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.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous glucose monitor.
- Who it may be relevant to
- Registry conditions: CGM, Intensive Care (ICU), Liver Transplant Surgery, Solid Organ Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Determining the Reliability and Accuracy of the Dexcom G7 Continuous Glucose Monitoring System in the ICU
Overview
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.
Interventions
- Device Continuous glucose monitor
Continuous measurement of glucose from subcutaneous tissue
Primary outcome measures
- Calculate overall mean absolute relative difference between arms [Time frame: From enrolment to discharge from ICU care or up-to day 10]
Secondary outcome measures (1)
- Accuracy metrics [Time frame: From enrolment to discharge from ICU care or up-to day 10]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Triple blind
- Primary purpose
- Device feasibility
Study locations
Czechia · 1 center
- Institute of Clinical and Experimental Medice — Prague
Identifiers
NCT: NCT07611721 · G-25-71 · ID Project No. LX22NPO5104