Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT06883812
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2025-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Glucose Monitoring in Prediabetes with Health Education Videos
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D006266', 'term': 'Health Education'}], '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': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The CGM system generates automated records of glucose and does not require observation from an outcomes assessor. The investigator does not engage with participants and becomes aware of unmasking after trial is completed.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'An AB sequential condition design with CGM automated continuous glucose recording with glucose level masked and unmasked phases.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose levels', 'timeFrame': 'Maximum of 20 days of continuous wear', 'description': 'Mean glucose in mg/dL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Prediabetes', 'Glucose control', 'Feedback', 'Health education', 'Artificial intelligence', 'Behavioral analysis'], 'conditions': ['Prediabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.dexcom.com', 'label': 'Dexcom G CGM system specifications'}]}, 'descriptionModule': {'briefSummary': 'The objective of this project is to deliver a behavior health education video series that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with prediabetes. The goal is to prevent transition to type 2 diabetes and advanced metabolic complications.', 'detailedDescription': 'A health education video series, ¡Mi Control!, led by community health workers known as Promotores de Salud (PdS), will be integrated with continuous glucose monitoring (CGM) to support self-monitoring of glucose levels and excursions. Study G2 is a Phase 0 feasibility study enrolling 30 Spanish- and/or English-speaking PdS who test positive for prediabetes via a finger-prick A1c% screening. Participants will wear CGM devices for 20 days, with glucose data masked for the first 10 days and unmasked for the next 10 days. During the unmasked phase, participants will receive daily health education videos on their smartphones. The study will compare the duration of glucose excursions between the masked and unmasked phases to assess the impact of CGM feedback and health education on glucose regulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPre-diabetes determined by finger prick A1c% Willingness to wear a CGM sensor Community health worker\n\nExclusion Criteria:\n\nCurrently pregnant Diagnosed with any disorder likely interfering with blood glucose levels Influential medical disorder or event affecting ability to participate in the study Incompatible smartphone device not pairing with the Dexcom CGM system'}, 'identificationModule': {'nctId': 'NCT06883812', 'acronym': 'G2', 'briefTitle': 'Continuous Glucose Monitoring in Prediabetes with Health Education Videos', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Continuous Glucose Monitoring in Prediabetes with Health Education Videos', 'orgStudyIdInfo': {'id': 'UP-23-01001(a)'}, 'secondaryIdInfos': [{'id': '3P50MD017344-03S3', 'link': 'https://reporter.nih.gov/quickSearch/3P50MD017344-03S3', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'CGM', 'type': 'DEVICE', 'description': "The CGM sensor is worn on the back of the arm and glucose levels are recorded continuously but levels are not shown on the participant's phone app in phase A."}, {'name': 'CGM', 'type': 'DEVICE', 'description': "The CGM sensor is worn on the back of the arm and glucose levels are recorded continuously with levels shown on the participant's phone app in phase B."}]}, 'contactsLocationsModule': {'locations': [{'zip': '90031', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Southern California Center for Latino Health SCCLH', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'David S Black, PhD MPH', 'role': 'CONTACT', 'email': 'davidbla@usc.edu', 'phone': '3234428223'}, {'name': 'Ruth Flores', 'role': 'CONTACT', 'email': 'rflores8@usc.edu'}], 'overallOfficials': [{'name': 'David S Black, PhD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California Keck School of Medicine'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicaltrials.gov', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'No longer than one year after the completion of the trial. Researchers can obtain de-identified data and statistical codes after publication of the study outcomes by email request and as supplemental material in future journal publications.', 'ipdSharing': 'YES', 'description': 'IPD sharing is set up with affiliate USC-CHLA P50 Center universities and hospitals under a registered data use agreement (DUA). Data and protocol documentation will be posted on the Open Science Framework', 'accessCriteria': 'Publicly available link or by request to PI or directly obtained as supplemental material from the website of the journal publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David S Black, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Tenured Associate Professor of Population and Public Health Sciences', 'investigatorFullName': 'David S Black, PhD', 'investigatorAffiliation': 'University of Southern California'}}}}