Long-Term Follow-Up of Patients Treated with Teplizumab for Stage 2 Type 1 Diabetes in Routine Care

What this Trial Is About

Researchers are observing the long-term outcomes of people with Stage 2 Type 1 Diabetes T1D who have received teplizumab treatment. The study aims to understand how teplizumab may delay the progression to Stage 3 T1D and assess its impact on quality of life, including emotional and social aspects. This observational study collects data from patients treated as part of routine care across multiple sites. Participants will be followed for up to 10 years after starting teplizumab treatment. The study does not provide the treatment but monitors patients who have received at least one infusion in real-world settings. Data collected includes clinical outcomes, patient-reported quality of life measures, and adverse events over time. Throughout the study, researchers will track the time from treatment start to the onset of Stage 3 T1D as the primary outcome. Secondary outcomes include treatment completion rates, adverse events, glycemic control measures like HbA1c and glucose monitoring, use of insulin and other therapies, and mental health assessments. Hospitalizations and emergency visits related to T1D complications will also be recorded. Participants may be involved in regular assessments and questionnaires for up to 10 years.

Long-Term Outcomes of Teplizumab in Routine Clinical Care