The HEADWIND Study - Part 4

Insel Gruppe AG, University Hospital Bern

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Other: Controlled hypoglycaemic state while driving

Study type

Interventional

Funder types

Other

Identifiers

NCT05308095

HEADWIND 4

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent as documented by signature
Type 1 Diabetes mellitus as defined by WHO for at least 1 year or confirmed C-peptide negative (<100pmol/l with concomitant blood glucose >4 mmol/l)
Age between 21-60 years
HbA1c ≤ 9.0 %
Functional insulin treatment with good knowledge of insulin self-management
Passed driver's examination at least 3 years before study inclusion. Possession of a valid, definitive Swiss driver's license.
Active driving in the last 6 months.

Exclusion criteria

Contraindications to the drug used to induce hypoglycaemia (insulin aspart), known hypersensitivity or allergy to the adhesive patch used to attach the glucose sensor.
Pregnancy or intention to become pregnant during the course of the study, lactating women or lack of safe contraception
Other clinically significant concomitant disease states as judged by the investigator
Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
Renal failure
Hepatic dysfunction
Coronary heart disease
Other cardiovascular disease
Epilepsy
Drug or alcohol abuse
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Participation in another study with an investigational drug within the 30 days preceding and during the present study
Total daily insulin dose >2 IU/kg/day
Specific concomitant therapy washout requirements prior to and/or during study participation
Current treatment with drugs known to interfere with metabolism or driving performance