A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
8 and older
Sex
Any
Study type
Observational
Participants needed
550 (estimated)
Sponsor
Sanofi · Industry
Who this trial is looking for
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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…
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
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* History of stage 2 type 1 diabetes with the presence of one or more diabetes-related autoantibodies and dysglycemia confirmed in the medical record
* At the time of enrollment either not yet diagnosed with stage 3 type 1 diabetes, or the progression occurred in the last 18 mon…
Inclusion Criteria:
* History of stage 2 type 1 diabetes with the presence of one or more diabetes-related autoantibodies and dysglycemia confirmed in the medical record
* At the time of enrollment either not yet diagnosed with stage 3 type 1 diabetes, or the progression occurred in the last 18 months prior to enrollment
* Aged 8 or older at the time of enrollment
* Aged 8 or older at the time of teplizumab infusion (if infused)
* Receipt of medical care in the United States
* Able to and does give written informed consent
Exclusion Criteria:
\- Failure to complete the baseline survey
Contacts
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