Correction factor testing using frequent blood glucose input

• US 10,357,607 B2
• Filed: 12/08/2015
• Issued: 07/23/2019
• Est. Priority Date: 05/24/2007
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Blomquist, Michael L., Pope, Rhall E.
• Primary Examiner(s): Auduong, Gene N
• Application Number:
  US14/962,635
• Publication Number:
  US 20160082188A1
• Time in Patent Office: 1,323 Days
• Field of Search: 700 83
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/507 Head Mounted Displays [HMD]
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: G05B 15/02 electric
• CPC Class Codes: G06N 5/027 Frames
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

An apparatus comprises receiving a user prompt in a blood glucose (BG) management device to start a determination of an effective correction factor, receiving sampled blood glucose data of a patient obtained during a specified time duration, including a time duration after delivery of an initial insulin correction bolus, determining the effective correction factor using the BG management device according to a determined decrease in the blood glucose level of the patient and an amount of insulin in the initial insulin correction bolus, and cancelling the determination of the effective correction factor if a blood glucose level of the patient is outside of a specified range of blood glucose levels.

Claims

1. An ambulatory insulin pump system, comprising:

a pump configured to deliver insulin to a user;

a user interface including a display;

a memory; and

a controller in electrical communication with the pump, the memory and the user interface, the controller configured to determine an effective correction factor for the user by conducting a correction factor test, the correction factor test comprising;

receiving sampled glucose level data of the user obtained during a specified time duration;

causing the pump to deliver an initial insulin correction bolus to the user during the specified time duration;

determining from the sampled glucose level data a decrease in the glucose level of the user during the specified time duration;

calculating an effective correction factor for the user based on the decrease in the glucose level and an amount of the initial insulin correction bolus; and

saving the effective correction factor in memory.

2. The ambulatory insulin pump system of claim 1, wherein the controller is configured to conduct the correction factor test in response to a prompt from a user received through the user interface.

3. The ambulatory insulin pump system of claim 1, wherein the controller is configured to display information relating to the correction factor test on the display.

4. The ambulatory insulin pump system of claim 3, wherein the information includes instructions to the user.

5. The ambulatory insulin pump system of claim 1, wherein the initial insulin correction bolus is delivered at a beginning of the specified time duration.

6. The ambulatory insulin pump system of claim 1, wherein the correction factor test further comprises calculating the amount of the initial insulin correction bolus prior to causing the pump to deliver the initial insulin correction bolus.

7. The ambulatory insulin pump system of claim 1, further comprising a communications port and wherein the controller is configured to receive the sampled glucose level data from a separate device.

8. The ambulatory insulin pump system of claim 7, wherein the separate device is a continuous glucose monitor.

9. The ambulatory insulin pump system of claim 1, wherein the controller is contained within one of the pump, a continuous glucose monitor or a device that does not include the pump or sample the glucose level data.

10. An ambulatory insulin pump system for delivering insulin to a user, the insulin pump system having a controller, the controller being programmed with an algorithm configured to:

receive input data related to a first user glucose level;

initiate infusion of a known predetermined quantity of insulin to the user;

record a time of the infusion of the known quantity of insulin;

wait a length of time after the infusion of the known quantity of insulin;

receive input data related to a second user glucose level;

calculate a change in glucose level between the first user glucose level and the second user glucose level;

calculate a correction factor for the user by diving the change in glucose level by the known predetermined quantity of insulin;

save the correction factor in memory;

receive input of a current glucose level and target glucose level;

calculate an insulin dose to bring the current glucose level to the target glucose level using the calculated correction factor; and

deliver the calculated dose to the user.

11. The ambulatory insulin pump system of claim 10, wherein the controller is configured to initiate receipt of the input data by presenting instructions to the user on a display to perform a glucose level measurement.

12. The ambulatory insulin pump system of claim 10, wherein the controller is configured to receive the input data from a continuous glucose monitor.

13. The ambulatory insulin pump system of claim 10, wherein the controller is configured to execute the algorithm in response to a prompt from the user to initiate a correction factor test.

14. The ambulatory insulin pump system of claim 10, wherein the controller is further configured to calculate the known predetermined quantity of insulin.

15. An ambulatory insulin pump system, comprising:

a pump configured to deliver insulin to a user;

a user interface including a display;

a memory; and

a controller in electrical communication with the pump, the memory and the user interface, the controller including a timer, a correction factor module and an insulin calculation module and configured to;

receive sampled glucose level data of the user obtained during a specified time duration;

cause the pump to deliver an initial insulin correction bolus to the user during the specified time duration;

determine from the sampled glucose level data a decrease in the glucose level of the user during the specified time duration with the correction factor module;

calculate with the correction factor module an effective correction factor for the user based on the decrease in the glucose level and an amount of the initial insulin correction bolus; and

save the effective correction factor in memory.

16. The ambulatory insulin pump system of claim 15, wherein the initial insulin correction bolus is calculated by the insulin calculation module.

17. The ambulatory insulin pump system of claim 15, further comprising a communications port and wherein the controller is configured to receive the sampled glucose level data from a separate device.

18. The ambulatory insulin pump system of claim 17, wherein the separate device is a continuous glucose monitor.

19. The ambulatory insulin pump system of claim 15, wherein the controller is configured to calculate with the insulin calculation module future insulin boluses using the effective correction factor saved in memory.

20. The ambulatory insulin pump system of claim 15, wherein the controller is further configured to receive a prompt from the user through the user interface to determine the effective correction factor.

21. The ambulatory insulin pump system of claim 15, wherein the controller is configured to display instructions to the user on the display.

22. The ambulatory insulin pump system of claim 15, wherein the controller is contained within one of the pump, a continuous glucose monitor or a device that does not include the pump or sample the glucose level data.