Manual vs. Automated moNitoring Accuracy of GlucosE.

13-aug-2012:
ntroduction:

Hyperglycemia, hypoglycemia, and glycemic variability are all associated with morbidity and mortality of critically ill patients. Blood glucose control with insulin prevents hyperglycemia but is associated with a higher incidence of hypoglycemia and may not decrease blood glucose variability. Implementation strategies of blood glucose control with insulin in critically ill patients have mainly used manually operated whole blood portable glucose meters, which suffer from a variety of error sources that can put these patients at risk for insulin over– and/or under–dosing. Continuous or near–continuous blood glucose monitoring devices have the potential to improve the safety (i.e., prevention of hypoglycemia) and effectiveness (i.e., obtain a higher percent of values in the therapeutic range and decrease blood glucose variability) of blood glucose control with insulin in critically ill patients. OptiScan Biomedical Corporation has developed a near–continuous glucose monitoring technology, called the OptiScanner, which provides accurate blood glucose measurements at a wide range of glucose concentrations.

Hypotheses:

The OptiScanner provides accurate blood glucose levels in critically ill patients.

Study design:

This is an investigator–initiated observational study comparing the OptiScanner with 3 standard blood glucose meters in critically ill patients subjected to glucose control with insulin.

Objectives:

The objective of this study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients when compared to a reference YSI 2300 STAT Plus (Yellow Springs Instruments) reading. The study will also compare readings taken from the OptiScanner to whole blood glucose measurements by the RAPIDlab 1265 (Siemens).

Study population:

Patients admitted to the intensive care units of the Academic Medical Center, Amsterdam or the Gelre Hospitals Apeldoorn, the Netherlands, with an expected length of stay ≥ 3 days.

Intervention:

The OptiScanner is a point of care device for measurement of blood glucose as well as other analytes. It works by measuring the optical infrared absorption of glucose in a very small amount of plasma. Blood is drawn into the measurement engine of the device, a mid–infrared spectrometer, on a near–continuous basis.

Main study parameters/endpoints:

1. Glucose prediction error, defined as the results of the YSI versus the OptiScanner, using arterial blood;

2. Clarke Error Grid analysis showing the percentage of paired data values falling within each zone between the results of the YSI versus the OptiScanner, using arterial blood;

3. Linearity between the results of the YSI versus the OptiScanner, using arterial blood.

Secondary study parameters/endpoints:

1. Glucose prediction error, defined as the results of the OptiScanner, versus the RAPIDlab, using arterial blood;

2. Clarke Error Grid analysis showing the percentage of paired data values falling within each zone between the results of the OptiScanner versus the RAPIDlab, using arterial blood;

3. Linearity between the results of the OptiScanner versus the RAPIDlab, using arterial blood.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

The OptiScanner has been tested and validated in a number of pre–clinical and clinical studies, and has been found to be both safe and accurate. Potential benefits include reduced risk of hypoglycemia, and decreased glycemic variability.

The OptiScanner provides accurate blood glucose levels in critically ill patients.

13-aug-2012:
Every day (for a maximum of 3 days), 12 blood samples (total of 36) will be drawn to be compared to the OptiScanner measurements.

13-aug-2012:
The OptiScanner is a point of care device for measurement of blood glucose as well as other analytes. It works by measuring the optical infrared absorption of glucose in a very small amount of plasma. Blood is drawn into the measurement engine of the device, a mid–infrared spectrometer, on a near–continuous basis.



Next to this, 12 blood samples per day will be drawn to be compared with measurements with a ysi 2300 stat plus, and RAPIDlab blood gas analyser.