Methods, devices, and systems related to analyte monitoring

• US 9,872,641 B2
• Filed: 11/27/2013
• Issued: 01/23/2018
• Est. Priority Date: 11/29/2012
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Sloan, Mark K., Cheng, Royce, Hayter, Gary A., Taub, Marc B., Gopal, Mani
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US14/092,035
• Publication Number:
  US 20140148659A1
• Time in Patent Office: 1,518 Days
• CPC Class Codes: A61B 2560/029 adapted for auto-initiation
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Generally, methods, devices, and systems related to analyte monitoring and data logging are provided—e.g., as related to in vivo analyte monitoring devices and systems. In some aspects, methods, devices, and systems are provided that relate to enable related settings based on an expected use of an in vivo positioned sensor; logging or otherwise recording analyte levels acquired or derived—e.g., sample analyte levels more frequently than they are logged or otherwise recorded in memory; dynamically adjust the data logging frequency; randomly determine times of acquiring or storing analyte levels from the in-vivo positioned analyte sensors; and enable recording related settings when the system is operable.

Claims

1. An analyte monitoring device, comprising:

receiver electronics adapted to wirelessly receive sensor-use information and analyte data of a user from an on body unit comprising an in vivo positionable analyte sensor, wherein the sensor-use information indicates the on body unit as being a clinical use type or a personal use type;

a display;

a processor; and

memory operably coupled to the processor, wherein the memory includes instructions stored therein that, when executed by a processor, cause the processor to;

identify, based on the sensor-use information, at least one of a plurality of modes associated with the on body unit'"'"'s type, wherein the plurality of modes comprises a masked mode and an unmasked mode;

operate the analyte monitoring device in the masked mode if the on body unit is the clinical use type, wherein the masked mode prevents analyte values of the user from being displayed on the display; and

operate the analyte monitoring device in the unmasked mode if the on body unit is the personal use type, wherein the analyte values of the user are displayed on the display in the unmasked mode,

and wherein the analyte monitoring device is configured to switch between the masked mode and the unmasked mode, without user intervention, based on a communication from the on body unit.

2. The analyte monitoring device of claim 1, wherein the masked mode causes the analyte monitoring device to collect data indicative of the analyte values of the user from the on body unit for a period of time, subsequently output data indicative of the analyte values of the user for analysis by a person other than the user, and prevent output of the collected data to the display of the analyte monitoring device during the entire period in which the analyte monitoring device receives analyte data from the on body unit.

3. The analyte monitoring device of claim 1, wherein the unmasked mode causes the analyte monitoring device to collect data indicative of the analyte values of the user from the on body unit and display the analyte values to the user on the display for routine monitoring of a condition of the user.

4. The analyte monitoring device of claim 1, wherein the masked mode causes the analyte monitoring device to collect data indicative of the analyte values of the user from the on body unit for a period of time, subsequently output data indicative of the analyte values of the user for analysis by a person other than the user, and prevent output of the collected data to the display of the analyte monitoring device during the entire period in which the analyte monitoring device receives analyte data from the on body unit;

and

wherein the unmasked mode causes the analyte monitoring device to collect data indicative of the analyte values of the user from the on body unit and display the analyte values to the user on the display for routine monitoring of a condition of the user.

5. The analyte monitoring device of claim 4, wherein the memory includes instructions stored therein that, when executed by a processor, cause the processor to:

identify the masked mode based on first sensor-use information received from an on body unit of the clinical use type;

operate the analyte monitoring device in the masked mode and collect data indicative of the analyte values of the user from the on body unit of the clinical use type;

after operation of the analyte monitoring device in the masked mode, identify the unmasked mode based on second sensor-use information received from an on body unit of the personal use type; and

operate the analyte monitoring device in the unmasked mode and collect data indicative of the analyte values of the user from the on body unit of the personal use type.

6. The analyte monitoring device of claim 5, wherein the memory includes instructions stored therein that, when executed by a processor, cause the processor to:

operate the analyte monitoring device in the masked mode and collect data indicative of the analyte values of the user from the on body unit of the clinical use type until use of the on body unit of the clinical use type is finished;

after use of the on body unit of the clinical use type is finished, identify the unmasked mode based on second sensor-use information received from an on body unit of the personal use type; and

operate the analyte monitoring device in the unmasked mode and collect data indicative of the analyte values of the user from the on body unit of the personal use type.

7. The analyte monitoring device of claim 1, wherein the memory includes instructions stored therein that, when executed by a processor, cause the processor to:

identify the masked mode based on first sensor-use information received from an on body unit of the clinical use type;

operate the analyte monitoring device in the masked mode and collect data indicative of the analyte values of the user from the on body unit of the clinical use type;

after operation of the analyte monitoring device in the masked mode, identify the unmasked mode based on second sensor-use information received from an on body unit of the personal use type; and

operate the analyte monitoring device in the unmasked mode and collect data indicative of the analyte values of the user from the on body unit of the personal use type.

8. The analyte monitoring device of claim 1, wherein the sensor-use information includes unique identification information associated with the on body unit.

9. The analyte monitoring device of claim 1, wherein the memory includes instructions stored therein that, when executed by a processor, cause the processor to activate or deactivate, based on the sensor-use information, at least one of a plurality of features of the analyte monitoring device comprising a logbook feature, flagging of analyte values as pre-meal or post-meal, and deriving analyte level pattern information.

10. The analyte monitoring device of claim 1, wherein the memory includes instructions stored therein that, when executed by the processor, cause the processor to automatically switch between the masked mode to the unmasked mode if a change in the on body unit type is detected based on the sensor-use information.

11. An analyte monitoring system, comprising:

an on body unit comprising an in vivo positionable analyte sensor and transmitter electronics adapted to wirelessly transmit sensor-use information and analyte data of a user, wherein the sensor-use information indicates the on body unit as being a clinical use type or a personal use type; and

an analyte monitoring device, comprising;

receiver electronics adapted to wirelessly receive the sensor-use information and the analyte data;

a display;

a processor; and

memory operably coupled to the processor, wherein the memory includes instructions stored therein that, when executed by a processor, cause the processor to;

identify, based on the sensor-use information, at least one of a plurality of modes associated with the on body unit'"'"'s type, wherein the plurality of modes comprises a masked mode and an unmasked mode;

operate the analyte monitoring device in the masked mode if the on body unit is the clinical use type, wherein the masked mode prevents analyte values of the user from being displayed on the display; and

operate the analyte monitoring device in the unmasked mode if the on body unit is the personal use type, wherein the analyte values of the user are displayed on the display in the unmasked mode,

and wherein the analyte monitoring device is configured to switch between the masked mode and the unmasked mode, without user intervention, based on a communication from the on body unit.

12. The analyte monitoring system of claim 11, wherein the masked mode causes the analyte monitoring device to collect data indicative of the analyte values of the user from the on body unit for a period of time, subsequently output data indicative of the analyte values of the user for analysis by a person other than the user, and prevent output of the collected data to the display of the analyte monitoring device during the entire period in which the analyte monitoring device receives analyte data from the on body unit.

13. The analyte monitoring system of claim 11, wherein the unmasked mode causes the analyte monitoring device to collect data indicative of the analyte values of the user from the on body unit and display the analyte values to the user on the display for routine monitoring of a condition of the user.

14. The analyte monitoring system of claim 11, wherein the masked mode causes the analyte monitoring device to collect data indicative of the analyte values of the user from the on body unit for a period of time, subsequently output data indicative of the analyte values of the user for analysis by a person other than the user, and prevent output of the collected data to the display of the analyte monitoring device during the entire period in which the analyte monitoring device receives analyte data from the on body unit;

and

wherein the unmasked mode causes the analyte monitoring device to collect data indicative of the analyte values of the user from the on body unit and display the analyte values to the user on the display for routine monitoring of a condition of the user.

15. The analyte monitoring system of claim 14, wherein the memory includes instructions stored therein that, when executed by a processor, cause the processor to:

identify the masked mode based on first sensor-use information received from an on body unit of the clinical use type;

operate the analyte monitoring device in the masked mode and collect data indicative of the analyte values of the user from the on body unit of the clinical use type;

after operation of the analyte monitoring device in the masked mode, identify the unmasked mode based on second sensor-use information received from an on body unit of the personal use type; and

operate the analyte monitoring device in the unmasked mode and collect data indicative of the analyte values of the user from the on body unit of the personal use type.

16. The analyte monitoring system of claim 15, wherein the memory includes instructions stored therein that, when executed by a processor, cause the processor to:

operate the analyte monitoring device in the masked mode and collect data indicative of the analyte values of the user from the on body unit of the clinical use type until use of the on body unit of the clinical use type is finished;

after use of the on body unit of the clinical use type is finished, identify the unmasked mode based on second sensor-use information received from an on body unit of the personal use type; and

operate the analyte monitoring device in the unmasked mode and collect data indicative of the analyte values of the user from the on body unit of the personal use type.

17. The analyte monitoring system of claim 11, wherein the memory includes instructions stored therein that, when executed by a processor, cause the processor to:

identify the masked mode based on first sensor-use information received from an on body unit of the clinical use type;

operate the analyte monitoring device in the masked mode and collect data indicative of the analyte values of the user from the on body unit of the clinical use type;

after operation of the analyte monitoring device in the masked mode, identify the unmasked mode based on second sensor-use information received from an on body unit of the personal use type; and

operate the analyte monitoring device in the unmasked mode and collect data indicative of the analyte values of the user from the on body unit of the personal use type.

18. The analyte monitoring system of claim 11, wherein the sensor-use information includes unique identification information associated with the on body unit.

19. The analyte monitoring system of claim 11, wherein the transmitter electronics of the on body unit are adapted to wirelessly transmit sensor-use information as part of an initial pairing procedure between the on body unit and the analyte monitoring device.

20. The analyte monitoring system of claim 11, wherein the transmitter electronics of the on body unit are adapted to wirelessly transmit sensor-use information and analyte data in the same transmission.

21. The analyte monitoring system of claim 11, wherein the memory includes instructions stored therein that, when executed by a processor, cause the processor to activate or deactivate, based on the sensor-use information, at least one of a plurality of features of the analyte monitoring device comprising a logbook feature, flagging of analyte values as pre-meal or post-meal, and deriving analyte level pattern information.