TEPLIzumab: Quality of Life Evaluation During Stage Transition in Stage 2 Type 1 Diabetes

What this Trial Is About

Researchers are studying the real-world experiences of people with stage 2 type 1 diabetes, comparing those who have received an infusion of teplizumab with those who have not. This observational, non-interventional study in the United States aims to describe health-related quality of life, diabetes-related anxiety and burden, ease of diabetes management, and overall well-being in these two groups. The study also looks at clinical transitions, diagnostic accuracy, glucose monitoring, insulin use, and healthcare resource use over time. Participants are grouped based on their history of teplizumab infusion: one group includes those who have been infused with teplizumab, and the other includes those who have not. No treatments are administered as part of the study; it only observes participants in their usual clinical care. The study follows participants for about five years from enrollment, collecting data at multiple points to understand their diabetes management and progression. During the study, participants will provide information through surveys every six months, reporting on ease of diabetes management, psychological well-being, anxiety, and diabetes distress. Researchers will also collect medical history, sociodemographic data, glucose monitoring data, and information on insulin use and healthcare visits. The main outcomes focus on changes in these patient-reported measures and clinical data over the approximately five-year observation period, helping to better understand the experiences of people with stage 2 type 1 diabetes in real-world settings.

A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States