This invention is an approach which combines the kinetic hard modeling with spectroscopic tracking of bioanalytes to create a calibration model which can detect the concentration of blood analytes.
Blood constituent (analyte) monitoring forms a substantial component of medical diagnostics, ranging from critical-care to point-of-care testing. The concentration levels of these analytes are tightly controlled, and thus any deviation from the well-established ranges can be immediately correlated with an abnormality in body function. Formulation of non-invasive, continuous measurement strategies for such analytes, particularly glucose in diabetic patients-is highly desirable due to the significant challenges and inconvenience associated with multiple blood withdrawals per day. Furthermore, a non-invasive blood analyte detecting device would significantly aid neonatal and ICU monitoring as well as screening for pre-diabetes and gestational diabetes. Currently, the latter pathological conditions are diagnosed via functional loading tests, where the insulin action is monitored by discrete finger-prick measurements over the duration of a few hours following an initial glucose stimulus.
To address the unmet clinical need for a non-invasive measurement of blood analytes, the Inventors have developed an approach which uses a spectroscopic measurement device to acquire spectral data, and a computing device to process the data. To measure the concentration of blood analytes, a biological calibration sample is obtained from the patient. Spectral data of an analyte in a biological sample is obtained by the use of a probe. Calibrated spectral data is then generated by using measured data from the biological calibration sample. The computing device determines a kinetic model parameter shift that reduces a residual between a concentration profile computed from the kinetic model parameters and a concentration profile obtained from the calibrated spectral data to provide final kinetic model parameters. The computing device then transforms a concentration value obtained from the second spectral data measured after a time interval using the final kinetic model parameters to generate a calibrated concentration value of the analyte. This analytical formulation proposed by the Inventors enables spectroscopy-based prediction of analyte information without necessitating reference concentration information for the development of the calibration model. The framework is called improved concentration independent calibration (ICONIC). This approach can be applied to non-invasive glucose monitoring or monitoring of chemical reaction dynamics.
- Predicts concentration levels of an analyte based on components of the spectral data
- Requires minimum information compared with current techniques to develop a calibration model