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RecruitingNCT04910841GALIUpdated May 22, 2026

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

An interventional study of CGM GUARDIAN 2 in Hyperglycemia, Hypotension and Shock, Septic, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperglycemia
  • Hypotension
  • Shock, Septic
03

In context

Hyperglycemia

800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.

This study's planned enrollment of 55 is close to the median of 50 across 620 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient in septic shock
  • Arterial hypotension requiring noradrenaline
  • Hyperglycaemia requiring insulin therapy

Exclusion criteria

Exclusion Criteria:

  • Patients under guardianship, curatorship or deprived of liberty
  • Pregnant or breastfeeding women
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    Connect

    Device: CGM GUARDIAN 2

Interventions

  • DeviceCGM GUARDIAN 2

    continuous blood glucose monitoring system

06

What researchers measure

Primary outcomes

  1. Glucose level

    Time frame: Day 6

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04910841
Responsible party
Sponsor
First posted
Jun 2, 2021
Start date
Sep 11, 2023
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
May 22, 2026

Study contacts

Florent BILGER
Contact
bilger.f@chu-nice.fr
492035510 ext. +33
Florent BILGER
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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