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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient in septic shock

• Arterial hypotension requiring noradrenaline

• Hyperglycaemia requiring insulin therapy

Locations
Other Locations
France
CHU de Nice
RECRUITING
Nice
Contact Information
Primary
Florent BILGER
bilger.f@chu-nice.fr
492035510
Time Frame
Start Date: 2023-09-11
Estimated Completion Date: 2026-09
Participants
Target number of participants: 55
Treatments
Experimental: Connect
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov