Type 1 Diabetes
Conditions
Brief summary
This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.
Detailed description
Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.
Interventions
DRUGTeplizumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
- * Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. * Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab. (Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.) • Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations.
Exclusion criteria
- * Participants who had participated in a previous clinical trial for teplizumab. * Participants enrolled in a clinical trial within 6 months prior to study enrollment. (Note: Participants enrolled in other observational studies may be included.) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from teplizumab infusion start to the onset of Stage 3 T1D | From start of infusion to maximum of 10 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who complete teplizumab treatment course | Up to end of infusion, maximum of 5 years | — |
| Number of participants with adverse events during the infusion period | Till 6 weeks post last infusion, maximum of 5 years | — |
| Number of participants with adverse events of special interest and serious adverse events | From 6 weeks post last infusion through the follow-up, maximum of 10 years | — |
| Number of participants with T1D-related complications | From infusion up to end of study, maximum of 10 years | Including but not limited to the following: diabetic ketoacidosis, severe hypoglycemia, retinopathy, nephropathy, neuropathy, cardiovascular events |
| Glycemic control assessment values | From baseline through follow-up, maximum of 10 years | — |
| Change from baseline in glycated hemoglobin (HbA1c) | From baseline through follow-up, maximum of 10 years | — |
| Proportion of participants achieving target HbA1c ≤ 6.5% | From baseline through follow-up, maximum of 10 years | — |
| Proportion of participants using home glycemic control assessments (eg, SMBG, CGM) | From baseline through follow-up, maximum of 10 years | — |
| Proportion of participants using glycemic control assessments in-clinic (eg, OGTT, FPG, MMTT, RPG) | From baseline through follow-up, maximum of 10 years | — |
| Mean change from baseline in Time in range (TIR) (70 to 180 mg/dL [3.9 to 10 mmol/L]) | From baseline through follow-up, maximum of 10 years | CGM reading 70 to 180 mg/dL \[3.9 to 10 mmol/L\] |
| Mean change from baseline in Time in tight range (TITR) (70 to 140 mg/dL [3.9 to 7.8 mmol/L]) | From baseline through follow-up, maximum of 10 years | CGM reading 70 to 140 mg/dL \[3.9 to 7.8 mmol/L\] |
| Mean change from baseline in Time above tight range (TATR): >140 mg/dL (>7.8 mmol/L) | From baseline through follow-up, maximum of 10 years | CGM reading \>140 mg/dL (\>7.8 mmol/L) |
| Mean change from baseline in Time above range (TAR): >180 mg/dL (>10 mmol/L) | From baseline through follow-up, maximum of 10 years | CGM reading \>180 mg/dL (\>10 mmol/L) |
| Mean change from baseline in Time above range (TAR): >250 mg/dL (>13.9 mmol/L) | From baseline through follow-up, maximum of 10 years | CGM reading \>250 mg/dL (\>13.9 mmol/L) |
| Mean change from baseline in Time below range (TBR): <70 mg/dL (<3.9 mmol/L) | From baseline through follow-up, maximum of 10 years | CGM reading \<70 mg/dL (\<3.9 mmol/L) |
| Mean change from baseline in Time below range (TBR): <54 mg/dL (<3.0 mmol/L) | From baseline through follow-up, maximum of 10 years | CGM reading \<54 mg/dL (\<3.0 mmol/L) |
| Mean change from baseline in within-day glucose coefficient of variation | From baseline through follow-up, maximum of 10 years | — |
| Mean change from baseline in between-day glucose coefficient of variation | From baseline through follow-up, maximum of 10 years | — |
| Proportion of participants using insulin during the study period | Up to end of study, maximum of 10 years | Continuous subcutaneous insulin infusion, insulin pump, or pump integrated with an automated insulin delivery system |
| Proportion of participants using other glucose lowering therapies during the study period | Up to end of study, maximum of 10 years | — |
| Change in EuroQol 5-Dimensions (EQ-5D) scores in adult and pediatric participants | From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years | — |
| Change in Hospital Anxiety and Depression Scale (HADS) scores in adult participants | From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years | — |
| Change in World Health Organization-Five Well-Being Index (WHO-5) scores in pediatric participants | From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years | — |
| Change in Diabetes Distress Scale (DDS) scores in adult participants | From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years | — |
| Change in Hypoglycemia Fear Survey-II (HFS-II) scores in adult and pediatric participants | From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years | — |
| Annualized rate of hospitalizations due to T1D related disease and complications | Up to end of study, maximum of 10 years | — |
| Annualized rate of emergency room visits related to T1D related disease and complications | Up to end of study, maximum of 10 years | — |
Countries
Israel
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed