Critical IllnessICONS-ICUNCT07088549
Intermittent Versus Continuous Glucose Monitoring in Intensive Care Unit
A study testing Continuous glucose monitoring in people with Critical Illness and Hyperglycaemia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Hyperglycaemia, Hypoglycaemia
- What is being tested?
- Continuous glucose monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- admission to the level 3 ICU
- two consecutive blood glucose measurements > 10.0 mmol/L
- intravenous insulin therapy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
University Medical Center Ljubljana
Ljubljana
Peter Radsel, MD, PhD, + 386 1 522 9513, peter.radsel@kclj.si
Milica Lukic, MD
About this study
Official title: Effect of Continuous Interstitial Glucose Monitoring on Glycaemic Targets and Clinical Outcomes in Critically Ill
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.
Read the detailed description
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.
- Conditions
- Critical Illness, Hyperglycaemia, Hypoglycaemia
- Being tested
- Continuous glucose monitoring, Control Arm - standard of care
- Keywords
- continuous glucose monitoring, icu
- Medical subject headings
- Critical Illness, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
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 careDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| CGM monitoring | Active comparator | DexcomG7 continuous glucose monitor Receives: Device: Continuous glucose monitoring |
| Standard of care | Active comparator | Radiometer ABL800 blood glucose measurement Receives: Diagnostic Test: Control Arm - standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range 7,8 - 10,0 mmol/l
Percentage of time within recommended glucose range
Measured: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
Secondary outcomes (5)
Mean glucose levels
Measured: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
Glycemic variability
assessed by the coefficient of variation (CV) and standard glucose variation
Measured: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
Vasopressor inotropic score
estimated amount of vasopressor support, daily calculated with the Vasoactive Inotropic Score (VIS): minimum 0 - 5 points (low doses), maximum > 45 points (highest doses)
Measured: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
Hospital acquired infections
pneumonia, bloodstream infections, urinary infections
Measured: from the enrollment until hospital discharge, approximately 30 days
Acute renal failure
defined by AKIN (acute kidney injury) classification
Measured: from the enrollment until hospital discharge, approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Radsel, University Medical Centre Ljubljana
- Investigators
- Milica Lukic, MD, Study chair, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088549
- Sponsor's protocol ID
- ICONS-ICU
- Acronym
- ICONS-ICU
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Interstitial Glucose Monitoring on Glycaemic Targets and Clinical Outcomes in Critically Ill
- ClinicalTrials.gov ID
- NCT07088549
- Acronym / sponsor ID
- ICONS-ICU / ICONS-ICU
- Conditions
- Critical Illness, Hyperglycaemia, Hypoglycaemia
- Keywords
- continuous glucose monitoring, icu
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM monitoring | Active comparator | Device: Continuous glucose monitoringDexcomG7 continuous glucose monitor |
| Standard of care | Active comparator | Diagnostic Test: Control Arm - standard of careRadiometer ABL800 blood glucose measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years
- admission to the level 3 ICU
- two consecutive blood glucose measurements > 10.0 mmol/L
- intravenous insulin therapy
Key exclusion criteria (8 listed)
- expected ICU stay < 48 hours
- pregnancy
- type 1 diabetes
- diabetic emergencies (DKA, DAHS)
- severe skin disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoringIntravenous 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. | Device | CGM monitoring |
| Control Arm - standard of careIntravenous 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. | Diagnostic test | Standard of care |
Primary outcome
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
5 secondary outcomes
Mean glucose levels
Time frame: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
Glycemic variability
Time frame: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
Vasopressor inotropic score
Time frame: from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
Hospital acquired infections
Time frame: from the enrollment until hospital discharge, approximately 30 days
Acute renal failure
Time frame: from the enrollment until hospital discharge, approximately 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Milica Lukic, MD study chair
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring in people with Critical Illness and Hyperglycaemia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milica Lukic, MD (+386 1 522 7283, milica.lukic@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.