Fault discrimination and responsive processing based on data and context

Patent metadata

Field	Value
Publication number	US-12048540-B2
Application number	US-201916261339-A
Country	US
Kind code	B2
Filing date	Jan 29, 2019
Priority date	Jun 6, 2014
Publication date	Jul 30, 2024
Grant date	Jul 30, 2024

Abstract

Systems and methods disclosed here provide ways to discriminate fault types encountered in analyte sensors and systems and further provide ways to process such discriminated faults responsively based on sensor data, clinical context information, and other data about the patient or patient's environment. The systems and methods thus employ clinical context in detecting and/or responding to errors or faults associated with an analyte sensor system, and discriminating the type of fault, and its root cause, particularly as fault dynamics can appear similar to the dynamics of physiological systems, emphasizing the importance of discriminating the fault and providing appropriate responsive processing. Thus, the disclosed systems and methods consider the context of the patient's health condition or state in determining how to respond to the fault.

First claim

What is claimed is:

1. A method for discriminating a fault type in a continuous in vivo analyte monitoring system comprising an analyte sensor, the method comprising:
receiving, by a processor and from the analyte sensor, a signal that is indicative of a glucose concentration level;
receiving, by the processor, clinical context data;
evaluating, by the processor, the clinical context data against clinical context criteria to determine clinical context information;
detecting, by the processor, a fault of the analyte monitoring system;
determining, by the processor, a fault type describing the fault of the analyte monitoring system, the determining of the fault type being based at least in part on the received signal from the analyte sensor and the clinical context information;
determining, by the processor, a responsive action, the determining of the responsive action being based at least in part on the fault type; and
executing, by the processor, the responsive action during continuous operation of the analyte monitoring system, the executing of the responsive action comprising prompting a therapeutic device in communication with the analyte monitoring system to transition from a first therapeutic mode in which the therapeutic device delivers a medicament based on an output of the analyte monitoring system to a second therapeutic mode in which the therapeutic device does not deliver the medicament based on the output of the analyte monitoring system changing.

2. The method of claim 1 , the determining of the fault type comprising determining that the fault is a sensor environment fault or a system error/artifact fault.

3. The method of claim 1 , the determining of the fault type comprising determining that the fault is a compression fault or an early wound response fault.

4. The method of claim 1 , further comprising:
sampling the signal at a first sampling rate; and
sampling the signal at a second sampling rate different than the first sampling rate, the determining of the fault type being based on the sampling of the signal at the first sampling rate and the sampling of the signal at the second sampling rate.

5. The method of claim 1 , wherein the received clinical context data comprises at least one of age, anthropometric data, drugs currently operating on a host, temperature as compared to a criteria, a fault history of the host, activity level of the host, exercise level of the host, a host level of interaction with a glucose monitor, patterns of glucose signal values, clinical glucose value and its derivatives, a range of host glucose levels over a time period, a duration over which host glucose levels are maintained in a range, a host glucose state, a glycemic urgency index, time of day, and pressure.

6. The method of claim 1 , further comprising receiving an additional signal.

7. The method of claim 1 , further comprising receiving an additional signal, wherein the additional signal is a sensor temperature signal, an impedance signal, an oxygen signal, a pressure signal, or a background signal.

8. The method of claim 1 , wherein the clinical context information corresponds to data about a host excluding a signal value measured at the analyte sensor.

9. The method of claim 1 , wherein the clinical context criteria includes at least one predefined value or range of parameters selected from drugs currently operating on a host, temperature, a fault history of the host, activity level of the host, exercise level of the host, a host level of interaction with a glucose monitor, patterns of glucose signal values, clinical glucose value and its derivatives, a range of host glucose levels over a time period, a duration over which host glucose levels are maintained in a range, a host glucose state, a glycemic urgency index, time of day, or pressure.

10. The method of claim 1 , wherein the clinical context data comprises temperature, the clinical context criteria includes a pattern of temperatures, the evaluating determines the clinical context information to be that a host is in contact with water at a sensor site, and the determining of the fault type comprises discriminating the fault type as water ingress.

11. The method of claim 1 , wherein the clinical context data comprises host activity level or time of day, the clinical context criteria includes a pattern of host activity levels, the evaluating determines the clinical context information to be that a host is compressing a sensor site, and the discriminating the fault type includes discriminating the fault type as compression.

12. The method of claim 1 , wherein the clinical context data includes time since implant, the clinical context criteria includes a range of times since implant in which dip and recover faults are likely, the evaluating determines the clinical context information to be that the analyte sensor is recently implanted, and the discriminating the fault type includes discriminating the fault type as a dip and recover fault.

13. The method of claim 1 , wherein the clinical context data includes a clinical glucose value and at least one of age, anthropometric data, activity, exercise, clinical use of data, or host interaction with monitor.

14. The method of claim 1 , the executing of the responsive action further comprising providing a display to a user, the display including a warning, an alert, an alarm, a confidence indicator, a range of values, a predicted value, or a blank screen, the providing of the display being responsive to the determining of the fault type.

15. The method of claim 1 , the executing of the responsive action further comprising modifying a level of filtering of the received signal from a first level to a second level of filtering that is different than the first level of filtering.

16. The method of claim 1 , the executing of the responsive action further comprising performing a self diagnostics routine.

17. An electronic device for monitoring data associated with a physiological condition, the electronic device comprising:
a continuous glucose sensor, wherein the continuous glucose sensor is configured to continuously measure a concentration of glucose in a host, and to provide continuous sensor data associated with the glucose concentration in the host; and
a processor module configured to perform operations comprising:
receiving from an analyte monitor, a signal that is indicative of a glucose concentration level;
receiving clinical context data;
evaluating the clinical context data against clinical context criteria to determine clinical context information;
detecting, by the processor, a fault of the continuous glucose sensor;
determining, by the processor, a fault type describing the fault of the continuous glucose sensor, the determining of the fault type being based at least in part on the received signal from the continuous glucose sensor and the clinical context information;
determining, by the processor, a responsive action, the determining of the responsive action being based at least in part on the fault type; and

executing, by the processor, the responsive action during continuous operation of the continuous glucose sensor, the executing of the responsive action comprising prompting a therapeutic device in communication with the processor module to transition from a first therapeutic mode in which the therapeutic device delivers a medicament based on an output of the continuous glucose sensor to a second therapeutic mode in which the therapeutic device does not deliver the medicament based on the output of the continuous glucose sensor.

18.

Assignees

• Dexcom Inc

Inventors

• Vanslyke Stephen J
• Bhavaraju Naresh C
• Böhm Sebastian
• Bowman Leif N
• Estes Michael J
• Garcia Arturo
• Kamath Apurv Ullas
• Pal Andrew Attila
• Peyser Thomas A
• Davis Anna Leigh
• Rong Daiting
• Sheth Disha B
• Simpson Peter C
• Sokolovsky Dmytro

Classifications

• G16Z99/00 Primary

  Subject matter not provided for in other main groups of this subclass · CPC title

• A61B2560/0276

  Determining malfunction · CPC title

• A61B2560/0252

  using ambient temperature · CPC title

• A61B5/14532

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

• A61B5/7221 Primary

  Determining signal validity, reliability or quality (preventing, reducing or removing noise induced by motion artefacts A61B5/7207; noise originating from a therapeutic or surgical apparatus A61B5/7217) · CPC title