Need for regulatory change to incorporate beyond A1C glycemic metrics

Charles M. Alexander; Stephanie Amiel; Roy Beck; Richard M. Bergenstal; Zachary Bloomgarden; Adam Brown; Bruce Buckingham; William T. Cefalu; Kelly L. Close; Isabel Chin; Thomas Danne; Daniel DeSalvo; Jane K. Dickinson; Emily Fitts; Brian Frier; Robert A. Gabbay; George Grunberger; Irl Hirsch; Philip Home; Aaron Kowalski; Lori Laffel; Anthony McCall; Christopher G. Parkin; Anne L. Peters; Robert Ratner; Bart Van Der Schueren; Richard Wood

doi:10.2337/dci18-0010

Need for regulatory change to incorporate beyond A1C glycemic metrics

Charles M. Alexander, Stephanie Amiel, Roy Beck, Richard M. Bergenstal, Zachary Bloomgarden, Adam Brown, Bruce Buckingham, William T. Cefalu, Kelly L. Close, Isabel Chin, Thomas Danne, Daniel DeSalvo, Jane K. Dickinson, Emily Fitts, Brian Frier, Robert A. Gabbay, George Grunberger, Irl Hirsch, Philip Home, Aaron KowalskiLori Laffel, Anthony McCall, Christopher G. Parkin, Anne L. Peters, Robert Ratner, Bart Van Der Schueren, Richard Wood

Research output: Contribution to journal › Article › peer-review

75 Scopus citations

Original language	English
Pages (from-to)	e92-e94
Journal	Diabetes Care
Volume	41
Issue number	6
DOIs	https://doi.org/10.2337/dci18-0010
State	Published - 1 Jun 2018

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10.2337/dci18-0010

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Alexander, C. M., Amiel, S., Beck, R., Bergenstal, R. M., Bloomgarden, Z., Brown, A., Buckingham, B., Cefalu, W. T., Close, K. L., Chin, I., Danne, T., DeSalvo, D., Dickinson, J. K., Fitts, E., Frier, B., Gabbay, R. A., Grunberger, G., Hirsch, I., Home, P., ... Wood, R. (2018). Need for regulatory change to incorporate beyond A1C glycemic metrics. Diabetes Care, 41(6), e92-e94. https://doi.org/10.2337/dci18-0010

@article{e36a86d2f1c64c699c1bd4c2aadebbac,

title = "Need for regulatory change to incorporate beyond A1C glycemic metrics",

author = "Alexander, {Charles M.} and Stephanie Amiel and Roy Beck and Bergenstal, {Richard M.} and Zachary Bloomgarden and Adam Brown and Bruce Buckingham and Cefalu, {William T.} and Close, {Kelly L.} and Isabel Chin and Thomas Danne and Daniel DeSalvo and Dickinson, {Jane K.} and Emily Fitts and Brian Frier and Gabbay, {Robert A.} and George Grunberger and Irl Hirsch and Philip Home and Aaron Kowalski and Lori Laffel and Anthony McCall and Parkin, {Christopher G.} and Peters, {Anne L.} and Robert Ratner and {Van Der Schueren}, Bart and Richard Wood",

note = "Funding Information: 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.{\textquoteright}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{\textquoteright}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{\textquoteright}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{\textquoteright} 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{\textquoteright} bureau for Eli Lilly, Novo Nordisk, Janssen, Boehringer Ingelheim, Sanofi, and Astra-Zeneca. 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 In-gelheim, 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 Sense-onics. 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{\textquoteright} 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. Author Contributions. All members of the Beyond A1C Writing Group contributed significantly to the writing, editing, and reviewing process. W.T.C. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Funding Information: to acknowledge James S. Hirsch (The diaTribe Foundation) for his editing and writing contributions. Funding and Duality of Interest. 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.{\textquoteright}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.",

year = "2018",

month = jun,

day = "1",

doi = "10.2337/dci18-0010",

language = "English",

volume = "41",

pages = "e92--e94",

journal = "Diabetes Care",

issn = "0149-5992",

publisher = "American Diabetes Association Inc.",

number = "6",

}

Alexander, CM, Amiel, S, Beck, R, Bergenstal, RM, Bloomgarden, Z, Brown, A, Buckingham, B, Cefalu, WT, Close, KL, Chin, I, Danne, T, DeSalvo, D, Dickinson, JK, Fitts, E, Frier, B, Gabbay, RA, Grunberger, G, Hirsch, I, Home, P, Kowalski, A, Laffel, L, McCall, A, Parkin, CG, Peters, AL, Ratner, R, Van Der Schueren, B & Wood, R 2018, 'Need for regulatory change to incorporate beyond A1C glycemic metrics', Diabetes Care, vol. 41, no. 6, pp. e92-e94. https://doi.org/10.2337/dci18-0010

TY - JOUR

T1 - Need for regulatory change to incorporate beyond A1C glycemic metrics

AU - Alexander, Charles M.

AU - Amiel, Stephanie

AU - Beck, Roy

AU - Bergenstal, Richard M.

AU - Bloomgarden, Zachary

AU - Brown, Adam

AU - Buckingham, Bruce

AU - Cefalu, William T.

AU - Close, Kelly L.

AU - Chin, Isabel

AU - Danne, Thomas

AU - DeSalvo, Daniel

AU - Dickinson, Jane K.

AU - Fitts, Emily

AU - Frier, Brian

AU - Gabbay, Robert A.

AU - Grunberger, George

AU - Hirsch, Irl

AU - Home, Philip

AU - Kowalski, Aaron

AU - Laffel, Lori

AU - McCall, Anthony

AU - Parkin, Christopher G.

AU - Peters, Anne L.

AU - Ratner, Robert

AU - Van Der Schueren, Bart

AU - Wood, Richard

N1 - Funding Information: 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 Astra-Zeneca. 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 In-gelheim, 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 Sense-onics. 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. Author Contributions. All members of the Beyond A1C Writing Group contributed significantly to the writing, editing, and reviewing process. W.T.C. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Funding Information: to acknowledge James S. Hirsch (The diaTribe Foundation) for his editing and writing contributions. Funding and Duality of Interest. 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.

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DO - 10.2337/dci18-0010

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