Exploration of Continuous Glucose Monitoring on the Intensive Care Unit (CGM-IC)

Comparison of Continuous Glucose Monitoring and Point-of-Care Measurements on the Intensive Care Unit: An Exploratory Study

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.

Study Overview

• Status: Completed
• Conditions: Hypoglycemia, Hyperglycemia
• Intervention / Treatment: Device: Continuous glucose monitoring (CGM) device

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Almelo, Overijssel, Netherlands, 7609 PP
      • Zorggroep Twente Almelo
    • Deventer, Overijssel, Netherlands, 7416SE
      • Deventer Ziekenhuis
    • Enschede, Overijssel, Netherlands, 7512 KZ
      • Medisch Spectrum Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous glucose monitoring	Device: Continuous glucose monitoring (CGM) device; All included study participants recieve a CGM sensor (Dexcom G7) to monitor blood glucose. The treatment team is blind for the CGM values; the gold standard for glucose control (POC interval measures) will be followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discrepancy glucose CGM - POC	Discrepancy between glucose levels (in mmol/L) measured with Continuous Glucose Monitoring (measured with the Dexcom G7 sensor) and Point-Of-Care (measured with the Accu-check) measurement in insulin-dependent Intensive Care Unit patients. The discrepancy is defined as the difference in absolute glucose levels in arterial blood samples.	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Variation discrepancy across patient-related factors	The variation of the potential difference in glucose levels (in mmol/L) between CGM (measured with the Dexcom G7 sensor) and POC (measured with the Accu-check) will be analyzed among the following patient-related factors: Age at the time of inclusion (in years). Body Mass Index (BMI) (in kg/m²). Gender (Male/Female). Comorbidities: Hypertension (Yes/No). Hypotension (Yes/No). Pre-existing diabetes (Yes/No). Edema (measured as weight gain in kg). Acidosis (pH value, continuous scale). Medication use: Corticosteroids (Yes/No). Inotropics (Yes/No and dosage in µg/kg/min). Vasopressors (Yes/No and dosage in µg/kg/min). APACHE II score (Scale). SOFA score (Scale). Reason for ICU admission (Categorical variable, e.g., sepsis, trauma, etc.). Length of ICU stay (in days). Duration of mechanical ventilation (in hours or days). Dialysis (Yes/No).	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	The number of reported adverse events, such as infections, bleeding, and decubitus, linked to the continuous glucose sensor (Dexcom G7)	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Number of missed hypo- and hypreglycemia episodes	The number and percentage of missed hypoglycemia episodes (defined as a glucose level < 4.0 mmol/L) and hyperglycemia episodes (defined as a glucose level > 10 mmol/L), as indicated by the continuous glucose monitoring (CGM) using the Dexcom G7 sensor, were not detected by point-of-care (POC) interval measurements with the Accu-Chek device.	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Delay in detection hypo- or hyperglycemia episodes	The time in minutes between the onset of hypoglycemia (defined as a glucose level < 4.0 mmol/L) or hyperglycemia (defined as a glucose level > 10 mmol/L) detected by the continuous glucose monitoring (CGM) using the Dexcom G7 sensor and its subsequent detection via point-of-care (POC) testing with the Accu-Chek device.	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Insertion CGM: time till reliable data and lasting time	The duration of time, in minutes, it takes for the CGM (Dexcom G7 sensor) to reliably measure the glucose (defined as MARD <14%) after the sensor is inserted. Duration of time, in hours, the CGM reliably measures the glucose (defined as MARD <14%) after the sensor is inserted.	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Impact radiologic procedure	The difference in discrepancies between glucose levels (in mmol/L) measured by continuous glucose monitoring (CGM) using the Dexcom G7 sensor and point-of-care (POC) testing with the Accu-Chek device following radiologic procedures (e.g., CT scans and X-rays) is evaluated. Discrepancy is defined as the difference in absolute glucose levels in arterial blood samples measured with the POC compared to the continuous glucose levels measured with the CGM.	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days, but only if a radiologic procedure is performed
Location GCM sensor	The difference in mean absolute relative difference (MARD) between glucose levels (in mmol/L) measured by continuous glucose monitoring (CGM) using the Dexcom G7 sensor and point-of-care (POC) testing with the Accu-Chek device is assessed when the CGM sensor is placed in the abdomen compared to the upper arm	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.

Collaborators and Investigators

• Sponsor: Kim Kamphorst
• Collaborators: DexCom, Inc.; Pioneers in Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; insulin; Intensive care units
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Nutritional and Metabolic Diseases; Hypoglycemia; Hyperglycemia; Insulin Resistance; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: NL87243.100.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are committed to sharing individual participant data (IPD) in accordance with established data-sharing principles. However, access to our IPD will only be granted upon formal request. Researchers interested in obtaining the data must submit a detailed request to the study's designated contact person. This request should include a thorough explanation of the intended use of the data, the research plan, and ethical considerations. Each request will be carefully evaluated based on the proposed study's merits and alignment with our data-sharing policies before a decision is made regarding data access.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes