Type 1 Diabetes
Conditions
Brief 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.
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
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
• Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol. 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 | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from Stage 1 T1D confirmation to Stage 2 confirmation | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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) | Anti-GAD65, IAA, Anti-IA-2, ICA, Anti-ZnT8 |
| Proportion of participants who complete teplizumab treatment course | 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 | 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 | At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months | — |
Countries
Italy, Spain
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed