search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)
Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Continuous Glucose Monitoring, Flash Glucose Monitoring, Hypoglycaemia, Time in Range

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

rtCGM

FGM

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of time in hypoglycemic ranges
<3.9 mmol/L [70 mg/dl] and <3.0 mmol/L [54 mg/dl]
Percentage of time in target ranges
3.9-10.0 mmol/L [70-180 mg/dl]
Percentage of time in hyperglycemic ranges
>10.0 mmol/L [180 mg/dl] and >13.9 mmol/L [250 mg/dl]
Changes in glycemic variability
Expressed as the standard deviation
Mean sensor glucose concentration
Measured by rtCGM or FGM
Incidence of severe hypoglycaemia
Requiring third-party assistance to treat
Incidence of severe ketoacidosis
Requiring hospitalization
Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor
Skin reaction, infection or hematoma reported by patients

Full Information

First Posted
February 15, 2021
Last Updated
February 15, 2021
Sponsor
Charles University, Czech Republic
search

1. Study Identification

Unique Protocol Identification Number
NCT04759495
Brief Title
Is Real-time CGM Superior to Flash Glucose Monitoring in Real Life Study (CORRIDA LIFE)
Official Title
Comparison of CGM in Non-randomised Real Life Study of Real-time and Intermittently Scanned Systems in Patients With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Continuous Glucose Monitoring, Flash Glucose Monitoring, Hypoglycaemia, Time in Range

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rtCGM
Arm Type
Experimental
Arm Description
Patients with use of the DEXCOM G5 or G6 system (real time continuous glucose monitoring).
Arm Title
FGM
Arm Type
Experimental
Arm Description
Patients with use of the FreeStyle Libre Flash system (flash glucose monitoring).
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)
Intervention Description
rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)
Intervention Description
FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
Primary Outcome Measure Information:
Title
Changes in glycated haemoglobin (HbA1c)
Description
Differences between HbA1c values in the Run in period and after 12 month of follow-up and differences of HbA1c between groups.
Time Frame
Up to 13 months
Secondary Outcome Measure Information:
Title
Percentage of time in hypoglycemic ranges
Description
<3.9 mmol/L [70 mg/dl] and <3.0 mmol/L [54 mg/dl]
Time Frame
Up to 13 months
Title
Percentage of time in target ranges
Description
3.9-10.0 mmol/L [70-180 mg/dl]
Time Frame
Up to 13 months
Title
Percentage of time in hyperglycemic ranges
Description
>10.0 mmol/L [180 mg/dl] and >13.9 mmol/L [250 mg/dl]
Time Frame
Up to 13 months
Title
Changes in glycemic variability
Description
Expressed as the standard deviation
Time Frame
Up to 13 months
Title
Mean sensor glucose concentration
Description
Measured by rtCGM or FGM
Time Frame
Up to 13 months
Title
Incidence of severe hypoglycaemia
Description
Requiring third-party assistance to treat
Time Frame
Up to 13 months
Title
Incidence of severe ketoacidosis
Description
Requiring hospitalization
Time Frame
Up to 13 months
Title
Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor
Description
Skin reaction, infection or hematoma reported by patients
Time Frame
Up to 13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Soupal
Organizational Affiliation
Charles University, Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
City
Prague
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32859607
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.
Results Reference
background
PubMed Identifier
24526393
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.
Results Reference
background
PubMed Identifier
27482825
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.
Results Reference
background
PubMed Identifier
31530663
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.
Results Reference
background
PubMed Identifier
28118453
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.
Results Reference
background
PubMed Identifier
29273897
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.
Results Reference
background
PubMed Identifier
27634581
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.
Results Reference
background
PubMed Identifier
29459019
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.
Results Reference
background
PubMed Identifier
36037056
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs