HLA Demographics Study in Adults With Type 1 Diabetes

GentiBio, Inc

Status: Enrolling

Conditions: Diabetes Mellitus, Type I

Treatments: Other: blood draw or cheek swab

Study type: Observational

Funder types: Industry

Identifiers

NCT06860516

GNTI-T1D-HLA-1002

Details and patient eligibility

About

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

Full 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 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 24 hours after the study visit.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

200 participants in 1 patient group

all participants

Description:

aged ≥ 18 to ≤ 55 years recently (within 6 months of the study visit) diagnosed with T1D

Treatment:

Other: blood draw or cheek swab