Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-28 @ 6:36 PM
Study NCT ID:
NCT04641650
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2020-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study : FreeStyle Libre Pro Flash Continuous Glucose Monitoring System in Subjects With Diabetes on HemoDIALsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between estimated Hba1c (or Glucose Management Index (GMI)) with FreeStyle Libre Pro sensor and laboratory Hba1c', 'timeFrame': 'At sensor removal (day 14)', 'description': 'Comparison between estimated HbA1c with 14 days of CGM data and laboratory HbA1c (routine blood test in hemodialysis) in each subject'}], 'secondaryOutcomes': [{'measure': 'Time in glucose range', 'timeFrame': 'At sensor removal (day 14)', 'description': 'Percent (%) time in glucose range of ≥70 to ≤180 mg/dL (≥3.9 to ≤10 mmol/L), obtained using professional continuous glucose monitoring (CGM)'}, {'measure': 'Time with Glucose < 70mg/dL', 'timeFrame': 'At sensor removal (day 14)', 'description': '% time with glucose \\<70 mg/dL'}, {'measure': 'Time with Glucose > 180 mg/dL', 'timeFrame': 'At sensor removal (day 14)', 'description': '% time with glucose \\>180 mg/dL'}, {'measure': 'Glucose total coefficient of variation (CV)', 'timeFrame': 'At sensor removal (day 14)', 'description': 'Glucose total CV (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glycemia', 'diabetes', 'kidney failure', 'dialysis', 'glucose sensor'], 'conditions': ['Kidney Failure', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'Continuous monitoring of glucose with a FreeStyle Libre pro sensor in diabetic and dialysis patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with diabetes on hemodialysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes without any change in treatment in the last 3 months\n* Hemodialysis for \\> 3 months\n* Recent laboratory HbA1c (\\< 15 days)\n\nExclusion Criteria:\n\n* Patient does not show non-opposition\n* Skin allergy to the sensor\n* Sepsis / Acute anaemia'}, 'identificationModule': {'nctId': 'NCT04641650', 'acronym': 'FSL DIAL', 'briefTitle': 'Pilot Study : FreeStyle Libre Pro Flash Continuous Glucose Monitoring System in Subjects With Diabetes on HemoDIALsis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Saint Joseph Saint Luc de Lyon'}, 'officialTitle': 'FreeStyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System in Subjects With Diabetes on HemoDIALsis (FSL-DIAL Pilot Study)', 'orgStudyIdInfo': {'id': 'FSL DIAL'}}, 'contactsLocationsModule': {'locations': [{'zip': '69365', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Hospitalier Saint Joseph Saint Luc', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Lucien Marchand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Saint Joseph Saint Luc de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}