Clinical trial NCT05308095: The HEADWIND Study - Part 4
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetes Mellitus, Type 1
Keywords: Automotive Technology
Hypoglycemia
Hypoglycaemia
Driving
Car
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
name: University of St.Gallen
First posted: 2022-04-01
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Diagnostic accuracy of the hypoglycaemia warning system using in-vehicle data to detect hypoglycaemia quantified as the area under the receiver operating characteristics curve (AUROC).
timeFrame: 240 minutes
Secondary outcomes:
measure: Diagnostic accuracy of the hypoglycaemia warning system using wearable data to detect hypoglycaemia quantified as the area under the receiver operating characteristics curve (AUROC).
timeFrame: 240 minutes
measure: Diagnostic accuracy of the hypoglycaemia warning system using in-vehicle data and recordings of the continous glucose monitoring (CGM) system to detect hypoglycaemia quantified as sensitivity and specificity.
timeFrame: 240 minutes
measure: Diagnostic accuracy of the hypoglycaemia warning system using wearable data and recordings of the CGM system to detect hypoglycaemia quantified as sensitivity and specificity.
timeFrame: 240 minutes
measure: Change in driving features over the glycaemic trajectory.
timeFrame: 240 minutes
measure: Change of gaze coordinates over the glycaemic trajectory.
timeFrame: 240 minutes
measure: Change of head pose over the glycaemic trajectory.
timeFrame: 240 minutes
measure: Change of heart rate over the glycaemic trajectory
timeFrame: 240 minutes
measure: Change of heart rate variability over the glycaemic trajectory
timeFrame: 240 minutes
measure: Change of electrodermal activity over the glycaemic trajectory
timeFrame: 240 minutes
measure: Hypoglycaemic symptoms over the glycaemic trajectory.
timeFrame: 240 minutes
measure: Change of cognitive performance over the glycaemic trajectory.
timeFrame: 240 minutes
measure: Time course of the hormonal response over the glycaemic trajectory
timeFrame: 240 minutes
measure: Self assessment of driving performance over the glycaemic trajectory.
timeFrame: 240 minutes
measure: Number of driving mishaps over the glycaemic trajectory.
timeFrame: 240 minutes
measure: CGM accuracy over the glycaemic trajectory
timeFrame: 240 minutes
measure: Accuracy of our protocol to induce hypoglycaemia in achieving the intended hypoglycaemic range.
timeFrame: 240 minutes
measure: Number of Adverse Events (AEs)
timeFrame: 2 weeks, from screening to close out visit in each participant
measure: Number of Serious Adverse Events (SAEs)
timeFrame: 2 weeks, from screening to close out visit in each participant
measure: Emotional response to the hypoglycaemia warning system
timeFrame: 240 minutes
measure: Technology acceptance of the hypoglycaemia warning system
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Department of Endocrinology, Diabetology, Clinical Nutrition and Metabolism
Study officials:
affiliation: Inselspital, Bern University Hospital, University of Bern, Switzerland, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Bern, Switzerland
name: Christoph Stettler, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: