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HLA Demographics Study in Adults With Type 1 Diabetes
RecruitingObservational study
A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes (T1D)
Who can join
Ages 18 to 55 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Male and female participants aged ≥ 18 to ≤ 55 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis: 1. Fasting glucose ≥ 126 mg/dL (7.0 mmol/L), or 2. 2-hour oral glucose tolerance test plasma glucose ≥ 200 mg/dL (11.0 mmol/L), or 3. Hemoglobin A1c ≥ 6.5%, or 4. Random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) (with documented classic hyperglycemia symptoms or hyperglycemic crisis). 2. Date of T1D diagnosis within 6 months of the study visit. 3. Able and willing to provide written, informed consent as approved by the institutional review board (IRB). Participants must be able to consent directly; no other person or guardian may consent for them in this study. Exclusion Criteria: 1. Participant is an employee of, or an immediate family member of an employee, of the Sponsor, study site, or of a contractor/vendor who is involved in direct study conduct for this protocol. 2. Participant is unwilling or unable to comply with the study visit assessments.
About the study
This is a study to evaluate the HLA-DRB1\*04:01 genotype in adults that have been diagnosed with type 1 diabetes
What is being tested
- blood draw or cheek swab (other)
Sponsor: GentiBio, Inc · Participants: 200 · Started: Jun 6, 2025
Contact the study team
- Kristin M Neff, MS · Phone: 85-732-75483
- Mark Bach, MD · Phone: 908-578-3634
Official record on ClinicalTrials.gov — NCT06860516
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.