Apparatus and methods for taking blood glucose measurements and recommending insulin doses

• US 9,341,614 B2
• Filed: 11/03/2010
• Issued: 05/17/2016
• Est. Priority Date: 04/04/2008
• Status: Active Grant

• Current Assignee: Hygieia, Inc.
• Original Assignee: Hygieia, Inc.
• Inventors: Goebel, James, Bielawa, Holly, Demetris, Carissa, Morton, Carol Treat, Pomorski, Michelle, Puricelli, Thomas, Rodgers, Jim, Bashan, Eran, Hodish, Israel, Hindinger, John R.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): FISHER, BRITTANY I
• Application Number:
  US12/926,234
• Publication Number:
  US 20110152657A1
• Time in Patent Office: 2,022 Days
• Field of Search: 422/404
• US Class Current: 1/1
• 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: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/507 Head Mounted Displays [HMD]
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• 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: A61M 5/31571 Means preventing accidental administration for automatic syringes A61M5/20
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/63 for local operation

Abstract

The present disclosure related to an apparatus that may be used for taking blood glucose measurements and providing individualized insulin dose recommendations wherein the apparatus is easy to use and facilitates improved diabetes control in patients. Also disclosed are related methods.

Claims

1. An apparatus comprising;

a test strip port for receiving a test strip;

at least a first a computer-readable memory;

a display screen;

a processor operatively connected to the at least first computer-readable memory and the display screen, the processor configured to;

A. cause the successive display of information corresponding to at least the following;

(i) a patient'"'"'s current blood glucose level measurement as determined from a sample of the patient'"'"'s blood provided on a test strip;

(ii) an event associated with the said current blood glucose level measurement; and

(iii) a recommended insulin dose; and

B. cause the continuous and simultaneous display of indicia corresponding to at least the patient'"'"'s current blood glucose level measurement, an event associated said current blood glucose level measurement, and a recommended insulin dosage while simultaneously causing the display of said successive information; and

a plurality of buttons that may be user-activated operatively connected to the processor, the plurality of buttons including a first button operative to enable a user to selectively cycle through the successive information displays on the display screen, and second and third buttons operative to enable a user to selectively alter the information displayed in one or more of the successive information displays on the display screen; and

wherein the continuously displayed indicia corresponding to each of the successive information displays are positioned on the display screen in an alignment with the position of the first button, and the successively displayed information is positioned on the display screen in an alignment with the second and third buttons.

2. The apparatus of claim 1, wherein the processor is configured to cause the successive display of information corresponding to at least the following:

(i) a patient'"'"'s current blood glucose level measurement as determined from a sample of the patient'"'"'s blood provided on a test strip;

(ii) an event associated with the said current blood glucose level measurement;

(iii) an estimate for the number of carbohydrates associated with the said event; and

(iv) a recommended insulin dose.

3. The apparatus of claim 1, wherein the successive display on the display screen of the information display corresponding to an event associated with the said current blood glucose level measurement automatically succeeds the display of the information display corresponding to a patient'"'"'s current blood glucose level measurement if the first button is not user-actuated within a predetermined period of time.

4. The apparatus of claim 1, wherein the apparatus is programmed to enable a user to selectively override the recommended insulin dose displayed on the display screen using one or more of the plurality of buttons.

5. The apparatus of claim 1, wherein the apparatus comprises a labeling area on which personalized identifying indicia may be provided.

6. The apparatus of claim 1, wherein the estimation of the number of carbohydrates associated with the said event is a measurement of the number of carbohydrates.

7. The apparatus of claim 1, wherein the plurality of user-actuated buttons operatively connected to the processor are positioned adjacent the display screen.

8. The apparatus of claim 1, wherein the continuously displayed indicia corresponding to each of the successive information displays are positioned on the display screen in said alignment that is longitudinal with the position of the first button.

9. The apparatus of claim 1, wherein the continuously displayed indicia corresponding to each of the successive information displays are positioned on the display screen in said alignment with the position of the first button and the successively displayed information is positioned on the display screen in a longitudinal alignment with the second and third buttons.

10. The apparatus of claim 1, wherein the continuously displayed indicia corresponding to each of the successive information displays are positioned on the display screen in an alignment that is longitudinal with the position of the first button, and the successively displayed information is positioned on the display screen in a longitudinal alignment with the second and third buttons.

11. The apparatus claim 1, wherein the plurality of user-actuated buttons are arranged such that it is intuitive to a user that actuation of each of these buttons will effect modification in each of the associated information displays.

12. The apparatus of claim 1, wherein the visual alignment between the plurality of user-actuated buttons and the associated information displays results in a user-friendly and intuitive to use apparatus.

13. The apparatus of claim 1, wherein the display screen is divided into two distinct sections including a navigation bar section and a dynamic content section.

14. The apparatus of claim 1, wherein the at least one of the user-actuated buttons is a software programmable button located on a display screen.

15. The apparatus of claim 1, wherein the apparatus enables at least 85% of intended users to become proficient in the primary operation of the apparatus after two test uses.

16. The apparatus of claim 1, wherein the apparatus is intuitive and simple to use with conspicuous features on the display screen and the apparatus enables at least 85% of intended users to become proficient in the primary operation of the apparatus after two test uses.

17. The apparatus of claim 1, wherein the apparatus enables at least 70%, 80%, 85%, 90%, or 95% of intended users to become proficient in the primary operation of the apparatus after one, two or three test uses.

18. An apparatus comprising:

a test strip port for receiving a test strip;

at least a first a computer-readable memory;

a display screen;

a processor operatively connected to the at least first computer-readable memory and the display screen, the processor configured to;

A. cause the successive display of information corresponding to at least the following;

(i) a patient'"'"'s current blood glucose level measurement as determined from a sample of the patient'"'"'s blood provided on a test strip;

(ii) an event associated with the said current blood glucose level measurement; and

(iii) a recommended insulin dose; and

B. cause the continuous and simultaneous display of indicia corresponding to at least the patient'"'"'s current blood glucose level measurement, an event associated said current blood glucose level measurement, and a recommended insulin dosage while simultaneously causing the display of said successive information; and

at least one button that may be user-actuated operatively connected to the processor, the at least one button operative to enable a user to selectively cycle through the successive information displays on the display screen.

19. The apparatus of claim 18, wherein the at least one button is a single button.

20. The apparatus of claim 18, wherein the at least one button is a software programmable button located on a display screen.

21. The apparatus of claim 18, wherein the continuously displayed indicia corresponding to each of the successive information displays are positioned on the display screen in an alignment with the position of the least one button.

22. The apparatus of claim 18, wherein the successive display on the display screen of the information display corresponding to an event associated with the said current blood glucose level measurement automatically succeeds the display of the information display corresponding to a patient'"'"'s current blood glucose level measurement if the of the least one button is not user-actuated within a predetermined period of time.

23. The apparatus of claim 18, wherein the apparatus comprises a labeling area on which personalized identifying indicia may be provided.

24. The apparatus of claim 18, wherein the at least one button operatively connected to the processor is positioned adjacent the display screen.

25. The apparatus of claim 18, wherein the continuously displayed indicia corresponding to each of the successive information displays are positioned on the display screen in said alignment that is longitudinal with the position of the at least one button.

26. The apparatus of claim 18, wherein the continuously displayed indicia corresponding to each of the successive information displays are positioned on the display screen in said alignment with the position of the at least one button.

27. The apparatus of claim 18, wherein the continuously displayed indicia corresponding to each of the successive information displays are positioned on the display screen in an alignment that is longitudinal with the position of the at least one button.

28. The apparatus of claim 18, wherein the at least one button is arranged such that it is intuitive to a user that actuation of the button will effect modification in each of the associated information displays.

29. The apparatus of claim 18, wherein the visual alignment between the at least one button and the associated information displays results in a user-friendly and intuitive to use apparatus.

30. The apparatus of claim 18, wherein the display screen is divided into two distinct sections including a navigation bar section and a dynamic content section.

31. The apparatus of claim 18, wherein the apparatus enables at least 85% of intended users to become proficient in the primary operation of the apparatus after two test uses.

32. The apparatus of claim 18, wherein the apparatus is intuitive and simple to use with conspicuous features on the display screen and the apparatus enables at least 85% of intended users to become proficient in the primary operation of the apparatus after two test uses.

33. The apparatus of claim 18, wherein the apparatus enables at least 70%, 80%, 85%, 90%, or 95% of intended users to become proficient in the primary operation of the apparatus after one, two or three test uses.