Validation of Non-invasive Blood Glucose Monitor

Period of Performance: 09/15/2000 - 08/31/2001


Phase 1 SBIR

Recipient Firm

Vivascan Corporation
Worcester, MA 01605
Principal Investigator


DESCRIPTION (adapted from applicant's abstract): This phase I application requests support for conducting a patient pilot study for a prototype non-invasive blood glucose monitor, and for analyzing the resulting data. The prototype device used is the company's Optical Bridge spectroscopic sensor technology in which one or more balanced wavelength pairs, rather than a large number of single wavelengths, are tuned for maximal background rejection, thereby reducing the number of interfering substances and amplifying the signal produced by the analyte of interest. The proposed device applies "squeeze force" equivalent to three times blood pressure to the subject's earlobe, and the two wavelengths selected have equal attenuation at the squeezed position but unequal attenuation by glucose. The applicants have already assembled a prototype device, and observed, in a very limited number of patients over 7-8 weeks, average absolute errors (when compared to conventional glucose strip monitoring devices) of 18-20 mg/dl. The data collected during this phase I pilot period will be used to determine the best manner in which device measurements will be translated into blood glucose predictions, and to determine the accuracy of the device with a high level of confidence. Specific efforts will be made to develop a calibration technique, to develop methods for measurement of hemoglobin and "other secondary measurements," and to identify a method for indicating anomalous measurements. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE