Methods of incorporating CGM data into diabetes therapy

Patent metadata

Field	Value
Publication number	US-11969576-B2
Application number	US-202016920895-A
Country	US
Kind code	B2
Filing date	Jul 6, 2020
Priority date	Jul 3, 2019
Publication date	Apr 30, 2024
Grant date	Apr 30, 2024

Abstract

Disclosed herein are apparatuses and methods incorporating an infusion pump and a CGM that can include software that automatically populates a blood glucose section of a bolus calculator with a most recent valid CGM value. The software can additionally be programmed to automatically populate the bolus calculator with a single CGM reading only when one or more predefined conditions are met that aid in mitigating the risk of inaccurate and/or invalid single CGM readings.

First claim

The invention claimed is:

1. An ambulatory infusion pump system, comprising:
a pump mechanism configured to facilitate delivery of insulin to a user;
a user interface;
a communications device adapted to receive glucose levels from a continuous glucose monitor;
a processor functionally linked to the pump mechanism, the user interface and the communications device, the processor configured to:
automatically calculate insulin doses with a closed loop delivery algorithm based on glucose levels received from the continuous glucose monitor;
deliver the calculated insulin doses to the user with the pump mechanism;
display a bolus programming feature for programming a bolus delivery of insulin to the user;
determine whether the closed loop delivery algorithm supports an auto-population feature;
determine whether a current glucose level received from the continuous glucose monitor is valid; and
activate the auto-population feature to automatically populate a blood glucose field in the bolus programming feature with a most recent glucose level received from the continuous glucose monitor only if the closed loop delivery algorithm supports the auto-population feature, the current glucose level received from the continuous glucose monitor is valid, and a rate of change of glucose levels received from the continuous glucose monitor satisfies a certain defined threshold.

2. The system of claim 1 , wherein determining whether the glucose levels received from the continuous glucose monitor are valid includes determining whether one or more icons relating to the glucose levels were displayed on the user interface when the bolus programming feature was displayed.

3. The system of claim 2 , wherein the one or more icons include a current glucose level.

4. The system of claim 2 , wherein the one or more icons include a trend arrow providing an indication of a glucose trend based on a series of glucose values from the continuous glucose monitor.

5. The system of claim 2 , wherein determining whether the one or more icons relating to the glucose levels were displayed on the user interface incudes determining whether the one or more icons were displayed on a home screen of the user interface.

6. The system of claim 1 , wherein the processor is further configured to compare the most recent glucose level from the continuous glucose monitor automatically populated into the blood glucose field in the bolus programming feature to a target glucose level.

7. The system of claim 6 , wherein if the most recent glucose level is below the target glucose level, a meal bolus programmed with the bolus programming feature is reduced based on a difference between the target glucose level and the most recent glucose level.

8. The system of claim 6 , wherein if the most recent glucose level is above the target glucose level, a meal bolus programmed with the bolus programming feature is increased based on a difference between the most recent glucose level and the target glucose level.

9. The system of claim 1 , wherein the user interface is part of an ambulatory infusion pump that includes the pump mechanism.

10. The system of claim 1 , wherein the user interface is part of a remote control device for remotely controlling an ambulatory infusion pump that includes the pump mechanism.

11. An ambulatory infusion pump system, comprising:
a pump mechanism configured to facilitate delivery of insulin to a user;
a user interface;
a communications device adapted to receive glucose levels from a continuous glucose monitor;
a processor functionally linked to the pump mechanism, the user interface and the communications device, the processor configured to:
automatically calculate insulin doses with a closed loop delivery algorithm based on glucose levels received from the continuous glucose monitor;
deliver the calculated insulin doses to the user with the pump mechanism;
display a bolus programming feature for programming a bolus delivery of insulin to the user;
execute an auto-population risk mitigation procedure required to automatically populate a most recent glucose level received from the continuous glucose monitor into a blood glucose field of the bolus programming feature, the risk mitigation procedure requiring verification of one or more predefined conditions that aid in mitigating the risk of an inaccurate or invalid most recent glucose level; and
automatically populate the blood glucose field in the bolus programming feature with the most recent glucose level received from the continuous glucose monitor only if the auto-population risk mitigation procedure verifies the one or more predefined conditions including whether a rate of change of glucose levels received from the continuous glucose monitor satisfies a certain defined threshold.

12. The system of claim 11 , wherein the one or more predefined conditions include that the closed loop delivery algorithm supports the auto-population feature.

13. The system of claim 11 , wherein the one or more predefined conditions include that the bolus programming feature was manually accessed by the user.

14. The system of claim 11 , wherein the one or more predefined conditions include that recent glucose levels received from the continuous glucose monitor are valid.

15. The system of claim 14 , wherein verifying that the glucose levels received from the continuous glucose monitor are valid includes determining whether one or more icons relating to the glucose levels were displayed on the user interface when the bolus programming feature was displayed.

16. The system of claim 15 , wherein the one or more icons include a current glucose level.

17. The system of claim 15 , wherein the one or more icons include a trend arrow providing an indication of a glucose trend based on a series of glucose values from the continuous glucose monitor.

18. The system of claim 1 , wherein the processor is further configured to compare the most recent glucose level from the continuous glucose monitor automatically populated into the blood glucose field in the bolus programming feature to a target glucose level.

19. The system of claim 18 , wherein if the most recent glucose level is below the target glucose level, a meal bolus programmed with the bolus programming feature is reduced based on a difference between the target glucose level and the most recent glucose level.

20. The system of claim 18 , wherein if the most recent glucose level is above the target glucose level, a meal bolus programmed with the bolus programming feature is increased based on a difference between the most recent glucose level and the target glucose level.

Assignees

• Tandem Diabetes Care Inc

Inventors

• Michaud Michael
• Marin Garrett
• Kruse Geoffrey A
• Kearns Jacob
• Ulrich Thomas R
• Denbo Trevor
• Berger David

Classifications

• A61M5/1723 Primary

  using feedback of body parameters, e.g. blood-sugar, pressure (measurement of body parameters A61B5/00) · CPC title

• A61M2205/3553

  remote, e.g. between patient's home and doctor's office · CPC title

• A61M2205/3569

  sublocal, e.g. between console and disposable · CPC title

• A61M2205/50

  with microprocessors or computers · CPC title

• A61M2205/502

  User interfaces, e.g. screens or keyboards · CPC title