Clinical trial NCT05183191: The HEADWIND Study - Part 3
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 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetes Mellitus, Type 1
Keywords: Automotive Technology
Hypoglycemia
Hypoglycaemia
Driving
Driving simulator
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: ETH Zurich
name: University of St.Gallen
First posted: 2022-01-10
Enrollment: 11
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 using a validated research driving simulator. Based on the driving variables provided by the simulator the investigators aim at establishing algorithms capable of discriminating eu- and hypoglycemic 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 hypoglycemia during driving at an early stage.

During controlled eu- and hypoglycemia, participants with type 1 diabetes mellitus drive in a validated driving simulator while in-vehicle data are 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 is confirmed C-peptide negative (\<100pmol/l with concomitant blood glucose \>4 mmol/l)
* Subjects aged between 21-60 years
* HbA1c ≤ 9.0 % based on analysis from central laboratory
* Functional insulin treatment with insulin pump therapy or basis-bolus insulin for at least 3 months with good knowledge of insulin self-management
* Passed driver's examination at least 3 years before study inclusion. Possession of a valid Swiss driver's license.
* Active driving in the last 6 months before the study.

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
* Women who are pregnant or breastfeeding
* Intention to become pregnant during the study
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
* Other clinically significant concomitant disease states as judged by the investigator (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
* Known or suspected non-compliance, 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
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Total daily insulin dose \>2 IU/kg/day.
* Specific concomitant therapy washout requirements prior to and/or during study participation
* Physical or psychological disease is likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator (especially coronary heart disease or epilepsy).
* Current treatment with drugs known to interfere with metabolism (e.g. systemic corticosteroids, etc.) or driving performance (e.g. opioids, benzodiazepines)
* Patients not capable of driving with the driving simulator or patients experiencing motion sickness during the simulator test driving session.

Primary outcomes:
measure: Diagnostic accuracy of the hypoglycemia warning system using in-vehicle data to detect hypoglycemia (blood glucose <3.9mmol/L) quantified as the area under the receiver operator characteristics curve (AUC ROC).
timeFrame: 240 minutes
Secondary outcomes:
measure: Diagnostic accuracy of the hypoglycemia warning system using wearable data to detect hypoglycemia (blood glucose <3.9mmol/L) quantified as the area under the receiver operator characteristics curve (AUC ROC).
timeFrame: 240 minutes
measure: Diagnostic accuracy of the hypoglycemia warning system using in-vehicle data and recordings of the continous glucose monitoring (CGM) system to detect hypoglycemia (blood glucose <3.9mmol/L) quantified as sensitivity and specificity.
timeFrame: 240 minutes
measure: Diagnostic accuracy of the hypoglycemia warning system using wearable data and recordings of the CGM system to detect hypoglycemia (blood glucose <3.9mmol/L) quantified as sensitivity and specificity.
timeFrame: 240 minutes
measure: Change in driving features over the glycemic trajectory.
timeFrame: 240 minutes
measure: Change of gaze coordinates over the glycemic trajectory.
timeFrame: 240 minutes
measure: Change of head pose over the glycemic trajectory.
timeFrame: 240 minutes
measure: Change of heart rate over the glycemic trajectory
timeFrame: 240 minutes
measure: Change of heart rate variability over the glycemic trajectory
timeFrame: 240 minutes
measure: Change of electrodermal activity over the glycemic trajectory
timeFrame: 240 minutes
measure: Hypoglycemic symptoms over the glycemic trajectory.
timeFrame: 240 minutes
measure: Time course of the hormonal response over the glycemic trajectory
timeFrame: Time Frame: 240 minutes
measure: Self assessment of driving performance over the glycemic trajectory.
timeFrame: 240 minutes
measure: CGM accuracy over the glycemic trajectory
timeFrame: 240 minutes
measure: Incidence of Adverse Events (AEs)
timeFrame: 2 weeks, from screening to close out visit in each participant
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: 2 weeks, from screening to close out visit in each participant
measure: Emotional response to hypoglycemia warning system
timeFrame: 240 minutes
measure: Technology acceptance of the hypoglycemia 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, Universität of Bern
name: Christoph Stettler, MD
role: PRINCIPAL_INVESTIGATOR
References: