Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT06253351
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2024-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes
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': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2024-02-02', 'studyFirstSubmitQcDate': '2024-02-09', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c after HCL', 'timeFrame': 'at 3 months', 'description': 'Comparison of HbA1c (%) before and after HCL (at least 3 months of use)'}], 'secondaryOutcomes': [{'measure': 'HbA1c after HCL', 'timeFrame': 'at 6 months', 'description': 'Comparison of HbA1c (%) before and after HCL (at least 3 months of use)'}, {'measure': 'HbA1c after HCL', 'timeFrame': 'at 12 months', 'description': 'Comparison of HbA1c (%) before and after HCL (at least 3 months of use)'}, {'measure': 'HbA1c after HCL', 'timeFrame': 'at 24 months', 'description': 'Comparison of HbA1c (%) before and after HCL (at least 3 months of use)'}, {'measure': 'Use of HCL', 'timeFrame': 'at 3 months', 'description': 'Percentage of use of HCL'}, {'measure': 'HCL stop', 'timeFrame': 'at 3 months', 'description': 'number of HCL stop'}, {'measure': 'Glycemic parameters with CGM', 'timeFrame': 'at 3 months', 'description': 'pourcentage time In Range (TIR) 70-180 mg/dl'}, {'measure': 'Glycemic parameters with CGM', 'timeFrame': 'at 3 months', 'description': 'pourcentage time Below Range (TBR) \\< 70 mg/dl'}, {'measure': 'Glycemic parameters with CGM', 'timeFrame': 'at 3 months', 'description': 'pourcentage Coefficient of Variation (CV)'}, {'measure': 'keto-acidosis and severe hypoglycemia', 'timeFrame': 'at 3 months', 'description': 'Comparision of keto-acidose and severe hypoglycemia events the year before HCL and after HCL'}, {'measure': 'retinopathy', 'timeFrame': 'at 3 months', 'description': 'Comparison of retinography results before HCL and after HCL'}, {'measure': 'nephropathy', 'timeFrame': 'at 3 months', 'description': 'Comparison microalbuminuria/creatininuria dosage the year before HCL and after HCL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 1 diabetes', 'hybrid closed-loop', 'adolescents', 'young adults', 'HbA1c', 'TIR'], 'conditions': ['Type1 Diabetes', 'Adolescents', 'Young Adults']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.', 'detailedDescription': "Type 1 diabetes (T1D) constitutes a major public health challenge due to acute complications requiring emergency hospitalizations, as well as many chronic complications that need to be managed over the long term. However, these complications can be prevented by maintaining correct glycemic control, according to international guidelines.\n\nFor the past few years, the arrival of new technologies as insulin pump and particularly Continuous Glucose Monitoring (CGM) showed a significant improvement on metabolic control.\n\nNevertheless, adolescents and young adults with type 1 diabetes need a special focus because they still fail to meet glycemic control targets.\n\nAt this time, hybrid closed loop, pairing Continuous Glucose Monitoring with insulin pump, enables insulin delivery in a semi-autonomous way thanks to algorithms, and leads to the best metabolic results we've never got in randomized trials and real-world studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Tertiary care center from Centre Hospitalier Sud Francilien', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged between 15 and 25 years old\n* Type 1 diabetes since at least 1 year at the moment of instauring HCL\n* At least 3 months of HCL use\n\nExclusion Criteria:\n\n* Informed patient that have been opposed for their data collect'}, 'identificationModule': {'nctId': 'NCT06253351', 'acronym': 'BFHado', 'briefTitle': 'Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Sud Francilien'}, 'officialTitle': 'Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes', 'orgStudyIdInfo': {'id': '2023/0060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group1', 'description': 'Patients between 15 and 25 years old with type 1 diabetes and treated by hybrid closed loop', 'interventionNames': ['Device: Hybrid closed loop (HCL)']}], 'interventions': [{'name': 'Hybrid closed loop (HCL)', 'type': 'DEVICE', 'description': '* Control IQ : T-Slim pump with Dexcom G6\n* Smartguard : Medtronic 780G pump with Guardian G4S\n* Diabeloop : Kaliedo pump with Dexcom G6', 'armGroupLabels': ['Group1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}], 'overallOfficials': [{'name': 'Juliette EROUKHMANOFF, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Sud Francilien'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Sud Francilien', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}