Bolus dose determination for a therapeutic fluid dispensing system

• US 8,845,613 B2
• Filed: 01/28/2009
• Issued: 09/30/2014
• Est. Priority Date: 01/28/2008
• 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
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US12/865,042
• Publication Number:
  US 20110054439A1
• Time in Patent Office: 2,071 Days
• Field of Search: 604/503, 604/504, 604/65, 604/66, 604/67
• US Class Current: 604/504
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• 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 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Disclosed is a medical device to treat diabetes. The medical device includes a bolus calculator to determine an insulin bolus based on, at least in part, a glycemic index value associated with an intake to be consumed by a user, the bolus calculator further adapted to determine the insulin bolus using one or more inputs selected from the group consisting of a carbohydrate load of the intake, a current glucose level of the user, a residual insulin of the user, a carbohydrate to insulin ration, an insulin sensitivity of the user and a target glucose level of the user. The bolus calculator is housed in one or more of, for example, an insulin dispensing pump, a handheld remote control unit for the insulin dispensing pump and/or a handheld glucose monitor.

Claims

1. A medical device to treat diabetes, the medical device comprising:

a processor;

a bolus calculator comprising computer instructions that, when executed by the processor, cause the processor to perform operations comprising;

receiving a meal type corresponding to a food intake to be consumed by a user, the meal type can be a first meal type representing a simple meal or a second meal type representing a composite meal;

receiving a plurality of food types associated with the food intake to be consumed by the user if the second meal type is received;

calculating a bolus to be delivered to the user for the food intake to be consumed by the user;

the bolus being calculated based, at least in part, on;

the meal type, a carbohydrate load of the food intake to be consumed by the user if the first meal type is received, the plurality of food types associated with the food intake to be consumed by the user if the second meal type is received, a current glucose level of the user, a residual insulin of the user, a carbohydrate-to-insulin ratio of the user, an insulin sensitivity of the user, and a target glucose level of the user;

wherein the processor is housed in one or more of;

an insulin dispensing pump, a handheld remote control for the insulin dispensing pump and a handheld glucose monitor;

and wherein the computer instructions further include instructions to reevaluate an effect of the carbohydrate load based on a value associated with a glycemic index of the food intake.

2. The medical device of claim 1, further comprising a user interface configured to receive at least one or more of:

the carbohydrate load if the first meal type is received, the meal type, the plurality of food types associated with the food intake to be consumed by the user if the second meal type is received, the glycemic index, the value associated with the glycemic index, the current glucose level, the residual insulin, the carbohydrate-to-insulin ratio, the insulin sensitivity, and the target glucose level.

3. The medical device of claim 1, further comprising a user interface configured to display to the user one or more of:

the calculated bolus, a food database, the glycemic index, the value associated with the glycemic index, a meal selection, a composite glycemic index, the carbohydrate load if the first meal type is received, the current glucose level, the residual insulin, the carbohydrate-to-insulin ratio, the insulin sensitivity, and the target glucose level.

4. The medical device of claim 1, wherein at least some of the food types have different glycemic indices.

5. The medical device of claim 1, further comprising:

a user interface configured to receive input of the meal type corresponding to the food intake to be consumed by the user and the food types associated with the food intake to be consumed if the second meal type is received, each of the food types being associated with a respective glucose index and a respective amount of carbohydrates;

wherein the computer instructions further comprise instructions to determine a weighted average glucose index based on the respective glucose index and the respective amount of carbohydrates of each of the food types if the second meal type is received.

6. The medical device of claim 1, further comprising a memory storing a food database including glycemic indices corresponding to a plurality of food intakes, the bolus calculator being configured to retrieve at least the glycemic indices.

7. The medical device of claim 1, further comprising the insulin dispensing pump, wherein the bolus calculator is used in conjunction with the processor of the pump to dispense insulin to the user in correspondence with the calculated bolus.

8. The medical device of claim 1, further comprising the glucose monitor configured to measure the current glucose level of the user.

9. The medical device of claim 1, wherein the processor operating the bolus calculator is located in the handheld remote control.

10. The medical device of claim 1, wherein the value associated with the glycemic index of the food intake is multiplied by the carbohydrate load.

11. The medical device of claim 1, wherein the value associated with the glycemic index (GI) of the food intake is associated with a relative insulinemic response (RIR) computed based on:

RIR=2.9*(0.6*G/+0.003*GI²)*(1−

e<sup>−

0.0078*carb</sup>)+5

wherein carb is the carbohydrate load of the food intake.

12. The medical device of claim 1, wherein the computer instructions further comprise instructions to calculate the bolus based on a relationship:

13. The medical device of claim 1, wherein if the second meal type is received, the computer instructions further comprise instructions to determine a composite glycemic index based on respective glycemic indices and carbohydrate loads of the plurality of food types.

14. The medical device of claim 13, wherein the composite glycemic index is determined based on:

15. The medical device of claim 1, wherein the current glucose level includes one or more of:

a blood glucose level of the user and a glucose level in interstitial fluids of the user.

16. The medical device of claim 1, further comprising a screen to display to the user one or more of:

the calculated bolus, a food database, the glycemic index, the value associated with the glycemic index, and a meal selection.

17. A method for treating diabetes, the method comprising:

providing a processor housed in at least one of an insulin dispensing pump, a handheld remote control for the insulin dispensing pump and a handheld glucose monitor;

providing a bolus calculator application comprising computer instructions for operating on the processor to determine a bolus for delivery to a user;

receiving input comprising a meal type corresponding to a food intake to be consumed by the user, the meal type can be a first meal type representing a simple meal or a second meal type representing a composite meal, a carbohydrate load of a food intake to be consumed by the user if the first meal type is received, a plurality of food types associated with the food intake to be consumed by the user if the second meal type is received, a current glucose level of the user, a residual insulin of the user, a carbohydrate-to-insulin ratio of the user, an insulin sensitivity of the user, and a target glucose level of the user;

determining the bolus based at least in part on the carbohydrate load of the food intake to be consumed by the user if the first meal type is received, the plurality of food types associated with the food intake to be consumed by the user if the second meal type is received, the current glucose level of the user, the residual insulin of the user, the carbohydrate-to-insulin ratio of the user, the insulin sensitivity of the user, and the target glucose level of the user; and

reevaluating an effect of the carbohydrate load based on a value associated with a glycemic index of the food intake.

18. The method of claim 17, further comprising receiving input to select the food intake having the associated glycemic index.

19. The method of claim 17, further comprising providing the insulin dispensing pump, wherein the bolus calculator application is used in conjunction with the processor of the pump to dispense insulin to the user in correspondence with the determined bolus.

20. The method of claim 17, further comprising multiplying the value associated with the glycemic index of the food intake by the carbohydrate load.