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The HEADWIND-Study

NCT04035993 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-06-08

No results posted yet for this study

Summary

To analyse driving behavior of individuals with type 1 diabetes in eu- and progressive 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 neural networks (deep machine learning classifiers).

Conditions

Interventions

OTHER

Controlled hypoglycaemic state while driving with a driving simulator

Patients will arrive in the morning after an overnight fast. During the controlled hypoglycaemic state, participants will drive on a designated circuit using a driving simulator. Initially, euglycaemic state (5.0-8.0 mmol/L) will be kept stable and then blood glucose will be declined progressively targeting at a level between 2.0-2.5mmol/L by administering an insulin bolus. Glucose will be kept stable at the hypoglycaemic level for 30 minutes. Thereafter, it will be raised again and kept stable for another 30 minutes at an euglycaemic level between 5.0-8.0mmol/L. During the procedure, we will analyse counterregulatory hormones. Heart rate, skin conductance, CGM values, eye movement and facial expression, will be recorded by a smart-watch, a CGM device, an eye-tracker and an onboard camera, respectively. Participants will be blinded to the glucose values during the procedure. They will have to rate their symptoms and their performance on a 0-6 scale every 15 minutes.

Sponsors & Collaborators

  • ETH Zurich

    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

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2020-07-02
Completion
2020-07-06

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 NCT04035993 on ClinicalTrials.gov