The HEADWIND Study - Part 3

NCT05183191 | Completed

• 1 other identifier: HEADWIND 3
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Keywords

Automotive Technology; Hypoglycemia; Hypoglycaemia; Driving; Driving simulator

Outcome Measures

Primary Outcomes (1)

• 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).

  The machine learning model is developed and evaluated based on in-vehicle data generated in eu- and hypoglycemia. Detection performance of hypoglycemia is quantified as AUROC.

  240 minutes

Secondary Outcomes (17)

• 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).

  240 minutes

• 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.

  240 minutes

• 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.

  240 minutes

• Change in driving features over the glycemic trajectory.

  240 minutes

• Change of gaze coordinates over the glycemic trajectory.

  240 minutes

Study Arms (1)

Intervention group

EXPERIMENTAL

Other: Controlled hypoglycaemic state while driving with a driving simulator

Interventions

Controlled hypoglycaemic state while driving with a driving simulator OTHER

Participants arrive in the morning after an overnight fast. During the controlled hypoglycaemic state, participants drive on a designated circuit using a driving simulator. Initially, a euglycaemic state (5.0-8.0 mmol/L) is kept stable and blood glucose is then progressively declined targeting at a level between 3.0-3.5 mmol/L by administering insulin. Blood glucose is kept stable in the hypoglycaemic range for 30 minutes. Thereafter, blood glucose is raised again and kept stable for another 30 minutes at an euglycaemic level between 5.0-8.0mmol/L. During the procedure, the investigators analyse counterregulatory hormones. Heart rate, skin conductance, CGM values, eye movement and facial expression are recorded by a smart-watch, a CGM device, an eye-tracker and an onboard camera, respectively. Participants are blinded to the blood glucose values during the procedure and have to rate their symptoms and their driving performance on a 0-6 scale every 15 minutes.

Intervention group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Active driving in the last 6 months before the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• ETH Zurich: collaborator
• University of St.Gallen: collaborator

Study Sites (1)

University Department of Endocrinology, Diabetology, Clinical Nutrition and Metabolism

Bern, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 38635313 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Christoph Stettler, MD

  Inselspital, Bern University Hospital, Universität of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: November 29, 2021
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Access Criteria: Only applications for non-commercial use will be considered and should be sent to the PI (Prof. Ch. Stettler).

Locations

CH (1)