Study Stopped
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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)
1 other identifier
observational
30
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2019
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2019
CompletedStudy Start
First participant enrolled
December 5, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2022
CompletedApril 29, 2021
April 1, 2021
3 years
June 5, 2019
April 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Variability of glucose concentration (mmol/L) in-flight
18 months
Variability of glucose concentration (mmol/L) at non-flying normal living
18 months
Quality of life (generic, disease-specific) evaluation and flying-specific evaluation scores.
18 months
HbA1c mmol/mol
18 months
Height (cm)
18 months
- +6 more secondary outcomes
Other Outcomes (4)
Glucose concentrations below 4 mmol/L
18 months
Reactions to the sensors
18 months
Aviation assessments as defined by the European Commission Aircrew Regulation ARA.MED.330 diabetes protocol.
18 months
- +1 more other outcomes
Study Arms (1)
Flying pilots
Flying pilots holding class 1 and class 2 certificates
Interventions
Continuous glucose monitoring during flight and normal living life
Eligibility Criteria
Pilots with class 1 and flying instructors or private pilots with class 2 medical certificates with insulin dependent diabetes
You may qualify if:
- 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
You may not qualify if:
- Outside of stated age range.
- Those who are part of the protocol but are not flying currently.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Surreylead
- UK Civil Aviation Authoritycollaborator
- Irish Civil Aviation Authoritycollaborator
- Austrian Civil Aviation Authoritycollaborator
Study Sites (3)
Diabetes Endocrinology General Internal Medicine,University of Graz
Graz, 8036, Austria
Whitfield Clinic, Butlerstown North, Cork Rd
Waterford, Ireland
Aviation house
Gatwick, West Sussex, RH6 0YR, United Kingdom
Related Publications (1)
Garden GL, Shojaee-Moradie F, Hutchison EJ, Frier BM, Shaw KM, Heller SR, Koehler G, Mader JK, Maher D, Roberts GA, Russell-Jones DL. Continuous Glucose Monitoring by Insulin-Treated Pilots Flying Commercial Aircraft Within the ARA.MED.330 Diabetes Protocol: A Preliminary Feasibility Study. Diabetes Technol Ther. 2023 Aug;25(8):543-548. doi: 10.1089/dia.2023.0069.
PMID: 37384853DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Russell-Jones, BSc
University of Surrey
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
May 20, 2020
Study Start
December 5, 2019
Primary Completion
December 2, 2022
Study Completion
December 2, 2022
Last Updated
April 29, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.