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HLA Demographics Study in Adults With Type 1 Diabetes

Description

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

Conditions

Diabetes Mellitus, Type I
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Related Conditions:

Diabetes Mellitus, Type I

Study Overview

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Study Details

Study overview

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

A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes (T1D)

HLA Demographics Study in Adults With Type 1 Diabetes

Condition
Diabetes Mellitus, Type I
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94158

Gainesville

University of Florida- Gainesville, Gainesville, Florida, United States, 32610

Boston

Joslin Diabetes Center, Boston, Massachusetts, United States, 02215

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27514

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male and female participants aged ≥ 18 to ≤ 45 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:
  • 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.
  • 1. 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.
  • 2. Participant is unwilling or unable to comply with the study visit assessments.

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GentiBio, Inc,

Mark Bach, MD, STUDY_DIRECTOR, GentiBio, Inc

Study Record Dates

2026-06