Exploration of Continuous Glucose Monitoring on the Intensive Care Unit

Last updated: October 2, 2025
Sponsor: Kim Kamphorst
Overall Status: Completed

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Hormone Deficiencies

Hypertriglyceridemia

Treatment

Continuous glucose monitoring (CGM) device

Clinical Study ID

NCT06645873
NL87243.100.24
  • Ages > 18
  • All Genders

Study Summary

Both hyperglycemia and hypoglycemia in patients at the intensive care unit (ICU) are strongly associated with increased morbidity and mortality. Accurate and timely measurements of glucose levels in this population are therefore crucial. Continuous glucose monitoring (CGM) appears promising for this purpose, but it is not yet used in the ICU due to insufficient knowledge about its reliability in critically ill patients. The aim of this study is to investigate the discrepancy between CGM and point-of-care measurements in ICU patients and whether this discrepancy is consistent across all ICU patient groups/characteristics.

This study investigates whether continuous glucose monitoring can be used in the intensive care setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients admitted to the ICU

  • Insulin-dependent as defined in local protocol

  • Age: ≥ 18 y

  • Expected length of stay in ICU more than 2 days

Exclusion

Exclusion Criteria:

  • Pregnancy

  • No informed consent

  • Therapeutic hypothermia (less than 34 degrees celsius)

  • Platelet count less than 50,000/μL at time of inclusion

  • Use of hydroxyurea

  • Use of acetaminophen more than 4 g/day

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Continuous glucose monitoring (CGM) device
Phase:
Study Start date:
December 17, 2024
Estimated Completion Date:
September 30, 2025

Study Description

Hyperglycemia is present in up to 50% of patients admitted to an intensive care unit (ICU) and is strongly associated with elevated morbidity and mortality rates. Therefore, it is important to monitor glucose levels closely. In the ICU, glucose monitoring primarily relies on periodic measurements through point-of-care (POC) meters, which involve invasive blood sampling from venous or arterial lines. To maintain blood glucose concentrations within acceptable ranges, a possible improvement is continuous glucose monitoring (CGM), which is now used to manage glucose levels in diabetic patients in general settings and has shown significant benefits. Studies on the use of CGM in the ICU setting are limited. If CGM reliably measures glucose levels in critically ill patients, it enables earlier intervention and might help to predict hypo- or hyperglycemia based on measurement trends.

Objective: To investigate the discrepancy between CGM and POC measurements in insulin-dependent ICU patients and to study whether these potential discrepancies between CGM and POC vary across patient-related factors, like gender, age, comorbidities, medication use, disease severity scores, treatment in ICU.

Study design: Prospective, multi-centre, single-arm intervention, exploratory study

Intervention: All study participants receive one CGM sensor to monitor glucose levels. A second CGM sensor will only be applied if the first CGM sensor needed to be replaced within 8 days after insertion. The measurements will be blinded to all except the research team.

Connect with a study center

  • Zorggroep Twente Almelo

    Almelo, Overijssel 7609 PP
    Netherlands

    Site Not Available

  • Deventer Ziekenhuis

    Deventer, Overijssel 7416SE
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede, Overijssel 7512 KZ
    Netherlands

    Site Not Available

  • Zorggroep Twente Almelo

    Almelo 2759887, Overijssel 2748838 7609 PP
    Netherlands

    Site Not Available

  • Deventer Ziekenhuis

    Deventer 2756987, Overijssel 2748838 7416SE
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede 2756071, Overijssel 2748838 7512 KZ
    Netherlands

    Site Not Available

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