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Teplizumab · TEPLI-QUEST

Ensayo de Sanofi en Diabetes tipo 1.

Más ensayos de: Diabetes tipo 1.

Todo sobre el fármaco: Teplizumab.

Fase

no aplica

Estado

Reclutando pacientes

Participantes

550

previstos

Centros

1

Fin del objetivo primario

dic 2030

estimado por el promotor

Título oficial en el registro (en inglés): A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en oct 2025.

De principio a fin

1. Empieza el ensayo (oct 2025)
2. Hoy
3. Lectura de resultados dic 2030 (prevista)

Los cambios los anota PivotalWire desde agosto de 2026; lo anterior no lo tenemos. El historial completo, versión a versión, está en ClinicalTrials.gov.

Qué mide

Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions (From baseline, repeated every 6 months up to end of study, approximately 5 years) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is an observational, longitudinal, non-interventional real-world study in the United States. The study is meant to describe the experience of participants with a history of stage 2 type 1 diabetes who have been infused with teplizumab and the experience of participants with stage 2 type 1 diabetes who have not been infused with teplizumab, and to compare descriptively the experiences of the two groups. Primary Objective: - To characterize health related quality of life, diabetes-related anxiety, diabetes-related burden, and ease of diabetes management, and how participants feel, form and function in those who infused and those who did not infuse with teplizumab Secondary Objectives: * To show the clinical transitions experienced by those who infused and those who did not infuse with teplizumab * To describe the prevalence and timing of diabetes misclassification and the temporal patterns between misclassification, antibody testing, and the correct diagnosis of type 1 diabetes in those who infused and those who did not infuse with teplizumab * To estimate the impact of diagnostic misclassification on the timing of progression to stage 3 type 1 diabetes in those who infused and those who did not infuse with teplizumab * To characterize glucose monitoring strategies in those who infused and those who did not infuse with teplizumab where possible * To characterize insulin use in those who infused and those who did not infuse with teplizumab where possible * To characterize longitudinal health care resource utilization in those who infused and those who did not infuse with teplizumab

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Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07260110), actualizada en nov 2025.