Determining the Reliability and Accuracy of the Dexcom G7 Continuous Glucose Monitoring System in the ICU

What this Trial Is About

Researchers are evaluating the accuracy of the Dexcom G7 Continuous Glucose Monitoring (CGM) system in critically ill patients who are undergoing major abdominal surgeries or solid organ transplantation in the intensive care unit (ICU). The study focuses on patients who require blood glucose monitoring for insulin therapy and aims to determine how well the CGM system measures glucose levels compared to standard blood glucose meters. The study also aims to assess the device's ability to detect low and high blood sugar events and to identify factors that affect its accuracy in this ICU setting. Each patient in the ICU will wear two Dexcom G7 sensors placed in the infraclavicular position: one sensor will be blinded and inactive for glucose monitoring, while the other will actively monitor glucose levels and can be used to adjust insulin doses. Calibration of the active sensor is performed using blood glucose meter readings at specified intervals during the first three days and as needed thereafter. Patients will wear the sensors for up to 10 days, covering their stay in the ICU and immediate care unit, with no interference in standard clinical care. Participants will have glucose measurements taken four times a day for up to six days, along with daily recording of their Sequential Organ Failure Assessment (SOFA) score. Researchers will calculate the mean absolute relative difference (MARD) between the calibrated and non-calibrated sensors as the primary outcome. Additional accuracy metrics, sensor performance data, and safety will also be monitored throughout the study period, which lasts until ICU discharge or up to 10 days.

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.