Use of Dexcom G6 in Commercial Pilots With Insulin Treated Diabetes

Study Overview
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Brief Summary
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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
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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 .

Official Title
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The Use of the Dexcom G6 in Commercial Pilots With Insulin Dependent Diabetes (DEXFLY)

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Continuous Glucose monitoring DEXCOM G6


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Flying pilots<br>Flying pilots holding class 1 and class 2 certificates | Device: Continuous Glucose monitoring DEXCOM G6<br>* Continuous glucose monitoring during flight and normal living life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose concentration (mmol/L) | To compare the glucose monitoring CGMS Dexcom G6® with the usual self-glucose monitoring in pilots by way of assessing times achieved in safe Green flying range, in Amber flying range and in Red flying range as defined by the ARA.MED.330 diabetes protocol. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of glucose concentration (mmol/L) in-flight | Variability of glucose concentration while flying monitored using Dexcom G6 in comparison to the finger prick self-glucose monitoring | 18 months | 
| Variability of glucose concentration (mmol/L) at non-flying normal living | Time in and out of range during non-flying normal living (targets used as other clinical trials) | 18 months | 
| Quality of life (generic, disease-specific) evaluation and flying-specific evaluation scores. | Participants will be asked to fill in the quality of life (generic, disease-specific) evaluation and flying-specific evaluation questionnaires at the visit 1 and the end of the trial Visit 2. | 18 months | 
| HbA1c mmol/mol | HbA1C (mmol/mol) results from the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2 . | 18 months | 
| Height (cm) | Height measured at the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2 | 18 months | 
| Weight (kg) | Weigh (kg) measured at the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2 | 18 months | 
| Blood pressure (systolic and diastolic) mmHg | Blood pressure (systolic and diastolic) mmHg measured at the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2 | 18 months | 
| Age (y) | Age of the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2 | 18 months | 
| Total Cholesterol (mmol/L) | Lipid profile values from the biochemical analysis obtained at the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2 | 18 months | 
| Creatinine (mmol/L) | Creatinine concentration from the biochemical analysis obtained at the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2. This will be used to calculate glomerular filtration rate (GFR), mL/min/1.73 m2, or creatinine clearance using Cockcroft-Gault Equation. | 18 months | 
| Plasma albumin concentration (g/dL) | albumin concentration from the biochemical analysis obtained at the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2. The ratio of will be used to calculate, the state of microalbumin urea in both visits. | 18 months |