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

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 frame: From the date of Stage 1 T1D confirmation to date of first assessment of dysglycemia or positive autoantibody test up to date of first dose of teplizumab (teplizumab initiation), approximately 6 months to a year

Time from Stage 2 T1D confirmation to teplizumab initiation

Time frame: From the date of first assessment of dysglycemia or positive autoantibody test up to date of first dose of teplizumab (teplizumab initiation), approximately 6 months to a year

Assessment of blood glucose test results: Glycated hemoglobin (HbA1c)

Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)

Assessment of blood glucose test results: Fasting Plasma Glucose (FPG)

Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)

Assessment of blood glucose test results: Oral Glucose Tolerance Test (OGTT)

Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)

Assessment of blood glucose test results: Random Plasma Glucose (PG)

Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)

Assessment of blood glucose test results: Post-prandial Glucose (PPG)

Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)

Assessment of blood glucose test results: Continuous glucose monitoring (CGM)

Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)

Assessment of C-peptide test results

Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)

Assessment of autoantibody test results

Anti-GAD65, IAA, Anti-IA-2, ICA, Anti-ZnT8

Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)

Proportion of participants who complete teplizumab treatment course

Time frame: At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months

Proportion of participants using insulin during the study period

Time frame: At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months

Proportion of participants using other glucose lowering therapies during the study period

Time frame: At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months