Multicenter Observational Study of the First-Generation Intravenous Blood Glucose Monitoring System in Hospitalized Patients

Abstract

Background: Current methods of blood glucose (BG) monitoring and insulin delivery are labor intensive and commonly fail to achieve the desired level of BG control. There is great clinical need in the hospital for a user-friendly bedside device that can automatically monitor the concentration of BG safely, accurately, frequently, and reliably. Methods: A 100-patient observation study was conducted at 6 US hospitals to evaluate the first generation of the Intravenous Blood Glucose (IVBG) System (Edwards Lifesciences LLC & Dexcom Inc). Device safety, accuracy, and reliability were assessed. A research nurse sampled blood from a vascular catheter every 4 hours for ≤ 72 hours and BG concentration was measured using the YSI 2300 STAT Plus Analyzer (YSI Life Sciences). The IVBG measurements were compared to YSI measurements to calculate point accuracy. Results: The IVBG systems logged more than 5500 hours of operation in 100 critical care patients without causing infection or inflammation of a vein. A total of 44135 IVBG measurements were performed in 100 patients with 30231 measurements from the subset of 75 patients used for accuracy analysis. In all, 996 IVBG measurements were time-matched with reference YSI measurements. These pairs had a mean absolute difference (MAD) of 11.61 mg/dl, a mean absolute relative difference (MARD) of 8.23%, 93% met 15/20% accuracy defined by International Organization for Standardization 15197:2003 standard, and 93.2% were in zone A of the Clarke error grid. The IVBG sensors were exposed to more than 200 different medications with no observable effect on accuracy. Conclusions: The IVBG system is an automated and user-friendly glucose monitoring system that provides accurate and frequent BG measurements with great potential to improve the safety and efficacy of insulin therapy and BG control in the hospital, potentially leading to improved clinical outcomes.

Continuous glucose monitoring in the ICU: clinical considerations and consensus

“… As each new study is published, we learn more about how current systems can be improved. For example, a recent study reporting on the safety, accuracy, and reliability of an intravenous blood glucose system demonstrated that more than half of the sensors inserted had to be removed before the end of the planned 72-hour study period [ 59 ]. Similarly in a RCT comparing the use of subcutaneous CGM with frequent point-of-care measurements, only 177 of the 1954 patients initially screened were finally included [ 60 ].…”

Point-of-care testing in diabetes management

“…The first-generation intravenous CGMS was evaluated in a multicenter observational study, in 100 critically-ill patients (43). The authors concluded that it was easy to set up and use, attached to a peripheral venous catheter.…”

“…Of the intravenous glucose monitoring measurements, 93% met the 2003 ISO Standards for accura- cy. Frequent and accurate POC blood glucose testing may improve the safety and efficacy of insulin therapy and blood glucose control in hospitalized patients (43). A randomized controlled trial compared subcutaneous CGMS with frequent POC measurements in 156 critically ill patients (42).…”

Vascular Glucose Sensor Symposium

“…Obstruction of venous blood flow by thrombus may cause reaspiration of flush solution and a preanalytical dilution error. [112][113][114][115] The OptiScanner® (OptiScan, Inc, Hayward, CA, USA ) is CE Mark approved for monitoring the concentration of plasma glucose in blood sampled from the proximal port of a CVC every 15 minutes for 72 hours. The CGMS automatically transports a small sample of blood from the CVC to a bedside monitor that contains a centrifuge, spectrometer, and data display.…”

“…Obstruction of venous blood flow by thrombus may cause reaspiration of flush solution and a preanalytical dilution error. 112-115…”