A Study to Investigate the Function, Safety and Tolerability of a Transdermal Continuous Glucose Monitoring System in Diabetic Patients (type 1 and 2) for a Period of 28 Days
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Short and mid term performance of the transdermal CGM sensor determined as MARD
研究概览
简要总结
Single-centre, open label (unblinded). A maximum of 48 patients will be enrolled in 4 Cohorts of 10 patients and 2 potential replacements each. Diabetic patients (type 1 and 2). Duration up to 11 weeks: up to 6 weeks of screening phase (42 days); 4 weeks of treatment/measurement phase (28 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.
The eligibility of the patient is determined in up to two steps, a screening (see inclusion criteria) and in case of women of childbearing potential a urine pregnancy test at the day of sensor insertion (independent of any re-screening). Women of childbearing potential are only enrolled after a negative outcome of the urine pregnancy test. 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: Up to 6 weeks (42 days), 1 visit
Insertion/Measurement phase: Up to 4 weeks (28 days), up to 6 in-house measurement visits
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Negative urine pregnancy test immediately before sensor insertion (only women of childbearing potential)
- •Signed written Informed Consent
排除标准
- •Inability to follow the protocol schedule
- •Participating in another clinical trial
- •Pregnant or lactating females, , including positive urine pregnancy test immediately before sensor insertion
- •Any known hypersensitivity to any of the products used in the study, including preservatives etc. Especially hypersensitivity against legumes
- •Tattoos at the abdominal or upper arm skin area where the fiber sensor is supposed to be placed
- •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 addiction
- •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
Short and mid term performance of the transdermal CGM sensor determined as MARD
时间窗: 0, 3, 7, 14, 21 and 28 days
Mean absolute relative difference (MARD) of FiberSense system to blood glucose
Incidence of adverse events
时间窗: 0, 3, 7,14, 21, 28 and 35-38 days
Assessment of adverse events and local tolerability occurred during the study
次要结局
- Stability of the blood glucose to fluorescence correlation(0, 3, 7, 14, 21 and 28 days)
- Changes in blood glucose to fluorescence lag time over a period of up to 28 days(0, 3, 7, 14, 21 and 28 days)
- Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements(0, 3, 7, 14, 21 and 28 days)
- Signal-to-noise ratio(0, 3, 7, 14, 21 and 28 days)
- Signal drift(0, 3, 7, 14, 21 and 28 days)
- User satisfaction assessed by the Likert scale(35-38 days)