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NCT Number: NCT07088549

Intermittent Versus Continuous Glucose Monitoring in Intensive Care Unit

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.

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Key information

Conditions

Critical Illness Disease Attributes Glucose Metabolism Disorders Hyperglycaemia Hyperglycemia Hypoglycaemia Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Ljubljana

Ljubljana, Slovenia

Location contact

Alenka Golicnik, MD, PhD

SUB_INVESTIGATOR

Milica Lukic, MD

PRINCIPAL_INVESTIGATOR

Peter Radsel, MD, PhD

CONTACT

[email protected]

+ 386 1 522 9513

About this study

This study will be an investigator-initiated, non-commercial, prospective, single-center, parallel-group, randomized controlled trial. Critically ill patients with hyperglycemia requiring intravenous insulin therapy will be randomly assigned to two groups: an intervention group that will receive intravenous insulin therapy aided by continuous glucose monitoring (CGM) measurements and a control group that will receive intravenous insulin therapy guided by arterial blood glucose measurements (RadiometerABL800). Patients will be enrolled within 48 hours after ICU admission. Intravenous insulin dosing will be adjusted according to the in-house glycaemic management protocol. After enrollment, patients will be monitored for maximal 10 days (duration of the sensor) or until stopping intravenous insulin therapy, ICU discharge or death, whichever occurs first, if these events happen before the sensor duration ends.

The primary outcome of the study will be the proportion of time spent within the target range of 7.8-10.0 mmol/L. Secondary outcomes will include mean glucose levels and other CGM metrics, daily vasoactive-inotropic score calculation, hospital length of stay, hospital-acquired infections, and acute renal failure.

Additionally, an accuracy analysis in extreme clinical conditions (pH < 7.20, post-resuscitation, ECMO support, severe haemodynamic instability, hypoxia) will be performed by comparing CGM measurements measured by DexcomG7 with arterial blood glucose measurements (RadiometerABL800) from the electronic health record. Satisfaction of health-care personnel will be evaluated. Sensor-related complications will be monitored.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18 years
  • admission to the level 3 ICU
  • two consecutive blood glucose measurements > 10.0 mmol/L
  • intravenous insulin therapy

Exclusion criteria

  • expected ICU stay < 48 hours
  • pregnancy
  • type 1 diabetes
  • diabetic emergencies (DKA, DAHS)
  • severe skin disease
  • severe neutropenia (< 0.5 × 10^9/L)
  • severe coagulopathy (thrombocytes < 20 × 10^9/L)
  • manufacturer-defined conditions (hydroxyurea use, acetaminophen more than 4 g daily)

Treatment and study plan

Continuous glucose monitoring

Device

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.

Control Arm - standard of care

Diagnostic Test

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.

Primary outcomes

  1. Time in range 7,8 - 10,0 mmol/l

    Time frame: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)

    Percentage of time within recommended glucose range

Secondary outcomes

  1. Mean glucose levels

    Time frame: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)

  2. Glycemic variability

    Time frame: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)

    assessed by the coefficient of variation (CV) and standard glucose variation

  3. Vasopressor inotropic score

    Time frame: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)

    estimated amount of vasopressor support, daily calculated with the Vasoactive Inotropic Score (VIS): minimum 0 - 5 points (low doses), maximum > 45 points (highest doses)

  4. Hospital acquired infections

    Time frame: from the enrollment until hospital discharge, approximately 30 days

    pneumonia, bloodstream infections, urinary infections

  5. Acute renal failure

    Time frame: from the enrollment until hospital discharge, approximately 30 days

    defined by AKIN (acute kidney injury) classification

Other outcomes

  1. Hospital mortality

    Time frame: from the enrollment and before hospital discharge, approximately 30 days

    death during hospitalization

  2. Time above range (level 1 and 2)

    Time frame: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)

    percentage of time above 10,1 - 13,9 mmol/l (level 1) and above 13,9 mmol/l (level 2)

  3. Time below range (level 1 and 2)

    Time frame: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)

    percentage of time below 3,0 - 3,8 mmol/l (level 1) and below 3,0 mmol/l (level 2)

Study contacts

Contact information is provided by the study sponsor or research team.

Alenka Golicnik, MD PhD

CONTACT

[email protected]

+386 1 522 9516

Milica Lukic, MD

CONTACT

[email protected]

+386 1 522 7283

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Effect of Continuous Interstitial Glucose Monitoring on Glycaemic Targets and Clinical Outcomes in Critically Ill

Acronym: ICONS-ICU

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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