Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
Study NCT ID:
NCT05932966
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2023-06-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 317}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2023-06-21', 'studyFirstSubmitQcDate': '2023-07-03', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of glycemic control obtained under closed loop according to the system used: SG versus CIQ', 'timeFrame': 'at 12 months', 'description': 'Time spent in target range (between 70 and 180 mg/dL) after 12 months following initiation of the closed-loop system, as measured by continuous glucose monitoring (CGM).system, as measured by continuous glucose monitoring (CGM).'}], 'secondaryOutcomes': [{'measure': 'Time below target (< 70 mg/dL)', 'timeFrame': 'at 12 months', 'description': 'Compare glycemic control'}, {'measure': 'Glycemic coefficient of variation (CV)', 'timeFrame': 'at 12 months', 'description': 'Compare glycemic control'}, {'measure': 'glucose management indicator', 'timeFrame': 'at 12 months', 'description': 'Compare glycemic control'}, {'measure': 'HBA1c', 'timeFrame': 'at 12 months', 'description': 'Compare glycemic control'}, {'measure': 'weight daily insulin dose', 'timeFrame': 'at 12 months', 'description': 'Compare glycemic control'}, {'measure': 'daily insulin dose', 'timeFrame': 'at 12 months', 'description': 'Compare glycemic control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes type 1', 'closed loop insulin delivery system', 'continuous glucose monitoring', 'sensor-augmented pump'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'This study aims to compare glycemic control obtained under closed loop depending on the system : Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1.', 'detailedDescription': 'Since 2021, several closed-loop insulin delivery systems have been reimbursed in France for patients living with type 1 diabetes. The "real-life" efficacy and safety of these systems have already been the subject of several publications, confirming the results of clinical trials.\n\nTo date, there are no clinical trial comparing closed-loop systems. There are, however, a few observational studies that have attempted such a comparison, but with few patients included or a poorly adapted methodology.\n\nGiven the size of the cohort of patients with type 1 diabetes fitted with a closed-loop system in the diabetology department of the Centre Hospitalier Sud-Francilien since 2021 (\\> 400), we propose a single-center analysis to compare real-life performance of Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1 during a follow-up of 12 months and using a propensity score'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population will be selected from the diabetes department of a French public hospital. All eligible patients will be included in the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient \\> 16 years\n* Patient with diabetes type 1.\n* Patient treated with a CONTROL-IQ or SMARTGUARD closed-loop insulin delivery system between 01/2021 and 05/2022.\n* Follow-up patient in Centre Hospitalier Sud Francilien\n\nExclusion Criteria:\n\n* Women who had pregnancy within 12 months of system initiation.\n* Patient who have been treated with both systems within 12 months.\n* Patient or parental authority objecting the use of data'}, 'identificationModule': {'nctId': 'NCT05932966', 'acronym': 'COMPARE-CLIDS', 'briefTitle': 'Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Sud Francilien'}, 'officialTitle': 'Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems', 'orgStudyIdInfo': {'id': '2023/0024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with type 1 Diabetes equipped with control-IQ closed loop system', 'description': 'Patients with type 1 Diabetes equipped with control-IQ closed loop system', 'interventionNames': ['Device: Insulin closed-loop delivery system']}, {'label': 'Patients with type 1 diabetes equipped with Smart GUARD closed loop system', 'description': 'Patients with type 1 diabetes equipped with Smart GUARD closed loop system', 'interventionNames': ['Device: Insulin closed-loop delivery system']}], 'interventions': [{'name': 'Insulin closed-loop delivery system', 'type': 'DEVICE', 'description': 'Insulin closed-loop delivery system', 'armGroupLabels': ['Patients with type 1 Diabetes equipped with control-IQ closed loop system', 'Patients with type 1 diabetes equipped with Smart GUARD closed loop system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}], 'overallOfficials': [{'name': 'Coralie AMADOU, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Sud Francilien'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Sud Francilien', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}