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| ID | Type | Description | Link |
|---|---|---|---|
| ID Project No. LX22NPO5104 | Other Grant/Funding Number | MH CZ-DRO (Institute for Clinical and Experimental Medicine-IKEM, IN 00023001 |
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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:
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.
Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open labeled CGM | Active Comparator | Additional calibrations performed on CGM device during monitoring period |
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| Control labeled CGM | Sham Comparator | No additional calibrations performed on CGM device during monitoring period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitor | Device | Continuous measurement of glucose from subcutaneous tissue |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marek Protus, MD | Contact | +420602278062 | marek.protus@ikem.cz | |
| Alexander Macek, MD | Contact | +421910631876 | alexander.macek@ikem.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical and Experimental Medice | Recruiting | Prague | Czechia |
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| From enrolment to discharge from ICU care or up-to day 10 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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