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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT07258394
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who provide written informed consent.
2. Aged 18-65 years.
3. Diagnosed with Type 1 Diabetes Mellitus (per ADA 2024 criteria).
4. Positive for ≥2 autoantibodies: Insulin autoantibody (IAA) Glutamic acid decarboxylase autoantibody (GADA) Protein tyrosine phosphatase antibody (IA-2A) Islet cell antibody (ICA) Zinc transporter 8 autoantibody (ZnT8A) Note: For IAA-positive subjects with insulin use \>14 days, ≥2 additional autoantibodies must be positive.
5. Disease duration ≤100 days post-T1DM diagnosis.
6. Random C-peptide ≥ 200 pmol/L.
Exclusion Criteria:
1. Pregnancy, lactation, or women of childbearing potential not using contraception.
2. Well-controlled glycemia with oral hypoglycemic agents alone.
3. Participation in other diabetes/immune-modulating trials.
4. ALT/AST \>3× upper limit of normal (ULN).
5. History of malignancy, uncontrolled autoimmune disorders, or active infections.
6. Alcohol/drug abuse, psychiatric disorders, or conditions unsuitable for trial participation.
7. Use of immunosuppressants within 12 weeks prior.
8. Participation in other drug trials within 12 weeks prior.
9. History of drug allergies, hypersensitivity, or drug addiction.
10. Any condition deemed by investigators to compromise study integrity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07258394
Study Brief:
Protocol Section:
NCT07258394