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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

Sponsor: GentiBio, Inc · Participants: 200 · Started: Jun 6, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06860516

Locations in the U.S.

CaliforniaUniversity of California, San Francisco, San Francisco
FloridaUniversity of Florida- Gainesville, Gainesville
MassachusettsJoslin Diabetes Center, Boston
New YorkIcahn School of Medicine at Mount Sinai, New York
North CarolinaUniversity of North Carolina at Chapel Hill, Chapel Hill

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.