Why monitor glucose in critically ill patients?

Clinical studies have shown improved morbidity and mortality when glucose is controlled to < 180 mg/dL (10 mmol/L), as well when preventing hypoglycemic events or excessive glucose variably. However, studies have also shown that good glycemic control is difficult to achieve. It is posited that this difficulty could be related to inaccuracy of readings, uncalibrated instruments, lack of trending data, etc. The OptiScanner® 5000 is designed to automatically measure glucose and deliver trending information without the burden of calibration or additional resources to help clinicians achieve the right glucose control.

What data is available showing the accuracy of current methods to measure glucose in the ICU?

A sample of key clinical studies on measuring glucose can be found in the Clinical Benefits section of the website.

How does the OptiScanner measure glucose?

Unlike enzymatic-based systems that measure glucose from whole blood and use a standard calculation to convert to a plasma equivalent, the OptiScanner 5000 Glucose Monitoring System measures glucose directly from a plasma sample. The OptiScanner has an integrated spectrometer that uses mid-infrared wavelength light to detect glucose in blood plasma. Glucose concentration in a centrifuged sample of whole blood is then calculated using an algorithm that accounts for multiple interferents.

What is the target patient population for the OptiScanner?

Critically ill patients frequently suffer from stress-induced hyperglycemia, glycemic variability or hypoglycemia which has been associated with increased morbidity and mortality in both diabetic and non-diabetic patients. The OptiScanner 5000, which directly measures plasma glucose levels using an integrated blood centrifuge and spectrometer, automatically measures and trends glucose levels every 15 minutes, delivering an early warning system that supports proactive intervention.

What is the clinical evidence supporting the OptiScanner 5000?

The OptiScanner Glucose Monitoring System has been the subject of multiple clinical studies in critically ill patients. Its performance has been shown in 11 human studies which included 667 patients and 10,419 paired data points. Learn more.

Why is the OptiScanner the only system that requires no calibration?

The OptiScanner does not use reagents, which depend on blood enzymatic reaction to oxidize glucose and release electrons. This methodology requires frequent calibration – at least once per shift. Instead, the OptiScanner uses an infrared optical measurement based on the spectrum of glucose.

The OptiScanner is calibrated during the manufacturing process and maintenance calibration is conducted annually. The signal integrity is assessed with every reading by splitting the beam into two; one is used to measure the sample and the other verifies the strength of the signal.

Why is OptiScan the only company pursuing a non-reagent based product?

Reagent systems represent a technology that can be very specific to an analyte (i.e. glucose); however, they require extensive calibration. OptiScan Biomedical chose to develop a more sophisticated technology because of the strong benefit of eliminating calibration, as well as the potential to expand the core technology to identify additional analytes from the same sample of blood.

What is unique about OptiScan’s proprietary patient connector?

The proprietary connector ensures that there are no dead spaces, providing a smooth transition between the disposable unit and the patient’s IV. This seamless connection with the distal port of any vascular access line eliminates the need for heparin delivery to the patient. Heparin poses a risk to ICU patients due its narrow therapeutic index, increased risk for bleeding and potential for heparin-induced thrombocytopenia.

How is the system used?

The OptiScan 5000 combines a plasma-based measurement approach with the convenience of real-time bedside monitoring. The system draws a small amount of patient blood (only consuming 0.1 mL per draw) every 15 minutes, separates the blood plasma in a micro-centrifuge, and then transports the plasma to be read by a mid-range infrared spectrometer. A proprietary algorithm automatically adjusts for interferences and within a few minutes of the blood draw, a reading is displayed on the front of the OptiScanner. The OptiScanner uses a disposable, single-patient-use cartridge containing the fluid pathway through which the blood is sampled, stored, processed and analyzed. One cartridge can be used for the monitoring of a single patient for up to three days.

What vascular access points are needed?

The OptiScanner is designed to connect to the proximal port of a vascular access line. CVCs are the most commonly used access points in the ICU and tend to remain patent. Please contact OptiScanner for an updated list of vascular access catheters that have been tested for compatibility with the OptiScanner system. Hospital protocols to manage vascular access patency should be followed.

Can I connect the OptiScanner to an arterial line?

Not at this time.

How long can the system be used with a single patient?

A single cartridge can be used to monitor a single patient for up to 72 hours.

What is the reportable range of the OptiScanner 5000?

40 to 400 mg/dL (2.22 to 22.20 mmol/L)

How much blood is used by the system?

< 0.2 mL / sample; < 15 mL / day.

How much saline is sent back to the patient?

5 mL / hour; <300 mL / day.

Can you adjust the system to provide test readings hourly versus every 15 minutes?

Because the rate of change for a sick patient can be very rapid, OptiScan believes more frequent trending information is important. The volume of blood used is miniscule.

What data output is possible with the system?

Data can be printed using a USB port or exported using HL7. Notes can be inserted for inclusion in patient records and/or printouts.

Can OptiScanner readings be displayed on other patient monitoring devices?

Yes, the system supports standard HL7 protocol.

With space at a premium in ICUs, why is the OptiScanner relatively larger than other devices?

The OptiScanner was designed to be space neutral. It is equipped with two poles for saline/meds and mounting infusion pumps.

How will you measure future analytes?

OptiScan Biomedical is currently in the process of expanding the OptiScanner platform to provide hospitals and healthcare providers with a cost-effective single source that automates trend monitoring of a suite of metabolic and hemodynamic analytes.

Will the OptiScanner be integrated with insulin delivery systems?

The OptiScanner represents a platform technology that could be expanded in the future; however, current priorities are focused on expanding analytes.

Is the OptiScanner system CE Marked?

The OptiScanner 5000 CE Mark was obtained in September, 2011. The OptiScanner 6000 CE Mark was obtained in January, 2017.

Where is the product available for sale?

Currently the OptiScanner 5000 is only available in Italy. Assessment continues of other countries, with increased distribution expected in the near future.

Who is your distributor in Italy?

Voden Medical in Milan, Italy. Learn more.

When will the OptiScanner be available in the U.S.?

In the U.S., the device is an investigational device and will be for sale when FDA clearance is obtained. In April 2014, the company enrolled its first patient in a pivotal, multi-center Investigational Device Exemption (IDE) clinical study of the OptiScanner 5000.