Status:
COMPLETED
The HEADWIND-Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
ETH Zurich
University of St.Gallen
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
21-50 years
Phase:
NA
Brief 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 simula...
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 (Appendix Informed Consent Form)
- DM1 as defined by WHO for at least 1 year or is confirmed C-peptide negative (\<100pmol/l with concomitant blood glucose \>4 mmol/l)
- Subjects aged between 21-50 years
- HbA1c ≤ 8.5 % based on analysis from central laboratory
- Functional insulin treatment with insulin pump therapy (CSII) or basis-bolus insulin for at least 3 months with good knowledge of insulin self-management
- Only for the main-study: Passed driver's examination at least 3 years before study inclusion. Possession of a valid Swiss driver's license. Active driving in the last 6 months before the study.
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
- Women who are pregnant or breastfeeding
- Intention to become pregnant during the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Other clinically significant concomitant disease states as judged by the investigator (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Known or suspected non-compliance, 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
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Total daily insulin dose \>2 IU/kg/day.
- Specific concomitant therapy washout requirements prior to and/or during study participation
- Physical or psychological disease is likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator (especially coronary heart disease or epilepsy).
- Current treatment with drugs known to interfere with metabolism (e.g. systemic corticosteroids, statins etc.) or driving performance (e.g. opioids, benzodiazepines)
- Only for the main-study: Patients not capable of driving with the driving simulator or patients experiencing motion sickness during the simulator test driving session (at visit 2).
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04035993
Start Date
October 7 2019
End Date
July 6 2020
Last Update
June 8 2021
Active Locations (1)
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1
University Department of Endocirnology, Diabetology, Clinical Nutrition and Metabolism
Bern, Switzerland