Is Real-time CGM Superior to Flash Glucose Monitoring in Real Life Study (CORRIDA LIFE)

NCT04759495 | Unknown FDA Device

• 1 other identifier: CORRIDA LIFE
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Continuous Glucose Monitoring; Flash Glucose Monitoring; Hypoglycaemia; Time in Range

Outcome Measures

Primary Outcomes (1)

• Changes in glycated haemoglobin (HbA1c)

  Differences between HbA1c values in the Run in period and after 12 month of follow-up and differences of HbA1c between groups.

  Up to 13 months

Secondary Outcomes (8)

• Percentage of time in hypoglycemic ranges

  Up to 13 months

• Percentage of time in target ranges

  Up to 13 months

• Percentage of time in hyperglycemic ranges

  Up to 13 months

• Changes in glycemic variability

  Up to 13 months

• Mean sensor glucose concentration

  Up to 13 months

Study Arms (2)

rtCGM

EXPERIMENTAL

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

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

FGM

EXPERIMENTAL

Patients with use of the FreeStyle Libre Flash system (flash glucose monitoring).

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

Interventions

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

rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.

rtCGM

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

FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.

FGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University

Prague, Czechia

Location

Related Publications (9)

• 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: 32859607 BACKGROUND

• 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: 24526393 BACKGROUND

• 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: 27482825 BACKGROUND

• 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: 31530663 BACKGROUND

• 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: 28118453 BACKGROUND

• 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: 29273897 BACKGROUND

• 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: 27634581 BACKGROUND

• 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: 29459019 BACKGROUND

• 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.

  PMID: 36037056 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jan Soupal

  Charles University, Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: June 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: September 30, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)