Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy: a Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- sensitivity, specificity and accuracy of Neuropad to detect DAN
研究概览
简要总结
Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.
详细描述
Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes mellitus
排除标准
- •age>75 years,
- •estimated creatinine clearance rate (using the Cockcroft-Gault formula) <30 ml/ min,
- •history of limp amputation,
- •causes of neuropathy other than diabetes,
- •drugs that can affect perspiration, and
- •skin disorders that could affect the result.
结局指标
主要结局
sensitivity, specificity and accuracy of Neuropad to detect DAN
时间窗: 1 year
sensitivity, specificity and accuracy of Neuropad to detect DAN
次要结局
未报告次要终点
研究者
Prof. Triantafyllos Didangelos
Professor of Internal Medicine and Diabetology
Aristotle University Of Thessaloniki