Fault discrimination and responsive processing based on data and context

Patent metadata

Field	Value
Publication number	US-10238322-B2
Application number	US-201514717643-A
Country	US
Kind code	B2
Filing date	May 20, 2015
Priority date	Jun 6, 2014
Publication date	Mar 26, 2019
Grant date	Mar 26, 2019

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:
receiving a signal from an analyte monitor;
receiving clinical context data;
evaluating the clinical context data against clinical context criteria to determine clinical context information;
discriminating the fault type based on both the received signal from the analyte monitor and the clinical context information; and
performing responsive processing based on at least the discriminated fault type, wherein the responsive processing includes controlling a medicament delivery device, the controlling including adjusting a basal value or, where medicament is being delivered, suspending medicament delivery.

2. The method of claim 1 , wherein the discriminating includes categorizing the fault based on the received signal, the clinical context information, or both.

3. The method of claim 2 , wherein the categorizing the fault includes categorizing the fault as a sensor environment fault or as a system error/artifact fault.

4. The method of claim 3 , wherein the discriminating includes categorizing the fault as a sensor environment fault, and further comprising subcategorizing the fault as a compression fault or an early wound response fault.

5. The method of claim 1 , wherein the discriminating includes slow versus fast sampling.

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

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

8. 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.

9. The method of claim 1 , wherein the clinical context information corresponds to data about the patient excluding a signal value measured at a sensor associated with the analyte monitor.

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

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

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

13. 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 sensor is recently implanted, and the discriminating the fault type includes discriminating the fault type as a dip and recover fault.

14. The method of claim 1 , wherein the clinical context data includes a clinical glucose value and a datum selected from the group consisting of age, anthropometric data, activity, exercise, clinical use of data, and patient interaction with monitor.

15. The method of claim 1 , wherein the responsive processing includes 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.

16. The method of claim 1 , wherein the performing responsive processing includes adjusting a level of filtering of the received signal.

17. The method of claim 1 , wherein the performing responsive processing includes performing a self diagnostics routine.

18. The method of claim 1 , wherein the performing responsive processing includes switching from a first therapeutic mode to a second therapeutic mode.

19. An electronic device for monitoring data associated with a physiological condition, comprising:
a continuous glucose sensor, wherein the continuous glucose sensor is configured to substantially continuously measure the concentration of glucose in the host, and to provide continuous sensor data associated with the glucose concentration in the host; and
a processor module configured to perform the method of claim 1 .

20. An electronic device for delivering insulin to a host, the device comprising:
a medicament delivery device configured to deliver insulin to the host, wherein the insulin delivery device is operably connected to a continuous glucose sensor, wherein the continuous glucose sensor is configured to substantially continuously measure the concentration of glucose in the host, and to provide continuous sensor data associated with the glucose concentration in the host; and
a processor module configured to perform the method of claim 1 .

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
• Rack-Gomer Anna Leigh
• Rong Daiting
• Sheth Disha B
• Simpson Peter C
• Sokolovsky Dmytro

Classifications

• A61B2560/0276

  Determining malfunction · CPC title

• A61B2560/0252

  using ambient temperature · 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

• A61B5/14532

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

• A61M2230/201

  Glucose concentration · CPC title