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NCT04910841 Clinical Trial

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

Hypotension Clinical Trial

— GALI  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04910841
Other study ID # 19-AOI-10
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 11, 2023
Est. completion date June 1, 2025

Study information
Verified date August 2023
Source Centre Hospitalier Universitaire de Nice
Contact Florent BILGER
Phone 492035510
Email bilger.f@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 55
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• CGM GUARDIAN 2
continuous blood glucose monitoring system

Locations
Country Name City State
France CHU de Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glucose level Day 6
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