A Study to Investigate the Function, Safety and Tolerability of a Subcutaneous Continuous Glucose Monitoring System in Diabetic Patients (type 1 and 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Correlation between blood glucose and interstitial fluid (ISF) glucose concentration
研究概览
简要总结
Mono-centre, open label (unblinded). 8 patients + 2 potential replacements. Duration up to 9 weeks: up to 6 weeks screening (42 days), 2 weeks of treatment (14 days, depending on sensor functionality) and 1 week of follow up (7 days)
详细描述
This study is an investigational study, which will be conducted only at one site in Germany. The investigators, the patient and the sponsor will be unblinded.
As soon as the eligibility of the patient is confirmed the patient is enrolled. The screening results are valid up to 42 days. Within that time the first measurement visit including the insertion of the device should be performed. If the first measurement visit is delayed a re-screening has to be performed. Should the patient not pass the re-screening, the patient is considered as a screening failure and must be excluded.
The trial is structured into three phases, the screening/enrolment phase, the insertion/measurement phase and the follow-up phase.
Screening/Enrolment Phase: 6 weeks (42 days), 1 visit
Insertion/Measurement phase: Up to 2 weeks (14days), up to 6 measurement visits
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index within the range of 19-40 kg/m2, inclusive
- •Diabetes type 1 and 2
- •Females (if of childbearing potential) must agree to abstain from sexual intercourse or use reliable forms of contraception e.g. condom or diaphragm with spermicide or oral contraceptives to prevent pregnancy during the study
- •Signed written Informed Consent
排除标准
- •Inability to follow the protocol schedule
- •Participating in another clinical trial, if it is not a "non-investigational clinical study (NICS)
- •Pregnant or lactating females,
- •Any known hypersensitivity to any of the products used in the study, including preservatives etc.
- •Malignancies requiring therapy during the study
- •Severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study
- •Acute severe infection disease at the time of enrolment
- •Alcohol and/or drug abuses
- •Vulnerable patients (e.g. persons kept in detention)
- •Poorly controlled diabetes mellitus with hemoglobin A1C higher than 10%
结局指标
主要结局
Correlation between blood glucose and interstitial fluid (ISF) glucose concentration
时间窗: 6 measurements within 14 days
Mean absolute relative difference (MARD) of fluorescence sensor values and laboratory blood glucose values
Adverse event reporting
时间窗: 14 days
Incidence of reported ADE, with focus on number of SADE
次要结局
- Lag time(6 measurements within 14 days)
- Stability of measurements(6 measurements within 14 days)
- Signal drift(6 measurements within 14 days)
- Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements(6 measurements within 14 days)
- Signal to noise ratio(6 measurements within 14 days)
- Patient impression(after 14 days)