Accuracy and Safety of a Novel Intravenous Continuous Glucose Monitoring System in Patients Admitted to a Cardiothoracic ICU: A Pilot Trial

Abstract

Background:

In critically ill patients, deviations in glucose levels may lead to significant harm to individuals with and without diabetes. Although subcutaneous continuous glucose monitoring (scCGM) has proven beneficial for patients in standard wards, its implementation in critical care settings has been limited due to multiple factors, potentially resulting in inadequate glycemic control and consequent complications; here, intravascular systems (ivCGM) have the potential to overcome these limitations.

Method:

This single-center, open-label study, aimed to assess accuracy and safety of a novel intravenous glucose monitoring system in patients with and without diabetes, admitted to a cardiothoracic surgery intensive care unit. Glucose levels were continuously monitored for up to 72 hours in the predefined glucose range of 20 to 400 mg/dL and compared with arterial glucose measurements (blood gas analyses [BGAs]).

Results:

Twenty-eight participants successfully completed the study, allowing the collection of 1224 ivCGM/BGA data pairs. Due to the exploratory nature of the trial in this vulnerable patient population, no data pairs <70 mg/dL and limited data pairs in level 2 hyperglycemia (>250 mg/dL) were observed. A mean absolute relative difference (MARD) of 8.7 ± 7.8% was found, whereas the mean absolute difference (MAD) for values <100 mg/dL was 3.3 ± 2.7 mg/dL. In participants with diabetes (N = 8,332 ivCGM/BGA data pairs), MARD was 9.6 ± 8.1%. Diabetes Technology Society Error Grid (DTSEG) analysis revealed that all data pairs fell within clinically acceptable zones A and B. Notably, no serious adverse events associated with the device were observed during the study.

Conclusion:

The present findings indicate that the investigated intravenous glucose monitoring system provides accurate glucose monitoring and demonstrates its safety in critical care settings. This technology offers promise for improved glycemic management in critically ill patients, particularly those with diabetes, potentially mitigating the associated risks and complications.