RECRUITING

HLA Demographics Study in Adults With Type 1 Diabetes

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Conditions

Diabetes Mellitus, Type I

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-06-06
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06860516

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female participants aged ≥ 18 to ≤ 45 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:
  2. 1. Fasting glucose ≥ 126 mg/dL (7.0 mmol/L), or
  3. 2. 2-hour oral glucose tolerance test plasma glucose ≥ 200 mg/dL (11.0 mmol/L), or
  4. 3. Hemoglobin A1c ≥ 6.5%, or
  5. 4. Random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) (with documented classic hyperglycemia symptoms or hyperglycemic crisis).
  6. 2. Date of T1D diagnosis within 2 months of the study visit.
  7. 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. 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. 2. Participant is unwilling or unable to comply with the study visit assessments.

Contacts and Locations

Study Contact

Kristin M Neff, MS
CONTACT
85-732-75483
kristin.neff@gentibio.com
Mark Bach, MD
CONTACT
908-578-3634
mark.bach@gentibio.com

Principal Investigator

Mark Bach, MD
STUDY_DIRECTOR
GentiBio, Inc

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94158
United States
University of Florida- Gainesville
Gainesville, Florida, 32610
United States
Joslin Diabetes Center
Boston, Massachusetts, 02215
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: GentiBio, Inc

  • Mark Bach, MD, STUDY_DIRECTOR, GentiBio, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-06
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-06-06
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type I