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The HEADWIND Study - Part 2

NCT04569630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-06-29

No results posted yet for this study

Summary

To analyse driving behavior of individuals with type 1 diabetes in eu- and progressive hypoglycaemia while driving in a real car. Based on the driving variables provided by the car 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

Participants will drive on a designated circuit with a real car on a test track accompanied by a driving instructor. Driving data will be recorded in 4 subsequent glycemic states using an adapted hypoglycemic clamp protocol: euglycemia (d1, 5-8 mmol/l), progressive hypoglycaemia (d2, declining from 4.5 to 2.5 mmol/l), stable hypoglycemia (d3, 2.0-2.5 mmol/l), and again in euglycaemia (d4, 5-8 mmol/l). Patients will be blinded to their glucose levels.

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
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-05-27
Completion
2021-05-28

Countries

  • Switzerland

Study Locations

More Related Trials

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 NCT04569630 on ClinicalTrials.gov