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

NCT ID: NCT04910841

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperglycemia Hypotension Shock, Septic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Connect

Group Type EXPERIMENTAL

CGM GUARDIAN 2

Intervention Type DEVICE

continuous blood glucose monitoring system

Interventions

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CGM GUARDIAN 2

continuous blood glucose monitoring system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florent BILGER

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Florent BILGER

Role: CONTACT

[email protected]
492035510 ext. +33

Facility Contacts

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Florent BILGER

Role: primary

[email protected]
492035510 ext. +33

Other Identifiers

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19-AOI-10

Identifier Type: -

Identifier Source: org_study_id

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