Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:34 AM
Study NCT ID:
NCT07470593
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year.', 'timeFrame': '1 year post-transplant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes (T1D)']}, 'descriptionModule': {'briefSummary': 'Islet transplantation is associated with drastically improvement glucose control in people with type 1 diabetes. This treatment resulted in the disappearance of severe hypoglycemic events. However, its long-term effectiveness is limited by progressive loss of graft function. Currently, there is no standardized method to detect early dysfunction of the transplanted islets.\n\nThis study aims to determine whether a parameter derived from continuous glucose monitoring (CGM), Time in Tight Range (70-140 mg/dL), is associated with pancreatic islet grafts function.\n\nThe study hypothesis is that a decrease in Time in Tight Range reflects early loss of islet graft function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old\n* Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis)\n* Patient who has completed a full cycle of pancreatic islet transplantation, either:\n\n * Islet Transplantation Alone (ITA), or\n * Islet After Kidney (IAK), or\n * Simultaneous Islet Kidney (SIK), with \\>10,000 IEQ/kg of recipient body weight, or \\<10,000 IEQ/kg but having achieved insulin independence\n* Patient who has provided consent for reuse of their data for this research\n\nExclusion Criteria:\n\n* Patient refusal to wear continuous glucose monitoring device\n* Pancreatic islet autotransplantation\n* Inability to provide informed consent (e.g., difficulties understanding study information)\n* Patient under judicial protection (safeguard of justice)\n* Patient under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT07470593', 'acronym': 'ISLET-TITR', 'briefTitle': 'Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Prospective Longitudinal Observational Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.', 'orgStudyIdInfo': {'id': 'RC25-0034'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Insulin-dependent diabetes patients with full cycle of pancreatic islet transplantation', 'description': 'Continuous glucose monitoring (CGM) with TITR measurement', 'interventionNames': ['Other: Continuous glucose monitoring (CGM) with TITR measurement']}], 'interventions': [{'name': 'Continuous glucose monitoring (CGM) with TITR measurement', 'type': 'OTHER', 'description': 'Continuous glucose monitoring (CGM) with TITR measurement', 'armGroupLabels': ['Insulin-dependent diabetes patients with full cycle of pancreatic islet transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67200', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Luc RAKOTOARISOA', 'role': 'CONTACT', 'email': 'luc.rakotoarisoa@unistra.fr', 'phone': '033 3 88 12 75 76'}, {'name': 'Luc RAKOTOARISOA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Pargol ZANDYAZDI', 'role': 'CONTACT', 'email': 'pargol.zandyazdi@chru-strasbourg.fr', 'phone': '0033 3 88 11 54 30'}], 'overallOfficials': [{'name': 'Luc RAKOTOARISOA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOPITAUX UNIVERSITAIRES DE STRASBOURG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}