Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Accuracy of the GlucoMenDay
研究概览
简要总结
Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped with the GlucoMen®Day system, over up to 100 hours observation after implantation of the microdialysis probe. Different meal/hypo procedures will be performed at the study centre.
详细描述
This is a monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, who will be equipped with the GlucoMen®Day system.
Each subject will be investigated for up to 100 hours after implantation of the microdialysis probe.
In order to verify the clinical effectiveness of the GlucoMenDay the subjects will be asked to perform a total of six self testing measurements per day using the GlucoCard G-Meter according to the following scheme:
- before breakfast
- before lunch
- 60-120 minutes after lunch
- before dinner
- 60-120 minutes after dinner
- at 3 AM
Subjects will be asked to come to the research facility every day to obtain a venous blood sample and to check system functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Established diagnosis of type-1-diabetes
- •Ability to provide informed consent
- •Age 18-75 years
排除标准
- •Subjects under anti-coagulant treatments
- •Alcoholism
- •Body mass index (BMI) > 32 kg/m2
- •Inability to adhere to the protocol or to attend the required follow- up visits and tests
- •Diseases or conditions of the abdominal wall which, in the opinion of Clinician might contraindicate the insertion of the hypodermic needle into the subcutaneous tissue
- •Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
- •Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
- •Subjects currently participating in a clinical study
- •Pregnancy or breastfeeding
结局指标
主要结局
Accuracy of the GlucoMenDay
时间窗: 1 week
Assessed by methods such as the Clarke Error Grid Analysis (EGA), CG-EGA, MARD, MAD
次要结局
- Safety of the GlucoMenDay System(1 week)
研究者
Pieber Thomas, MD
MD, Prof. of Medicine
Medical University of Graz