hypoglycemia decreased by 6 and 11 points, respectively, from baseline to 12 months. More than half reported issues with sleep interruption at night due to alarms and 40% did not like frequent exits from Auto Mode. For the subset who had complete continuous glucose monitor data ( n = 27), mean percent time in target range (70–180 mg/dL) was 66% at baseline, and 74% and 68% at 6 and 12 months, respectively. Conclusions: With this study, we have captured real-time feedback from patients with T1D who initiated the 670G system and continued to use it over 12 months regarding their experience with the system. This has helped to illuminate both benefits and burdens associated with the first commercially available hybrid closed-loop system.