Visser, Margaretha M. http://orcid.org/0000-0003-0216-4028
Van Muylder, Astrid http://orcid.org/0000-0002-5387-6108
Charleer, Sara
Isitt, John J.
Roze, Stéphane
De Block, Christophe
Maes, Toon
Vanhaverbeke, Gerd
Nobels, Frank
Keymeulen, Bart
Mathieu, Chantal
Luyten, Jeroen
Gillard, Pieter http://orcid.org/0000-0001-9111-4561
Verhaeghe, Nick http://orcid.org/0000-0001-9956-4970
Funding for this research was provided by:
Dexcom (OUS-2018-011)
Article History
Received: 5 July 2023
Accepted: 8 November 2023
First Online: 18 January 2024
Acknowledgements
: University Hospitals Leuven (sponsor of the ALERTT1 trial) acted as sponsor of this study and received a research grant from Dexcom. Representatives of Dexcom reviewed the manuscript, but had no role in the study design, data collection, data analysis, data interpretation, writing of the report, or the decision to submit for publication. The authors would like to thank all the local investigators and their teams for collecting the data during the ALERTT1 trial. Some of the data were presented as an abstract at The Official Journal of ATTD Advanced Technologies & Treatments for Diabetes Conference in 2023.
: This cost–utility analysis is based on data from the original randomised controlled ALERTT1 trial. Please refer to the original manuscript for information on data availability [CitationRef removed].
: University Hospitals Leuven acted as sponsor of the ALERTT1 trial and received a research grant from Dexcom. Dexcom provided the experimental rtCGM device and technical support (to study teams only) in the case of device issues.
: UZ Leuven received non-financial support for travel from Novo Nordisk, and from Boehringer Ingelheim for MMV. MMV has served on the speakers bureau for Dexcom, and financial compensation for these activities has been received by KU Leuven. KU Leuven received research support from Roche Diabetes Care, Novo Nordisk and Sanofi for SC. JJI is an employee of Vyoo Agency USA, which has received consulting fees from Dexcom. SR is the CEO of Vyoo Agency, which has received consulting fees from Dexcom. CDB has received consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer Ingelheim, A. Menarini Diagnostics, Indigo Diabetes, Insulet, Eli Lilly, Medtronic, Novo Nordisk and Roche, and has served on advisory panels for Eli Lilly, Indigo Diabetes and Novo Nordisk. GV serves or has served on advisory panels for Merck Sharp and Dohme, Boehringer Ingelheim and Eli Lilly. GV has received consulting fees and honoraria for speaking from Merck Sharp and Dohme, Boehringer Ingelheim, AstraZeneca, Sanofi-Aventis, Novo Nordisk and Eli Lilly. FN has received consulting fees and honoraria for speaking from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Johnson and Johnson, Medtronic, Merck Sharp and Dohme, Novo Nordisk, Roche and Sanofi-Aventis. CM serves or has served on advisory panels for Novo Nordisk, Sanofi, Merck Sharp and Dohme, Eli Lilly, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, Imcyse, Insulet, Zealand Pharma, Avotres, Mannkind, Sandoz and Vertex. Financial compensation for these activities has been received by KU Leuven; KU Leuven has also received research support for CM from Medtronic, Imcyse, Novo Nordisk, Sanofi and ActoBio Therapeutics. CM also serves or has served on the speakers bureaux for Novo Nordisk, Sanofi, Eli Lilly, Boehringer Ingelheim, AstraZeneca and Novartis. Financial compensation for these activities has been received by KU Leuven. JL has acted as a technical advisor on economic evaluation of vaccines (for Pfizer and Merck Sharp and Dohme) and medically assisted reproduction (Merck), for which KU Leuven has received financial compensation. PG serves or has served on advisory panels for Novo Nordisk, Sanofi-Aventis, Boehringer Ingelheim, Janssen Pharmaceuticals, Roche, Medtronic, Abbott and Bayer. Financial compensation for these activities has been received by KU Leuven. PG serves or has served on the speakers bureaux for Merck Sharp and Dohme, Boehringer Ingelheim, Bayer, Medtronic, Insulet, Novo Nordisk, Abbott, Roche, VitalAire and Dexcom. Financial compensation for these activities has been received by KU Leuven. KU Leuven received non-financial support for travel for PG from Sanofi-Aventis, A. Menarini Diagnostics, Novo Nordisk, Medtronic and Roche. All disclosures are unrelated to the present work. AVM, TM, BK and NV declare that there are no relationships or activities that might bias, or be perceived to bias, their work.
: MMV and AVM contributed equally to this manuscript, both from their own professional expertise. MMV and AVM analysed and discussed the data, created figures and tables, and wrote the manuscript. JJI and SR performed statistical analyses, discussed the data, created figures and edited the manuscript. JL, PG and NV analysed and discussed the data, and wrote the manuscript. SC, CDB, TM, GV, FN, BK and CM analysed and discussed the data and edited the manuscript. MMV and PG are the guarantors of this work and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.