Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225455
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
University of Surrey

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.

Condition or disease Intervention/treatment
Insulin Dependent Diabetes Device: Glucose monitoring

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Use of the Dexcom G6® in Commercial Pilots With Insulin-treated Diabetes (DEXFLY)
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : September 20, 2020
Estimated Study Completion Date : December 2, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin


Intervention Details:
  • Device: Glucose monitoring

    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]



Primary Outcome Measures :
  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 [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]

    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]



Secondary Outcome Measures :
  1. Glucose variability while flying [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]

    The pilots will be asked to mark the flying time as an event on the receiver while on the 6-month trial with CGMS Dexcom G6. This will allow us to compare the glucose monitoring CGMS Dexcom G6® with their routine self-glucose monitoring while flying during the blinded or unblinded period 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]


  2. Glucose variability during non-flying normal living [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]

    As flying times are marked on the receiver we will also be able to compare the glucose monitoring CGMS Dexcom G6® data during the non-flying normal living with the routine self-glucose monitoring during the blinded or unblinded period 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]


  3. Bolus Insulin Questionnaire [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in Quality of Life / Patient Related Outcomes (QOL/ PRO) questionnaire, "Bolus Insulin Questionnaire". The questionnaire is validated and proven to be useful to evaluate CGM in other studies in subjects with diabetes. The scores collected from the various questions on the use and frequency of injection of the fast acting insulin will be will be compared at baseline and at the end of trial (6-month) using paired test.

  4. CGM Attitudes Questionnaire, [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in QOL/ PRO, "CGM Attitudes questionnaire". The questionnaire is validated and proven to be useful to evaluate CGM in other studies in subjects with diabetes. The scores collected from the various questions on the use CGM eg the ease and reliability at baseline, that is, if the pilots are already wearing any form of CGM, will be compared with the scores collected at the end of the trial (6-month) CGM Dexcom G6 using paired test.

  5. CGM Expectations Questionnaire, [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in QOL/ PRO, "CGM Expectations questionnaire". The questionnaire is validated and proven to be useful to evaluate CGM in other studies in subjects with diabetes. The scores collected from the various questions on the patient expectations on the use of CGM at baseline, that is, if the pilots are already wearing any form of CGM, will be compared with the scores collected at the end of the trial (6-month) CGM Dexcom G6 using paired test.

  6. CGM Satisfaction Scale Questionnaire [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in QOL/ PRO questionnaire, "CGM Satisfaction Scale" . The questionnaire is validated and proven to be useful to evaluate CGM in other studies in subjects with diabetes. The scores collected from the various questions on the use CGM eg the ease and the impact of the use at baseline, that is, if the pilots are already wearing any other form of CGM, will be compared with those collected at the end of the trial (6-month) CGM Dexcom G6 using paired test.

  7. Clarke Hypoglycaemia Awareness Survey Questionnaire [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in QOL/ PRO, "Clarke Hypoglycaemia Awareness Survey Questionnaire" . The questionnaire is validated and proven to be useful to evaluate CGM in other studies in subjects with diabetes. The scores collected from the various questions on the use CGM eg number hypoglycaemic episodes per week and how aware of the low glucose level at baseline, will be compared with those collected at the end of the trial (6-month) with CGM Dexcom G6 using paired test.

  8. Diabetes Distress Scale Questionnaire [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in QOL/ PRO, "Diabetes Distress Scale Questionnaire". This questionnaire deals with problems and hassles that people with diabetes could face. These problems can vary greatly in severity. Participants will be asked to score their problems which may range from minor hassles to major life difficulties. The questionnaire is validated and proven to be useful to evaluate CGM in other studies in subjects with diabetes. The scores collected from the various questions on the problems listed at baseline, will be compared with those collected at the end of the trial (6-month) with CGM Dexcom G6 using paired test.

  9. Health Questionnaire (EuroQol Group) EQ-5D-5L [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in QOL/ PRO, "Health Questionnaire (EuroQol Group) EQ-5D-5L". This questionnaire list questions on whether or not the participants has problems with mobility, self care, usual activity, pain and discomfort, anxiety and depression. The scores collected from the various questions on the problems listed at baseline, will be compared with those collected at the end of the trial (6-month) with CGM Dexcom G6 using paired test.

  10. Hypoglycaemic Fear Survey, Worry subscale (HFS-W) [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in QOL/ PRO, "Hypoglycaemic Fear Survey, Worry subscale (HFS-W)". In this questionnaire, the concerns of people with diabetes about having low blood sugar have been listed. The participants will be asked to score the listed concerns. The scores collected from the various questions at baseline, will be compared with those collected at the end of the trial (6-month) with CGM Dexcom G6 using paired test.

  11. Hypoglycaemia Confidence Scale [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in QOL/ PRO, "Hypoglycaemia Confidence Scale". In this questionnaire, the confidence levels of the participants with concerns about having low blood sugar have been presented with scores. The participants will be asked to score the listed concerns. The scores collected from the various questions at baseline, will be compared with those collected at the end of the trial (6-month) with CGM Dexcom G6 using paired test.

  12. Health Service Utilization Form [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in QOL/ PRO, "Health Service Utilization Form Questionnaire". This questionnaire lists questions on whether or not the participants have used the accident and emergency units at the health service or if any hospitalisation has occurred in the previous 6 months. The scores collected from the various questions on the problems listed at baseline, will be compared with those collected at the end of the trial (6-month) with CGM Dexcom G6 using paired test.

  13. WHO-5 Well-Being Index [ Time Frame: There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, participants will be asked to fill in QOL/ PRO, "WHO-5 Well-Being Index Questionnaire". This questionnaire lists 5 statements of well being such as feeling calm, cheerful, fresh, and active the scoring is looking for over the last two weeks of the visit by the participants. The ranking score is as such that the higher the number the better well-being. The scores collected from the various statements listed at baseline, will be compared with those collected at the end of the trial (6-month) with CGM Dexcom G6 using paired test.

  14. Weight (kg) [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, weight will be measured. The data collected from the baseline will be compared with data at 6 months using pared students T-test.

  15. Height (cm) [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, height will be measured. The data collected from the baseline will be compared with data at 6 months.

  16. BMI (kg/m squared) [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots BMI will be calculated. The data collected from the baseline will be compared with data at 6 months.

  17. Clinical chemistry data- Glucose [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, the concentration of glucose measured enzymatically using a clinical analyser will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  18. Clinical chemistry data- Triglycerides [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, the concentration of triglycerides measured enzymatically using a clinical analyser will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  19. Clinical chemistry data- Total Cholesterol [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, the concentration of total cholesterol measured enzymatically using a clinical analyser will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  20. Clinical chemistry data- HDL-Cholesterol [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, the concentration of HDL cholesterol measured enzymatically using a clinical analyser will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  21. Clinical chemistry data- LDL-Choletserol [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, the concentration of LDL cholesterol measured enzymatically using a clinical analyser will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  22. Clinical chemistry data- Creatinine [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, the concentration of creatinine measured enzymatically using a clinical analyser will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  23. Clinical chemistry data- ACR [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, the urine albumin to creatinine ratio (ACR) will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  24. Clinical chemistry data- HbA1c [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, point-of-care HbA1c test results will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  25. Systolic blood pressure [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots, systolic blood pressure will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  26. Diastolic blood pressure [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots diastolic blood pressure will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  27. Heart rate [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1 and visit 3, which occurred at the standard CAA required 6 month clinic visit of the pilots heart rate will be recorded from the clinic notes at the CAA. The data collected from the baseline will be compared with the data collected at 6 months.

  28. Previous 6 months logged data [ Time Frame: At the end of 6 months monitoring of each pilot. There will be an interim data analysis with the data collected from 10 pilots and the main analysis will be conducted once all participants have completed monitoring period within 18 months ]
    At visit 1, the previous 6 months figure-stick self-glucose monitoring data from the pilots' log books will be recorded. The previous 6 months data will be compared with the data collected with CGMS Dexcom G6 and the accompanied fingerstick glucose measurements from the pilots' log books.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
30 pilots with class 1 and flying instructors or private pilots with class 2 medical certificates with insulin dependent diabetes
Criteria

Inclusion Criteria:

  • 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

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): NCT04225455


Contacts
Layout table for location contacts
Contact: Fariba Shojaee-Moradie, PhD +44 (0)1483 688644 f.shojaee-moradie@surrey.ac.uk
Contact: David Russell-Jones, MD PhD +44 (0) 1483 464049 davidrussell-jones@nhs.net

Locations
Layout table for location information
United Kingdom
University of Surrey FHMS Nutritional Sciences Recruiting
Guildford, Surrey, United Kingdom, GU2 7WG
Contact: Fariba Shojaee-Moardie, PhD    +44 1483 688644    f.shojaee-moradie@surrey.ac.uk   
Contact: David AM Russell-Jones, MD PhD    +44 1483 464049    davidrussell-jones@nhs.net   
Principal Investigator: David Russell-Jones, MBBS PhD         
Sub-Investigator: Gillian Garden, MBBS         
Sub-Investigator: Fariba Shojaee-Moardie, PhD         
Sponsors and Collaborators
University of Surrey
DexCom, Inc.
Investigators
Layout table for investigator information
Principal Investigator: David Russell-Jones, MD PhD University of Surrey

Layout table for additonal information
Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT04225455    
Other Study ID Numbers: Protocol version 3 09/07/2019
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

Layout table for additional information
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:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs