Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 6:41 AM
Study NCT ID:
NCT06962735
Status:
COMPLETED
Last Update Posted:
2025-05-11
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monitoring (Switch CGM Retro)
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c at 6-12-month follow-up compared to baseline', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To evaluate change in HbA1c at 6-12-month follow-up compared to baseline after switching from an isCGM system to a rtCGM system in adults with type 1 diabetes'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c in the rtCGM switch cohort compared to a matched isCGM cohort', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To compare 6-12 month change in HbA1c in the rtCGM switch cohort, who switched from isCGM to rtCGM, compared to a propensity score matched isCGM cohort, who maintained isCGM use, among a subgroup of patients with T1D and HbA1c ≥ 7.5%.'}, {'measure': 'Change in percent time in target glucose range (TIR) at 6-12 months follow-up', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To evaluate change in percent TIR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.'}, {'measure': 'Change in percent time below target glucose range (TBR)', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To evaluate change in percent TBR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.'}, {'measure': 'Change in percent time above target glucose range (TAR)', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To evaluate change in percent TAR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.'}, {'measure': 'Change in mean glucose', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To evaluate change in mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.'}, {'measure': 'Change in standard deviation (SD) of mean glucose', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To evaluate change in SD of mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.'}, {'measure': 'Change in coefficient of variation (CV) of mean glucose', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To evaluate change in CV of mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.'}, {'measure': 'Change in weight', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To evaluate change in weight at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.'}, {'measure': 'Proportion of patients who achieve HbA1c ≤7.0%', 'timeFrame': 'evaluated at 6- to-12-month follow-up', 'description': 'To evaluate the proportion of patients who achieve HbA1c ≤7.0% at 6-12 months follow-up in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% at baseline and propensity score matched isCGM cohort with HbA1c ≥ 7.5% at baseline.'}, {'measure': 'Weekly incidence of self-reported hypoglycemia', 'timeFrame': 'evaluated at 6- to-12-month follow-up', 'description': 'To evaluate weekly incidence of self-reported hypoglycemia at 6-12 months in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.'}, {'measure': 'Proportion of patients with ≥ 1 self-reported hypoglycemic event', 'timeFrame': 'evaluated at 6- to-12-month follow-up', 'description': 'To evaluate proportion of patients with ≥ 1 self-reported hypoglycemic event at 6-12 months in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.'}, {'measure': 'Change in total daily dose (TDD) of insulin', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To evaluate change in TDD of insulin at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%.'}, {'measure': 'Proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort', 'timeFrame': 'from index date to 6- to-12-month follow-up', 'description': 'To evaluate proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort during the study period from baseline to 6-12 months follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The objective of this retrospective, observational study, is to better understand the real-world glycemic effectiveness of switching to real time continuous glucose monitoring (rtCGM) from intermittently scanned continuous glucose monitoring (isCGM) among adults with type 1 diabetes or type 2 diabetes in Canada.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes adults, who were active patients with type 1 diabetes or type 2 diabetes at LMC, who switched from intermittently scanned continuous glucose monitoring to real-time continuous glucose monitoring (rtCGM switch cohort) or initiated and maintained intermittently scanned continuous glucose monitoring use (isCGM cohort).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older as of the index date\n* Clinical diagnosis of T1D or T2D ≥ one year\n* Using either MDI or CSII therapy\n* Initiated a FreeStyle Libre® isCGM device between January 1, 2018 and July 31, 2023 (isCGM cohort)\n* Switched from a FreeStyle Libre® 1 or Libre 2® isCGM device to a Dexcom® G5 or G6 CGM device between April 1, 2018 and July 31, 2023 (rtCGM cohort)\n* Baseline HbA1c ≥7.0% for primary objective with rtCGM cohort\n* Baseline HbA1c ≥8.0% for key secondary objective comparing rtCGM cohort to isCGM cohort\n* Known rtCGM/isCGM start date (month and year)\n* Exclusive use of isCGM for ≥ 3 months\n* ≥ one HbA1c value up to 6 months (± 6 weeks) prior to index date (HbA1c value must be after isCGM initiation and no more than 6 weeks after the index date)\n* ≥ one HbA1c value 6-12 months (± 6 weeks) following the index date\n* Informed consent for their medical record data to be used for research purposes\n\nExclusion Criteria:\n\n* Have a prior history of rtCGM within 12 months of the index date\n* Are pregnant at the time of isCGM initiation or time of switch to rtCGM\n* Used the isCGM or rtCGM for \\< 3 months'}, 'identificationModule': {'nctId': 'NCT06962735', 'briefTitle': 'Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monitoring (Switch CGM Retro)', 'organization': {'class': 'OTHER', 'fullName': 'LMC Diabetes & Endocrinology Ltd.'}, 'officialTitle': 'Effect of Switching From Intermittently Scanned Continuous Glucose Monitoring to Real-time Continuous Glucose Monitoring on Glycemic Outcomes in Adults With Diabetes: A Real-world, Canadian Retrospective Study', 'orgStudyIdInfo': {'id': 'Switch CGM retro'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'real-time continuous glucose monitoring switch group (rtCGM switch group)', 'description': 'adults with diabetes that switched from an isCGM to an rtCGM', 'interventionNames': ['Device: real-time continuous glucose monitor']}, {'label': 'intermittently scanned continuous glucose monitoring group (isCGM group)', 'description': 'adults with diabetes that remained on an isCGM'}], 'interventions': [{'name': 'real-time continuous glucose monitor', 'type': 'DEVICE', 'description': 'Individuals who switched from using isCGM to rtCGM', 'armGroupLabels': ['real-time continuous glucose monitoring switch group (rtCGM switch group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4G3E8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Diabetes & Endocrinology Ltd.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a real-world study using data retrieved from a national Diabetes Registry. IPD will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMC Diabetes & Endocrinology Ltd.', 'class': 'OTHER'}, 'collaborators': [{'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}