A type I diabetes prevention study that is part of the TrialNet program at Vanderbilt is now enrolling children as young as 8 years old, following an FDA decision allowing the drug Teplizumab (anti-CD3) to be used in younger children.
TrialNet is an international network of diabetes researchers exploring ways to prevent, delay and reverse the progression of type 1 diabetes.
Previously, eligible subjects for this study were between ages 16 and 45 and hadn't yet developed type 1 diabetes, according to William Russell, M.D., professor of Pediatrics and principal investigator for the TrialNet study.
Teplizumab, which interferes with the function of T-cells in the immune system, is being tested to see if the drug can prevent or delay the development of type 1diabetes.
"The significant change in the protocol is that TrialNet took all of its safety data on the use of Teplizumab (anti-CD3) in children to the FDA for review," Russell said. "And the FDA concurred that the safety record for this drug now warrants its study in younger subjects."
The incidence of type 1 diabetes is increasing about 5 percent each year, with 1-4 year olds representing the fastest-growing segment of the population. Vanderbilt sees about 300 new cases each year in children, Russell said.
Subjects selected for this study need to have antibody evidence (from a blood test) of an immune system attack on their insulin-producing cells as well as abnormal, but not yet diabetic, glucose levels as determined by an oral glucose tolerance test.
Russell said participants screened and selected for trial inclusion will have an 85 percent likelihood to develop type 1 diabetes within the next five years.
"The goal of TrialNet is to discover how we can prevent type 1 diabetes from developing. Since type 1 diabetes has its usual onset in children and young adults, it is very important that our type 1 diabetes research focus on the young because they are most likely to benefit," Russell said.
"Being able to test this promising prevention approach in children as young as 8 allows us to take this research much closer to those who will ultimately benefit the most. All of us on the TrialNet team are very committed to putting an end to type 1 diabetes."