An Exploratory Study to Assess the Accuracy in the Normo- to Hyperglycemic Range of the Spiden Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM), in Trial Participants with Type 1 or Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia
研究概览
简要总结
This is a single-centre, multiple cohort, open study.
详细描述
The study will include 5 cohorts. After each cohort, optimisation of the Spiden Clinical Demo 2.0 system and machine learning models may be pursued before the next cohort is started. Trial participants with type 1 or type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female trial participant with clinically diagnosed type 1 or type 2 diabetes for at least 1 year.
- •Age between 18 and 65 years, both inclusive.
- •Treated with insulin and/or oral antidiabetic drugs (OADs; type 2 only), multiple dosing insulin therapy (MDI), continuous subcutaneous insulin infusion (CSII) or a hybrid closed loop system.
排除标准
- •Known or suspected hypersensitivity to any of the components of the Liom Clinical Demo 2.
- •Trial participant with any injury, infection, atypical skin condition (e.g., hyperkeratosis, hyperpigmentation) of or tattoo on the wrists.
- •Presence or history of a cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.
研究组 & 干预措施
Interventional arm
Induction of hyperglycaemia and hypoglcemia states and measurements of transcutaneous spectral data with the investigational device and reference blood glucose values measured by Super GL and Freestyle Libre 3.
干预措施: Clinical Demo 2.0 (Device)
结局指标
主要结局
Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia
时间窗: The data is collected during the study procedure (up to 5 hours)
Spectroscopic research platform and associated computational models will be used to detect and track glucose changes noninvasively and transcutaneously in dynamic states of glycaemia
次要结局
未报告次要终点