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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT06994403
Eligibility Criteria:
Inclusion Criteria:
Study 1
* Healthy male volunteers
* Age between 18 and 50 years
* Body Mass Index (BMI) between 18 and 29 kg/m²
Study 2
* Male and female individuals
* Age ≥ 18 years
* Confirmed diagnosis of type 1 diabetes mellitus
* Use of a continuous glucose monitoring (CGM) system
Exclusion Criteria:
Study 1
* Diagnosis of diabetes mellitus
* Presence of any chronic-degenerative disease
* Any acute or chronic medical condition that could seriously compromise overall health
* Diagnosis of celiac disease
Study 2
* Presence of serious chronic illnesses (e.g., coronary heart disease, renal failure, liver diseases, endocrine disorders)
* Gastrointestinal disorders
* Pregnancy or breastfeeding
* Alcohol or drug dependence
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06994403
Study Brief:
Protocol Section:
NCT06994403