Intermittent Versus Continuous Glucose Monitoring in Intensive Care Unit

NCT07088549 | Not Yet Recruiting FDA Device

• 1 other identifier: ICONS-ICU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Hyperglycaemia; Hypoglycaemia

Keywords

continuous glucose monitoring; icu

Outcome Measures

Primary Outcomes (1)

• Time in range 7,8 - 10,0 mmol/l

  Percentage of time within recommended glucose range

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

Secondary Outcomes (5)

• Mean glucose levels

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

• Glycemic variability

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

• Vasopressor inotropic score

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

• Hospital acquired infections

  from the enrollment until hospital discharge, approximately 30 days

• Acute renal failure

  from the enrollment until hospital discharge, approximately 30 days

Other Outcomes (3)

• Hospital mortality

  from the enrollment and before hospital discharge, approximately 30 days

• Time above range (level 1 and 2)

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

• Time below range (level 1 and 2)

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

Study Arms (2)

CGM monitoring

ACTIVE COMPARATOR

DexcomG7 continuous glucose monitor

Device: Continuous glucose monitoring

Standard of care

ACTIVE COMPARATOR

Radiometer ABL800 blood glucose measurement

Diagnostic Test: Control Arm - standard of care

Interventions

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.

CGM monitoring

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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Critical Illness; Hyperglycemia; Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Milica Lukic, MD

  University Medical Centre Ljubljana

  STUDY CHAIR

Central Study Contacts

Milica Lukic, MD

CONTACT

+386 1 522 7283; milica.lukic@kclj.si

Alenka Golicnik, MD PhD

CONTACT

+386 1 522 9516; alenka.golicnik@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Department of Internal Intensive Care Medicine

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 28, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Start date: 1 month after publication End date: no end date
• Access Criteria: IPD and supporting information will be stored and shared in the Repository of the University of Ljubljana, Slovenia. Access will be provided on request by the Repository.

Locations

SL (1)