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

• US 9,192,338 B2
• Filed: 06/03/2009
• Issued: 11/24/2015
• Est. Priority Date: 11/01/2001
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ginsberg, Barry H.
• Primary Examiner(s): D'Angelo, Michael
• Assistant Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US12/457,185
• Publication Number:
  US 20090240129A1
• Time in Patent Office: 2,365 Days
• Field of Search: 600/345, 600/347, 600/365
• US Class Current: 1/1
• 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. An apparatus for patient condition monitoring comprising:

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 memory device, said annunciator and said user input device and programmed to calculate an average medical data level using at least n stored medical data levels selected from a subset of the stored medical data levels in said memory device that correspond to stored medical data levels taken during a selected time period where n is an integer greater than or equal to 2, the n stored 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.

2. An apparatus as claimed in claim 1, 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.

3. An apparatus as claimed in claim 1, wherein the medical data levels are blood glucose levels and the apparatus is a blood glucose meter.

4. An apparatus as claimed in claim 1, wherein said processing device is programmable to determine and annunciate a variability indicator via said annunciator that indicates the variability between the 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. An apparatus as claimed in claim 1, 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.

6. An apparatus as claimed in claim 1, 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.

7. An apparatus as claimed in claim 1, 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 stored with a corresponding one of the n stored medical data levels in said third area when it is being displayed as a constituent value in said first area.

8. An apparatus as claimed in claim 1, wherein said processing device is programmable to select 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.

9. An apparatus as claimed in claim 1, wherein said user input device comprises forward and backward arrow keys for navigation forward and backward, respectively, among the annunciated said constituent values.