Apparatus and method for monitoring blood glucose levels including convenient display of blood glucose value average and constituent values

• US 7,570,980 B2
• Filed: 09/10/2003
• Issued: 08/04/2009
• Est. Priority Date: 09/11/2002
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ginsberg, Barry H.
• Primary Examiner(s): Nasser; Robert L
• Application Number:
  US10/658,209
• Publication Number:
  US 20040059201A1
• Time in Patent Office: 2,155 Days
• Field of Search: 600/204, 600/365, 600/600, 600/300, 600/301, 600/364, 600/316, 600/347
• US Class Current: 600/347
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A method of presenting glucose data to a person with diabetes from a blood glucose meter is provided in which an effective meal average (EMA) value is presented, followed by two or more of the individual values that make up the EMA, to provide improved feedback data for clinical decisions by patients who need to alter their dose of insulin. The EMA can also comprise a measure of the variability of its constituent values. The EMA encompasses those values that occur at specified times such as 1 hour before and 1 hour after a specified meal time. The EMA is calculated over a limited number of days previous to the calculation (e.g., 3 days) and has a minimum number of values that must be obtained within the time and date ranges. An algorithm allows for exclusion of any given reading from the average (e.g., post-prandial or control solution readings). Patients can use 1 to 8 EMA on any given date range (e.g., preferably 4, that is, breakfast, lunch, supper and bedtime snack).

Claims

1. A method of annunciating a patient'"'"'s medical data levels using a medical data level monitoring device comprising the steps of:

storing medical data levels with the corresponding dates and times of day the respective medical data levels were taken;

calculating using a processing device an average medical data level from at least

a first medical data level and a second medical data level selected from the stored medical data levels;

annunciating said average medical data level;

receiving a first user input to annunciate said first medical data level;

annunciating said first medical data level;

receiving a second user input to annunciate said second medical data level; and

annunciating said second medical data level;

wherein said calculating step further comprises the steps of

selecting the stored medical data levels used to determine said average medical data level based on the date and time of day the stored medical data levels were taken;

defining a time period during a day when the average medical data level is desired for that time period on each of a selected number of days;

receiving a user input requesting an average medical data level of said time period for a selected number of days beginning with the current day;

determining if said time period has been entered or passed on said current day;

using a reading of an medical data level taken during the time period for said current day when determining said average medical data level if said time period has been entered or has passed for the current day; and

selecting a stored medical data level taken on the previous day when determining said average medical data level if said time period has yet not been entered or passed for the current day.

2. A method as claimed in claim 1, wherein said selected number of days is three.

3. A method as claimed in claim 1, wherein said using step further comprises the step of selecting one of the earliest and the most recent of a plurality of readings taken on said current day during said time period based on their respective times of day.

4. A method as claimed in claim 1, wherein said selecting step further comprises the step of selecting one of the earliest and the most recent of a plurality of readings taken on said previous day during said time period based on their respective times of day.

5. A method as claimed in claim 1, wherein said using step further comprises the step of using a stored medical data level from the previous day if no valid medical data levels are available from said time period for the current day, and said selecting step further comprises the step of using a stored medical data level from the day before said previous day if no valid medical data levels are available from said time period for the previous day.

6. A method as claimed in claim 1, wherein said calculating step further comprises the step of using stored medical data levels from as many as a selected maximum number of previous days if no valid medical data levels are available for said current day.

7. A method as claimed in claim 1, wherein said selected maximum number of days is five.

8. An apparatus for patient condition monitoring comprising:

a reader for measuring a selected medical data level for said patient;

a memory device for storing a plurality of the medical data levels along with their respective dates and time of day they were taken;

an annunciator;

a user input device; and

a processing device connected to said reader, said memory device, said annunciator and said user input device and programmable to calculate an average medical data level from at least a first medical data level and a second medical data level selected from the stored medical data levels in said memory device, to annunciate the average medical data level via said annunciator, to receive a first user input from said user input device to annunciate the first medical data level, to annunciate the first medical data level in response to said first user input, to receive a second user input from said user input device to annunciate the second medical data level, and to annunciate the second medical data level in response to said second user input;

wherein said processing device is programmed to select the stored medical data levels used to determine said average medical data level based on the date and time of day the stored medical data levels were taken;

wherein said processing device is operable to generate prompts via said annunciator to allow a user to define via said user input device a time period during a day when the average medical data level is desired for that time period on each of a selected number of days;

wherein said processing device is further programmed to receive a user input requesting an average medical data level of said time period for a selected number of days beginning with the current day, to determine if said time period has been entered or passed on said current day, to use a reading of an medical data level taken during the time period for said current day when determining the average medical data level if said time period has been entered or has passed for the current day, and to select a stored medical data level taken on the previous day when determining the average medical data level if said time period has yet not been entered or passed for the current day.

9. An apparatus as claimed in claim 8, wherein said selected number of days is three.

10. An apparatus as claimed in claim 8, wherein said processing device is programmable to select one of the earliest and the most recent of a plurality of readings taken on said current day during said time period based on their respective times of day.

11. An apparatus as claimed in claim 8, wherein said processing device is programmable to select one of the earliest and the most recent of a plurality of readings taken on said previous day during said time period based on their respective times of day.

12. An apparatus as claimed in claim 8, wherein said processing device is programmable to use a stored medical data level from the previous day if no valid medical data levels are available from said time period for the current day, and, when selecting a stored medical data level taken on the previous day, to use a stored medical data level from the day before said previous day if no valid medical data levels are available from said time period for the previous day.

13. An apparatus as claimed in claim 8, wherein said processing device is programmable to use stored medical data levels from as many as a selected maximum number of previous ago if no valid medical data levels are available for said current day.

14. An apparatus as claimed in claim 13, wherein said selected maximum number of days is five.

15. A method of displaying blood glucose levels using a blood glucose meter comprising the steps of:

storing blood glucose levels with the corresponding dates and times of day the respective blood glucose levels were taken;

calculating using a processing device an average blood glucose level from at least a three of the stored blood glucose levels as the constituent values;

displaying the average blood glucose level using a display device of said blood glucose meter;

receiving a first user input to display a first one of the constituent values;

displaying the first one of the constituent values in response to the first user input;

receiving a second user input to display a second one of the constituent values; and

displaying the second one of the constituent values in response to the second user input;

wherein said calculating step further comprises the steps of

defining a time period during a day when the average blood glucose level is desired for that time period on each of a selected number of days;

receiving a user input requesting an average blood glucose level of said time period for a selected number of days beginning with the current day;

determining if said time period has been entered or passed on said current day;

using a reading of an blood glucose level taken during the time period for said current day when determining the average blood glucose level if said time period has been entered or has passed for the current day; and

selecting a stored blood glucose level taken on the previous day when determining the average blood glucose level if said time period has yet not been entered or passed for the current day.

16. A method as claimed in claim 15, wherein said selected number of days is three.

17. A method as claimed in claim 15, wherein said using step further comprises the step of selecting one of the earliest and the most recent of a plurality of readings taken on said current day during said time period based on their respective times of day.

18. A method as claimed in claim 15, wherein said selecting step further comprises the step of selecting one of the earliest and the most recent of a plurality of readings taken on said previous day during said time period based on their respective times of day.

19. A method as claimed in claim 15, wherein said using step further comprises the step of using a stored blood glucose level from the previous day if no valid blood glucose levels are available from said time period for the current day, and said selecting step further comprises the step of using a stored blood glucose level from the day before said previous day if no valid blood glucose levels are available from said time period for the previous day.

20. A method as claimed in claim 15, wherein said calculating step further comprises the step of using stored blood glucose levels from as many as a selected maximum number of previous days if no valid blood glucose levels are available for said current day.

21. A method as claimed in claim 20, wherein said selected maximum number of days is five.

22. A method of displaying blood glucose levels using a blood glucose meter comprising the steps of:

storing blood glucose levels with the corresponding dates and times of day the respective blood glucose levels were taken;

calculating using a processing devicean average blood glucose level from at least a three of the stored blood glucose levels as the constituent values;

displaying the average blood glucose level using a display device of said blood glucose meter; and

displaying the constituent values at least one of substantially simultaneously with said average blood glucose level, and after the average blood glucose level using sequential display screens for respective ones of the average blood glucose level and the constituent values that can be generated in a round robin manner;

wherein said calculating step comprises the steps of

selecting the stored blood glucose levels used to determine said average blood glucose level based on the date and time of day the stored blood glucose levels were taken;

defining a time period during a day when the average blood glucose level is desired for that time period on each of a selected number of days;

receiving a user input requesting an average blood glucose level of said time period for a selected number of days beginning with the current day;

determining if said time period has been entered or passed on said current day;

using a reading of an blood glucose level taken during the time period for said current day when determining the average blood glucose level if said time period has been entered or has passed for the current day; and

selecting a stored blood glucose level taken on the previous day when determining the average blood glucose level if said time period has yet not been entered or passed for the current day.

23. A method as claimed in claim 22, further comprising the step of displaying a variability indicator that indicates the variability between said constituent blood glucose levels.

24. A method as claimed in claim 23, wherein the variability indicator is at least one of a scalar value, and a statistical parameter selected from the group consisting of a standard deviation and a coefficient of variance.

25. A method as claimed in claim 22, wherein said selected number of days is three.

26. A method as claimed in claim 22, wherein said using step further comprises the step of selecting one of the earliest and the most recent of a plurality of readings taken on said current day during said time period based on their respective times of day.

27. A method as claimed in claim 22, wherein said selecting step further comprises the step of selecting one of the earliest and the most recent of a plurality of readings taken on said previous day during said time period based on their respective times of day.

28. A method as claimed in claim 22, wherein said using step further comprises the step of using a stored blood glucose level from the previous day if no valid blood glucose levels are available from said time period for the current day, and said selecting step further comprises the step of using a stored blood glucose level from the day before said previous day if no valid blood glucose levels are available from said time period for the previous day.