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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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rtCGM

Patients with use of the DEXCOM G5 or G6 system (real time continuous glucose monitoring).

Group Type EXPERIMENTAL

Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)

Intervention Type DEVICE

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).

Group Type EXPERIMENTAL

Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with T1D naive to rt-CGM and FGM
* Type 1 diabetes for \> 1 year
* ≥ 18 years old
* CSII without automatic functions or MDI

Exclusion Criteria

* previous rtCGM or FGM use
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Jan Soupal, MD

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Czechia

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.

Reference Type BACKGROUND
PMID: 32859607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24526393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27482825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31530663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28118453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29273897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27634581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29459019 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36037056 (View on PubMed)

Other Identifiers

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CORRIDA LIFE

Identifier Type: -

Identifier Source: org_study_id

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