CGMDREAM-ICUNCT07611721
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.
A study testing Continuous glucose monitor in people with CGM and Intensive Care (ICU), run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CGM, Intensive Care (ICU), Liver Transplant Surgery
- What is being tested?
- Continuous glucose monitor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteCzechia
- Study dates
- 14 Jan 2026to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or over
- Intensive care unit admission
- Requiring blood glucose monitoring for insulin therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Institute of Clinical and Experimental Medice
Prague
Marek Protus, MD, +420602278062, marek.protus@ikem.cz
Alexander Macek, MD, +421910631876, alexander.macek@ikem.cz
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- CGM, Intensive Care (ICU), Liver Transplant Surgery, Solid Organ Transplantation, Major Abdominal Surgeries, Diabetes (Insulin-requiring, Type 1 or Type 2)
- Being tested
- Continuous glucose monitor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitorDevice
Continuous measurement of glucose from subcutaneous tissue
| Study group | Role | What they receive |
|---|---|---|
| Open labeled CGM | Active comparator | Additional calibrations performed on CGM device during monitoring period Receives: Device: Continuous glucose monitor |
| Control labeled CGM | Sham comparator | No additional calibrations performed on CGM device during monitoring period Receives: Device: Continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolment to discharge from ICU care or up-to day 10
Secondary outcomes (1)
Accuracy metrics
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.
Measured: From enrolment to discharge from ICU care or up-to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start14 Jan 2026
- Primary completionSep 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CGMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marek Protuš, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611721
- Sponsor's protocol ID
- G-25-71
- Other IDs
- ID Project No. LX22NPO5104
- Acronym
- DREAM-ICU
- Status last verified
- Apr 2026
- First submitted
- 14 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No