Status:
COMPLETED
The HEADWIND Study - Part 4
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Swiss Federal Institute of Technology
University of St.Gallen
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
21-60 years
Phase:
NA
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 algo...
Detailed Description
Hypoglycaemia is among the most relevant acute complications of diabetes mellitus. During hypoglycaemia physical, psychomotor, executive and cognitive function significantly deteriorate. These are imp...
Eligibility Criteria
Inclusion
- 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
- Passed driver's examination at least 3 years before study inclusion. Possession of a valid, definitive Swiss driver's license.
- Active driving in the last 6 months.
Exclusion
- 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
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05308095
Start Date
April 13 2022
End Date
June 23 2022
Last Update
December 21 2022
Active Locations (1)
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1
University Department of Endocrinology, Diabetology, Clinical Nutrition and Metabolism
Bern, Switzerland