RECRUITINGOBSERVATIONAL
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)
About This Trial
This is a study to evaluate the HLA-DRB1\*04:01 genotype in adults that have been diagnosed with type 1 diabetes
Who May Be Eligible (Plain English)
Who May Qualify:
1. Male and female participants aged ≥ 18 to ≤ 45 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 2 months of the study visit.
3. Able and willing to provide written, willing to sign a consent form 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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Male and female participants aged ≥ 18 to ≤ 45 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 2 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.
Treatments Being Tested
OTHER
blood draw
a blood draw for testing of HLA-DRB1\*04:01
Locations (5)
University of California, San Francisco
San Francisco, California, United States
University of Florida- Gainesville
Gainesville, Florida, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States