The HEADWIND-Study

NACompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

October 7, 2019

Primary Completion Date

July 2, 2020

Study Completion Date

July 6, 2020

Conditions
DiabetesDiabetes Mellitus, Type 1
Interventions
OTHER

Controlled hypoglycaemic state while driving with a driving simulator

"Patients will arrive in the morning after an overnight fast. During the controlled hypoglycaemic state, participants will drive on a designated circuit using a driving simulator. Initially, euglycaemic state (5.0-8.0 mmol/L) will be kept stable and then blood glucose will be declined progressively targeting at a level between 2.0-2.5mmol/L by administering an insulin bolus. Glucose will be kept stable at the hypoglycaemic level for 30 minutes. Thereafter, it will be raised again and kept stable for another 30 minutes at an euglycaemic level between 5.0-8.0mmol/L. During the procedure, we will analyse counterregulatory hormones. Heart rate, skin conductance, CGM values, eye movement and facial expression, will be recorded by a smart-watch, a CGM device, an eye-tracker and an onboard camera, respectively.~Participants will be blinded to the glucose values during the procedure. They will have to rate their symptoms and their performance on a 0-6 scale every 15 minutes."

Trial Locations (1)

Unknown

University Department of Endocirnology, Diabetology, Clinical Nutrition and Metabolism, Bern

All Listed Sponsors
collaborator

ETH Zurich

OTHER

collaborator

University of St.Gallen

OTHER

lead

Insel Gruppe AG, University Hospital Bern

OTHER

NCT04035993 - The HEADWIND-Study | Biotech Hunter | Biotech Hunter