Analyte Monitoring Device and Methods of Use

• US 20100094111A1
• 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 8,346,337 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7242 using integration
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

In aspects of the present disclosure, a multi compatible or universal blood glucose monitoring unit including a calibration unit is integrated with one or more components of an analyte monitoring system to provide compatibility with in vitro test strip that require calibration code and test strips that do not require calibration code. Also disclosed are methods, systems, devices and kits for providing the same.

Claims

1. An integrated monitor and display unit, comprising:

a housing, comprising;

an rf receiver disposed in the housing to receive data from a transmitter that is configured and arranged to transmit data relating to analyte signals from a transcutaneous analyte sensor;

an analyte sensor port coupled with the housing and configured to receive an in vitro analyte sensor, wherein the 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 analyte sensor port is configured to receive a first type of in vitro analyte sensor which is not associated with a predetermined calibration parameter and a second type of in vitro analyte sensor which is associated with the predetermined calibration parameter.

2. The integrated monitor and display unit of claim 1 wherein the processor is configured to execute a first predetermined routine when it detects the first type of in vitro analyte sensor in the sensor port, and further, wherein the processor is configured to execute a second predetermined routine with it detects the second type of in vitro analyte sensor in the sensor port.

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

4. The integrated monitor and display unit of claim 1, wherein the second type of in vitro analyte sensor requires user input of a calibration information relating to the second type of in vitro analyte sensor into the integrated monitor and display unit upon positioning in the analyte sensor port.

5. The integrated monitor and display unit of claim 1, a memory comprising configured to store the predetermined calibration parameter.

6. The integrated monitor and display unit of claim 5 herein the predetermined calibration parameter includes a calibration code.

7. The integrated monitor and display unit of claim 1, wherein the analyte sensor port is configured to contact an insertion monitor on a surface of the first type of in vitro analyte sensor and further, wherein the processor is configured to determine a predetermined calibration parameter from the insertion monitor associated with the first type of in vitro analyte sensor.

8. The integrated monitor and display unit of claim 7, wherein the processor is configured to recognize the predetermined calibration parameter based on a shape of the insertion monitor.

9. The integrated monitor and display unit of claim 7, wherein the processor is configured to recognize the predetermined calibration parameter based on a position of the insertion monitor.

10. The integrated monitor and display unit of claim 7, wherein the processor is configured to recognize the predetermined calibration parameter based on an electrical characteristic of the insertion monitor.

11. The integrated monitor and display unit of claim 7, wherein the processor is configured to recognize the predetermined calibration parameter based on a resistance of the insertion monitor.

12. The integrated monitor and display unit of claim 7, wherein the analyte sensor port comprises a first contact structure and a second contact structure configured to contact the insertion monitor.

13. The integrated monitor and display unit of claim 1, wherein the first type of in vitro analyte sensor is a calibration-adjusted in vitro analyte sensor having associated with the predetermined calibration parameter.

14. The integrated monitor and display unit of claim 5, wherein the at least one predetermined calibration parameter is a universal calibration parameter used with a first type of calibration-adjusted in vitro analyte sensor.

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

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

17. 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.

18. The integrated monitor and display unit of claim 1, wherein the rf receiver is configured to receive data transmitted by the transmitter at predetermined time intervals.

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

20. A method, comprising:

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

determining a type of in vitro test strip upon detecting the presence of the test strip in the strip port;

processing one or more signals generated by the test strip based on the fluid sample using the integrated monitor and the determined type of the in vitro test strip; 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 processing the one or more signals generated by the test strip 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 associated with the in vitro test strip when the determined type of the in vitro test strip is of a second type.

21. 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.

22. The method of claim 20 including calibrating the one or more signals generated by the test strip of the second type automatically based on the retrieved calibration parameter using the integrated monitor without user interaction.

23. The method of claim 20 including calibrating the received time spaced signals using the integrated monitor based on the processed one or more signals.

24. An apparatus, comprising:

an integrated housing including;

a test strip interface coupled to the housing;

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 an in vitro analyte test strip having a fluid sample thereon using an integrated monitor connected to a strip port configured for receiving the test strip, to determine a type of in vitro test strip upon detecting the presence of the test strip in the strip port, to process one or more signals generated by the test strip based on the fluid sample using the integrated monitor and the determined type of the in vitro test strip, 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,

wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to generate 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 to retrieve the calibration parameter associated with the in vitro test strip when the determined type of the in vitro test strip is of a second type.

25. The apparatus of claim 24 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.

26. The apparatus of claim 24 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.