Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 5:49 AM
Study NCT ID:
NCT05584293
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2022-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DIABASE; Diabetes Mellitus Registry in Second Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2060-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real world data from medical devices and clinical outcome in a registry', 'timeFrame': '0-30 years', 'description': 'Examine real world data from medical devices and clinical outcome in a registry to gain the necessary insights to be able to improve individual patient care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '41083304', 'type': 'DERIVED', 'citation': 'Urgert T, Kappert KDR, Veldhuis A, Geerdink J, van Beijnum BJF, Laverman GD. DIABASE: an automatically filled single-centre registry of diabetes mellitus in the Netherlands, combining clinical data with real-world longitudinal wearable device data-a study protocol. BMJ Open. 2025 Oct 13;15(10):e096888. doi: 10.1136/bmjopen-2024-096888.'}, {'pmid': '39083801', 'type': 'DERIVED', 'citation': 'den Braber N, Braem CIR, Vollenbroek-Hutten MMR, Hermens HJ, Urgert T, Yavuz US, Veltink PH, Laverman GD. Consequences of Data Loss on Clinical Decision-Making in Continuous Glucose Monitoring: Retrospective Cohort Study. Interact J Med Res. 2024 Jul 31;13:e50849. doi: 10.2196/50849.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to examine real world data from medical devices and clinical outcome from diabetes mellitus patients to gain the necessary insights to be able to improve individual patient care by building a registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult patients with type 1 or type 2 diabetes mellitus.\n\nPatients are recruited at the outpatient clinic of internal medicine, diabetes clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 1 or type 2 diabetes\n* Patients aged 18 years or older\n* Patients visiting the outpatient clinic internal medicine in the ZGT Hospital\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe general diseases or mental disorders making the participation in the study impossible'}, 'identificationModule': {'nctId': 'NCT05584293', 'acronym': 'DIABASE', 'briefTitle': 'DIABASE; Diabetes Mellitus Registry in Second Care', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuisgroep Twente'}, 'officialTitle': 'DIABASE; Diabetes Mellitus Registry in Second Care', 'orgStudyIdInfo': {'id': 'ZGT20-40'}, 'secondaryIdInfos': [{'id': 'W20.197', 'type': 'OTHER', 'domain': 'Medical Research Ethics Committees United'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7609PP', 'city': 'Almelo', 'state': 'Overijssel', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Thomas Urgert, MSc', 'role': 'CONTACT', 'email': 't.urgert@zgt.nl', 'phone': '+31887083236'}, {'name': 'Goos Laverman, prof. dr.', 'role': 'CONTACT', 'email': 'g.laverman@zgt.nl', 'phone': '+31887083079'}, {'name': 'Goos Laverman, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thomas Urgert, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ziekenhuisgroep Twente', 'geoPoint': {'lat': 52.35667, 'lon': 6.6625}}], 'centralContacts': [{'name': 'Thomas Urgert, MSc', 'role': 'CONTACT', 'email': 't.urgert@zgt.nl', 'phone': '+31887083236'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuisgroep Twente', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Twente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}