Medical Device Daily Contributing Writer
ZICHRON YAAKOV, Israel - Another flight of the imagination is now in the intensive care unit (ICU). For the first time, not only noninvasive, but continuous accurate measurement of glucose has been demonstrated in an acute-care setting.
Results of the study using the noninvasive glucose monitoring system developed by OrSense (Nes Ziona, Israel) were presented this week at the 26th International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels by principal investigator Pierre Singer.
Tight glycemic control has been shown to significantly improve patient care and survival, while it shortens hospitalization time, and reduces staff workload. But, with no means to measure glucose in real time, this goal has evaded clinicians and clinical researchers.
“The ability to maintain normal levels of glucose in acute-care patients is currently one of the most important goals of intensive care units,“ said Singer, director of the general intensive care unit of Rabin Medical Center (Petah-Tikva, Israel).
“Recent studies show that preventing hyperglycemia with insulin substantially improves outcome of critical illness and reduces mortality in critical care patients,“ he said. “And that maintenance of normal glucose levels can shorten ICU stay, significantly reducing healthcare expense and improving quality of life for patients. Based on our study, the OrSense noninvasive glucose monitoring system could be used for continuous, accurate, safe and easy-to-use glucose evaluation in intensive care units.“
The researchers took double-blind measurements from the OrSense device and compared them to measurements obtained by conventional invasive methods, finding similar equivalents.
The study demonstrated that the OrSense sensor device is both sensitive and specific, showing median relative absolute difference of 11.5% in glucose levels of 64-247 mg/dl, showing unprecedented accuracy measures of glucose levels in an acute care setting.
Hyperglycemia, elevated blood glucose levels, and insulin resistance are common findings in critically ill patients, even those without diabetes.
“Currently, monitoring methods cannot fulfill the need for continuous glucose monitoring needed to safely implement tight glucose control-based protocols,“ OrSense CEO Lior Ma'ayan told Medical Device Daily.
“The results of this study are indicative of OrSense's capabilities in producing breakthrough noninvasive glucose monitoring technology,“ he said. “We are continuing in our commitment to deliver the same level of accurate measurement for home glucose testing as in hospital settings,“ he added, showing MDD the mock-up of the portable finger monitor that he said had already been shown to work in several trial cases.
The ICU study is one arm of three trials that were carried out on a total of 30 patients in three different hospitals in Israel. The results being presented come from a study conducted on six patients, three women and three men, between the ages of 44 and 88, while in the Rabin Medical Center ICU.
In the study, the OrSense sensor produced continuous noninvasive measurements for up to 24 hours. These running results were compared to measurements obtained by conventional invasive methods taken throughout the day. The range of the glucose levels measured in the study was 64-247 mg/dl. The resulting Median Relative Absolute Difference was 11.5%, and the Median Absolute Difference was 18 mg/dl.
The OrSense device is based on its Occlusion Spectroscopy technology. The company also has developed and is marketing a noninvasive monitoring product for other critical blood parameters, including hemoglobin and hematocrit in Europe.
Ma'ayan told MDD that OrSense has an intellectual property portfolio consisting of 18 granted patents, with more than 25 additional applications in process.
He noted that serial entrepreneur Shimon Eckhouse is chairman of the board of the company, taking this as a vote of confidence for the technology, which he said also had been vetted by another board member, Karen Drexler, founder, president and CEO of Amira Medical (Scotts Valley, California), a company that was acquired by Roche Diagnostics (Indianapolis) in 2001.
Investors in OrSense include Israel Health Care Ventures and STAR Ventures.