Garden, Gillian L. https://orcid.org/0000-0003-1111-8541
Fan, Ka Siu https://orcid.org/0000-0002-0861-1944
Paterson, Megan https://orcid.org/0009-0005-1091-1603
Shojaee-Moradie, Fariba https://orcid.org/0000-0002-3514-0447
Borg Inguanez, Monique https://orcid.org/0000-0003-3496-7132
Manoli, Antonios
Edwards, Victoria
Lee, Vivienne
Frier, Brian M. https://orcid.org/0000-0002-9590-9473
Hutchison, Ewan J.
Maher, Declan
Mathieu, Chantal https://orcid.org/0000-0002-4055-5233
Mitchell, Stuart J.
Heller, Simon R. https://orcid.org/0000-0002-2425-9565
Roberts, Graham A.
Shaw, Kenneth M. https://orcid.org/0000-0002-0846-3013
Koehler, Gerd
Mader, Julia K. https://orcid.org/0000-0001-7854-4233
King, Bruce R. https://orcid.org/0000-0002-8958-7404
Russell-Jones, David L. https://orcid.org/0000-0002-9490-2480
,
Mathieu, Chantal
Russell-Jones, David
Eekhoff, E. Marelise W.
Hutchison, Ewan
Shojaee-Moradie, Fariba
Strollo, Felice
Köhler, Gerd
Roberts, Graham
Mader, Julia
Cigler, Monika
Mecani, Renald
Helsdingen, Richard
Mitchell, Stuart
Pieber, Thomas
Funding for this research was provided by:
European Union Aviation Safety Agency
Article History
Received: 4 July 2024
Accepted: 29 August 2024
First Online: 4 November 2024
Acknowledgements
: We thank B. Dick (Tams Group, Australia) for assisting with the design and construction of our equipment setup, and D. Connolly (QinetiQ, Salisbury, UK) and QinetiQ Ltd, MOD Boscombe Down for facilitating our experiments in the hypobaric chamber. We also thank the teams at Insulet, Medtronic and Tandem Diabetes Care for their product support. We are very grateful to the pilots with insulin-treated diabetes who participated in this study. We also thank J. Vening and J. Montague (aeromedical nurses, UK CAA) and D. Coghlan (aeromedical nurse, IAA) for their help with data collection and management. We also thank C. I. Panait and P. N. P. Caetano for their input on this manuscript as technical reviewers for EASA (EASA, Germany). No other individual or agency was involved in the preparation of this manuscript. The hypobaric simulation study was presented as an e-poster discussion at the 7th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) 2024 conference, 6–9 March. The abstract was titled ‘The effects of atmospheric pressure experienced during routine airline flight on infusion rates of insulin pumps’ and was published in <i>Diabetes Technology & Therapeutics</i>, Volume 26, Issue S2/February, as abstract no. 144 (page A-133). This study has also been accepted at the 60th EASD Annual Meeting under the title of ‘Simulated commercial flights and the effects of atmospheric pressure changes on insulin pump delivery’. The findings of the retrospective observational study were presented as an oral presentation at the 7th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) 2024 conference on 6–9 March. The abstract was titled ‘The effects of changes in atmospheric pressure on glycaemic control in pilots with insulin-treated diabetes using insulin pumps during commercial flying’ and was published in <i>Diabetes Technology & Therapeutics</i>, Volume 26, Issue S2/February, as abstract no. 659 (page A-58).EASA Consortium members are as follows: Chantal Mathieu (KU Leuven, Leuven, Belgium), David Russell-Jones (University of Surrey, Guildford, UK), E. Marelise W. Eekhoff (Amsterdam University Medical Center, Amsterdam, the Netherlands), Ewan Hutchison (Civil Aviation Authority, Crawley, UK), Fariba Shojaee-Moradie (University of Surrey, Guildford, UK), Felice Strollo (IRCCS San Raffaele Pisana, Rome, Italy), Gerd Köhler (Medical University of Graz, Graz, Austria), Graham Roberts (Irish Aviation Authority, Dublin, Ireland), Julia Mader (Medical University of Graz, Graz, Austria), Monika Cigler (Medical University of Graz, Graz, Austria), Renald Mecani (Medical University of Graz, Graz, Austria), Richard Helsdingen (TUI, Amsterdam, the Netherlands), Stuart Mitchell (University of Surrey, Guildford, UK) and Thomas Pieber (Medical University of Graz, Graz, Austria).
: Authors agree to make data and materials supporting the results or analyses presented in their paper available upon reasonable request.
: The hypobaric simulation part of the study was conducted in conjunction with the Safe Use of New technologies in Diabetes in Flight (SUNDIF; NCT06408558) funded by the EASA Horizon Europe Work Programme 2021–2022. Pumps and associated expenses were covered by unrestricted grants and gifts. Insulin pump manufacturers provided product support but were not involved in the study design or carrying out of the study. No additional sources of funding was received for the retrospective observational study.
: BMF is a member of the UK Civil Aviation (CAA) Advisory Panel for diabetes and flying and is a member of the advisory board of Zucara Pharmaceuticals. GK is contracted as an independent advisor to Austro Control and has received research funding, speaker and advisory board honoraria from Astra Zeneca, Amgen, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, Novartis, Novo Nordisk, Roche Diagnostics and Sanofi. CM is the president of EASD and serves or has served on the advisory panel for Novo Nordisk, Sanofi, Eli Lilly, Novartis, Boehringer Ingelheim, Roche, Medtronic, Imcyse, Insulet and Vertex. Financial compensation for these activities has been received by KU Leuven. KU Leuven has received research support for CM from Medtronic, Imcyse, Novo Nordisk, Sanofi and ActoBio Therapeutics. CM serves or has served on the speakers bureau for Novo Nordisk, Sanofi, Eli Lilly, Medtronic and Boehringer Ingelheim. Financial compensation for these activities has been received by KU Leuven. All external support of EASD is to be found on . JKM is a consultant physician for Internal Medicine, Dept of Internal Medicine Medical University of Graz, is a member on the advisory board of Abbott Diabetes Care, Becton-Dickinson, Boehringer Ingelheim, Eli Lilly, Embecta, Medtronic, Novo Nordisk A/S, Pharmasens AG, Roche Diabetes Care, Viatris and Sanofi-Aventis and received speaker honoraria from Abbott Diabetes Care, A. Menarini Diagnostics, AstraZeneca, Boehringer Ingelheim, Becton-Dickinson, Dexcom, Eli Lilly, Medtrust AG, MSD, Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis, Servier, Viatris and Ypsomed. She is a shareholder of decide Clinical Software GmbH and elyte Diagnostics and serves as CMO of elyte Diagnostics. SRH has served as a member of an expert panel of the UK CAA and provides consultancy for Novo Nordisk, Eli Lilly, and Zealand Pharma, for which his institution receives remuneration, and serves on speaker panels for Novo Nordisk and AstraZeneca, for which he receives personal remuneration. GAR is contracted as an independent advisor to the Irish Aviation Authority (IAA) and has received research funding and advisory board honoraria from Novo Nordisk, Mundipharma and Sanofi. KMS has served as a contracted medical consultant (clinical assessments) and an independent advisor to the UK Civil Aviation Authority (CAA). He has previously served on specialist advisory boards for Abbott, GSK, Merk, Novo Nordisk, Novartis, Pfizer, Sanofi and Servier. DLR-J is a Professor of Diabetes and Endocrinology at Royal Surrey County Hospital and at Nutritional Sciences, FHMS, University of Surrey, Guildford, Surrey, UK. He is also contracted as an independent advisor to the UK Civil Aviation Authority (CAA). He has received research funding and advisory board honoraria from Abbott Diabetes Care, AstraZeneca, Dexcom, Eli Lilly, Medtronic, Novartis, Novo Nordisk and Sanofi. The authors declare that there are no other relationships or activities that might bias, or be perceived to bias, their work.
: The conception and design of the studies were developed by GLG, MP, FSM, BRK, DLRJ, KSF, AM, VE, VL, GK, CM, MBI, EJH, DM, SJM, BMF, KMS, SRH, GAR and JKM. Data acquisition was executed by GLG, KSF, MP, FSM, AM, VE, VL, BRK and DRJ. The subsequent analysis and interpretation of the data was performed by GLG, KSF, MBI, MP, FSM, BRK and DRJ. The drafting of the manuscript was undertaken by GLG, KSF, MP, FSM, AM, VE, VL, GK, CM, JKM, BRK, MBI, EJH, DM, SJM, BMF, KMS, SRH, GAR and DRJ. Critical revision of the manuscript was carried out by GLG, KSF, MP, FSM, AM, VE, VL, GK, CM, JKM, BRK, MBI, EJH, DM, GK, SJM, BMF, KMS, SRH, GAR and DLRJ. All authors approved the final version of the manuscript. BRK and DRJ are the guarantors of the hypobaric simulation study and DLRJ is the guarantor for the retrospective observational study. As such, BRK and DLRJ had full access to the respective data in the studies and take responsibility for the integrity of the data and the accuracy of the data analysis.