SYSTEMS AND METHODS FOR MULTIPLE ANALYTE ANALYSIS

• US 20140124384A1
• Filed: 11/02/2012
• Published: 05/08/2014
• Est. Priority Date: 11/02/2012
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Diebold, Eric R., Gerber, Martin T.
• Granted Patent: US 8,920,628 B2
• Time in Patent Office: Days
• US Class Current: 205/782
• 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 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 27/307 Disposable laminated or multilayered electrodes G01N27/3272 takes precedence
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• 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 27/416 Systems G01N27/27 takes precedence
• CPC Class Codes: G01N 33/492 Determining multiple analytes
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

Systems and methods for multiple analyte analysis are provided. In one embodiment, a method includes determining concentrations of first and second analytes in a sample. The first and second analytes may be, for example, glucose and hydroxybutyrate. In this form, an indication related to the measured concentration of hydroxybutyrate is provided in response to determining that the concentration of hydroxybutyrate is above a predetermined value. In a further aspect of this form, a quantitative indication representative of the measured glucose concentration is automatically provided regardless of the value of the measured glucose concentration. In another embodiment, a system includes a meter configured to interact with a test element to assess first and second analytes in a sample. Further embodiments, forms, objects, features, advantages, aspects, and benefits shall become apparent from the description and drawings.

Claims

1. A method, comprising:

providing a test element configured for analyzing first and second analytes in a sample;

contacting the test element with the sample;

determining concentration of the first analyte in the sample and providing an indication related to concentration of the first analyte in response to determining the first analyte concentration is above a predetermined value; and

determining concentration of the second analyte in the sample.

2. The method of claim 1, which further comprises displaying information corresponding to the second analyte concentration.

3. The method of claim 1, wherein the first analyte is hydroxybutyrate and the second analyte is glucose.

4. The method of claim 3, wherein the predetermined value is 0.6 mM.

5. The method of claim 1, wherein the step of providing the indication in response to determining the first analyte concentration is above a predetermined value includes at least one of displaying the first analyte concentration, providing a warning, providing a list of actions to take in response to the first analyte concentration being above the predetermined value, and transmitting a message to at least one of a user of the test element, healthcare provider, caregiver and parent or guardian.

6. The method of claim 1, wherein providing the indication in response to determining the first analyte concentration is above the predetermined level includes transmitting a message to a mobile device or computer.

7. The method of claim 6, wherein providing the indication in response to determining the first analyte concentration is above the predetermined level further includes displaying a message related to the first analyte concentration on a test meter.

8. The method of claim 1, wherein providing the indication in response to determining the first analyte concentration is above the predetermined level includes displaying a message related to the first analyte concentration.

9. The method of claim 1, wherein providing the indication in response to determining the first analyte concentration is above the predetermined level includes changing a color of at least a portion of a display screen.

10. The method of claim 1, wherein providing the indication in response to determining the first analyte concentration is above the predetermined level includes displaying an information icon on a display screen.

11. The method of claim 10, which further includes providing a message in response to a selection of the information icon.

12. The method of claim 11, wherein the message includes at least one of a description of the first analyte concentration, a list of actions to take in response to the first analyte concentration being above the predetermined level, and contact information of a healthcare provider.

13. A system, comprising:

a test element configured for analyzing first and second analytes in a sample; and

a meter configured to interact with the test element and including a controller structured to;

determine concentration of the first analyte in the sample and, if the concentration of the first analyte is above a predetermined value, provide a first signal for providing an indication related thereto; and

determine concentration of the second analyte in the sample and provide a second signal for outputting information related to the concentration of the second analyte.

14. The system of claim 13, wherein the indication includes at least one of outputting information corresponding to the concentration of the first analyte, providing a warning, providing a list of actions to take in response to the first analyte concentration being above the predetermined value, and transmitting information related to the concentration of the first analyte to at least one of a user of the system, healthcare provider, caregiver and parent or guardian.

15. The system of claim 13, wherein the first analyte is hydroxybutyrate and the second analyte is glucose.

16. The system of claim 15, wherein the predetermined value is in the range of 0.5 mM to 3.0 mM.

17. The system of claim 13, wherein the meter further includes a display responsive to the first signal to display the indication related to the concentration of the first analyte.

18. The system of claim 17, wherein the display is responsive to the first signal to provide an icon related to the concentration of the first analyte.

19. The system of claim 17, wherein at least a portion of the display is configured to change color in response to the first signal.

20. The system of claim 17, wherein the display is configured to provide an information icon in response to the first signal.

21. The system of claim 20, wherein the display is further configured to provide a message in response to a selection of the information icon, the message including at least one of a description of the first analyte concentration, a list of actions to take in response to the first analyte concentration being above the predetermined level, and contact information of a healthcare provider.

22. The system of claim 13, wherein the meter further includes a communication module configured to transmit a message to a mobile device or computer in response to the first signal.

23. The system of claim 13, wherein the controller is further structured to provide a third signal for providing an approval indication if the concentration of the first analyte is below the predetermined value.

24. A method, comprising:

performing a plurality of tests to determine concentrations of first and second analytes in a sample, wherein each of the tests includes applying the sample to a test element configured for analyzing the first and second analytes in the sample;

storing the first analyte concentration determined from each test performed;

analyzing the stored concentrations of the first analyte to monitor for an existence of an upwardly increasing trend in the stored concentrations toward a predetermined value; and

providing a first indication in response to detecting the existence of the trend.

25. The method of claim 24, which further includes providing a second indication in response to determining the first analyte concentration is above the predetermined value in any one or more of the plurality of tests.

26. The method of claim 25, which further includes automatically providing a third indication related to the concentration of the second analyte after performing each of the tests.

27. The method of claim 26, wherein the first analyte is hydroxybutyrate and the second analyte is glucose.

28. The method of claim 24, wherein the first indication includes one of a graphical illustration of the trend and an information icon.

29. The method of claim 24, wherein providing the first indication includes displaying an information icon on a meter display.

30. The method of claim 29, which further includes providing a graphical illustration of the trend in response to a selection of the information icon.

31. A method, comprising:

providing a hand held device comprising a display, a processor and a storage memory, the device being operative to engage one or more test elements and to determine concentration of at least first and second analytes in a fluid sample provided on said one or more test elements;

using the device, recording in the storage memory the value of the determined concentration of each of the at least first and second analytes;

using the device, determining whether the determined concentration for the first analyte is above a first predetermined value;

using the device, determining whether the determined concentration for the second analyte is above a second predetermined value; and

using the device, activating a watch mode when the determined concentration for either of the first and second analytes is above the respective first and second predetermined values.

32. The method of claim 31, wherein the storage memory comprises a plurality of recorded values of determined concentrations for each of the first and second analytes, the method further comprising:

selecting at least one of the first and second analytes for monitoring trending information;

using the device, determining whether the trending information for the analyte selected for monitoring generally matches predetermined criteria for recommending an increased frequency for determining the concentration for the analyte selected; and

using the device, activating the watch mode regardless of the determined concentration for either of the first and second analytes being above the respective first and second predetermined values when the trending information generally matches the predetermined criteria.

33. The method of claim 32 wherein the first analyte is hydroxybutyrate and the second analyte is glucose, and the analyte selected for monitoring comprises hydroxybutyrate.

34. The method of claim 31, wherein the watch mode comprises the device providing at least one recommendation for an increased frequency for determining the concentration for at least one of the first and second analytes.

35. The method of claim 31, further comprising when the watch mode is activated, displaying a visual indication on the display, the visual indication configured to indicate the activation of the watch mode.

36. The method of claim 31, wherein the first analyte is hydroxybutyrate and the second analyte is glucose.