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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT03154060
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of T1D for more than 6 months
* Adult patients ≥ 18 years
* Signed informed consent form
Exclusion Criteria:
* Pregnancy
* Patients with severe cognitive dysfunction or other disease which makes FGM use difficult.
* History of allergic reaction to any of the FGMs materials or adhesives when in contact with the skin.
* History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
* Abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
* Presence of concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as eGFR \< 45 ml/min).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03154060
Study Brief:
Protocol Section:
NCT03154060