Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-02-25 @ 5:40 PM
Study NCT ID:
NCT05676593
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2022-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We therefore propose a prospective randomised study in 2 arms :\n\n* a group of people living with diabetes receiving standard TPE vs\n* a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of change in glycated hemoglobine at 3 months', 'timeFrame': '3 months', 'description': 'biological control of glycated hemoglobin in a laboratory'}], 'secondaryOutcomes': [{'measure': 'Rate of change of the time in range, time above range and time below range', 'timeFrame': '6 months', 'description': 'data of the freestyle libre'}, {'measure': 'Rate of change in glycated hemoglobin at 6 months', 'timeFrame': '6 months', 'description': 'biological control'}, {'measure': 'Rate of change in weight in kg', 'timeFrame': 'In kg each 3,6 months'}, {'measure': 'Quality of Life questionnary', 'timeFrame': 'Set a score out of 100 (100 good good quality of life - 0 bad quality of life) performed at 3,6 months', 'description': 'EQVOD - Scale of Quality of Life, Obesity and Dietetics'}, {'measure': 'Rate of change arteriel pressure', 'timeFrame': 'In mmHg each 3,6 months'}, {'measure': 'Concentration of of LDL cholesterol', 'timeFrame': 'In g/L each 3,6 months'}, {'measure': 'Concentration of Triglyceride', 'timeFrame': 'In g/L each 3,6 months'}, {'measure': 'Anxiety and depression scale questionnary', 'timeFrame': '14 questions (high score depression, anxiety - low score good health) performed at 3,6 months', 'description': 'HAD - Hospital Anxiety and Depression scale'}, {'measure': 'Quality of Life questionnary', 'timeFrame': 'From 0 to 100 (100 good quality of life - 0 bad quality of life) performed at 3,6 months', 'description': 'EQ-5D - EuroQoL-5D'}, {'measure': 'Eating behavior questionnaire', 'timeFrame': "33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months", 'description': 'DEBQ-Dutch Eating Behaviour Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sensor', 'Therapeutic education', 'Diabete', 'Glucose'], 'conditions': ['Endocrinology', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Therapeutic patient education (TPE) is a key element in the management of people living with type 2 diabetes.\n\nThe benefit of therapeutic education (TPE) has been clearly established on glycaemic control.\n\nContinuous interstitial glucose monitoring (CGM) can be considered as a TPE tool for people living with diabetes. A direct reading of the effects of diet and physical activity on glycaemic levels could have an impact on the initiation and maintenance of therapeutic lifestyle modifications.\n\nThe investigators therefore propose a prospective randomised study in 2 arms :\n\n* a group of people living with diabetes receiving standard TPE vs\n* a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms', 'detailedDescription': 'Main objective to the investigators is to determine the benefit of continuous interstitial glucose monitoring (by fresstyle 2) for 28 days coupled with standard TPE (Patient Therapeutic Education) vs standard TPE alone in newly diagnosed type 2 diabetics on HbA1c at 3 months.\n\nThe secondary objectives are to evaluate the effect of the TPE coupled with FSL vs TPE alone on :\n\n* HbA1c at 6 months (assessment of persistence or not of a remote effect)\n* weight change at 3 and 6 months\n* other cardiovascular risk factors : variation in blood pressure, lipid profil at 3 and 6 months\n* eating behaviour/ eating habits at 3 and 6 months\n* treatment satisfaction, anxiety and quality of life scores'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* recently diagnosed diabete mellitus (\\<1 an) treated by non medical therapeutics and/or metformine\n* \\> 18 years old\n* initial glycated hemoglobin between 7 and 8.5%\n\nExclusion Criteria:\n\n* Person whose physical and/or psychological health is severely impaired\n* Person deprived of his rights, person under guardianship or curatorship\n* Person deprived of liberty (by judicial or administrative decision)\n* Person who does not speak the French language\n* Absence of affiliation to/Not beneficiary of a Social Security scheme\n* Absence of written informed consent to participate in the study\n* Unable to understand the nature, purpose and methodology of the study\n* Bariatric surgery planned within 6 months of inclusion'}, 'identificationModule': {'nctId': 'NCT05676593', 'acronym': 'FREEDIA', 'briefTitle': 'Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Interest of Freestyle Libre 2 as a Tool for Therapeutic Education in Recently Diagnosed Type 2 Diabetics Patients', 'orgStudyIdInfo': {'id': 'RECHMPL22_0232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'People living with diabete standard TPE', 'description': 'HBA1c at 3 and 6 months Therapeutic education Auto questionnary on Aviitam plateform at 3 and 6 months', 'interventionNames': ['Other: Therapeutic education']}, {'type': 'EXPERIMENTAL', 'label': 'People living with diabete standard TPE + FSL 28 days', 'description': 'Continuous mesure of glucose (FSL2) during 28 days at enrollment Therapeutic education HBA1c at 3 and 6 months Auto questionnary on Aviitam plateform at 3 and 6 months\n\nAuto questionnary on Aviitam plateform at 3 and 6 months', 'interventionNames': ['Device: Freestyle Libre 2', 'Other: Therapeutic education']}], 'interventions': [{'name': 'Freestyle Libre 2', 'type': 'DEVICE', 'description': 'The FSL will be placed on patient for 28 days to measure interstitial glucose', 'armGroupLabels': ['People living with diabete standard TPE + FSL 28 days']}, {'name': 'Therapeutic education', 'type': 'OTHER', 'description': 'Therapeutic education', 'armGroupLabels': ['People living with diabete standard TPE', 'People living with diabete standard TPE + FSL 28 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ariane SULTAN, PI', 'role': 'CONTACT', 'email': 'a-sultan@chu-montpellier.fr', 'phone': '04 67 33 84 02', 'phoneExt': '+33'}], 'facility': 'UHM Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'SULTAN Ariane, PU-PH', 'role': 'CONTACT', 'email': 'a-sultan@chu-montpellier.fr', 'phone': '+33467338402'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}