Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-03 @ 11:28 AM
Study NCT ID:
NCT06165159
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Type 1 Diabetes (T1DM) Treatment Type on Mental Workload
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome corresponds to the score obtained after completing the study questionnaire. The questionnaire is completed at the participation agreement.', 'timeFrame': '1 day', 'description': 'The primary outcome is the treatment burden according to the treatment modality (semi-closed loop versus insulin pump versus multi-injection) assessed using a specific questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'Children', 'Adolescents', 'Parents', 'Pump', 'Multiple injections', 'Closed loop', 'Burden of treatment', 'Quality of life'], 'conditions': ['Type 1 Diabetes', 'Treatment']}, 'descriptionModule': {'briefSummary': 'Influence of the type of treatment for type 1 diabetes (pump versus multiple injections versus closed loop) on the treatment burden of children and adolescents and their parents.', 'detailedDescription': '"The guidelines for the treatment of children and adolescents with type 1 diabetes emphasise an individualised approach to the child and provide target values (time in range, glycaemia and coefficient of variation). These recommendations aim to prevent long-term complications. It is rarely possible to achieve and maintain this level of control over the long term. Achieving these recommendations requires a great deal of investment from children and their families, which can significantly increase their psychological workload and reduce their quality of life.\n\nThe main aim of this study was to assess burden of treatment according to the treatment type (pump versus multiple injections versus closed loop) on a large scale."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients will be recruited from the national network of the Association d'Aide aux Jeunes Diabetiques (AJD). The AJD federates local patient associations, which are regularly asked to distribute questionnaires to their members.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children over the age of 8 whose type 1 diabetes has been diagnosed for at least 6 months\n* Parents or people involved in the day-to-day life of children with type 1 diabetes who have been diagnosed for at least 6 months\n\nExclusion Criteria:\n\n* Parents not involved in managing their child's type 1 diabetes (child in care)\n* Have already completed the questionnaire (one questionnaire completed per child and their parents or family caregivers)"}, 'identificationModule': {'nctId': 'NCT06165159', 'acronym': 'CHAM&DIAB', 'briefTitle': 'Influence of Type 1 Diabetes (T1DM) Treatment Type on Mental Workload', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Influence du Type de Traitement du diabète de Type 1 (DT1) Sur la Charge Mentale Des Adolescents Avec un DT1 et Des Parents Ayant un Enfant Avec DT1.', 'orgStudyIdInfo': {'id': '49RC23_0257'}}, 'armsInterventionsModule': {'interventions': [{'name': 'children and adolescents with type 1 diabetes and their parents', 'type': 'OTHER', 'description': '"Children over the age of 8 with type 1 diabetes diagnosed more than 6 months ago in France, followed in one of the hospitals that are members of the Aide aux Jeunes Diabétiques (AJD) association.\n\nParents or people involved in the day-to-day life of children with type 1 diabetes diagnosed at least 6 months ago, whose child is being followed in France in one of the hospitals affiliated to the AJD association."'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Emmanuelle LABARRE', 'role': 'CONTACT', 'email': 'Emmanuelle.Labarre@chu-angers.fr', 'phone': '+33241354053'}], 'facility': 'Emmanuelle LABARRE', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'Emmanuelle LABARRE', 'role': 'CONTACT', 'email': 'Emmanuelle.Labarre@chu-angers.fr', 'phone': '+33241354053'}], 'overallOfficials': [{'name': 'Emmanuelle LABARRE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Angers University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}