NCT05771090已完成不适用
First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes: a Single-arm Pilot Study
DCB Research AG2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Characteristics of volatile organic compound (VOC) signals measured by the Sokru device
研究概览
简要总结
The primary aim of this clinical study is to find signal characteristics of VOCs detected by Sokru device during fasting, insulin injection and after glucose intake and to find the association with blood glucose variation in variant states of glycemia and hypoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •T1D with MDI or CSII therapy >1 year
- •Age 18 - 50 (inclusive)
- •Caucasian ethnicity
- •BMI between 18.5 and 24.9 kg/m2 (inclusive)
- •Usage of a continuous glucose monitoring (CGM)
排除标准
- •Pregnancy or breastfeeding
- •History of cardiovascular diseases
- •Diabetes-related comorbidities
- •HbA1c >9 %
- •Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
- •Known sensitivity to Latex
- •Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
结局指标
主要结局
Characteristics of volatile organic compound (VOC) signals measured by the Sokru device
时间窗: During the study procedure (approximately 5 hours)
The primary outcome are changes in VOC signals measured by the Sokru at low glucose levels (below 3.0 -3.9 mmol/L) or during the time when the blood glucose level is decreasing (from 10 and 3.9 mmol/L).
次要结局
- Blood glucose concentration(During the study procedure (approximately 5 hours))
- Heart rate(During the study procedure (approximately 5 hours))
- Oxygen saturation(During the study procedure (approximately 5 hours))
- Volatile Organic Compound Signals(During the study procedure (approximately 5 hours))
- Time of onset of subjective symptoms of hypoglycemia(During the study procedure (approximately 5 hours))
研究者
研究点 (2)
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