Granted Patent B2

US 12,620,473 · App. 18/324,140 · Granted May 5, 2026

Inventors: Robert C. Booth (Greer, SC); Harry Hebblewhite (Atlanta, GA)

Assignee: Glytec, LLC

G16H20/60A61B5/0022A61B5/14532A61B5/4839A61B5/7475A61M5/1723G16H10/40G16H10/60G16H20/17G16H40/63G16H40/67A61B5/14503A61B5/7239A61B5/7405A61M2205/3303

Abstract

Claims (86)

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.

Assignments (3)

Continuity (5)

References Cited (400)