Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT05348551
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2022-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Overview of Telemedicine in Children 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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the proportion of pediatric patients with access to remote monitoring', 'timeFrame': '1 day', 'description': 'Proportion of pediatric patients with access to remote monitoring'}], 'secondaryOutcomes': [{'measure': 'Description of the different means and modalities of remote monitoring for patients', 'timeFrame': '1 day', 'description': 'Proportion of patients in the different modalities of remote monitoring'}, {'measure': 'Description of the different means and modalities of remote monitoring for patients', 'timeFrame': '1 day', 'description': 'Proportion of patients in the different objectives of remote monitoring'}, {'measure': "Evaluation of patients' (and parents') perception of telemonitoring using a scale", 'timeFrame': '1 day', 'description': "Perceived importance of this remote monitoring score using a scale from 1 (mean no importance, I could do without) to 10 (mean it's very important, I think it's essential)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes mellitus type 1', 'Children', 'Telemedicine'], 'conditions': ['Telemedicine', 'Diabetes Mellitus, Type 1', 'Children, Only']}, 'descriptionModule': {'briefSummary': 'Assessment of the proportion of pediatric patients with type 1 diabetes with access to remote monitoring', 'detailedDescription': "In the follow-up of type 1 diabetes in children, contact with families besides the appointements with medical et paramedic staff (paediatrician, diabetologist, nurses) is very common but not well coded, start from telehealth hubs (like myDiabby), to less unofficial contact by phone or email. This is even more so widespread since generalization of continuous glucometer (freestyle, dexcom,...), which allowed a quick data transfer to the medical staff.\n\nSome studies had shown that telemedicine in diabetes allowed a better glycemic control and a higher implication in the desease. Indeed, in 1999 already, HbA1c significant improvement was shown when patients was regularly called by a nurse (Thompson et al.). Same finding was demonstrated in Schiaffini and al. clinical trial in 2016. This trial also shown a better adhesion to the follow up into the telemedicine group. Despite all of this studies, in France, remote monitoring isn't standardised and financed, except the national experimentation ETAPES which promotes and financially supports the deployment of remote monitoring projects around the territory."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 0 to 17 years with type 1 diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with type 1 diabetes\n\nExclusion Criteria:\n\n* No consent'}, 'identificationModule': {'nctId': 'NCT05348551', 'acronym': 'TLS-DID', 'briefTitle': 'Overview of Telemedicine in Children With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'State of Play of Telemedicine in the Follow-up of Children With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '2021-A02641-40'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clémentine DUPUIS', 'role': 'CONTACT', 'email': 'cdupuis2@chu-grenoble.fr', 'phone': '0476760924'}], 'overallOfficials': [{'name': 'Clémentine DUPUIS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}