# US 2021/0330883 A1 · Analyte sensor quality measures and related therapy actions for an automated therapy delivery system

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- Number: US 2021/0330883 A1
- Document ID: US20210330883A1
- Status: Published application
- Kind: A1
- Application number: 16/856,838
- Filed: 2020-04-23
- Published: 2021-10-28
- Earliest claimed: 2020-04-23
- Assignees: Medtronic MiniMed, Inc.
- Applicants: Medtronic Minimed, Inc.
- Inventors: Louis J. Lintereur; Alexander S. Campbell; Dmytro Y. Sokolovskyy; Neha J. Parikh; Maria Diana Miller
- Web page: https://patentgrep.com/patent/US20210330883A1

## CPC

- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 20/17: delivered via infusion or injection
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 2205/18: with alarm
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- A61M 2205/702: automatically during use
- A61M 2230/201: Glucose concentration
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Disclosed is a method of controlling operation of a medical device that regulates delivery of a fluid medication to a user. The method obtains a current sensor-generated value that is indicative of a physiological characteristic of the user, and is produced in response to operation of a continuous analyte sensor device. The method continues by: calculating a sensor quality metric that indicates reliability and trustworthiness of the current sensor-generated value; adjusting, in response to the calculated sensor quality metric, therapy actions of the medical device to configure a quality-specific operating mode of the medical device; managing generation of user alerts at the medical device in response to the calculated sensor quality metric; and regulating delivery of the fluid medication from the medical device, in accordance with the current sensor-generated value and the quality-specific operating mode of the medical device.

## Claims

### Claim 1

A method of controlling operation of a medical device that regulates delivery of a fluid medication to a user, the method comprising:
obtaining a current sensor-generated value that is indicative of a physiological characteristic of the user, the current sensor-generated value produced in response to operation of a continuous analyte sensor device;
calculating a sensor quality metric that indicates reliability and trustworthiness of the current sensor-generated value;
adjusting, in response to the calculated sensor quality metric, therapy actions of the medical device to configure a quality-specific operating mode of the medical device;
managing generation of user alerts at the medical device in response to the calculated sensor quality metric; and
regulating delivery of the fluid medication from the medical device, in accordance with the current sensor-generated value and the quality-specific operating mode of the medical device.

### Claim 2 (depends on 1)

The method of claim 1, wherein the sensor quality metric is calculated from information generated by or derived from the continuous analyte sensor device.

### Claim 3 (depends on 2)

The method of claim 2, wherein the information comprises sensor age data, raw sensor signal values, and historical sensor-generated values produced in response to operation of the continuous analyte sensor device.

### Claim 4 (depends on 1)

The method of claim 1, wherein managing generation of user alerts comprises:
generating user alerts when the calculated sensor quality metric satisfies alert-generating criteria; and
inhibiting user alerts when the calculated sensor quality metric fails the alert-generating criteria.

### Claim 5 (depends on 1)

The method of claim 1, wherein:
the sensor quality metric is calculated by the continuous analyte sensor device;
the current sensor-generated value is obtained by the medical device; and
the method further comprises the step of communicating the calculated sensor quality metric from the continuous analyte sensor device to the medical device.

### Claim 6 (depends on 1)

The method of claim 1, wherein the calculating step calculates the sensor quality metric based on:
sensor age data that indicates age of the continuous analyte sensor device;
measurement noise of raw signal output of the continuous analyte sensor device; and
changes in sensor-generated values that cannot be attributed to a natural physiological condition of the user.

### Claim 7 (depends on 1)

The method of claim 1, wherein:
the medical device is an insulin infusion device;
the fluid medication comprises insulin;
the physiological characteristic of the user is blood glucose; and
the continuous analyte sensor device is a continuous glucose sensor device.

### Claim 8 (depends on 7)

The method of claim 7, wherein:
when the sensor quality metric indicates an uncertain quality, the adjusting step enables automatic basal insulin delivery by the insulin infusion device, disables an automatic bolus delivery feature of the insulin infusion device, and inhibits generation of any user alert related to the current sensor-generated value having uncertain quality;
when the sensor quality metric indicates high quality, the adjusting step enables automatic basal insulin delivery by the insulin infusion device, enables the automatic bolus delivery feature, and inhibits generation of any user alert related to the current sensor-generated value having high quality;
when the sensor quality metric indicates medium quality, the adjusting step enables automatic basal insulin delivery by the insulin infusion device, enables a restricted automatic bolus delivery feature, and inhibits generation of any user alert related to the current sensor-generated value having medium quality; and
when the sensor quality metric indicates low quality, the adjusting step enables a safe basal insulin delivery mode of the insulin infusion device, disables the automatic bolus delivery feature, and generates a user alert to prompt the user to take corrective action.

### Claim 9 (depends on 8)

The method of claim 8, wherein the user alert prompts the user to calibrate the continuous glucose sensor device.

### Claim 10 (depends on 1)

The method of claim 1, wherein the adjusting step adjusts the therapy actions of the medical device such that aggressiveness of fluid medication therapy is proportional to quality of the current sensor-generated value as indicated by the calculated sensor quality metric.

### Claim 11

A medical device that regulates delivery of medication to a user, the medical device comprising:
a drive system;
at least one processor device that regulates operation of the drive system to deliver a fluid medication from the medical device;
a user interface; and
at least one memory element associated with the at least one processor device, the at least one memory element storing processor-executable instructions configurable to be executed by the at least one processor device to perform a method of controlling operation of the medical device, the method comprising:
obtaining a current sensor-generated value that is indicative of a physiological characteristic of the user, the current sensor-generated value produced in response to operation of a continuous analyte sensor device;
receiving or calculating a sensor quality metric that indicates reliability and trustworthiness of the current sensor-generated value;
adjusting therapy actions of the medical device in response to the calculated sensor quality metric, to configure a quality-specific operating mode of the medical device;
managing generation of user alerts at the user interface in response to the calculated sensor quality metric; and
regulating delivery of the fluid medication from the medical device, in accordance with the current sensor-generated value and the quality-specific operating mode of the medical device.

### Claim 12 (depends on 11)

The medical device of claim 11, wherein the medical device receives the sensor quality metric from the continuous analyte sensor device.

### Claim 13 (depends on 11)

The medical device of claim 11, wherein the medical device calculates the sensor quality metric only from information generated by or derived from the continuous analyte sensor device.

### Claim 14 (depends on 13)

The medical device of claim 13, wherein the medical device calculates the sensor quality metric based on:
sensor age data that indicates age of the continuous analyte sensor device;
measurement noise of raw signal output of the continuous analyte sensor device; and
changes in sensor-generated values that cannot be attributed to a natural physiological condition of the user.

### Claim 15 (depends on 11)

The medical device of claim 11, wherein:
the medical device is an insulin infusion device;
the fluid medication comprises insulin;
the physiological characteristic of the user is blood glucose; and
the continuous analyte sensor device is a continuous glucose sensor device.

### Claim 16 (depends on 15)

The medical device of claim 15, wherein:
when the sensor quality metric indicates an uncertain quality, the adjusting step enables automatic basal insulin delivery by the insulin infusion device, disables an automatic bolus delivery feature of the insulin infusion device, and inhibits generation of any user alert related to the current sensor-generated value having uncertain quality;
when the sensor quality metric indicates high quality, the adjusting step enables automatic basal insulin delivery by the insulin infusion device, enables the automatic bolus delivery feature, and inhibits generation of any user alert related to the current sensor-generated value having high quality;
when the sensor quality metric indicates medium quality, the adjusting step enables automatic basal insulin delivery by the insulin infusion device, enables a restricted automatic bolus delivery feature, and inhibits generation of any user alert related to the current sensor-generated value having medium quality; and
when the sensor quality metric indicates low quality, the adjusting step enables a safe basal insulin delivery mode of the insulin infusion device, disables the automatic bolus delivery feature, and generates a user alert to prompt the user to take corrective action.

### Claim 17 (depends on 11)

The medical device of claim 11, wherein the adjusting step adjusts the therapy actions of the medical device such that aggressiveness of fluid medication therapy is proportional to quality of the current sensor-generated value as indicated by the sensor quality metric.

### Claim 18

A method of assessing operational quality of a continuous analyte sensor device, the method comprising:
obtaining a current sensor-generated value that is indicative of a physiological characteristic of the user, the current sensor-generated value produced in response to operation of the continuous analyte sensor device;
calculating a sensor quality metric that indicates reliability and trustworthiness of the current sensor-generated value, wherein the calculating is based on information generated by or derived from the continuous analyte sensor device; and
formatting the sensor quality metric for compatibility with a fluid medication delivery device, such that therapy actions of the fluid medication delivery device are adjusted in response to the calculated sensor quality metric, and such that aggressiveness of fluid medication therapy provided by the fluid medication delivery device is proportional to quality of the current sensor-generated value as indicated by the calculated sensor quality metric.

### Claim 19 (depends on 18)

The method of claim 18, wherein:
the information comprises sensor age data that indicates age of the continuous analyte sensor device, raw sensor output values of the continuous analyte sensor device, and historical sensor-generated values produced in response to operation of the continuous analyte sensor device; and
the calculating step calculates the sensor quality metric based on the sensor age data, measurement noise of the raw sensor output values, and changes in sensor-generated values that cannot be attributed to a natural physiological condition of the user.

### Claim 20 (depends on 18)

The method of claim 18, wherein:
the fluid medication delivery device is an insulin infusion device;
when the sensor quality metric indicates an uncertain quality, the insulin infusion device responds by enabling automatic basal insulin delivery, disabling an automatic bolus delivery feature, and inhibiting generation of any user alert related to the current sensor-generated value having uncertain quality;
when the sensor quality metric indicates high quality, the insulin infusion device responds by enabling automatic basal insulin delivery, enabling the automatic bolus delivery feature, and inhibiting generation of any user alert related to the current sensor-generated value having high quality;
when the sensor quality metric indicates medium quality, the insulin infusion device responds by enabling automatic basal insulin delivery, enabling a restricted automatic bolus delivery feature, and inhibiting generation of any user alert related to the current sensor-generated value having medium quality; and
when the sensor quality metric indicates low quality, the insulin infusion device responds by enabling a safe basal insulin delivery mode, disabling the automatic bolus delivery feature, and generating a user alert to prompt the user to take corrective action.