Intermittent Versus Continuous Glucose Monitoring in Intensive Care Unit

NCT ID: NCT07088549

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

CGM monitoring

DexcomG7 continuous glucose monitor

Group Type: ACTIVE_COMPARATOR

Continuous glucose monitoring

Intervention Type: 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.

Standard of care

Radiometer ABL800 blood glucose measurement

Group Type: ACTIVE_COMPARATOR

Control Arm - standard of care

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Peter Radsel

Head of Clinical Department of Internal Intensive Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Milica Lukic, MD

Role: STUDY_CHAIR

University Medical Centre Ljubljana

Locations

University Medical Center Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Central Contacts

Milica Lukic, MD

Role: CONTACT

milica.lukic@kclj.si

+386 1 522 7283

Alenka Golicnik, MD PhD

Role: CONTACT

alenka.golicnik@kclj.si

+386 1 522 9516

Facility Contacts

Peter Radsel, MD, PhD

Role: primary

peter.radsel@kclj.si

+ 386 1 522 9513

Other Identifiers

ICONS-ICU

Identifier Type: -

Identifier Source: org_study_id