33rd Annual ISICEM Conference Symposium Features Breakthrough Clinical Results Supporting OptiScanner™ from OptiScan Biomedical
Industry Thought-Leaders Highlight Paradigm-Shifting Potential of Automated, Bedside Glucose Monitoring System for Critically Ill Patients
BRUSSELS, Belgium, March 21, 2013 – OptiScan Biomedical Corporation, a developer of innovative continuous glucose monitoring systems for use in intensive care units (ICU), today announced that the OptiScanner™, the company’s first-of-its-kind automated, bedside glucose monitoring system, was the focus of a special symposium at the 33rd International Symposium on Intensive Care and Emergency Medicine (ISICEM) being held this week in Brussels, Belgium. The symposium featured several industry thought-leaders in the area of glycemic control who discussed data from multiple recently completed clinical trials that supported the role of the OptiScanner as an enhanced, next-generation glucose monitoring platform for critically ill ICU patients. Additionally, the speakers highlighted several unique attributes of the OptiScanner that position the technology with critical competitive advantages over current glucose monitoring systems for optimizing glucose monitoring and guiding the appropriate delivery of insulin in the ICU.
James Krinsley, M.D., FCCM, director of critical care at Stamford Hospital at the Columbia University College of Physicians and Surgeons, discussed the clinical findings from a recently published nine-center, 23-ICU study that involved approximately 45,000 patients on four continents. Data from the study demonstrated the separate and important roles that all three domains of glycemic control (hyperglycemia, hypoglycemia and glycemic variability) play in mortality risks for ICU patients. Interestingly, the findings demonstrated that hyperglycemia, hypoglycemia and glycemic variability each had its own unique impact on patient mortality, with these impacts also differing significantly for diabetics versus non-diabetics.
These new detailed findings led Dr. Krinsley to suggest that the careful monitoring and consideration of all three glycemic control domains would be essential for effective intensive insulin therapy in critically ill patients. This would require significantly increasing the frequency of glucose monitoring with Dr. Krinsley suggesting a goal of at least 24 measurements per day. However, he indicated that current monitoring technologies such as meters and blood gas analyzers were not capable of testing patients in the accurate, frequent and timely manner required to achieve this standard.
In discussing the requirements for a next-generation monitoring technology that can meet the needs related to glycemic control in the ICU, Dr. Krinsley highlighted a number of the novel technology advantages of the OptiScanner platform. These included the use of mid-infrared spectroscopy to measure glucose, allowing for the display of glucose levels every 15 minutes without requiring any calibration of the system over a full year. He also cited the OptiScanner as the only glucose monitor that measures in plasma and referenced its ability to measure glucose with just approximately 0.1 ml of non-diluted blood. Overall, these capabilities position the OptiScanner to handle the increased workload required to meet the new suggested testing parameters outlined by Dr. Krinsley based on his clinical research.
As part of the symposium, Serge Brimioulle, M.D., Ph.D., department of intensive care at Erasme University Hospital in Brussels, Belgium, provided the first public presentation of clinical data from OptiScan’s recently completed MANAGE II Study (Manual vs. Automated moNitoring Accuracy of GlucosE). Data presented included 24-hour results from a total of 31 critically ill medical and surgical ICU patients and demonstrated an excellent accuracy profile for the OptiScanner. Using Clarke Error Grid (CEG) analysis, 98 percent of the OptiScanner patient test results appeared in the grid’s A zone with only 2 percent falling in the B zone. CEG is considered the gold standard for assessing the accuracy of glucose measurement devices, with the grid’s A zone representing results that are the most clinically accurate and results in B zone considered clinically acceptable. These findings support and slightly improve upon similar CEG analysis data from the company’s MANAGE I Study, presented at last year’s ISICEM conference. According to Dr. Brimioulle, one important advantage of the OptiScanner’s ability to provide frequent and highly accurate glucose readings is the enabling of earlier interventions when either glucose values are changing rapidly or when staffing is limited, particularly at night.
In the symposium’s final presentation, Michele Umbrello, M.D., staff intensivist, San Paolo University Hospital in Milan, Italy, presented the findings of a study conducted by his team comparing the OptiScanner to central lab glucose measurements and a Radiometer ABL blood gas analyzer, which involved 28 measurements per day over three days. Key findings included:
- While OptiScanner and Radiometer devices were equivalent in accuracy, the OptiScanner provided values every 15 minutes at a far lower comparable cost with no need for external validation.
- One particular patient case suggested the ability of the OptiScanner to document a sudden spike in glucose that resulted in earlier identification of sepsis than otherwise achievable.
- Dr. Umbrello concluded that the OptiScanner allowed for earlier detection of insulin resistance, and was potentially able to detect metabolic derangements that normally would go undiagnosed. This potential to avoid hypoglycemia should allow patients to experience fewer adverse events.
Commenting on the OptiScanner, Dr. Umbrello stated, “We think that with the continuous monitoring of glucose in the most severe, stressed patients, we can have an earlier detection of what goes on in patients, with the possibility of detecting derangements that we otherwise wouldn’t have realized.”
“This symposium represented a uniquely valuable event for OptiScan as it provided a single venue for the presentation of such a broad range of both clinical data and customer experiences related to the OptiScanner. It was truly exciting to hear three of the world’s leading experts in this field provide such powerful and compelling cases for the advantages of our technology, as well as the system’s potential to be positioned as the next-generation platform of choice in this important area,” said Peter Rule, chairman and chief executive officer of OptiScan Biomedical.