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
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 .
研究组 & 干预措施
Flash continuous glucose monitoring system
Participants will wear the FREESTYLE LIBRE device and receive a specific therapeutic education for its use.
干预措施: FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System (Device)
Standard self monitoring blood glucose system
Participants will use their own usual self monitoring blood glucose system and receive a C They will wear a masked FREESTYLE LIBRE Pro system.
干预措施: Usual self monitoring Blood Glucose device (Device)
结局指标
主要结局
Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring
时间窗: 14 days
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)
次要结局
- Prevalence of each component of the primary outcome(14 days)
- Mean QT interval(First 24 hours)
- Prevalence of ≥ 5 minutes Atrial Fibrillation episodes(14 days)
- Prevalence of ventricular extrasystoles(First 24 hours)