# US 11,998,721 B2 · Continuous analyte sensor quality measures and related therapy actions for an automated therapy delivery system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,721 B2 - Document ID: US11998721B2 - Status: Granted - Kind: B2 - Application number: 18/317,877 - Filed: 2023-05-15 - Published: 2023-09-07 - Granted: 2024-06-04 - 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/US11998721B2 ## 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 Techniques disclosed herein relate to continuous analyte sensor quality measures. In some embodiments, the techniques may involve obtaining a current sensor-generated value that is indicative of a physiological characteristic of a user of a medical device, the current sensor-generated value produced in response to operation of a continuous analyte sensor device. The techniques may further involve obtaining a sensor quality metric that indicates accuracy of the current sensor-generated value. The techniques may further involve causing, in response to obtaining the sensor quality metric, configuration of a quality-specific operating mode of the medical device, the quality-specific operating mode comprising separate regulation of basal and bolus deliveries of a fluid medication based on the obtained sensor quality metric. The techniques may further involve causing regulation of fluid medication delivery 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 processor-implemented method comprising: obtaining a current sensor-generated value that is indicative of a physiological characteristic of a user of a medical device, the current sensor-generated value produced in response to operation of a continuous analyte sensor device; obtaining a sensor quality metric that indicates accuracy of the current sensor-generated value; causing, in response to obtaining the sensor quality metric, configuration of a quality-specific operating mode of the medical device, the quality-specific operating mode comprising separate regulation of basal and bolus deliveries of a fluid medication based on the obtained sensor quality metric; and causing regulation of fluid medication delivery 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, further comprising managing generation of user alerts at the medical device in response to the obtained sensor quality metric. ### Claim 5 (depends on 4) The method of claim 4, wherein managing generation of user alerts comprises: generating user alerts when the obtained sensor quality metric satisfies alert-generating criteria; and inhibiting the user alerts when the calculated sensor quality metric fails the alert-generating criteria. ### Claim 6 (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 communicating the calculated sensor quality metric from the continuous analyte sensor device to the medical device. ### Claim 7 (depends on 1) The method of claim 1, wherein obtaining the sensor quality metric comprises calculating the sensor quality metric based on: sensor age data that indicate 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 8 (depends on 1) The method of claim 1, wherein when the sensor quality metric indicates an uncertain quality, the quality-specific operating mode enables automatic basal delivery by the medical device, disables an automatic bolus delivery feature of the medical device, and inhibits generation of any user alert related to the current sensor-generated value having uncertain quality. ### Claim 9 (depends on 1) The method of claim 1, wherein when the sensor quality metric indicates high quality, the quality-specific operating mode enables automatic basal delivery by the medical device, enables an automatic bolus delivery feature of the medical device, and inhibits generation of any user alert related to the current sensor-generated value having high quality. ### Claim 10 (depends on 1) The method of claim 1, wherein when the sensor quality metric indicates medium quality, the quality-specific operating mode enables automatic basal delivery by the medical device, enables a restricted automatic bolus delivery feature of the medical device, and inhibits generation of any user alert related to the current sensor-generated value having medium quality. ### Claim 11 (depends on 1) The method of claim 1, wherein when the sensor quality metric indicates low quality, the quality-specific operating mode enables a safe basal delivery mode of the medical device, disables an automatic bolus delivery feature of the medical device, and generates a user alert to prompt the user to take corrective action. ### Claim 12 (depends on 11) The method of claim 11, wherein the user alert prompts the user to calibrate the continuous analyte sensor device. ### Claim 13 (depends on 1) The method of claim 1, wherein causing configuration of the quality-specific operating mode comprises causing adjustment of 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 14 (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 a glucose level; and the continuous analyte sensor device is a continuous glucose sensor device. ### Claim 15 One or more non-transitory processor-readable media storing instructions which, when executed by one or more processors, cause performance of: obtaining a current sensor-generated value that is indicative of a physiological characteristic of a user of a medical device, the current sensor-generated value produced in response to operation of a continuous analyte sensor device; obtaining a sensor quality metric that indicates accuracy of the current sensor-generated value; causing, in response to obtaining the sensor quality metric, configuration of a quality-specific operating mode of the medical device, the quality-specific operating mode comprising separate regulation of basal and bolus deliveries of a fluid medication based on the obtained sensor quality metric; and causing regulation of fluid medication delivery from the medical device, in accordance with the current sensor-generated value and the quality-specific operating mode of the medical device. ### Claim 16 A system comprising: one or more processors; and one or more processor-readable media storing instructions which, when executed by one or more processors, cause performance of: obtaining a current sensor-generated value that is indicative of a physiological characteristic of a user of a medical device, the current sensor-generated value produced in response to operation of a continuous analyte sensor device; obtaining a sensor quality metric that indicates accuracy of the current sensor-generated value; causing, in response to obtaining the sensor quality metric, configuration of a quality-specific operating mode of the medical device, the quality-specific operating mode comprising separate regulation of basal and bolus deliveries of a fluid medication based on the obtained sensor quality metric; and causing regulation of fluid medication delivery from the medical device, in accordance with the current sensor-generated value and the quality-specific operating mode of the medical device. ### Claim 17 (depends on 16) The system of claim 16, wherein the sensor quality metric is obtained from the continuous analyte sensor device. ### Claim 18 (depends on 16) The system of claim 16, wherein the medical device calculates the sensor quality metric from information generated by or derived from the continuous analyte sensor device, the information comprising: sensor age data that indicate 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 19 (depends on 16) The system of claim 16, wherein: when the sensor quality metric indicates an uncertain quality, the quality-specific operating mode enables automatic basal delivery by the medical device, disables an automatic bolus delivery feature of the medical 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 quality-specific operating mode enables automatic basal delivery by the medical 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 quality-specific operating mode enables automatic basal delivery by the medical 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 quality-specific operating mode enables a safe basal delivery mode of the medical device, disables the automatic bolus delivery feature, and generates a user alert to prompt the user to take corrective action. ### Claim 20 (depends on 16) The system of claim 16, wherein causing configuration of the quality-specific operating mode comprises causing adjustment of 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.