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

TEPLIzumab: QUality of Life Evaluation During Stage Transition

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

Each participant is expected to participate in the study from the time of their enrollment through the last data delivery, which is estimated to occur five years after the first participant is enrolled.

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