Clinical trial NCT04395378: Use of Dexcom G6 in Commercial Pilots With Insulin Treated Diabetes
Official title: The Use of the Dexcom G6 in Commercial Pilots With Insulin Dependent Diabetes (DEXFLY)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Type 1 Diabetes
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: UK Civil Aviation Authority
name: Irish Civil Aviation Authority
name: Austrian Civil Aviation Authority
First posted: 2020-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pilots with class 1 and flying instructors or private pilots with class 2 medical certificates with insulin dependent diabetes

Brief 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.

Detailed 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Glucose concentration (mmol/L)
timeFrame: 18 months
Secondary outcomes:
measure: Variability of glucose concentration (mmol/L) in-flight
timeFrame: 18 months
measure: Variability of glucose concentration (mmol/L) at non-flying normal living
timeFrame: 18 months
measure: Quality of life (generic, disease-specific) evaluation and flying-specific evaluation scores.
timeFrame: 18 months
measure: HbA1c mmol/mol
timeFrame: 18 months
measure: Height (cm)
timeFrame: 18 months
measure: Weight (kg)
timeFrame: 18 months
measure: Blood pressure (systolic and diastolic) mmHg
timeFrame: 18 months
measure: Age (y)
timeFrame: 18 months
measure: Total Cholesterol (mmol/L)
timeFrame: 18 months
measure: Creatinine (mmol/L)
timeFrame: 18 months
measure: Plasma albumin concentration (g/dL)
timeFrame: 18 months
Other outcomes:
measure: Glucose concentrations below 4 mmol/L
timeFrame: 18 months
measure: Reactions to the sensors
timeFrame: 18 months
measure: Aviation assessments as defined by the European Commission Aircrew Regulation ARA.MED.330 diabetes protocol.
timeFrame: 18 months
measure: Glucose concentration from the pilots log books for the previous 6 months
timeFrame: 18 months
Locations:
city: Graz
country: Austria
facility: Diabetes Endocrinology General Internal Medicine,University of Graz
city: Waterford
country: Ireland
facility: Whitfield Clinic, Butlerstown North, Cork Rd
city: Gatwick
country: United Kingdom
facility: Aviation house
state: West Sussex
Study officials:
affiliation: University of Surrey
name: David Russell-Jones, BSc
role: PRINCIPAL_INVESTIGATOR
References: