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.

NCT07611721 | Recruiting

• 2 other identifiers: G-25-71ID Project No. LX22NPO5104
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Abdominal Surgeries; CGM; Intensive Care (ICU); Liver Transplant Surgery; Solid Organ Transplantation; Diabetes (Insulin-requiring, Type 1 or Type 2)

Outcome Measures

Primary Outcomes (1)

• Calculate overall mean absolute relative difference between arms

  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 Outcomes (1)

• Accuracy metrics

  From enrolment to discharge from ICU care or up-to day 10

Study Arms (2)

Open labeled CGM

ACTIVE COMPARATOR

Additional calibrations performed on CGM device during monitoring period

Device: Continuous glucose monitor

Control labeled CGM

SHAM COMPARATOR

No additional calibrations performed on CGM device during monitoring period

Device: Continuous glucose monitor

Interventions

Continuous glucose monitor DEVICE

Continuous measurement of glucose from subcutaneous tissue

Control labeled CGM; Open labeled CGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute of Clinical and Experimental Medice

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Marek Protus, MD

CONTACT

+420602278062; marek.protus@ikem.cz

Alexander Macek, MD

CONTACT

+421910631876; alexander.macek@ikem.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Department of Anaesthesiology, resuscitation and intensive medicine

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-04

Locations

CZ (1)