Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04910841

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

Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-05-22

55

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Glycemic imbalances frequently occur in patients with septic shock admitted to intensive care units. Researchers are evaluating the feasibility of using the CGM GUARDIAN 2 system to measure glucose levels in interstitial fluid in these critically ill patients. This device has been validated in insulin-dependent diabetic patients but not yet tested in intensive care settings. The study focuses on patients with arterial hypotension requiring noradrenaline and hyperglycemia needing insulin therapy. The study involves using the CGM GUARDIAN 2 device, which includes an electrode placed on the patient's abdomen or arm for up to six days. This electrode has a subcutaneous needle inserted only during placement. A sensor attached to the electrode reads glucose levels every minute, averaging the data every five minutes. The device is linked to an insulin pump that does not deliver therapy but serves as an information reader to monitor glucose trends. Participants will have their glucose levels closely monitored throughout the study, with the primary outcome being the glucose level measured on day six. The study includes routine blood glucose measurements every two hours using fingertip capillary samples to compare with the device readings. The research team will assess glucose control feasibility, device performance, and patient comfort during intensive care. The total study duration for each participant is at least six days, with ongoing monitoring of glucose levels and related parameters.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient in septic shock
  • Arterial hypotension requiring noradrenaline
  • Hyperglycaemia requiring insulin therapy
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 6 days

Participants use the CGM GUARDIAN 2 continuous blood glucose monitoring system during intensive care.

Daily monitoring visits during device use

Trial Site Locations

Total: 1 location

1

CHU de Nice

Nice, France

Actively Recruiting

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Research Team

F

Florent BILGER

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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