רדאר ניסויים קליניים

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

Glucose variability while flying

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. \[Green: 5-15 mmol/L; Amber: 4 to \<5mmol/L and \>15 to 20mmol/L; Red: \<4mmol/L and \>20mmol/L\]

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

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. \[Green: 5-15 mmol/L; Amber: 4 to \<5mmol/L and \>15 to 20mmol/L; Red: \<4mmol/L and \>20mmol/L\]

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 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.

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 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.

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