HLA-DRB1*04:01 genetics in adults with type 1 diabetes

A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes (T1D)

This test will look for the HLA-DRB1*04:01 gene in adults diagnosed with type 1 diabetes within the past six months.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: GentiBio, Inc (industry)
• Locations: 5 sites (San Francisco, California and 4 other locations)
• Trial ID: NCT06860516 on ClinicalTrials.gov

What this trial studies

This non-interventional protocol collects a single blood draw or optional cheek swab from adults aged 18–55 who were diagnosed with type 1 diabetes within the prior six months. Investigators will genotype samples for the HLA-DRB1*04:01 allele and record basic demographic information during one clinic visit. The participation window is approximately 24 hours and includes a follow-up phone call about 24 hours after the visit to confirm sample collection and address any questions. No investigational treatments are given and the study focuses solely on genetic characterization.

Who should consider this trial

Good fit: Adults aged 18–55 diagnosed with type 1 diabetes within the past six months who can provide written informed consent are the ideal candidates.

Not a fit: People diagnosed more than six months ago, those outside the 18–55 age range, or individuals unable to provide informed consent would not be eligible and are unlikely to gain benefit from joining.

Why it matters

Potential benefit: If common associations are confirmed, the findings could help identify patients who might benefit from genotype-targeted research or future personalized approaches.

How similar studies have performed: Prior genetic research has repeatedly linked HLA class II alleles including DRB1*04:01 to type 1 diabetes risk, so genotyping to characterize patients is an established approach.

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.

Where this trial is running

San Francisco, California and 4 other locations

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

Study contacts

• Study coordinator: Kristin M Neff, MS

Conditions: Diabetes Mellitus, Type I