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OrSense, an Israeli company that is developing a noninvasive CGM system based on occlusion spectroscopy technology, showed results at EASD September 14 on the accuracy of its device.
This technology measures blood constituents through an optical beam shot 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.” The trials compared OrSense’s finger cuff to conventional subcutaneous CGM systems. The mean relative absolute difference has ranged from 15% to about 20%, depending on the application, and was 19.5% in the EASD results. Clarke error grid analysis showed that ~95% of measurements fall within zones A and B. Though these studies were done with the NBM-100G model, the first model expected to be launched is actually the NBM-200G, which is about a quarter of the size – potentially exciting. There is no word yet on the likely launch date.
OrSense is preparing FDA trials now, and these trials will focus on type 1 and insulin-dependent type 2 diabetes patients who make decisions with frequent testing. However, "there is no limitation to who are the right patients," suggested CEO Lior Ma’yaan, and the system can be used for spot measurement as well as continuous monitoring and can be used in the ICU as well as at home. Reimbursement is a concern. However, "the cost of this device will be lower than what we're used to with subcutaneous devices," said Ma’ayan. The device has two arts,
the sensor and the receiver; the sensor is disposable or semi-disposable because accuracy deteriorates overtime, but duration studies have not been done yet to determine how long it would be indicated to last.
Diabetes Close Up
October 2006, No. 62
By Kelly L. Close
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