Devices, systems and methods for quantifying bolus doses according to user parameters

• US 9,919,105 B2
• Filed: 09/16/2010
• Issued: 03/20/2018
• Est. Priority Date: 09/18/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Shapira, Gali, Gescheit, Iddo M.
• Primary Examiner(s): Hayman, Imani
• Application Number:
  US13/496,716
• Publication Number:
  US 20120283694A1
• Time in Patent Office: 2,742 Days
• Field of Search: 604 31, 604 65- 67, 604347, 604365, 604500, 604503-504, 6048901-8921
• 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 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

Abstract

Devices, systems and methods for determining a recommended bolus dose of therapeutic fluid to be delivered to the body are disclosed. Such a recommended bolus dose may be provided by establishing an initial bolus dose for a user based on one or more first parameters relating to the user and adjusting (e.g., increasing or decreasing) this initial bolus dose amount based on one or more second user parameters by multiplying the initial bolus dose by one or more multiplier values that correlate to at least one of the second parameters and/or by adding or subtracting an absolute value of at least one of the second parameters from the initial bolus dose amount.

Claims

1. A method for determining a recommended bolus dose of therapeutic fluid to be delivered to the body of a user, the method comprising:

receiving by a processor a current blood glucose level (CBG) of the user;

receiving by the processor a BG trend including a direction and/or rate of change of blood glucose level (BG) of the user;

receiving by the processor one or more additional parameters relating to the user;

determining by the processor an initial bolus dose of the therapeutic fluid for the user before delivery to the body of the user based on the CBG, the BG trend and the one or more additional parameters relating to the user;

determining by the processor a recommended bolus dose to be delivered to the body of the user based on the initial bolus dose being multiplied by one or more multiplier values, wherein the one or more multiplier values represent a magnitude on a relative scale of an associated one of the BG trend and the one or more additional parameters, such that delivering the recommended bolus dose to the user compensates for a change in a BG level of the user, and wherein the recommended bolus is determined by the processor after determining the initial bolus dose and before delivery of any one of the initial bolus dose and the recommended bolus dose; and

notifying, by the processor, the user of the recommended bolus dose.

2. The method of claim 1, wherein the one or more additional parameters relating to the user are selected from a group consisting of insulin sensitivity (IS), carbohydrate-to-insulin ratio (CIR), target blood glucose level (TBG), an amount of carbohydrate to be consumed (TC), and residual insulin (RI).

3. The method of claim 1, wherein the one or more additional parameters relating to the user are selected from a group consisting of:

glycemic index (GI), fat content of the meal, and fiber content of the meal.

4. The method of claim 1, wherein the CBG is measured via a continuous glucose monitor (CGM).

5. The method of claim 1, wherein the BG trend is received from a continuous glucose monitor (CGM).

6. The method of claim 1, wherein at least one of the one or more additional parameters relating to the user, the CBG and the BG trend is received via a user interface.

7. The method of claim 1, further comprising retrieving, from a memory, the one or more multiplier values correlating to the BG trend.

8. The method of claim 1, wherein determining the recommended bolus dose includes adding or subtracting one or more absolute values to or from the initial bolus dose.

9. The method of claim 8, further comprising retrieving, from a memory, the one or more absolute values corresponding to the BG trend.

10. The method of claim 8, wherein:

the one or more absolute values are added when the BG trend is increasing;

the one or more the absolute values are subtracted when the BG trend is decreasing; and

the one or more absolute values equals 0 when the BG level is constant.

11. The method of claim 8, wherein the one or more absolute values are determined based on a mathematical function that correlates the BG trend with the one or more absolute values.

12. The method of claim 1, wherein the one or more multiplier values correlate to the BG trend, and wherein the one or more multiplier values are greater than 1 when the BG trend is increasing;

the one or more multiplier values are less than 1 when the BG trend is decreasing; and

the one or more multiplier values equal 1 when the BG level is constant.

13. The method of claim 1, wherein the one or more multiplier values are determined based on a mathematical function that correlates the BG trend with the one or more multiplier values.

14. The method of claim 1, wherein the notifying is via a display.

15. The method of claim 1, further comprising delivering the therapeutic fluid according to the recommended bolus dose.

16. The method of claim 1, wherein the one or more additional parameters relating to the user has a first group of parameters comprised of one or more of insulin sensitivity (IS), carbohydrate-to-insulin ratio (CIR), target blood glucose level (TBG), an amount of carbohydrate to be consumed (TC), residual insulin (RI), a received user input via a user interface, glycemic index (GI), and content of the meal, and a second group of parameters comprised of physical activity level, emotional stress level, blood ketones level and/or trend, blood pH level and/or trend, presence of an illness and/or menstruation, and body temperature, and wherein the initial bolus dose is based on the one or more of the additional parameters being selected from the first group of parameters and the CBG, and the one or more multiplier values correlate with at least one of the one or more additional parameters being selected from the second group of parameters and the BG trend.

17. The method of claim 1, wherein determining the recommended bolus dose comprises:

averaging a plurality of multiplier values of the one or more multiplier values, wherein at least one of the one or multiplier values correlates to the BG trend; and

determining the recommended bolus dose includes multiplying the initial bolus dose with the average of the plurality of multiplier values.

18. The method of claim 1, further comprising adjusting a timing and/or duration associated with the recommended bolus dose based on at least the BG trend.

19. The method of claim 1, wherein:

the recommended bolus dose is less than the initial bolus dose if the BG trend is decreasing;

the recommend bolus dose is greater than the initial bolus dose if the BG trend is increasing; and

the recommended bolus dose equals the initial bolus dose if the BG level of the user is constant.

20. The method of claim 1, wherein the therapeutic fluid comprises insulin.

21. The method of claim 1, further comprising receiving by the processor, from a user interface, the one or more multiplier values correlating to the one or more additional parameters.

22. A method for determining a recommended bolus dose of therapeutic fluid to be delivered to the body of a user, the method comprising:

receiving by a processor a current blood glucose level (CBG) of the user;

receiving by the processor a BG trend including a direction and/or rate of change of blood glucose level (BG) of the user;

receiving by the processor one or more additional parameters relating to the user;

determining by the processor an initial bolus dose of the therapeutic fluid for the user before delivery to the body of the user based on the CBG, the BG trend and the one or more additional parameters relating to the user;

determining by the processor a recommended bolus dose to be delivered to the body of the user based on the initial bolus dose being multiplied by one or more multiplier values, wherein the one or more multiplier values represent a magnitude on a relative scale of an associated one of the BG trend and the one or more additional parameters, such that delivering the recommended bolus dose to the user compensates for a change in a BG level of the user, and wherein the recommended bolus is determined by the processor after determining the initial bolus dose and before delivery of any one of the initial bolus dose and the recommended bolus dose; and

notifying, by the processor, the user of the recommended bolus dose, wherein the one or more additional parameters relating to the user has a first group of parameters is comprised of insulin sensitivity (IS), carbohydrate-to-insulin ratio (CIR), target blood glucose level (TBG), an amount of carbohydrate to be consumed (TC), residual insulin (RI), a received user input via a user interface, glycemic index (GI), fat content of the meal, and fiber content of the meal, and a second group of parameters comprised of physical activity level, emotional stress level, blood ketones level and/or trend, blood pH level and/or trend, presence of an illness and/or menstruation and body temperature, and wherein the initial bolus dose is based on the one or more of the additional parameters being selected from the first group of parameters and the CBG, and the one or more multiplier values correlate with at least one of the one or more additional parameters being selected from the second group of parameters and the BG trend.