Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT03367351
Status:
COMPLETED
Last Update Posted:
2018-12-17
First Post:
2017-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, un-blinded intervention/control design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-14', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to CGM', 'timeFrame': '3 months', 'description': 'Analyzing CGM data to determine if there is a difference in adherence between treatment and control group'}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '1-week run in, 3-months post implementation', 'description': 'The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.'}, {'measure': 'CGM Satisfaction', 'timeFrame': '1-week run in, 7 weeks', 'description': 'Survey instrument that measures self-reported satisfaction with CGM use'}, {'measure': 'CGM Self-Efficacy', 'timeFrame': '1-week run in, 7 weeks', 'description': 'Survey instrument that measures self-reported self-efficacy related to CGM use'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus', 'Continuous Glucose Monitor']}, 'referencesModule': {'references': [{'pmid': '33560234', 'type': 'DERIVED', 'citation': "Smith MB, Albanese-O'Neill A, Yao Y, Wilkie DJ, Haller MJ, Keenan GM. Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study. JMIR Diabetes. 2021 Feb 9;6(1):e15410. doi: 10.2196/15410."}]}, 'descriptionModule': {'briefSummary': 'The goal of this pilot study is to produce a high-quality, theory-driven, therapeutic, web-based intervention that provides extended training and peer support to adolescents and young adults with type 1 diabetes who are newly implementing CGM. Overall, this web-based intervention represents an efficient way to bring together professionally-supported CGM educational materials and social support to overcome known barriers and address factors associated with inconsistent CGM use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability to read and speak English\n2. Diagnosed with type 1 diabetes (T1D) for \\> 3 months before consent is obtained\n3. Aged \\>15 years and \\<24 years at time of enrollment\n4. Must have access to a smartphone, tablet or laptop/desktop computer with high speed internet access and speaker\n5. Must be using/initiating a Dexcom CGM\n\nExclusion Criteria:\n\n1. Cognitive or learning disability (e.g., inability to read) that would preclude their ability to comply with the study protocol\n2. Significant medical comorbidity in the adolescent or young adult that could, in the opinion of the PI, affect subject's capacity to follow study protocol\n3. Previous use of a CGM within the last 3 months\n4. Unwilling or unlikely to return to clinic for a follow-up HbA1c test\n5. Unwillingness to accept randomization"}, 'identificationModule': {'nctId': 'NCT03367351', 'acronym': 'IDEAL CGM', 'briefTitle': 'Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring', 'orgStudyIdInfo': {'id': 'UFT1DCGM2017'}, 'secondaryIdInfos': [{'id': 'IRB201701822', 'type': 'OTHER', 'domain': 'University of Florida'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Web-Based Educational Intervention', 'description': 'Participants receiving the Web-Based Educational Intervention will be enrolled to the research protocol for six weeks of module-based learning and online discussion sessions and followed for a total of 3-months post CGM implementation to collect study measures.', 'interventionNames': ['Behavioral: Web-Based Education', 'Behavioral: Social Support']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard of Care', 'description': 'Participants will receive standard clinical care. Similar study measures will be collected to compare between groups.', 'interventionNames': ['Behavioral: Standard of Care']}], 'interventions': [{'name': 'Web-Based Education', 'type': 'BEHAVIORAL', 'description': 'Completion of a CGM specific web-based educational intervention that includes a series of online learning modules.', 'armGroupLabels': ['Web-Based Educational Intervention']}, {'name': 'Social Support', 'type': 'BEHAVIORAL', 'description': 'Engagement in peer-led CGM specific discussion boards', 'armGroupLabels': ['Web-Based Educational Intervention']}, {'name': 'Standard of Care', 'type': 'BEHAVIORAL', 'description': 'Standard of Care - serves as the control group for the treatment arm', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32603', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Madison B Smith, BSN, PhD Candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}