The HEADWIND Study - Part 4

NCT05308095 | Completed

• 1 other identifier: HEADWIND 4
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Keywords

Automotive Technology; Hypoglycemia; Hypoglycaemia; Driving; Car

Outcome Measures

Primary Outcomes (1)

• 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).

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

  240 minutes

Secondary Outcomes (20)

• Diagnostic accuracy of the hypoglycaemia warning system using wearable data to detect hypoglycaemia quantified as the area under the receiver operating characteristics curve (AUROC).

  240 minutes

• 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.

  240 minutes

• Diagnostic accuracy of the hypoglycaemia warning system using wearable data and recordings of the CGM system to detect hypoglycaemia quantified as sensitivity and specificity.

  240 minutes

• Change in driving features over the glycaemic trajectory.

  240 minutes

• Change of gaze coordinates over the glycaemic trajectory.

  240 minutes

Study Arms (1)

Intervention group

EXPERIMENTAL

Other: Controlled hypoglycaemic state while driving

Interventions

Controlled hypoglycaemic state while driving 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.

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 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
• Active driving in the last 6 months.

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.
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss Federal Institute of Technology: 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; Carney Complex

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Myxoma; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Heart Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Heart Diseases; Cardiovascular Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Abnormalities

Study Officials

• Christoph Stettler, Prof. MD

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

  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: March 24, 2022
• First Posted: April 1, 2022
• Study Start: April 13, 2022
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Access Criteria: Only applications for non-commercial use will be considered and should be sent to the PI.

Locations

CH (1)