Handheld diabetes management device with bolus calculator

• US 8,615,366 B2
• Filed: 12/22/2010
• Issued: 12/24/2013
• Est. Priority Date: 10/15/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Galley, Paul J., Wilson, Richard W., Price, John F., Greenburg, Alan M., Parker, Marshall
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US12/976,507
• Publication Number:
  US 20120095318A1
• Time in Patent Office: 1,098 Days
• Field of Search: None
• US Class Current: 702/19
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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

A method for monitoring blood glucose (bG) levels of a diabetic user. The method may be implemented on a non-transitory computer readable medium adapted to run on a processing subsystem, the processing subsystem forming a portion of a handheld diabetes management device for monitoring the bG levels of a diabetic user and determining a correction bolus to be provided to the user. The method may comprise using a memory to store information in a plurality of different time blocks. The information may include a plurality of differing user defined health events that each include a predetermined associated percentage value set by the user by which a correction bolus calculation will be modified to account for one of an increase or a decrease in insulin associated with each one of the defined health events. The processing subsystem may be used to communicate with the memory and to obtain the information and to calculate therefrom the correction bolus.

Claims

1. A method implemented on a non-transitory computer readable medium adapted to run on a processing subsystem, the processing subsystem forming a portion of a handheld diabetes management device for monitoring blood glucose (bG) levels of a diabetic user and determining a correction bolus to be provided to the user, the method comprising:

using a memory to store information in a plurality of different time blocks, the information including;

an upper target bG value for each one of the plurality of different time blocks, defined by the user, during a twenty four hour period;

a lower target bG value for each one of the plurality of different time blocks during the twenty four hour period;

a hypoglycemic warning value, defined by the user, representing a hypoglycemic bG value for the user;

a conversion factor for converting from glucose to insulin;

one or more health events which can be associated by the user with a request for an insulin recommendation, where each health event includes a percentage value set by the user; and

a carbohydrate value input by the user in connection with a meal;

receiving, by a processor of the processing subsystem, a request for an insulin recommendation for a patient;

determining, by the processor, how many health events are associated with the request for an insulin recommendation;

prompting, by the processor, the user for an input for the health events associated with the insulin recommendation, where the prompting is in response to a determination that two or more health events are associated with the request for an insulin recommendation;

receiving, by the processor, an input value from the user in response to the prompting, where the input is a numeric value representing a cumulative effect of the health events on the insulin of the patient; and

computing, by the processor, the correction bolus for the patient based on the input value.

2. The method of claim 1, further comprising calculating a meal bolus using a conversion factor for converting the carbohydrate value to a corresponding insulin value.

3. The method of claim 2, further comprising enabling the user to define and store in the memory different insulin sensitivity and carbohydrate ratio values for each one of the plurality of time blocks.

4. The method of claim 3, wherein the correction bolus is modified by an insulin sensitivity of the insulin and one of the percentage values associated with one of the health events.

5. The method of claim 2, wherein the calculated meal bolus is modified by a carbohydrate ratio and one of the percentage values associated with one of the health events.

6. The method of claim 1, further comprising using the processing subsystem to use the information to generate a carbohydrate amount recommendation for the user when the user'"'"'s bG level is below the hypoglycemic warning value.

7. The method of claim 1, further comprising using the processing subsystem to consider an action shape of a previously taken correction bolus, the action shape being defined by a bG lowering potential of the previously taken correction bolus, an offset time of insulin associated with the previously taken correction bolus, and an acting time of the insulin associated with the previously taken correction bolus, and the action shape being considered by the processing subsystem when generating a new bolus recommendation.

8. The method of claim 7, wherein the action shape is considered by the processing subsystem when generating a carbohydrate suggestion.

9. The method of claim 1, further comprising using the processing subsystem to consider an action shape of a last previous meal, the action shape being defined by a meal rise glucose amplitude, an offset time of the last previous meal, an acting time of the last previous meal, and the action shape being considered by the processing subsystem when generating a new bolus recommendation.

10. The method of claim 7, further comprising using the processing subsystem to receive as inputs from the user, the acting time and the offset time.

11. The method of claim 9, further comprising using the processing subsystem to receive as inputs from the user a meal rise glucose amplitude, acting time and offset time.

12. The method of claim 1, wherein the plurality of user defined differing health events comprise custom user selected and user named health events including at least one of an exercise event, a stress event, an illness event and a periodic physiological cycle event.

13. The method of claim 1, further comprising recommending, displaying and allowing the modification of the correction bolus, a meal bolus and a total bolus to the user on a visual display of the device.

14. A method implemented on a non-transitory computer readable medium adapted to run on a processing subsystem, the processing subsystem forming a portion of a handheld diabetes management device for monitoring blood glucose (bG) levels of a diabetic user and determining a total bolus to be provided to the user, the method comprising:

using a memory to store;

an upper target bG value for each one of a plurality of different time blocks during a twenty four hour period;

a lower target bG value for each one of the plurality of different time blocks during the twenty four hour period;

a maximum allowed bG value representing a currently corrected for bG value of the user, which is computed from prior bG history records;

one or more health events which can be associated by the user with a request for an insulin recommendation, where health events include an exercise event, a stress event and an illness event and each health event includes a percentage value set by the user;

a carbohydrate value input by the user in connection with a meal;

receiving, by a processor of the processing subsystem, a request for an insulin recommendation for a patient;

determining, by the processor, how many health events are associated with the request for an insulin recommendation;

prompting, by the processor, the user for an input for the health events associated with the insulin recommendation, where the prompting is in response to a determination that two or more health events are associated with the request for an insulin recommendation;

receiving, by the processor, an input value from the user in response to the prompting, where the input is a numeric value representing a cumulative effect of the health events on the insulin of the patient;

calculating, by the processor, a meal bolus based on the carbohydrate value input by the user, the meal bolus representing an amount of insulin needed to compensate for the carbohydrate value representing the meal;

calculating, by the processor, a correction bolus representing an additional amount of insulin needed beyond the insulin represented by the meal bolus;

summing the meal bolus and the correction bolus to obtain a summed total bolus value; and

displaying the correction bolus, the meal bolus, the total bolus value and the maximum allowed bG value to the user on a display of the device.

15. The method of claim 14, wherein the processing subsystem further is adapted to consider, in determining the maximum allowed bG value and a currently allowed bG value, the following:

an offset time, input by the user, for insulin being taken by the user, before generating a new bolus recommendation; and

an acting time, input by the user, for insulin being taken by the user, before generating a new bolus recommendation.

16. The method of claim 14, wherein the processing subsystem further is adapted to use the information to generate a carbohydrate amount recommendation for the user when the user'"'"'s bG level is below a hypoglycemic warning value for the user.

17. A customizable, handheld diabetes management device for monitoring blood glucose (bG) levels of a diabetic user and determining a total bolus to be provided to the user, the device comprising:

a housing adapted to be held in a hand of the user;

a memory contained in the housing and configured to store information including;

an upper target bG value for each one of a plurality of different time blocks defined by the user during a twenty four hour period;

a lower target bG value for each one of the plurality of different time blocks during the twenty four hour period;

one or more health events which can be associated by the user with a request for an insulin recommendation, where health events include an exercise event, a stress event and an illness event and each health event includes a percentage value set by the user; and

a carbohydrate value input by the user in connection with a meal;

a processing subsystem contained in the housing and being in communication with the memory, the processing subsystem configured to receive a request for an insulin recommendation for a patient, determine how many health events are associated with the request for an insulin recommendation and prompt the user for an input for the health events associated with the insulin recommendation, where the prompting is in response to a determination that two or more health events are associated with the request for an insulin recommendation;

the processing subsystem further configured to receive an input value from the user in response to the prompting, where the input is a numeric value representing a cumulative effect of the health events on the insulin of the patient and calculate a meal bolus, a correction bolus and a recommended total bolus that is a sum of the meal bolus and the correction bolus; and

a display system contained in the housing for displaying a plurality of fields that the user is able to configure to include the information, and for displaying the recommended total bolus to the user.

18. The system of claim 17, wherein the information further comprises insulin sensitivity information pertaining to the user, the insulin sensitivity information being input by the user and used by the processing subsystem to modify the calculated correction bolus.

19. The system of claim 18, wherein the insulin sensitivity information comprises a plurality of differing insulin sensitivities input by the user for different ones of the plurality of different time blocks.

20. The system of claim 19, wherein the calculated correction bolus is modified by one of the insulin sensitivities and the percentage value associated with one of the user defined health events.

21. The system of claim 19, wherein the calculated meal bolus is modified by the carbohydrate ratio and the percentage value associated with one of the user defined health events.

22. The system of claim 17, wherein the processing subsystem further is adapted to use the information to generate a carbohydrate amount recommendation for the user when the user'"'"'s bG level is below a hypoglycemic warning limit.

23. The system of claim 17, wherein the processing subsystem further is adapted to consider an acting time, input by the user, for insulin being taken by the user, before generating a new bolus recommendation.

24. The system of claim 23, wherein the processing subsystem further is adapted to consider an offset time, input by the user, for insulin being taken by the user, before generating a new bolus recommendation.

25. The system of claim 17, wherein the plurality of user defined differing health events comprise custom user selected and user named health events that include at least one of an exercise event, a stress event, an illness event and a periodic physiological cycle event.