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.
Patient written or electronic informed consent or assent (for patients < 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity.
Patient received ≥ 1 day of teplizumab treatment as part of MAPs.
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Patients diagnosed with Stage 2 T1D who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. Approximately 60 participants, in approximately 15 sites across at least 5 countries will be enrolled.
Cohort
Retrospective
Teplizumab
DrugThis study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Participant demographics at teplizumab initiation
Age, sex at birth, height, weight, Body mass index (BMI), body surface area
Participants' family history of T1D and autoimmune diseases
First- and second-degree relatives with T1D
Presence of T1D susceptibility genes
Genetic risk score
Presence of T1D susceptibility genes
Human Leukocyte Antigen (HLA)-haplotype
Time from Stage 1 T1D confirmation to Stage 2 confirmation
Only participants with a date of Stage 1 T1D confirmation will be included in this analysis.
Time from Stage 2 T1D confirmation to teplizumab initiation
Assessment of blood glucose test results: Glycated hemoglobin (HbA1c)
Assessment of blood glucose test results: Fasting Plasma Glucose (FPG)
