TrialNet Natural History Study of the Development of Type 1 Diabetes: Screening

Clinical Trial

Offered by: Nemours Children's Specialty Care, Jacksonville
Location: Jacksonville, Fla.

Trial Name

TrialNet Natural History Study of the Development of Type 1 Diabetes: Screening

What is the trial about?

The specific purpose of the study is to learn more about how type 1 diabetes occurs. This study is a part of the TrialNet research program. The goal of the program is to develop studies to learn more about the prevention of type 1 diabetes. 

Who can participate?

  • Must be aged 1–45 years and have a first degree blood relative (sibling, child or parent) with type 1 diabetes OR
  • Must be aged 1–20 years and have a second or third degree blood relative (aunt, uncle, niece, nephew, grandparent, cousin or half sibling) with type 1 diabetes.
  • Your relative must have been diagnosed with type 1 diabetes before age 40, and started taking insulin within the first year of diagnosis, for you to be eligible.

What is involved?

To be screened for diabetes-related autoantibodies, you will need to give a blood sample. We test for three autoantibodies: GAD65A, IA-2A, and mIAA (Insulin autoantibodies). If at least one autoantibody is present on the first sample, we will need a second blood sample on a different day. The reason for the second sample is to be absolutely sure that autoantibodies are present. We will test for five autoantibodies on the screening confirmation. The first three autoantibodies again and two more: islet cell autoantibodies (ICA) and ZnT8A. We will take less than a teaspoon of blood from a vein for each of the samples. The blood sample will be shipped to a TrialNet central laboratory, where it will be tested for the autoantibodies. You will be told whether you have autoantibodies that increase your risk of developing type 1 diabetes.

1 blood draw.

Contact Nemours Clinical Trials

Trial Name: Risk Screening for relatives of people with Type 1 Diabetes

Contact Information

(800) 354-5690
ClinicalTrials@nemours.org