Insulin on board calculation, schedule and delivery

• US 10,188,793 B2
• Filed: 06/08/2015
• Issued: 01/29/2019
• Est. Priority Date: 06/10/2014
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Mazlish, Bryan
• Primary Examiner(s): Vanni, G Steven
• Application Number:
  US14/733,567
• Publication Number:
  US 20150352282A1
• Time in Patent Office: 1,331 Days
• Field of Search: None
• 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: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system is provided with an insulin delivery device configured to deliver insulin to a user of the system and a computer-based control unit associated with the insulin delivery device. The computer-based control unit includes a user interface and a computer-based processor. The computer-based processor is configured to calculate a relative insulin on board value for a specific time by calculating a first value that represents a reference insulin on board value at the specific time, calculating a second value that represents an automated insulin on board value at the specific time, and subtracting one of the first and second values from the other. The automated insulin on board value represents at least one insulin delivery automatically specified by the computer-based control unit. Methods of use are also disclosed.

Claims

1. An insulin delivery system comprising:

an insulin delivery device configured to deliver insulin to a user of the system; and

a computer-based control unit associated with the insulin delivery device, the computer-based control unit having a computer-based processor, wherein the computer-based processor is configured to;

calculate a relative insulin on board value for a specific time by calculating a first value that represents a reference insulin on board value at the specific time, calculating a second value that represents an automated insulin on board value at the specific time, and subtracting one of the first and second values from the other;

determine a future insulin delivery schedule over a period of time based in part on the calculated relative insulin on board value; and

configure the insulin delivery device to deliver insulin according to the determined future insulin delivery schedule, and

wherein the automated insulin on board value represents at least one insulin delivery automatically specified by the computer-based control unit.

2. The system of claim 1, wherein the relative insulin on board calculation further includes adding a third value that represents a non-automated insulin on board value to the second value that represents an automated insulin on board value when calculating the second value, wherein a non-automated insulin on board value represents at least one insulin delivery manually specified by the user or a caregiver.

3. The system of claim 2, wherein the relative insulin on board calculation takes into account one or more values representative of all insulin delivered to the user prior to the specific time that has not been completely absorbed by the user prior to the specific time, including any and all basal doses delivered to the user.

4. The system of claim 1, further comprising a glucose monitor configured to measure glucose values of the user, wherein the glucose monitor is configured to automatically transfer the glucose values to the computer-based control unit, and wherein the computer-based control unit is configured with a mode to automatically control insulin delivery to the user through the insulin delivery device, thereby forming an automatic feedback control loop.

5. The system of claim 4, wherein the computer-based processor is configured to calculate the relative insulin on board value by subtracting the first value from the second value.

6. The system of claim 4, wherein the first value is representative of all insulin delivered according to a reference insulin delivery schedule and the second value is representative of all insulin delivered according to an automated insulin delivery schedule.

7. The system of claim 4, wherein the reference insulin on board value is greater than the automated insulin on board value.

8. The system of claim 4, further comprising a user interface on a display device, wherein the user interface is configured to present an indication of the relative insulin on board value to the user or a caregiver.

9. The system of claim 8, wherein the indication of the relative insulin on board value is a relative insulin on board function over a time period.

10. The system of claim 9, wherein at least a portion of the time period is a future time.

11. The system of claim 10, wherein the user interface is configured to present a predicted change in glucose levels associated with the relative insulin on board function.

12. The insulin delivery system of claim 4, wherein the computer-based control unit further comprises a bolus calculator configured to use the calculated relative insulin on board value to determine a bolus dosage.

13. The insulin delivery system of claim 1, wherein the computer-based control unit further comprises a bolus calculator configured to use the calculated relative insulin on board value to determine a bolus dosage.

14. An insulin delivery device comprising:

an insulin delivery mechanism configured to deliver insulin to a user of the device; and

a computer-based control unit coupled to the insulin delivery mechanism to automatically deliver insulin to the user, the computer-based control unit having a computer-based processor, wherein the computer-based processor is configured to;

calculate a relative insulin on board value associated with a specific time period by calculating a first value that represents a reference insulin on board value associated with the specific time period, calculating a second value that represents an automated insulin on board value associated with the specific time period, and subtracting one of the first and second values from the other, wherein the automated insulin on board value represents at least one insulin delivery automatically specified by the computer-based control unit;

determine a future insulin delivery schedule over a period of time based in part on the calculated relative insulin on board value; and

configure the insulin delivery mechanism to deliver insulin according to the determined future insulin delivery schedule,

wherein the reference insulin on board value may be greater than the automated insulin on board value.

15. The insulin delivery device of claim 14, wherein the computer-based control unit further comprises a bolus calculator configured to use the calculated relative insulin on board value to determine a bolus dosage.