Use of Dexcom G6 in Commercial Pilots With Insulin Treated Diabetes (DEXFLY)

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

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.

Study Overview

• Status: Suspended
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Continuous Glucose monitoring DEXCOM G6

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 .

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Diabetes Endocrinology General Internal Medicine,University of Graz
• Ireland
  • Waterford, Ireland
    • Whitfield Clinic, Butlerstown North, Cork Rd
• United Kingdom
  • West Sussex
    • Gatwick, West Sussex, United Kingdom, RH6 0YR
      • Aviation house

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Flying pilots; Flying pilots holding class 1 and class 2 certificates	Device: Continuous Glucose monitoring DEXCOM G6; Continuous glucose monitoring during flight and normal living life

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose concentrations below 4 mmol/L	Incidence of hypoglycaemic episodes (all, minor, major and symptoms only) will be collected from Dexcom G6 monitoring and compare to the finger prick glucose values during the trial for 6 months.	18 months
Reactions to the sensors	Any adverse event such as discomfort to having the sensor under the skin and the adhesive covering the sensors during the trial will be recorded.	18 months
Aviation assessments as defined by the European Commission Aircrew Regulation ARA.MED.330 diabetes protocol.	Data collected from aviation assessments as defined by the European Commission Aircrew Regulation ARA.MED.330 diabetes protocol. This is a requirement for all pilots who fly on insulin.	18 months
Glucose concentration from the pilots log books for the previous 6 months	Glucose concentrations form the participating pilots' log books will be collected. the data will be analysed and compared to the data on the log books during the trial.	18 months

Collaborators and Investigators

• Sponsor: University of Surrey
• Collaborators: UK Civil Aviation Authority; Irish Civil Aviation Authority; Austrian Civil Aviation Authority
• Investigators: Principal Investigator: David Russell-Jones, BSc, University of Surrey

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2019
• Primary Completion (ANTICIPATED): December 2, 2022
• Study Completion (ANTICIPATED): December 2, 2022

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (ACTUAL): May 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: Spon_2019_015_FHMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to identifiable data (e.g., name, address) will be limited to selected members of the research team and to regulatory authorities, the Sponsor, and the host organisation for auditing and monitoring purposes. This information and other personal details will not be included in analysis, or in publications or reports. All information collected during the study will be identified by a unique code so that the participant cannot be identified.
• IPD Sharing Time Frame: 18 months

IPD Sharing Access Criteria

All data will be kept on secure CAA or University of Surrey computer servers and in a secure office environment within the CAA and University of Surrey.

If data transfer is required password protected inscription will take place that meet the data transfer.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes