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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT02624804
Eligibility Criteria:
Inclusion Criteria:
* Adult patients \>/=18 years
* Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes Association criteria for the Clarification and Diagnosis of diabetes
* Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet cells (IAA, IA2, GAD 65, ZnT8)
* Fasting C-peptide level \> 0.3 ng/ml
* Adequate venous access for apheresis
* Ability to provide informed consent
* Must agree to comply with all study requirements and be willing to complete all study visits
Exclusion Criteria:
* AST or ALT 2 \> x upper limit of normal.
* Creatinine \> 2.0 mg/dl.
* Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.
* Known active infection
* Pregnancy or breastfeeding mothers
* Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
* Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.)
* Anticoagulation other than ASA.
* Hemoglobin \< 10 g/dl or platelets \< 100 k/ml
* Is unable or unwilling to provide informed consent
* Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02624804
Study Brief:
Protocol Section:
NCT02624804