TrialNet Natural History

Study name

TrialNet Natural History Study of the Development of Type 1 Diabetes Mellitus

Study sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Principal investigator

Lorraine Levitt Katz, MD

Who can participate?

  • Those 1-45 years old with an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
  • Those 1-20 years old with an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)

What is this study about?

The purpose of this research study is to learn more about the development of type 1 diabetes in order to better characterized the risk of diabetes and identify factors that may be important to the pathway for prevention and improved treatments.

What does participation involve?

The study consists of an initial screening visit for all eligible volunteers. A blood sample will be collected and screened for diabetes-related autoantibodies. These autoantibodies can lead to type 1 diabetes in some people, though not all. We only expect about 5% (or 1 in 20) eligible volunteers to screen positive.

What is important to consider about screening?

  • Screening positive for the autoantibodies does not mean you will get type 1diabetes. It means you are at an increased risk.
  • Also, screening negative does not mean you will never get diabetes, but your risk is much lower than if you were positive. That might change. So, volunteers under 18 years old can be screened every year.
  • Volunteers that screen positive may be eligible for additional testing to learn more about their risk of type 1. This testing would be completed at visits up to twice a year.
  • Volunteers that screen positive may also be eligible for other TrialNet studies that attempt to delay or prevent the onset of Type 1 Diabetes (See TrialNet Oral Insulin).

How long will this study last?

Total clinical trial participation may last from a one-time blood draw up to follow-up visits every 6 months.

Reimbursement

Study-related care and supplies are provided at no cost to you. Participants that screen positive and complete the additionally testing will be compensated for their time and effort required for the study visits.

More information

Type 1 Diabetes TrialNet website

ClinicalTrials.gov - Natural History Study of the Development of Type 1 Diabetes

If you are interested in the study 

Please email Beth Schwartzman at schwartzmann@email.chop.edu or call: 267-426-7433.

CHOP #: 04-003946
Approval Date: 12/16/11
Expiration Date: N/A

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