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Have a Relative With Type 1 Diabetes? Join a Clinical Trial To Learn Your Risk

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A person gets a blood test for diabetes

Key takeaways: 

  • If you are related to someone with type 1 diabetes, you can participate in this free trial to find out your risk of developing diabetes. 
  • Screening is important for early diagnosis and proper management of diabetes, which can help delay complications. 
  • Study participants will undergo a simple blood test. Those who test positive for diabetes antibodies can receive additional testing and monitoring. 

Clinical Trials Identifier: NCT00097292

Trial Name: TrialNet Pathway to Prevention of T1D

Diabetes Type: Relatives of people with type 1 diabetes

Trial Sponsor: University of South Florida 

What is the trial researching? 

This study aims to understand the different characteristics that put people at risk for developing type 1 diabetes. These include demographic traits, such as age and gender, as well as physical traits. 

The study is conducted by TrialNet, an international group of experts that research the prevention and early treatment of type 1 diabetes through trials like this one. According to TrialNet, relatives of people with type 1 diabetes have a 5% chance of testing positive for the antibodies associated with diabetes. 

The study involves two parts: screening and monitoring. 

The screening involves a simple blood test to check for diabetes-related autoantibodies. If either of the two main autoantibodies are detected, then additional screening for three other T1D-related autoantibodies will be conducted. The additional testing will help determine participants’ risk of developing diabetes in the next five years. Additional screening and monitoring includes:

  • If someone has only one autoantibody, they will be invited to be re-tested annually to check for the development of multiple antibodies. 
  • Those already with multiple autoantibodies are invited to take an oral glucose tolerance test (OGTT), re-testing for multiple autoantibodies (if needed), and an A1C test
  • Multiple autoantibody participants with normal glucose tolerance and A1C less than 6% will be asked to follow-up annually. 
  • Multiple autoantibody participants with an abnormal glucose tolerance or an A1C greater than 6% will be asked to follow up semi-annually 

Participants can get their screening tests done at a TrialNet Clinical Center, an affiliate center, or by requesting a screening kit to have their blood drawn by a local physician or laboratory.

What are antibodies? 

Antibodies are part of your immune system and their purpose is to identify and neutralize bacteria and viruses. An autoantibody is an antibody that mistakenly targets your body’s own tissues and organs. 

In people with or at risk for type 1 diabetes, the islet autoantibodies made by the immune system destroys the pancreatic beta cells that make insulin. 

There are five different islet autoantibodies associated with type 1 diabetes. Generally, people with two or more islet autoantibodies have nearly a 100% chance of developing type 1 diabetes in their lifetime. 

Why is this important? 

Screening for type 1 diabetes is key because it can help delay the progression of type 1 diabetes. 

Identifying people who are at high risk allows for close monitoring and proactive treatment. This is especially important now that Tzield (teplizumab) is available to delay the onset of type 1 diabetes. 

Screening for type 1 diabetes may also reduce the risk of diabetic ketoacidosis (DKA), a potentially life-threatening condition of severe high blood sugar. Approximately 30% of children with diabetes are diagnosed due to DKA. 

Now that Tzield is available, many experts have recommended screening for type 1 diabetes in the general population. However, it’s not so easy for healthcare systems to roll out large-scale screening. In the meantime, studies like this one could help identify people with early type 1 diabetes from a higher-risk group. 

Are you interested? 

You may be eligible if you: 

  • Are between 2.5-45 years old and have an immediate family member (child, parent, or sibling) with type 1 diabetes; OR
  • Are between 2.5-20 years old and have an extended family member (cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling) with type 1 diabetes

People who have already been diagnosed with diabetes, are currently taking immunosuppressive medications, or have known serious diseases are not eligible for this study. See a full list of inclusion and exclusion criteria here.

This study is recruiting in many locations across the U.S., Canada, and Australia. To learn more about this study, contact the TrialNet Central Information Center or call (+)1-800-425-8361. 

Learn more about type 1 diabetes screening and trials: