US-12620473-B2 - Method and dosing controller for administering a correction dose of insulin

US12620473B2US 12620473 B2US12620473 B2US 12620473B2US-12620473-B2

Abstract

A method of administering insulin includes receiving scheduled glucose time intervals and obtaining glucose data of a patient that includes glucose measurements, glucose times, and insulin dosages previously administered by the patient. The method also includes applying a set of filters to identify which of the glucose measurements associated with at least one of the scheduled time intervals are usable and which of the glucose measurements associated with the at least one scheduled time interval are unusable. The method also includes aggregating the glucose measurements associated with the at least one scheduled time interval identified as usable to determine a representative aggregate glucose measurement and determining a next recommended insulin dosage for the patient based on the representative aggregate glucose measurement and the insulin dosages previously administered by the patient.

Inventors

Robert C. Booth
Harry Hebblewhite

Assignees

Aseko, Inc.

Dates

Publication Date: 20260505
Application Date: 20230525

Claims (20)

1 . A computer-implemented method executed on data processing hardware that causes the data processing hardware to perform operations comprising: identifying a scheduled glucose measurement time interval within a day for a patient having a diagnosis of diabetes, wherein the scheduled glucose measurement time interval comprises a meal insulin bolus administration time, wherein the scheduled glucose measurement time interval is one of a plurality of non-overlapping scheduled glucose measurement time intervals within the day for the patient; obtaining glucose data of the patient from a continuous glucose monitoring system in communication with the data processing hardware, the glucose data including a plurality of glucose measurements of the patient and a plurality of glucose measurement times, wherein each glucose measurement of the plurality of glucose measurements is associated with a respective glucose measurement time of the plurality of glucose measurement times; identifying which of the plurality of glucose measurements have a respective glucose measurement time falling within the scheduled glucose measurement time interval and are usable, wherein determining that a glucose measurement is usable comprises identifying that the glucose measurement time associated with the glucose measurement is at or before the meal insulin bolus administration time associated with the scheduled glucose measurement time interval; processing the glucose measurements identified as having the respective glucose time falling within the scheduled glucose measurement time interval and as usable to determine a representative glucose measurement for the scheduled glucose measurement time interval by: determining a sum of the glucose measurements identified as having the respective glucose time falling within the scheduled glucose measurement time interval and as usable; and determining a mean value for the scheduled glucose measurement time interval by dividing the sum by a total number of the glucose measurements identified as having the respective glucose time falling within the scheduled glucose measurement time interval and as usable, wherein the mean value comprises the representative glucose measurement for the scheduled glucose measurement time interval; determining a next recommended insulin dosage for a correction dose of insulin for the patient's diagnosis of diabetes based on the representative glucose measurement; transmitting the next recommended insulin dosage for the correction dose of insulin from the data processing hardware to a portable device associated with the patient, the portable device configured to display the next recommended insulin dosage; and administering the correction dose of insulin to the patient to treat the patient's diagnosis of diabetes by transmitting instructions comprising the next recommended insulin dosage for the correction dose of insulin to an administration device in communication with the data processing hardware, the administration device comprising: a doser; and an administration computing device in communication with the doser, the administration computing device configured to, in response to the instructions, cause the doser to administer the correction dose of insulin to the patient.
2 . The method of claim 1 , wherein obtaining the glucose data comprises one or more of: receiving the glucose data from a remote computing device in communication with the data processing hardware during a batch download process, the remote computing device executing a download program for downloading the glucose data from the continuous glucose monitoring system; receiving the glucose data from the continuous glucose monitoring system; or receiving the glucose data from a patient device in communication with the data processing hardware and the continuous glucose monitoring system, the patient device receiving the glucose data from the continuous glucose monitoring system.
3 . The method of claim 1 , wherein the operations further comprise: identifying a glucose measurement as invalid and unusable when the glucose measurement corresponds to one of a numerical value less than or equal to zero, a numerical value greater than or equal to a maximum limit associated with the continuous glucose monitoring system, or text; and identifying a glucose measurement as valid when the glucose measurement corresponds to a positive integer less than the maximum limit associated with the continuous glucose monitoring system; determining the glucose measurement exceeds a threshold value based on a mean of the glucose measurements and a standard deviation of the glucose measurements; and based on determining the glucose measurement exceeds the threshold value based on the mean of the glucose measurements and the standard deviation of the glucose measurements, identifying the glucose measurement identified as valid as unusable.
4 . The method of claim 3 , wherein identifying that the glucose measurement is usable further comprises at least one of: identifying the glucose measurement as usable when the respective glucose measurement time is at or before an end of an ideal mealtime associated with the scheduled glucose measurement time interval, or the glucose measurement is less than or equal to an upper limit of a target glucose range for the patient; or identifying the glucose measurement as usable when the respective glucose measurement time is within the scheduled glucose measurement time interval.
5 . The method of claim 1 , wherein the operations further comprise: receiving a specified date range from a remote healthcare provider computing device in communication with the data processing hardware; aggregating one or more of the glucose measurements associated with the specified date range to determine a daily aggregate glucose measurement for each day within the specified date range; and aggregating the one or more of the daily aggregate glucose measurement associated with the specified date range to determine a representative aggregate glucose measurement associated with the specified date range.
6 . The method of claim 5 , wherein the operations further comprise: calculating a minimum number of available daily aggregate values by multiplying the total number of days within the specified date range by a configurable set point equal to a value between zero and one; and aggregating the daily aggregate glucose measurement associated with the lowest values up until the minimum number of available daily aggregate values to determine the representative aggregate glucose measurement associated with the specified date range.
7 . The method of claim 6 , wherein the operations further comprise: determining the total number of daily aggregate values associated with the specified date range is greater than or equal to the minimum number of available daily aggregate values; and preventing adjustments to a previous recommended insulin dosage governed by the specified date range based on determining the total number of daily aggregate values associated with the specified date range is less than the minimum number of available daily aggregate values.
8 . The method of claim 7 , wherein the operations further comprise, based on determining the total number of daily aggregate values associated with the specified date range is greater than or equal to the minimum number of available daily aggregate values, adjusting the previous recommended insulin dosage governed by the specified date range based on the representative aggregate glucose measurement associated with the specified date range.
9 . The method of claim 5 , wherein the operations further comprise: selecting a governing glucose measurement as the representative aggregate glucose measurement associated with the specified date range; determining an adjustment factor for adjusting a next recommended meal bolus governed by the specified date range based on the selected governing glucose measurement; obtaining a previous day recommended meal bolus governed by the specified date range; and determining the next recommended meal bolus by multiplying the adjustment factor times the previous day recommended meal bolus, wherein the specified date range includes one of a lunch glucose time interval, a dinner glucose time interval, or a bedtime glucose time interval.
10 . The method of claim 1 , wherein each scheduled glucose measurement time interval correlates to an associated glucose type including one of a pre-breakfast glucose measurement, a pre-lunch glucose measurement, a pre-dinner glucose measurement, a bedtime glucose measurement and a midsleep glucose measurement.
11 . A dosing controller comprising: data processing hardware; and memory hardware in communication with the data processing hardware, the memory hardware storing instructions for a subcutaneous outpatient program that, when executed on the data processing hardware, cause the data processing hardware to perform operations comprising: identifying a scheduled glucose measurement time interval within a day for a patient having a diagnosis of diabetes, wherein the scheduled glucose measurement time interval comprises a meal insulin bolus administration time, wherein the scheduled glucose measurement time interval is one of a plurality of non-overlapping scheduled glucose measurement time intervals within the day for the patient; obtaining glucose data of the patient from a continuous glucose monitoring system in communication with the data processing hardware, the glucose data including a plurality of glucose measurements of the patient and a plurality of glucose measurement times, wherein each glucose measurement of the plurality of glucose measurements is associated with a respective glucose measurement time of the plurality of glucose measurement times; identifying which of the plurality of glucose measurements have a respective glucose measurement time falling within the scheduled glucose measurement time interval and are usable, wherein determining that a glucose measurement is usable comprises identifying that the glucose measurement is usable when the glucose measurement time associated with the glucose measurement is at or before the meal insulin bolus administration time associated with the scheduled glucose measurement time interval; processing the glucose measurements identified as having the respective glucose time falling within the scheduled glucose measurement time interval and as usable to determine a representative glucose measurement for the scheduled glucose measurement time interval by: determining a sum of the glucose measurements identified as having the respective glucose time falling within the scheduled glucose measurement time interval and as usable; and determining a mean value for the scheduled glucose measurement time interval by dividing the sum by a total number of the glucose measurements identified as having the respective glucose time falling within the scheduled glucose measurement time interval and as usable, wherein the mean value comprises the representative glucose measurement for the scheduled glucose measurement time interval; determining a next recommended insulin dosage for a correction dose of insulin for the patient's diagnosis of diabetes based on the representative glucose measurement; transmitting the next recommended insulin dosage for the correction dose of insulin from the data processing hardware to a portable device associated with the patient, the portable device configured to display the next recommended insulin dosage; and administering the correction dose of insulin to the patient to treat the patient's diagnosis of diabetes by transmitting instructions comprising the next recommended insulin dosage for the correction dose of insulin to an administration device in communication with the data processing hardware, the administration device comprising: a doser; and an administration computing device in communication with the doser, the administration computing device configured to, in response to the instructions, cause the doser to administer the correction dose of insulin to the patient.
12 . The dosing controller of claim 11 , wherein obtaining the glucose data comprises one or more of: receiving the glucose data from a remote computing device in communication with the dosing controller during a batch download process, the remote computing device executing a download program for downloading the glucose data from the continuous glucose monitoring system; receiving the glucose data from the continuous glucose monitoring system; or receiving the glucose data from a patient device in communication with the dosing controller and the continuous glucose monitoring system, the patient device receiving the glucose data from the continuous glucose monitoring system.
13 . The dosing controller of claim 11 , wherein the operations further comprise: identifying a glucose measurement as invalid and unusable when the glucose measurement corresponds to one of a numerical value less than or equal to zero, a numerical value greater than or equal to a maximum limit associated with the continuous glucose monitoring system, or text; and identifying a glucose measurement as valid when the glucose measurement corresponds to a positive integer less than the maximum limit associated with the continuous glucose monitoring system; determining the glucose measurement exceeds a threshold value based on a mean of the glucose measurements and a standard deviation of the glucose measurements; and based on determining the glucose measurement exceeds the threshold value based on the mean of the glucose measurements and the standard deviation of the glucose measurements, identifying the glucose measurement identified as valid as unusable.
14 . The dosing controller of claim 13 , identifying that the glucose measurement is usable further comprises at least one of: identifying the glucose measurement as usable when the respective glucose measurement time is at or before an end of an ideal mealtime associated with the scheduled glucose measurement time interval, or the glucose measurement is less than or equal to an upper limit of a target glucose range for the patient; or identifying the glucose measurement as usable when the respective glucose measurement time is within the scheduled glucose measurement time interval.
15 . The dosing controller of claim 11 , wherein the operations further comprise: receiving a specified date range from a remote healthcare provider computing device in communication with the data processing hardware; aggregating one or more of the glucose measurements associated with the specified date range to determine a daily aggregate glucose measurement for each day within the specified date range; and aggregating one or more of the daily aggregate glucose measurement associated with the specified date range to determine a representative aggregate glucose measurement associated with the specified date range.
16 . The dosing controller of claim 15 , wherein the operations further comprise: calculating a minimum number of available daily aggregate values by multiplying the total number of days within the specified date range by a configurable set point equal to a value between zero and one; and aggregating the daily aggregate glucose measurement associated with the lowest values up until the minimum number of available daily aggregate values to determine the representative aggregate glucose measurement associated with the specified date range.
17 . The dosing controller of claim 16 , wherein the operations further comprise: determining the total number of daily aggregate values associated with the specified date range is greater than or equal to the minimum number of available daily aggregate values; and preventing adjustments to a previous recommended insulin dosage governed by the specified date range based on determining the total number of daily aggregate values associated with the specified date range is less than the minimum number of available daily aggregate values.
18 . The dosing controller of claim 17 , wherein the operations further comprise, based on determining the total number of daily aggregate values associated with the specified date range is greater than or equal to the minimum number of available daily aggregate values, adjusting the previous recommended insulin dosage governed by the specified date range based on the representative aggregate glucose measurement associated with the specified date range.
19 . The dosing controller of claim 15 , wherein the operations further comprise: selecting a governing glucose measurement as the representative aggregate glucose measurement associated with the specified date range; determining an adjustment factor for adjusting a next recommended meal bolus governed by the specified date range based on the selected governing glucose measurement; obtaining a previous day recommended meal bolus governed by the specified date range; and determining the next recommended meal bolus by multiplying the adjustment factor times the previous day recommended meal bolus, wherein the specified date range includes one of a lunch glucose time interval, a dinner glucose time interval, or a bedtime glucose time interval.
20 . The dosing controller of claim 11 , wherein each scheduled glucose measurement time interval correlates to an associated glucose type including one of a pre-breakfast glucose measurement, a pre-lunch glucose measurement, a pre-dinner glucose measurement, a bedtime glucose measurement and a midsleep glucose measurement.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This U.S. patent application is a continuation of, and claims priority under 35 U.S.C. § 120 from, U.S. application Ser. No. 17/305,658, filed on Jul. 12, 2021, which is a continuation of U.S. application Ser. No. 15/496,419, filed on Apr. 25, 2017, which is a continuation-in-part of, and claims priority under 35 U.S.C. § 120 from, U.S. application Ser. No. 14/922,763, filed on Oct. 26, 2015, which claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62/069,195, filed on Oct. 27, 2014. The disclosures of these prior applications are considered part of the disclosure of this application and are hereby incorporated by reference in their entireties. TECHNICAL FIELD This disclosure relates to a system for managing insulin administration or insulin dosing. BACKGROUND Managing diabetes requires calculating insulin doses for maintaining blood glucose measurements within desired ranges. Managing diabetes requires calculating insulin doses for maintaining blood glucose measurements within desired ranges. Manual calculation may not be accurate due to human error, which can lead to patient safety issues. Different institutions use multiple and sometimes conflicting protocols to manually calculate an insulin dosage. Moreover, the diabetic population includes many young children or elderly persons whom have difficulty understanding calculations for insulin doses. SUMMARY One aspect of the disclosure provides a method for subcutaneous outpatient management. The method includes receiving, at data processing hardware, scheduled blood glucose time intervals for a patient. Each scheduled blood glucose time interval is associated with a corresponding time boundary within a day that does not overlap time boundaries associated with the other scheduled blood glucose time intervals. The method also includes obtaining, at the data processing hardware, blood glucose data of the patient from a glucometer in communication with the data processing hardware. The blood glucose data includes blood glucose measurements of the patient. The blood glucose data also includes glucose times associated with a time of measuring a corresponding blood glucose measurement and insulin dosages previously administered by the patient and associated with the blood glucose measurements. The method also includes applying, by the data processing hardware, a set of filters to identify which of the blood glucose measurements associated with at least one of the scheduled blood glucose time intervals are usable and which of the blood glucose measurements associated with the at least one scheduled blood glucose time interval are unusable. The method further includes aggregating, by the data processing hardware, the blood glucose measurements associated with the at least one scheduled blood glucose time interval identified as usable by the set of filters to determine a representative aggregate blood glucose measurement associated with the at least one scheduled blood glucose time interval. The method further includes determining, by the data processing hardware, a next recommended insulin dosage for the patient based on the representative aggregate blood glucose measurement and the insulin dosages previously administered by the patient. The method also includes transmitting the next recommended insulin dosage from the data processing hardware to a portable device associated with the patient. The portable device displays the next recommended insulin dosage. Implementations of the disclosure may include one or more of the following optional features. In some implementations, the method includes transmitting the next recommended insulin dosage to an administration in communication with the data processing hardware. The administration device may include a doser and an administration computing device in communication with the doser. The administration computing device may be configured to cause the doser to administer the next recommended insulin dosage to the patient. In some examples, obtaining the blood glucose data includes one or more of: receiving the blood glucose data from a remote computing device in communication with the data processing hardware during a batch download process; receiving the blood glucose data from the glucometer upon measuring the blood glucose measurement; receiving the blood glucose data from a meter manufacturer computing device in communication with the data processing hardware during the batch download process, the meter manufacturer receiving the blood glucose data from the glucometer; and receiving the blood glucose data from a patient device in communication with the data processing hardware and the glucometer. The remote computing device may execute a download program for downloading the blood glucose data from the glucometer. The patient device may receive the blood glucose data from the glucometer. In some implementations, applying the set of filters to the blood gl