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)

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type I
• Intervention / Treatment: Other: blood draw or cheek swab

Detailed Description

This is a non-interventional study to evaluate the distribution of human leukocyte antigen (HLA)-DRB1*04:01 genotype in participants that are recently (within 6 months of the study visit) diagnosed with T1D, with a single blood draw for the analysis of HLA genotype within the study participants. Some participants may elect to collect buccal cells via cheek swabs for genotype analysis. The study duration will be approximately 24 hours and will include a single study visit for the collection of demographic data and a single blood draw or cheek swab, and a follow-up telephone call approximately 24 hours after the study visit.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Kristin M Neff, MS; Phone Number: 85-732-75483; Email: kristin.neff@gentibio.com
• Study Contact Backup: Name: Mark Bach, MD; Phone Number: 908-578-3634; Email: mark.bach@gentibio.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California, San Francisco
      • Principal Investigator: Stephen Gitelman, MD
      • Contact: Rebecca Wesch, Recruitment Coordinator; Phone Number: 844-813-8273; Email: clinicalresearch@diabetes.ucsf.edu
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida- Gainesville
      • Principal Investigator: Michael Haller, MD
      • Contact: Jennifer Hosford; Phone Number: 352-294-5759; Email: jennifer.hosford@peds.ufl.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Joslin Diabetes Center
      • Principal Investigator: Jason Gaglia, MD
      • Contact: Michelle Zhang; Phone Number: 888-813-8669; Email: T1DTrials@joslin.harvard.edu
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Carol Levy, MD
      • Contact: Carol Levy, MD; Phone Number: 212-241-0068; Email: carol.levy@mssm.edu
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Principal Investigator: Klara Klein, MD
      • Contact: Alex Kass; Phone Number: 984-974-3004; Email: uncdiabetes@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study will enroll up to approximately 200 adults aged ≥ 18 to ≤ 55 years with recently (within 6 months of the study visit) diagnosed T1D who have met the American Diabetes Association T1D diagnosis criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
all participants; aged ≥ 18 to ≤ 55 years recently (within 6 months of the study visit) diagnosed with T1D	Other: blood draw or cheek swab; a blood draw or cheek swab for testing of HLA-DRB1*04:01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HLA DRB1*04:01 positive	to evaluate the frequency of adults with recently diagnosed type 1 diabetes that are HLA DRB1*04:01 positive at time of enrollment	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HLA-DRB1*04:01 genotype by ethnic and racial subgroups	to determine the distribution of HLA-DRB1*04:01 genotype in adults recently diagnosed with type 1 diabetes at the time of enrollment by ethnic and racial subgroups	Day 1

Collaborators and Investigators

• Sponsor: GentiBio, Inc
• Investigators: Study Director: Mark Bach, MD, GentiBio, Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: GNTI-T1D-HLA-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: will share study results through a publication or conference presentation
• IPD Sharing Time Frame: within 6 months from study completion
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No