Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT06892002
Status:
COMPLETED
Last Update Posted:
2025-08-15
First Post:
2025-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Description of Patients With Type 1 Diabetes Treated With Teplizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502540', 'term': 'teplizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-03-18', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant demographic characteristics at teplizumab initiation', 'timeFrame': 'At Day 1 (first dose of teplizumab)', 'description': 'Age, sex at birth, race (for US participants only), ethnicity (for US participants only), height, weight, Body mass index (BMI)'}, {'measure': "Participants' family history of T1D and autoimmune diseases", 'timeFrame': 'At Day 1 (first dose of teplizumab)', 'description': 'First- and second-degree relatives with T1D'}, {'measure': 'Presence of T1D susceptibility genes: Genetic risk score', 'timeFrame': 'At Day 1 (first dose of teplizumab)'}, {'measure': 'Presence of T1D susceptibility genes: Human Leukocyte Antigen (HLA)-haplotype', 'timeFrame': 'At Day 1 (first dose of teplizumab)'}, {'measure': "Participants' medical history", 'timeFrame': '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', 'description': 'Date of stage 1 confirmation, date of dysglycemia confirmation'}, {'measure': 'Assessment of blood glucose test results: CGM', 'timeFrame': '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)"'}], 'secondaryOutcomes': [{'measure': 'Development of stages of T1D', 'timeFrame': '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', 'description': 'Patient monitoring for T1D progression from early to late stages'}, {'measure': 'Assessment of blood glucose test results: HbA1c', 'timeFrame': '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': 'Assessment of blood glucose test results: Fasting Plasma Glucose (FPG)', 'timeFrame': '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': 'Assessment of blood glucose: Oral glucose tolerance test (OGTT)', 'timeFrame': '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': 'Assessment of blood glucose test results: Random Plasma Glucose (PG)', 'timeFrame': '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': 'Assessment of bloog glucose test results: Continuous glucose monitoring (CGM)', 'timeFrame': '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': 'Assessment of blood glucose test results: Post-prandial glucose (PPG)', 'timeFrame': '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': 'Assessment of autoantibody tests results', 'timeFrame': '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)"', 'description': 'Anti-GAD65, IAA, Anti-IA-2, ICA, Anti-ZnT8'}, {'measure': 'Assessment of C-peptide test results', 'timeFrame': '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': 'Treatments participants received: teplizumab treatment and other treatments', 'timeFrame': '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', 'description': 'Teplizumab treatment and other treatment variables (insulin, other glucose lowering agents)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Teplizumab', 'Type 1 Diabetes', 'Real-world study', 'Stage 2 Type 1 Diabetes', 'Stage 3 Type 1 Diabetes', 'Disease progression', 'Treatment patterns', 'Patient monitoring'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': '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.\n\nTeplizumab 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient informed consent or assent (for patients \\< 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity.\n* Patient received ≥ 1 day of teplizumab treatment.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT06892002', 'acronym': 'TEPLI-REAL', 'briefTitle': 'Description of Patients With Type 1 Diabetes Treated With Teplizumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab', 'orgStudyIdInfo': {'id': 'PDE0109'}, 'secondaryIdInfos': [{'id': 'U1111-1315-4417', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Teplizumab treated participants', 'description': 'Participants who received teplizumab as part of their routine clinical care', 'interventionNames': ['Drug: Teplizumab']}], 'interventions': [{'name': 'Teplizumab', 'type': 'DRUG', 'description': 'This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.', 'armGroupLabels': ['Teplizumab treated participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital Research Institute", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center For Childhood Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Medical Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF Diabetes Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': "Doctor's Clinic", 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Childrens Healthcare of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital Division of Endocrinology", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Health', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Hassenfeld Children's Hospital at NYU Langone", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Morgan Stanley Children's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10306', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': "Ten's Medical PC", 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University PARENT', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Sanford Research/USD', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '38133', 'city': 'Bartlett', 'state': 'Tennessee', 'country': 'United States', 'facility': 'AM Diabetes & Endocrinology Center', 'geoPoint': {'lat': 35.20453, 'lon': -89.87398}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79902-4646', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso Medical Research Institute', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospitals & Clinics', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84093', 'city': 'Sandy City', 'state': 'Utah', 'country': 'United States', 'facility': 'Diabetes and Endocrine Treatment Specialists', 'geoPoint': {'lat': 40.59161, 'lon': -111.8841}}, {'zip': '4920235', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Schneider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "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"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}