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NCT07260110 · ClinicalTrials.gov registry record
A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States
A clinical trial of Type 1 Diabetes, sponsored by Sanofi.
- Recruiting
- Registry status
- 550
- Enrollment target
- 1
- Study location
NCT07260110 is a study of Type 1 Diabetes that is actively recruiting participants, run by Sanofi. The registered enrollment target is 550 participants, below the 821-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07260110, a study of Type 1 Diabetes, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- 550 participants
- Enrollment target
- 1
- Study location
Study Summary
This 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
Conditions Studied
Interventions
- DRUG Teplizumab
Study Locations (1)
California
- Investigational Site - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2025-10-31 |
| Est. Completion | 2030-12-03 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07260110
The ClinicalTrials.gov registry entry for NCT07260110 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 821-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (33% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Teplizumab is the first listed.
NCT07260110 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT07260110 about?
NCT07260110 is a clinical study titled "A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States". This 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...
What is the current status of trial NCT07260110?
This trial is currently recruiting. The enrollment target is 550 participants. The study started on 2025-10-31. Estimated completion is 2030-12-03.
What conditions does trial NCT07260110 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT07260110?
The interventions under investigation include: Teplizumab (DRUG).
Who is sponsoring clinical trial NCT07260110?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07260110 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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