An Evaluation of the Safety of Pilots With Insulin-Treated Diabetes in Europe Flying Commercial and Noncommercial Aircraft

Abstract

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 insulintreated pilots to fly commercially. RESEARCH DESIGN AND METHODSThis 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). RESULTSA 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 5 0.97). Blood glucose values (n 5 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. CONCLUSIONSThe 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.

Enabling equality of employment with insulin treated diabetes in safety‐critical occupations

“…Encouraged by these early positive observations, the protocol project has continued, and by December 2019, the study had approved 49 pilots with insulin treated diabetes (84% T1DM, 16% T2DM), of whom 30 (61%) had been issued a class 1 (commercial) medical certificate and 19 (39%) a class 2 private pilot's licence (PPL). From this further experience, the results of an enormous amount of recorded data, believed to be the most extensive to date pertaining to people with diabetes treated with insulin working in a safety‐critical occupation, have recently been published 11 . A total of 38,621 blood glucose values during 22,078 flying hours have been analysed, with results again very similar to the interim findings, 97.69% of measurements being recorded in the ‘acceptable green’ range.…”

“…Prof Ken Shaw is a former Member of the Secretary of State for Transport's DVLA Medical Panel (2004–2015) and currently Consultant Advisor (Diabetes) to the Civil Aviation Authority, Gatwick (from 2010). He is a co‐author of ‘An Evaluation of the Safety of Pilots with Insulin‐Treated Diabetes’, 11 of which Gillian Garden was the Lead author. In particular, the contribution of the primary corresponding author, Prof David Russell‐Jones, University of Surrey, Guildford, UK, is gratefully acknowledged.…”

Pilots flying with insulin‐treated diabetes

“…A much more extensive follow-on study, reporting over 22 000 flying hours with 49 pilots from the United Kingdom, Ireland and Austria (partners in the EASA ARA.MED.330 protocol) has recently been reported, and represents the largest amount of systematically collected data from insulin-treated people undergoing a safety-critical occupation. 21 A total of 49 pilots issued Class 1 or Class 2 medical certificates for type 1 (84%) or type 2 (16%) diabetes were studied. The median diabetes duration was 10.9 years.…”

“…The high-value, closely controlled, and regulated environment of aviation has facilitated data collection in controlled situations, which now becomes applicable to wider uses including driving, occupational health, and relative risk assessment. 21 The large volumes of detailed data produced by pilots provide a protocol and basis for the safe functioning of individuals treated with hypoglycaemic agents. These protocols and data now allow the empowerment of individuals with diabetes and the return of a valuable sector of society to some productive activities.…”

Blood glucose monitoring by insulin‐treated pilots of commercial and private aircraft: An analysis of out‐of‐range values

“…All pilots are required to measure capillary blood glucose, obtained by fingerprick, before and during each flight, and to use a traffic light system of ranges to determine any further action 6 . The safety data from this cohort have been analysed and reported previously and represent the only systematic collection of such data from a safety‐critical occupation that allows operatives treated with insulin 7 . In the present study we evaluated all recorded blood glucose measurements that were out of range to ascertain preceding and subsequent glucose concentrations, their time course during flight, and any consequences in order to be confident that the amber and red action ranges were appropriate to prevent any form of incapacity.…”