NCT03570138

Efficacy of Flash Glucose-Sensing Technology on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia

Efficacy of Flash Continuous Glucose Monitoring (FREESTYLE LIBRE) on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia in Patients With Type 2 Diabetes, High Risk of Hypoglycemia and Insulin Therapy : Open-label Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with type 2 diabetes (T2D). The study hypothesize is that the hypoglycemia reduction, achieved with the FREESTYLE LIBRE device, a Glucose Continuous Monitoring system, may decrease cardiac arrythmias associated with hypoglycemia. So the main objective is to evaluate the efficacy of the FREESTYLE LIBRE system, associated with a specific therapeutic education on the cardiac arrythmias reduction, compared to a capillary ASG system with standard therapeutic education, in patient with T2D with high risk of hypoglycemia. This is a open, multicenter, controlled, randomized study in parallel group.

Conditions

• Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia

Interventions

Type	Name	Description
DEVICE	FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System	Specific therapeutic education for diabetes self management
DEVICE	Usual self monitoring Blood Glucose device	Standard therapeutic education for diabetes self management

Timeline

• Start date: 2018-06-29
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2018-06-26
• Last updated: 2020-10-22

Locations

7 sites across 1 country: France