Systems and methods for processing sensor data

• US 10,506,982 B2
• Filed: 05/22/2013
• Issued: 12/17/2019
• Est. Priority Date: 12/17/2007
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Kamath, Apurv Ullas, Mensinger, Michael Robert, Li, Ying, Mahalingam, Aarthi, Dobbles, J. Michael
• Primary Examiner(s): Bloch, Michael R
• Application Number:
  US13/899,905
• Publication Number:
  US 20130253418A1
• Time in Patent Office: 2,400 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/6848 Needles
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/00 : ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Systems and methods for processing sensor data are provided. In some embodiments, systems and methods are provided for calibration of a continuous analyte sensor. In some embodiments, systems and methods are provided for classification of a level of noise on a sensor signal. In some embodiments, systems and methods are provided for determining a rate of change for analyte concentration based on a continuous sensor signal. In some embodiments, systems and methods for alerting or alarming a patient based on prediction of glucose concentration are provided.

Claims

1. A system for processing continuous analyte sensor data, comprising:

a continuous analyte sensor configured to continuously measure a concentration of an analyte in a host;

a computer system configured to receive sensor data from the continuous analyte sensor and to calibrate sensor data using calibration information, which is derived from an existing calibration set comprising a plurality of matched data pairs, each matched data pair comprising an analyte sensor signal and a corresponding analyte concentration, wherein the computer system is further configured to determine a predictive accuracy of the calibrated sensor data, wherein the predictive accuracy is a measure of an accuracy of prediction of a newly received matched data pair based on the calibration information derived from the existing calibration set that does not contain the newly received matched data pair, to compare the determined predictive accuracy with one or more accuracy level thresholds to produce an accuracy output, and to output the accuracy output; and

an insulin delivery device controlled by insulin delivery instructions and/or insulin therapy instructions to control insulin delivery, wherein the insulin delivery instructions and/or insulin therapy instructions are based at least in part on the accuracy output.

2. The system of claim 1, wherein the one or more accuracy level thresholds delineate at least two predetermined ranges of accuracy.

3. The system of claim 1, wherein the one or more accuracy level thresholds delineate at least three predetermined ranges of accuracy.

4. The system of claim 1, wherein the computer system is configured to control insulin delivery instructions and/or insulin therapy instructions to a user interface for display based on the accuracy output.

5. The system of claim 1, wherein the computer system is configured to control insulin delivery instructions and/or insulin therapy instructions using a transmission based on the accuracy output.

6. The system of claim 1, wherein the computer system is configured to control insulin delivery instructions and/or insulin therapy instructions by determining when to trigger a failsafe in a closed loop insulin delivery system based on the accuracy output.

7. The system of claim 1, wherein the computer system is configured to control insulin delivery instructions and/or insulin therapy instructions by requesting user interaction in a closed loop insulin delivery system based on the accuracy output.

8. A method for processing continuous analyte sensor data, comprising:

receiving sensor data from a continuous analyte sensor, the sensor data comprising one or more sensor data points;

calibrating the sensor data using calibration information, which is derived from a first calibration set comprising a plurality of matched data pairs, each matched data pair comprising an analyte sensor signal and a corresponding analyte concentration;

on a processor, determining a predictive accuracy of the calibrated sensor data, wherein the predictive accuracy is evaluated by a difference between a first calibration line formed from the first calibration set and a second calibration line formed from a second calibration set containing a newly received matched data pair not contained in the first calibration set;

on the processor, comparing the determined predictive accuracy with one or more accuracy level thresholds to produce an accuracy output;

outputting the accuracy output; and

controlling an insulin delivery device using insulin delivery instructions and/or insulin therapy instructions to control insulin delivery, wherein the insulin delivery instructions and/or insulin therapy instructions are based at least in part on the accuracy output.

9. The method of claim 8, wherein the one or more accuracy level thresholds delineate at least two predetermined ranges of accuracy.

10. The method of claim 8, wherein the one or more accuracy level thresholds delineate at least three predetermined ranges of accuracy.

11. The method of claim 8, wherein the determining the predictive accuracy is performed on calibrated sensor data in units of blood glucose concentration.

12. The method of claim 8, wherein the insulin delivery device is an insulin pump.

13. The method of claim 8, wherein the controlling the insulin delivery device using the insulin delivery instructions and/or insulin therapy instructions comprises displaying, on a user interface, the insulin delivery instructions and/or insulin therapy instructions.

14. The method of claim 8, wherein the controlling the insulin delivery device using the insulin delivery instructions and/or insulin therapy instructions comprises transmitting the insulin delivery instructions and/or insulin therapy instructions.

15. The method of claim 8, wherein the controlling the insulin delivery device using the insulin delivery instructions and/or insulin therapy instructions comprises determining when to trigger a failsafe in a closed loop insulin delivery system.

16. The method of claim 8, wherein the controlling the insulin delivery device using the insulin delivery instructions and/or insulin therapy instructions comprises requesting user interaction in a closed loop insulin delivery system.