Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT07271433
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Glucose Monitoring for Post-kidney Transplantation in Pre-existing Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-24', 'size': 333503, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-26T12:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in Range (TIR)', 'timeFrame': '6 months', 'description': 'Percent of patients who achieved Time in Range (55 mg/dL to 180 mg/dL Glucose) as measured by the Continuous Glucose Monitor'}, {'measure': 'Hospital Readmission', 'timeFrame': '6 months', 'description': 'Percent of patients who experienced a hospital readmission'}, {'measure': 'Time below range (TBR)', 'timeFrame': '6 months', 'description': 'Percent of patients who achieved Time below range (\\<54 mg/dL Glucose) as measured by the Continuous Glucose Monitor'}, {'measure': 'Time above range (TAR)', 'timeFrame': '6 months', 'description': 'Percent of patients who achieved Time above range (181-250mg/dL and \\>250 mg/dL Glucose) as measured by the Continuous Glucose Monitor'}, {'measure': 'Rejection', 'timeFrame': '6 months', 'description': 'Percent of patients who experienced a rejection of the transplanted kidney'}, {'measure': 'Delayed graft function', 'timeFrame': '6 months', 'description': 'Percent of patients who experienced delayed graft function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CGM', 'Kidney Transplant', 'Continuous Glucose Monitor'], 'conditions': ['Kidney Transplant']}, 'descriptionModule': {'briefSummary': 'Use of continuous glucose monitor (CGM) in post kidney transplant patients to better assess changes in glucose levels post kidney transplant', 'detailedDescription': 'This is a non-randomized perspective single arm study with a planned enrollment of 20 patients. The primary objective is to characterize the glucometrics (description of glucose readings in relation to target goals) achieved by a CGM-based insulin titrating protocol for glucocorticoid taper for post kidney transplant patients. The secondary objective is to explore the relationship between the CGM glucometrics and rates of readmission, rejection and delayed graft function in post kidney transplant patients.\n\nA total of 20 patients that are post kidney transplant, will undergo intervention until 3 months post-transplant. Informed consent will be obtained prior to start of study. The final visit will be at 3 months. Patients will be discharged to their local endocrinologist or primary care physician at this 3-month mark. Data will continue to be gathered for 3 more months after exit from intervention. Enrollment will be within the first 2 weeks of hospital discharge. Visits are standard of care (SOC) at the Kidney Transplant Clinic or at the Endocrinology clinic and will be virtual, in-person or telephone encounter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a non-randomized prospective single arm study with a planned enrollment of 20 patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sex: men and women\n2. Ethnicity: all ethnic groups\n3. Age: ≥ 18\n4. Known type 2 diabetes before kidney transplant\n5. Kidney transplant alone\n6. On multiple daily insulin injection\n7. Standard prednisone taper\n8. Smart phone - compatible with the LibreView App\n\nExclusion Criteria:\n\n1. Simultaneous pancreas-kidney transplant\n2. Allergy to Freestyle Libre components including adhesive\n3. Use of vitamin C at doses 500 mg or greater\n4. Blood dyscrasias that prevent hemoglobin A1c interpretation\n5. Lack of mobile app accessibility\n6. Rapid prednisone taper'}, 'identificationModule': {'nctId': 'NCT07271433', 'briefTitle': 'Continuous Glucose Monitoring for Post-kidney Transplantation in Pre-existing Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Continuous Glucose Monitoring for Post-kidney Transplantation in Pre-existing Type 2 Diabetes', 'orgStudyIdInfo': {'id': '23-390'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post Kidney Transplant, using CGM', 'description': 'A total of 20 patients that are post kidney transplant, will wear a Continuous Glucose Monitor (CGM) until 3 months post-transplant.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared due to the disclosure on the consent form for which IRB approval was received. Deidentified summarized results will be shared via publication in a medical journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}