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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT04164966
Eligibility Criteria:
Inclusion Criteria:
Type 1 Diabetes (T1D)
1. Age 12-18 years inclusive
2. Diagnosis of T1D according to American Diabetes Association (ADA) criteria with an acute onset and presence of islet associated autoantibody by history.
3. T1D duration of ≤ 3 months from the diagnosis
Healthy Normal Volunteers (HNV)
1. Age 12-18 years inclusive
2. No personal history of diabetes according to ADA criteria
3. No history of T1D or insulin treated diabetes in first degree relatives (FDR)
Exclusion Criteria:
Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic and immune function including, but not limited to:
1. History of type 2 diabetes
2. Suspicion of non-type 1 diabetes (e.g. maturity onset diabetes of the young or secondary diabetes)
3. History of thyroid dysfunction in which the participant has not been on a stable dose (at least 6 weeks prior to enrollment) of thyroid replacement medication or antithyroid drugs.
4. History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
5. History of organ transplant
6. History of HIV, active Hepatitis B or C, or Tuberculosis
7. Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
8. Psychiatric disease prohibiting adherence to study protocol
9. Use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs.
10. Use of any other medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids \[steroids\], prescribed medications for weight loss, etc.)
11. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study visits
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT04164966
Study Brief:
Protocol Section:
NCT04164966