GentiBio, Inc
This is a study to evaluate the HLA-DRB1\*04:01 genotype in adults that have been diagnosed with type 1 diabetes
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 6 months of the study visit) diagnosed with T1D, with a single blood draw for the analysis of HLA genotype within the study participants. Some participants may elect to collect buccal cells via cheek swabs for genotype analysis. The study duration will be approximately 24 hours and will include a single study visit for the collection of demographic data and a single blood draw or cheek swab, and a follow-up telephone call approximately…
Inclusion Criteria: 1. Male and female participants aged ≥ 18 to ≤ 55 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 6 months of the study visit. 3. Able and willing to provide written, informed consent as approved by the institution…
a blood draw or cheek swab for testing of HLA-DRB1\*04:01 and other HLA alleles
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