Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. (DREAM-ICU)

May 20, 2026 updated by: Marek Protuš, Institute for Clinical and Experimental Medicine

Determining the Reliability and Accuracy of the Dexcom G7 Continuous Glucose Monitoring System in the ICU

Main objective:

The goal is to to determine the accuracy of Dexcom G7 Continuous glucose monitor system in critically ill patients, undergoing major abdominal surgery and solid organ transplantation, in the intensive care unit.

On admission to the intensive care unit or at the end of surgery, two Dexcom G7 sensors are placed in the infraclavicular position.

Sensor number 1 will be blinded and will only be active when paired with the receiver, without the ability to monitor glucose levels.

Sensor number 2 is used for continuous glucose monitoring and can be used to adjust the insulin dose.

Patients will wear the continuous glucose monitoring sensor for a maximum of 10 days, including the time spent in the intensive care unit and the immediate care unit. The study will not interfere with any usual care clinical workflows.

Calibration is only performed on an unblinded sensor. The reference method for calibration is the glucose from the blood glucose meter.

Calibrate on the first day of monitoring: 4 times a day after approximately 6 hours, or if the blood glucose reading from the blood glucose meter is not within the estimated error range of the continuous glucose monitor (difference greater than 1,5mmol/L).

Calibration on days 2 and 3 of monitoring: once in the morning, or when the meter's glucose reading is not within the estimated error range of the continuous glucose monitoring (difference greater than 1,5mmol/L) On subsequent days when the blood glucose meter reading is not within the estimated error range of continuous glucose monitoring (difference greater than 1,5mmol/L).

Hypothesis:

  • Ho: No difference in mean absolute relative difference (MARD) between calibrated and non-calibrated sensors.
  • Ha: Calibrated sensors have lower mean absolute relative difference (δ = 4%, SD = 5%).

Further objectives:

To evaluate further aspects regarding the Dexcom G7 continuous glucose monitor system's performance in the intensive care unit (ICU), particularly in terms of sensitivity and specificity to detect hypo- and hyperglycaemic events, data availability, device deficiencies and safety.

To identify predictive factors of the accuracy of the Dexcom G7 continuous glucose monitor system in critically ill patients in the ICU.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Design:

  • Each intensive care unit patient wears two sensors (calibrated + non-calibrated).
  • 4 glucose measurements/day × 6 days = 24 measurements/subject.
  • Sequential Organ Failure Assessment (SOFA) score recorded daily.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Prague, Czechia
        • Recruiting
        • Institute of Clinical and Experimental Medice
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or over
  • Intensive care unit admission
  • Requiring blood glucose monitoring for insulin therapy

Exclusion Criteria:

  • High-dose ascorbic acid or acetaminophen > 4g/day
  • Physical or mental health condition precluding continuous wear of the continuous glucose monitor, as judged by the physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open labeled CGM
Additional calibrations performed on CGM device during monitoring period
Device: Continuous glucose monitor
Continuous measurement of glucose from subcutaneous tissue
Sham Comparator: Control labeled CGM
No additional calibrations performed on CGM device during monitoring period
Device: Continuous glucose monitor
Continuous measurement of glucose from subcutaneous tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculate overall mean absolute relative difference between arms
Time Frame: From enrolment to discharge from ICU care or up-to day 10
Analyse the difference in mean absolute relative difference (MARD) of Dexcom G7 continuous glucose monitor between calibrated and uncalibrated sensor, in patients undergoing major abdominal surgery and solid organ transplantation.
From enrolment to discharge from ICU care or up-to day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy metrics
Time Frame: From enrolment to discharge from ICU care or up-to day 10

To evaluate further aspects regarding the Dexcom G7 continuous glucose monitor system's performance in the intensive care unit (ICU), particularly in terms of sensitivity and specificity to detect hypo- and hyperglycaemic events, data availability, device deficiencies and safety.

To identify predictive factors of the accuracy of the Dexcom G7 continuous glucose monitor system in critically ill patients in the ICU.
From enrolment to discharge from ICU care or up-to day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical and Experimental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 14, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-25-71
  • ID Project No. LX22NPO5104 (Other Grant/Funding Number: MH CZ-DRO (Institute for Clinical and Experimental Medicine-IKEM, IN 00023001)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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