DRKS00028604已完成未知
System accuracy evaluation of 4 blood glucose monitoring systems based on ISO 15197:2013 / EN ISO 15197:2015 - IfDT-2172(2)-AB
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)0 个研究点目标入组 113 人开始时间: 2022年3月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 113
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Signed informed consent form
- •- Subjects 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 if venous samples are needed
- •- Severe acute disease that compromises the subject’s capability to participate in the study (at the study physician’s discretion)
- •- Severe chronic disease with potential risk during the test procedures (at the study physician’s discretion)
- •- Medical relevant anemia
- •- Suspected lack of compliance
- •- Dependence on investigator or sponsor
- •- If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy:
- •- Pregnancy or lactation period
- •- Subjects with type 1 diabetes, suffering from
- •- Coronary heart disease
- •- Condition after myocardial infarction
- •- Condition after cerebral events
- •- Peripheral arterial occlusive disease
- •- Hypoglycemia unawareness
研究者
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