Checks an immune gene type in adults recently diagnosed with type 1 diabetes
Looks at an immune gene variant in adults newly diagnosed with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: HLA Demographics Study in Adults With Type 1 Diabetes
Key facts
- Where
- Boston, Chapel Hill, Gainesville, New York, and San Francisco, United StatesSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT06860516, who can take part
Where in United States
- Joslin Diabetes CenterBoston, United StatesTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- University of Florida - GainesvilleGainesville, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GentiBio, Inc
- Trial code
- NCT06860516
- Record updated
- 28 August 2026
- Original description
This is a study to evaluate the HLA-DRB1*04:01 genotype in adults that have been diagnosed with type 1 diabetesRead full original descriptionShow less
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
Inclusion: 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: 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.