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:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT03613805
Eligibility Criteria:
Inclusion Criteria:
* Male and female participants of at least 18 years of age
* Diagnosis of type 1 diabetes mellitus (diagnosed according to World Health Organization criteria) for at least 1 year
* Body Mass Index (BMI) \<35 kg / m²
* Availability to wear study equipment and to comply with the study protocol for its entire duration
* HbA1c \<10%
* Signature of informed consent before any procedure related to the study.
Exclusion Criteria:
* Pregnancy, breastfeeding, intention to undergo pregnancy or refusal to use contraceptive methods during the study period (for female subjects).
* Known allergies to skin patches or disinfectants used during the study.
* Skin lesions, irritation, redness, edema in sites where sensors can be applied, as this might interfere with sensor's placement or with the accuracy of the glycaemic value detection.
* Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period.
* Use of acetaminophen or other drugs that could influence sensor accuracy
* Severe medical or psychological conditions, which, in the opinion of the medical team, may compromise patients' safety while participating in the study.
* Patients enrolled in other clinical trials.
* Known disorders of adrenal glands, pancreatic tumors or insulinoma
* Patient's inability to comply with the procedures of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03613805
Study Brief:
Protocol Section:
NCT03613805