# US 11,992,656 B2 · Controlling medical infusion device operation and features based on detected patient sleeping status > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,992,656 B2 - Document ID: US11992656B2 - Status: Granted - Kind: B2 - Application number: 17/005,939 - Filed: 2020-08-28 - Published: 2021-03-04 - Granted: 2024-05-28 - Earliest claimed: 2019-08-29 - Assignees: Medtronic MiniMed, Inc. - Applicants: Medtronic Minimed, Inc. - Inventors: Lavie Golenberg; Louis J. Lintereur; Benyamin Grosman; Di Wu; Maria Diana Miller - Web page: https://patentgrep.com/patent/US11992656B2 ## CPC - A61M 5/142: Pressure infusion, e.g. using pumps - A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure} - A61B 5/11: Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb {(A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721)} - A61B 5/4809: {Sleep detection, i.e. determining whether a subject is asleep or not} - A61B 5/4815: {Sleep quality} - A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms} - A61M 5/14248: {of the skin patch type} - A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body} - A61M 5/172: electrical or electronic - A61M 2205/18: with alarm - 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 2205/587: Lighting arrangements - A61M 2205/8206: battery-operated - A61M 2230/005: Parameter used as control input for the apparatus - A61M 2230/201: Glucose concentration - A61M 2230/63: Motion, e.g. physical activity - 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)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A method of operating an insulin infusion device involves: operating the infusion device in an automatic mode to automatically control delivery of insulin to a user, in accordance with a first target glucose setpoint value; receiving user status data that indicates sleeping status of the user, the user status data generated by a sleep detection system; and determining, from the user status data, that the user is sleeping while the insulin infusion device is operating in the automatic mode. In response to the determining, the method transitions from the first target glucose setpoint value to a second (different) target glucose setpoint value for use during the automatic mode, the transitioning occurring without user input. The method continues to operate the infusion device in the automatic mode to automatically control delivery of insulin to the user, in accordance with the second target glucose setpoint value. ## Claims ### Claim 1 A method of operating an insulin infusion device comprising a fluid pump mechanism and at least one controller that regulates operation of the fluid pump mechanism to deliver insulin from the insulin infusion device, the method comprising: operating the insulin infusion device in an automatic mode to automatically control delivery of insulin to a user, in accordance with a first target glucose setpoint value; receiving user status data that indicates sleeping status of the user, the user status data being sensor data generated by a sleep detection system; determining, from the user status data, that the user is sleeping while the insulin infusion device is operating in the automatic mode; in response to the determining, transitioning from the first target glucose setpoint value to a second target glucose setpoint value for use during the automatic mode, the transitioning occurring without user input, and the second target glucose setpoint value being different from the first target glucose setpoint value; and continuing to operate the insulin infusion device in the automatic mode to automatically control delivery of insulin to the user, in accordance with the second target glucose setpoint value. ### Claim 2 (depends on 1) The method of claim 1, wherein the second target glucose setpoint value is lower than the first target glucose setpoint value. ### Claim 3 (depends on 1) The method of claim 1, further comprising: receiving additional user status data that indicates sleeping status of the user, the additional user status data generated by the sleep detection system; determining, from the additional user status data, that the user is awake; in response to determining that the user is awake, transitioning from the second target glucose setpoint value to the first target glucose setpoint value without user input; and continuing to operate the insulin infusion device in the automatic mode to automatically control delivery of insulin to the user, in accordance with the first target glucose setpoint value. ### Claim 4 (depends on 1) The method of claim 1, wherein: the user status data includes a sleep quality metric for the user, the sleep quality metric generated by the sleep detection system; and the transitioning adjusts the first target glucose setpoint value as a function of the sleep quality metric to obtain the second target glucose setpoint value. ### Claim 5 (depends on 1) The method of claim 1, wherein: the user status data includes a sleep duration metric for the user, the sleep duration metric generated by the sleep detection system; and the transitioning adjusts the first target glucose setpoint value as a function of the sleep duration metric to obtain the second target glucose setpoint value. ### Claim 6 (depends on 1) The method of claim 1, wherein: the sleep detection system is separate and distinct from the insulin infusion device; and the insulin infusion device performs the receiving, determining, and transitioning steps. ### Claim 7 (depends on 1) The method of claim 1, wherein: the insulin infusion device comprises the sleep detection system; and the insulin infusion device performs the receiving, determining, and transitioning steps. ### Claim 8 (depends on 1) The method of claim 1, wherein: the receiving and determining steps are performed by an ancillary control system that communicates with the insulin infusion device; and the ancillary control system sends at least one command to the insulin infusion device, the at least one command causing the insulin infusion device to perform the transitioning. ### Claim 9 (depends on 1) The method of claim 1, wherein the transitioning gradually adjusts the first target glucose setpoint value to the second target glucose setpoint value over a predetermined period of time. ### Claim 10 (depends on 1) The method of claim 1, further comprising: monitoring a sleep duration of the user; and initiating the transitioning when the sleep duration exceeds a threshold time period. ### Claim 11 An insulin infusion device comprising: a fluid pump mechanism; at least one controller that regulates operation of the fluid pump mechanism to deliver insulin from the insulin infusion device; and at least one memory element associated with the at least one controller, the at least one memory element storing processor-executable instructions configurable to be executed by the at least one controller to perform a method of controlling operation of the insulin infusion device, the method comprising: operating the insulin infusion device in an automatic mode to automatically control delivery of insulin to a user, in accordance with a first target glucose setpoint value; receiving user status data that indicates sleeping status of the user, the user status data being sensor data generated by a sleep detection system; determining, from the user status data, that the user is sleeping while the insulin infusion device is operating in the automatic mode; in response to the determining, transitioning from the first target glucose setpoint value to a second target glucose setpoint value for use during the automatic mode, the transitioning occurring without user input, and the second target glucose setpoint value being different from the first target glucose setpoint value; and continuing to operate the insulin infusion device in the automatic mode to automatically control delivery of insulin to the user, in accordance with the second target glucose setpoint value. ### Claim 12 (depends on 11) The insulin infusion device of claim 11, wherein the insulin infusion device receives the user status data directly from the sleep detection system. ### Claim 13 (depends on 11) The insulin infusion device of claim 11, wherein the method performed by the at least one controller further comprises: receiving additional user status data that indicates sleeping status of the user, the additional user status data generated by the sleep detection system; determining, from the additional user status data, that the user is awake; in response to determining that the user is awake, transitioning from the second target glucose setpoint value to the first target glucose setpoint value without user input; and continuing to operate the insulin infusion device in the automatic mode to automatically control delivery of insulin to the user, in accordance with the first target glucose setpoint value. ### Claim 14 (depends on 11) The insulin infusion device of claim 11, wherein: the user status data includes a sleep quality metric for the user, the sleep quality metric generated by the sleep detection system; and the transitioning adjusts the first target glucose setpoint value as a function of the sleep quality metric to obtain the second target glucose setpoint value. ### Claim 15 (depends on 11) The insulin infusion device of claim 11, wherein: the user status data includes a sleep duration metric for the user, the sleep duration metric generated by the sleep detection system; and the transitioning adjusts the first target glucose setpoint value as a function of the sleep duration metric to obtain the second target glucose setpoint value. ### Claim 16 (depends on 11) The insulin infusion device of claim 11, wherein the transitioning gradually adjusts the first target glucose setpoint value to the second target glucose setpoint value over a predetermined period of time. ### Claim 17 (depends on 11) The insulin infusion device of claim 11, wherein the method performed by the at least one controller further comprises: monitoring a sleep duration of the user; and initiating the transitioning when the sleep duration exceeds a threshold time period. ### Claim 18 A system comprising: an insulin infusion device that regulates delivery of insulin to a user; a sleep detection system configured to generate user status data that includes sensor data and indicates sleeping status of the user, and configured to communicate the user status data; and at least one controller that controls operation of the insulin infusion device, the at least one controller configured to: operate the insulin infusion device in an automatic mode to automatically control delivery of insulin to the user, in accordance with a first target glucose setpoint value; receive the user status data generated by the sleep detection system; determine, from the user status data, that the user is sleeping while the insulin infusion device is operating in the automatic mode; in response to determining that the user is sleeping, transition from the first target glucose setpoint value to a second target glucose setpoint value for use during the automatic mode, the transitioning occurring without user input, and the second target glucose setpoint value being different from the first target glucose setpoint value; and continue to operate the insulin infusion device in the automatic mode to automatically control delivery of insulin to the user, in accordance with the second target glucose setpoint value. ### Claim 19 (depends on 18) The system of claim 18, wherein the insulin infusion device comprises the at least one controller. ### Claim 20 (depends on 18) The system of claim 18, wherein the sleep detection system comprises a gesture-based, motion-based, or activity-based detection system.