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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
200
Specific therapeutic education for diabetes self management
Standard therapeutic education for diabetes self management
University Hospital, Bordeaux
Bordeaux, France
RECRUITINGUniversity Hospital, Limoges
Limoges, France
RECRUITINGUniversity Hospital, Nantes
Nantes, France
RECRUITINGHospital, Niort
Niort, France
NOT_YET_RECRUITINGHospital, Pau
Pau, France
RECRUITINGUniversity Hospital, Poitiers
Poitiers, France
RECRUITINGUniversity Hospital, Toulouse
Toulouse, France
RECRUITINGPrevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring
Cardiac arrythmic events : * Bradycardia \< 45 bpm for ≥ 10 seconds * or Asystole ≥ 3 seconds * or Atrial Fibrillation ≥ 30 seconds * or Non-sustained ventricular tachycardia defined as runs of beats arising from the ventricles with duration between 3 beats and 30 s with QRS ≥ 120ms and with RR intervall ≤ 600 ms (\>100 bpm)
Time frame: 14 days
Prevalence of each component of the primary outcome
Time frame: 14 days
Prevalence of ≥ 5 minutes Atrial Fibrillation episodes
Time frame: 14 days
Mean QT interval
Time frame: First 24 hours
Prevalence of ventricular extrasystoles
Time frame: First 24 hours
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