HLA Demographics Study in Adults With Type 1 Diabetes

Recruiting now

Conditions studied: Diabetes Mellitus, Type I

In brief

This is a study to evaluate the HLA-DRB1\*04:01 genotype in adults that have been diagnosed with type 1 diabetes

Key facts

Study ID: NCT06860516
Run by: GentiBio, Inc
People needed: 200
Starts: 2025-06-06
Expected to finish: 2027-03-01
Last updated by the study team: 2026-05-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female participants aged ≥ 18 to ≤ 55 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:
Fasting glucose ≥ 126 mg/dL (7.0 mmol/L), or
2-hour oral glucose tolerance test plasma glucose ≥ 200 mg/dL (11.0 mmol/L), or
Hemoglobin A1c ≥ 6.5%, or
Random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) (with documented classic hyperglycemia symptoms or hyperglycemic crisis).
Date of T1D diagnosis within 6 months of the study visit.
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.

You may not qualify if…

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.
Participant is unwilling or unable to comply with the study visit assessments.

Where it is running

University of California, San Francisco — San Francisco, California, United States (enrolling)
University of Florida- Gainesville — Gainesville, Florida, United States (enrolling)
Joslin Diabetes Center — Boston, Massachusetts, United States (enrolling)
Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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