OBS20675
Research type
Research Study
Full title
A Real-World Retrospective Observational Study Characterizing Patients With stage 2 Type 1 Diabetes Treated with Teplizumab as Part of MAPs
IRAS ID
357672
Contact name
Renuka Dias
Contact email
Sponsor organisation
N/A
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
This multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics, monitoring and treatment practices related to T1D progression, and time to Type 1 Diabetes (T1D) progression in participants who received teplizumab as part of 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.
The data collection period for each participant begins 6 months prior to teplizumab initiation or the earliest date of all data contributing to Stage 2 T1D diagnosis (i.e. first record of dysglycemia and/or positive autoantibody test) (whichever is earlier) and extends to the medical records abstraction date. Participants who have an index date at least 6 weeks before site activation and who meet the inclusion and exclusion criteria will be eligible for the study. This is to ensure that each participant included in the study has at least 6 weeks of potential follow-up time following the start of teplizumab treatment.
Approximately 60 patients are planned to be included.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0379
Date of REC Opinion
15 Jan 2026
REC opinion
Further Information Favourable Opinion