Device and Method for Noninvasive Glucose Assessment.

BACKGROUND: Intensive monitoring of blood glucose levels is crucial in diabetes management. This article presents a new device, the TensorTip Combo Glucometer (CoG), developed by Cnoga Medical Ltd, which enables to predict capillary tissue glucose concentration noninvasively.
METHODS: Noninvasive glucose readings usually provide irregular or disordered mathematical manifold over the measurement space. To establish a transfer function, which correctly correlates the noninvasive raw data and the actual invasive glucose level, we suggest a mathematical concept that employs a personal calibration procedure to associate glucose pattern and multiple optical signals derived from tissue response to light emission in the range of visible to IR. The traversed light is detected by a color image sensor to predict the tissue glucose concentration at the fingertip. This article presents the mathematical concept underlying the technology and the requirements for device operation.
RESULTS: The device was clinically evaluated and compared to standard invasive blood glucose monitoring devices in few medical centers and by home users. Based on consensus error grid analysis, more than 98% of the measurements of each study were in zones A (more than 81%) and B (more than 11%). Postmarketing evaluations showed high correlations comparing the CoG to other invasive reference devices.
CONCLUSIONS: The CoG device employs a unique mathematical approach to predict glucose concentrations based on multiple optical signals. The first clinical results indicate that the device may show appropriate agreement with reference methods to be used for pain-free glucose assessment in daily routine.