Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-06-06
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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all participants
aged ≥ 18 to ≤ 45 years recently (within 2 months of the study visit) diagnosed with T1D
blood draw
a blood draw for testing of HLA-DRB1\*04:01
Interventions
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blood draw
a blood draw for testing of HLA-DRB1\*04:01
Eligibility Criteria
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Inclusion Criteria
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 2 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
2. Participant is unwilling or unable to comply with the study visit assessments.
18 Years
45 Years
ALL
No
Sponsors
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GentiBio, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Bach, MD
Role: STUDY_DIRECTOR
GentiBio, Inc
Locations
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University of California, San Francisco
San Francisco, California, United States
University of Florida- Gainesville
Gainesville, Florida, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GNTI-T1D-HLA-1002
Identifier Type: -
Identifier Source: org_study_id
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