System for optimizing a patient's insulin dosage regimen
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Publication Number
US-11869648-B2
Publication Date
2024-01-09
Expiration Date
Abstract
A system 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 in order to maintain the patient's future blood-glucose-level measurements within a predefined range.
Core Innovation
A system for monitoring and optimizing a patient's insulin dosage regimen over time stores patient data including an initial carbohydrate ratio, an initial long-acting insulin dose, an initial plasma glucose correction factor, and multiple blood-glucose-level measurements determined at a plurality of times. The system receives blood-glucose-level measurements repeatedly from a glucose measuring device and asynchronously monitors a plurality of predetermined time periods using at least one timer.
The system evaluates whether obtained measurements fall within a predefined range within a current one of the plurality of predetermined time periods and automatically calculates whether and by how much to vary one or more components in the patient's present insulin dosage regimen with respect to the stored patient data. The variation is calculated to maintain the patient's future blood-glucose-level measurements within a predetermined range while there is a lower risk of the patient experiencing a hypoglycemic event during subsequent time periods.
When the blood-glucose-level measurements represent a severe hypoglycemic event, the system sends signals to an operatively connected insulin pump to instruct the insulin pump to vary at least one of the one or more components in the patient's present insulin dosage regimen. The system further determines whether there have been an excessive number of hypoglycemic events over at least one predetermined time period such that the patient's blood-glucose-level measurements collectively exhibit an abnormal distribution pattern, and it varies at least one of the one or more components in response.
When the insulin dosage regimen is updated, whether in consequence of a periodic update evaluation or an asynchronous update, the current timer is reset, and the processor visually displays revised components to the patient via a configurable, interactive display. The processor is connected to a network accessible to a healthcare provider through which data are input and information related to the patient's insulin dosage regimen are communicated.
Claims Coverage
The patent excerpt includes one independent claim covering the overall system architecture and logic for asynchronous monitoring and regimen optimization, including pump signaling for severe hypoglycemia, rolling storage, abnormal distribution-based adjustment, timer reset behavior, patient display, and network connectivity. The inventive features are further narrowed in dependent claims by specifying regimen component types, measurement-context timing, statistical criteria, and quantization/rounding rules using an insulin sensitivity correction factor.
Asynchronous monitoring of predetermined time periods for regimen optimization
A timer is used to asynchronously monitor a plurality of predetermined time periods, with the current timer reinitiated after the determination of whether and by how much to vary at least one component within the current time period.
Automatic evaluation and within-range maintenance for future blood-glucose
The processor repeatedly receives blood-glucose-level measurements and automatically evaluates whether obtained measurements fall within a predefined range, then calculates whether and by how much to vary one or more components in the patient's present insulin dosage regimen to maintain future blood-glucose-level measurements within the predetermined range and lower the risk of hypoglycemic events during subsequent time periods.
Severe hypoglycemic-event pump signaling and revised regimen display
When the patient's blood-glucose-level measurements represent a severe hypoglycemic event, the processor sends signals to an operatively connected insulin pump to vary at least one component in the present insulin dosage regimen, and sends a control signal to a configurable, interactive display to visually display the revised components.
Abnormal distribution-based response to an excessive number of hypoglycemic events
The processor automatically determines from the patient's blood-glucose-level measurements over at least one predetermined time period if there have been an excessive number of hypoglycemic events such that the measurements collectively exhibit an abnormal distribution pattern during the course of the period, and it varies at least one component in response to said determination.
Rolling hypoglycemic-event database for a predefined period of time
The processor stores blood-glucose measurements associated with hypoglycemic events in a separate, rolling database that stores data for a predefined period of time.
Timer reset behavior on periodic or asynchronous regimen updates
When the insulin dosage regimen is updated, whether in consequence of a periodic update evaluation or an asynchronous update, the current timer is reset.
Network accessibility for healthcare provider data input and communication
The processor is connected to a network accessible to a healthcare provider through which data are input and information related to the patient's insulin dosage regimen are communicated.
Context-specific long-acting regimen variation based on blood-glucose timing
Using patient identifier information and blood-glucose measurement timing, the processor classifies measurements as morning or bedtime, checks whether the morning and bedtime blood-glucose levels are within a predefined range, and varies only a long-acting insulin dosage component when those levels fall outside the predefined range.
Short-acting regimen variation using carbohydrate ratio and plasma glucose correction factor
The processor uses a short-acting insulin component characterized by a carbohydrate ratio and a plasma glucose correction factor, and determines whether and how much to vary those parameters.
Quantization/rounding of fractional component changes using insulin sensitivity correction factor
When determining whether and by how much to vary one or more components, the processor uses an insulin sensitivity correction factor that specifies both the percentage allowable variation and the rounding direction of fractional component changes to the nearest whole number.
Normal versus abnormal distribution determination using a third moment criterion
The system determines whether the patient's blood glucose level measurements over multiple times are normally or abnormally distributed by checking whether the distribution's third moment falls within a predefined range.
Across the independent claim and the dependent refinements described, the core inventive coverage centers on timer-controlled asynchronous monitoring; automatic within-range evaluation and component variation in a present insulin dosage regimen; severe hypoglycemic-event detection that triggers pump signals and patient display of revised components; abnormal distribution-based response to excessive hypoglycemia using a rolling database; and implementation refinements that include context-specific long-acting variation, short-acting parameters, quantization/rounding rules, and normal/abnormal distribution determination via a third moment.
Stated Advantages
Lower risk of the patient experiencing a hypoglycemic event during subsequent time periods.
Maintains the patient's future blood-glucose-level measurements within a predetermined range.
Visually displays revised insulin dosage regimen components to the patient.
Documented Applications
No documented applications found
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