DRKS00014229已完成未知
Investigation of the influence of the partial pressure of oxygen in capillary blood on SMBG measurements - IDT-1348-I
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IDT); Dr. med. Guido Freckmann0 个研究点目标入组 60 人开始时间: 2018年3月7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
- 60
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
- •Type 1 diabetes, type 2 diabetes or subjects without diabetes; Signed informed consent form; Subjects are legally competent and capable to understand character, meaning and consequences of the study; In order to ensure that capillary blood samples meet the requirements indicated in the manufacturer’s labelling, a physician will review the subjects’ anamnesis and medication and check for interfering substances indicated in the manufacturer’s labelling; and the hematocrit value of each subject will be checked to be within the range indicated in the manufacturer’s labelling
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
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