Funding for this research was provided by:
Eli Lilly and Company (2017-6004)
Text and Data Mining valid from 2020-01-06
Received: 25 June 2019
Accepted: 23 December 2019
First Online: 6 January 2020
Ethics approval and consent to participate
: The study protocol was approved by Quorum Review, Inc. (now Advarra) (QR #33480/1) and was retrospectively registered on ExternalRef removed (#NCT03830840). Revision amendments, safety reports and progress reports will be submitted to Quorum Review, Inc. (now Advarra) and regulatory authorities as required by local laws and regulations. The Principal Investigator will not provide care to subjects; rather, subjects will receive care from their local health care provider. All participants will provide written informed consent. For minor participants (aged ≥7 years and < 18 years), both participant and parent will receive study information; the participant’s parent will sign on behalf of the minor participant and the minor will sign an assent form.
: Not applicable.
: Jessikah Morales, Namino Glantz, Arianna Larez, Wendy Bevier, Mary Conneely, and David Kerr are employees of Sansum Diabetes Research Institute. David Kerr is medical advisor to Glooko, Vicentra and Hi.Health. He has received remuneration for participation in advisory boards for Sanofi, Ascensia, NovoNordisk and Abbott Diabetes Care and is in receipt of research funding from Lilly, NovoNordisk and Sanofi.Ludi Fan, Beverly Reed, Carlos Alatorre, and Rosirene Paczkowski are employees and stockholders of Eli Lilly and Company.Tamim Ahmed, Andrew Mackenzie, and Ian Duncan declare that they have no competing interest.This study is partially funded by Eli Lilly and Company, and the study protocol has undergone peer-review by Eli Lilly and Company.