Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of cardiac arrhythmias during hypoglycaemia, euglycaemia, hyperglycaemia.
研究概览
简要总结
The investigators hypothesise that patients with type 1 diabetes have clinically relevant, but often unrecognised, episodes of arrhythmias linked to episodes of hypoglycaemia and/or clinically significant fluctuations in plasma glucose.
详细描述
30 patients with type 1 diabetes will be recruited for a one-year observational study employing CGM (Continuous glucose monitor) and ILR (Implantable loop recorder). Patients will be scheduled for a three-week run-in period to ensure that the implanted ILR provides reliable data. Patient visits are planned for 0, 3, 6, 9, and 12 months and will include clinical examination, blood and urine samples, echocardiography (only first and last visit) and implant/explant of CGM. After 12 months, the participants will continue with an extended observation period of 2 years employing ILR and clinical examination.
Device: Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA) Implantation of a loop-recorder
Device: Continuous glucose monitoring (Eversense XL, Senseonics, USA) Monitoring with a continuous glucose monitor
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed and written consent
- •Type 1 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
- •Age 18-80 years
- •Fulfilling at least one of the below criteria*:
- •Recurrent hypoglycaemia (defined as >1 episode/week with a plasma glucose measurement ≤3.9 mmol/l within the last 4 weeks)
- •An episode of severe hypoglycaemia within the last year (according to the ADA definition, an event requiring assistance of another person to actively administer carbohydrates and/or glucagon, or take other corrective actions)
- •Hypoglycaemic symptom unawareness (history of impaired autonomic response during hypoglycaemia)
- •(*The aim is that all patients will fulfil criteria a or b. If the targeted sample size cannot be recruited, patients fulfilling criteria c will be included)
- •Insulin treatment
- •One or more clinical relevant complications to diabetes defined as**:
- •Nephropathy (creatinine >130 μmol/l and/or microalbuminuria)
- •Macrovascular disease defined as coronary disease (stable angina pectoris. previous unstable angina pectoris or myocardial infarction), cerebrovascular disease (previous stroke or transitional cerebral ischaemia), and peripheral vascular disease (previous intermittent claudication or prior acute ischemia)
- •Peripheral neuropathy with vibration perception threshold of >25 volt determined by biothesiometry
- •Moderate to severe retinopathy
- •Well-functioning ILR during run-in period (acceptable readings judged by an arrhythmologist)
- •Participation in the extended study
- •(**The aim is that all patients will fulfil criteria a or b. If the targeted sample size cannot be recruited, patients fulfilling criteria c or d will be included)
排除标准
- •Arrhythmia diagnosed prior to the screening visit
- •ICD or pacemaker at the time of inclusion
- •Severe heart failure (left ventricular ejection fraction <25%)
- •Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
- •Thyroid dysfunction (except for well-regulated eltroxine substituted myxoedema)
结局指标
主要结局
Incidence of cardiac arrhythmias during hypoglycaemia, euglycaemia, hyperglycaemia.
时间窗: Within 12 months
Incidence of clinically relevant arrhythmias during hypoglycaemia (plasma glucose ≤3.9 mmol/l) compared to euglycaemia and hyperglycaemia.
次要结局
- The relationship between diabetes complication status at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV(Within 12 months)
- The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV(Within 12 months)
- Hypoglycaemia and cardiac arrhythmia(Within 12 months)
- Plasma glucose variation and cardiac arrhythmias(Within 12 months)
- CV, SD, ADRR, LBGI, HBGI, CONGA-1 and cardiac arrhythmias(Within 12 months)
- Mean amplitude of glycaemic excursions (MAGE) and cardiac arrhythmia.(Within 12 months)
- Prevalence of cardiac arrhythmias(Within 12 months)
- Cardiac arrhythmias during LGV, HGV.(Within 12 months)
- The relationship between cardiovascular disease at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV(Within 12 months)