NCT04641650已完成不适用
FreeStyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System in Subjects With Diabetes on HemoDIALsis (FSL-DIAL Pilot Study)
Centre Hospitalier Saint Joseph Saint Luc de Lyon1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Difference between estimated Hba1c (or Glucose Management Index (GMI)) with FreeStyle Libre Pro sensor and laboratory Hba1c
研究概览
简要总结
Continuous monitoring of glucose with a FreeStyle Libre pro sensor in diabetic and dialysis patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes without any change in treatment in the last 3 months
- •Hemodialysis for > 3 months
- •Recent laboratory HbA1c (< 15 days)
排除标准
- •Patient does not show non-opposition
- •Skin allergy to the sensor
- •Sepsis / Acute anaemia
结局指标
主要结局
Difference between estimated Hba1c (or Glucose Management Index (GMI)) with FreeStyle Libre Pro sensor and laboratory Hba1c
时间窗: At sensor removal (day 14)
Comparison between estimated HbA1c with 14 days of CGM data and laboratory HbA1c (routine blood test in hemodialysis) in each subject
次要结局
- Time in glucose range(At sensor removal (day 14))
- Time with Glucose > 180 mg/dL(At sensor removal (day 14))
- Glucose total coefficient of variation (CV)(At sensor removal (day 14))
- Time with Glucose < 70mg/dL(At sensor removal (day 14))
研究者
研究点 (1)
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