NL-OMON36537尚未招募不适用
Standardized procedure for the assessment of new-to-market continuous glucose monitoring systems. - SPACE Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •aged 18 years or above
- •diagnosed with Type 1 diabetes mellitus at least 6 months according to the WHO definition
- •Body Mass Index (BMI) <35 kg/m²
- •willing and able to wear a CGM device for the duration of the study and undergo all study
排除标准
- •Patient is pregnant, or breast feeding during the period of the study.
- •Patient 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 patient*s safety or successful participation in the study.
- •Patient is actively enrolled in another clinical trial or took part in a study within 30 days
研究者
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