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The HEADWIND Study - Part 4

NCT05308095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-12-21

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Swiss Federal Institute of Technology

    collaborator OTHER

  • University of St.Gallen

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Christoph Stettler, Prof. MD · Inselspital, Bern University Hospital, University of Bern, Switzerland, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Bern, Switzerland

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2022-06-23
Completion
2022-06-23

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05308095 on ClinicalTrials.gov