What is TrialNet?
TrialNet is an international network of the world’s leading Type 1 diabetes (T1D) researchers who are exploring ways to prevent, delay and slow the progression of the disease. The National Institutes of Health (NIH) created TrialNet in 2000 with the objective of conducting research studies to prevent T1D. Today, more than 200 centers (in the United States, Canada, United Kingdom, Germany, Italy, Finland, Australia and New Zealand) participate in the TrialNet network. Studies are available for the relatives of people with Type 1 diabetes, as well as for people newly diagnosed with T1D.
Why are studies available for relatives?
The relatives of people with Type 1 diabetes have a 15 times greater risk for developing T1D than people with no family history. For relatives of those with T1D, the TrialNet Pathway to Prevention study offers a no-cost screening to test blood for five autoantibodies that signal an increased risk for Type 1 diabetes years before symptoms appear. Almost all individuals who have two or more of these autoantibodies will develop Type 1 diabetes.
What happens if risk is determined?
Participants who screen positive for autoantibodies are eligible to continue in the study’s “Monitoring” phase, during which they are routinely monitored for the earliest signs of Type 1 diabetes. TrialNet participants who go on to develop T1D are usually diagnosed before symptoms ever occur. Their doctor can start them on insulin before they start feeling sick or experience life-threatening diabetic ketoacidosis.
Depending on their test results, those who screen positive for autoantibodies may be eligible to enroll in one of TrialNet’s ongoing prevention studies. These studies are testing whether certain treatments can delay or prevent the onset of T1D. “The Oral Insulin” study is testing whether a capsule of crystallized insulin may delay onset in those with a specific (MIAA) autoantibody, as suggested by an earlier study that showed a delay in the onset of the disease by up to 10 years. Abatacept and Teplizumab are medications that have both shown promise in preserving insulin production in people newly diagnosed with T1D. They are both currently being studied now in at-risk individuals to see if they can help delay or prevent the onset of T1D.
Who exactly can enroll?
Eligible participants for the “Pathway to Prevention” study include first-degree relatives of those with T1D ages 1-45 (parents, siblings, children), and second/third-degree relatives ages 1-20 (cousins, half-siblings, nieces and nephews, grandchildren).
What does enrollment entail?
Enrollment in the Pathway to Prevention study involves some paperwork, signed consent and a simple blood draw. This “screening” visit occurs at a TrialNet center or affiliated physician’s office. TrialNet can also send test kits for participants to take to a local lab. The results are returned 4 to 6 weeks after the screening.
See a list of TrialNet centers and affiliates HERE.
What have we learned from TrialNet studies?
Most recently, TrialNet and other longitudinal studies of at-risk individuals have led researchers to redefine the definition of “Type 1 diabetes.” T1D is classically diagnosed at the onset of overt high blood sugar and its corresponding symptoms like increased thirst, urination, weight loss and blurred vision. Researchers in affiliation with the Juvenile Diabetes Research Foundation (JDRF), the Endocrine Society and the American Diabetes Association (ADA) now view T1D as a continuum featuring three disease stages.
- Stage 1 is marked by the presence of two or more autoantibodies and normal glucose levels.
- Stage 2 features two or more autoantibodies and occasional abnormal glucose levels (as demonstrated during an Oral Glucose Tolerance Test). People in “Stage 2” do not yet display symptoms.
- Stage 3 features the emergence of diabetes-related symptoms and diagnosis of T1D.
Read more on the stages of Type 1 diabetes HERE.
What studies are available for people recently diagnosed with T1D?
TrialNet is currently recruiting for the ATG/GCSF study, testing the combination of two drugs [antithymocyte globulin (ATG) and granulocyte-colony stimulating factor (GCSF)] to slow progression in people newly diagnosed with T1D. Participants must be ages 12-45 and start study treatment within 100 days of diagnosis.
You can help spread the word about TrialNet screening and prevention/new onset studies to your family members and friends who have a relative with Type 1 diabetes. Screening is the first step on the pathway to prevention.