ANALYTE TESTING METHOD AND DEVICE FOR DIABETES MANGEMENT

• US 20110077493A1
• Filed: 06/30/2010
• Published: 03/31/2011
• Est. Priority Date: 09/29/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: TEFT, Gillian, COMSTOCK, Lorraine, CAVAYE, Robert, LONGMUIR, Alistair, ANDERSON, Gretchen, McEVOY, Mary, STRACHAN, Alexander, SHADFORTH, Ian, PRICE, David, GRAHAM, Douglas
• Granted Patent: US 8,974,387 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• 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 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04L 67/12 specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks

Abstract

Various embodiments are described and illustrated to calculate an insulin bolus, recommend such bolus, and provide reminder messages for performing an additional glucose test.

Claims

1. A method of managing blood glucose value of a diabetes user, the method comprising:

conducting a plurality of glucose measurements from physiological fluids of a user with a glucose measurement unit coupled to a data management unit;

verifying whether a most recent glucose measurement was made within a first predetermined time period;

based on the user'"'"'s selection, recommending an insulin bolus amount for (a) glucose correction only;

(b) carbohydrate coverage only;

or (c) both carbohydrate and glucose correction, the recommending comprises;

verifying whether an insulin bolus amount for glucose correction was entered by the user within a third predetermined time period and if true then (a) warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin; and

(b) recommending an insulin amount for glucose correction otherwise determining;

(1) whether a pre-meal flag is set with a glucose measurement conducted within the third predetermined time period and if true then (a) warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin; and

(b) recommending an insulin amount for glucose correction;

(2) whether a latest glucose measurement is flagged as post-meal within the third predetermined time period and if true then (a) warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin; and

(b) recommending an insulin amount for glucose correction; and

annunciating the insulin bolus recommendation.

2. The method of claim 1, in which the recommending comprises:

inputting an amount of carbohydrate to be ingested by the user; and

calculating the insulin bolus amount based on an insulin sensitivity of the user, insulin to carbohydrate ratio, and a target glucose value.

3. The method of claim 2 further comprising, the step of recommending a default amount of carbohydrate to the user ranging from about 30 grams to about 50 grams.

4. The method of claim 3, in which the third predetermined time period comprises any value from about 3 hours to about 5 hours.

5. A method of managing blood glucose value of a diabetes user, the method comprising:

conducting a plurality of glucose measurements from physiological fluids of a user with an analyte measurement and management device;

verifying whether a most recent glucose measurement was made within a first predetermined time period;

querying the user as to whether an insulin calculation was utilized by the user in a third predetermined time period and if true, warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin and recommending an insulin bolus based on both carbohydrate coverage and glucose correction.

6. The method of claim 5, in which the third predetermined time period comprises any value from about 3 hours to about 5 hours.

7. A method of managing blood glucose value of a diabetes user, the method comprising:

conducting a plurality of glucose measurements from physiological fluids of a user with an analyte measurement and management device;

verifying whether a most recent glucose measurement was made within a first predetermined time period;

determining an insulin bolus for delivery to the user based on at least one of the plurality of blood glucose measurement values, insulin sensitivity of the user, insulin to carbohydrate ratio, and target glucose value; and

reminding the user to conduct a glucose measurement within a second predetermined time period whenever a glucose measurement from the user'"'"'s physiological fluid indicates an abnormal glucose value.

8. The method of claim 7, further comprising the step of conducting at least one glucose measurement after a meal whenever a post meal glucose value is within a predetermined deviation of a pre-meal blood glucose measurement value.

9. The method of claim 7, in which the reminding comprises:

evaluating whether a last measured glucose measurement value is within a normal range;

in the event that the last measured glucose measurement value is outside a normal range then determining whether the last measured value is a high value and setting a reminder to retest within a first retest time period;

or

determining whether the last measured value is a low value and setting a reminder to retest within a second retest time period.

10. The method of claim 8, in which the conducting comprises:

evaluating whether a pre-meal flag or a post-meal flag was set in the analyte measurement and management device; and

in the event a pre-meal flag was set, determining the insulin bolus.

11. The method of claim 7, in which the determining of the insulin bolus comprises:

if the verifying returns a no, reminding the user to conduct a glucose measurement otherwise, recommending an insulin bolus based on a combination of recommended carbohydrates amount and user-provided carbohydrates amount.

12. The method of claim 7, in which the determining of the insulin bolus comprises:

if the verifying returns a no, reminding the user to conduct a glucose measurement otherwise, recommending an insulin bolus amount for (a) glucose correction only;

(b) carbohydrate coverage only;

or (c) both carbohydrate and glucose correction; and

annunciating the insulin bolus recommendation.

13. The method of claim 7, in which the determining of the insulin bolus comprises:

recommending an amount of carbohydrates;

determining whether to adjust insulin amount for a meal;

upon no adjustment then evaluating whether to adjust insulin for target glucose value or concentration of the user; and

upon no adjustment, receiving from the user an amount of carbohydrates and evaluating whether to adjust insulin for carbohydrate coverage only or both carbohydrate and glucose correction.

14. The method of claim 13, in which the amount of carbohydrate ranges from about 30 grams to about 50 grams.

15. The method of claim 7, in which the determining of the insulin bolus comprises:

verifying whether an insulin bolus amount for glucose correction was entered by the user within a third predetermined time period and if true then (a) warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin; and

(b) recommending an insulin amount for glucose correction otherwise determining

(1) whether a pre-meal flag is set with a glucose measurement conducted within the third predetermined time period and if true then (a) warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin; and

(b) recommending an insulin amount for glucose correction;

(2) whether a latest glucose measurement is flagged as post-meal within the third predetermined time period and if true then (a) warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin; and

(b) recommending an insulin amount for glucose correction.

16. The method of claim 15, in which the third predetermined time period comprises any value from about 3 hours to about 5 hours.

17. A method for diabetes management of a user with an analyte measurement and management device, the method comprising:

flagging a glucose measurement conducted by the user as a fasting glucose measurement;

in the event the flagged fasting glucose measurement is less than a first threshold, reminding the user to conduct another glucose measurement after a first retest time period;

in the event the flagged fasting glucose measurement is greater than a second threshold, reminding the user to conduct another glucose measurement after a second retest time period.

18. The method of claim 17, in which the first threshold comprises a glucose value or concentration of the user of about 60 mg/dL and the first retest time period comprises any value from about 5 to about 30 minutes.

19. The method of claim 17, in which the second threshold comprises a glucose value or concentration of the user of about 180 mg/dL and the second retest time period comprises any value from about 30 to about 180 minutes.

20. A method of notifying a diabetes user of certain glycemic condition of the user with an analyte measurement and management device, the method comprising:

conducting a glucose measurement before a meal with the analyte measurement and management device;

flagging the before meal glucose measurement in a memory of the analyte measurement and management device as a pre-meal glucose value;

conducting a glucose measurement after a meal with the analyte measurement and management device;

flagging the after-meal glucose measurement in the memory of the analyte measurement and management device as a post-meal value;

determining whether a difference between the flagged post-meal glucose value and flagged pre-meal glucose value is within about 50 mg/dL; and

notifying the user whenever the difference is greater than about 50 mg/dL and reminding the user to re-test in a second retest time period.

21. The method of claim 20, in which the reminding comprises prompting the user to set a reminder.

22. The method of claim 20, further comprising notifying the user of a normal message whenever the difference between the flagged post-meal glucose value and flagged pre-meal glucose value is less than about 50 mg/dL.

23. The method of claim 20, in which the flagging comprises selecting a type of flag from a menu of flags in which the selected flag comprises an increased font size relative to the unselected menu of flags.

24. An analyte measurement and management device comprising:

a housing having;

a biosensor port coupled to an analyte measurement unit and configured to receive a biosensor;

a glucose measurement unit coupled to the biosensor port to provide data regarding an amount of glucose measured in a user'"'"'s physiological fluid deposited on the biosensor;

a communication output unit disposed on the housing; and

a plurality of user interface buttons;

a processor coupled to the analyte measurement unit, a memory, user interface buttons and communication output unit; and

in which the processor is programmed to

(a) verify whether a most recent glucose measurement was made within a first predetermined time period;

(b) query the user as to whether an insulin calculation was utilized by the user in a third predetermined time period and if true, warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin; and

(c) recommend an insulin bolus based on both carbohydrate coverage and glucose correction.

25. The method of claim 24, in which the third predetermined time period comprises any value from about 3 hours to about 5 hours.

26. An analyte measurement and management device comprising:

a housing having;

a biosensor port coupled to an analyte measurement unit and configured to receive a biosensor;

a glucose measurement unit coupled to the biosensor port to provide data regarding an amount of glucose measured in a user'"'"'s physiological fluid deposited on the biosensor;

a communication output unit disposed on the housing; and

a plurality of user interface buttons;

a processor coupled to the analyte measurement unit, a memory, user interface buttons and communication output unit; and

in which the processor is programmed to;

(a) verify whether a most recent glucose measurement was made within a first predetermined time period;

(b) determine an insulin bolus for delivery to the user based on at least one of the plurality of blood glucose measurement values, insulin sensitivity of the user, insulin to carbohydrate ratio, and target glucose value; and

(c) remind the user to conduct a glucose measurement within a second predetermined time period whenever a glucose measurement from the user'"'"'s physiological fluid indicates an abnormal glucose value.

27. An analyte measurement and management device comprising:

a housing having;

a biosensor port coupled to an analyte measurement unit and configured to receive a biosensor;

a glucose measurement unit coupled to the biosensor port to provide data regarding an amount of glucose measured in a user'"'"'s physiological fluid deposited on the biosensor;

a communication output unit disposed on the housing; and

a plurality of user interface buttons;

a processor coupled to the analyte measurement unit, a memory, user interface buttons and communication output unit; and

in which the processor is programmed to;

(a) flag a glucose measurement conducted by the user as a fasting glucose measurement;

(b) in the event the flagged fasting glucose measurement is less than a first threshold, remind the user to conduct another glucose measurement after a first retest time period;

(c) in the event the flagged fasting glucose measurement is greater than a second threshold, remind the user to conduct another glucose measurement after a second retest time period.

28. An analyte measurement and management device comprising:

a housing having;

a biosensor port coupled to an analyte measurement unit and configured to receive a biosensor;

a glucose measurement unit coupled to the biosensor port to provide data regarding an amount of glucose measured in a user'"'"'s physiological fluid deposited on the biosensor;

a communication output unit disposed on the housing; and

a plurality of user interface buttons;

a processor coupled to the analyte measurement unit, a memory, user interface buttons and communication output unit; and

in which the processor is programmed to;

(a) flag the before meal glucose measurement in the memory of the analyte measurement and management device as a pre-meal glucose value;

(b) flag an after-meal glucose measurement in the memory of the analyte measurement and management device as a post-meal value;

(c) determine whether a difference between the flagged post-meal glucose value and flagged pre-meal glucose value is within about 50 mg/dL;

(d) notify the user whenever the difference is greater than about 50 mg/dL; and

(e) remind the user to re-test in a second retest time period.