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Article History

Received: 25 March 2024

Accepted: 2 September 2024

First Online: 17 October 2024

Declarations

:

: This manuscript describes the activities of a quality improvement initiative. As such they do not require review by an Institutional Review Board (IRB). This manuscript does not include data deemed to require IRB oversight. The relevant IRB is University of Michigan Institutional Review Boards (IRBMED), a unit of the Medical School Office of Research located at:Room 3214.North Campus Research Complex.Building 520, 2800 Plymouth Road.Ann Arbor, MI 48109 − 2800.Phone: 734-763-4768.Fax: 734-763-1234.Email: irbmed@umich.edu.The instance relevant to this manuscript for which MCT2D has submitted applications to the above reference IRB include:Convening and Conduction of the Patient Advisory Board.Regulatory Identifier: HUM00200547.Determination: Not Regulated.

: Not applicable.

: Informed consent was not obtained as part of this quality improvement initiative per the University of Michigan Institutional Review Board as the University does not require investigators to seek a formal “Not Regulated” determination from the IRB when the activity falls outside of the Common Rule and FDA definitions of human subjects research or where the University is not engaged in the research.” The relevant OHRP FAQ on this subject (see is cited above. Participating physician organizations agreed to aggregate reporting of de-identified data through data use agreements.

: Lauren Oshman: Stock holdings in the following companies that may be involved in producing products relevant to Type 2 Diabetes care: Procter Gamble, Johnson Johnson, Merck, Abbvie, Eli Lilly, Abbott, Dupont. Rodica Pop-Busui: Consultant: Novo Nordisk, Lexicon Pharmaceuticals, Roche, Nevro Inc, Procter and Gamble.