NCT06860516Recruiting
HLA Demographics Study 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)
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
This is a study to evaluate the HLA-DRB1\*04:01 genotype in adults that have been diagnosed with type 1 diabetes
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 25 Feb 2025
- Start date
- 6 Jun 2025
- Primary completion date
- 30 Jan 2027
- Lead sponsor
- GentiBio, Inc
- Diseases
- Type 1 diabetes
- NCT number
- NCT06860516
What you commit to
- Study type: Observational
- Planned participants: 200
- From 6 Jun 2025 to the primary completion date, 30 Jan 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Joslin Diabetes Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| University of Florida - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.