Lived Experience of Advanced Hybrid Closed-Loop Versus Hybrid Closed-Loop: Patient-Reported Outcomes and Perspectives

Abstract

This article reports on the lived experience of Medtronic advanced hybrid closed-loop (AHCL) in comparison to first generation hybrid closed-loop (HCL) in a randomized, open-label, two-period crossover trial. Patient-reported outcome (PROs) measures were administered before randomization and at the end of each study period in 113 adolescents and young adults with type 1 diabetes. Glucose monitoring satisfaction subscales for emotional burden and behavioral burden improved significantly (P < 0.01) over time with use of AHCL versus HCL and co-occurred with glycemic improvements (reduced percent time above 180 mg/dL during the day and no change in % time less than 54 mg/dL across 24 h) and greater time in Auto Mode. PROs, including distress, technology attitudes, and hypoglycemia confidence, were not different. AHCL use was associated with improved glucose monitoring satisfaction. Satisfaction was greater in those participants who had more appreciable glycemic benefit and stayed in Auto Mode more often. Clinical Trial Registration number: NCT03040414.

Keywords: Adolescents; Automated insulin delivery; Closed loop; Patient-reported outcomes; Type 1 diabetes; Young adults.

Conflict of interest statement

K.K.H. reports grants from Dexcom, personal fees from LifeScan Diabetes Institute and Cercacor, Inc., outside the submitted work. M.P. reports grants from the National Institutes of Health via Health Partners, during the conduct of the study; grants from Insulet, Dexcom, Medtronic, Roche, Eli Lilly, Lexicon, OPKO, and AstraZeneca, grants and personal fees from Novo Nordisk and Sanofi, grants, personal fees, and owning stock from DreaMed Diabetes, personal fees from RSP Systems and Qulab Medical, grants and personal fees from Pfizer, grants and owning stock from Nutriteen Professional and NG Solutions, outside the submitted work. L.M.L. reports grants from the National Institutes of Health during the conduct of the study; personal fees from Sanofi, NovoNordisk, Eli Lilly, Roche, Lifescan, Convatec, Insulogic, Laxmi, Boehringer Ingelheim, Johnson & Johnson, Dexcom, and Insulet, outside the submitted work. D.S. reports grants from the National Institutes of Health, during the conduct of the study; grants from the Leona M. and Harry B. Helmsley Charitable Trust, outside the submitted work. T.D. reports owning stock in DreaMed Ltd. during the conduct of the study; grants and personal fees from AstraZeneca, Dexcom, Boehringer, NovoNordisk, Medtronic, Sanofi, Eli Lilly, and Insulet, outside the submitted work. S.A.W. reports grants from the National Institutes of Health, during the conduct of the study; personal fees from Medtronic, Insulet, Tandem, Eli Lilly, Sanofi, and Zealand, outside the submitted work. R.N. reports grants from National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, nonfinancial support from Medtronic MiniMed, Inc., during the conduct of the study; grants, personal fees, and other from DreaMed Diabetes Ltd., grants and nonfinancial support from Medtronic MiniMed, Inc., nonfinancial support from Dexcom, nonfinancial support from Insulet, grants, and personal fees from Eli Lilly, grants and personal fees from Novonordisk, outside the submitted work. J.S. reports no conflicts of interest. R.J.B. reports no conflicts of interest. P.C. reports personal fees from Dexcom outside the submitted work. R.B. reports grants from the National Institutes of Health, nonfinancial support from Medtronic Minimed, Inc., during the conduct of the study. R. Beck reports grants from National Institutes of Health, nonfinancial support from Medtronic during the conduct of the study; grants, nonfinancial support, and study supplies from Dexcom, consulting fees paid to nonprofit employer from Bigfoot Biomedical, outside the submitted work. R.M.B. reports grants and other from Abbott Diabetes Care, grants and other from Eli Lilly, outside the submitted work. In addition, Dr. M.P. has a patent WO2010097796 issued to DreaMed Diabetes, a patent WO2011039741 issued to DreaMed Diabetes, and a patent WO2019077482 pending.