System and method for adjusting insulin delivery

• US 10,881,792 B2
• Filed: 01/12/2018
• Issued: 01/05/2021
• Est. Priority Date: 01/13/2017
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Mazlish, Bryan, Desborough, Lane, Naylor, Ross
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US15/870,591
• Publication Number:
  US 20180200434A1
• Time in Patent Office: 1,089 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/003 Kits for diabetics
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices

Abstract

The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Such personalization may include adjusting user specific dosage parameters in response to a user provided insulin delivery amount, including a user provided insulin delivery amount that varies from a recommended insulin delivery amount. Methods and systems may include locking out automated modification of a baseline basal rate of insulin for the user for the time period after a user provides an insulin delivery amount.

Claims

1. A method comprising:

providing a recommended bolus dose of insulin;

receiving a user override of the recommended bolus dose of insulin such that a different amount of insulin than the recommended bolus dose of insulin is delivered;

for a time period after the user override, locking out automated modification of a baseline basal rate of insulin for the user for the time period; and

permitting automated modification of at least one of an insulin sensitivity factor and a carbohydrate-to-insulin ratio for at least a portion of the time period while locking out automated modification of a daily basal rate of insulin.

2. The method of claim 1, wherein the time period is a diurnal time period of another day that corresponds to a time of day when the user override is received.

3. The method of claim 2, wherein the diurnal time period is at least 20 hours after the time of day.

4. The method of claim 1, further comprising locking out automated modification of an insulin sensitivity factor and a carbohydrate-to-insulin ratio for the time period.

5. The method of claim 1, further comprising:

tracking a number of times that the user overrides the recommended bolus dose of insulin; and

based on the number of times exceeding a threshold, sending a notification to the user indicating that the number of times exceeded the threshold.

6. The method of claim 1, further comprising:

tracking a magnitude of difference between the different amount of insulin and the recommended bolus dose of insulin; and

based on the magnitude of difference exceeding a threshold, sending a notification to the user indicating that the magnitude of difference exceeded the threshold.

7. The method of claim 1, further comprising,

providing a second recommended bolus dose of insulin;

receiving notification that the second recommended bolus dose of insulin is delivered; and

for a second time period after the second recommended bolus dose of insulin is delivered, automatedly modifying the baseline basal rate of insulin for the user for the second time period.

8. The method of claim 1, wherein providing the recommended bolus dose of insulin comprises displaying the recommended bolus dose of insulin on a graphical user interface of an electronic device.

9. The method of claim 1, wherein locking out modification of a baseline basal rate of insulin for the user comprises continuing to deliver insulin at the baseline basal rate rather than at a ratio of the baseline basal rate of insulin determined by a selected insulin delivery profile including a series of insulin delivery actions of insulin delivery at a variable ratio of the baseline basal rate.

10. The method of claim 1, wherein the baseline basal rate of insulin is a scaled back baseline basal rate based on the user transitioning from an injection-based insulin delivery device to an insulin pump.

11. The method of claim 10, wherein the scaled back baseline basal rate is between approximately 85% and 95% of a baseline basal rate of the user when using the injection-based insulin delivery.

12. The method of claim 1, further comprising:

delivering basal insulin from an insulin pump to a person with diabetes based on blood glucose data, wherein an amount of basal insulin delivered is based on the baseline basal rate of insulin and is selected to achieve a desired blood glucose level;

wherein the locking out automated modification of the baseline basal rate of insulin for the user for the time period includes altering one or more of the one or more stored basal insulin delivery rates while ignoring the amount of basal insulin delivered during a lockout time period subsequent to the user override.

13. The method of claim 12, wherein the lockout time period is a predetermined period of time.

14. The method of claim 12, wherein the lockout time period is based on a difference between the different amount of insulin and the recommended bolus dose of insulin.

15. The method of claim 1, wherein locking out automated modification of a baseline basal rate of insulin for the user comprises continuing to deliver insulin at the baseline basal rate rather than at a ratio of the baseline basal rate determined by a selected insulin delivery profile including a series of insulin delivery actions of insulin delivery at a variable ratio of the baseline basal rate of insulin.

16. A system comprising:

an insulin delivery device configured to deliver insulin to a person with diabetes based on glucose data and one or more stored basal insulin delivery rates, wherein an amount of basal insulin delivered is selected to achieve a desired blood glucose level or range; and

a control device configured to perform one or more operations, the operations including;

providing a recommended bolus dose of insulin to be delivered via the insulin delivery device, the recommended bolus dose of insulin being calculated to achieve the desired blood glucose level or range; and

receiving a user override of the recommended bolus dose of insulin such that a different amount of insulin than the recommended bolus dose of insulin is delivered via the insulin delivery device,

wherein the insulin delivery device or the control device is configured to store the one or more stored basal insulin delivery rates and to alter the one or more stored basal insulin delivery rates based on the amount of basal insulin delivered, wherein the insulin delivery device or the control device does not alter the one or more stored basal insulin delivery rates based on an amount of basal insulin delivered during a lockout time period subsequent to a delivered bolus.

17. The system of claim 16, wherein the insulin delivery device includes an insulin pump.

18. The system of claim 16, wherein the insulin delivery device includes one of an insulin pen or an insulin syringe.

19. The system of claim 16, wherein the insulin delivery device and the control device are included in a single device.

20. The system of claim 16, wherein the lockout time period is invoked only after receiving the user override.

21. A method for personalizing basal insulin delivery rates in an automated insulin delivery system comprising:

receiving blood glucose data regarding a person with diabetes from a glucose sensor;

delivering basal insulin from an insulin pump to the person with diabetes based on the blood glucose data, wherein an amount of basal insulin delivered is selected to achieve a desired blood glucose level or range;

altering one or more stored basal insulin delivery rates for one or more future time periods based on the amount of basal insulin delivered during one or more past time periods;

receiving bolus instructions from a user; and

delivering a bolus based on the bolus instructions;

wherein the altering of the one or more stored basal insulin delivery rates ignores the amount of basal insulin delivered during the one or more past time periods for a lockout time period subsequent to the user override.

22. The method of claim 21, wherein the amount of basal insulin delivered is a predetermined ratio of a target basal insulin delivery rate.

23. The method of claim 22, wherein the target basal insulin delivery rate is variable for a plurality of diurnal time periods throughout a day.

24. The method of claim 22, wherein the user is one of the person with diabetes or a caregiver of the person with diabetes.

25. The method of claim 21, further comprising altering at least one of an insulin sensitivity factor and a carbohydrate-to-insulin ratio during the lockout time period.

26. The method of claim 21, further comprising:

receiving a bolus inquiry from a user;

providing a recommended bolus dose of insulin to the user upon receiving the bolus inquiry, the recommended bolus dose of insulin being based upon consumption of carbohydrates, an elevated blood glucose level, or a combination thereof, the recommended bolus dose of insulin being calculated in order to achieve the desired blood glucose level or range; and

receiving a user override of the recommended bolus dose of insulin such that a different amount of insulin than the recommended bolus dose of insulin is delivered by the insulin pump.

27. The method of claim 26, wherein the bolus inquiry indicates an amount of carbohydrates to be consumed by the person with diabetes.

28. The method of claim 26, wherein the bolus inquiry is indicated as being intended to correct for a high blood glucose level without consumption of additional carbohydrates.

29. A method comprising:

providing a recommended bolus dose of insulin;

receiving a user override of the recommended bolus dose of insulin such that a different amount of insulin than the recommended bolus dose of insulin is delivered; and

for a time period after the user override, locking out automated modification of a baseline basal rate of insulin for the user for the time period,

wherein the time period is a diurnal time period of another day that corresponds to a time of day when the user override is received.