Clinical trial NCT06645873: Exploration of Continuous Glucose Monitoring on the Intensive Care Unit
Official title: Comparison of Continuous Glucose Monitoring and Point-of-Care Measurements on the Intensive Care Unit: An Exploratory Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoglycemia, Hyperglycemia
Keywords: Intensive care units
insulin
Continuous Glucose Monitoring
Lead sponsor: Deventer Ziekenhuis
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
name: Pioneers in Healthcare
First posted: 2024-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Discrepancy glucose CGM - POC
timeFrame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
measure: Variation discrepancy across patient-related factors
timeFrame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Secondary outcomes:
measure: Adverse events
timeFrame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
measure: Number of missed hypo- and hypreglycemia episodes
timeFrame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
measure: Delay in detection hypo- or hyperglycemia episodes
timeFrame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
measure: Insertion CGM: time till reliable data and lasting time
timeFrame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
measure: Impact radiologic procedure
timeFrame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days, but only if a radiologic procedure is performed
measure: Location GCM sensor
timeFrame: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Zorggroep Twente Almelo
state: Overijssel
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
state: Overijssel
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
Study officials:
References: