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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
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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Joslin Diabetes Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of North Carolina at Chapel Hill
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
University of Florida - Gainesville
Coordinator of this site? Confirm its status
GainesvilleUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.