Healthcare Industry News: blood glucose
News Release - June 12, 2006
OrSense's Non-Invasive Continuous Glucose Monitoring System Achieves Accurate Performance in Home Use SettingResults Presented at the Scientific Session of the 66th American Diabetes Association (ADA) Show Median Relative Absolute Difference of 12.9% in a Wide Range of Glucose Levels
NES ZIONA, Israel--(HSMN NewsFeed)--June 12, 2006--Results of a study by a group of clinicians at the Chaim Sheba Medical Center, presented at the 66th Scientific Session of the American Diabetes Association (ADA) taking place June 9-13, 2006 in Washington, D.C., indicate that the NBM-100G, a non-invasive continuous glucose monitoring sensor developed by OrSense Ltd., accurately measures levels of glucose in a home like setting.
The study consisted of three phases: one focused on low glucose levels and two additional trials which simulated home use, including night time measurements. The trials consisted of 107 daily sessions measuring 24 subjects, 11 females and 13 males, between the ages 20-74; 14 subjects were Type I diabetes patients and 10 were Type II.
In all three trial settings, the results provided by the NBM-100G were compared to measurements obtained by conventional invasive methods collected every 20-60 minutes. The range of the glucose levels measured in the study was 38-485 mg/dl. The resulting Median Relative Absolute Difference was 12.9%. A Deming Regression yielded a slope of 0.94 and a Clarke error grid analysis showed that 95.3% of the measurements fell within the clinically accurate and acceptable zones A and B.
"A growing body of work supports the benefit of continuous glucose monitoring in improving the treatment and health of diabetes patients," said Prof. Avraham Karasik, Director of the Institute of Endocrinology, Chaim Sheba Medical Center, Tel Hashomer, Israel and the principal investigator of the study. "Based on the study's conclusions, we believe that OrSense's non-invasive glucose monitoring system could be used for continuous, accurate, safe and easy to use glucose evaluation for the home environment," Prof. Karasik concluded.
Lior D. Ma'ayan, Chief Executive Office, OrSense said, "Continuous non-invasive monitoring of blood glucose has the potential of significantly improving diabetes care. This trial conducted by researchers at the Sheba Medical Center is the first external validation of the performance of the NBM-100G device in a home like scenario, showing accurate measurements across all ranges of glucose levels, during both day and night."
The NBM-100G uses a ring-shaped cuff applied to the patient's finger. The device is based on "Occlusion Spectroscopy", OrSense's proprietary measurement technology. This breakthrough technology enables, for the first time, the generation of optical signals across the finger which overcomes the key technological barrier related to the very low signal to noise ratio and non-specificity inherent in competing approaches. Analysis of the signal provides the sensitivity necessary to measure blood glucose and other analyte concentrations.
OrSense is a medical device company developing non-invasive glucose monitoring systems for people with diabetes. The Company's products are based on its proprietary Occlusion Spectroscopy technology. OrSense also develops and markets non-invasive monitoring products for other critical blood parameters, such as hemoglobin. The Company's first commercial product is CE approved for monitoring hemoglobin and hematocrit. OrSense's intellectual property portfolio consists of 20 granted patents, with over 25 additional applications in process. Investors include Israel Health Care Ventures and STAR Ventures. For additional information, please visit OrSense's corporate Website at www.orsense.com.
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