RecruitingNot Applicable

HLA Demographics Study in Adults With Type 1 Diabetes

United States200 participantsStarted 2025-06-06

Plain-language summary

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

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

HLA DRB1*04:01 positive

Timeframe: Day 1

NCT IDNCT06860516

SponsorGentiBio, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-01-30

Kristin M Neff, MS