Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT03648918

Conditions

Type1diabetes

Diabetes Mellitus, Type 1

Type1 Diabetes Mellitus

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

Blood Collection

Study Details

Brief summary:

The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.

Conditions

Type1diabetes

Diabetes Mellitus, Type 1

Type1 Diabetes Mellitus

Diabetes Mellitus

Study ID

NCT03648918

Start date

Aug, 2001

Status verified date

Mar, 2026

Completion date

Jan, 2050

Anticipated

Primary completion date

Jan, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Inclusion Criteria (Families):

  • 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

Exclusion Criteria (Families):

  • Families with no history of type 1 diabetes
  • Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)

Inclusion Criteria (Controls):

  • No family history of type 1 diabetes or other autoimmune conditions
  • Age 2 or older

Exclusion Criteria (Controls):

  • Personal or family history of autoimmune disease

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Blood Collection

Blood will be collected via venipuncture and analyzed. Blood samples will be analyzed for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility), plasma-induced signature, diabetes autoantibodies, complete blood count with differential, and serum and plasma for storage. For family members with diabetes, blood will also be tested for A1c.

Primary outcome measure

  • Onset of Type 1 diabetes [ Time Frame: Up to 10 years ]
  • Autoantibody Measurement [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Martin Hessner, PhD

414-955-4903t1dinfo@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Martin Hessner, PhD

414-955-4903t1dinfo@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • Family
  • Healthy Controls
  • Siblings

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-03-16.