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Intermittent Versus Continuous Glucose Monitoring in Intensive Care Unit

NCT07088549 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-28

No results posted yet for this study

Summary

Glucose control is an important part of supportive care for critically ill patients. Achieving optimal glucose control in such situations is challenging due to frequent fluctuations in blood glucose levels. These changes are often difficult to detect because the monitoring procedures are complex and require significant staff involvement, frequent blood draws, and consequent blood loss. Continuous glucose monitoring (CGM) is a simple and minimally invasive technique that has been approved and increasingly used by people with diabetes mellitus. However, its effectiveness in terms of glucose control management and accuracy in conditions with severe organ dysfunction has not been established.

The goal of this study is to assess the performance of CGM-guided glucose control in comparison to the standard glucose monitoring procedure. Additionally, the accuracy of CGM measurements under critical conditions will be evaluated against the standard of care.

Conditions

  • Critical Illness
  • Hyperglycaemia
  • Hypoglycaemia

Interventions

DEVICE

Continuous glucose monitoring

Intravenous insulin therapy will be guided by interstitial glucose measurements using DexcomG7 continuous glucose monitor. Confirmatory blood glucose tests will be performed daily. In extreme clinical conditions (post-resuscitation, pH \< 7.20, severe hypoxia, severe haemodynamic compromise), confirmatory blood tests will be performed in 2 hour intervals until clinical improvement.

DIAGNOSTIC_TEST

Control Arm - standard of care

Intravenous insulin dosing will be guided according to blood glucose measurements using RadiometerABL800 (standard of care). DexcomG7 continuous glucose monitor will be applied in blinded mode for interstitial glucose monitoring for later CGM metrics and comparison analysis.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Milica Lukic, MD · University Medical Centre Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07088549 on ClinicalTrials.gov