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

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.

Inclusion criteria:

• Type 2 diabetes (diagnosis based on the World Health Organization criteria)

• Treatment with insulin therapy (continuous subcutaneous insulin Infusion or more than 1 daily injection)

• Resting heart beat ≥ 60bpm

• High risk of hypoglycemia defined as :

  • Estimated glomerular filtration rate 15-59 ml/min/1.73 m² (according to CKD-EPI formula)
  • Or history of stable proliferative diabetic retinopathy
  • Or body mass index ≤ 30 kg/m²
  • Or history of severe hypoglycemia in the previous 6 months
  • Or history of non-severe ≤70mg/dL hypoglycemia in the previous 4 weeks

Exclusion criteria:

• Type 1 diabetes mellitus or diabetes due to other cause
• History of atrial fibrillation
• Pacemaker
• Estimated glomerular filtration rate <15 ml/min/1.73 m² (according to CKD-EPI formula)
• Currently using a flash continuous Glucose Monitoring device
• In the investigator's opinion, acute or chronic medical condition considered as unsuitable for inclusion in the study .