NCT05851469已完成不适用
An Explorative, Non-randomized, Open-label, In-clinic Study, Investigating the Performance of a Novel Non-invasive Glucose Monitoring Device Using a New Guided Calibration Model
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical performance
研究概览
简要总结
This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject ≥18 years.
- •Subject with type 2 diabetes.
- •Signed informed consent form (ICF).
排除标准
- •Individual treated with intensified insulin treatment.
- •Sodium, Potassium. Creatinine, eGFR, and ALAT (more than three times the upper limit of normal range).
- •Clinically relevant anaemia or thrombocytopenia.
- •Infection with hepatitis B, C or HIV (if subject participates in subprotocol 1).
- •Intake of anticoagulant medication (with the exception of acetylsalicylic acid, ASS 100).
- •For female subjects: Pregnancy or breastfeeding or lack of a negative pregnancy test (except in case of menopause, sterilization, or hysterectomy).
- •Subjects not able to understand and read local language.
- •Cognitive impairment, or in investigator's opinion, subject is not able to follow instructions provided and as specified in the clinical investigation plan (CIP).
- •Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease).
- •Skin changes, tattoos, or diseases on right thenar (measurement site).
- •Reduced circulation in right hand evaluated by Allen's test.
- •Known allergy to medical grade alcohol.
- •Haemodialysis.
- •Topical administration of glucocorticoids at the right hand for the past 7 days or during the study period.
- •Any disorder, which in the investigator's opinion, might jeopardise subject's safety or compliance with the CIP.
- •Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g., mental, or visual incapacity, language barriers, alcohol or drug abuse.
- •Dependency from the sponsor or the clinical investigator (e.g., co-workers of the sponsor, the study site, and/ or their families).
- •Subjects currently participating in another study.
研究组 & 干预措施
RSP-26-01
Experimental
干预措施: Prototype 0.5 (Device)
RSP-26-02
Experimental
干预措施: Prototype 0.5 (Device)
结局指标
主要结局
Clinical performance
时间窗: 2 days
Repeated measurements of blood sugar, to cover the diurnal variation, with the non-invasive examination device, and compare the result with blood drawn capillary and venous
次要结局
- Adverse events(4 days)
研究者
研究点 (1)
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