Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT05308095
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT05308095
Study Brief:
Protocol Section:
NCT05308095