The HEADWIND Study - Part 3

NACompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

November 29, 2021

Primary Completion Date

March 3, 2022

Study Completion Date

March 3, 2022

Conditions
DiabetesDiabetes Mellitus, Type 1
Interventions
OTHER

Controlled hypoglycaemic state while driving with a driving simulator

Participants arrive in the morning after an overnight fast. During the controlled hypoglycaemic state, participants drive on a designated circuit using a driving simulator. Initially, a euglycaemic state (5.0-8.0 mmol/L) is kept stable and blood glucose is then progressively declined targeting at a level between 3.0-3.5 mmol/L by administering insulin. Blood glucose is kept stable in the hypoglycaemic range for 30 minutes. Thereafter, blood glucose is raised again and kept stable for another 30 minutes at an euglycaemic level between 5.0-8.0mmol/L. During the procedure, the investigators analyse counterregulatory hormones. Heart rate, skin conductance, CGM values, eye movement and facial expression are recorded by a smart-watch, a CGM device, an eye-tracker and an onboard camera, respectively. Participants are blinded to the blood glucose values during the procedure and have to rate their symptoms and their driving performance on a 0-6 scale every 15 minutes.

Trial Locations (1)

Unknown

University Department of Endocrinology, 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

NCT05183191 - The HEADWIND Study - Part 3 | Biotech Hunter | Biotech Hunter