Genetics of Autoimmunity in Type 1 Diabetes Study

This study aims to understand how Type 1 diabetes develops by looking at genetic and environmental factors that affect the immune system. Researchers will collect blood samples to analyze your genes (HLA haplotype, a genetic sequence related to type 1 diabetes susceptibility), immune system responses, and other blood markers. They hope to learn more about the step-by-step process that leads to Type 1 diabetes. You may be eligible if you have a first-degree family member (like a parent, sibling, or child) with Type 1 diabetes who was diagnosed before age 39, and you are at least 2 years old. The study will track the onset of Type 1 diabetes and changes in autoantibodies (markers of immune system activity) for up to 10 years.

Study design
This is an observational study planning to enroll 4000 participants. It involves families where at least one member has Type 1 diabetes.
What's involved
You will have a blood draw, a brief medical history questionnaire, and measurements of your height and weight. Some participants may have annual follow-up visits for up to 10 years.
Compensation
Not stated in the trial record.
Follow-up
Some participants will be followed for up to 10 years to monitor for the onset of Type 1 diabetes and changes in autoantibodies.

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NCT03648918

Genetics Of Autoimmunity In Type I Diabetes

Recruiting
Not specifiedAges 2+Observational
Medical College of Wisconsin
~4,000 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:Blood Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Onset of Type 1 diabetes
Measured over Up to 10 years
+1 more outcome measured
Type1diabetes
Diabetes Mellitus, Type 1
Type1 Diabetes Mellitus
Diabetes Mellitus
1 sites across 1 states
Wisconsin1
  • Martin Hessner, PhD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

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Eligibility criteria

Inclusion

Families where at least one first-degree family member has type 1 diabetes
The diabetic proband in the family was diagnosed before the age of 39
Family members must be at least 2 years old to participate
No family history of type 1 diabetes or other autoimmune conditions
Age 2 or older

Exclusion

Families with no history of type 1 diabetes
Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)
Personal or family history of autoimmune disease
  • Onset of Type 1 diabetesUp to 10 years

    The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on the presence of symptoms and unequivocal hyperglycemia.

  • Autoantibody MeasurementUp to 10 years

    Presence or absence of the autoantibodies related to type 1 diabetes: IA-2 (islet antigen), GAD65 (pancreatic islet cell autoantibody), IAA (insulin autoantibody), ZnT8 (zinc transporter 8)