Need for Regulatory Change to Incorporate Beyond A1C Glycemic Metrics

sponsorship: Support for the "Glycemic Outcomes Beyond A1C: Standardization and Implementation" meeting and development of this article was provided by The diaTribe Foundation. Abbott Diabetes Care, AstraZeneca, Boehringer Ingelheim, Becton Dickinson, Eli Lilly, Merck, Novo Nordisk, Sanofi, and The Apple Pickers Foundation provided funding to The diaTribe Foundation to support the consensus meeting. The diaTribe Foundation contracted with James S. Hirsch and C.G.P. for editorial support. S. A. has served on advisory boards for Novo Nordisk, Medtronic, and Roche. R.B.'s nonprofit employer has received consultant payments, research funds, or research supplies on his behalf from Abbott Diabetes Care, Animas, Ascenia, Bigfoot Biomedical, Dexcom, Insulet, Eli Lilly, Roche, and Tandem, with no personal compensation to R.B. R.M.B. declared research support, acted as a consultant, or has been on a scientific advisory board for Abbott Diabetes Care, Becton Dickinson, Dexcom, Eli Lilly, Glooko, Helmsley Charitable Trust, Hygieia, Johnson & Johnson, Medtronic, Merck, Novo Nordisk, Roche, and Sanofi. R.M.B.'s nonprofit employer contracts for his services and no personal income goes to R.M.B. He has inherited Merck stock. He is a volunteer for ADA and JDRF and has worked on the development and implementation of the AGP. Z.B. is a consultant/adviser for Sanofi, AstraZeneca, Janssen, Merck, Intarcia, and Novartis; a speaker for Amgen, Merck, AstraZeneca, and Janssen; and a stockholder in Allergan, Zimmer Biomet, and Novartis. A.B., K.L.C., I.C., and E.F. report disclosures for The diaTribe Foundation, which receives donations from a number of pharmaceutical and device companies in the diabetes field. A.B. and K.L.C. also report disclosures for Close Concerns, for which several academic institutions, government bodies, and pharmaceutical and device companies in the diabetes field subscribe to the company's fee-based newsletter, Closer Look. B.B. has received research funding from National Institutes of Health, Medtronic, Tandem, Insulet, Xeris, and Dexcom; has served on advisory board or consulted for Novo Nordisk, Tandem, and Convatec; and has received honorarium or expenses from Insulet and Novo Nordisk. T.D. has acted as consultant, advisory board member, or speaker for Abbott, Medtronic, Roche, Lexicon, Menarini, Boehringer Ingelheim, AstraZeneca, Novo Nordisk, Sanofi, Dexcom, and Eli Lilly and has received research grants from Abbott, AstraZeneca, Novo Nordisk, Medtronic, and Sanofi. He is a shareholder of DreaMed Diabetes, Ltd. D.D. has received speaker's honoraria from Dexcom and Insulet. B.F. has served on advisory panels for Eli Lilly, Novo Nordisk and the Kuwait Foundation for Science and has taken part in a speakers' bureau for Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Merck, Sanofi, Roche Diagnostics, and Takeda. R.A.G. is a consultant for Onduo and Health Reveal. G.G. has received research support from Medtronic and Novo Nordisk and is on the speakers' bureau for Eli Lilly, Novo Nordisk, Janssen, Boehringer Ingelheim, Sanofi, and AstraZeneca. I.H. has received a research grant from Medtronic Diabetes and has served as consultant with Abbott Diabetes Care, Adocia, Bigfoot Biomedical, and Roche. P.H., or institutions with which he is associated, received funding from AntriaBio, AstraZeneca, Biocon, GlaxoSmithKline, Janssen, Merck, Novo Nordisk, Roche Diagnostics, and Sanofi for his advisory, research, or speaking activities. L.L.has served as a consultant for Eli Lilly, Sanofi, Novo Nordisk, MannKind, AstraZeneca, Boehringer Ingelheim, Merck, Johnson & Johnson, Dexcom, Insulet, Roche Diagnostics, and Unomedical. C.G.P. has received consulting fees from Animas, CeQur, Dexcom, Insulet, Johnson & Johnson Diabetes Institute, Roche Diabetes Care, Sanofi, and Senseonics. A.L.P. has participated on advisory boards for Abbott Diabetes Care, Becton Dickinson, Bigfoot Biomedical, Boehringer Ingelheim, Eli Lilly, Lexicon, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, Sanofi, and Science 37. She has provided research support for Dexcom and MannKind and is on the speakers' bureau of Novo Nordisk. R.R. is a consultant for Dexcom, Merck, Novo Nordisk, and Intarcia. No other potential conflicts of interest relevant to this article were reported. (diaTribe Foundation, Abbott Diabetes Care, AstraZeneca, Boehringer Ingelheim, Becton Dickinson, Eli Lilly, Merck, Novo Nordisk, Sanofi, Apple Pickers Foundation, Animas, Ascenia, Bigfoot Biomedical, Dexcom, Insulet, Roche, Tandem, Glooko, Helmsley Charitable Trust, Hygieia, Johnson Johnson, Medtronic, National Institutes of Health, Xeris, Abbott, Medtronic Diabetes, AntriaBio, Biocon, GlaxoSmithKline, Janssen, Roche Diagnostics, CeQur, Johnson & Johnson Diabetes Institute, Roche Diabetes Care, Senseonics)