Institut Fuer Diabetes-Technologie Surveillance Program for Blood Glucose Monitoring Systems in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Analysis of system accuracy based on ISO 15197
研究概览
简要总结
Assessment of the system accuracy of different blood glucose monitoring systems available in Europe
详细描述
A variety of blood glucose monitoring systems (BGMS) are available on the European market. For many of these BGMS, the system accuracy is unknown or it has not yet been assessed in manufacturer-independent studies. The IDT surveillance program aims at assessing the system accuracy of different BGMS that are available in Europe in a manufacturer-independent, investigator-initiated study. The initial study will cover 18 BGMS from 18 different manufacturers. Per BGMS, one test strip lot will be assessed based on procedures stated in the international standard ISO 15197:2013 / EN ISO 15197:2015.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes
- •Signed informed consent form
- •Minimum age of 18 years
- •ubjects are legally competent and capable to understand character, meaning and consequences of the study.
- •If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy:
- •Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
- •Signature of subjects to document consent with these procedures on informed consent form.
排除标准
- •Pregnancy or lactation period
- •Severe acute disease (at the study physician's discretion)
- •Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
- •Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- •Being unable to give informed consent
- •< 18 years
- •Legally incompetent
- •Being committed to an institution (e.g. psychiatric clinic)
- •Language barriers potentially compromising an adequate compliance with study procedures
- •Dependent on investigator or sponsor
- •If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from:
- •Coronary heart disease
- •Condition after myocardial infarction
- •Condition after cerebral events
- •Peripheral arterial occlusive disease
- •Hypoglycemia unawareness
结局指标
主要结局
Analysis of system accuracy based on ISO 15197
时间窗: For each subject, the experimental phase has an expected duration of up to 6 hours
Assessment of the analytical measurement performance of 18 blood glucose montoring systems based on procedures defined in ISO 15197
次要结局
未报告次要终点