跳至主要内容
临床试验/NCT04910841
NCT04910841招募中不适用

Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
1
主要终点
Glucose level

研究概览

简要总结

Glycemic imbalances are very common in shock patients admitted to intensive care units. A blood glucose control every 2 hours is routinely performed in patients requiring insulin therapy. In practice, we use a protocol and management software called "CPG" (Personalized Control of Blood Glucose). This involves taking capillary samples from the fingertips. In addition to the pain generated, local haematomas and sensitivity disorders have been described. Night-time sampling also leads to repeated awakenings. The "CGM GUARDIAN 2" system has been validated for the measurement of glucose in interstitial fluid in insulin-dependent diabetic patients. An electrode is placed on the patient's abdomen or arm for up to 6 days. This electrode consists of a needle that is inserted subcutaneously only during the placement. The sugar level is read using a sensor placed on the electrode and an insulin pump (which will not deliver therapy (for our study) and which will be used only as an information reader to know the glucose level and trends). Interstitial fluid is automatically drawn from the electrode every minute and averaged every 5 minutes.

This device has not yet been validated in resuscitation patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient in septic shock
  • Arterial hypotension requiring noradrenaline
  • Hyperglycaemia requiring insulin therapy

排除标准

  • Patients under guardianship, curatorship or deprived of liberty
  • Pregnant or breastfeeding women

研究组 & 干预措施

Connect

Experimental

干预措施: CGM GUARDIAN 2 (Device)

结局指标

主要结局

Glucose level

时间窗: Day 6

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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