NCT05308095

The HEADWIND Study - Part 4

Non-randomised, Controlled, Interventional Single-centre Study for the Design and Evaluation of an In-vehicle Hypoglycaemia Warning System in Diabetes The HEADWIND Study Part IV

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To analyse driving behavior of individuals with type 1 diabetes in eu- and mild hypoglycaemia while driving in a real car. Based on the in-vehicle variables, the investigators aim at establishing algorithms capable of discriminating eu- and hypoglycaemic driving patterns using machine learning classifiers.

Detailed description

Hypoglycaemia is among the most relevant acute complications of diabetes mellitus. During hypoglycaemia physical, psychomotor, executive and cognitive function significantly deteriorate. These are important prerequisites for safe driving. Accordingly, hypoglycaemia has consistently been shown to be associated with an increased risk of driving accidents and is, therefore, regarded as one of the relevant factors in traffic safety. Therefore, this study aims at evaluating a machine-learning based approach using in-vehicle data to detect hypoglycaemia during driving. During controlled eu- and hypoglycaemia, participants with type 1 diabetes mellitus drive in a driving school car on a closed test-track while in-vehicle data is recorded. Based on this data, the investigators aim at building machine learning classifiers to detect hypoglycemia during driving.

Conditions

• Diabetes
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
OTHER	Controlled hypoglycaemic state while driving	Participants will drive on a designated circuit with a real car on a test track accompanied by a driving instructor. Initially, a euglycaemic state (5.0 - 8.0 mmol/L) is established and blood glucose is then declined to hypoglycaemia (3.0 - 3.5 mmol/L) by administering insulin. Thereafter, blood glucose is raised again to euglycaemia (5.0 - 8.0mmol/L). During the procedure, driving data is recorded. Additionally, eye movement, head pose, facial expression, heart rate, skin conductance, and CGM values are recorded throughout the glycemic trajectory. Participants are blinded to the blood glucose values during the procedure.

Timeline

• Start date: 2022-04-13
• Primary completion: 2022-06-23
• Completion: 2022-06-23
• First posted: 2022-04-01
• Last updated: 2022-12-21

Locations

1 site across 1 country: Switzerland