Recruiting

HLA-DRB1*04:01

Sponsor:

GentiBio, Inc

Code:

NCT06860516

Conditions

Diabetes Mellitus, Type I

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

blood draw or cheek swab

Study Details

Brief summary:

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

Study ID

NCT06860516

Start date

Jun 6, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male and female participants aged ≥ 18 to ≤ 55 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 6 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:

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

all participants

aged ≥ 18 to ≤ 55 years recently (within 6 months of the study visit) diagnosed with T1D

Interventions

blood draw or cheek swab

a blood draw or cheek swab for testing of HLA-DRB1\*04:01 and other HLA alleles

Primary outcome measure

  • HLA DRB1*04:01 positive [ Time Frame: Day 1 ]

Central Contacts and Locations

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Rebecca Wesch, Recruitment Coordinator

844-813-8273clinicalresearch@diabetes.ucsf.edu

Principal Investigator:

Stephen Gitelman, MD

University of Florida- Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Principal Investigator:

Michael Haller, MD

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Jason Gaglia, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Carol Levy, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Principal Investigator:

Klara Klein, MD

More Information

Sponsor

GentiBio, Inc

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by GentiBio, Inc on 2026-08-28.