Fluid component analysis system and method for glucose monitoring and control
Inventors
Assignees
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Publication Number
US-12514979-B2
Publication Date
2026-01-06
Expiration Date
Abstract
Disclosed are methods and apparatuses for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment dose (e.g. insulin, dextrose, etc.) and provide glycemic control. The dose of the treatment drug may be based on the patient's calculated sensitivity to treatment dosing, for example. The dose of the treatment drug may be based on the concentration of the analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte. Delivery of the treatment drug can be cut off if the determined analyte concentration indicates that continued delivery would be harmful to the patient.
Core Innovation
The invention provides a patient monitoring and dosing system that measures a concentration of an analyte in a sample of bodily fluid from a patient. A monitoring device measures the analyte concentration, and a treatment dosing system is in communication with the monitoring device. The treatment dosing system uses a treatment dosing algorithm to access a history of insulin dosages stored in a database and to estimate insulin sensitivity for the patient using the measured analyte concentration together with the insulin dosage history over a prior time period.
The system determines an accuracy of the calculated estimated insulin sensitivity based at least in part on previously measured concentrations of the patient’s analyte, and in one formulation also based at least in part on an actual insulin sensitivity value of the patient. Using the estimated insulin sensitivity and the accuracy, the system calculates a recommended treatment dosage of a treatment substance for the patient.
The dosing calculation uses a sliding scale protocol that increases a responsiveness of the treatment dosing algorithm to changes in the measured concentration of the analyte as the accuracy of the calculated estimated insulin sensitivity increases, or selects between a first dosing protocol and a second dosing protocol depending on whether the accuracy is above or below a predetermined level.
The treatment dosing system is configured to automatically deliver the calculated recommended treatment dosage from a source of the treatment substance to the patient, and the disclosed approach supports logic that adapts delivery based on monitoring outputs, including refining estimated insulin sensitivity and associated accuracy using prior analyte concentrations and insulin dosage history.
Claims Coverage
The document includes two independent claims. Across the independent claims, the core claim coverage is a patient monitoring and dosing system that measures analyte concentration in bodily fluid and uses a treatment dosing algorithm to estimate insulin sensitivity, evaluate an accuracy metric, and compute and automatically deliver a recommended treatment dosage using accuracy-dependent protocol behavior.
Patient monitoring and dosing system for analyte-driven treatment delivery
A monitoring device is configured to measure a concentration of an analyte in a sample of bodily fluid from a patient; a source of a treatment substance is provided; and a treatment dosing system in communication with the monitoring device automatically delivers a recommended treatment dosage to the patient based on an analyte concentration measurement.
Estimated insulin sensitivity from analyte concentration and insulin dosage history
A treatment dosing algorithm accesses a history of insulin dosages from a database and calculates an estimated insulin sensitivity for the patient based at least in part on the measured concentration of the analyte in the sample and the history of insulin dosages over a prior time period.
Accuracy of estimated insulin sensitivity from prior analyte measurements
The treatment dosing algorithm calculates an accuracy of the calculated estimated insulin sensitivity based at least in part on previously measured concentrations of the analyte of the patient, and in the second independent claim also based on an actual insulin sensitivity value of the patient.
Sliding-scale recommended dosage responsive to insulin-sensitivity accuracy
The treatment dosing algorithm calculates a recommended treatment dosage using a sliding scale protocol that increases a responsiveness of the treatment dosing algorithm to changes in the measured concentration of the analyte as the accuracy of the calculated estimated insulin sensitivity increases.
Protocol selection based on accuracy relative to a predetermined level
When calculating the recommended treatment dosage, the processor calculates the recommended treatment dosage according to a first dosing protocol if the accuracy is above a predetermined level, and calculates the recommended treatment dosage according to a second dosing protocol if the accuracy is below the predetermined level, wherein the second dosing protocol is less sensitive to changes in the measured concentration of the analyte than the first dosing protocol.
The independent claims cover measuring analyte concentration, estimating insulin sensitivity from analyte concentration and insulin dosage history, determining accuracy of the estimate, and using that accuracy to calculate and automatically deliver a recommended treatment dosage through a sliding scale protocol or a less sensitive second dosing protocol.
Stated Advantages
Increased responsiveness of the treatment dosing algorithm to changes in the measured concentration of the analyte as accuracy of the estimated insulin sensitivity increases.
Adaptive dosing that uses a less sensitive protocol when estimated insulin sensitivity accuracy is below a predetermined level.
Documented Applications
Glucose monitoring and glycemic control/TGC using a patient monitoring and dosing system with insulin dosing based on measured analyte concentration in bodily fluid and computed estimated insulin sensitivity.
Automatically delivered insulin treatment dosage including basal infusion versus bolus injection modalities tied to analyte measurements.
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