Actively Recruiting
A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes
Led by GentiBio, Inc · Updated on 2026-05-06
200
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the distribution of the HLA-DRB1*04:01 genotype in adults recently diagnosed with type 1 diabetes. This observational study focuses on participants aged 18 to 55 who have been diagnosed within six months. The goal is to better understand the genetic makeup of this group, which could help inform future research and treatment strategies. Participants will take part in a single study visit lasting about 24 hours. During this visit, they will provide demographic information and undergo either a blood draw or cheek swab to collect samples for genotype analysis. Some participants may choose to provide both types of samples. There is also a follow-up phone call approximately 24 hours after the visit to check on participants. Throughout the study, researchers will analyze the presence of the HLA-DRB1*04:01 genotype and examine its distribution across different ethnic and racial subgroups. Participants will be monitored with a single visit and brief follow-up, including data collection and sample testing. The study is led by GentiBio, Inc and is designed to be completed quickly with minimal burden on participants.
CONDITIONS
Brief Title
HLA Demographics Study in Adults With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 65 18 to 64 55 years
- Diagnosed with type 1 diabetes meeting American Diabetes Association criteria
- Diagnosis within 6 months of the study visit
- Able and willing to provide written informed consent personally
You will not qualify if you...
- Employee or immediate family member of the sponsor, study site, or contractor involved in the study
- Unwilling or unable to comply with study visit assessments
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 24 hours
Participants attend a single study visit for demographic data collection and a blood draw or cheek swab for HLA genotype analysis.
1 visit (in-person)
Duration - 24 hours
Participants receive a follow-up telephone call approximately 24 hours after the study visit to discuss any questions or concerns.
1 follow-up call
Trial Site Locations
Total: 5 locations
1
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
2
University of Florida- Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
3
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
5
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
K
Kristin M Neff, MS
M
Mark Bach, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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