CA2482814A1 - Real time self-adjusting calibration algorithm - Google Patents

Real time self-adjusting calibration algorithm Download PDF

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Publication number
CA2482814A1
CA2482814A1 CA002482814A CA2482814A CA2482814A1 CA 2482814 A1 CA2482814 A1 CA 2482814A1 CA 002482814 A CA002482814 A CA 002482814A CA 2482814 A CA2482814 A CA 2482814A CA 2482814 A1 CA2482814 A1 CA 2482814A1
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CA
Canada
Prior art keywords
calibration
sensor
sensor data
current
reference value
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002482814A
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French (fr)
Other versions
CA2482814C (en
Inventor
John J. Shin
Kris R. Holtzclaw
Nandita D. Dangui
Sami Kanderian, Jr.
John J. Mastrototaro
Peter I. Hong
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Medtronic Minimed Inc
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Individual
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Filing date
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Publication of CA2482814A1 publication Critical patent/CA2482814A1/en
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Publication of CA2482814C publication Critical patent/CA2482814C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495—Calibrating or testing of in-vivo probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A61M2005/1726—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure the body parameters being measured at, or proximate to, the infusion site

Abstract

A method of calibrating glucose monitor data includes collecting the glucose monitor data over a period of time at predetermined intervals. It also includes obtaining at least two reference glucose values from a reference source that temporally correspond with the glucose moinitor data obtained at the predetermined intervals. Also included is calculating the calibration characteristics using the reference glucose values and the corresponding glucose monitor data to regress the obtained glucose monitor data. And calibrating the obtained glucose monitor data using the calibration characteristics is included. In pereferred embodiments, the reference source is a blood glucosemeter, and the at least two reference glucose values are obtained from blood tests. In additional embodiments, the calculation of the calibration characteristics is obtained using linear regression and inparticular embodiments, least squares linear regression. Alternatively, th e calculation of the calibration characteristics is obtained using non-linear regression. Sensor failure or change in sensor sensitivity may be recognised by comparing subsequent calculated calibration factors.

Claims (39)

1. A method of calibrating sensor data collected from a sensor, wherein a calibration formula based on past calibrations is used to interpret the sensor data, the method comprising the steps of:
obtaining a calibration reference value for the sensor;
calculating a current calibration factor based on the calibration reference value and a current sensor data point;
identifying either a possible error or change in sensitivity in the sensor from the current calibration factor; and confirming a sensor failure or recognizing a change in sensor sensitivity.
2. The method of claim 1, further comprising:
updating the calibration formula with the calibration reference value if the sensor failure is not confirmed and no change in sensor sensitivity is recognized;
and interpreting the collected sensor data using the updated calibration formula.
3. The method of claim 1, wherein the step of confirming a sensor failure or recognizing a change in sensor sensitivity further comprises:
comparing the current calibration factor with an estimated value determined from the calibration formula and a past calibration factor; and confirming a sensor failure when at least two unexpected calibration factors are received in succession without supporting each other.
4. The method of claim 3, wherein the step of confirming a sensor failure or recognizing a change in sensor sensitivity further comprises:
recognizing a change in sensor sensitivity when an unexpected past calibration factor is supported by a subsequent current calibration factor in succession;
restarting the calibration formula calculation when a change in sensor sensitivity is recognized.
5. The method of claim 4, further comprising:
interpreting the collected sensor data using the restarted calibration formula.
6. The method of claim 4, wherein the step of restarting the calibration formula calculation further comprises:
creating an artificial calibration reference value; and formulating the calibration formula using the artificial calibration reference value, a past calibration reference value and a current calibration reference value.
7. The method of claim 2, wherein the calibration formula is a modified regression method.
8. The method of claim 7, wherein the modified regression method is Gaussian regression method.
9. The method of claim 7, wherein the calibration formula weights past calibrations based on how recent the calibration was performed.
10. The method of claim 2, wherein the calibration is performed while obtaining the sensor data.
11. The method of claim 1, wherein the sensor is a glucose sensor.
12. The method of claim 1, wherein the current sensor data point is obtained by the steps of:
sampling characteristic sensor data at a predetermined rate from a sensor over time;
deriving at least one current sensor data point from the sampled characteristic sensor data at a predetermined memory storage rate.
13. The method of claim 1, wherein the current sensor data point is obtained by the steps of:
sampling characteristic sensor data;
deriving interval values by applying clipping limits and averaging the post-clipped sampled characteristic sensor data over a predetermined interval rate; and deriving at least one current sensor data point by averaging the derived interval values at a predetermined memory storage rate.
14. An apparatus for calibrating sensor data collected from a sensor, wherein a calibration formula based on past calibrations is used to interpret the sensor data, the apparatus comprising:
means for obtaining a calibration reference value for the sensor;
means for calculating a current calibration factor based on the calibration reference value and a current sensor data point;
means for identifying either a possible error or change in sensitivity in the sensor from the current calibration factor; and means for confirming a sensor failure or recognizing a change in sensor sensitivity.
15. The apparatus of claim 14, further comprising:
means for updating the calibration formula with the calibration reference value if the sensor failure is not confirmed and no change in sensor sensitivity is recognized; and means for interpreting the collected sensor data using the updated calibration formula.
16. The apparatus of claim 14, wherein the means for confirming a sensor failure or recognizing a change in sensor sensitivity further comprises:
means for comparing the current calibration factor with an estimated value determined from the calibration formula and a past calibration factor;
and means for confirming a sensor failure when at least two unexpected calibration factors are received in succession without supporting each other.
17. The apparatus of claim 16, wherein the means for confirming a sensor failure or recognizing a change in sensor sensitivity further comprises:
means for recognizing a change in sensor sensitivity when an unexpected past calibration factor is supported by a subsequent current calibration factor in succession;
means for restarting the calibration formula calculation when a change in sensor sensitivity is recognized.
18. The apparatus of claim 17, further comprising:
means for interpreting the collected sensor data using the restarted calibration formula.
19. The apparatus of claim 17, wherein the means for restarting the calibration formula calculation further comprises:
means for creating an artificial calibration reference value; and means for formulating the calibration formula using the artificial calibration reference value, a past calibration reference value and a current calibration reference value.
20. The apparatus of claim 15, wherein the calibration formula is a modified regression method.
21. The apparatus of claim 20, wherein the modified regression method is Gaussian regression method.
22. The apparatus of claim 20, wherein the calibration formula weights past calibrations based on how recent the calibration was performed.
23. The apparatus of claim 15, wherein the calibration is performed while obtaining the sensor data.
24. The apparatus of claim 14, wherein the sensor is a glucose sensor.
25. The apparatus of claim 14, wherein the current sensor data point is obtained by:
means for sampling characteristic sensor data at a predetermined rate from a sensor over time;
means for deriving at least one current sensor data point from the sampled characteristic sensor data at a predetermined memory storage rate.
26. The method of claim 14, wherein the current sensor data point is obtained by:
means for sampling characteristic sensor data;
means for deriving interval values by applying clipping limits and averaging the post-clipped sampled characteristic sensor data over a predetermined interval rate; and means for deriving at least one current sensor data point by averaging the derived interval values at a predetermined memory storage rate.
27. An article of manufacture containing code for calibrating sensor data collected from a sensor, wherein a calibration formula based on past calibrations is used to interpret the sensor data, comprising a computer usable media including at least one embedded computer program that is capable of causing at least one computer to perform:
obtaining a calibration reference value for the sensor;
calculating a current calibration factor based on the calibration reference value and a current sensor data point;
identifying either a possible error or change in sensitivity in the sensor from the current calibration factor; and confirming a sensor failure or recognizing a change in sensor sensitivity.
28. The article of manufacture of claim 27, further performing:
updating the calibration formula with the calibration reference value if the sensor failure is not confirmed and no change in sensor sensitivity is recognized;
and interpreting the collected sensor data using the updated calibration formula.
29. The article of manufacture of claim 27, wherein the step of confirming a sensor failure or recognizing a change in sensor sensitivity further performs:
comparing the current calibration factor with an estimated value determined from the calibration formula and a past calibration factor; and confirming a sensor failure when at least two unexpected calibration factors are received in succession without supporting each other.
30. The article of manufacture of claim 29, wherein the step of confirming a sensor failure or recognizing a change in sensor sensitivity further performs:
recognizing a change in sensor sensitivity when an unexpected past calibration factor is supported by a subsequent current calibration factor in succession;
restarting the calibration formula calculation when a change in sensor sensitivity is recognized.
31. The article of manufacture of claim 30, further performing:
interpreting the collected sensor data using the restarted calibration formula.
32. The article of manufacture of claim 30, wherein the step of restarting the calibration formula calculation further performs:
creating an artificial calibration reference value; and formulating the calibration formula using the artificial calibration reference value, a past calibration reference value and a current calibration reference value.
33. The article of manufacture of claim 28, wherein the calibration formula is a modified regression method.
34. The article of manufacture of claim 33, wherein the modified regression method is Gaussian regression method.
35. The article of manufacture of claim 33, wherein the calibration formula weights past calibrations based on how recent the calibration was performed.
36. The article of manufacture of claim 28, wherein the calibration is performed while obtaining the sensor data.
37. The article of manufacture of claim 27, wherein the sensor is a glucose sensor.
38. The article of manufacture of claim 27, wherein the current sensor data point is obtained by performing the steps of:
sampling characteristic sensor data at a predetermined rate from a sensor over time;
deriving at least one current sensor data point from the sampled characteristic sensor data at a predetermined memory storage rate.
39. The method of claim 27, wherein the current sensor data point is obtained by performing the steps of:
sampling characteristic sensor data;
deriving interval values by applying clipping limits and averaging the post-clipped sampled characteristic sensor data over a predetermined interval rate; and deriving at least one current sensor data point by averaging the derived interval values at a predetermined memory storage rate.
CA002482814A 2002-05-08 2003-04-29 Real time self-adjusting calibration algorithm Expired - Lifetime CA2482814C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/141,375 2002-05-08
US10/141,375 US6895263B2 (en) 2000-02-23 2002-05-08 Real time self-adjusting calibration algorithm
PCT/US2003/013199 WO2003094714A1 (en) 2002-05-08 2003-04-29 Real time self-adjusting calibration algorithm

Publications (2)

Publication Number Publication Date
CA2482814A1 true CA2482814A1 (en) 2003-11-20
CA2482814C CA2482814C (en) 2010-01-19

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US (2) US6895263B2 (en)
EP (1) EP1503660B1 (en)
JP (1) JP3934137B2 (en)
AU (1) AU2003228741A1 (en)
CA (1) CA2482814C (en)
DE (1) DE60311250T2 (en)
WO (1) WO2003094714A1 (en)

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