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Intermittent Versus Continuous Glucose Monitoring in Intensive Care Unit

ConditionsCritical IllnessHyperglycaemiaHypoglycaemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥ 18 years

admission to the level 3 ICU

two consecutive blood glucose measurements > 10.0 mmol/L

intravenous insulin therapy

Disqualifiers

expected ICU stay < 48 hours

pregnancy

type 1 diabetes

diabetic emergencies (DKA, DAHS)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: CGM monitoringActive comparator 1 intervention
Group B: Standard of careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Percentage of time within recommended glucose range

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

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

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

Time frame
from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
3

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)

Time frame
from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
4

Hospital acquired infections

pneumonia, bloodstream infections, urinary infections

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

Other outcomes

1

Hospital mortality

death during hospitalization

Time frame
from the enrollment and before hospital discharge, approximately 30 days
2

Time above range (level 1 and 2)

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

Time frame
from the enrollment until completion of the continuous glucose monitoring (up to 10 days)
3

Time below range (level 1 and 2)

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Centre Ljubljana

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: