Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-31 @ 1:07 AM
Study NCT ID:
NCT03228004
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2017-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Type 1 Diabetes Data Acquisition and Transfer Adherence Study
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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2017-07-21', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved glycemic control', 'timeFrame': '16 weeks', 'description': 'HbA1c'}, {'measure': 'Frequency of data upload', 'timeFrame': '16 weeks', 'description': 'The number of times glucose data is uploaded between clinic visits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine if training and support, combined with reminders to facilitate glucose data sharing with the diabetes care team in between clinic visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have HbA1c levels above target.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis with T1D at least 6 months before consent is obtained\n* Aged ≥ 2 years and ≤17 years at time of enrollment\n* Must have access to a smartphone, tablet or computer at home with wireless connectivity\n* Last HbA1c of ≥7.6% and ≤11%\n* Using fixed doses, multiple daily injections or an insulin pump as primary diabetes management regimen\n* Ability to read and speak English\n* Patient at UF Health Pediatric Diabetes Clinic\n\nExclusion Criteria:\n\n* Significant medical comorbidity in the child or adolescent that could, in the opinion of the PI, affect participant's capacity to complete study follow up\n* Inability to read and speak English\n* Not using insulin therapy\n* Lack of access to mobile device or computer with wireless internet connectivity\n* Unwilling or unable to use clinic's software (Glooko) to facilitate glucose data upload"}, 'identificationModule': {'nctId': 'NCT03228004', 'acronym': 'T1D-DATA', 'briefTitle': 'Type 1 Diabetes Data Acquisition and Transfer Adherence Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Type 1 Diabetes Data Acquisition and Transfer Adherence Study', 'orgStudyIdInfo': {'id': 'IRB201700818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Participants will be provided with training on how to upload glucose data via GLOOKO and will receive reminders to upload glucose data on a biweekly basis between clinic visits.', 'interventionNames': ['Behavioral: Glooko MeterSync']}], 'interventions': [{'name': 'Glooko MeterSync', 'type': 'BEHAVIORAL', 'description': 'The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': "Anastasia Albanese-O'Neill, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}