The HEADWIND Study - Part 4

NCT ID: NCT05308095

Last Updated: 2022-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-13
• Study Completion Date: 2022-06-23

Brief 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

Keywords

Automotive Technology; Hypoglycemia; Hypoglycaemia; Driving; Car

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

Controlled hypoglycaemic state while driving

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Federal Institute of Technology

OTHER

Sponsor Role: collaborator

University of St.Gallen

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Stettler, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Inselspital, Bern University Hospital, University of Bern, Switzerland, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Bern, Switzerland

Locations

University Department of Endocrinology, Diabetology, Clinical Nutrition and Metabolism

Bern, , Switzerland

Countries

Switzerland

References

Berube C, Maritsch M, Lehmann VF, Kraus M, Feuerriegel S, Zuger T, Wortmann F, Stettler C, Fleisch E, Kocaballi AB, Kowatsch T. Multimodal In-Vehicle Hypoglycemia Warning for Drivers With Type 1 Diabetes: Design and Evaluation in Simulated and Real-World Driving. JMIR Hum Factors. 2024 Apr 18;11:e46967. doi: 10.2196/46967.

Reference Type: DERIVED

PMID: 38635313 (View on PubMed)

Other Identifiers

HEADWIND 4

Identifier Type: -

Identifier Source: org_study_id