Method for selecting bolus doses and bolus delivery patterns in a drug delivery device

• US 8,480,649 B2
• Filed: 04/28/2009
• Issued: 07/09/2013
• Est. Priority Date: 04/29/2008
• 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
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US12/990,179
• Publication Number:
  US 20110106050A1
• Time in Patent Office: 1,533 Days
• Field of Search: 604 65- 67, 604 30- 34, 604/218, 604/131, 604/154, 604/504, 700/87, 700/282, 707/758
• US Class Current: 604/504
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• 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 5/14248 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: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Embodiments of the present disclosure include methods, systems and devices for selecting a bolus configuration and may include one or more of providing a user interface for selection of one or more user interface elements, where each element corresponds to a bolus configuration of a drug, each element is spatially positioned within a multi-dimensional space corresponding to at least three dimensions and the element'"'"'s position corresponding to each dimension.

Claims

1. A method for selecting a bolus configuration in a drug delivery device for infusing a drug into a body of a user, the method comprising:

providing a fluid delivery system including a processor having instructions operating thereon to enable the system and/or allow the system to perform the steps of;

receiving a current glucose value of a user;

receiving a carbohydrate load value of a food intake to be consumed by the user;

receiving one or more additional inputs; and

automatically determining a bolus configuration to be delivered to the user, wherein the bolus configuration comprises an amount of a drug to be delivered and a delivery pattern;

wherein determining the bolus configuration comprises;

displaying to the user at least one grid of one or more bolus configurations stored in a memory, wherein each bolus configuration corresponds to a different combination of values of three or more inputs including the current glucose value of the user, the carbohydrate load value of the food intake to be consumed by the user and the one or more additional inputs, and wherein the at least one grid comprises three or more dimensions, each of the dimensions corresponding to one of the three or more inputs; and

retrieving a selected bolus configuration from the stored one or more bolus configurations based on user selection of at least one of the one or more bolus configurations via a user interface for determining the bolus configuration to be delivered to the user.

2. The method of claim 1, wherein determining the bolus configuration comprises:

determining the amount of drug to be delivered based on the current glucose value and the carbohydrate load; and

determining the delivery pattern based on at least one of the one or more additional inputs.

3. The method of claim 2, wherein the one or more additional inputs is selected from the group consisting of:

the glycemic index (GI) of the intake, the content of the intake, glycemic load (GL) of the intake, fat content of the food intake, fiber content of the food intake, residual insulin (RI), and a physiological parameter of the user.

4. The method of claim 1, wherein the bolus configuration is determined based on previous bolus configurations.

5. The method of claim 1, wherein the value of at least one of the current glucose value of the user, the carbohydrate load of a food intake to be consumed and the one or more additional inputs are represented as qualitative descriptive values.

6. The method of claim 5, wherein each qualitative descriptive value comprises one or more value ranges of an input of the at least one of the current glucose value of the user, the carbohydrate load of a food intake to be consumed by the user and the one or more additional inputs.

7. The method of claim 5, wherein the qualitative descriptive values comprise small, medium and large.

8. The method of claim 1, wherein the amount of the drug to be delivered does not exceed a pre-determined maximal overshoot and/or minimal undershoot criteria.

9. The method of claim 8, wherein the maximal overshoot and/or minimal undershoot criteria are configurable by the user.

10. The method of claim 1, further comprising providing a drug delivery device infusing the drug according to the bolus configuration.

11. The method of claim 1, wherein each grid of the at least one grid is defined by one or more user parameters selected from the group consisting of CIR, IS, TBG and RI.

12. The method of claim 1, further comprising providing a user interface for presenting the at least one grid in a multi-dimensional space presentation corresponding to the three or more dimensions of the at least one grid, wherein each bolus configuration is spatially positioned within the multi-dimensional space in accordance to the different values combination of the three or more inputs.

13. The method of claim 1, further comprising providing a user interface for presenting the at least one grid in a two-dimensional space presentation corresponding to two dimensions of the three or more dimensions of the at least one grid, wherein each bolus configuration is spatially positioned within the dimensional space in accordance to the different values combination of the three or more inputs.

14. The method of claim 1, further comprising providing a user interface implemented in a remote control, a skin-securable patch-pump delivering the drug according to the bolus configuration, and optionally a glucometer providing the current glucose value.

15. The method of claim 1, further comprising providing a continuous glucose monitor (CGM) adopted for providing glucose values.

16. A drug delivery system for infusing a drug into a body of a user, the system comprising:

a processor having instructions operating thereon to enable the system to;

receive a glucose value of a user;

receive a carbohydrate load value of a food intake to be consumed by the user;

receive one or more additional inputs; and

automatically determining a bolus configuration, wherein the bolus configuration comprises an amount of a drug to be delivered and a delivery pattern;

wherein determining the bolus configuration comprises;

displaying to the user at least one grid of one or more bolus configurations stored in a memory, wherein each of the one or more bolus configurations corresponds to a different combination of values of three or more inputs including the current glucose value of the user, the carbohydrate load value of the food intake to be consumed by the user and the one or more additional inputs, and wherein the at least one grid comprises three or more dimensions, each of the dimensions corresponding to one of the three or more inputs; and

retrieving a selected bolus configuration from the stored one or more bolus configurations based on user selection of at least one of the one or more bolus configurations via a user interface for determining the bolus configuration to be delivered to the user; and

a drug delivery device for infusing the drug to the user.

17. A method for selecting a bolus configuration in a drug delivery device for infusing a drug into a body of a user, the method comprising:

providing a fluid delivery system including a processor having instructions operating thereon to enable and/or perform the steps of;

receiving values of three or more inputs;

providing a user interface for presenting one or more bolus configurations as at least one grid in a multi-dimensional space presentation corresponding to three or more dimensions, wherein each of one or more the bolus configurations corresponds to a different combination of three or more input values, and wherein each of the one or more bolus configurations is spatially positioned within the multi-dimensional space in accordance to the different values combination of the three or more inputs; and

retrieving a selected bolus configuration, from the memory, based on user selection of at least one of the bolus configurations via the user interface;

the selected bolus configuration comprising an amount of drug to be delivered and a delivery pattern.

18. The method of claim 17, wherein:

the three or more inputs include a current glucose value and carbohydrate load of a food intake to be consumed by the user; and

determining the bolus configuration comprises determining the amount of drug to be delivered based on the current glucose value and the carbohydrate load and determining the delivery pattern based on at least one other input of the three or more inputs.

19. The method of claim 18, wherein at least one other input of the three or more inputs is selected from a group consisting of:

a content of the intake, a GI of the intake, a fat content of the intake, a fiber content of the intake, a glycemic load (GL) of the intake, a residual insulin (RI) and one or more physiological parameters of the user.