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临床试验/NCT05994755
NCT05994755尚未招募不适用

Association Between Cardiac ARRHYTHMIAs and Glycemic Variability in Patient With Type 2 Diabetes Monitored Through FREEstyle Libre and Bluetooth Technology. (ARRHYTHMIA FREE)

Antonio Rapacciuolo1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2023年10月30日最近更新:
适应症

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

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

发起方
Antonio Rapacciuolo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Antonio Rapacciuolo

Principal Investigator

Federico II University

研究点 (1)

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