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

Not Applicable

Recruiting

• Conditions: Shock, Septic; Hypotension; Hyperglycemia
• Interventions: Device: CGM GUARDIAN 2

• Registration Number: NCT04910841
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-02
• Status Verified: 2023-08
• Study Start: 2023-09-11
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Connect	CGM GUARDIAN 2	-

Primary Outcome Measures

Name	Time	Method
Glucose level	Day 6

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France