The Teplizumab Prevention Study has two phases: treatment and follow up.
In the treatment phase, participants make daily visits to a TrialNet site for 14 days in a row. Each visit takes about 4 hours and includes a 30-minute intravenous infusion (I.V.), followed by two hours of observation.
In the follow up phase, participants return for visits until the study is over or until they develop T1D:
• Year 1: Visits at 20 days, 6 weeks, 3 months, 6 months, and 12 months
• Years 2 and beyond: Visits two times a year
Half the people in the study will get the study drug. The other half will get a placebo (looks like the study drug but is inactive). A computer randomly selects who gets the study drug, and no one knows who is in which group until the end of the study.
Regardless of which group you are in, you play an important role in advancing T1D research for the immediate study and well into the future. Once the study is over, blood samples from participants in the placebo arm of the study are used in other studies looking to answer questions about how T1D progresses and how to stop it.
All study participants receive close monitoring. If you develop T1D, our tests will likely show this before you have any symptoms. For people taking part in T1D research, the risk of diabetic ketoacidosis (DKA) at diagnosis drops from 30% to less than 4%. DKA is a serious condition that can be life-threatening.
With early notification, you will be able to see your doctor and start taking insulin before you feel sick. If there aren’t any studies for newly diagnosed T1D that are right for you, we will invite you to take part in long-term follow up.