# US 2010/0168545 A1 · System and methods for processing analyte sensor data for sensor calibration

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- Number: US 2010/0168545 A1
- Document ID: US20100168545A1
- Status: Published application
- Kind: A1
- Application number: 12/683,724
- Filed: 2010-01-07
- Published: 2010-07-01
- Earliest claimed: 2005-03-10
- Assignees: DexCom, Inc.
- Inventors: Apurv Ullas Kamath; Paul V. Goode; James H. Brauker
- Web page: https://patentgrep.com/patent/US20100168545A1

## CPC

- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/1451: {for interstitial fluid}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/1468: using chemical or electrochemical methods, e.g. by polarographic means
- A61B 5/14735: {comprising an immobilised reagent}
- A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor.

## Claims

### Claim 1

A method for analyzing data from a continuous glucose sensor, comprising:
receiving data from the continuous glucose sensor, the data comprising at least one sensor data point; and
calibrating the at least one sensor data point, wherein the step of calibrating comprises utilizing prior information to calibrate the continuous glucose sensor, and wherein the prior information comprises information obtained from at least one of in vitro testing of at least one continuous glucose sensor and in vivo use of at least one continuous glucose sensor.

### Claim 2 (depends on 1)

The method of claim 1, wherein the prior information is configured to guide or validate at least one of the baseline and sensitivity of the continuous glucose sensor.

### Claim 3 (depends on 1)

The method of claim 1, wherein the step of calibrating comprises determining at least one of a sensitivity or a baseline, and wherein the prior information comprises at least one boundary applied to the at least one of the sensitivity or the baseline.

### Claim 4 (depends on 3)

The method of claim 3, further comprising determining an acceptability of the at least one of the sensitivity or the baseline, wherein an acceptability is determined if the sensitivity falls with at least one boundary.

### Claim 5 (depends on 3)

The method of claim 3, further comprising determining an acceptability of at least one of the sensitivity and the baseline, wherein an acceptability is determined if the baseline falls with at least one boundary.

### Claim 6 (depends on 1)

The method of claim 1, wherein the step of calibrating comprises drawing a calibration line, and wherein the prior information comprises at least one boundary applied to the calibration line.

### Claim 7 (depends on 6)

The method of claim 6, further comprising determining an acceptability of the calibration, wherein the calibration is acceptable if the calibration line falls within the at least one boundary.

### Claim 8 (depends on 6)

The method of claim 6, further comprising determining an acceptability of the calibration, wherein the calibration is not acceptable if the calibration line does not fall within the at least one boundary.

### Claim 9 (depends on 1)

The method of claim 1, wherein the prior information comprises baseline information, whereby a baseline is obtained for sensor calibration.

### Claim 10 (depends on 1)

The method of claim 1, wherein the prior information comprises sensitivity information, whereby a sensitivity is obtained for sensor calibration.

### Claim 11 (depends on 1)

The method of claim 1, wherein the prior information comprises prior distribution information.

### Claim 12 (depends on 11)

The method of claim 11, wherein the prior distribution information comprises at least one of a slope or a baseline geometrically determined closest to a maximum joint probability.

### Claim 13 (depends on 1)

The method of claim 1, wherein the step of is performed without manual glucose measurements.

### Claim 14

A system for analyzing data from a continuous glucose sensor, comprising:
a sensor data receiving module configured to receive sensor data from the continuous glucose sensor, the sensor data comprising at least one sensor data point; and
a processor module configured to calibrate the at least one sensor data point utilizing prior information, wherein the prior information comprises information obtained from at least one of in vitro testing of at least one continuous glucose sensor and in vivo use of at least one continuous glucose sensor.

### Claim 15

A system for detecting analyte levels in a host, comprising:
an introducer; and
an analyte sensor coupled to the introducer for inserting at least a portion of the analyte sensor transcutaneously, wherein the analyte sensor is configured to be calibrated using information obtained prior to inserting in a host by the introducer.

### Claim 16 (depends on 15)

The system of claim 15, wherein the analyte sensor is calibrated without non-continuous analyte measurements.

### Claim 17 (depends on 15)

The system of claim 15, further comprising sensor electronics configured to receive one or more signals from the analyte sensor.

### Claim 18 (depends on 17)

The system of claim 17, wherein the one or more signals are associated with an analyte level.

### Claim 19 (depends on 17)

The system of claim 17, further including a processor module configured to receive data from the sensor electronics.

### Claim 20 (depends on 19)

The system of claim 19, wherein the processor module is configured to receive data from the sensor electronics wirelessly.

### Claim 21 (depends on 19)

The system of claim 19, wherein the data processor is configured to output information associated with the received data.

### Claim 22 (depends on 19)

The system of claim 19, wherein the system further comprises an external device, and wherein the data processor is configured to output information to the external device.

### Claim 23 (depends on 22)

The system of claim 22, wherein the external device comprises an insulin delivery device.

### Claim 24 (depends on 22)

The system of claim 22, wherein the external device comprises at least one of a server, a personal computer, a personal digital assistant, an insulin pump, and an insulin pen, a medical device, a pacemaker, a telemetry device, an infusion device, and an analyte sensor patch.

### Claim 25 (depends on 19)

The system of claim 19, wherein the system comprises a receiver, and wherein the receiver comprises the data processor.

### Claim 26 (depends on 25)

The system of claim 25, wherein the receiver comprises an insulin delivery device, and wherein the analyte sensor comprises a glucose sensor.

### Claim 27 (depends on 25)

The system of claim 25, wherein the receiver comprises at least one of a server, a personal computer, a personal digital assistant, an insulin pump, or an insulin pen.

### Claim 28 (depends on 27)

The system of claim 27, wherein the receiver is integral with at least one of a personal computer, a personal digital assistant, a cell phone, a non-continuous glucose sensor, or an insulin delivery device.