The Use of the Dexcom G6® in Commercial Pilots With Insulin-treated Diabetes

NCT04225455 | Active Not Recruiting DMC FDA Device

• 1 other identifier: Protocol version 6.1 21OCT2022
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

To compare glucose control achieved by using real time continuous glucose monitoring (CGMS) Dexcom G6® in combination with self-monitored blood glucose during flight and also with free living in pilots.

Conditions

Insulin Dependent Diabetes

Outcome Measures

Primary Outcomes (1)

• To compare the data generated from the continuous glucose monitoring system (CGMS) Dexcom G6® with their routine self-glucose monitoring in pilots with class 1 and class 2 certificates

  At visit 1 at the Civil Aviation Authority (CAA)- CGMS Dexcom G6® measures capillary glucose concentration continuously via a sensor secured under the skin. The glucose concentration is then transmitted to a hand held receiver and uploaded regularly, these data will be used to monitor glucose concentration at all times by the pilots except for the blinded period. The pilots will be blinded to the receiver data during the first month of the trial but will be unblinded there on so they will be able to see the glucose readings on the receiver for the next 5 months. The data generated from the CGMS Dexcom G6® will be compared with the routine self-glucose monitoring recorded in the log books 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. \[Green: 5-15 mmol/L; Amber: 4 to \<5mmol/L and \>15 to 20mmol/L; Red: \<4mmol/L and \>20mmol/L\]

  At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 25 pilots and the main analysis will be conducted once all participants have completed monitoring period within 12 months

Secondary Outcomes (4)

• Glucose variability while flying

  At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 25 pilots and the main analysis will be conducted once all participants have completed monitoring period within 12 months

• Glucose variability during non-flying normal living

  At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 25 pilots and the main analysis will be conducted once all participants have completed monitoring period within 12 months

• Clinical chemistry data- HbA1c

  At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 25 pilots and the main analysis will be conducted once all participants have completed monitoring period within 12 months

• Previous 6 months logged data

  At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 25 pilots and the main analysis will be conducted once all participants have completed monitoring period within 12 months

Interventions

Glucose monitoring DEVICE

To compare the glucose monitoring CGMS Dexcom G6® with their 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. \[Green: 5-15 mmol/L; Amber: 4 to \<5mmol/L and \>15 to 20mmol/L; Red: \<4mmol/L and \>20mmol/L\]

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 pilots with class 1 and flying instructors or private pilots with class 2 medical certificates with insulin dependent diabetes

You may qualify if:

• Age between 18 and 75 y inclusive.
• Any ethnicity
• 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.

Sponsors & Collaborators

• University of Surrey: lead
• DexCom, Inc.: collaborator

Study Sites (1)

University of Surrey FHMS Nutritional Sciences

Guildford, Surrey, GU2 7WG, United Kingdom

Location

Related Publications (2)

• 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: 37384853 BACKGROUND

• Garden GL, Fan KS, Paterson M, Shojaee-Moradie F, Borg Inguanez M, Manoli A, Edwards V, Lee V, Frier BM, Hutchison EJ, Maher D, Mathieu C, Mitchell SJ, Heller SR, Roberts GA, Shaw KM, Koehler G, Mader JK, King BR, Russell-Jones DL; EASA Diabetes Consortium. Effects of atmospheric pressure change during flight on insulin pump delivery and glycaemic control of pilots with insulin-treated diabetes: an in vitro simulation and a retrospective observational real-world study. Diabetologia. 2025 Jan;68(1):52-68. doi: 10.1007/s00125-024-06295-1. Epub 2024 Nov 4.

  PMID: 39496965 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Russell-Jones, MD PhD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 13, 2020
• Study Start: December 5, 2019
• Primary Completion: October 1, 2025
• Study Completion: December 30, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

GB (1)