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

• US 9,629,588 B2
• Filed: 05/09/2016
• Issued: 04/25/2017
• Est. Priority Date: 11/01/2001
• Status: Expired due to Term

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ginsberg, Barry H.
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US15/149,942
• Publication Number:
  US 20160249865A1
• Time in Patent Office: 351 Days
• 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

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 comprise a measure of the variability of its constituent values, encompass values that occur at specified times such as 1 hour before and after a specified meal time, and be calculated over a limited number of days previous to the calculation (e.g., 3 days) and have a minimum number of values that must be obtained within the time and date ranges. An algorithm can exclude 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 comprising the steps of:

selecting a time period and a corresponding subset of a plurality of medical data levels comprising medical data levels taken during the time period and storing at least the subset of medical data levels in a memory device;

calculating using a processing device an average medical data level using at least n stored medical data levels selected from the subset of stored medical data levels where n is an integer greater than or equal to 2, the n stored medical data levels being constituent values of said average medical data level;

sequentially annunciating said average medical data level and respective ones of the constituent values comprising

annunciating said average medical data level,

annunciating a first medical data level in response to first user input to annunciate said first medical data level from among the constituent values, and

annunciating a second medical data level in response to a second user input annunciate said second medical data level from among the constituent values;

wherein each of the annunciating steps comprises displaying a corresponding one of said average medical data level and said constituent values on a display screen, the display screen comprising a first area for displaying one value selected from the group consisting of the average medical data level and said constituent values, and second area configured to simultaneously display n indicators corresponding to respective ones of said n stored medical data levels at least when one of said constituent values is displayed, and the annunciating steps for displaying said constituent values comprises displaying one of said n indicators corresponding to the constituent value currently being annunciated differently from the other ones of said n indicators in the second area to indicate which of said constituent values is currently being annunciated.

2. A method as claimed in claim 1, wherein each of the three said annunciating steps for annunciating said average medical data level, said first medical data level and said second medical data level, respectively, can be accompanied by generating a corresponding audible signal via a speaker.

3. A method as claimed in claim 1, wherein the medical data levels are blood glucose levels and the medical data levels are provided by a blood glucose meter.

4. A method as claimed in claim 1, further comprising the step of annunciating a variability indicator that indicates the variability between said n stored medical data levels by at least one of displaying said variability indicator on the display screen and generating a corresponding audible signal via a speaker.

5. A method as claimed in claim 4, wherein said 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.

6. A method as claimed in claim 1, further comprising the steps of:

annunciating a next medical data level in response to another user input to annunciate the next medical data level among said n stored medical data levels after said first medical data level and said second medical data level; and

repeating annunciating the next medical data level in response to another user input to annunciate the next medical data level among the n medical data levels until each of said constituent values have been annunciated.

7. A method as claimed in claim 6, wherein said repeating step comprises the step of annunciating the average medical data level after the last medical data level among said constituent values has been annunciated.

8. A method as claimed in claim 1, further comprising the step of displaying each of said n indicators as nonflashing items when said first area is displaying said average medical data level, and flashing the corresponding one of said n indicators when its corresponding n medical data level is being displayed as one of the constituent values.

9. A method as claimed in claim 1, wherein said display screen comprises a third area for displaying a time of day and a date, and further comprising the step of displaying the time of day and date stored with a corresponding one of said n stored medical data levels in said third area when it is being displayed as a constituent value in said first area.

10. A method as claimed in claim 1, wherein said calculating step comprises the step of selecting the n 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.

11. A method as claimed in claim 10, wherein the time period is a period of time during a day, the subset of stored medical data levels comprises stored medical data levels taken during the period of time on a selected number of days, and said calculating step further comprises calculating the average medical data level for that time period over the selected number of days.

12. A method of displaying blood glucose levels comprising the steps of:

selecting a time period and a corresponding subset of a plurality of blood glucose levels comprising blood glucose levels taken during the time period and storing at least the subset of the medical data levels in a memory device;

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

sequentially displaying the average blood glucose level using a display device and respective ones of the constituent values comprising

displaying said average blood glucose level,

displaying a first one of the constituent values in response to a first user input to display the first one of the constituent values,

displaying a second one of the constituent values in response to a second user input to display the second one of the constituent values,

displaying a third one of the constituent values in response to a third user input to display the third one of the constituent values, and

displaying the average blood glucose level again in response to another user input to display a value;

wherein each of the displaying steps comprises displaying said average blood glucose level and the constituent values on a display screen, the display screen comprising a first area for displaying one value selected from the group consisting of the average blood glucose level and the constituent values, and a second area configured to simultaneously display three indicators corresponding to respective ones of the three constituent values at least when one of said constituent values is displayed, and the displaying steps for displaying the constituent values comprise displaying one of the three indicators corresponding to the constituent value currently being displayed in the first area differently from the other ones of the three indicators in the second area to indicate which of the constituent values is currently being displayed.

13. A method as claimed in claim 12, wherein display screen is on a display device that comprises forward and backward arrow keys for navigation forward and backward, respectively, among the different displayed constituent values.

14. A method as claimed in claim 12, further comprising the step of displaying each of said three indicators as nonflashing items when said first area is displaying the average blood glucose level, and flashing the corresponding one of said three indicators when its corresponding constituent value is being displayed.

15. A method as claimed in claim 12, wherein said calculating step comprises the step 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.

16. A method as claimed in claim 12, wherein said calculating step further comprises selecting the time period to be a period of time during a day, the subset of stored medical data levels comprises stored medical data levels taken during the period of time on a selected number of days, and calculating the average blood glucose level for that time period over the selected number of days.

17. An apparatus for patient condition monitoring comprising:

an annunciator;

a user input device; and

a processing device connected to said annunciator and said user input device, provided with at least a subset of a plurality of medical data levels along with their respective dates and times of day they were taken, and programmed to calculate an average medical data level using at least n medical data levels selected from a subset of the plurality of medical data levels that correspond to medical data levels taken during a selected time period where n is an integer greater than or equal to 2, the n medical data levels being constituent values of the average medical data level, and to sequentially annunciate the average medical data level and respective ones of the constituent values via said annunciator by, receiving a first user input from said user input device to annunciate a first medical data level from among the constituent values, annunciating the first medical data level in response to said first user input, receiving a second user input from said user input device to annunciate a second medical data level from among the constituent values, and annunciating the second medical data level in response to said second user input;

wherein said annunciator comprises a display device and the average medical data level and the constituent values are annunciated using a display screen, said display screen comprising a first area for displaying one value from the group consisting of the average medical data level and the constituent values, and a second area configured to simultaneously display n indicators corresponding to respective ones of the n medical data levels at least when one of said constituent values is displayed, and said annunciator displays one of said n indicators corresponding to the constituent value currently being annunciated differently from the other said n indicators in the second area to indicate which of the constituent values is currently being annunciated.

18. An apparatus as claimed in claim 17, wherein said annunciator is at least one of the display device and a speaker, and said processing device is operable to annunciate by at least one of displaying on said display screen, and generating a corresponding audible signal via said speaker.

19. An apparatus as claimed in claim 17, wherein the medical data levels are blood glucose levels.

20. An apparatus as claimed in claim 17, wherein said processing device is programmable to determine and annunciate a variability indicator via said annunciator that indicates the variability between the n medical data levels by at least one of displaying said variability indicator on the display screen and generating a corresponding audible signal via a speaker.

21. An apparatus as claimed in claim 17, 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.

22. An apparatus as claimed in claim 17, wherein said processing device is programmed to display each of said n indicators as nonflashing items when said first area is displaying the average medical data level, and flash the corresponding one of said n indicators when its corresponding n medical data level is being displayed as one of the constituent values.

23. An apparatus as claimed in claim 17, wherein said display screen comprises a third area for displaying a time of day and a date, said processing device being further programmed to display the time of day and date of a corresponding one of the n medical data levels in said third area when it is being displayed as a constituent value in said first area.

24. An apparatus as claimed in claim 17, wherein said processing device is programmable to select the n medical data levels used to determine said average medical data level based on the date and time of day the medical data levels were taken.

25. An apparatus as claimed in claim 17, wherein said user input device comprises forward and backward arrow keys for navigation forward and backward, respectively, among the annunciated said constituent values.