MONITORING DEVICE

• US 20100152554A1
• Filed: 12/14/2007
• Published: 06/17/2010
• Est. Priority Date: 12/14/2006
• Status: Abandoned Application

• Current Assignee: Egomedical Swiss AG
• Original Assignee: Egomedical Swiss AG
• Inventors: Steine, Matthias, Jones, Eurig Wyn
• Application Number:
  US12/518,924
• Publication Number:
  US 20100152554A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets

Abstract

Provided is a small sized, portable monitoring device capable of determining an analyte under investigation and having a system and method for providing compliance information to a user of his management of a disease, and for easily navigating a menu structure by means of manual control(s). Further provided is the provision of feedback to the user in form of a disease management information to be easily understood by a user such as the further described COMPLIANCE WINDOW or the INDICATOR CATEGORIES. The user interface can be used in connection with a glucose diagnostic device, a coagulation diagnostic device, immunoassay diagnostic device, and other monitoring devices such as an blood pressure monitor or a pedometer.

Claims

1. A monitoring device comprising

a processor (6),

a built-in sensor or a port (14) equipped with a disposable sensor,

characterized in that

the device is adapted for relating the stored measurement values of the sensor to a medically useful compliance range.

2. The monitoring device of claim 1, wherein the compliance range extends from a lower limit to an upper limit.

3. The monitoring device of claim 1, wherein the device relates the stored measurement values of the sensor to a medical useful compliance range by determining one or more mean values and/or one or more statistical representations of the measurement values.

4. The monitoring device of claim 1, wherein the monitoring device is adapted for evaluating the measurement values of the sensor in accordance with a predefined set of specific events.

5. The monitoring device of claim 4, wherein the predefined set of specific events comprises one or more of:

pre- and/or post-prandial meal time events, activities, medical treatment events.

6. The monitoring device of claim 5, wherein the specific events comprise pre- and/or post-prandial mealtime events, further preferably one or more of:

pre-breakfast, post-breakfast, pre-lunch, post-lunch, pre-dinner, post-dinner, and/or bed-time, wake-up-time.

7. The monitoring device of claim 1, further comprising event input means for relating a current measurement value to a specific event.

8. The monitoring device of claim 7, wherein a specific event comprises a predefined time frame within a 24 hour time period.

9. The monitoring device of claim 7, wherein a specific event is defined by a time frame and an event marker.

10. The monitoring device of claim 4, wherein the predefined set of specific events forms a compliance management profile stored in the device memory.

11. The monitoring device of claim 10, wherein the compliance management profile reoccurs every 24 hours.

12. The monitoring device of claim 10, wherein the compliance management profile extends over a 24 hour time period and comprises one day and one night.

13. The monitoring device of claim 10, providing multiple compliance management profiles each specific to calculated averages and/or statistical representation of all measurements of a predefined number of days, i.e. the last 7, 14, or 30 days.

14. The monitoring device of claim 1, wherein the device provides a self-learning mode adapted for generating settings for a compliance management profile.

15. The monitoring device of claim 1, further comprising a display to show the relationship between the statistically processed measurement values and the compliance range graphically or using an iconic representation.

16. The monitoring device of claim 15, wherein the display is adapted for showing a compliance window with a compliance range and a current measurement indicator.

17. The monitoring device of claim 15, wherein the display is adapted for showing a compliance window with a compliance range, a mean measurement indicator and a current measurement indicator.

18. The monitoring device of claim 15, wherein the display is adapted for showing a compliance window with a lower limit and an upper limit indicator, a mean value indicator, and a current measurement indicator.

19. The monitoring device of claim 1, wherein a mean value is determined as an arithmetic mean of former measurements that have respectively occurred at a time of day defined by a time frame related to a specific event.

20. The monitoring device of claim 1, wherein the monitoring device is adapted for determining a mean value by averaging former measurement values that lie within the time frame corresponding to a specific event.

21. The monitoring device of claim 1, the monitoring device is adapted for determining a mean value by averaging former measurement values that lie within the time frame corresponding to a specific event, wherein the measurement values have been acquired during a predefined number of days.

22. The monitoring device of claim 1, wherein the predefined sets of a plurality of measurement values represents a mean value of measurements in a predefined number of days, such as the last 7 days, 14 days, or 30 days.

24. The monitoring device of claim 1, wherein the compliance range is provided in form of a graphical or iconic indicator to provide a compliance window to be targeted by the user.

25. The monitoring device of claim 24, wherein the left-hand side of compliance window represents a lower limit of the compliance range.

26. The monitoring device of claim 24, wherein the right-hand side of the compliance window represents an upper limit of the target compliance range.

27. The monitoring device of claim 24, wherein the center line of the compliance window represents the target value according to medically recommended analyte concentration.

28. The monitoring device of claim 1, having a compliance window for displaying on a display screen;

the graphical or iconic compliance window comprising;

a geometric shape suitable for a segmented liquid crystal display representing a scale for a deviation of the measurement values from the predetermined compliance range.

29. The monitoring device of claim 1, further comprising at least one mean value indicator representing a mean value of a plurality of measurement values acquired during a time frame related to a specific event.

30. The monitoring device of claim 1, further comprising an actual value indicator representing a current measurement value in relation to the at least one mean value indicator.

31. The monitoring device of claim 1, the monitoring device being adapted for determining, for a current measurement value, an updated mean value over a predetermined number of past days.

32. The monitoring device of claim 1, further comprising input means adapted for providing a scrolling function for scrolling through former measurement values and former mean values, both the former measurement values and the former mean values for a certain meal time event being displayed in the compliance window.

33. The monitoring device of claim 32, wherein by scrolling through former measurement values and former mean values, the trend of the movement of the mean values is visualized.

34. The monitoring device of claim 1, further comprising comparison means adapted for at least one of:

comparing a target value with an updated mean value,

comparing a target value with a current measurement value;

comparing a current measurement value with an updated mean value.

35. The monitoring device of claim 1, the monitoring device being equipped with an interactive navigational area having a selection window (80) located in its center, wherein one of the plurality of first level menu items is disposed while selected by the user.

36. The monitoring device of claim 35, wherein the interactive navigational area is provided on a display screen (38) for displaying a menu comprising a plurality of first level menu items in a sequential arrangement and being configured such that a selection of one of the plurality of first level menu items causes a plurality of second level menu items associated with one first level menu item to replace the first level menu items in the sequential arrangement.

37. The monitoring device of claim 36, wherein at least two of the plurality of first level menu items are disposed adjacent to the selection window during user operation.

38. The monitoring device of claim 35, wherein the interactive navigational area and the plurality of first level menu items include a text or an icon to represent a user operation.

39. The monitoring device of claim 35, wherein the plurality of first level menu items or second level menu items are populated according to a default configuration.

40. The monitoring device of claim 35, wherein the plurality of first level menu items or second level menu items are populated according to a user preference.

41. The monitoring device of claim 1, wherein the monitoring device is one of:

a personal diagnostic device for disposable test elements, a personal battery powered diagnostic handheld device, a portable monitoring device.

42. The monitoring device of claim 1, further comprising an analog input device handling the user interaction and providing at least one selection button and at least one confirmation button.

43. The monitoring device of claim 42, wherein the analog input device is detecting the selection of a manual button, and/or a manual switch.

44. The monitoring device of claim 42, wherein the analog input device is adapted for detecting the change of capacitance and/or impedance and/or resistance on specially dedicated areas of the device housing to provide for user interactions.

45. The monitoring device of claim 28, wherein the compliance window and an interactive navigational area are provided on the same area of the display screen (38).

46. The monitoring device of claim 45, wherein the display screen (38) is used further to provide legible compliance information (38a).

47. The monitoring device of claim 45, wherein manipulation of compliance window and interactive navigational area is effected by operating at least one selection button and/or at least one confirmation button.

48. The monitoring device of claim 1, wherein the monitoring device is equipped and connected with an adaptor by means of a communication bus.

49. The monitoring device of claim 48, wherein the communication bus is a universal serial bus (USB).

50. The monitoring device of claim 36, wherein the display screen comprises at least one of:

an organic light emitting diode, a dot matrix display screen, a segmented display screen, a hybrid dot matrix-segmented display screen.

51. The monitoring device of claim 41, wherein the personal diagnostic device is one or more of:

a glucose diagnostic device, a coagulation diagnostic device, an immunoassay diagnostic device.

52. A method of using a monitoring device according to claim 1 comprising:

inserting a test element into the monitoring device;

activating the monitoring device automatically;

prompting meal time category automatically;

confirming meal time category by user;

prompting of user to apply blood sample of blood onto appropriate area of test element;

displaying measurement result with meal time indicator.

53. The method of using a monitoring device according to claim 52, wherein the user is informed by means of alphanumerical, graphical, or iconic illustration about his compliance stage and/or health condition.

54. The method of claim 52, further comprising

prompting pre or post meal time automatically;

confirming pre or post meal time by user.

55. A method according to claim 52, in which the automatic prompting of the meal time categories prompted to the user comprise one or more of:

“

Breakfast”

, “

Lunch”

, “

Dinner”

, “

Night”

.

23. The monitoring device of claim 23, wherein the mean value of measurement values of a predefined number of days is determined for a specific event.