Evaluation of a Non-Invasive Alternative Glucose Monitor System in Patients with Diabetes Mellitus
Technical Report,01 Apr 2007,31 Mar 2008
Walter Reed Army Medical Ctr Washington United States
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The primary objectives of the study were to determine if the Nostix non-invasive glucometer monitored blood glucose levels in patients with insulin-requiring diabetes mellitus with accuracy comparable to that of standard invasive glucometers and using the Clark Error Grid determine whether or not errors in treatment would have occurred if the non-invasive device would have been used in place of the standard device. Eleven subjects 45 approved were enrolled in the study before subject accrual was suspended due to the poor correlation between the Nostix non-invasive measurement and fingerstick measurements. The developers of Nostix are currently modifying the device in order to develop a more accurate method of non-invasively monitoring glucose levels. An amendment to test another non-invasive continuous glucose sensing device developed by Flexible Medical Systems was approved by the Department of Clinical Investigation at WRAMC in January 2008. FY08 AAMTI funding will support the efforts of a full-time project officer and the supplies required to complete the study.
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