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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kristin.neff@gentibio.com
• Phone: 85-732-75483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.