Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine (GALI)
Primary Purpose
Hyperglycemia, Hypotension, Shock, Septic
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CGM GUARDIAN 2
Sponsored by
About this trial
This is an interventional other trial for Hyperglycemia
Eligibility Criteria
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
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Connect
Arm Description
Outcomes
Primary Outcome Measures
Glucose level
Secondary Outcome Measures
Full Information
NCT ID
NCT04910841
First Posted
May 27, 2021
Last Updated
October 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04910841
Brief Title
Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine
Acronym
GALI
Official Title
Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Hypotension, Shock, Septic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Connect
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CGM GUARDIAN 2
Intervention Description
continuous blood glucose monitoring system
Primary Outcome Measure Information:
Title
Glucose level
Time Frame
Day 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florent BILGER
Phone
492035510
Ext
+33
Email
bilger.f@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florent BILGER
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florent BILGER
Phone
492035510
Ext
+33
Email
bilger.f@chu-nice.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine
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