Overview
This is a study to evaluate the HLA-DRB1*04:01 genotype in adults that have been diagnosed with type 1 diabetes
Description
This is a non-interventional study to evaluate the distribution of human leukocyte antigen (HLA)-DRB1*04:01 genotype in participants that are recently (within 2 months of the study visit) diagnosed with T1D, with a single blood draw for the analysis of HLA genotype within the study participants. The study duration will be 24 hours and will include a single study visit for the collection of demographic data and a single blood draw, and a follow-up telephone call 24 hours after the study visit.
Eligibility
Inclusion Criteria:
- Male and female participants aged ≥ 18 to ≤ 45 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 2 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.