Use of Dexcom G6 in Commercial Pilots With Insulin Treated Diabetes

Type 1 Diabetes Clinical Trial

— DEXFLY  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04395378
• Other study ID #: Spon_2019_015_FHMS
• Status: Suspended
• Start date: December 5, 2019
• Est. completion date: December 2, 2022

Study information

• Verified date: April 2021
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

Intervention

Device:
• Continuous Glucose monitoring DEXCOM G6
Continuous glucose monitoring during flight and normal living life

Locations

Country	Name	City	State
Austria	Diabetes Endocrinology General Internal Medicine,University of Graz	Graz
Ireland	Whitfield Clinic, Butlerstown North, Cork Rd	Waterford
United Kingdom	Aviation house	Gatwick	West Sussex

Sponsors (4)

Lead Sponsor	Collaborator
University of Surrey	Austrian Civil Aviation Authority, Irish Civil Aviation Authority, UK Civil Aviation Authority

Countries where clinical trial is conducted

Austria,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Height (cm)	Height measured at the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2	18 months
Secondary	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
Secondary	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
Secondary	Age (y)	Age of the participants' usual clinic visit at the CAA will be recorded in visit 1 and visit 2	18 months
Secondary	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
Secondary	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
Secondary	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