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Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)

Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)

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Overview

This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.

Eligibility

Inclusion Criteria:

  • Have a diagnosis of Cerebral Palsy
  • Are between 6 to 17 years old with sufficient cognitive capacity and cooperation to sit without a break for 30 minutes at a time
  • MACS levels I (handles objects easily) to III (handles objects with difficulty)
  • No visual limitations that would interfere with video conferencing
  • Has a caregiver willing to participate and can questions about preferences
  • Have an appropriate device and internet access for video conferencing

Exclusion Criteria:

\- Active treatments (e.g. Botulinum Toxin injections or constraint therapy in the last two months, or upper extremity surgery in the last 6 months) that might impact upper limb function stability over the study period.

Study details
    Type 1 Diabetes

NCT07457580

Sanofi

13 May 2026

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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