Analyte monitoring device and methods of use

• US 8,920,319 B2
• Filed: 12/28/2012
• Issued: 12/30/2014
• Est. Priority Date: 11/01/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Adam, Feldman, Benjamin Jay, Karinka, Shridhara Alva, Wang, Yi, Galasso, John R.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US13/729,965
• Publication Number:
  US 20130116525A1
• Time in Patent Office: 732 Days
• Field of Search: 600/309, 600345-366
• US Class Current: 600/365
• 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. A device of an in vivo continuous glucose monitoring system that determines glucose level by way of in vivo glucose sensors and in vitro glucose test strips, comprising:

a test strip receiving port that receives coded in vitro glucose test strips that require user calibration action to calibrate the in vitro test strips and non-coded in vitro glucose test strips that do not require user calibration action to calibrate the in vitro test strips;

a processor configured to determine glucose concentration from an electrical signal obtained from in vivo glucose sensors at least partially inserted into the skin of a user, and from both the coded and the non-coded in vitro glucose test strips received in the test strip receiving port by first determining if a received in vitro glucose test strip is a coded or a non-coded test strip, selecting a coded or a non-coded processing algorithm to process a signal from the in vitro test strip once determined, and processing the signal from the in vitro test strip to determine an in vitro glucose value; and

a user interface configured to communicate the glucose concentration determined by the processor.

2. The device of claim 1, further comprising programming to automatically determine if the received in vitro glucose test strip is a coded or a non-coded test strip.

3. The device of claim 1, further comprising user-selectable inputs that identify the received in vitro glucose test strip as the coded or the non-coded test strip.

4. The device of claim 1, wherein the processor is programmed to generate a request for a calibration code if a coded test strip is received in the test strip port.

5. The device of claim 1, further comprising an insulin administration system integrated with the device.

6. The device of claim 1, wherein the processor is programmed to use the determined in vitro glucose value to calibrate the electrical signal from the in vivo glucose sensors to generate a calibrated in vivo glucose value.

7. The device of claim 6, wherein the processor is programmed to use a single in vitro glucose value to calibrate the signal from the in vivo glucose sensors.

8. The device of claim 6, wherein the processor is programmed to calibrate the in vivo glucose sensors only if the determined in vitro glucose value is within an acceptable range.

9. The device of claim 6, wherein the processor is programmed to determine a rate of change of the in vivo glucose level and calibrate the in vivo glucose sensors only if the determined rate of change is within an acceptable range.

10. The device of claim 1, wherein the device includes an in vitro glucose test strip detection circuitry that automatically recognizes receipt of an in vitro glucose test strip in the test strip port and, once recognized, automatically determines whether the received test strip is a coded or no-coded test strip.

11. A method of determining glucose level by in vivo glucose sensors and in vitro glucose test strips, comprising:

receiving, at a test strip receiving port, one of a coded in vitro glucose test strip that requires user calibration action to calibrate the test strip or a non-coded in vitro glucose test strip that does not require user calibration action to calibrate the test strip;

determining, using one or more processors, glucose concentration from an electrical signal obtained from in vivo glucose sensors at least partially inserted into the skin of a user, and from the coded and the non-coded in vitro glucose test strips received in the test strip receiving port by first determining, using the one or more processors, if a received in vitro glucose test strip is a coded or a non-coded test strip, selecting, using the one or more processors, a coded or a non-coded processing algorithm to process a signal from the in vitro test strip once determined, and processing, using the one or more processors, the signal from the in vitro test strip to determine an in vitro glucose value; and

communicating the determined glucose concentration with a user interface.

12. The method of claim 11, further comprising automatically determining if the received in vitro glucose test strip is a coded or a non-coded test strip.

13. The method of claim 11, further comprising identifying the received in vitro glucose test strip as a coded or a non-coded test strip with user-selectable inputs.

14. The method of claim 11, further including generating a request for a calibration code if the coded test strip is received in the test strip port.

15. The method of claim 11, further comprising integrally providing an insulin administration system with the user interface.

16. The method of claim 11, further comprising calibrating the electrical signal from the in vivo glucose sensors with the determined in vitro glucose value to generate a calibrated in vivo glucose value.

17. The method of claim 16, further comprising calibrating the electrical signal from the in vivo glucose sensors with a single in vitro glucose value.

18. The method of claim 16, further comprising calibrating the electrical signal from the in vivo glucose sensors only if the determined in vitro glucose value is within an acceptable range.

19. The method of claim 16, determining a rate of change of the in vivo glucose level and calibrating the in vivo glucose sensors only if the determined rate of change is within an acceptable range.

20. The method of claim 11, automatically recognizing receipt of the in vitro glucose test strip in the test strip port and, once recognized, automatically determining whether the received test strip is the coded or the non-coded test strip.