DRKS00009604已完成未知
Standardized Evaluation of SPIDIMAn Glucose Monitoring System under routine environmental conditions - SPIDIMAN-02
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie0 个研究点目标入组 12 人开始时间: 2015年12月17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
- 12
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 64 Years（—）
- 性别
- All
入选标准
- •Informed consent obtained after being advised of the nature of the study;
- •Male or female aged =18 years;
- •Type 1 diabetes for at least 6 months according to the WHO definition;
- •Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months;
- •Body Mass Index (BMI) < 35 kg/m²;
- •Willing and able to wear 4 CGM devices for the duration of the study and undergo all study procedures;
- •HbA1c = 86 mmol/mol
排除标准
- •Any disease or condition which the investigator feels would interfere with the trial or the safety of the subject
- •Female of childbearing potential who is pregnant, breast-feeding or intend to become
- •pregnant or is not using adequate contraceptive methods
- •Any mental condition rendering the subject incapable of giving his consent
- •Subject is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
- •Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject’s safety or successful
- •participation in the study.
- •Subject is actively enrolled in another clinical trial
- •Subject donated blood in the last 3 months
研究者
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