Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 12:08 PM
Study NCT ID:
NCT06875167
Status:
RECRUITING
Last Update Posted:
2025-04-20
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Semi-closed Loop Automated Insulin Therapy in the Pediatric Population Aged 2-6 Years With Type 1 Diabetes: Impact on Quality of Life and Glycemic Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'An improvement in the score on the general quality of life questionnaire in pediatrics PedsQL 4.0 which will be evaluated before the implementation of the semi-closed loop, at 1 month and 6 months after the implementation of the semi-closed loop.', 'timeFrame': 'the assessment of quality of life via the PedsQL 4.0 questionnaire will be evaluated before the implementation of the semi-closed loop, at 1 month and 6 months after the implementation of the semi-closed loop.', 'description': 'The quality of life questionnaire includes 4 categories of questions regarding the last month: 1 category on physical capacity problems, 1 category on emotional state problems, 1 category on problems relating to others, and 1 category on problems with the community.\n\nEach category is rated from 0 (never) to 4 (almost always). The quality of life questionnaire intended for children aged 5 to 6 years concerns the last 7 days. The response is rated using a face scale (3 different faces) corresponding to the rating 0 (never), 2 (sometimes) and 4 (almost always).\n\nThe overall quality of life of the diabetic child corresponds to the combined score of all the questions. The score range is 0 to 92, with lower scores indicating better quality of life.'}], 'secondaryOutcomes': [{'measure': 'Compare the glycemic balance of patients on automated insulin therapy versus other treatments (open loop or injections) via TIR (time in range or time within the target).', 'timeFrame': 'The evaluation of the secondary criteria is carried out before the implementation of the semi-closed loop, then at 1 month and 6 months after implementation.', 'description': 'Evolution of TIR (time in range or time in the target) when switching to semi-closed loop versus open loop.'}, {'measure': 'Compare the glycemic balance of patients on automated insulin therapy versus other treatments (open loop or injections) via HbA1c.', 'timeFrame': 'The evaluation of the secondary criteria is carried out before the implementation of the semi-closed loop, then at 1 month and 6 months after implementation.', 'description': 'Evolution of HbA1c during the transition to semi-closed loop versus open loop.'}, {'measure': 'Compare the number of hypoglycemic episodes', 'timeFrame': 'The evaluation of the secondary criteria is carried out before the implementation of the semi-closed loop, then at 1 month and 6 months after implementation.', 'description': 'Evolution of TUR (time spent in hypoglycemia) when switching to semi-closed loop versus open loop.'}, {'measure': 'Compare time in hyperglycemia', 'timeFrame': 'The evaluation of the secondary criteria is carried out before the implementation of the semi-closed loop, then at 1 month and 6 months after implementation.', 'description': 'Evolution of TAR (time spent in hyperglycemia) when switching to semi-closed loop versus open loop'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Closed-loop insulin therapy', 'type 1 Diabetic', 'Quality of life', 'pediatric patient'], 'conditions': ['Type 1 Diabetes', 'Closed Loop', 'Insulin', 'Quality of Life', 'Pediatric']}, 'descriptionModule': {'briefSummary': 'The incidence of type 1 diabetes is increasing, with an incidence of +4% per year in France today.\n\nThe treatment for type 1 diabetes is insulin therapy. In recent years, new systems have emerged, so-called "semi-closed loop" systems, also called automated insulin therapy, which have proven their superiority in terms of quality of life and glycemic balance in adults and children over 6 years old.\n\nSince January 24, 2024, the HAS now recognizes the indication of the semi-closed loop for the YPSOPUMP model in children aged 2 to 6 years. This is the first reimbursement in France of a closed loop system for the 2-6 year old age group. There are currently few studies comparing the quality of life of children in semi-closed loop versus other treatments (open loop or injections). Regarding quality of life, the studies found mainly concern the contribution for parents and the improvement of adolescents\' sleep as in the study by Erin C Cobry et al from 2020 (6).\n\nOur study therefore aims to demonstrate an improvement in quality of life but also in diabetes balance in type 1 diabetic patients on a closed loop insulin pump versus open loop or injections in the pediatric population aged 2-6 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 Diabetic children aged 2 to 6 years treated with a semi-closed loop insulin pump at the Nice pediatric hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -Patients aged 2 to 6 years inclusive\n* Presenting type 1 diabetes on insulin therapy\n* Social security affiliates\n* Patient initiating semi-closed loop treatment\n* Family (at least one parent or representative of parental authority) agreeing to follow the training necessary for continuous measurement of glucose in real time.\n* collection of non-opposition from one of the two parents or the representative of parental authority agreement\n\nExclusion Criteria:\n\n* Opposition to participation in research involving humans or opposition to the use of data or samples and associated data (withdrawal of non-opposition).'}, 'identificationModule': {'nctId': 'NCT06875167', 'acronym': 'Diablife', 'briefTitle': 'Semi-closed Loop Automated Insulin Therapy in the Pediatric Population Aged 2-6 Years With Type 1 Diabetes: Impact on Quality of Life and Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Lenval'}, 'officialTitle': 'Semi-closed Loop Automated Insulin Therapy in the Pediatric Population Aged 2-6 Years With Type 1 Diabetes: Impact on Quality of Life and Glycemic Control', 'orgStudyIdInfo': {'id': '24-HPNCL-07 Diablife'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study of the quality of life of diabetic children closed loop treatment versus other insulin therapy', 'description': "Study of the quality of life of T1D children aged 2 to 6 years inclusive treated with a semi-closed loop insulin pump versus other types of insulin therapy. Each patient will be it's one controle."}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Aline JOULIE, PHD', 'role': 'CONTACT', 'email': 'joulie.a@chu-nice.fr', 'phone': '+33492030520'}, {'name': 'Valentine FOURNY-SARGHAT, MD', 'role': 'CONTACT', 'email': 'valentine.fourny@free.fr', 'phone': '+33602273069'}], 'overallOfficials': [{'name': 'Céline Gouillard-Darnaud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Lenval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Lenval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}