Exploration of Continuous Glucose Monitoring on the Intensive Care Unit

NCT ID: NCT06645873

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-17
• Study Completion Date: 2025-09-30

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.

Conditions

Hypoglycemia, Hyperglycemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Continuous glucose monitoring

Group Type: EXPERIMENTAL

Continuous glucose monitoring (CGM) device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Pioneers in Healthcare

UNKNOWN

Sponsor Role: collaborator

Kim Kamphorst

OTHER

Sponsor Role: lead

Responsible Party

Kim Kamphorst

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zorggroep Twente Almelo

Almelo, Overijssel, Netherlands

Deventer Ziekenhuis

Deventer, Overijssel, Netherlands

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Countries

Netherlands

Other Identifiers

NL87243.100.24

Identifier Type: -

Identifier Source: org_study_id