NCT06860516 HLA Demographics Study in Adults With Type 1 Diabetes
| NCT ID | NCT06860516 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GentiBio, Inc |
| Condition | Diabetes Mellitus, Type I |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-06-06 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a study to evaluate the HLA-DRB1\*04:01 genotype in adults that have been diagnosed with type 1 diabetes
Eligibility Criteria
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.
Contact & Investigator
Mark Bach, MD
STUDY DIRECTOR
GentiBio, Inc
Frequently Asked Questions
Who can join the NCT06860516 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Diabetes Mellitus, Type I. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06860516 currently recruiting?
Yes, NCT06860516 is actively recruiting participants. Contact the research team at kristin.neff@gentibio.com for enrollment information.
Where is the NCT06860516 trial being conducted?
This trial is being conducted at San Francisco, United States, Gainesville, United States, Boston, United States, New York, United States and 1 additional location.
Who is sponsoring the NCT06860516 clinical trial?
NCT06860516 is sponsored by GentiBio, Inc. The principal investigator is Mark Bach, MD at GentiBio, Inc. The trial plans to enroll 200 participants.
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