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

Condition(s) studied

Investigational drug(s) / intervention(s)

Teplizumab: This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Study summary

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

Primary outcome measure(s)

• Participant demographics at teplizumab initiation — At Day 1 (first dose of teplizumab)
  Age, sex at birth, height, weight, Body mass index (BMI), body surface area
• Participants' family history of T1D and autoimmune diseases — At Day 1 (first dose of teplizumab)
  First- and second-degree relatives with T1D
• Presence of T1D susceptibility genes — At Day 1 (first dose of teplizumab)
  Genetic risk score
• Presence of T1D susceptibility genes — At Day 1 (first dose of teplizumab)
  Human Leukocyte Antigen (HLA)-haplotype
• Participants' medical history — From 6 months prior to the first dose of teplizumab (teplizumab initiation) (or the earliest date of all data contributing to Stage 2 T1D diagnosis, whichever is earlier) up to medical records abstraction date, approximately 3-4 years
  Date of stage 1 confirmation, date of dysglycemia confirmation

Trial sites (14)

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