Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 825
- 试验地点
- 1
- 主要终点
- Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography
研究概览
简要总结
Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular or neuropathic complications; in addition to an optimal treatment, prevention of diabetes complications requires to control associated risk factors, such as hypertension or dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and marked morbidity and mortality, one increasingly interesting aspect is its relationship with metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be underestimated in this population. In this context, it appears to be important to estimate the prevalence of sleep respiratory diseases in patients with type 1 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 to 75 years
- •Type 1 diabetic
- •Treated on insulin therapy by external pump
- •Take home monitoring as part of a usual care for insulin therapy by external pump
- •Voluntary to participate in research with written informed consent
- •Patient affiliated to the social security or similar regime
排除标准
- •Privited person of liberty by judicial or administrative decision, person covered by legal protection (pregnant or lactating women, patients under guardianship) Article L1121-8
- •In exclusion period of other studies
- •Patient may, at the discretion of the investigator, not comply with the study procedures
结局指标
主要结局
Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography
时间窗: 2 years
Number of patients presenting an obstructive apnea syndrome
次要结局
- Relationship between sleep apnea syndrome severity and micro/macro vascular complications of type 1 diabetes(2 years)
- Relationship between sleep apnea syndrome severity and type 1 diabetes control(2 years)
- Compliance of the Continuous Positive Airway Pressure (CPAP) after 3 months of use in patients with type 1 diabetes treated for severe SAS.(2 years)
- Incidence of new cardiovascular events and changes in microangiopathic complications of diabetes patients depending on the presence of sleep apnea syndrome and to the adherence to CPAP treatment in case of sleep apnea syndrome treated(2 years)