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

Not Applicable

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring); Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)

• Registration Number: NCT04759495
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-11-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-18
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 187

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rtCGM	Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)	Patients with use of the DEXCOM G5 or G6 system (real time continuous glucose monitoring).
FGM	Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)	Patients with use of the FreeStyle Libre Flash system (flash glucose monitoring).

Primary Outcome Measures

Name	Time	Method
Changes in glycated haemoglobin (HbA1c)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University; 🇨🇿 Prague, Czechia