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Article History

Received: 15 December 2022

Accepted: 14 September 2023

First Online: 9 October 2023

Declarations

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: The study will be conducted in accordance with guidelines for Good Clinical Practice (GCP) and the Declaration of Helsinki. All potential participants will be provided with written and verbal information regarding the study, the procedures involved and all potential risks related to participating. A study investigator will obtain written informed consent from each participant prior to commencing study procedures. The participant will be provided with a copy of the signed consent form.The study has received approval from an independent research ethics committee at the lead clinical site. No individual data will be identified. The ethics approval number is HREC 101/21. Any substantial amendments to the study protocol will be reported to the independent ethics committees for approval prior to implementation, updated on the ANZCTR, and the study investigators will be advised in writing. Safety and progress reports will be sent to the HREC. Reports will be forwarded to the HREC at least annually and within 3 months of study completion.The study will be sponsored and indemnified by St Vincent’s Hospital Melbourne. This sponsor had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data or decision to submit results.Sponsor Reference: SVHM 101/21Contact name: Dr. Megan Robertson MBBS FRACP FANZCA FCICMAddress: Group Chief Research Officer, St Vincent’s Health Australia; PO Box 2900; 41 Victoria Parade, Fitzroy VIC 3065.Telephone: + 61 3 9288 3895Email: megan.robertson@svha.org.au

: DNO has received honoraria from Medtronic, Insulet, Abbott, Novo and Sanofi; research support from Medtronic, Insulet, Dexcom, Roche, GlySense, BioCapillary and Endogenex; and is on Advisory Boards for Medtronic, Insulet, Abbott, Ypsomed, Novo and Sanofi.EIE’s institution has received research funding from Eli Lilly, Boehringer-Ingelheim, Novo Nordisk and Pharmasol. EIE has received funding for honoraria for speakers and advisory fees from Abbott, Bayer and Sanofi, and the money received is directly donated to EIE’s institution for diabetes research.SF has received honoraria for speaker fees for AstraZeneca, Boehringer-Ingelheim, Lilly and Novo Nordisk and honoraria for advisor fees for Medtronic, Mylan, Pfizer and Sanofi.ST reports nonfinancial support from Abbott Diabetes.