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

Charles University, Czech Republic

Status: Unknown

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring); Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)

Study type: Interventional

Funder types: Other

Identifiers

NCT04358263

CORRIDA

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

rtCGM

Experimental group

Description:

Patients with use of the Guardian Connect Mobile system (real-time continuous glucose monitoring).

Treatment:

Device: Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)

isCGM

Experimental group

Description:

Patients with use of the FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring).

Treatment:

Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)