The Use of the Dexcom G6® in Commercial Pilots With Insulin-treated Diabetes (DEXFLY2)

People with diabetes sometimes consider that they are subjected to unfair discrimination in the occupational or work environment. These include safety-critical activities such as operating machinery and driving. Some occupations preclude the use of medications that lower blood glucose, particularly insulin. Safety regulators, occupational health physicians and national organisations frequently have to balance the competing priorities of individual rights against public safety.

Modern treatment, with advances in insulin therapy and glucose monitoring, combined with rigorous clinical assessment and review, has allowed stereotypical attitudes to be challenged, and advocated individual assessment with respect to safety criteria. Several national authorities (Australia, Canada, UK, and USA) have, over recent years, allowed private pilots to fly for recreation while receiving treatment with insulin Canada (in 2002) was the first country to allow commercial pilots, treated with insulin, to fly commercially and have granted licences to a small number of insulin-treated pilots on a case-by-case basis and subject to close supervision.

In 2010 the UK Civil Aviation Authority (CAA) convened an expert committee to review current scientific knowledge and international policies concerning flying. The committee advised that a protocol for safe flying could be developed and produced the first iteration with subsequent refinement. It was decide that continuous glucose monitoring systems (CGMS) did not provide an accurate measurement of glucose, thus, finger prick-blood glucose monitoring was thought to provide accurate blood glucose measurement and was stipulated in the protocol (4). In 2012 the UK CAA started issuing EU Class 1 medical certificates for commercial flying to pilots with insulin-treated diabetes, having published a rigorous protocol and started collecting data systematically. Ireland and Austria have subsequently joined the protocol. The protocol has been shown to be feasible, practical and to date no safety concerns have arisen. The results from the first 26 pilots have been presented at the annual EASD conference and published in The Lancet Diabetes & Endocrinology (5). A copy of the policy is attached in appendix 1 "UK CAA policy for the Medical Certification of Pilots and Air Traffic Controllers (ATCOs) with Diabetes". In summary, the policy describes that pilots have to be in good health in terms of diabetes and associated diseases of cardiovascular system.

There should be a log book of the glucose monitoring results with each pilot at all times. The protocol suggests that the logged data will be checked against the stored memory of the glucose meters from time to time to ensure accurate data collection. The Aircrew Regulation (European Commission Regulation (EU) 1178/2011) was amended in 2015 with the inclusion of ARA.MED.330 'Special Medical Circumstances' in Annex VI (Part ARA). This allowed research to be carried out to gather evidence on the safe exercise of privileges when new medical developments (eg treatment, procedures or new medical technology) are identified that may justify a fit assessment of applicants who would not otherwise comply with certificatory requirements. This amendment was not included in the Air Traffic Control Officer (ATCO) regulations. The detailed text is available in and easy access form issued by the European Aviation Safety Agency (EASA) in May 2019.

RATIONALE We believe that reliable CGMS will have significant benefits such as access immediate access to the glucose results to the pilots, which will help them reliably to decide and adjust the insulin requirements both at flying and in free living giving rise to a controlled glucose monitoring. The pilots from UK and Austria and Ireland who have been approached are universally keen to help with any initiative that may promote safety and acceptance of the ARA.MED 330 diabetes protocol.