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

February 15, 2021 updated by: Jan Soupal, MD, Charles University, Czech Republic

Comparison of CGM in Non-randomised Real Life Study of Real-time and Intermittently Scanned Systems in Patients With Type 1 Diabetes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rtCGM
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)
rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
Experimental: FGM
Patients with use of the FreeStyle Libre Flash system (flash glucose monitoring).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in glycated haemoglobin (HbA1c)
Time Frame: Up to 13 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time in hypoglycemic ranges
Time Frame: Up to 13 months
<3.9 mmol/L [70 mg/dl] and <3.0 mmol/L [54 mg/dl]
Up to 13 months
Percentage of time in target ranges
Time Frame: Up to 13 months
3.9-10.0 mmol/L [70-180 mg/dl]
Up to 13 months
Percentage of time in hyperglycemic ranges
Time Frame: Up to 13 months
>10.0 mmol/L [180 mg/dl] and >13.9 mmol/L [250 mg/dl]
Up to 13 months
Changes in glycemic variability
Time Frame: Up to 13 months
Expressed as the standard deviation
Up to 13 months
Mean sensor glucose concentration
Time Frame: Up to 13 months
Measured by rtCGM or FGM
Up to 13 months
Incidence of severe hypoglycaemia
Time Frame: Up to 13 months
Requiring third-party assistance to treat
Up to 13 months
Incidence of severe ketoacidosis
Time Frame: Up to 13 months
Requiring hospitalization
Up to 13 months
Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor
Time Frame: Up to 13 months
Skin reaction, infection or hematoma reported by patients
Up to 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Principal Investigator: Jan Soupal, Charles University, Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORRIDA LIFE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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