Guided structured testing kit

• US 8,349,612 B2
• Filed: 11/15/2010
• Issued: 01/08/2013
• 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, Csavas, Colleen, Porsch, Ulrich
• Primary Examiner(s): Wallenhorst, Maureen
• Application Number:
  US12/946,356
• Publication Number:
  US 20120122227A1
• Time in Patent Office: 785 Days
• Field of Search: 436/63, 436/95, 436/149, 436/164, 436/169, 422/400, 422/420, 422/430, 422/68.1, 422/82.01, 422/82.02, 422/82.05, 422/559, 435/14, 435/810, 435/287.7, 600/365
• 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 which may include 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 includes 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 for assaying blood, the diagnostic test strip comprising:

a support element;

a glucose reagent, which reacts with glucose in the blood, 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 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 into the test strip meter.

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 a measurement of the blood is taken as pre-prandial, post-prandial, pre-event, post-event, fasting, bedtime, or combinations thereof.

11. A guided structured testing kit for assaying blood comprising a test strip container, a test strip meter, a testing protocol advisor, and at least one diagnostic test strip,

wherein the at least one diagnostic test strip comprises a support element, a reagent which reacts with glucose in the blood 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 and is provided in the testing kit as a paper tool, on the testing kit as a paper tool, in the testing kit as a stand-alone electronic device or electronically by the test strip meter.

12. The guided structured testing kit of claim 11, wherein the test strip meter comprises a memory system configured to store the glycemic context of the at least one diagnostic test strip when inputted into the test strip meter, and associate the inputted glycemic context with a blood glucose test result provided by the at least one diagnostic test strip.

13. The guided structured testing kit of claim 11, wherein the test strip container of 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.

14. The guided structured testing kit of claim 13, wherein the visual notification comprises a calendar comprising a plurality of scheduled tests.

15. The guided structured testing kit of claim 11, wherein the at least one glycemic testing protocol comprises at least one scheduled glycemic test.

16. The guided structured testing kit of claim 15, wherein the testing protocol advisor detects the status of the at least one of scheduled glycemic test.

17. The guided structured testing kit of claim 16, 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.

18. The guided structured testing kit of claim 11, wherein the glycemic testing protocol is programmable by a user.

19. The guided structured testing kit of claim 11, 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.

20. A method for performing a guided structured test for assaying blood, the method comprising:

providing a diagnostic test strip having a glycemic context code and a glucose reagent which reacts with glucose in blood associated with the diagnostic test strip and a test strip meter;

applying blood to the diagnostic test strip;

executing a blood glucose measurement on the blood by inserting the diagnostic test strip into the test strip meter; and

signaling a glycemic context to the test strip meter by inputting the glycemic context code associated with the diagnostic test strip into the test strip meter, wherein the test strip meter associates the signaled glycemic context with a blood glucose test result provided by the diagnostic test strip and stores the blood glucose test result with the glycemic context in a memory of the test strip meter.

21. The method of claim 20, further comprising,

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

22. The method of claim 20, further comprising,

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

23. The method of claim 20, further comprising,

establishing a reminder system based on historically stored glycemic context from the memory of the test strip meter which reminds a user to execute a blood glucose measurement within a specific time window and/or under specific conditions that have been determined from the historically stored glycemic context.

24. The method of claim 20, wherein the glycemic context is pre-prandial, post-prandial, pre-event, post-event, fasting, bedtime, or combinations thereof.

25. The method of claim 20, wherein the glycemic context code is machine-readable.

26. The method of claim 25, wherein the machine-readable glycemic context code is an optical signaling indicia, an electrical signaling indicia, a mechanical signaling indicia, or combinations thereof.

27. The method of claim 20, wherein a plausibility check is executed automatically by the test strip meter with respect to the glycemic context inputted via the glycemic context code and a signal is provided by the test strip meter if an incorrect glycemic context is provided.

28. The method of claim 27, wherein the plausibility check is based on a time, a current measured blood glucose value, historical data or combinations thereof.

29. The method of claim 20, wherein a signal is provided if a scheduled test is missed.

30. The method of claim 29, wherein the scheduled test is determined to be missed based on information about a time, a current measured blood glucose value, historical data or combinations thereof.

31. A guided structured testing kit for assaying blood comprising a test strip container, a test strip meter, a testing protocol advisor, and at least one diagnostic test strip, wherein the at least one diagnostic test strip comprises a support element, a reagent which reacts with glucose in the blood 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 at least one internal volume to hold the at least one diagnostic test strip and comprises a lid,

wherein the testing protocol advisor notifies a user of an at least one glycemic testing protocol, and is provided in the testing kit as a paper tool, on the testing kit as a paper tool, in the testing kit as a stand-alone electronic device or electronically by the test strip meter, 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.

32. The guided structured testing kit of claim 31, wherein the testing protocol advisor is programmed with structured testing parameters.

33. 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, which reacts with glucose in blood, 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.