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Recruiting Not applicable

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

NCT04910841 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-09-11
Last updated
2026-05-22

Condition(s) studied

HyperglycemiaHypotensionShock, Septic

Investigational drug(s) / intervention(s)

CGM GUARDIAN 2

CGM GUARDIAN 2: continuous blood glucose monitoring system

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Glucose level — Day 6

Trial sites (1)

FacilityCityRegionStatus
CHU de Nice Nice France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04910841 on ClinicalTrials.gov ↗ ← All trials in France