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ICU pilot trial

The GlySure continuous glucose monitoring system has been tested in over 160 intensive care patients to date. A snapshot of the latest results and a copy of data published at ISICEM 2012 and WFSICCM 2013 can be found below.  The graphs compare GlySure's CGM system with results from intermittent blood glucose measurement on a YSI analyser. Over two years of human use trials in the challenging environment of the ICU have confirmed the sensor's performance and the ability of Glysure to provide a new dimension in glycemic control.  Results to date show that the Glysure CGM system is capable of monitoring throughout the length of a patient's stay in the ICU.  These developments are part of the ongoing programme which will lead to formal submissions to the regulatory bodies in the USA and EMEA.

Variability - control requires visibility

Recent research has demonstrated an association between increased glycemic variability and mortality. The case below demonstrates the challenge of identifying and controlling variability with intermittent monitoring. Note the sharp peak in glucose between 11 and 13 hours that is missed by the intermittent testing.

A graph of 50 hours of the GlySure ICU pilot trial data, showing accurate CGM compared with lab analysis.

 

Immediate feedback on therapeutic interventions

This is a patient with sepsis being managed in an ICU. Not only does the sensor correlate well with the comparative readings from the laboratory analyser (eye-icon), but when the patient receives dextrose infusions right at the beginning of the monitoring period, and again at approximately 7 hours, the sensor swiftly responds to show the increase in blood glucose attributable to the infusion. In the absence of a continuous trace, reliance on the intermittent points at 6 and 10 hours might be interpreted as little change in the overall downward trend.

The graph compares the picture presented by CGM versus intermittent lab analysis.

 

ICU Patients are unpredictable

This is a CABG patient with well controlled glucose on the first day post surgery. In this example the sensor shows very close correlation with the intermittent laboratory readings (eye-icon) and without the benefit of the continuous trace (dash-icon) a caregiver might decide to reduce the frequency of blood glucose assays around the 24 hour point. The continuous signal clearly indicates a steep rise in blood glucose at around this time which the next intermittent reading confirms.

A graph showing CGM readings demonstrating how rapidly and unpredictably glucose levels can change

As with all these cases the sensor continues to track throughout the patients stay in the intensive care facility

ISICEM 2012 abstract

See GlySure's published data showing performance on medical and surgical intensive care patients throughout their length of stay in ICU.

View the abstract

WFSICCM 2013 Poster

At the World Federation of Societies of Intensive and Critical Care Medicine Glysure presented the results of a post cardiac surgery ICU patient trial.

View the poster

Clinical demand

Reduction in severe hypoglycemia.

These devices offer the promise of a reduction in severe hypoglycemia, glycemic variability and the nursing work burden, and will probably become a cornerstone of SEGC.

Read more