Trialnet: Pathway to Prevention Study on Type 1 Diabetes

Pathway to Prevention Study

February 10, 2016



Type 1 Diabetes TrialNet

Pathway to Prevention Study

About this Study

The Natural History Study of the Development of type 1 diabetes will study people at increased risk for type 1 diabetes to learn more about how type 1 diabetes occurs.

TrialNet is screening close blood relatives of people with type 1 diabetes because relatives of people with type 1 diabetes have a 10 to 15 times greater risk for developing the disease than people with no family history.

Eligibility Criteria

To be screened, you must fulfill at least one of the two conditions below:

  • 2 to 45 years of age and have a brother, sister, child, or parent with type 1 diabetes
  • 2 to 20 years of age and have a cousin, aunt, uncle, niece, nephew, half sibling, or grandparent with type 1 diabetes


The study is divided into two parts: screening and monitoring. During screening, you will be tested for diabetes-related autoantibodies in the blood. Autoantibodies are proteins that are made by the body’s immune system. If these proteins are present, it could mean that cells in the pancreas which produce insulin are damaged. Certain kinds of autoantibodies can be found in the blood years before type 1 diabetes occurs.

If the screening blood tests show that you have autoantibodies, we will ask you to participate in the monitoring part of the study.


We will ask you to provide information about yourself and your family history of diabetes. We will take up to 1 tablespoon of blood at each visit to test for diabetes related autoantibodies. A member of the TrialNet research team will contact you if you have one or more autoantibodies present in the blood (you are positive). You will then be asked to return for a repeat blood test to confirm the presence of autoantibodies.

If we do not find autoantibodies in your blood (you are negative), you will receive results by letter. Testing negative for autoantibodies does not mean you will never get diabetes, but the chances are much lower than if you tested positive. It is still possible that you could develop autoantibodies in the future. For this reason, we will offer to test you each year until you turn 18. We may ask some people who are negative for antibodies to be in the monitoring part of the study so that we can compare their results with people who are positive.

How to participate

If you have questions or if you would like to learn more about how to participate in TrialNet, please email Gail Gannon at