Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial
Author:
Sherr Jennifer L.1ORCID, Bode Bruce W.2, Forlenza Gregory P.3, Laffel Lori M.4ORCID, Schoelwer Melissa J.5, Buckingham Bruce A.6, Criego Amy B.7, DeSalvo Daniel J.8ORCID, MacLeish Sarah A.9, Hansen David W.10, Ly Trang T.11ORCID, Sherr Jennifer L., Weyman Kate, Tichy Eileen, VanName Michelle, Brei Michelle, Zgorski Melinda, Steffen Amy, Carria Lori, Bode Bruce W., Busby Anna, Forlenza Gregory P., Wadwa R. Paul, Slover Robert, Cobry Erin, Messer Laurel, Laffel Lori M., Isganaitis Elvira, Ambler-Osborn Louise, Freiner Emily, Turcotte Christine, Volkening Lisa, Schoelwer Melissa, Brown Sue A., Krauthause Katie, Emory Emma, Oliveri Mary, Buckingham Bruce A., Ekhlaspour Laya, Kingman Ryan, Criego Amy B., Schwartz Betsy L., Gandrud Laura M., Grieme Aimee, Hyatt Jamie, DeSalvo Daniel J., McKay Siripoom, DeLaO Kylie, Villegas Carolina, MacLeish Sarah A., Wood Jamie R., Kaminski Beth A., Casey Terri, Campbell Wendy, Behm Kim, Adams Ramon, Hansen David W., Stone Sheri L., Bzdick Suzan, Bulger Jane, Agostini Lynn, Doolittle Sarah, Kivilaid Kaisa, Kleve Krista, Ly Trang T., Dumais Bonnie, Vienneau Todd, Huyett Lauren M., Lee Joon Bok, O’Connor Jason, Benjamin Eric,
Affiliation:
1. 1Department of Pediatrics, Yale School of Medicine, New Haven, CT 2. 2Atlanta Diabetes Associates, Atlanta GA 3. 3Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO 4. 4Joslin Diabetes Center, Harvard Medical School, Boston, MA 5. 5Center for Diabetes Technology, University of Virginia, Charlottesville, VA 6. 6Division of Pediatric Endocrinology, Department of Pediatrics, Stanford University, Stanford, CA 7. 7Park Nicollet Pediatric Endocrinology, International Diabetes Center, Minneapolis, MN 8. 8Department of Pediatrics, Baylor College of Medicine, Houston, TX 9. 9Department of Pediatrics, University Hospitals Cleveland Medical Center, Rainbow Babies and Children’s Hospital, Cleveland, OH 10. 10Department of Pediatrics, State University of New York Upstate Medical University, Syracuse, NY 11. 11Insulet Corporation, Acton, MA
Abstract
OBJECTIVE
Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population.
RESEARCH DESIGN AND METHODS
A total of 80 children aged 2.0–5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy.
RESULTS
There were no episodes of severe hypoglycemia or diabetic ketoacidosis. By study end, HbA1c decreased by 0.55% (6.0 mmol/mol) (P < 0.0001). Time with sensor glucose levels in target range 70–180 mg/dL increased by 10.9%, or 2.6 h/day (P < 0.0001), while time with levels <70 mg/dL declined by median 0.27% (P = 0.0204).
CONCLUSIONS
Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline.
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
Cited by
35 articles.
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