Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-29 @ 7:55 PM
Study NCT ID:
NCT06668935
Status:
RECRUITING
Last Update Posted:
2025-01-15
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring
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': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the length of time subjects in each group remain on a GLP-1 or GLP-1/GIP combination drug', 'timeFrame': '210 days', 'description': 'The primary outcome is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) helps prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1) and dual gastric inhibitory polypeptide/glucagon-like peptide 1 (GIP/GLP-1) agonists.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.', 'detailedDescription': 'Subjects with type 2 diabetes who are newly beginning GLP-1 or GLP-1/GIP drug therapy will be randomized to use either FSL3 or their existing Standard of Care to manage their diabetes. Up to 800 subjects will be enrolled across the United States with 200 evaluable subjects in each group (intervention and control) for a total of 400 evaluable subjects. Subjects will be on the study approximately 210 days. Subjects will wear one sensor applied to the back of the upper arm and will have a paired smartphone that will be used to start the sensor and collect glucose readings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject must be at least 18 years of age.\n2. Subject must be able to read and understand English.\n3. Subject must have a type 2 diabetes diagnosis.\n4. In the investigator's opinion, subject must meet the criteria for beginning use of GLP-1 or GIP/GLP-1 medications for management of their diabetes.\n5. Subject is beginning use of GLP-1 / GIP/GLP-1 medication for management of their diabetes.\n6. Subject must be willing to allow venous samples to be obtained to test HbA1c.\n7. Subject must be willing to either continue using their existing standard of care device or must be willing to use the FreeStyle Libre 3 Continuous Glucose Monitoring System to manage their diabetes throughout the duration of the study.\n8. In the investigator's opinion, the subject 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.\n9. Subject must be available to participate in all study visits.\n10. Subject must be willing and able to provide written signed and dated informed consent.\n\n Exclusion Criteria:\n11. Subject is a member of the Study Staff.\n12. Subject has a diagnosis of type 1 or gestational diabetes.\n13. Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.\n14. Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.\n15. Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.\n16. Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin.\n17. 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.\n18. Subject currently is participating in another clinical trial.\n19. Subject is unsuitable for participation due to any other cause as determined by the Investigator"}, 'identificationModule': {'nctId': 'NCT06668935', 'briefTitle': 'Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Diabetes Care'}, 'officialTitle': 'Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring', 'orgStudyIdInfo': {'id': 'ADC-US-RES-24254'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Randomization to FSL 3 or Standard of Care', 'description': 'Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes.', 'interventionNames': ['Device: To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists']}], 'interventions': [{'name': 'To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists', 'type': 'DEVICE', 'description': "All subjects will then begin use of their prescribed GLP-1 or combination GIP/GLP-1 medication in accordance with the HCP's instructions. Subjects will be titrated to their maximum tolerable dose per the medication's approved titration schedule and according to their HCP's standard of care between Visits 2 and 3.", 'armGroupLabels': ['Randomization to FSL 3 or Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Goldfaden, Pharm D', 'role': 'CONTACT', 'email': 'rg@eastcoastresearch.net', 'phone': '904-854-1354'}, {'name': 'Wasim Deeb, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'East Coast Institute for Research, LLC', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33169', 'city': 'Miami Gardens', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Martinez, OD', 'role': 'CONTACT', 'email': 'amartinez@emrclinic.com', 'phone': '786-320-5229'}, {'name': 'Miguel Trujillo, DNP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Excellence Medical and Research', 'geoPoint': {'lat': 25.94204, 'lon': -80.2456}}], 'centralContacts': [{'name': 'Mohamed Mohamed Nada, PhD', 'role': 'CONTACT', 'email': 'adc.clinical@abbott.com', 'phone': '5107495416'}, {'name': 'Shridhara Karinka, PhD', 'role': 'CONTACT', 'email': 'adc.clinical@abbtott.com', 'phone': '510 7495416'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}