HLA Demographics Study in Adults With Type 1 Diabetes

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

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.

Conditions:
• Diabetes Mellitus
• Diabetes Mellitus, Type 1