GUIDED STRUCTURED TESTING KIT

• US 20120122227A1
• Filed: 11/15/2010
• Published: 05/17/2012
• Est. Priority Date: 11/15/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wiegel, Christopher, Porsch, Ulrich, Csavas, Colleen
• Granted Patent: US 8,349,612 B2
• Time in Patent Office: Days
• US Class Current: 436/95
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/48778 Containers specially adapted therefor, e.g. for dry storage
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A guided structured testing kit comprising a test strip container, a test strip meter, a testing protocol advisor, and at least one of diagnostic test strip is presented. The diagnostic test strip comprising a support element, a glucose reagent provided on the support element, and a glycemic context code provided on the support element. The glycemic context code can be machine-readable. The glycemic context code signals a glycemic context to a test strip meter, either upon insertion of the diagnostic test strip or by a user manually inputting the glycemic context into the test strip meter. A method for performing a guided structured test is also provided.

Claims

1. A diagnostic test strip, the diagnostic test strip comprising:

a support element;

a glucose reagent provided on the support element; and

a glycemic context code provided on the support element, wherein the glycemic context code indicates a glycemic context for the diagnostic test strip.

2. The diagnostic test strip of claim 1, wherein a user inputs the glycemic context code into a test strip meter, wherein the glycemic context code indicates the glycemic context of the diagnostic test strip to a test strip meter.

3. The diagnostic test strip of claim 2, wherein the glycemic context code is an optical signaling indicia, a mechanical signaling indicia, or combinations thereof.

4. The diagnostic test strip of claim 1, wherein the glycemic context code is machine-readable.

5. The diagnostic test strip of claim 4, wherein the glycemic context code indicates a glycemic context to a test strip meter upon insertion of the diagnostic test strip.

6. The diagnostic test strip of claim 4, wherein the machine-readable glycemic context code is an optical signaling indicia, an electrical signaling indicia, a mechanical signaling indicia, or combinations thereof.

7. The diagnostic test strip of claim 6, wherein the optical signaling indicia is a bar code, a hole pattern, a color, or combinations thereof.

8. The diagnostic test strip of claim 6, wherein the mechanical signaling indicia is an indent pattern, a hole pattern, strip width or combinations thereof.

9. The diagnostic test strip of claim 6, wherein the electrical signal indicia is a resistance pattern, capacitance pattern, break pattern, or combinations thereof.

10. The diagnostic test strip of claim 1, wherein the glycemic context sets the condition under which the measurement is taken as pre-prandial, post-prandial, pre-event;

post-event, fasting, bedtime, or combinations thereof.

11. The diagnostic test strip of claim 1, wherein a plausibility check is executed with respect to the glycemic context and a signal is provided if an incorrect glycemic context is provided.

13. The diagnostic test strip of claim 1, wherein a signal is provided if a scheduled test is missed.

14. The diagnostic test strip of claim 13, wherein the scheduled test is determined to be missed based on information about the time, the current measured blood glucose value, historical data or combinations thereof.

12. The diagnostic test strip of claim 12, wherein the plausibility check is based on the time, the current measured blood glucose value, historical data or combinations thereof.

15. A guided structured testing kit comprising a test strip container, a test strip meter, a testing protocol advisor, and at least one of diagnostic test strip,

wherein the at least one of the diagnostic test strip comprises a support element, a reagent provided on the support element, and a glycemic context code provided on the support element, wherein the glycemic context code provides a glycemic context of the at least one diagnostic test strip,

wherein the test strip container defines an internal volume to hold the at least one diagnostic test strip, and

wherein the testing protocol advisor notifies a user of an at least one glycemic testing protocol.

16. The guided structured testing kit of claim 15, wherein the test strip meter comprises a memory system to store the signaled glycemic context of the at least one diagnostic test strip, and associate the signaled glycemic context with a blood glucose test result provided by the at least one diagnostic test strip, and wherein the testing protocol advisor is provided on the guided structured testing kit.

17. The guided structured testing kit of claim 15, wherein the test strip meter comprises a memory system to store the signaled glycemic context of the at least one diagnostic test strip, and associate the signaled glycemic context with a blood glucose test result provided by the at least one diagnostic test strip, and wherein the testing protocol advisor is integrated into the test strip meter.

18. The guided structured testing kit of claim 15, wherein the guided structured testing kit further comprises a lid, wherein the lid comprises at least one display, wherein the at least one display provides a visual notification of the at least one glycemic testing protocol.

19. The guided structured testing kit of claim 18, wherein the visual notification comprises a calendar comprising a plurality of scheduled tests.

20. The guided structured testing kit of claim 15, wherein the at least one glycemic testing protocol comprises at least one scheduled glycemic test.

21. The guided structured testing kit of claim 20, wherein the testing protocol advisor detects the status of the at least one of scheduled glycemic test.

22. The guided structured testing kit of claim 21, wherein the testing protocol advisor comprises a device to inform a user of a recommended action based on the status of the at least one scheduled glycemic test.

23. The guided structured testing kit of claim 15, wherein the glycemic testing protocol is programmable by a user.

24. The guided structured testing kit of claim 15, wherein the at least one diagnostic test strip comprises a glycemic context identifier corresponding to the indicated glycemic context of the at least one diagnostic test strip.

25. A method for performing a guided structured test, the method comprising:

providing a diagnostic test strip having a glycemic context code associated with the diagnostic test strip and a test strip meter;

executing a blood glucose measurement by the diagnostic test strip and the test strip meter

before or after signaling a glycemic context to the test strip meter from the glycemic context code associated with the diagnostic test strip and storing the glycemic context into a memory of the test strip meter; and

associating the signaled glycemic context with a blood glucose test result provided by the diagnostic test strip and storing the blood glucose test result with the glycemic context.

26. The method of claim 25, further comprising,

evaluating the blood glucose test result in conjugation with the glycemic context associated with that blood glucose test result.

27. The method of claim 25, further comprising,

generating a report with respect to the blood glucose test result and the glycemic context associated with that blood glucose test result.

28. The method of claim 25, further comprising,

establishing a reminder system based on historically stored glycemic context to remind the user to execute an action.

29. The method of claim 25, wherein the glycemic context is pre-prandial, post-prandial, pre-event, post-event, fasting, bedtime, or combinations thereof.

30. The method of claim 25, wherein the glycemic context code is machine-readable.

31. The method of claim 30, wherein the machine-readable glycemic context code is an optical signaling indicia, an electrical signaling indicia, a mechanical signaling indicia, or combinations thereof.

32. A guided structured testing kit comprising a lid, a test strip container, a test strip meter, a testing protocol advisor, and at least one of diagnostic test strip,

wherein the test strip container defines at least one internal volume to hold the at least one diagnostic test strip,

wherein the testing protocol advisor notifies a user of an at least one glycemic testing protocol, and

wherein the lid comprises at least one display, wherein the at least one display provides a visual notification of the at least one glycemic testing protocol comprising a plurality of scheduled tests.

33. The guided structured testing kit of claim 32, wherein the testing protocol advisor is programmed with structured testing parameters.

34. A test strip container, the test strip container comprising:

at least one internal volume to hold at least one diagnostic test strip;

a plurality of a compartments, wherein each compartment houses at least one diagnostic test strip, wherein each diagnostic test strip comprises,

a support element,

a glucose reagent provided on the support element, and

at least one glycemic context code provided on the test strip container and associated with each compartment in the plurality, wherein the glycemic context code indicates a glycemic context for the diagnostic test strip housed within each compartment.