Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy.

"Duality of Interest. G.M.D. reports research support from Insulet and has served as a consultant for Medscape. B.W.B. reports research support from Insulet during the conduct of the study, as well as research support from Abbott, Advance, Diasome, DexCom, Janssen, Eli Lilly and Company, Medtronic, Novo Nordisk, Provention Bio, Sanofi, Sanvita, Senseonics, REMD Biotherapeutics, Xeris, and vTv Therapeutics. B.W.B. reports consultant and speaking fees from Boehringer Ingelheim, Insulet, Eli Lilly and Company, Mannkind, Medtronic, Novo Nordisk, Sanofi, Senseonics, Xeris, and Zealand. A.L.C. conducts research sponsored by Medtronic, Abbott, Insulet, Dexcom, Sanofi, UnitedHealth, Eli Lilly and Company, and Novo Nordisk; and has served as a consultant, speaker, and/or advisory board member for Mannkind, Medtronic, and Sanofi. A.L.P. served on an advisory board for Abbott Diabetes Care, Astra-Zeneca, Eli Lilly and Company, NovoNordisk, Vertex, Zealand, and Medscape; and received research funding from Insulet, Dexcom, and Abbott. A.L.C. has stock options from Teladoc and Omada Health. L.M.H., B.D., T.E.V., and T.T.L. are full-time employees of and own stock in Insulet Corporation. No other potential conflicts of interest relevant to this article were reported."

"Funding. This study was funded by Insulet Corporation."

"This was a single-arm, multicenter feasibility study conducted in the U.S. across four clinical sites between November 2020 and July 2021. The protocol was approved by a central institutional review board and relevant local review boards. The U.S. Food and Drug Administration approved an investigational device exemption. An independent medical monitor provided study oversight. The trial was registered at ClinicalTrials.gov (identifier NCT04617795). Clinical trial registration no. NCT04617795, clinicaltrials.gov"