Long-term Safety Observation of TZIELD Teplizumab-mzwv in Patients with Early Stage 2 Type 1 Diabetes in the US

What this Trial Is About

This research focuses on Stage 2 Type 1 Diabetes T1D, an early phase marked by abnormal blood sugar levels without clear symptoms. The study aims to gather information about patients with Stage 2 T1D and to observe the long-term effects of TZIELD teplizumab-mzwv, a drug approved by the U.S. FDA to delay the progression to clinical T1D in adults and children aged 8 years and older. This is an observational study where no treatments are administered by the researchers. Instead, patients who are either about to start or have recently started TZIELD treatment within six months, as well as patients not receiving TZIELD, will be followed. The study records the use of TZIELD as prescribed in real-world clinical practice without interference. Participants will be monitored for up to about 10 years to track adverse events, serious adverse events, maternal and infant outcomes if exposed during pregnancy, and infant development up to 12 months after birth. Data will be collected through routine clinical assessments and safety monitoring, helping to understand the long-term safety of TZIELD in this patient group.

Registry for Stage 2 Type 1 Diabetes