Systems and methods for multiple analyte analysis

• US 9,921,176 B2
• Filed: 02/19/2015
• Issued: 03/20/2018
• 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:
  US14/625,997
• Publication Number:
  US 20150300974A1
• Time in Patent Office: 1,125 Days
• 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:

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

determining concentration of the first analyte in the sample via a test meter configured to interact with the test element and providing an indication related to concentration of the first analyte if the first analyte concentration is above a first predetermined value, wherein providing the indication in response to determining the first analyte concentration is above the first predetermined value includes displaying an information icon on a display screen of the test meter and further providing a message in response to a selection of the information icon;

determining concentration of the second analyte in the sample and automatically providing the concentration of the second analyte; and

initiating a ketone watch if the first analyte concentration is above the first predetermined value or if the second analyte concentration is above a second predetermined value, wherein the ketone watch comprises at least one action selected from the group consisting of;

(1). recommending increased frequency of testing for at least one of the first analyte and the second analyte,

(2). automatically providing the concentration of the first analyte concentration with the concentration of the second analyte regardless of the value of the concentration of the second analyte, and

(3). initiating a ketone trending analysis that monitors for rising first analyte concentration values, wherein each first analyte concentration is stored or retained regardless of whether each first analyte concentration is above the first predetermined value to permit trending analysis to be conducted on the stored or retained first analyte concentration values, and

wherein the first predetermined value is at least 0.6 mM and the second predetermined value is at least 240 mg/dL.

2. The method of claim 1, wherein the ketone is hydroxybutyrate.

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

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

5. The method of claim 4, wherein providing the indication in response to determining the first analyte concentration is above the first predetermined value further includes displaying a message related to the first analyte concentration on the test meter.

6. The method of claim 1, wherein providing the indication in response to determining the first analyte concentration is above the first predetermined value includes displaying a message related to the first analyte concentration on the test meter.

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

8. The method of claim 1, 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 first predetermined value, and contact information of a healthcare provider.

9. The method of claim 1, wherein the first predetermined value is in a range between 0.6 mM and 3.0 mM.

10. The method of claim 1, wherein the first predetermined value does not exceed 1.0 mM.