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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1315-4417 | Registry Identifier | ICTRP |
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Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment.
Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teplizumab treated participants | Participants who received teplizumab as part of their routine clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teplizumab | Drug | This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant demographic characteristics at teplizumab initiation | Age, sex at birth, race (for US participants only), ethnicity (for US participants only), height, weight, Body mass index (BMI) | At Day 1 (first dose of teplizumab) |
| Participants' family history of T1D and autoimmune diseases | First- and second-degree relatives with T1D | At Day 1 (first dose of teplizumab) |
| Presence of T1D susceptibility genes: Genetic risk score | At Day 1 (first dose of teplizumab) | |
| Presence of T1D susceptibility genes: Human Leukocyte Antigen (HLA)-haplotype | At Day 1 (first dose of teplizumab) | |
| Participants' medical history | Date of stage 1 confirmation, date of dysglycemia confirmation | 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 the medical records abstraction date, approximately 3-4 years |
| Assessment of blood glucose test results: 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)" |
| Measure | Description | Time Frame |
|---|---|---|
| Development of stages of T1D | Patient monitoring for T1D progression from early to late stages | 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 1 year |
| Assessment of blood glucose test results: HbA1c |
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Inclusion Criteria:
Exclusion Criteria:
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Patients whose index date (teplizumab initiation date) was ≥ 6 weeks before site activation and who meet the eligibility criteria outlined below will be eligible for enrollment into the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | 72202 | United States | ||
| University of California, San Francisco |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| 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: 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 bloog 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 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 autoantibody tests results | Anti-GAD65, IAA, Anti-IA-2, ICA, Anti-ZnT8 | 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)" |
| Treatments participants received: teplizumab treatment and other treatments | Teplizumab treatment and other treatment variables (insulin, other glucose lowering agents) | From earliest of 6 months or the earliest date of all data contributing to Stage 2 T1D diagnosis (i.e. first record of dysglycemia and/or positive autoantibody test) and after teplizumab treatment until end of follow-up, approximately 3-4 years |
| San Francisco |
| California |
| 94158 |
| United States |
| Barbara Davis Center For Childhood Diabetes | Aurora | Colorado | 80045 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Miami Medical Center | Miami | Florida | 33136 | United States |
| USF Diabetes Center | Tampa | Florida | 33612 | United States |
| Doctor's Clinic | Vero Beach | Florida | 32960 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Childrens Healthcare of Atlanta | Atlanta | Georgia | 30329 | United States |
| Riley Hospital for Children | Carmel | Indiana | 46032 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Boston Children's Hospital Division of Endocrinology | Boston | Massachusetts | 02115 | United States |
| Atlantic Health | Morristown | New Jersey | 07960 | United States |
| Hassenfeld Children's Hospital at NYU Langone | New York | New York | 10016 | United States |
| Morgan Stanley Children's Hospital | New York | New York | 10032 | United States |
| Ten's Medical PC | Staten Island | New York | 10306 | United States |
| SUNY Upstate Medical University PARENT | Syracuse | New York | 13210 | United States |
| Sanford Research/USD | Fargo | North Dakota | 58122 | United States |
| AM Diabetes & Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| El Paso Medical Research Institute | El Paso | Texas | 79902-4646 | United States |
| University of Utah Hospitals & Clinics | Salt Lake City | Utah | 84108 | United States |
| Diabetes and Endocrine Treatment Specialists | Sandy City | Utah | 84093 | United States |
| Schneider Children's Medical Center | Petah Tikva | 4920235 | Israel |
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C502540 | teplizumab |
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