Is Real-time CGM Superior to Flash Glucose Monitoring (CORRIDA)

April 24, 2020 updated by: Jan Soupal, MD, Charles University, Czech Republic

Comparison of CGM in Randomised Study of Real-time and Intermittently-scanned Systems in T1D With Normal Awareness of Hypoglycemia (CORRIDA)

The aim of the investigator's study is to compare real-time continuous glucose monitoring and flash glucose monitoring in adult patients with Type 1 Diabetes during 4-day training program focused on physical activity and over 4 weeks of follow-up.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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
    • Czech Republic
      • Prague, Czech Republic, 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 rtCGM and isCGM
  • Type 1 diabetes for >2 years
  • ≥ 18 years old
  • CSII or MDI
  • GOLD score < 4, no history of severe hypoglycemia within last 6 month
  • written informed consent prior to starting study related activity

Exclusion Criteria:

  • severe noncompliance
  • severe diabetic retinopathy and/or macular edema
  • lactation, pregnancy, intending to become pregnant during study
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rtCGM
Patients with use of the Guardian Connect Mobile system (real-time continuous glucose monitoring).
Device: Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)
rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
Experimental: isCGM
Patients with use of the FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring).
Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)
rtCGM and isCGM are 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
Percentage of time in hypoglycemic ranges
Time Frame: Up to 2 months
<3,9 mmol/L (70 mg/dl) and <3,0 mmol/L (54 mg/dl)
Up to 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time in target ranges
Time Frame: Up to 2 months
3,9-10,0 mmol/L (70-180 mg/dl)
Up to 2 months
Percentage of time in hyperglycemic ranges
Time Frame: Up to 2 months
(>10,0 mmol/L (180 mg/dl) and >13,9 mmol/L (250 mg/dl)
Up to 2 months
Changes in glycemic variability
Time Frame: Up to 2 months
Expressed as the coefficient of variation
Up to 2 months
Mean sensor glucose concentration
Time Frame: Up to 2 months
Measured by rtCGM or isCGM
Up to 2 months
Changes in quality of life as assessed by validated questionnaire
Time Frame: Up to 2 months

Assessed by The World Health Organization Quality of Life (WHOQOL)-BREF (Field Trial Version).

This questionnaire contains in total 26 questions in four Domains (Physical health, Psychological health, Social relationships, Environment). Scores in total range between 4-20 (each Domain 0-5), higher scores denote higher quality of life.
Up to 2 months
Incidence of severe hypoglycaemia
Time Frame: Up to 2 months
Requiring third-party assistance to treat
Up to 2 months
Changes in glycated haemoglobin (HbA1c)
Time Frame: Up to 2 months
Differences between HbA1c values in the initial period and after follow-up and differences of HbA1c between groups.
Up to 2 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)

September 1, 2018

Primary Completion (Actual)

April 30, 2019

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORRIDA

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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