Systems, methods and devices for achieving glycemic balance
Inventors
Assignees
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Publication Number
US-11826163-B2
Publication Date
2023-11-28
Expiration Date
Abstract
Systems, methods and/or devices for optimizing a patient's insulin dosage regimen over time, comprising at least a first memory for storing data inputs corresponding at least to one or more components in a patient's present insulin dosage regimen, and data inputs corresponding at least to the patient's blood-glucose-level measurements determined at a plurality of times, and a processor operatively connected to the at least first memory. The processor is programmed at least to determine from the data inputs corresponding to the patient's blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the one or more components in the patient's present insulin dosage regimen. Also disclosed are systems, methods and/or devices for treating a patient's diabetes by providing treatment guidance, wherein the patient's current glycemic state is determined relative to a desired balance point; and determining from at least one of a plurality of the data corresponding to the patient's blood glucose-level measurements whether and by how much to vary at least one of the one or more components in the patient's present insulin dosage regimen to get closer to the patient's desired balance point; wherein the desired balance point is the patient's lowest blood glucose-level within a predetermined range achievable before increasing the frequency of hypoglycemic events above a predetermined threshold.
Core Innovation
The invention provides systems, methods, and an apparatus for optimizing a patient’s diabetes medication dosage over time by adjusting an insulin dosage regimen. Components of the insulin dosage regimen are stored in memory, and blood glucose-level measurements from a glucose monitor are obtained at a plurality of times and stored in the memory. A timer is incremented based on passage of time and receipt of at least one blood glucose-level measurement, enabling time-based determination of when to update the regimen.
Each blood glucose-level measurement is tagged with an identifier reflective of when or why the reading was obtained. The apparatus determines the patient’s current glycemic state relative to a desired balance point, where the desired balance point is the patient’s lowest blood glucose-level within a predetermined range achievable before increasing the frequency of hypoglycemic events above a predetermined threshold. From the plurality of stored measurements, the system determines whether and by how much to vary at least one component of the present insulin dosage regimen to get closer to the desired balance point, and the timer is reinitiated after determining whether and by how much to vary the component.
The invention further determines whether data corresponding to at least one blood glucose-level measurement is missing and applies safety measures when missing data is present. Safety measures include predefined limits on allowable change for one or more components within a predefined period of time, a predefined limit on the ratio between fast acting and long acting insulin dosage components, and capping the long acting insulin dosage component at no more than a predefined percentage of the total daily amount of insulin injected. Additionally, when missing data corresponds to a blood glucose-level measurement tagged with an identifier, one or more dosage components are automatically capped to be administered at some multiple of the corresponding dosage components that would be administered at a later measurement tagged with an identifier.
Claims Coverage
Two independent claims are present: clm-00001 (method) and clm-00014 (apparatus). Across the independent claims, the coverage includes time-based receipt and tagging of glucose-monitor measurements, determining glycemic state relative to a desired balance point, varying insulin regimen components to move toward that balance point, and missing-data handling using safety limits and caps.
Time-tagged glucose monitoring with timer-driven updates
Storing one or more components of the patient’s insulin dosage regimen; obtaining data from a glucose monitor corresponding to blood glucose-level measurements determined at a plurality of times; incrementing a timer based on passage of time and receipt of at least one blood glucose-level measurement; and reinitiating the timer after determining whether and by how much to vary at least one component.
Glycemic state determination relative to a desired balance point
Tagging the blood glucose-level measurements with an identifier reflective of when or why the reading was obtained; determining the patient’s current glycemic state relative to a desired balance point; wherein the desired balance point is the patient’s lowest blood glucose-level within a predetermined range achievable before increasing the frequency of hypoglycemic events above a predetermined threshold.
Regimen variation to get closer to the desired balance point
Determining from at least one of a plurality of the data corresponding to the patient’s blood glucose-level measurements whether and by how much to vary at least one of the one or more components in the patient’s present insulin dosage regimen to get closer to the patient’s desired balance point.
Missing-data safety measures with caps and limits
Determining whether data corresponding to at least one blood glucose-level measurement is missing; wherein if said data is missing then certain safety measures are applied to make sure that one or more components in the patient’s present insulin dosage regimen are not going to incur changes that exceed a predefined threshold; wherein a predefined limit is placed on allowable change for one or more components within a predefined period of time as a safety measure; wherein a predefined limit is placed on the ratio between fast acting and long acting insulin dosage components; wherein the long acting insulin dosage component is capped at no more than a predefined percentage of the total daily amount of insulin injected; and wherein the presence of missing data corresponding to a blood glucose-level measurement tagged with an identifier automatically caps one or more dosage components to be administered at some multiple of the corresponding dosage components that would be administered at a later measurement tagged with an identifier.
The independent claims collectively cover an insulin-dosage optimization approach that uses time-based, identifier-tagged glucose-monitor measurements to determine a current glycemic state relative to a desired balance point, then varies insulin regimen components to move toward that balance point while applying safety caps and predefined limits when glucose data is missing.
Stated Advantages
Improved glycemic composite index balancing A1C and hypoglycemia.
Reduced hypoglycemia and/or improved A1C, including by shifting insulin distribution between administration points.
Documented Applications
Real-time optimization of a patient’s diabetes medication dosage by an apparatus/method that adjusts insulin dosage over time based on glucose monitor data and missing-data safety limits.
Population-level management/service enrollment and cost reduction rationale (as described in the provided summary of the document).
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