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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT05933616
Eligibility Criteria:
(as in VAARA study, NCT05771090)
Inclusion Criteria:
* Written informed consent.
* Type 1 Diabetes with Multiple daily insulin injection (MDI) or Continuous subcutaneous insulin infusion therapy (CSII) \>1 year
* Age 18 - 50 (inclusive)
* Caucasian ethnicity
* BMI between 18.5 and 24.9 kg/m2 (inclusive)
* Usage of a continuous glucose monitoring (CGM)
Exclusion Criteria:
* Pregnancy or lactation period
* History of cardiovascular diseases
* Diabetes-related comorbidities
* HbA1c \>9 %
* Epilepsy
* Smoking (last cigarette within past 6 months)
* Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome.
* Known sensitivity to Latex.
* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05933616
Study Brief:
Protocol Section:
NCT05933616