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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT05505669
Eligibility Criteria:
Inclusion Criteria:
* Documented informed consent/ assent from the subject
* ONE of the following:
* Type 1 diabetes patients (including pediatric patients) -OR-
* Adult type 2 diabetes patients -OR-
* Volunteers who are islet auto-antibody positive (i.e. insulin, GAA, IA-2, IAA and ZnT8 antibodies) with HbA1c ≤ 5.6% (including pediatric patients)-OR-
* Adult participants with clinical diagnosis of high blood sugar (i.e. HbA1c of 5.7% to 6.4%)-OR-
* Adult control subjects with HbA1cc ≤ 5.6%
* Weight ≥ 30 kg
* Willingness to: Provide blood sample(s) and if applicable: permit medical record/ clinical laboratory result review
Exclusion Criteria:
* Control subjects must not have any chronic conditions or have undergone cellular, tissue or organ transplant
* Sickle cell disease or anemia (exception: anemia that is corrected with treatment and source documents confirm corrected blood parameters current within 6 months of blood draw)
* Active infection
* Active malignancy (i.e., currently undergoing treatment)
* Immunomodulatory therapy within 1 year of planned blood draw (may include immune checkpoint inhibitors, thalidomide, lenalidomide, pomalidomide, imiquimod, Bacillus Calmette-Guérin, and cytokines/ growth factors (e.g. interferons, interleukins)
* Type 1 diabetes only: polyclonal regulatory T cell and/or dendritic cell therapy
* Bleeding disorder
* Women of childbearing potential: Pregnant/ nursing (Note: Eligibility may be deferred per blood donation timelines for pregnancy/nursing)
* Diabetic patients only: Any clinical condition that might be adversely affected by the removal of up to 100 mL of blood
* An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager
* A direct study team member
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05505669
Study Brief:
Protocol Section:
NCT05505669