RecruitingNCT06860516

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)

Sponsor

GentiBio, Inc

Enrollment

50 participants

Start Date

Jun 6, 2025

Study Type

OBSERVATIONAL

Conditions

This is a study to evaluate the HLA-DRB1\*04:01 genotype in adults that have been diagnosed with type 1 diabetes

Min Age: 18 YearsMax Age: 45 Years

Male and female participants aged ≥ 18 to ≤ 45 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:
Fasting glucose ≥ 126 mg/dL (7.0 mmol/L), or
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 2 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.

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.