NCT04910841

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hyperglycemia
• Hypotension
• Shock, Septic

Interventions

Type	Name	Description
DEVICE	CGM GUARDIAN 2	continuous blood glucose monitoring system

Timeline

• Start date: 2023-09-11
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2021-06-02
• Last updated: 2023-10-10

Locations

1 site across 1 country: France