Calibrating Analyte Measurement Devices Using Alternative Site Blood Samples
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Solution Overview
Problem
Current glucose monitoring devices face challenges in accurately calibrating analyte-measurement devices due to variations in analyte concentrations across different body sites, leading to improper calibration and discomfort from fingertip blood extraction.
Innovation Solution
A method for calibrating analyte-measurement devices by determining analyte concentrations from alternative sites like the palm, arm, or abdomen, using in vitro or in vivo sensors, and adjusting signals based on these concentrations to account for site-specific variations, reducing pain and improving calibration accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If blood is extracted from fingertip for calibration, then calibration can be performed, but user comfort deteriorates due to pain and discomfort
Solution Approach 1:
The patent extracts the calibration function from the traditional fingertip blood extraction method and relocates it to alternative sites such as the arm, forearm, or abdomen. This allows calibration to be performed without accessing fingertip blood, thereby eliminating the pain and discomfort associated with finger pricking while still obtaining the necessary blood sample for calibration purposes.
Solution Approach 2:
The patent introduces an intermediary approach by using blood from alternative body sites as a mediator for calibration. Instead of directly extracting blood from the fingertip (which causes discomfort), the system uses blood from less sensitive areas like the arm or abdomen, which serves as an acceptable alternative mediator for achieving accurate calibration without the harmful effects of fingertip extraction.
2Object-affected harmful factors
If analyte concentration is measured from different body sites, then user comfort improves, but measurement precision deteriorates due to site-specific variations
Solution Approach 1:
The patent applies parameter changes by adjusting the calibration process to account for the specific characteristics of alternative measurement sites. The system modifies calibration parameters and algorithms to compensate for site-specific variations in analyte concentration, ensuring that measurements from the arm, forearm, or abdomen yield accurate calibration results comparable to fingertip measurements.
Solution Approach 2:
The patent recognizes that different body sites have different local qualities regarding analyte concentration characteristics. The system adapts the calibration approach to match the specific local quality of each alternative site, using site-specific calibration protocols that account for the unique physiological characteristics of the arm, forearm, or abdomen compared to the fingertip.
3Measurement precision
If traditional fingertip calibration method is used, then calibration can be performed, but device complexity increases due to need for multiple calibration approaches
Solution Approach 1:
The patent makes the calibration system universal by designing it to accept blood samples from multiple body sites using a single integrated approach. The calibration device is configured to handle samples from the fingertip, arm, forearm, or abdomen interchangeably, eliminating the need for separate calibration systems for each site and reducing overall device complexity while maintaining calibration accuracy.
Data Source
AI summary
The invention relates to a method for calibrating an analyte-measurement device that is used to evaluate a concentration of analyte in bodily fluid at or from a measurement site in a body. The method involves measuring a concentration, or calibration concentration, of an analyte in blood from an “off-finger” calibration site, and calibrating the analyte-measurement device based on that calibration concentration. The invention also relates to a device, system, or kit for measuring a concentration of an analyte in a body, which employs a calibration device for adjusting analyte concentration measured in bodily fluid based on an analyte concentration measured in blood from an “off-finger” calibration site.