Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2017-03-01', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability of the FreeStyle Flash Libre glucose monitoring system', 'timeFrame': '6-12 months follow up', 'description': 'Usability of the FreeStyle Flash Libre glucose monitoring system by a questionnaire'}], 'secondaryOutcomes': [{'measure': 'Problems associated with the FreeStyle Flash Libre glucose monitoring system', 'timeFrame': '6-12 months follow up', 'description': 'Problems associated with the FreeStyle Flash Libre glucose monitoring system by a questionnaire'}, {'measure': 'The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients', 'timeFrame': '6-12 months follow up', 'description': 'The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients by measurement of the HbA1c values'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flash Glucose Monitoring', 'Usability', 'Metabolic control'], 'conditions': ['Flash Glucose Monitoring', 'Metabolic Control']}, 'descriptionModule': {'briefSummary': 'Medium-term (6-12 months) evaluation of the use, the identified problems, the usability and the effect on the metabolic control of the FreeStyle Flash Libre glucose monitoring system in 90 children by questionnaires and routine measurement of HbA1c values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes mellitis\n* Being followed in the Pediatric Diabetes Unit of the Jessa Hospital\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03071159', 'briefTitle': 'An Evaluation of the FreeStyle Libre Flash Glucose Monitoring System', 'organization': {'class': 'OTHER', 'fullName': 'Jessa Hospital'}, 'officialTitle': 'A Medium-term Evaluation of the Use, the Identified Problems, the Usability and the Effect on the Metabolic Control of the FreeStyle Flash Libre Glucose Monitoring System', 'orgStudyIdInfo': {'id': 'JessaH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'cases', 'description': 'children (4-18 years) with type 1 diabetes mellitis using the FreeStyle Flash Libre glucose monitoring system (standard care)', 'interventionNames': ['Device: FreeStyle Flash Libre glucose monitoring system']}], 'interventions': [{'name': 'FreeStyle Flash Libre glucose monitoring system', 'type': 'DEVICE', 'description': 'glucose monitoring system with sensors', 'armGroupLabels': ['cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Guy Massa, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Jessa Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'centralContacts': [{'name': 'Guy Massa, MD, PhD', 'role': 'CONTACT', 'email': 'guy.massa@jessazh.be', 'phone': '+32 11 30 96 34'}, {'name': 'Ingrid Arijs, PhD', 'role': 'CONTACT', 'email': 'ingrid.arijs@jessazh.be', 'phone': '+32(0)11 33 82 65'}], 'overallOfficials': [{'name': 'Guy Massa, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jessa Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}