Analyte Monitoring Device and Methods of Use

• US 20100094112A1
• Filed: 06/30/2009
• Published: 04/15/2010
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Adam, Wang, Yi, Galasso, John R., Karinka, Shridhara Alva, Feldman, Benjamin Jay
• Granted Patent: US 8,465,425 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units

Abstract

In aspects of the present disclosure, an auto turn on blood glucose monitoring unit including a calibration unit integrated with one or more components of an analyte monitoring system is provided. Also disclosed are methods, systems, devices and kits for providing the same.

Claims

1. An integrated monitor and display unit, comprising:

a housing, comprising;

a radio frequency (RF) receiver disposed in the housing and configured to receive data relating to analyte signals generated by a transcutaneous analyte sensor from a transmitter;

an analyte sensor port coupled to the housing and configured to receive an in vitro analyte sensor, wherein the in vitro analyte sensor generates an analyte signal from a fluid sample; and

a processor disposed in the housing and configured to validate the data relating to analyte signals from the transcutaneous analyte sensor based at least in part on the analyte signal from the in vitro analyte sensor,

wherein the processor is configured to transition from an inactive mode to an active mode upon detection of the in vitro analyte sensor in the analyte sensor port.

2. The integrated monitor and display unit of claim 1, wherein the processor is configured to transition from the inactive mode to the active mode automatically upon detection of the in vitro test strip in the sensor port.

3. The integrated monitor and display unit of claim 1, wherein the processor is configured to turn on the integrated monitor and display unit by transitioning from the inactive mode to the active mode.

4. The integrated monitor and display unit of claim 1, wherein the active mode comprises fluid sample analysis mode.

5. The integrated monitor and display unit of claim 4 wherein the fluid sample analysis mode includes the processor executing one or more routines associated with determination of the analyte level from the fluid sample received from the in vitro analyte sensor.

6. The integrated monitor and display unit of claim 1, wherein processor transitions from the inactive mode to the active mode when the processor detects the in vitro analyte sensor at a predetermined location within the analyte sensor port.

7. The integrated monitor and display unit of claim 1, wherein the detection is a physical detection.

8. The integrated monitor and display unit of claim 1, wherein the detection is an optical detection.

9. The integrated monitor and display unit of claim 1, wherein the detection is an electrical detection.

10. The integrated monitor and display unit of claim 1, wherein the analyte sensor port comprises at least a first structure positioned to interact with the in vitro analyte sensor and transition the integrated monitor and display unit from the inactive mode to the active mode.

11. The integrated monitor and display unit of claim 10, wherein the structure interacts with the in vitro analyte sensor and provides a physical signal to transition the integrated monitor and display unit from the inactive mode to an active mode.

12. The integrated monitor and display unit of claim 10, wherein the structure interacts with the in vitro analyte sensor and provides an electrical signal to transition the integrated monitor and display unit from the inactive mode to an active mode.

13. The integrated monitor and display unit of claim 10, wherein the structure interacts with the in vitro analyte sensor and provides an optical signal to transition the integrated monitor and display unit from the inactive mode to an active mode.

14. The integrated monitor and display unit of claim 1, wherein the processor validates the data by determining whether a rate of change of analyte signals from the transcutaneous analyte sensor is within a predetermined acceptable range.

15. The integrated monitor and display unit of claim 1, wherein the processor validates the data by determining whether the analyte signal from the transcutaneous analyte sensor is within a predetermined acceptable analyte signal range.

16. The integrated monitor and display unit of claim 1, wherein the processor is configured to validate the data relating to analyte signals from the transcutaneous analyte sensor prior to recommending and/or executing a therapy action based on data relating to analyte signals from the transcutaneous analyte sensor.

17. The integrated monitor and display unit of claim 1, wherein the rf receiver continuously receives data transmitted by the transmitter.

18. The integrated monitor and display unit of claim 1, wherein the analyte is glucose.

19. The integrated monitor and display unit of claim 1, further comprising the in vitro analyte sensor positioned within the analyte sensor port.

20. A method, comprising:

detecting a presence of an in vitro analyte test strip having a fluid sample thereon using an integrated monitor physically coupled to a strip port configured for receiving the test strip;

activating one or more routines of the integrated monitor upon detection of the presence of the in vitro analyte test strip;

executing the activated one or more routines using the integrated monitor, at least one of the one or more routines associated with processing one or more signals generated by the test strip based on the fluid sample; and

wirelessly receiving a time spaced signals from a transmitter using the integrated monitor, each received time spaced signals corresponding to a monitored analyte level;

wherein executing the activated one or more routines further includes one or more of determining an analyte level from the fluid sample of the test strip using the integrated monitor, calibrating the wirelessly received time spaced signals, determining a type of the test strip detected in the strip port of the integrated monitor, or displaying the calibrated one or more time spaced signals.

21. The method of claim 20 wherein activating the one or more routines includes transitioning from an inactive operating mode to an active operating mode of the integrated monitor.

22. The method of claim 20 wherein executing the activated one or more routines includes generating a request to provide a calibration parameter associated with the in vitro test strip when the determined type of the in vitro test strip is of a first type, or retrieving the calibration parameter from a storage unit physically coupled to the integrated monitor associated with the in vitro test strip when the determined type of the in vitro test strip is of a second type.

23. The method of claim 20 including determining a corresponding analyte level based on the one or more signals generated by the test strip of the first type when the requested calibration parameter is received, and further, determining a corresponding analyte level based on the one or more signals generated by the test strip of the second type based on the retrieved calibration parameter.

24. The method of claim 20 including calibrating the received time spaced signals using the integrated monitor based on the determined analyte level from the fluid sample.

25. An apparatus, comprising:

an integrated housing including;

a test strip interface coupled to the housing and configured to receive an in vitro analyte test strip;

one or more processors disposed in the housing; and

a memory disposed in the housing and for storing instructions which, when executed by the one or more processors, causes the one or more processors to detect a presence of the in vitro analyte test strip having a fluid sample thereon, to activate one or more routines of the apparatus upon detection of the presence of the in vitro analyte test strip, to execute the activated one or more routines, at least one of the one or more routines associated with processing one or more signals generated by the test strip based on the fluid sample, and to wirelessly receive a time spaced signals from a transmitter using the integrated monitor, each received time spaced signals corresponding to a monitored analyte level.

26. The apparatus of claim 25 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to determine an analyte level from the fluid sample of the test strip using the integrated monitor, to calibrate the wirelessly received time spaced signals, determining a type of the test strip detected in the strip port of the integrated monitor, to display the calibrated one or more time spaced signals, or to perform one or more combinations thereof.

27. The apparatus of claim 25 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to transition from an inactive operating mode to an active operating mode.

28. The apparatus of claim 26 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to calibrate the one or more signals generated by the test strip of the second type automatically based on the retrieved calibration parameter without user interaction.

29. The apparatus of claim 26 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to calibrate the received time spaced signals based on the determined corresponding analyte level from the one or more signals generated by the test strip.