IP Library Granted Patent US 11,694,785
Granted Patent B2
US 11,694,785 · App. 17/305,658 · Granted Jul 4, 2023

Method and dosing controller for subcutaneous outpatient management

Inventors: Robert C. Booth (Columbus, NC); Harry Hebblewhite (Atlanta, GA)
Assignee: Aseko, Inc.
G16H20/60A61B5/0022A61B5/14532A61B5/4839A61B5/7475A61M5/1723G16H10/40G16H10/60G16H20/17G16H40/63G16H40/67A61B5/14503A61B5/7239A61B5/7405A61M2205/3303
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Quick Facts
Patent No.
US 11,694,785
App. No.
17/305,658
Granted
Jul 4, 2023
Kind
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.

Claims (105)

1. A computer-implemented method when executed on data processing hardware causes the data processing hardware to perform operations comprising:

receiving scheduled sequential glucose time intervals throughout a day for measuring glucose of a patient, each scheduled sequential glucose time interval associated with a corresponding time boundary within the day that does not overlap with time boundaries associated with the other scheduled sequential glucose time intervals;

obtaining glucose data of the patient from a continuous glucose monitoring system in communication with the data processing hardware, the glucose data including glucose measurements of the patient and glucose times each associated with a time of measuring a corresponding glucose measurement;

determining one or more valid glucose measurements by removing from the obtained glucose measurements each glucose measurement that 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;

displaying, on a display of a remote healthcare provider computing device in communication with the data processing hardware, a modal day scatter chart of the glucose data, the modal data scatter chart comprising a corresponding shaded area within each scheduled sequential glucose time interval;

receiving, based on received drag-and-drop inputs that adjust time boundaries of the corresponding shaded area within each scheduled sequential time interval, a corresponding ideal meal time associated with each of the scheduled sequential glucose time intervals;

determining one or more usable glucose measurements by removing from the determined one or more valid glucose measurements each glucose measurement that exceeds a threshold value and identifying each glucose measurement associated with each of the scheduled sequential glucose time intervals as usable when the associated glucose time is at or before an end of the corresponding ideal mealtime associated with the scheduled sequential glucose time interval, the threshold value based on a mean of the determined one or more valid glucose measurements and a standard deviation of the determined one or more valid glucose measurements;

receiving a specified date range from the remote healthcare provider computing device;

for at least one of the scheduled sequential glucose time intervals, determining a representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval based on the determined one or more usable glucose measurements for each day in the specified date range;

determining a next recommended insulin dosage for the patient based on the representative aggregate glucose measurement determined for the at least one of the scheduled sequential glucose time intervals; and

transmitting the next recommended insulin dosage from the data processing hardware to a portable device associated with the patient, the portable device configured to display, at time of day within the at least one of the scheduled sequential glucose time intervals, a number of units of insulin for the next recommended insulin dosage.

2. The method of claim 1 , wherein the operations further comprise transmitting the next recommended insulin dosage 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 cause the doser to administer the next recommended insulin dosage to the patient.

3. 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.

4. The method of claim 1 , wherein determining the one or more usable glucose measurements further comprises at least one of the following:

identifying each glucose measurement associated with the at least one of the scheduled sequential glucose time intervals as usable when the associated glucose time is at or before a meal bolus time associated with the scheduled sequential glucose time interval;

identifying each glucose measurement associated with the at least one of the scheduled sequential glucose time intervals as usable when the corresponding glucose measurement is less than or equal to an upper limit of a target glucose range for the patient; or

identifying each glucose measurement associated with the at least one of the scheduled sequential glucose time intervals as usable when the associated glucose time is within the time boundary associated with the scheduled sequential glucose time interval.

5. The method of claim 1 , wherein determining the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval comprises:

for each day in the specified date range, aggregating one or more of the determined one or more usable glucose measurements for the corresponding scheduled sequential glucose time interval to determine a daily aggregate glucose measurement for the corresponding scheduled sequential glucose time interval; and

aggregating the daily aggregate glucose measurement determined for each day in the specified date range for the corresponding scheduled sequential glucose time interval to determine the representative aggregate glucose measurement for the corresponding scheduled sequential glucose associated with the selected time interval.

6. The method of claim 5 , wherein aggregating the daily aggregate glucose measurement determined for each day in the specified date range for the corresponding scheduled sequential glucose time interval comprises:

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 values associated with the lowest values up until the minimum number of available daily aggregate values to determine the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval.

7. The method of claim 6 , wherein the operations further comprise:

determining whether the total number of daily aggregate values for the corresponding scheduled sequential glucose time interval 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 corresponding scheduled sequential glucose time interval when the total number of daily aggregate values for the corresponding scheduled sequential glucose time interval is less than the minimum number of available daily aggregate values.

8. The method of claim 7 , wherein the operations further comprise, when the total number of daily aggregate values for the corresponding scheduled sequential glucose time interval is greater than or equal to the minimum number of available daily aggregate values, adjusting the previous recommended insulin dosage governed by the corresponding scheduled sequential glucose time interval based on the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval.

9. The method of claim 1 , wherein the operations further comprise:

selecting a governing glucose measurement as the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval;

determining an adjustment factor for adjusting a next recommended meal bolus governed by the corresponding scheduled sequential glucose time interval based on the selected governing glucose measurement;

obtaining a previous day recommended meal bolus governed by the corresponding scheduled sequential glucose time interval; and

determining the next recommended meal bolus by multiplying the adjustment factor times the previous day recommended meal bolus,

wherein the corresponding scheduled sequential glucose time interval 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 the operations further comprise:

selecting a governing glucose measurement as the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval;

determining an adjustment factor for adjusting a next recommended carbohydrate-to-insulin ratio governed by the corresponding scheduled sequential glucose time interval based on the selected governing glucose measurement;

obtaining a previous day recommended carbohydrate-to-insulin ratio governed by the corresponding scheduled sequential glucose time interval; and

determining the next recommended carbohydrate-to-insulin ratio by multiplying the adjustment factor times the previous day recommended carbohydrate-to-insulin ratio, wherein the corresponding scheduled sequential glucose time interval includes one of a lunch glucose time interval, a dinner glucose time interval, or a bedtime glucose time interval.

11. The method of claim 1 , wherein the operations further comprise:

aggregating one or more of the glucose measurements associated with a breakfast glucose time interval to determine a representative aggregate breakfast glucose measurement;

aggregating one or more of the glucose measurements associated with a midsleep glucose time interval to determine a representative aggregate midsleep glucose measurement;

selecting a governing glucose measurement as a lesser one of the representative aggregate midsleep glucose measurement or the representative aggregate breakfast glucose measurement;

determining an adjustment factor for adjusting a next recommended basal dosage based on the selected governing glucose measurement;

obtaining a previous day recommended basal dosage; and

determining the next recommended basal dosage by multiplying the adjustment factor times the previous day recommended basal dosage.

12. The method of claim 1 , wherein each scheduled sequential glucose 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 or a midsleep glucose measurement.

13. 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:

receiving scheduled sequential glucose time intervals throughout a day for measuring glucose of a patient, each scheduled sequential glucose time interval associated with a corresponding time boundary within the day that does not overlap with time boundaries associated with the other scheduled sequential glucose time intervals;

obtaining glucose data of the patient from a continuous glucose monitoring system in communication with the data processing hardware, the glucose data including glucose measurements of the patient and glucose times each associated with a time of measuring a corresponding glucose measurement;

determining one or more valid glucose measurements by removing from the obtained glucose measurements each glucose measurement that 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;

displaying, on a display of a remote healthcare provider computing device in communication with the data processing hardware, a modal day scatter chart of the glucose data, the modal data scatter chart comprising a corresponding shaded area within each scheduled sequential glucose time interval;

receiving, based on received drag-and-drop inputs that adjust time boundaries of the corresponding shaded area within each scheduled sequential time interval, a corresponding ideal meal time associated with each of the scheduled sequential glucose time intervals;

determining one or more usable glucose measurements by removing from the determined one or more valid glucose measurements each glucose measurement that exceeds a threshold value and identifying each glucose measurement associated with each of the scheduled sequential glucose time intervals as usable when the associated glucose time is at or before an end of the corresponding ideal mealtime associated with the scheduled sequential glucose time interval, the threshold value based on a mean of the determined one or more valid glucose measurements and a standard deviation of the determined one or more valid glucose measurements;

receiving a specified date range from the remote healthcare provider computing device;

for at least one of the scheduled sequential glucose time intervals, determining a representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval based on the determined one or more usable glucose measurements for each day in the specified date range;

determining a next recommended insulin dosage for the patient based on the representative aggregate glucose measurement determined for the at least one of the scheduled sequential glucose time intervals; and

transmitting the next recommended insulin dosage from the data processing hardware to a portable device associated with the patient, the portable device configured to display, at time of day within the at least one of the scheduled sequential glucose time intervals, a number of units of insulin for the next recommended insulin dosage.

14. The dosing controller of claim 13 , wherein the operations further comprise transmitting the next recommended insulin dosage to an administration device in communication with the dosing controller, the administration device comprising:

a doser; and

an administration computing device in communication with the doser, the administration computing device configured to cause the doser to administer the next recommended insulin dosage to the patient.

15. The dosing controller of claim 13 , 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.

16. The dosing controller of claim 13 , wherein determining the one or more usable glucose measurements further comprises at least one of the following:

identifying each glucose measurement associated with the at least one of the scheduled sequential glucose time intervals as usable when the associated glucose time is at or before a meal bolus time associated with the scheduled sequential glucose time interval;

identifying each glucose measurement associated with the at least one of the scheduled sequential glucose time intervals as usable when the corresponding glucose measurement is less than or equal to an upper limit of a target glucose range for the patient; or

identifying each glucose measurement associated with the at least one of the scheduled sequential glucose time intervals as usable when the associated glucose time is within the time boundary associated with the scheduled sequential glucose time interval.

17. The dosing controller of claim 13 , wherein determining the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval comprises:

for each day in the specified date range, aggregating one or more of the determined one or more usable glucose measurements for the corresponding scheduled sequential glucose time interval to determine a daily aggregate glucose measurement for the corresponding scheduled sequential glucose time interval; and

aggregating the daily aggregate glucose measurement determined for each day in the specified date range for the corresponding scheduled sequential glucose time interval to determine the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval.

18. The dosing controller of claim 17 , wherein aggregating the daily aggregate glucose measurement determined for each day in the specified date range for the corresponding scheduled sequential glucose time interval comprises:

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 values associated with the lowest values up until the minimum number of available daily aggregate values to determine the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval.

19. The dosing controller of claim 18 , wherein the operations further comprise:

determining whether the total number of daily aggregate values for the corresponding scheduled sequential glucose interval 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 corresponding scheduled sequential glucose time interval when the total number of daily aggregate values for the corresponding scheduled sequential glucose time interval is less than the minimum number of available daily aggregate values.

20. The dosing controller of claim 19 , wherein the operations further comprise:

when the total number of daily aggregate values for the corresponding scheduled sequential glucose time interval is greater than or equal to the minimum number of available daily aggregate values, adjusting the previous recommended insulin dosage governed by the corresponding scheduled sequential glucose time interval based on the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval.

21. The dosing controller of claim 13 , wherein the operations further comprise:

selecting a governing glucose measurement as the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval;

determining an adjustment factor for adjusting a next recommended meal bolus governed by the corresponding scheduled sequential glucose time interval based on the selected governing glucose measurement;

obtaining a previous day recommended meal bolus governed by the corresponding scheduled sequential glucose time interval; and

determining the next recommended meal bolus by multiplying the adjustment factor times the previous day recommended meal bolus, wherein the corresponding scheduled sequential glucose time interval includes one of a lunch glucose time interval, a dinner glucose time interval, or a bedtime glucose time interval.

22. The dosing controller of claim 13 , wherein the operations further comprise:

selecting a governing glucose measurement as the representative aggregate glucose measurement for the corresponding scheduled sequential glucose time interval;

determining an adjustment factor for adjusting a next recommended carbohydrate-to-insulin ratio governed by the corresponding scheduled sequential glucose time interval based on the selected governing glucose measurement;

obtaining a previous day recommended carbohydrate-to-insulin ratio governed by the corresponding scheduled sequential glucose time interval; and

determining the next recommended carbohydrate-to-insulin ratio by multiplying the adjustment factor times the previous day recommended carbohydrate-to-insulin ratio,

wherein the corresponding scheduled sequential glucose time interval includes one of a lunch glucose time interval, a dinner glucose time interval, or a bedtime glucose time interval.

23. The dosing controller of claim 13 , wherein the operations further comprise:

aggregating one or more of the glucose measurements associated with a breakfast glucose time interval to determine a representative aggregate breakfast glucose measurement;

aggregating one or more of the glucose measurements associated with a midsleep glucose time interval to determine a representative aggregate midsleep glucose measurement;

selecting a governing glucose measurement as a lesser one of the representative aggregate midsleep glucose measurement or the representative aggregate breakfast glucose measurement;

determining an adjustment factor for adjusting a next recommended basal dosage based on the selected governing glucose measurement;

obtaining a previous day recommended basal dosage; and

determining the next recommended basal dosage by multiplying the adjustment factor times the previous day recommended basal dosage.

24. The dosing controller of claim 13 , wherein each scheduled sequential glucose 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 or a midsleep glucose measurement.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 2, 2024
From: ASEKO, INC.
To: GLYTEC, LLC
Reel/Frame 067320/0764 →
SECURITY INTEREST Recorded Aug 8, 2023
From: ASEKO, INC.
To: HAYFIN SERVICES LLP, AS THE AGENT
Reel/Frame 064517/0872 →
RELEASE OF SECURITY INTEREST Recorded Aug 8, 2023
From: NEWLIGHT CAPITAL LLC
To: ASEKO, INC.; GLYTEC, LLC
Reel/Frame 064530/0362 →
SECURITY INTEREST Recorded Jun 6, 2022
From: ASEKO, INC.; GLYTEC, LLC
To: NEWLIGHT CAPITAL LLC, AS SERVICER
Reel/Frame 060283/0849 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2021
From: BOOTH, ROBERT C.; HEBBLEWHITE, HARRY
To: ASEKO, INC.
Reel/Frame 056836/0627 →
Continuity (4)
Continuation 15496419 · Apr 25, 2017
Continuation In Part 14922763 · Oct 26, 2015
Provisional Application 62069195 · Oct 27, 2014
Related Publication 20210335477A1 · Oct 28, 2021