System for optimizing a patient's insulin dosage regimen
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Publication Number
US-8370077-B2
Publication Date
2013-02-05
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 method updates a patient's insulin dosage regimen by storing one or more components of the regimen and initiating a timer to monitor a predetermined time period. During the predetermined time period, the method measures the patient's blood glucose-level at a plurality of times, obtains data corresponding to the measurements, increments the timer based on passage of time and receipt of blood glucose-level measurements, and tags each of the plurality of blood glucose-level measurements with an identifier reflective of when each measurement is obtained.
After obtaining a blood glucose-level measurement but before obtaining a subsequent measurement, the method determines whether the obtained blood glucose-level measurement reflects a hypoglycemic event or a severe hypoglycemic event. In response to a determination that the most recently obtained blood glucose-level measurement represents a severe hypoglycemic event, at least one component of the insulin dosage regimen is reduced, and at least one component is also reduced in response to a determination that the most recently obtained blood glucose-level measurement results in an excessive number of hypoglycemic events during the predetermined time period.
At the end of the predetermined time period, the method determines whether and by how much to vary at least one component of the patient's present insulin dosage regimen from the plurality of blood glucose-level measurements in order to maintain the patient's blood glucose-level measurements within a predefined range. The timer is reinitiated after determining whether and by how much to vary the component, and the disclosed logic further includes determining whether measurements are within or outside the predefined range for variation decisions and using a statistical assessment of normal distribution through a third moment of the distribution criterion.
Claims Coverage
The independent claim is clm-00001, and the family includes eight inventive features, with dependent claims narrowing the method by adding user interaction for measurement identifiers, range-gating for variation decisions, a third-moment normality criterion, and specifying long-acting and short-acting components using carbohydrate ratio or fixed meal dose and a plasma glucose correction factor.
Time-tagged glucose monitoring with timer reinitiation
Initiating a timer to monitor a predetermined time period; measuring the patient's blood glucose-level at a plurality of times; obtaining data corresponding to the measurements; incrementing the timer based on passage of predetermined increments of time and receipt of measurements; and tagging the plurality of blood glucose-level measurements with an identifier reflective of when the measurement was obtained.
Severe hypoglycemia and excessive-event driven component reductions with reinitiation
Determining, after obtaining one of the plurality of blood glucose-level measurements but before obtaining a subsequent blood glucose-level measurement, whether the obtained measurement reflects a hypoglycemic event or a severe hypoglycemic event; reducing at least one component of the insulin dosage regimen in response to the most recently obtained measurement representing a severe hypoglycemic event; reducing at least one component in response to the most recently obtained measurement resulting in an excessive number of hypoglycemic events during the predetermined time period; and reinitiating the timer after determining excessive hypoglycaemic events over the predetermined amount of time.
End-of-period regimen variation to maintain glucose within a predefined range
Determining, at the end of the predetermined time period, from the plurality of data corresponding to the blood glucose-level measurements whether and by how much to vary at least one component of the patient's present insulin dosage regimen in order to maintain the patient's blood glucose-level measurements within a predefined range; wherein the timer is reinitiated after the determination of whether and by how much to vary at least one component.
User-modifiable measurement identifiers
Further enabling the method to include user modification of the identifier associated with each blood-glucose-level measurement.
Range-gated variation only when outside bounds
Determining whether the patient's blood glucose-level measurements are within or outside a predefined range and varying at least one component of the patient's present insulin dosage regimen only when the measurements are outside that range.
Third-moment criterion for normal distribution assessment
Determining whether a patient's blood glucose-level measurement data follow a normal distribution by checking whether the third moment of the distribution falls within a predefined range.
Long-acting insulin dosage component in regimen
Limiting the one or more components in the patient's current insulin dosage regimen such that the one or more components include a long-acting insulin dosage component.
Short-acting insulin component defined by carbohydrate ratio/fixed meal dose and plasma glucose correction factor
Including in the patient's present insulin dosage regimen a short-acting insulin dosage component defined by a carbohydrate ratio or a fixed meal dose and a plasma glucose correction factor.
Overall, the claims coverage centers on a time-tagged, timer-based glucose measurement workflow that reduces insulin regimen components in response to severe hypoglycemic events and excessive hypoglycemic event counts, followed by an end-of-period determination of whether and by how much to vary regimen components to maintain glucose within a predefined range. Dependent claims additionally constrain variation timing via measurement identifier modification, range gating, and a statistical normality assessment using a third-moment criterion, while further specifying that regimen components include long-acting and short-acting components defined via carbohydrate ratio or fixed meal dose together with a plasma glucose correction factor.
Stated Advantages
Maintain the patient's blood glucose-level measurements within a predefined range.
Documented Applications
Updating a diabetes patient's insulin dosage regimen between clinic visits using time-stamped blood glucose-level measurements collected at a plurality of times during a predetermined time period.
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