Mellor, Joseph http://orcid.org/0000-0003-1452-887X
Kuznetsov, Dmitry http://orcid.org/0000-0002-9972-947X
Heller, Simon http://orcid.org/0000-0002-2425-9565
Gall, Mari-Anne http://orcid.org/0000-0001-7149-0092
Rosilio, Myriam http://orcid.org/0000-0003-0296-9061
Amiel, Stephanie A. http://orcid.org/0000-0003-2686-5531
Ibberson, Mark http://orcid.org/0000-0003-3152-5670
McGurnaghan, Stuart http://orcid.org/0000-0002-3292-4633
Blackbourn, Luke http://orcid.org/0000-0003-4234-8040
Berthon, William http://orcid.org/0000-0003-1776-4798
Salem, Adel http://orcid.org/0009-0004-7056-4466
Qu, Yongming http://orcid.org/0000-0003-3643-8066
McCrimmon, Rory J. http://orcid.org/0000-0002-3957-1981
de Galan, Bastiaan E. http://orcid.org/0000-0002-1255-7741
Pedersen-Bjergaard, Ulrik http://orcid.org/0000-0003-0588-4880
Leaviss, Joanna http://orcid.org/0000-0002-5632-6021
McKeigue, Paul M. http://orcid.org/0000-0002-5217-1034
Colhoun, Helen M. http://orcid.org/0000-0002-8345-3288
Funding for this research was provided by:
Innovative Medicines Initiative (777460)
Article History
Received: 21 December 2023
Accepted: 28 March 2024
First Online: 25 May 2024
Data availability
: The data underlying the results presented in the study come from the Hypo-RESOLVE data repository, which will be maintained for a 2 year period following the end of the Hypo-RESOLVE project. Enquiries about third-party researcher data access and associated access criteria should be sent to the Hypo-RESOLVE data access committee (Jakob Haardt J.Haardt@eurice.eu / Mark Ibberson Mark.Ibberson@sib.swiss; or via ).
: This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement no. 777460. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations and T1DExchange, JDRF, International Diabetes Federation and Helmsley Charitable Trust. The industry partners supporting the JU include Abbott Diabetes Care, Eli Lilly, Medtronic, Novo Nordisk and Sanofi-Aventis. Results reflects only the authors’ views and JU is not responsible for any use that may be made of the information it contains. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.
: HMC has research grants from JDRF and Diabetes UK. She has participated in a speakers bureau, on an advisory board for Novo Nordisk, on an advisory panel for Bayer AG, and is a shareholder of Roche Pharmaceuticals and Bayer AG. SH has participated on advisory boards for Eli Lilly and Novo Nordisk and on a speakers bureau for Novo Nordisk and has received honorarium via his institution from Medtronic. He has consulted for Vertex Pharma, Zucara Pharmaceuticals and Zealand Pharma. AS is an employee of, and holds shares in, Novo Nordisk. UP-B received personal honorarium for lectures, presentations and expert testimony from Sanofi and Novo Nordisk and is a member of the editorial board of <i>Diabetologia</i>. BEdG is a member of the editorial board of <i>Diabetologia</i>. RJM received personal honorarium for lectures, and presentations from Sanofi and Novo Nordisk, and support for travel to lecture at an educational event from Sanofi. He is a non-executive member of NHS Tayside Health Board. MR is an employee of, and holds shares in, Eli Lilly and Company. SAA has served on Advisory Boards for Vertex Pharmaceuticals and spoken at educational events sponsored by Sanofi and Novo Nordisk. M-AG is an employee of, and holds shares in, Novo Nordisk. All other authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.
: BEdG, UP-B, M-AG, MR, SAA, SH, JL, YQ, RJM, PMM and HMC contributed to the initial analysis plan, including the literature review on important risk factors of hypoglycaemia, that informed this analysis. DK, AS and MI were involved in data cleaning, harmonisation, quality control and databasing of the data. JM coded the data analysis. BEdG, UP-B, M-AG, MR, SAA, SH, JL, YQ, RJM, SM, LB, WB, PMM and HMC contributed to the interpretation of the data. JM and HMC drafted the initial manuscript. All authors made critically important contributions to manuscript revision and all authors approved the final version. HMC is the guarantor and, as such, is responsible for the integrity of the work as a whole.