Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT03448367
Status:
TERMINATED
Last Update Posted:
2021-02-05
First Post:
2018-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Due to lower than anticipated enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of the FreeStyle Libre Flash Glucose Monitoring System', 'timeFrame': 'Approximately one year per subject.', 'description': 'The study is designed to characterize the safety of the FreeStyle Libre Flash Glucose Monitoring System when used in the pediatric patient population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in pediatric patients with diabetes.', 'detailedDescription': 'Up to 400 pediatric subjects aged 4-17 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 314 subjects who complete the final visit. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects and/or their caregivers will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 50% of the study population will be age 4-12 years of age.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be 4 - 17 years of age.\n* Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.\n* Subject is currently using SMBG for managing their diabetes.\n* Subject and/or caregiver must be able to read and understand English .\n* In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.\n* Subject and/or caregiver must have access to an internet connected computer for uploading data from the blood glucose meter and FreeStyle Libre system.\n* Subject must have an overnight companion (caregiver 18 years or older) present in the same home during participation of the study.\n* Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.\n\nExclusion Criteria:\n\n* Subject and/or caregiver is a member of the Site Staff.\n* Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes\n* Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.\n* Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.\n* Subject is on dialysis at the time of enrollment.\n* Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.\n* Subject currently is participating in another clinical trial.\n* Subject is unsuitable for participation due to any other cause as determined by the Investigator."}, 'identificationModule': {'nctId': 'NCT03448367', 'briefTitle': 'FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Diabetes Care'}, 'officialTitle': 'FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients', 'orgStudyIdInfo': {'id': 'ADC-US-PMS-17168-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SMBG/FreeStyle Libre', 'description': 'During the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring System for 6 months to managed their diabetes.', 'interventionNames': ['Device: FreeStyle Libre Flash Glucose Monitoring System']}], 'interventions': [{'name': 'FreeStyle Libre Flash Glucose Monitoring System', 'type': 'DEVICE', 'description': 'Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase).', 'armGroupLabels': ['SMBG/FreeStyle Libre']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Sansum Diabetes Research Institute', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center for Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mountain Diabetes & Osteoporosis Center', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Albuquerque Neuroscience Inc.', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Shridhara A Karinka, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Diabetes Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}