Systems and methods for multiple analyte analysis

• US 10,466,196 B2
• Filed: 03/22/2017
• Issued: 11/05/2019
• Est. Priority Date: 11/02/2012
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Gerber, Martin T., Diebold, Eric
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US15/465,717
• Publication Number:
  US 20170191958A1
• Time in Patent Office: 958 Days
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 of analyzing multiple analytes in a sample, the method comprising the steps of:

contacting a test element with the sample, wherein the test element is configured for electrochemically analyzing first and second analytes, respectively, in the sample, and wherein the first analyte is hydroxybutyrate and the second analyte is glucose;

determining a first analyte concentration and a second analyte concentration in the sample via a test meter configured to interact with the test element;

determining whether the first analyte concentration is above or below a predetermined value;

automatically displaying the second analyte concentration;

displaying the first analyte concentration only in response to determining that the first analyte concentration is above said predetermined value; and

providing a further indication related to the first analyte concentration only in response to determining that the first analyte concentration is above said predetermined value;

wherein

said further indication related to the first analyte concentration comprises displaying a message related to the first analyte concentration on the test meter, said message including a description of the first analyte concentration, and a warning relating to the first analyte concentration being above said predetermined value;

and wherein the predetermined value is about 0.6 mM.

2. The method of claim 1, wherein said message further includes at least one of a list of actions to take in response to the first analyte concentration being above the first predetermined value, contact information of a healthcare provider, and displaying an information icon on a display screen of the test meter.

3. The method of claim 2, said message comprising displaying said information icon on a display screen of the test meter and further comprising providing a message in response to a selection of the information icon.

4. The method of claim 1, wherein the step of determining the first analyte concentration and the second analyte concentration is completed within 10 seconds after contacting the test element with the sample.

5. The method of claim 4, wherein the step of determining the first analyte concentration and the second analyte concentration is completed within 7.5 seconds after contacting the test element with the sample.

6. The method of claim 4, wherein the step of determining the first analyte concentration and the second analyte concentration is completed within 5 seconds after contacting the test element with the sample.

7. The method of claim 1 further comprising the step of:

storing one or both of the first analyte concentration and the second analyte concentration, and wherein the step of providing the indication further comprises providing an indication related to the second analyte concentration upon user access to the stored second analyte concentration.