Devices, systems, and methods for measurement validation for chronic health condition management
Inventors
Miller, David • Miller, Devin • Jones, Michael • Derrick, David
Assignees
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Publication Number
US-11766221-B1
Publication Date
2023-09-26
Expiration Date
Abstract
Systems, methods, and devices of a health device network may include: a non-invasive glucometer that non-invasively measures analyte levels; an invasive glucometer communicatively coupled directly to the non-invasive glucometer; a cloud-based server communicatively coupled to the non-invasive glucometer or the invasive glucometer; a user device communicatively coupled to the cloud-based server; and/or a user interface that displays the invasive glucose measurement, the non-invasive glucose measurement, a data batch, and/or processed data to the user. The non-invasive glucometer and/or the invasive glucometer may aggregate an invasive glucose measurement and a non-invasive glucose measurement into the data batch. A data analytics application on the cloud-based server may be configured to: integrate the invasive glucose measurement and the non-invasive glucose measurement; identify a correlation between the invasive glucose measurement and the non-invasive glucose measurement; and/or generate a predictive model based on the invasive glucose measurement and the non-invasive glucose measurement.
Core Innovation
The invention determines levels of blood glucose of a subject using a wearable device that comprises a light source and a miniaturized spectrometer positioned to emit and receive light through an artery as the subject wears the wearable device. A processing device determines glucose levels based on the light received through the artery.
The invention validates a final level of a first set of non-invasively measured glucose levels using a validation level from an invasive glucometer measured concurrently with the final level. The processing device determines a measurement difference between the validation level and the final level and validates the final level based on whether the measurement difference meets a first threshold difference, including adjusting or disregarding non-invasive glucose measurements.
The invention includes additional non-invasively measured glucose levels in a second set and uses the validated final level to adjust the second set based on the measurement difference or based on another physiological characteristic whose change corresponds to a change in the amount of blood glucose of the subject. The system further supports revalidation using concurrently measured invasive and non-invasive levels.
Claims Coverage
The provided content includes three independent claims covering wearable non-invasive spectrometer measurement through an artery, concurrent invasive validation, difference computation against a final or initial non-invasive level, and validation by threshold-based adjustment/disregard or by another physiological characteristic corresponding to glucose or analyte change.
Wearable non-invasive glucose determination through an artery
A wearable device comprises a light source and a miniaturized spectrometer positioned to emit light through an artery and receive the light through the artery as the subject wears the wearable device, and a processing device determines levels of blood glucose based on the light received through the artery.
Concurrent invasive validation against a final non-invasive level
A validation level is determined from an invasive glucometer measured concurrently with a final level of a first set of non-invasively measured glucose levels, and a measurement difference is determined between the validation level and the final level.
Threshold-based validating of non-invasive levels
Validation includes adjusting or disregarding non-invasive glucose measurements based on whether the measurement difference meets a first threshold difference, and subsequent non-invasively measured analyte levels are adjusted based on whether a difference is greater than or equal to the first threshold difference.
Validation using another physiological characteristic corresponding to glucose change
Validation includes measuring another physiological characteristic, wherein a change in the other physiological characteristic corresponds to a change in blood glucose of the subject, and adjusting the second set of non-invasively measured glucose levels based on the measurement of the other physiological characteristic.
Initial invasive and non-invasive difference used to adjust subsequent analyte levels
A device processing device determines an initial invasively measured analyte level and an initial non-invasively measured analyte level concurrently, calculates a first difference between them, adjusts the initial non-invasively measured analyte level based on the first difference, and adjusts subsequent non-invasively measured analyte levels based on whether the first difference meets the first threshold difference or on a physiological-characteristic-based measurement relationship.
Across the independent claims, the core coverage combines wearable non-invasive determination via a miniaturized spectrometer emitting and receiving light through an artery, concurrent validation against an invasive glucometer validation level, difference computation, and validation or adjustment of non-invasive levels through threshold-based logic and/or another physiological characteristic corresponding to glucose or analyte changes.
Stated Advantages
Documented Applications
No documented applications found
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