Granted Patent B2

US 12,667,665 · App. 17/578,716 · Granted Jun 30, 2026

Inventors: Yibin Zheng (Harland, WI); Joon Bok Lee (Acton, MA)

Assignee: INSULET CORPORATION

A61M5/1723A61M5/14244A61M2205/52

Abstract

Claims (84)

1 . A method, comprising:

accessing, by a controller of a drug delivery device, a drug delivery history, a bolus drug history, a blood glucose measurement history, and a meal announcement history for a period of time from a memory coupled to the controller;

calculating a daily basal profile using respective data from each of the drug delivery history, the bolus drug history, the blood glucose measurement history, and the meal announcement history, wherein the daily basal profile is a time schedule for delivering respective basal delivery dosages;

generating, by the controller, a control signal for delivery of a basal dosage at a scheduled time from the daily basal profile; and

causing delivery of the basal dosage in the daily basal profile by outputting the control signal to a pump mechanism of the drug delivery device communicatively coupled to the controller.

2 . The method of claim 1 , further comprising:

determining an adjusted basal need for each of a plurality of preselected times, wherein the adjusted basal need is an individual entry in the daily basal profile and the basal dosage is determined according to the adjusted basal need.

3 . The method of claim 2 , wherein the bolus drug history further includes an indication of which bolus dosages in the bolus drug history were delivered manually; and the method further comprising:

determining the adjusted basal need for each respective time of the plurality of preselected times, using an aggregate factor; and

outputting the adjusted basal need for a respective time of the plurality of preselected times.

4 . The method of claim 2 , wherein determining the adjusted basal need for each of the plurality of preselected times, comprises:

for each respective time of the plurality of preselected times,

summing an obtained amount of the drug, a respective blood glucose measurement factor, and an obtained respective amount of the drug delivered in the bolus dose to provide an aggregate factor,

determining a proportion of an amount of drug provided via bolus dosages to an amount provided via the aggregate factor,

modifying the proportion based on a contribution factor,

determining a resultant by multiplying the aggregate factor by the modified proportion; and

outputting the resultant of the multiplying as the adjusted basal need for a respective time of the plurality of preselected times.

5 . The method of claim 4 , wherein the contribution factor is a bias weighting that reduces a value of an estimated correction factor to less than 1.0.

6 . The method of claim 2 , wherein determining the adjusted basal need further comprises:

summing an obtained amount of the drug, and an obtained respective amount of the drug delivered in the bolus dose to provide an aggregate factor;

subtracting from the aggregate factor a respective blood glucose measurement factor; and

outputting a result of the summing and subtracting as the adjusted basal need for a respective time of the plurality of preselected times.

7 . The method of claim 2 , wherein the daily basal profile includes times at which a basal delivery dosage of the respective basal delivery dosages is to be delivered.

8 . The method of claim 1 , further comprising: determining a meal announcement factor by:

retrieving a meal announcement value corresponding to a respective time in a series of time settings, wherein the meal announcement value is an estimate of a number of carbohydrates in a meal that triggered the meal announcement notification;

determining an insulin-to-carbohydrate ratio; and

dividing the meal announcement value by the insulin to carbohydrate ratio, wherein the quotient is the meal announcement factor.

9 . The method of claim 1 , wherein calculating the daily basal profile, further comprises:

determining a series of time settings in the time schedule;

calculating a blood glucose measurement factor that corresponds to each time in the series of time settings using a blood glucose measurement value, a fasting blood glucose target setting, a duration of insulin action value, and a correction factor;

calculating a drug delivery history factor of calculated basal delivery dosages that corresponds to each time in the series of time settings using bolus dosages from the bolus drug history; and

setting the daily basal profile based on the adjusted basal need determined for each of a plurality of preselected times.

10 . The method of claim 2 , wherein calculating the blood glucose measurement factor, further comprises:

for each respective time of the plurality of preselected times:

outputting a blood glucose measurement factor that is determined based on a blood glucose measurement value obtained from the blood glucose measurement history,

a fasting blood glucose target setting,

a duration of insulin action value multiplied by an estimated correction factor.

11 . The method of claim 1 , further comprising:

filtering, by the controller, respective data in each of the drug delivery history, the bolus drug history, the blood glucose measurement history, and the meal announcement history, according to predetermined filter settings related to a time interval of the period of time.

12 . A drug delivery device comprising:

a controller; and

a memory storing instructions that, when executed by the controller, configure the drug delivery device to:

access a drug delivery history, a bolus drug history, a blood glucose measurement history, and a meal announcement history for a period of time from a memory coupled to the controller;

calculate a daily basal profile using respective data from each of the drug delivery history, the bolus drug history, the blood glucose measurement history, and the meal announcement history;

generate, by the controller, a control signal for delivery of a basal dosage of a calculated basal delivery dosages at a scheduled time from the daily basal profile; and

apply the control signal to a pump mechanism of the drug delivery device communicatively coupled to the controller.

13 . The drug delivery device of claim 12 , wherein the drug delivery device, when calculating the daily basal profile, is further configured to:

determine a series of time settings in the daily basal profile;

calculate a blood glucose measurement factor that corresponds to each time in the series of time settings using a blood glucose measurement value, a fasting blood glucose target setting, a duration of insulin action value, and a correction factor;

calculate a drug delivery history factor of the calculated basal delivery dosages that corresponds to each time in the series of time settings using bolus dosages from the bolus drug history;

determine a meal announcement factor that corresponds to each time in the series of time settings based on the meal announcement history and a drug ratio related to meal content; and

determine an adjusted basal need for each of a plurality of preselected times in the series of time settings.

14 . The drug delivery device of claim 13 , wherein the drug delivery device, when determining the adjusted basal need for each of the plurality of preselected times, is further configured to:

for each respective time of the plurality of preselected times:

sum an obtained amount of the drug, an obtained respective amount of the drug delivered in the bolus dose, and a respective blood glucose measurement factor to provide an aggregate factor;

subtract from the aggregate factor the meal announcement factor; and

output a result of the summing and subtracting as the adjusted basal need for a respective time of the plurality of preselected times.

15 . The drug delivery device of claim 13 , wherein the drug delivery device, when determining the adjusted basal need for each of the plurality of preselected times, is further configured to:

for each respective time of the plurality of preselected times:

sum an obtained amount of the drug from the drug amount data in the drug delivery history, an obtained respective amount of the drug delivered in the bolus dose, and a respective blood glucose measurement factor to provide an aggregate factor;

subtract from the aggregate factor the meal announcement factor and a proportion of an amount of the drug in the bolus dosage delivered manually from the bolus drug history; and

output the result of the summing and subtracting as the adjusted basal need for a respective time of the plurality of preselected times.

16 . The drug delivery device of claim 13 , wherein the drug delivery device, when determining a plurality of blood glucose measurement factors from the blood glucose measurement history, is further configured to:

for each respective time of the plurality of preselected times:

output a blood glucose measurement factor that is determined based on a blood glucose measurement value obtained from the blood glucose measurement history,

the fasting blood glucose target setting, and

a duration of insulin action value multiplied by an estimated correction factor.

17 . The drug delivery device of claim 13 , wherein the drug delivery device, when determining the adjusted basal need for each of the plurality of preselected times, is further configured to:

for each respective time of each of the plurality of preselected times:

output the adjusted basal need for the respective time of the plurality of preselected times, wherein the adjusted basal need is determined based on an aggregate factor, and a contribution factor.

18 . The drug delivery device of claim 12 , wherein:

the drug delivery history is a data structure containing drug amount data related to background doses of a drug delivered at respective times over a course of the drug delivery history based on an algorithm executed by the controller,

the bolus drug history is a data structure containing bolus delivery time data related to delivery of bolus doses of the drug and an amount of the drug delivered in each bolus dose of the bolus doses,

the blood glucose measurement history is a data structure of blood glucose measurement values in which each blood glucose measurement value has a corresponding time when the blood glucose measurement value was obtained, and

the meal announcement history is a data structure of times when a meal announcement notification was received by the controller.

19 . The drug delivery device of claim 12 , wherein the daily basal profile includes a time schedule for delivering respective basal delivery dosages.

20 . A drug delivery device comprising:

a controller; and

a memory storing instructions that, when executed by the controller, configure the drug delivery device to:

access a drug delivery history, a bolus drug history, a blood glucose measurement history, and a meal announcement history for a period of time from a memory coupled to the controller;

filter, by the controller, respective data in each of the drug delivery history, the bolus drug history, the blood glucose measurement history, and the meal announcement history, according to predetermined filter settings related to a time interval of the period of time;

calculate a daily basal profile using the filtered, respective data from each of the drug delivery history, the bolus drug history, the blood glucose measurement history, and the meal announcement history;

generate, by the controller, a control signal for delivery of a basal dosage of the calculated basal delivery dosages at a scheduled time from the daily basal profile; and

cause delivery of the calculated basal delivery dosages at the scheduled time by applying the control signal to a pump mechanism of the drug delivery device communicatively coupled to the controller.

Assignments (2)

Continuity (2)

References Cited (400)