Is Real-time CGM Superior to Flash Glucose Monitoring in Real Life Study (CORRIDA LIFE)
NCT ID: NCT04759495
Last Updated: 2021-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
187 participants
INTERVENTIONAL
2019-06-01
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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rtCGM
Patients with use of the DEXCOM G5 or G6 system (real time continuous glucose monitoring).
Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)
rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
FGM
Patients with use of the FreeStyle Libre Flash system (flash glucose monitoring).
Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)
FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
Interventions
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Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)
rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)
FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes for \> 1 year
* ≥ 18 years old
* CSII without automatic functions or MDI
Exclusion Criteria
* treatment with insulin pump with automatic functions
* severe noncompliance
* known severe diabetic retinopathy and/or macular edema
* lactation, pregnancy, or intending to become pregnant during the study
* a condition likely to require MRI
* use of acetaminophen-containing medication
* unwillingness to use the study device for \>70% of time
18 Years
ALL
No
Sponsors
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Charles University, Czech Republic
OTHER
Responsible Party
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Jan Soupal, MD
Principal Investigator
Principal Investigators
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Jan Soupal
Role: PRINCIPAL_INVESTIGATOR
Charles University, Prague
Locations
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3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
Prague, , Czechia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CORRIDA LIFE
Identifier Type: -
Identifier Source: org_study_id
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