DRKS00011488已完成1 期
Standardized Evaluation of the SPIDIMAN Glucose Monitoring Systems under Routine Environmental Conditions using Prospective Calibration. - SPIDIMAN 03
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie0 个研究点目标入组 4 人开始时间: 2017年1月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
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 100 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.
- •Diagnosis of Diabetes Mellitus Type 1 for at least 6 months according to WHO criteria.
- •Treatment with multiple daily injections (MDI) or continous subcutaneous insulin infusion for at least 3 months.
- •Body Mass Index (BMI) < 35kg/m²
- •Willing and able to wear 4 SPIDIMAN Glucosemonitoring Systems for the duration of the 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 participation in 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.
- •Inability of subjects to understand subject information.
- •Inability of subject to sign the subject informed consent form
- •Intake of any medication that significantly impacts glucose metabolism (oral steroids).
- •Subject donated blood in the last 3 months
- •Intake of paracetamol while participatiin the the clinical study.
- •Severe medical or psychological condition or chronic condition that in the opinion of the investigator would compromise the subject's safety or successful participation in the clinical study.
研究者
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