Association Between Cardiac ARRHYTHMIAs and Glycemic Variability in Patient With Type 2 Diabetes Monitored Through FREEstyle Libre and Bluetooth Technology. (ARRHYTHMIA FREE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- association between hypoglycemia, glycemic variability and cardiac arrhythmias
研究概览
简要总结
The aim of this study is to investigate the association between hypoglycemia, glycemic variability and cardiac arrhythmias in patients with diabetes Type II (T2D) already implanted with implantable cardiac defibrillator (ICD) and monitored remotely through Bluetooth technology and CGM (continuous glucose monitoring).
详细描述
Studies have shown that, when diabetes is present, there is a 35% to 60% greater risk of developing atrial fibrillation (AF). Diabetic patients with AF had a 61% increase in total mortality, a 77% increase in cardiovascular death and a 68% increase in heart failure. The greatest risk with the combination of AF and Type 2 Diabetes Mellitus (T2D) is a 79% increase in thromboembolic risk, particularly stroke.Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with T2D.
However, these conclusions need to be tempered by the limitations of all studies available to date, making it difficult to determine the onset and burden of AF, especially when it is not a monitored end-point.Since prospective randomized trials would be unethical, future research should focus on establishing whether such a link exists by employing an observational design and taking advantage of modern tools for long-term, real-life monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient already wearing CIEDs (Implantable Cardiac Electronic Device) with Bluetooth technology
- •Diabetes Type II, no insulin-treated
- •Over 18 years of age
- •Patient in Sinus Rhythm at the time of the enrollment
- •Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations
排除标准
- •Subject who is, or is expected to be inaccessible for follow-up
- •Patients with persistent and longstanding persistent AF
结局指标
主要结局
association between hypoglycemia, glycemic variability and cardiac arrhythmias
时间窗: 6 months
Incidence of cardiac arrhythmias (atrial fibrillation, atrial flutter, PVC...) detected through remote monitoring and correlation with hypoglycemic episodes.
次要结局
- association between hypoglycemia, glycemic variability and heart failure(6 months)
研究者
Antonio Rapacciuolo
Principal Investigator
Federico II University
