Handheld diabetes management device with bolus calculator

• US 10,458,973 B2
• Filed: 08/24/2012
• Issued: 10/29/2019
• Est. Priority Date: 12/22/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Galley, Paul J., Greenburg, Alan M., Parker, Marshall M., Price, John F., Wagner, Robin S., Wilson, Richard W.
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US13/593,557
• Publication Number:
  US 20140058237A1
• Time in Patent Office: 2,622 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C

Abstract

According to some embodiments of the present disclosure, a device and method for determining an allowable amount of blood glucose (bG) of a patient is disclosed. The method further includes receiving a current bG measurement, determining a target bG value, and determining a correction delta bG value based on one or more advice history records. The method includes determining a correction meal rise value and determining a maximum allowed bG value based on the target bG value, the correction delta bG value, and the correction meal rise value. The method includes setting the allowable amount of bG value equal to the maximum allowed bG value when the current bG measurement is greater than the target bG value and determining the allowable amount of bG value using the target bG value and the correction delta bG value when the current bG measurement is less than the target bG value.

Claims

1. A computer-implemented method for determining an allowable amount of blood glucose (bG) of a patient, the allowable amount of blood glucose being used to calculate a bolus recommendation for a patient, the method comprising:

maintaining a plurality of active advice history records in a data store of a computing device, each of the plurality of active advice history records having been generated during a predetermined time period relative to a current time, and each of the plurality of active advice history records identifying data relating to one or more bG influencing events and including a time corresponding to the one or more bG influencing events;

measuring, by a sensor of the computing device, a current bG measurement corresponding to the patient, the current bG measurement indicating a current bG level of the patient;

determining, by one or more processors of the computing device, a target bG value for the patient, the target bG value corresponding to a desired bG level for the patient;

determining, at the one or more processors, a correction delta bG value based on one or more records of the plurality of active advice history records, the correction delta bG value being indicative of an aggregated bG lowering effect of the events defined in the one or more active advice history records on a bG value of the patient;

determining, at the one or more processors, a correction meal rise value based on a specific active advice history record of the plurality of active advice history records, the correction meal rise value being indicative of an amount the bG level of the patient can increase with respect to the target bG value without requiring a correction bolus;

determining, at the one or more processors, a maximum allowed bG value based on the target bG value, the correction delta bG value, and the correction meal rise value;

comparing, at the one or more processors, the current bG measurement to the target bG value;

setting, at the one or more processors, the allowable amount of bG value equal to the maximum allowed bG value when the current bG measurement is greater than the target bG value;

setting, at the one or more processors, the allowable amount of bG value using the target bG value and the correction delta bG value and excluding the correction meal rise value when the current bG measurement is less than the target bG value;

storing the allowable amount of bG value in the data store of the computing device;

calculating, at the one or more processors, a recommendation for the patient using the allowable amount of bG value; and

presenting the recommendation to the patient on a display of the computing device.

2. The method of claim 1, wherein when the current bG measurement is less than the target bG value, the allowable amount of bG value is set equal to the sum of the target bG value and the correction delta bG value.

3. The method of claim 1, wherein determining the correction delta bG value further comprises:

for each active advice history record of the plurality of active advice history records;

analyzing the active advice history record to determine a bG lowering effect associated with the active advice history record; and

aggregating the bG lowering effect associated with previous bG lowering effects corresponding to previously analyzed active advice history records,

wherein the correction delta bG value is determined based on the aggregation of the bG lowering effect of all of the plurality of active advice history records.

4. The method of claim 3, wherein determining the correction delta bG value further comprises:

for each active advice history record of the plurality of active advice history records;

after aggregating the bG lowering effect associated with the previous bG lowering effects corresponding to the previously analyzed active history records, determining whether the aggregated bG lowering effect is less than zero; and

when the aggregated bG lowering effect is less than zero, setting the aggregated bG lowering effect equal to zero,

wherein the correction delta bG value is determined based on the aggregation of the bG lowering effect of all of the plurality of active advice history records and the active advice history records are analyzed sequentially beginning with an oldest active advice history record.

5. The method of claim 3, wherein analyzing the active advice history record further comprises:

determining whether a bG measurement defined in the active advice history record is below a bG threshold;

when the bG measurement defined in the active history record is less than the bG threshold, determining the bG lowering effect associated with the active advice history record based on a carbohydrate amount defined in the active advice history record; and

when the bG measurement defined in the active history record is greater than the bG threshold, determining the bG lowering effect associated with the active advice history record based on an insulin amount defined in the active advice history record.

6. The method of claim 3, wherein analyzing the active advice history record further comprises:

determining an amount of time that that has lapsed since the active advice history record was generated;

comparing the amount of time to an offset time associated with the active advice history record, the offset time indicating a first duration during which the events defined in the active advice history record have a full effect on the bG level of the patient;

when the amount of time is greater than the offset time, adjusting the bG lowering effect associated with the active advice history record based on;

7. The method of claim 1, wherein determining the correction meal rise value comprises ensuring the events defined in the specific active advice history record include a bolus being associated with a carbohydrate intake event where the carbohydrate intake is greater than a predetermined threshold and further include an indication that insulin was administered to the patient and correspond to a time that is temporally closer to a current time than other active advice history records in the plurality of active advice history records defining events that include a meal bolus and a confirmation of insulin.

8. The method of claim 1, wherein determining the correction meal rise value further comprises:

determining an amount of time that has lapsed since the time corresponding to the specific active advice history record;

comparing the amount of time to a predetermined threshold associated with the specific active advice history record;

when the amount of time is less than the predetermined threshold, setting the correction meal rise value equal to a full meal rise value defined in the specific active advice history record; and

when the amount of time is greater than the predetermined threshold, setting the correction meal rise value equal to an adjusted meal rise value based on the amount of time and the full meal rise value.

9. The method of claim 8, wherein the adjusted meal rise value is determined according to:

10. A diabetes management device configured to determine an allowable amount of blood glucose (bG) of a patient, the allowable amount of blood glucose being used to calculate a bolus recommendation for a patient, the device comprising:

an advice history records database that stores a plurality of active advice history records, each of the plurality of active advice history records having been generated during a predetermined time period relative to a current time, and each of the plurality of active advice history records identifying data relating to one or more bG influencing events and including a time corresponding to the one or more bG influencing events;

a computer-readable medium storing computer-readable instructions;

one or more processors configured to execute the computer-readable instructions, the computer-readable instructions, when executed by the one or more processors, causing the one or more processors to;

receive a current bG measurement corresponding to the patient, the current bG measurement indicating a current bG level of the patient;

determine a target bG value for the patient, the target bG value corresponding to a desired bG level for the patient;

determine a correction delta bG value based on one or more records of the plurality of active advice history records, the correction delta bG value being indicative of an aggregated bG lowering effect of the events defined in the one or more active advice history records on a bG value of the patient;

determine a correction meal rise value based on a specific active advice history record of the plurality of active advice history records, the correction meal rise value being indicative of an amount the bG level of the patient can increase with respect to the target bG value without requiring a correction bolus;

determine, a maximum allowed bG value based on the target bG value, the correction delta bG value, and the correction meal rise value;

compare the current bG measurement to the target bG value;

set the allowable amount of bG value equal to the maximum allowed bG value when the current bG measurement is greater than the target bG value;

determine the allowable amount of bG value using the target bG value and the correction delta bG value and excluding the correction meal rise value when the current bG measurement is less than the target bG value; and

store the allowable amount of bG value.

11. The device of claim 10, wherein the computer readable instructions, when executed by the one or more processors, cause the one or more processors to set the allowable amount of bG value equal to the sum of the target bG value and the correction delta bG value when the current bG measurement is less than the target bG value.

12. The device of claim 10, wherein the computer readable instructions, when executed by the one or more processors, further cause the one or more processors to:

for each active advice history record of the plurality of active advice history records;

analyze the active advice history record to determine a bG lowering effect associated with the active advice history record; and

aggregate the bG lowering effect associated with previous bG lowering effects corresponding to previously analyzed active advice history records,

wherein the correction delta bG value is determined based on the aggregation of the bG lowering effect of all of the plurality of active advice history records and the active advice history records are analyzed sequentially beginning with an oldest active advice history record.

13. The device of claim 12, wherein the computer readable instructions, when executed by the one or more processors, further cause the one or more processors to:

for each active advice history record of the plurality of active advice history records;

after aggregating the bG lowering effect associated with the previous bG lowering effects corresponding to the previously analyzed active history records, determine whether the aggregated bG lowering effect is less than zero; and

set the aggregated bG lowering effect equal to zero when the aggregated bG lowering effect is less than zero.

14. The device of claim 12, wherein the computer readable instructions, when executed by the one or more processors, further cause the one or more processors to:

determine whether a bG measurement defined in the active advice history record is below a bG threshold;

determine the bG lowering effect associated with the active advice history record based on a carbohydrate amount defined in the active advice history record when the bG measurement defined in the active history record is less than the bG threshold; and

determine the bG lowering effect associated with the active advice history record based on an insulin amount defined in the active advice history record when the bG measurement defined in the active history record is greater than the bG threshold.

15. The device of claim 12, wherein the computer readable instructions, when executed by the one or more processors, further cause the one or more processors to:

determine an amount of time that that has lapsed since the active advice history record was generated;

compare the amount of time to an offset time associated with the active advice history record, the offset time indicating a first duration during which the events in the active advice history record have a full effect on the bG level of the patient;

when the amount of time is greater than the offset time, adjust the bG lowering effect associated with the active advice history record based on;

16. The device of claim 10 wherein determining the correction meal rise value further comprises ensuring the events defined in the specific active advice history record include a bolus being associated with a carbohydrate intake event where the carbohydrate intake is greater than a predetermined threshold and further include an indication that insulin was administered to the patient and correspond to a time that is more recent to a current time than other active advice history records in the plurality of active advice history records defining events that include a meal bolus and a confirmation of insulin.

17. The device of claim 10, wherein the computer readable instructions, when executed by the one or more processors, further cause the one or more processors to:

determine an amount of time that has lapsed since the time corresponding to the specific active advice history record;

compare the amount of time to an offset time associated with the specific active advice history record;

set the correction meal rise value equal to a full meal rise value defined in the specific active advice history record when the amount of time is less than the offset time; and

when the amount of time is greater than the offset time, set the correction meal rise value equal to;

18. The device of claim 10 further comprises a bG analyzer configured to receive a test strip and operates to determine the current bG measurement from a sample of blood on the test strip.

19. The device of claim 10 wherein the computer readable instructions, when executed by the one or more processors, further cause the one or more processors to:

determine at least one of a recommended amount of insulin or a recommended amount of carbohydrates for the patient; and

present the at least one of a recommended amount of insulin or a recommended amount of carbohydrates for the patient on a display of the device.