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 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT04905628
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Confirmed pregnancy
* Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)
* Willing to wear up to the required number of Systems for the total duration of study wear
* Able to follow study procedures;
* Able to speak, read, and write in English or Spanish.
Exclusion Criteria:
* Extensive skin changes/diseases that preclude wearing the required number of Systems at the proposed wear sites
* Known allergy to medical-grade adhesives
* Hematocrit outside specification
* Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy
* Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period
* Currently using Hydroxyurea for treatment
* Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04905628
Study Brief:
Protocol Section:
NCT04905628