Comparative Measurement of Microcirculation and Other Parameters With the Vital USA VitalDetect™ in Patients With Diabetes Mellitus Type 1 and Type 2 Versus Healthy Paricipants
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Accuracy of the Vital USA VitalDetectTM for assessment of microcirculation (in AU)
研究概览
简要总结
The purpose of this clinical study is to optimize the measurement algorithm of the Vital USA VitalDetectTM in measuring the microcirculating blood flow. Further optimization and finally the demonstration of the performance of the VitalDetectTM non-invasive monitoring biosensor in monitoring glucose, and heart rate in patients with type 1 and type 2 diabetes and healthy participants, when operated according to the instructions for use.
详细描述
The study procedures will be the same for all three groups during the single visit. In all groups of participants, the Vital USA VitalDetect™ will be individually introduced and assigned. During the experimental study visit, microcirculating blood flow (MBF), heart rate, and SpO2 will be measured using the Vital USA VitalDetect™ at 2 time points in between approx. 15 min. MBF will be measured in parallel by use of the LEA Medizintechnik O2C also using a finger on the same hand. The YSI glucose measurements will be employed to generate a robust algorithm for glucose measurements using the VitalDetect™. Parallel measurements of the heart rate and the SpO2 using a patient monitor (Edan iM8b) will be compared to the Vital USA VitalDetect™ device readings. Venous blood will be drawn from every subject to determine proinsulin, insulin and HbA1c values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 1 or Type 2 diabetic or healthy subject (25 Type 1, 25 Type 2, 50 healthy subjects)
- •Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
- •18 years old and above;
- •Anatomically suitable finger in discretion of the investigator
排除标准
- •Does not meet inclusion criteria;
- •Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars, tattoos;
- •Pregnancy;
- •Nursing mothers;
- •Any skin scratch(es), damage, over dry, long nails on the measured finger;
- •Unsuitable finger with the device might be excluded if recognized during the trial;
- •Medication containing nitrates
结局指标
主要结局
Accuracy of the Vital USA VitalDetectTM for assessment of microcirculation (in AU)
时间窗: 30 minutes
Accuracy and performance of Vital USA VitalDetectTM for assessment of microcirculation (in AU) by measuring microcirculation using the VitalDetectTM in comparison to the LEA Medizintechnik O2C device.
次要结局
未报告次要终点