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Aims/hypothesis: Glycaemic control and clinical outcomes in diabetes are improved by continuous subcutaneous insulin infusion (CSII). Atmospheric pressure changes during flights may affect insulin delivery from pumps and cause unintended metabolic consequences, including hypoglycaemia, in people with type 1 diabetes. The present report evaluates both hypobaric flight simulation and real-world data in pilots using insulin pumps while flying., Methods: In the flight simulation part of this study, an in vitro study of insulin pumps was conducted in a hypobaric chamber, de-pressurised to 550 mmHg to mimic the atmospheric pressure changes in airliner cabins during commercial flights. Insulin delivery rates and bubble formation were recorded for standard flight protocol. Insulin infusion sets, without pumps, were tested in a simulated rapid decompression scenario. The real-world observational study was a 7.5-year retrospective cohort study in which pre- and in-flight self-monitored blood glucose (SMBG) values were monitored in pilots with insulin-treated diabetes. Commercial and private pilots granted a medical certificate to fly within the European Union Aviation Safety Agency approved protocol and receiving insulin either by pump or multiple daily injections (MDI) were included., Results: In the flight simulation study, full cartridges over-delivered 0.60 U of insulin during a 20 min ascent and under-delivered by 0.51 U during descent compared with ground-level performance. During emergency rapid decompression, 5.6 U of excess insulin was delivered. In the real-world study, seven pilots using CSII recorded 4656 SMBG values during 2345 h of flying across 1081 flights. Only 33 (0.7%) values were outside an acceptable safe range (5.0-15.0 mmol/l [90-270 mg/dl]). No clinically significant fall in the median SMBG concentration was observed after aircraft ascent and no in-flight SMBG values were within the hypoglycaemic range (<4.0 mmol/l [<72 mg/dl]). Compared with pilots receiving MDI therapy, pilots using CSII recorded more SMBG values within the acceptable range (99.3% vs 97.5%), fewer values in the low red range (0.02% vs 0.1%), fewer in-flight out-of-range values (0.2% vs 1.3%) and maintained stricter glycaemic control during flight., Conclusions/interpretation: Ambient pressure reduction during simulated flights results in bubble formation and expansion within insulin cartridges. This causes unintended delivery of small insulin doses independent of pre-determined delivery rates and represents the maximum amount of insulin that could be delivered and retracted. However, in vivo, pilots using CSII in-flight did not experience a fall in blood glucose or episodes of hypoglycaemia during these atmospheric pressure changes and the use of insulin pumps can be endorsed in view of their clinical benefits., Competing Interests: 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 Diabetes Technology & Therapeutics, 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 Diabetes Technology & Therapeutics, 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). Data availability: Authors agree to make data and materials supporting the results or analyses presented in their paper available upon reasonable request. Funding: 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. Authors’ relationships and activities: 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 www.easd.org . 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. Contribution statement: 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., (© 2024. The Author(s).)

Background and Aims: A preliminary study compared the use of continuous glucose monitoring (CGM) with the use of self-monitored blood glucose (SMBG) by aircraft pilots with insulin-treated diabetes in the United Kingdom, Ireland, and Austria, certified to fly commercial aircraft within the European Aviation Safety Agency ARA.MED.330 protocol. Methods: SMBG and simultaneous interstitial glucose measurements using CGM (Dexcom G6 ® ) were recorded during pre- and in-flight periods. Results: Eight male pilots (seven with type 1 diabetes and one with type 3c diabetes), median age of 48.5 years and median diabetes duration of 11.5 years, participated. The correlation coefficient ( R ) between 874 contemporaneously recorded SMBG and CGM values was 0.843, P  < 0.001. The mean glucose concentration was 8.78 mmol/L (standard deviation [SD] 0.67) using SMBG compared with 8.71 mmol/L (SD 0.85) recorded using CGM. The mean absolute relative difference was 9.39% (SD 3.12). Conclusions: CGM using Dexcom G6 systems is a credible alternative to SMBG for monitoring glucose levels when insulin-treated pilots fly commercial aircraft. The study was registered with Clinical Trials.gov NCT04395378.

Aim: To examine blood glucose measurements recorded as part of the diabetes protocol operated by the UK, Ireland and Austria, which allows commercial airline pilots with insulin-treated diabetes to fly., Methods: An observational study was conducted in pilots with insulin-treated diabetes, granted medical certification to fly commercial or noncommercial aircraft, who recorded pre-flight and hourly in-flight blood glucose measurements. These values were correlated to a traffic light system (green 5.0 to 15.0 mmol/L; amber 4.0 to 4.9 mmol/L and 15.1 to 20.0 mmol/L; and red <4.0 mmol/L or >20.0 mmol/L) and studied for trends in glucose concentrations, time course within flight and any consequences. Pilot demographics were also analysed., Results: Forty-four pilots (90%) recorded one or more blood glucose value outside the green range during the 7 years of the study. Pilot age, diabetes type and duration, and follow-up period were comparable among subgroups, and mean glycated haemoglobin did not differ before and after certification in a way which would indicate poorer glycaemic control in any subgroup. A total of 892 blood glucose values (2.31%) were outside the green range, with half reported in-flight at various time intervals. There were 48 (0.12%) low red range values recorded, 14 (0.04%) of which occurred in-flight; all but four were restored to within the green range by the time of the next measurement. Appropriate corrective action was taken for all out-of-range values, with no reports of pilot incapacitation from any cause., Conclusions: The traffic light system appears effective in identifying and reducing the frequency and severity of out-of-range values., (© 2021 John Wiley & Sons Ltd.)

Objective: The risk of hypoglycemia in people with insulin-treated diabetes has debarred them from certain "safety-critical" occupations, including flying commercial aircraft. This report evaluates the effectiveness of a protocol enabling a large cohort of insulin-treated pilots to fly commercially., Research Design and Methods: This was an observational study of pilots with insulin-treated diabetes who were granted medical certification to fly commercial and noncommercial aircraft. Clinical details, pre- and in-flight (hourly and 30 min before landing) blood glucose values were correlated against the protocol-specified ranges: green (5-15 mmol/L), amber (low, 4-4.9 mmol/L; high, 15.1-20 mmol/L), and red (low, <4 mmol/L; high, >20 mmol/L)., Results: A total of 49 pilots with type 1 (84%) or type 2 (16%) diabetes who had been issued class 1 or class 2 certificates were studied. Median diabetes duration was 10.9 years. Mean HbA 1c was 7.2% (55.0 mmol/mol) before certification and 7.2% (55.1 mmol/mol) after certification ( P = 0.97). Blood glucose values ( n = 38,621) were recorded during 22,078 flying hours. Overall, 97.69% of measurements were within the green range, 1.42% within the low amber range, and 0.75% within the high amber range. Only 0.12% of readings were within the low red range and 0.02% within the high red range. Out-of-range readings declined from 5.7% in 2013 to 1.2% in 2019. No episodes of pilot incapacitation occurred, and glycemic control did not deteriorate., Conclusions: The protocol is practical to implement, and no events compromising safety were reported. This study represents what is, to our knowledge, the most extensive data set from people with insulin-treated diabetes working in a "safety-critical" occupation, which may be relevant when estimating risk in other safety-critical occupations., (© 2020 by the American Diabetes Association.)