Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-28 @ 10:41 PM
Study NCT ID:
NCT06965803
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-11
First Post:
2025-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This Study is to Evaluate Whether Receiving Education and Glucose Monitoring With the CGM Device Will Improve Patient-reported Outcomes by Improving Patient's Satisfaction and Quality of Life (QOL) With Glucose Monitoring Device.
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': 'ESTIMATED', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2025-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': '15 days', 'description': 'Glucose Monitoring Satisfaction Survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to improve patient-reported outcomes by improving patient's satisfaction and quality of life (QOL) with glucose monitoring device through pre and post satisfaction survey of patient with diabetes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '• Admitted patient with Type 1 or Type 2 diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 or older\n* diagnosed with Type 1 or Type 2 Diabetes who are on insulin\n* able to speak and understand English language\n* scheduled to receive a standard inpatient diabetes education consultation\n* must not have used CGM in the six months prior to admission\n* owns a smartphone\n* demonstrates the ability to follow instructions and be capable of providing informed consent to participate in the program\n\nExclusion Criteria:\n\n* those who are known to be pregnant. This is due to complexity of pregnancy-related changes in glucose metabolism and increased skin sensitivity, or changes in skin condition to adhesives and materials used in CGM devices.\n* non-English speakers. As this is small study to evaluate which method is favorable using a survey only validated in English, enrolling non-English speakers would require additional resources/translations/personnel for evaluation and the education intervention that are not logistically possible right now.'}, 'identificationModule': {'nctId': 'NCT06965803', 'acronym': 'CGM QOL', 'briefTitle': "This Study is to Evaluate Whether Receiving Education and Glucose Monitoring With the CGM Device Will Improve Patient-reported Outcomes by Improving Patient's Satisfaction and Quality of Life (QOL) With Glucose Monitoring Device.", 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Continuous Glucose Monitor (CGM) Discharge Program', 'orgStudyIdInfo': {'id': 'STUDY00003936'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Director, Clinical Support Programs', 'investigatorFullName': 'Matthew Monterola', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}