Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-30 @ 1:47 PM
Study NCT ID:
NCT04759495
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2021-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Real-time CGM Superior to Flash Glucose Monitoring in Real Life Study (CORRIDA LIFE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in glycated haemoglobin (HbA1c)', 'timeFrame': 'Up to 13 months', 'description': 'Differences between HbA1c values in the Run in period and after 12 month of follow-up and differences of HbA1c between groups.'}], 'secondaryOutcomes': [{'measure': 'Percentage of time in hypoglycemic ranges', 'timeFrame': 'Up to 13 months', 'description': '\\<3.9 mmol/L \\[70 mg/dl\\] and \\<3.0 mmol/L \\[54 mg/dl\\]'}, {'measure': 'Percentage of time in target ranges', 'timeFrame': 'Up to 13 months', 'description': '3.9-10.0 mmol/L \\[70-180 mg/dl\\]'}, {'measure': 'Percentage of time in hyperglycemic ranges', 'timeFrame': 'Up to 13 months', 'description': '\\>10.0 mmol/L \\[180 mg/dl\\] and \\>13.9 mmol/L \\[250 mg/dl\\]'}, {'measure': 'Changes in glycemic variability', 'timeFrame': 'Up to 13 months', 'description': 'Expressed as the standard deviation'}, {'measure': 'Mean sensor glucose concentration', 'timeFrame': 'Up to 13 months', 'description': 'Measured by rtCGM or FGM'}, {'measure': 'Incidence of severe hypoglycaemia', 'timeFrame': 'Up to 13 months', 'description': 'Requiring third-party assistance to treat'}, {'measure': 'Incidence of severe ketoacidosis', 'timeFrame': 'Up to 13 months', 'description': 'Requiring hospitalization'}, {'measure': 'Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor', 'timeFrame': 'Up to 13 months', 'description': 'Skin reaction, infection or hematoma reported by patients'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Continuous Glucose Monitoring', 'Flash Glucose Monitoring', 'Hypoglycaemia', 'Time in Range'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '32859607', 'type': 'BACKGROUND', 'citation': 'Haskova A, Radovnicka L, Petruzelkova L, Parkin CG, Grunberger G, Horova E, Navratilova V, Kade O, Matoulek M, Prazny M, Soupal J. Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial. Diabetes Care. 2020 Nov;43(11):2744-2750. doi: 10.2337/dc20-0112. Epub 2020 Aug 28.'}, {'pmid': '24526393', 'type': 'BACKGROUND', 'citation': 'Fullerton B, Jeitler K, Seitz M, Horvath K, Berghold A, Siebenhofer A. Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2014 Feb 14;2014(2):CD009122. doi: 10.1002/14651858.CD009122.pub2.'}, {'pmid': '27482825', 'type': 'BACKGROUND', 'citation': 'Soupal J, Petruzelkova L, Flekac M, Pelcl T, Matoulek M, Dankova M, Skrha J, Svacina S, Prazny M. Comparison of Different Treatment Modalities for Type 1 Diabetes, Including Sensor-Augmented Insulin Regimens, in 52 Weeks of Follow-Up: A COMISAIR Study. Diabetes Technol Ther. 2016 Sep;18(9):532-8. doi: 10.1089/dia.2016.0171. Epub 2016 Aug 2.'}, {'pmid': '31530663', 'type': 'BACKGROUND', 'citation': 'Soupal J, Petruzelkova L, Grunberger G, Haskova A, Flekac M, Matoulek M, Mikes O, Pelcl T, Skrha J Jr, Horova E, Skrha J, Parkin CG, Svacina S, Prazny M. Glycemic Outcomes in Adults With T1D Are Impacted More by Continuous Glucose Monitoring Than by Insulin Delivery Method: 3 Years of Follow-Up From the COMISAIR Study. Diabetes Care. 2020 Jan;43(1):37-43. doi: 10.2337/dc19-0888. Epub 2019 Sep 17.'}, {'pmid': '28118453', 'type': 'BACKGROUND', 'citation': 'Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.'}, {'pmid': '29273897', 'type': 'BACKGROUND', 'citation': 'Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018 Mar;61(3):539-550. doi: 10.1007/s00125-017-4527-5. Epub 2017 Dec 23.'}, {'pmid': '27634581', 'type': 'BACKGROUND', 'citation': 'Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.'}, {'pmid': '29459019', 'type': 'BACKGROUND', 'citation': 'Heinemann L, Freckmann G, Ehrmann D, Faber-Heinemann G, Guerra S, Waldenmaier D, Hermanns N. Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial. Lancet. 2018 Apr 7;391(10128):1367-1377. doi: 10.1016/S0140-6736(18)30297-6. Epub 2018 Feb 16.'}, {'pmid': '36037056', 'type': 'DERIVED', 'citation': 'Radovnicka L, Haskova A, Do QD, Horova E, Navratilova V, Mikes O, Cihlar D, Parkin CG, Grunberger G, Prazny M, Soupal J. Lower Glycated Hemoglobin with Real-Time Continuous Glucose Monitoring Than with Intermittently Scanned Continuous Glucose Monitoring After 1 Year: The CORRIDA LIFE Study. Diabetes Technol Ther. 2022 Dec;24(12):859-867. doi: 10.1089/dia.2022.0152. Epub 2022 Sep 22.'}]}, 'descriptionModule': {'briefSummary': "The aim of the investigator's study is to compare real-time continuous glucose monitoring (rt-CGM) and flash glucose monitoring (FGM) in adult patients with Type 1 Diabetes (T1D) in real life practice during 24 weeks of follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with T1D naive to rt-CGM and FGM\n* Type 1 diabetes for \\> 1 year\n* ≥ 18 years old\n* CSII without automatic functions or MDI\n\nExclusion Criteria:\n\n* previous rtCGM or FGM use\n* treatment with insulin pump with automatic functions\n* severe noncompliance\n* known severe diabetic retinopathy and/or macular edema\n* lactation, pregnancy, or intending to become pregnant during the study\n* a condition likely to require MRI\n* use of acetaminophen-containing medication\n* unwillingness to use the study device for \\>70% of time'}, 'identificationModule': {'nctId': 'NCT04759495', 'briefTitle': 'Is Real-time CGM Superior to Flash Glucose Monitoring in Real Life Study (CORRIDA LIFE)', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Comparison of CGM in Non-randomised Real Life Study of Real-time and Intermittently Scanned Systems in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'CORRIDA LIFE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rtCGM', 'description': 'Patients with use of the DEXCOM G5 or G6 system (real time continuous glucose monitoring).', 'interventionNames': ['Device: Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)']}, {'type': 'EXPERIMENTAL', 'label': 'FGM', 'description': 'Patients with use of the FreeStyle Libre Flash system (flash glucose monitoring).', 'interventionNames': ['Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)']}], 'interventions': [{'name': 'Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)', 'type': 'DEVICE', 'description': 'rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.', 'armGroupLabels': ['rtCGM']}, {'name': 'Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)', 'type': 'DEVICE', 'description': 'FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.', 'armGroupLabels': ['FGM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Jan Soupal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Prague'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jan Soupal, MD', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}