Exploration of Continuous Glucose Monitoring on the Intensive Care Unit

Not Applicable

Not yet recruiting

• Conditions: Hypoglycemia, Hyperglycemia

• Registration Number: NCT06645873
• Lead Sponsor: Kim Kamphorst

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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Discrepancy glucose CGM - POC	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.	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.
Variation discrepancy across patient-related factors	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.	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).

Secondary Outcome Measures

Name	Time	Method
Adverse events	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.	The number of reported adverse events, such as infections, bleeding, and decubitus, linked to the continuous glucose sensor (Dexcom G7)
Number of missed hypo- and hypreglycemia episodes	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.	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.
Delay in detection hypo- or hyperglycemia episodes	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.	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.
Insertion CGM: time till reliable data and lasting time	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.	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.
Impact radiologic procedure	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days, but only if a radiologic procedure is performed	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.
Location GCM sensor	From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.	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