NCT06860516 · GentiBio, Inc
HLA Demographics Study in Adults With Type 1 Diabetes
What this study is about
This is a study to evaluate the HLA-DRB1\*04:01 genotype in adults that have been diagnosed with type 1 diabetes
View original scientific description
This is a study to evaluate the HLA-DRB1\*04:01 genotype in adults that have been diagnosed with type 1 diabetes
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female participants aged ≥ 18 to ≤ 55 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:
- Fasting glucose ≥ 126 mg/dL (7.0 mmol/L), or
- 2-hour oral glucose tolerance test plasma glucose ≥ 200 mg/dL (11.0 mmol/L), or
- Hemoglobin A1c ≥ 6.5%, or
- Random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) (with documented classic hyperglycemia symptoms or hyperglycemic crisis).
- Date of T1D diagnosis within 6 months of the study visit.
- 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
- 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.
- Participant is unwilling or unable to comply with the study visit assessments.
Where
- San Francisco, California
- Gainesville, Florida
- Boston, Massachusetts
- New York, New York
- Chapel Hill, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations