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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at a gene type called HLA-DRB1*04:01 in adults with type 1 diabetes. It is for adults ages 18 to 55 who were diagnosed within 6 months before the study visit.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 55 years old.
  • You were diagnosed with type 1 diabetes within 6 months before the study visit.
  • At diagnosis, you met at least one of these blood sugar test results: fasting blood sugar of 126 mg/dL or higher; blood sugar of 200 mg/dL or higher 2 hours after a glucose drink; A1c (average blood sugar) of 6.5% or higher; or blood sugar of 200 mg/dL or higher at any time, with recorded signs of high blood sugar or a high blood sugar crisis.
  • You can and will sign a consent form yourself after learning about the study. No other person or guardian can consent for you.

Who can't join

  • You work for the study sponsor, study site, or a contractor or vendor directly involved in running the study, or you are an immediate family member of someone who does.
  • You cannot or will not complete the checks required at the study visit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (5)

CA

FL

MA

NC

NY