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

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ClinicalTrials.gov Identifier: NCT04395378
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborators:
UK Civil Aviation Authority
Irish Civil Aviation Authority
Austrian Civil Aviation Authority
Information provided by (Responsible Party):
University of Surrey

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.


Condition or disease Intervention/treatment
Type 1 Diabetes 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 .

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 6 Months
Official Title: The Use of the Dexcom G6 in Commercial Pilots With Insulin Dependent Diabetes (DEXFLY)
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : June 2, 2020
Estimated Study Completion Date : December 2, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Glucose concentration (mmol/L) [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. Variability of glucose concentration (mmol/L) in-flight [ Time Frame: 18 months ]
    Variability of glucose concentration while flying monitored using Dexcom G6 in comparison to the finger prick self-glucose monitoring

  2. Variability of glucose concentration (mmol/L) at non-flying normal living [ Time Frame: 18 months ]
    Time in and out of range during non-flying normal living (targets used as other clinical trials)

  3. Quality of life (generic, disease-specific) evaluation and flying-specific evaluation scores. [ Time Frame: 18 months ]
    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.

  4. HbA1c mmol/mol [ Time Frame: 18 months ]
    HbA1C (mmol/mol) results from the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2 .

  5. Height (cm) [ Time Frame: 18 months ]
    Height measured at the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2

  6. Weight (kg) [ Time Frame: 18 months ]
    Weigh (kg) measured at the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2

  7. Blood pressure (systolic and diastolic) mmHg [ Time Frame: 18 months ]
    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

  8. Age (y) [ Time Frame: 18 months ]
    Age of the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2

  9. Total Cholesterol (mmol/L) [ Time Frame: 18 months ]
    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

  10. Creatinine (mmol/L) [ Time Frame: 18 months ]

    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.


  11. Plasma albumin concentration (g/dL) [ Time Frame: 18 months ]
    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.


Other Outcome Measures:
  1. Glucose concentrations below 4 mmol/L [ Time Frame: 18 months ]
    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.

  2. Reactions to the sensors [ Time Frame: 18 months ]
    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.

  3. Aviation assessments as defined by the European Commission Aircrew Regulation ARA.MED.330 diabetes protocol. [ Time Frame: 18 months ]
    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.

  4. Glucose concentration from the pilots log books for the previous 6 months [ Time Frame: 18 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395378


Contacts
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Contact: davidrussell-jones@nhs.net, PhD +44 (0)1483 464049 davidrussell-jones@nhs.net
Contact: Fariba Shojaee-Moradie, PhD +44 (0)1483 688644 f.shojaee-moradie@surrey.ac.uk

Locations
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Austria
Diabetes Endocrinology General Internal Medicine,University of Graz Not yet recruiting
Graz, Austria, 8036
Contact: Gerd Koehler, MD    +43 316 385 82033    diabetesambulanz@gmail.com   
Ireland
Whitfield Clinic, Butlerstown North, Cork Rd Not yet recruiting
Waterford, Ireland
Contact: Graham Roberts, MD    +353 (0)51 842443    Graham.Roberts@hse.ie   
United Kingdom
Aviation house Recruiting
Gatwick, West Sussex, United Kingdom, RH6 0YR
Contact: David Russell-Jones, PhD    +44(0)14836844    davidrussell-jones@nhs.net   
Contact: Ewan Hutchison, MD       Ewan.Hutchison@caa.co.uk   
Sponsors and Collaborators
University of Surrey
UK Civil Aviation Authority
Irish Civil Aviation Authority
Austrian Civil Aviation Authority
Investigators
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Principal Investigator: David Russell-Jones, BSc University of Surrey

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Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT04395378    
Other Study ID Numbers: Spon_2019_015_FHMS
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 18 months
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.


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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases