Method and apparatus for providing data processing and control in a medical communication system

Patent metadata

Field	Value
Publication number	US-11828748-B2
Application number	US-202217735591-A
Country	US
Kind code	B2
Filing date	May 3, 2022
Priority date	May 14, 2007
Publication date	Nov 28, 2023
Grant date	Nov 28, 2023

Abstract

Techniques for data processing and control for a glucose monitoring system are provided, including obtaining a first sensitivity of a glucose sensor; obtaining a second sensitivity of the glucose sensor; comparing a difference between the first sensitivity and the second sensitivity to a predetermined range of values; if the difference is outside the predetermined range of the values, causing a calibration routine for the glucose sensor to be performed; and if the difference is within the predetermined range of values determining a composite sensitivity for a current calibration of the glucose sensor based on the first sensitivity and the second sensitivity and calculating the glucose level based on the current calibration of the glucose sensor.

First claim

What is claimed is:

1. A glucose monitoring system, comprising:
a glucose sensor comprising a plurality of electrodes including a working electrode and a reference electrode, wherein the glucose sensor is configured to be positioned with a first portion of the sensor above a skin layer of the user and a second portion of the sensor implanted transcutaneously below the skin layer of the user and in contact with a bodily fluid of the user, wherein the glucose sensor is configured to generate data signals associated with a glucose level of the bodily fluid;
a code based at least in part on a characteristic of the glucose sensor and associated with a sensitivity range of the glucose sensor;
a transmitter unit electrically and communicatively coupled with the glucose sensor, wherein the transmitter unit is configured to wirelessly communicate data signals indicative of the glucose level of the bodily fluid, wherein the transmitter unit comprises one or more processors, a battery, and a memory operatively coupled to the one or more processors; and
a receiver unit communicatively coupled with the transmitter unit, wherein the receiver unit is configured to wirelessly receive the data signals indicative of the glucose level of the bodily fluid, wherein the receiver unit comprises one or more processors, a battery, and a memory operatively coupled to the one or more processors for storing instructions which, when executed by the one or more processors,
prompt a user to enter the code, wherein the user is prompted after the glucose sensor is positioned with the second portion of the sensor implanted transcutaneously below the skin layer of the user;
use the code when associating the glucose sensor and the receiver unit;
use the code in performing an associated routine after associating the glucose sensor and the receiver unit; and
process the generated data signals from the glucose sensor and received from the transmitter unit to produce processed data signals, wherein the user is prompted to enter the code prior to processing the generated data signals.

2. The glucose monitoring system of claim 1 , wherein the code is provided as a label.

3. The glucose monitoring system of claim 2 , wherein the code is provided to the memory from the label prior to the transmitter processing the generated data signal.

4. The glucose monitoring system of claim 2 , wherein the label is provided externally to the glucose sensor and the transmitter unit.

5. The glucose monitoring system of claim 1 , wherein the code is determined during a manufacturing process of the glucose sensor.

6. The glucose monitoring system of claim 1 , wherein the code is further associated with a characteristic specific to the glucose sensor out of a batch of glucose sensors.

7. The glucose monitoring system of claim 1 , wherein the associated routine includes a data quality check.

8. The glucose monitoring system of claim 1 , wherein the associated routine includes a sensor sensitivity range acceptability confirmation.

9. The glucose monitoring system of claim 1 , wherein the associated routine includes a glucose rate of change verification.

10. The glucose monitoring system of claim 1 , wherein the instructions, when executed by the one or more processors, perform a data quality check on the processed data signals.

11. The glucose monitoring system of claim 1 , wherein the instructions, when executed by the one or more processors, receive the data signals indicative of the glucose level of the bodily fluid after the receiver unit has been synchronized with the transmitter.

12. The glucose monitoring system of claim 1 , wherein the instructions, when executed by the one or more processors, receive the processed data signals using a Bluetooth enabled communication protocol.

13. The glucose monitoring system of claim 12 , wherein the instructions, when executed by the one or more processors, receive the processed data signals unit at a predetermined frequency.

14. The glucose monitoring system of claim 12 , wherein the predetermined frequency includes once every five minutes.

15. The glucose monitoring system of claim 1 , wherein the instructions, when executed by the one or more processors, further, upon receiving the code, retrieve a sensitivity associated with the code.

16. The glucose monitoring system of claim 1 , wherein the instructions, when executed by the one or more processors, further transmit the processed data signals to an infusion device.

17. The glucose monitoring system of claim 16 , wherein the infusion device includes an insulin pump.

18. The glucose monitoring system of claim 1 , wherein the instructions, when executed by the one or more processors, further use the code to calibrate the generated data signal while processing the data signals.

19. The glucose monitoring system of claim 1 , wherein the code is further associated with a batch sensitivity of a batch of glucose sensors including the glucose sensor.

20. The glucose monitoring system of claim 19 , wherein the sensitivity range is one of a plurality of possible sensitivity ranges associated with the batch sensitivity.

21. The glucose monitoring system of claim 19 , wherein the batch sensitivity is based on a sensitivity value of a first set of one or more glucose sensors of the batch of glucose sensors.

22. The glucose monitoring system of claim 21 , wherein the batch sensitivity is determined if the sensitivity of the first set of one or more glucose sensors is within a predefined variation tolerance level.

23. The glucose monitoring system of claim 22 , wherein the sensitivity value of the first set of one or more glucose sensors is determined in vitro.

24. The glucose monitoring system of claim 23 , wherein determining the sensitivity value includes determining if the determined sensitivity value is within a predetermined range.

25. The glucose monitoring system of claim 1 , wherein the receiver unit is configured to provide an alert associated with a projected hypoglycemia condition.

26. The glucose monitoring system of claim 1 , wherein the receiver unit is configured to provide an alert associated with a projected hyperglycemia condition.

27. The glucose monitoring system of claim 1 , wherein the receiver unit is embodied in a wrist watch.

28. The glucose monitoring system of claim 1 , wherein the instructions when executed by the one or more processors, further transmit the processed data signals to a secondary receiver unit.

29. The glucose monitoring system of claim 1 , wherein the instructions when executed by the one or more processors, further to provide an alert if the receiver unit does not receive data signals indicative of the glucose level of the bodily fluid for a predetermined period of time.

Assignees

• Abbott Diabetes Care Inc

Inventors

• Hayter Gary Alan
• Mcgarraugh Geoffrey V
• Naegeli Andrew H
• Mazza John Charles
• Feldman Benjamin Jay

Classifications

• G01N33/49 Primary

  Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)} · CPC title

• A61B5/1473

  invasive, e.g. introduced into the body by a catheter · CPC title

• A61B5/1495

  Calibrating or testing of in-vivo probes · CPC title

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• G16H10/40

  for data related to laboratory analysis, e.g. patient specimen analysis · CPC title