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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Reliability and Accuracy of the Dexcom G7 Continuous Glucose Monitoring System in the ICU
- ClinicalTrials.gov ID
- NCT07611721
- Acronym / sponsor ID
- DREAM-ICU / G-25-71
- Conditions
- CGM, Intensive Care (ICU), Liver Transplant Surgery, Solid Organ Transplantation, Major Abdominal Surgeries, Diabetes (Insulin-requiring, Type 1 or Type 2)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open labeled CGM | Active comparator | Device: Continuous glucose monitorAdditional calibrations performed on CGM device during monitoring period |
| Control labeled CGM | Sham comparator | Device: Continuous glucose monitorNo additional calibrations performed on CGM device during monitoring period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or over
- Intensive care unit admission
- Requiring blood glucose monitoring for insulin therapy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitorContinuous measurement of glucose from subcutaneous tissue | Device | Control labeled CGM, Open labeled CGM |
Primary outcome
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.
1 secondary outcome
Accuracy metrics
Time frame: From enrolment to discharge from ICU care or up-to day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek Protus, MD (+420602278062, marek.protus@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculate overall mean absolute relative difference between arms (time frame: From enrolment to discharge from ICU care or up-to day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.