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

Charles University, Czech Republic

Status: Unknown

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring); Device: Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)

Study type: Interventional

Funder types: Other

Identifiers

NCT04759495

CORRIDA LIFE

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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187 participants in 2 patient groups

rtCGM

Experimental group

Description:

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

Treatment:

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

FGM

Experimental group

Description:

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

Treatment:

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