Use of Dexcom G6 in Commercial Pilots With Insulin Treated Diabetes

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    University of Surrey
Updated on 5 August 2020
replacement therapy
blood glucose monitoring
continuous glucose monitoring
hypoglycemic drugs
diabetes
insulin

Summary

The investigators wish to explore the use of the CGMS Dexcom G6 in pilots with insulin-treated diabetes, who are flying commercial aircraft with Class 1 and flying instructors or private pilots with class 2 certificates.

The aim of this study is to explore the severity and number of hypoglycaemic episodes recorded with rtCGMS compared to the results from other self-glucose monitoring following the current protocol of the UK Civil Air Aviation (UKCAA), and to explore the possibility of the use of rtCGMS during flight and free living.

This will involve using CGM Dexcom G6 for continuous glucose monitoring for 6 months in flight time and during free living. The participants will be blinded for the results for the first month but will be encouraged to use the data from the CGMS Dexcom G6 for the following 5 months during the trial.

Description

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. In 2012 the UK CAA started issuing 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 .

Details
Condition Diabetes Mellitus, diabetes (pediatric), Insulin dependent diabetes mellitus, diabetes (pediatric)
Age 18years - 75years
Treatment Continuous Glucose monitoring DEXCOM G6
Clinical Study IdentifierNCT04395378
SponsorUniversity of Surrey
Last Modified on5 August 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Any ethnithity
Pilots requiring insulin replacement therapy
Pilots holding a class 1 or class 2 certificate
Pilots currently participating in the current scheme
Able and willing to perform self-blood glucose monitoring
Able and willing to wear a Continuous Glucose Monitoring System (CGMS) for 6months

Exclusion Criteria

Outside of stated age range
Those who are part of the protocol but are not flying currently
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