Patent Publication Number: US-2023158235-A1

Title: Alert management based on sleeping status

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 17/005,929, filed Aug. 28, 2020, entitled “CONTROLLING MEDICAL DEVICE OPERATION AND FEATURES BASED ON DETECTED PATIENT SLEEPING STATUS,” which claims the benefits of U.S. Provisional Patent Application No. 62/947,942, filed Dec. 13, 2019, entitled “PUMP CONTROL BASED ON GESTURES,” and U.S. Provisional Patent Application No. 62/893,722, filed Aug. 29, 2019, entitled “INCORPORATING GESTURE DETECTION AND BIOSENSORS INTO DIABETES THERAPIES,” which are herein incorporated by reference in their entireties for all purposes. 
    
    
     TECHNICAL FIELD 
     The present technology is generally related to alert management based on sleeping status. 
     BACKGROUND 
     Medical therapy delivery systems, such as fluid infusion devices, are relatively well known in the medical arts, for use in delivering or dispensing an agent, such as insulin or another prescribed medication, to a patient. A typical insulin infusion device includes a fluid pump mechanism and an associated drive system that actuates a plunger or piston of a fluid reservoir to deliver fluid medication from the reservoir to the body of a patient via a fluid delivery conduit between the reservoir and the body of a patient. Use of infusion pump therapy has been increasing, especially for delivering insulin to diabetic patients. 
     Medical devices, including insulin infusion devices, can be controlled and operated to generate and output (or control the generation and outputting) of various alerts, alarms, messages, and notifications, in different contexts and for different reasons. Some alerts may be merely informative in nature, while other alerts may be more important. For example, alerts related to patient safety, operating health of the medical device, and patient health status may be categorized as high priority, while alerts related to battery charge status, patient reminders or recommendations, and non-critical device status may be categorized as low priority. 
     Control schemes have been developed to allow insulin infusion devices to monitor and regulate a patient&#39;s blood glucose level in a substantially continuous and autonomous manner. An insulin infusion device can be operated in an automatic mode wherein basal insulin is delivered at a rate that is automatically adjusted for the user. While controlling the delivery of basal insulin in this manner, the infusion device can also control the delivery of correction boluses to account for rising glucose trends, a sudden spike or drop in detected blood glucose, etc. Ideally, the amount of a correction bolus should be accurately calculated and administered to maintain the user&#39;s blood glucose within the desired range. In particular, an automatically generated and delivered correction bolus should safely manage the user&#39;s blood glucose level and keep it above a defined threshold level. To this end, an insulin infusion device operating in an automatic mode uses continuous glucose sensor data and control algorithms to regulate the user&#39;s blood glucose, based on a target glucose setpoint setting. 
     BRIEF SUMMARY 
     Techniques disclosed herein relate generally to alert management based on sleeping status. The techniques may be practiced using a system comprising one or more processors and one or more processor-readable media; a processor-implemented method; and/or one or more non-transitory processor-readable media. 
     According to certain embodiments, the techniques involve obtaining user status data indicative of a sleeping status of a user of a medical device, and controlling alert generation and output associated with the medical device in accordance with the sleeping status of the user. In some embodiments, controlling the alert generation and output includes, while the user is asleep, silencing at least one alert, queuing at least one alert for subsequent presentation to the user, delaying outputting of at least one alert, changing a default output type for at least one alert to an elevated output type that is more aggressive than the default output type, or a combination thereof. In some embodiments, the default output type is associated with outputting the at least one alert by a default alerting device, and the elevated output type is associated with outputting the at least one alert by an ancillary alerting device that is different from the default alerting device. In some embodiments, controlling the alert generation and output in accordance with the sleeping status of the user comprises, in response to determining from the user status data that the user is sleeping, activating a sleep mode alerting scheme; and controlling the alert generation and output in accordance with the sleep mode alerting scheme. 
     The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a simplified block diagram representation of an exemplary embodiment of a system that includes a medical device and a sleep detection system; 
         FIG.  2    is a block diagram representation of an exemplary embodiment of a computer-based or processor-based device suitable for deployment in the system shown in  FIG.  1   ; 
         FIG.  3    is a block diagram representation of a closed loop glucose control system arranged in accordance with certain embodiments; 
         FIG.  4    is a block diagram representation of a sleep detection system arranged in accordance with certain embodiments; 
         FIG.  5    is a flow chart that illustrates an alert control process according to certain embodiments; 
         FIG.  6    is a flow chart that illustrates an alert annunciation/output control process according to certain embodiments; and 
         FIG.  7    is a flow chart that illustrates an insulin infusion device control process according to certain embodiments. 
     
    
    
     DETAILED DESCRIPTION 
     The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and uses of such embodiments. As used herein, the word “exemplary” means “serving as an example, instance, or illustration.” Any implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. 
     It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device. 
     In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer). 
     Instructions may be configurable to be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements. 
     Techniques and technologies may be described herein in terms of functional and/or logical block components, and with reference to symbolic representations of operations, processing tasks, and functions that may be performed by various computing components or devices. Such operations, tasks, and functions are sometimes referred to as being computer-executed, computerized, software-implemented, or computer-implemented. It should be appreciated that the various block components shown in the figures may be realized by any number of hardware, software, and/or firmware components configured to perform the specified functions. For example, an embodiment of a system or a component may employ various integrated circuit components, e.g., memory elements, digital signal processing elements, logic elements, look-up tables, or the like, which may carry out a variety of functions under the control of one or more microprocessors or other control devices. 
     Turning now to  FIG.  1   , exemplary embodiments of a system  100  include, without limitation: a medical device  102  that regulates delivery of medication to a user; and a sleep detection system  104  configured to generate user status data that indicates sleeping status of the user. The medical device  102  and the sleep detection system  104  are owned by, operated by, or otherwise associated with a user/patient. The output of the sleep detection system  104  can be used to influence features, functions, and/or therapy-related operations of the medical device  102 . Certain embodiments of the system  100  may include any or all of the following, without limitation: an analyte sensor  106  to measure a physiological characteristic of the user, such that sensor data obtained from the analyte sensor  106  can be used to control, regulate, or otherwise influence the operation of the medical device  102 ; an ancillary control system  108  configured to remotely control at least some features, functions, or operations of the medical device  102  via suitably formatted commands, instructions, or control signals; and an ancillary alerting device  110  configured to generate alerts, alarms, messages, and/or notifications associated with the operation of the medical device  102 . Additionally or alternatively, the ancillary alerting device  110  is configured to remotely control or regulate the generation or outputting/annunciation of such alerts, alarms, messages, and/or notifications by a component of the system  100  (e.g., the medical device  102  or another device that is capable of displaying, presenting, playing, transmitting, or otherwise outputting such alerts, alarms, message, and/or notifications). Other configurations and topologies for the system  100  are also contemplated here, such as a system that includes additional intermediary, interface, or data repeating devices in the data path between a sending device and a receiving device. 
     At least some of the components of the system  100  are communicatively coupled with one another to support data communication, signaling, and/or transmission of control commands as needed, via at least one communications network  112 . The at least one communications network  112  may support wireless data communication and/or data communication using tangible data communication links.  FIG.  1    depicts network communication links in a simplified manner. In practice, the system  100  may cooperate with and leverage any number of wireless and any number of wired data communication networks maintained or operated by various entities and providers. Accordingly, communication between the various components of the system  100  may involve multiple network links and different data communication protocols. In this regard, the network can include or cooperate with any of the following, without limitation: a local area network; a wide area network; the Internet; a personal area network; a near-field data communication link; a cellular communication network; a satellite communication network; a video services or television broadcasting network; a network onboard a vehicle; or the like. The components of the system  100  may be suitably configured to support a variety of wireless and wired data communication protocols, technologies, and techniques as needed for compatibility with the at least one communication network  112 . 
     The analyte sensor  106  may communicate sensor data to the medical device  102  for use in regulating or controlling operation of the medical device  102 . Alternatively or additionally, the analyte sensor  106  may communicate sensor data to one or more other components in the system  100 . The sleep detection system  104  may communicate user status data (that indicates sleeping status of the user) directly to the medical device  102 , which receives and processes the user status data in an appropriate manner for use in regulating or controlling certain functions of the medical device  102 . Alternatively or additionally, the sleep detection system  104  may communicate user status data to the ancillary control system  108 , such that the ancillary control system  108  can remotely regulate or control certain functions of the medical device  102 . For example, the ancillary control system  108  can be configured to remotely control operation of the medical device in response to output provided by the sleep detection system  104 . Alternatively or additionally, the sleep detection system  104  may communicate user status data to the ancillary alerting device  110  for use in regulating or controlling alerts generated by the ancillary alerting device  110  (where the alerts are related to or associated with the operation of the medical device, the analyte sensor  106 , etc.). As mentioned previously, the ancillary control system  108  may communicate control signals, commands, or instructions to the medical device  102 , to the ancillary alerting device  110 , and/or other components of the system  100  to regulate or control settings, features, functions, and/or operations of those components. 
     In certain embodiments, the sleep detection system  104  and the medical device  102  are implemented as physically distinct and separate components, as depicted in  FIG.  1   . In such embodiments, the sleep detection system  104  is external to the medical device  102  and is realized as an ancillary component, relative to the medical device  102 . In accordance with alternative embodiments, however, the medical device  102  and the sleep detection system  104  can be combined into a single hardware component or provided as a set of attached hardware devices. For example, the medical device  102  may include the sleep detection system  104  or integrate the functionality of the sleep detection system  104 . Similarly, the ancillary control system  108  can be incorporated with the sleep detection system  104  or the ancillary alerting device  110  in some embodiments. Similarly, the ancillary alerting device  110  can be incorporated with the sleep detection system  104  in certain embodiments. These and other arrangements, deployments, and topologies of the system  100  are contemplated by this disclosure. 
     As described in more detail below, the sleep detection system  104  detects or determines whether the user is awake or sleeping. The sleep detection system  104  may also determine other sleep-related characteristics, such as the sleep onset time, the waking time, the duration of sleep, a quality metric or measurement that indicates how well the user slept, etc. The sleep detection system  104  generates and communicates user status data (that indicates the sleeping status of the user) to a destination device of the system  100 , e.g., the medical device  102 . In response to the sleeping status of the user, certain functions, settings, and/or operations of the medical device  102  can be regulated, controlled, or adjusted in an appropriate manner. In certain embodiments, a sleep mode alerting scheme of the medical device  102  is activated when the user is sleeping. The sleep mode alerting scheme regulates the generation, timing, prioritization, and/or output type of alerts associated with operation of the medical device  102 . In accordance with certain embodiments where the medical device  102  is an insulin infusion device, a target glucose setpoint value is adjusted (e.g., lowered) when the sleep detection system  104  determines that the user is sleeping. The lowered target glucose setpoint value is utilized during an automatic insulin delivery mode while the user remains asleep. 
     In accordance with certain embodiments, any or all of the components shown in  FIG.  1    can be implemented as a computer-based or a processor-based device, system, or component having suitably configured hardware and software written to perform the functions and methods needed to support the features described herein. In this regard,  FIG.  2    is a simplified block diagram representation of an exemplary embodiment of a computer-based or processor-based device  200  that is suitable for deployment in the system  100  shown in  FIG.  1   . 
     The illustrated embodiment of the device  200  is intended to be a high-level and generic representation of one suitable platform. In this regard, any computer-based or processor-based component of the system  100  can utilize the architecture of the device  200 . The illustrated embodiment of the device  200  generally includes, without limitation: at least one controller (or processor)  202 ; a suitable amount of memory  204  that is associated with the at least one controller  202 ; device-specific items  206  (including, without limitation: hardware, software, firmware, user interface (UI), alerting, and notification features); a power supply  208  such as a disposable or rechargeable battery; a communication module  210 ; and a display element  212 . Of course, an implementation of the device  200  may include additional elements, components, modules, and functionality configured to support various features that are unrelated to the primary subject matter described here. For example, the device  200  may include certain features and elements to support conventional functions that might be related to the particular implementation and deployment of the device  200  (e.g., haptic technology). In practice, the elements of the device  200  may be coupled together via at least one bus or any suitable interconnection architecture  214 . 
     The at least one controller  202  may be implemented or performed with a general purpose processor, a content addressable memory, a microcontroller unit, a digital signal processor, an application specific integrated circuit, a field programmable gate array, any suitable programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination designed to perform the functions described here. Moreover, the at least one controller  202  may be implemented as a combination of computing devices, e.g., a combination of a digital signal processor and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a digital signal processor core, or any other such configuration. 
     The memory  204  may be realized as at least one memory element, device, module, or unit, such as: RAM memory, flash memory, EPROM memory, EEPROM memory, registers, a hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. In this regard, the memory  204  can be coupled to the at least one controller  202  such that the at least one controller  202  can read information from, and write information to, the memory  204 . In the alternative, the memory  204  may be integral to the at least one controller  202 . As an example, the at least one controller  202  and the memory  204  may reside in an ASIC. At least a portion of the memory  204  can be realized as a computer storage medium that is operatively associated with the at least one controller  202 , e.g., a tangible, non-transitory computer-readable medium having computer-executable instructions stored thereon. The computer-executable instructions are configurable to be executed by the at least one controller  202  to cause the at least one controller  202  to perform certain tasks, operations, functions, and processes that are specific to the particular embodiment. In this regard, the memory  204  may represent one suitable implementation of such computer-readable media. Alternatively or additionally, the device  200  could receive and cooperate with computer-readable media (not separately shown) that is realized as a portable or mobile component or platform, e.g., a portable hard drive, a USB flash drive, an optical disc, or the like. 
     The device-specific items  206  may vary from one embodiment of the device  200  to another. For example, the device-specific items  206  will support: sensor device operations when the device  200  is realized as a sensor device; smartphone features and functionality when the device  200  is realized as a smartphone; activity tracker features and functionality when the device  200  is realized as an activity tracker; smart watch features and functionality when the device  200  is realized as a smart watch; medical device features and functionality when the device is realized as a medical device; etc. In practice, certain portions or aspects of the device-specific items  206  may be implemented in one or more of the other blocks depicted in  FIG.  2   . 
     If present, the UI of the device  200  may include or cooperate with various features to allow a user to interact with the device  200 . Accordingly, the UI may include various human-to-machine interfaces, e.g., a keypad, keys, a keyboard, buttons, switches, knobs, a touchpad, a joystick, a pointing device, a virtual writing tablet, a touch screen, a microphone, or any device, component, or function that enables the user to select options, input information, or otherwise control the operation of the device  200 . The UI may include one or more graphical user interface (GUI) control elements that enable a user to manipulate or otherwise interact with an application via the display element  212 . The display element  212  and/or the device-specific items  206  may be utilized to generate, present, render, output, and/or annunciate alerts, alarms, messages, or notifications that are associated with operation of the medical device  102 , associated with a status or condition of the user, associated with operation, status, or condition of the system  100 , etc. 
     The communication module  210  facilitates data communication between the device  200  and other components as needed during the operation of the device  200 . In the context of this description, the communication module  210  can be employed to transmit or stream device-related control data, patient-related user status (e.g., sleeping status data), device-related status or operational data, sensor data, calibration data, and the like. It should be appreciated that the particular configuration and functionality of the communication module  210  can vary depending on the hardware platform and specific implementation of the device  200 . In practice, an embodiment of the device  200  may support wireless data communication and/or wired data communication, using various data communication protocols. For example, the communication module  210  could support one or more wireless data communication protocols, techniques, or methodologies, including, without limitation: RF; IrDA (infrared); Bluetooth; BLE; ZigBee (and other variants of the IEEE 802.15 protocol); IEEE 802.11 (any variation); IEEE 802.16 (WiMAX or any other variation); Direct Sequence Spread Spectrum; Frequency Hopping Spread Spectrum; cellular/wireless/cordless telecommunication protocols; wireless home network communication protocols; paging network protocols; magnetic induction; satellite data communication protocols; wireless hospital or health care facility network protocols such as those operating in the WMTS bands; GPRS; and proprietary wireless data communication protocols such as variants of Wireless USB. Moreover, the communication module  210  could support one or more wired/cabled data communication protocols, including, without limitation: Ethernet; powerline; home network communication protocols; USB; IEEE 1394 (Firewire); hospital network communication protocols; and proprietary data communication protocols. 
     The display element  212  is suitably configured to enable the device  200  to render and display various screens, recommendation messages, alerts, alarms, notifications, GUIs, GUI control elements, drop down menus, auto-fill fields, text entry fields, message fields, or the like. Of course, the display element  212  may also be utilized for the display of other information during the operation of the device  200 , as is well understood. Notably, the specific configuration, operating characteristics, size, resolution, and functionality of the display element  212  can vary depending upon the implementation of the device  200 . 
     As shown in  FIG.  1   , the system  100  can support any type of medical device  102  that is compatible with the features and functionality described here. In certain embodiments, however, the medical device  102  includes or is realized as an insulin infusion device, e.g., a portable patient-worn or patient-carried insulin pump. For the sake of brevity, conventional techniques related to insulin infusion device operation, infusion set operation, and other functional aspects of the systems (and the individual operating components of the systems) may not be described in detail here. Examples of infusion pumps may be of the type described in, but not limited to, U.S. Pat. Nos. 4,562,751; 4,685,903; 5,080,653; 5,505,709; 5,097,122; 6,485,465; 6,554,798; 6,558,320; 6,558,351; 6,641,533; 6,659,980; 6,752,787; 6,817,990; 6,932,584; and 7,621,893; each of which are herein incorporated by reference. 
     Generally, a fluid infusion device includes a fluid pump mechanism having a motor or other actuation arrangement that is operable to linearly displace a plunger (or stopper) of a fluid reservoir provided within the fluid infusion device to deliver a dosage of fluid medication, such as insulin, to the body of a user. Dosage commands that govern operation of the motor may be generated in an automated manner in accordance with the delivery control scheme associated with a particular operating mode, and the dosage commands may be generated in a manner that is influenced by a current (or most recent) measurement of a physiological condition in the body of the user. For a glucose control system suitable for use by diabetic patients, a closed-loop or automatic operating mode can be used to generate insulin dosage commands based on a difference between a current (or most recent) measurement of the interstitial fluid glucose level in the body of the user and a target (or reference) glucose setpoint value. In this regard, the rate of infusion may vary as the difference between a current measurement value and the target measurement value fluctuates. For purposes of explanation, the subject matter is described herein in the context of the infused fluid being insulin for regulating a glucose level of a user (or patient); however, it should be appreciated that many other fluids may be administered through infusion, and the subject matter described herein is not necessarily limited to use with insulin. 
     As mentioned above, the medical device  102  is suitably configured and programmed to support an automatic mode to automatically control delivery of insulin to the user. In this regard,  FIG.  3    is a simplified block diagram representation of a closed loop glucose control system  300  arranged in accordance with certain embodiments. The system  300  depicted in  FIG.  3    functions to regulate the rate of fluid infusion into a body of a user based on feedback from an analyte concentration measurement taken from the body. In particular embodiments, the system  300  is implemented as an automated control system for regulating the rate of insulin infusion into the body of a user based on a glucose concentration measurement taken from the body. The system  300  is designed to model the physiological response of the user to control an insulin infusion device  302  in an appropriate manner to release insulin  304  into the body  306  of the user in a similar concentration profile as would be created by fully functioning human (3-cells when responding to changes in blood glucose concentrations in the body. Thus, the system  300  simulates the body&#39;s natural insulin response to blood glucose levels and not only makes efficient use of insulin, but also accounts for other bodily functions as well since insulin has both metabolic and mitogenic effects. 
     Certain embodiments of the system  300  include, without limitation: the insulin infusion device  302 ; a glucose sensor system  308  (e.g., the analyte sensor  106  shown in  FIG.  1   ); and at least one controller  310 , which may be incorporated in the insulin infusion device  302  as shown in  FIG.  3   . The glucose sensor system  308  generates a sensor signal  314  representative of blood glucose levels  316  in the body  306 , and provides the sensor signal  314  to the at least one controller  310 . The at least one controller  310  receives the sensor signal  314  and generates commands  320  that regulate the timing and dosage of insulin  304  delivered by the insulin infusion device  302 . The commands  320  are generated in response to various factors, variables, settings, and control algorithms utilized by the insulin infusion device  302 . For example, the commands  320  (and, therefore, the delivery of insulin  304 ) can be influenced by a variable target glucose setpoint value  322  that is maintained and regulated by the insulin infusion device  302 . As described in more detail below, the target glucose setpoint value  322  can be lowered when the system  100  (see  FIG.  1   ) determines that the user is asleep, and can be raised when the system  100  determines that the user is no longer asleep. 
     Generally, the glucose sensor system  308  includes a continuous glucose sensor, sensor electrical components to provide power to the sensor and generate the sensor signal  314 , a sensor communication system to carry the sensor signal  314  to the at least one controller  310 , and a sensor system housing for the electrical components and the sensor communication system. As mentioned above with reference to  FIG.  2   , the glucose sensor system  308  may be implemented as a computer-based or processor-based component having the described configuration and features. 
     Typically, the at least one controller  310  includes controller electrical components and software to generate commands for the insulin infusion device  302  based on the sensor signal  314 , the target glucose setpoint value  322 , and other user-specific parameters, settings, and factors. The at least one controller  310  may include a controller communication system to receive the sensor signal  314  and issue the commands  320 . 
     Generally, the insulin infusion device  302  includes a fluid pump mechanism  328 , a fluid reservoir  330  for the medication (e.g., insulin), and an infusion tube  332  to infuse the insulin  304  into the body  306 . In certain embodiments, the insulin infusion device  302  includes an infusion communication system to handle the commands  320  from the at least one controller  310 , electrical components and programmed logic to activate the fluid pump mechanism  328  motor according to the commands  320 , and a housing to hold the components of the insulin infusion device  302 . Accordingly, the fluid pump mechanism  328  receives the commands  320  and delivers the insulin  304  from the fluid reservoir  330  to the body  306  in accordance with the commands  320 . It should be appreciated that an embodiment of the insulin infusion device  302  can include additional elements, components, and features that may provide conventional functionality that need not be described herein. Moreover, an embodiment of the insulin infusion device  302  can include alternative elements, components, and features if so desired, as long as the intended and described functionality remains in place. In this regard, as mentioned above with reference to  FIG.  2   , the insulin infusion device  302  may be implemented as a computer-based or processor-based components having the described configuration and features, including the display element  212  or other device-specific items  206  as described above. 
     The at least one controller  310  is configured and programmed to regulate the operation of the fluid pump mechanism  328  and other functions of the insulin infusion device  302 . The at least one controller  310  controls the fluid pump mechanism  328  to deliver the fluid medication (e.g., insulin) from the fluid reservoir  330  to the body  306 . As mentioned above, the at least one controller  310  can be housed in the infusion device housing, wherein the infusion communication system is an electrical trace or a wire that carries the commands  320  from the at least one controller  310  to the fluid pump mechanism  328 . In alternative embodiments, the at least one controller  310  can be housed in the sensor system housing, wherein the sensor communication system is an electrical trace or a wire that carries the sensor signal  314  from the sensor electrical components to the at least one controller  310 . In accordance with some embodiments, the at least one controller  310  has its own housing or is included in a supplemental or ancillary device. In other embodiments, the at least one controller  310 , the insulin infusion device  302 , and the glucose sensor system  308  are all located within one common housing. 
     The sleep detection system  104  employs at least one sensor to obtain corresponding user-specific sensor data (i.e., user status data). The obtained user status data is processed or analyzed by the sleep detection system  104  and/or by a suitably configured device or component of the system  100  to determine whether the user is sleeping. The obtained user status data may also be processed or analyzed to obtain certain sleep-related parameters, characteristics, and/or metadata for the user. For example, the obtained user status data may identify, include, or indicate any or all of the following, without limitation: timestamp data corresponding to when the user initially fell asleep; timestamp data corresponding to when the user wakes up; timestamp data corresponding to periods of restless sleep; a sleep quality metric for the user, which indicates how well the user slept for a given period of time; a sleep duration metric for the user, which indicates how long the user continuously slept; user posture or position information, which indicates orientation of the user&#39;s body during sleep; body temperature; heartrate; blood pressure; respiratory rate; sweat level; eye or eyelid movement, which may indicate periods of rapid eye movement sleep; eyelid position (e.g., open or closed); images or video of the user; etc. 
     The sleep detection system  104  may include, cooperate with, or be implemented as a gesture-based system, a motion-based system, an activity-based system, a heartrate-based system, or the like. In certain embodiments, the sleep detection system  104  may be realized as a unitary “self-contained” wearable system that communicates with one or more other components of the system  100 . For example, the sleep detection system  104  can be implemented with a wearable device such as an activity monitor device, a smart watch device, a smart bracelet device, or the like. In some embodiments, the sleep detection system  104  may be realized as a portable or wearable device that includes or communicates with one or more external or ancillary sensor devices, units, or components. For example, the sleep detection system  104  can be implemented with a wearable or portable smart device that is linked with one or more external sensors worn or carried by the user. These and other possible deployments of the sleep detection system  104  are contemplated by this disclosure. In this regard, United States patent publication number US 2020/0135320 and U.S. patent application Ser. No. 16/886,360 (filed May 28, 2020) disclose gesture-based physical behavior detection systems that are suitable for use as the sleep detection system  104 ; the entire content of these United States patent documents is incorporated by reference herein. 
       FIG.  4    is a block diagram representation of a sleep detection system  400  arranged in accordance with certain embodiments. The sleep detection system  400  is suitable for use with the system  100  shown  FIG.  1   . In certain embodiments, the sleep detection system  400  is deployed as a wearable electronic device in the form factor of a bracelet or wristband that is worn around the wrist or arm of a user&#39;s dominant hand. The sleep detection system  400  may optionally be implemented using a modular design, wherein individual modules include one or more subsets of the disclosed components and overall functionality. The user may choose to add specific modules based on personal preferences and requirements. 
     The sleep detection system  400  includes a battery  402  and a power management unit (PMU)  404  to deliver power at the proper supply voltage levels to all electronic circuits and components. The PMU  404  may also include battery-recharging circuitry. The PMU  404  may also include hardware, such as switches, that allows power to specific electronics circuits and components to be cut off when not in use. 
     When there is no movement-based or gesture-based behavior event in progress, most circuitry and components in the sleep detection system  400  are switched off to conserve power. Only circuitry and components that are required to detect or help predict the start of a behavior event of interest (such as sleeping or waking) may remain enabled. For example, if no motion is being detected, all sensor circuits but an accelerometer  406  may be switched off and the accelerometer  406  may be put in a low-power wake-on-motion mode or in another lower power mode that consumes less power and uses less processing resources than its high performance active mode. A controller  408  of the sleep detection system  400  may also be placed into a low-power mode to conserve power. When motion or a certain motion pattern is detected, the accelerometer  406  and/or the controller  408  may switch into a higher power mode and additional sensors such as, for example, a gyroscope  410  and/or a proximity sensor  412  may also be enabled. When a potential start of a movement-based or gesture-based event is detected, memory variables for storing event-specific parameters, such as gesture types, gesture duration, etc. can be initialized. 
     In another example, upon detection of user motion, the accelerometer  406  switches into a higher power mode, but other sensors remain switched off until the data from the accelerometer  406  indicates that the start of a behavior event has likely occurred. At that point in time, additional sensors such as the gyroscope  410  and the proximity sensor  412  may be enabled. 
     In another example, when there is no behavior event in progress, both the accelerometer  406  and gyroscope  410  are enabled but at least one of either the accelerometer  406  or the gyroscope  410  is placed in a lower power mode compared to their regular power mode. For example, the sampling rate may be reduced to conserve power. Similarly, the circuitry required to transfer data from the sleep detection system  400  to a destination device may be placed in a lower power mode. For example, radio circuitry  414  could be disabled. Similarly, the circuitry required to transfer data from the sleep detection system  400  may be placed in a lower power mode. For example, the radio circuitry  414  could be disabled until a possible or likely start of a behavior event has been determined. Alternatively, it may remain enabled but in a low power state to maintain the connection between the sleep detection system  400  and one or more other components of the system  100 , but without transferring user status data, sensor data, or the like. 
     In yet another example, all motion-detection related circuitry may be switched off if, based on certain metadata, it is determined that the occurrence of a particular behavior event, such as a food intake event, is unlikely. This may be desirable to further conserve power. Metadata used to make this determination may, among other things, include one or more of the following: time of the day, location, ambient light levels, proximity sensing, and detection that the sleep detection system  400  has been removed from the wrist or hand, detection that the sleep detection system  400  is being charged, or the like. Metadata may be generated and collected by the sleep detection system  400 . Alternatively, metadata may be collected by another device that is external to the sleep detection system  400  and is configured to directly or indirectly exchange information with the sleep detection system  400 . It is also possible that some metadata is generated and collected by the sleep detection system  400 , while other metadata is generated and collected by a device that is external to the sleep detection system  400 . In case some or all of the metadata is generated and collected external to the sleep detection system  400 , the sleep detection system  400  may periodically or from time to time power up its radio circuitry  414  to retrieve metadata related information from another device. 
     In certain embodiments, some or all of the sensors may be turned on or placed in a higher power mode if certain metadata indicates that the occurrence of a particular behavior event, such as the user falling asleep, is likely. Metadata used to make this determination may, among other things, include one or more of the following: time of the day; location; ambient light levels; proximity sensing; historical user behavior patterns. Some or all of the metadata may be collected by sleep detection system  400  or by an ancillary device that cooperates or communicates with the sleep detection system  400 , as mentioned above. 
     User status data used to track certain aspects of a user&#39;s behavior may be stored locally inside memory  416  of the sleep detection system  400  and processed locally using the controller  408  of the sleep detection system  400 . User status data may also be transferred to the medical device  102 , the ancillary control system  108 , and/or the ancillary alerting device  110  (using, for example, the radio circuitry  414 ) for further processing and analysis. It is also possible that some of the processing and analysis are performed locally by the sleep detection system  400 , while further processing and analysis are performed by one or more other components of the system  100 . 
     The detection of the start of a behavior event, such as the start of a sleeping period, may trigger the power up and/or activation of additional sensors and circuitry, such as a camera module  418 . Power up and/or activation of additional sensors and circuitry may occur at the same time as the detection of the behavior event of interest or some time thereafter. Specific sensors and circuitry may be turned on only at specific times during a detected event, and may be switched off otherwise to conserve power. It is also possible that the camera module  418  only gets powered up or activated upon explicit user intervention such as, for example, pushing and holding a button  420 . Releasing the button  420  may turn off the camera module  418  to conserve power. 
     When the camera module  418  is powered up, a projecting light source  422  may also be enabled to provide visual feedback to the user about the area that is within view of the camera or to otherwise illuminate the field of view. Alternatively, the projecting light source  422  may only be activated sometime after the camera module  418  has been activated. In certain cases, additional conditions may need to be met before the projecting light source  422  is activated. Such conditions may include: the determination that the projecting light source  422  is likely aiming in the direction of the object of interest; the determination that the sleep detection system  400  is not moving excessively; or the like. In some embodiments, one or more light emitting diodes (LEDs)  426  may be used as the projecting light source  422 . 
     Images may be tagged with additional information or metadata such as: camera focal information; proximity information from the proximity sensor  412 ; ambient light levels information from an ambient light sensor  424 ; timestamp information; etc. Such additional information or metadata may be used during the processing and analysis of the user status data. 
     The projecting light source  422  may also be used to communicate other information. As an example, an ancillary device may use inputs from one or more proximity sensors  412 , process those inputs to determine if the camera module  418  is within the proper distance range from the object of interest, and use one or more light sources to communicate that the camera is within the proper distance range, that the user needs to increase the distance between camera and the object of interest, or that the user needs to reduce the distance between the camera and the object of interest. 
     The projecting light source  422  may also be used in combination with the ambient light sensor  424  to communicate to the user if the ambient light is insufficient or too strong for an adequate quality image capture. The projecting light source  422  may also be used to communicate information including, but not limited to, a low battery situation or a functional defect. 
     The projecting light source  422  may also be used to communicate dietary coaching information. As an example, the projecting light source  422  might, among other things, indicate if not enough or too much time has expired since a previous food intake event, or may communicate to the user how he/she is doing against specific dietary goals. 
     Signaling mechanisms to convey specific messages using one or more projecting light sources  422  may include, but are not limited to, one or more of the following: specific light intensities or light intensity patterns; specific light colors or light color patterns; specific spatial or temporal light patterns. Multiple mechanisms may also be combined to signal one specific message. 
     A microphone  428  may be used by the user to add specific or custom labels or messages to a detected event and/or image. Audio snippets may be processed by a voice recognition engine. 
     In certain embodiments, the accelerometer  406  (possibly combined with other sensors, including other inertial sensors) may, in addition to tracking at least one parameter that is directly related to a gesture-based behavior event, also be used to track one or more parameters that are not directly related to that particular event. Such parameters may, among other things, include physical activity, sleep, eating, or stress. 
     In addition to the particular sensors, detectors, and components mentioned above, the sleep detection system  400  may include or cooperate with any number of other sensors  430  as appropriate for the particular embodiment. The sleep detection system  400  obtains user status data from one or more of its sensors, detectors, and sources, wherein the user status data indicates sleeping status of the user. The user status data can be analyzed and processed by the sleep detection system  400  (and/or by one or more other components of the system  100 ) to determine whether the user is sleeping and, in certain embodiments, to determine additional information, characteristics, or metrics related to the user&#39;s sleeping status. In certain embodiments, the sleep detection system  400  and/or an ancillary system or device determines the user&#39;s sleeping status primarily based on the output of user-worn motion sensors, movement sensors, one or more inertial sensors (e.g., one or more accelerometers and/or one or more gyroscopes), one or more GPS sensors, one or more magnetometers, one or more force or physical pressure sensors, or the like, which are suitably configured, positioned, and arranged to measure physical movement or motion of the user&#39;s limbs, digits, joints, facial features, head, and/or other body parts. 
     In some embodiments, the sleep detection system  400  includes at least one haptic interface  440  that is suitably configured and operated to provide haptic feedback as an output. The at least one haptic interface  440  generates output(s) that can be experienced by the sense of touch by the user, e.g., mechanical force, vibration, movement, temperature changes, or the like. Haptic feedback generated by the at least one haptic interface  440  may represent or be associated with one or more of the following, without limitation: reminders; alerts; confirmations; notifications; messages; numerical values (such as measurements); status indicators; or any other type of output provided by the sleep detection system  400 . 
     In certain embodiments, the user status data (e.g., sensor data) is provided to a gesture recognizer unit or processing module. To this end, sensor data may be sent in raw format. Alternatively, a source of sensor data may perform some processing (e.g., filtering, compression, or formatting) on raw sensor data before sending the processed sensor data to the gesture recognizer unit. The gesture recognizer unit analyzes the incoming sensor data and converts the incoming sensor data into a stream of corresponding gestures, which may be predetermined or otherwise classified or categorized. The gesture recognizer unit may use one or more ancillary inputs to aid in the gesture determination process. Nonlimiting examples of an ancillary input include: time of day; the probability of a specific gesture occurring based on statistical analysis of historical gesture data for that user; geographical location; heart rate; other physiological sensor inputs. Other ancillary inputs are also possible. 
     The output of the gesture recognizer unit—the detected gestures—can be sent to an event detector or processing module. The event detector analyzes the incoming stream of gestures to determine if the start of an event of interest (e.g., sleep) has occurred, whether an event is ongoing, whether an event has ended, or the like. For example, if the event detector is implemented as a sleep detector intended to capture sleeping/waking events, it will be suitably configured to determine if the start of a sleeping period has occurred, if the user is still sleeping, or if the user is awake. Although this description focuses on sleep detection, a gesture-based physical behavior detection system may be suitably configured to monitor other types of physical behavior or activities. Such activities include, without limitation: reading; drinking; smoking; getting dressed; turning down a bed; making a bed; brushing teeth; combing hair; talking on the phone; inhaling or injecting a medication; and activities related to hand hygiene or personal hygiene. 
     Referring again to  FIG.  1   , certain functions, features, and/or therapy related operations of the medical device  102  can be adjusted or modified in response to the output of the sleep detection system  104 . More specifically, operation of the medical device  102  can be controlled or regulated based on a determination that the user is sleeping. For example, if the system  100  determines that the user is sleeping, a sleep mode alerting scheme of the medical device  102  can be activated (instead of a default alerting scheme). As another example, if the system  100  determines that the user is sleeping, then a target glucose setpoint value (utilized by an insulin infusion device during an automatic insulin delivery mode) can be temporarily lowered. 
       FIG.  5    is a flow chart that illustrates an alert control process  500  according to certain embodiments. The process  500  represents an automated method of controlling alerts associated with the operation of a medical device, such as an insulin infusion device. The process  500  receives user status data (e.g., sleep status data) that indicates the sleeping status of a user of the medical device (task  502 ). As mentioned above, the user status data is generated by sensors, detector units, or other sources of data that are included with or associated with a suitably configured sleep detection system (e.g., the analyte sensor  106 , the accelerometer  406 , the gyroscope  410 , the proximity sensor  412 , one or more other sensors  430 , the microphone  428 , and/or the camera module  418 ). Depending on the particular embodiment, task  502  may be performed by the sleep detection system and/or by an ancillary system or device other than the sleep detection system. The process  500  continues by analyzing or processing at least some of the received user status data to determine whether the user is sleeping (query task  504 ). If analysis of the user status data indicates that the user is sleeping (the “Yes” branch of query task  504 ), then the process  500  activates a sleep mode alerting scheme for the medical device (task  506 ). The sleep mode alerting scheme replaces, supplements, or modifies the existing alerting scheme (which may be a default, baseline, or standard alerting scheme utilized by the medical device, i.e., an unmodified scheme that is utilized during normally expected operation of the medical device while the user is awake). If analysis of the user status data indicates that the user is not asleep (the “No” branch of query task  504 ), then the process maintains and utilizes the currently active alerting scheme of the medical device, e.g., the default, baseline, or standard alerting scheme (task  508 ). After activating the sleep mode alerting scheme, the process  500  continues by controlling the generation and outputting of alerts associated with the operation of the medical device (task  510 ), wherein the generation and outputting of alerts are performed in accordance with the activated sleep mode alerting scheme. 
     In certain embodiments, the sleep mode alerting scheme silences (e.g., inhibits the generation or outputting, or generates but mutes), temporarily disables, or delays the outputting of at least one alert while the user is asleep. The sleep mode alerting scheme may queue at least one alert for subsequent presentation or outputting to the user in a first-in, first-out order or a rearranged order that may be influenced by a priority assigned to the alerts, the importance of the alerts, or any other criteria. In this regard, the process  500  can delay or queue an alert such that it does not wake up the user, but is displayed, output, or otherwise presented after the user wakes up. The user can be notified of any delayed or queued alerts, and reminded or prompted to view and clear such alerts. Delayed or queued alerts may be identified in a selectable list that allows the user to choose which alerts to view, and in which order. The user may be required to view and clear some alerts to silence an ongoing alert or to prevent repeated notifications or reminders. In some embodiments, delayed or queued alerts may be displayed in one or more windows or in one or more messages in succession or concurrently, and displayed messages/windows may be accompanied by audible alert sounds and/or haptic feedback intended to notify the user or otherwise obtain the attention of the user. It should be appreciated that the specific manner in which delayed, silenced, or queued alerts/messages are subsequently presented to the user may vary, depending on the particular implementation, the intended application of the medical device, user preferences or settings, healthcare provider preferences or settings, or the like. 
     In accordance with some embodiments, the sleep mode alerting scheme changes a default output type, mode, or source (for at least one alert) to an elevated output type, mode, or source that is more aggressive than the default output type, for example, an output type that is unmodified, unrestricted, or is normally utilized by the device during waking hours. As used here, an alert that is “more aggressive” than its default counterpart is louder, more noticeable, more recognizable, more frequent or repetitive, stronger, or otherwise designed to wake up a sleeping user. For example, the default output type may be associated with outputting of an alert by a default alerting device, such as the medical device itself. In contrast, the elevated output type may be associated with outputting of an alert by an ancillary alerting device that is different than the default alerting device, such as an alarm clock, the user&#39;s mobile phone, a security system alarm unit, the user&#39;s smart-watch, or the like. Different annunciation/output types include, without limitation: audible alarms, alerts, or messages; haptic feedback, such as vibration of a device in the system; visible alarms, alerts, or messages, such as flashing lights, a pattern of lights, or illumination of a display screen; and displayable alarms, alerts, or messages. In certain embodiments, the elevated output type can be utilized in concert with, or in lieu of, the default output type. Accordingly, the sleep mode alerting scheme can utilize the elevated output types, modes, or sources for important, critical, time sensitive, and/or safety-related alerts that occur when the user is sleeping. 
     The medical device  102  can generate any number of alerts, notifications, messages, reminders, or the like (collectively referred to herein as “alerts”). The alerts can be ranked or prioritized in the context of the default alerting scheme and/or in the context of the sleep mode alerting scheme. At least some alerts can be reprioritized for the sleep mode alerting scheme. Alerts may be related to status of the medical device  102  (e.g., battery status), status of disposables or consumables used by the medical device  102  (e.g., insulin reservoir level), user/patient status, therapy delivery, calendar entries, or the like. Alerts can be prioritized based on their relationship or association with patient safety, operating health of the medical device  102 , or the like. For example, routine reminders or notifications that are unrelated to therapy or patient health might be deemed “low priority” and, therefore, silenced while the user is sleeping. As another example, important or urgent alerts that relate to patient safety or critical functions or the medical device  102  may be deemed “high priority” and, therefore, kept active while the user is sleeping. 
     In some embodiments, the user status data provided by the sleep detection system  104  includes a sleep quality metric that measures, quantifies, or otherwise indicates how well the user has slept or how well the user is sleeping. For example, the sleep quality metric may be based on any or all of the following data, without limitation: heart rate; respiratory rate; amount of movement (tossing and turning) during sleep; eye movement; snoring sounds; etc. The sleep quality metric generated by the sleep detection system  104  can be used to regulate or adjust the sleep mode alerting scheme. More specifically, the sleep mode alerting scheme can be designed such that it regulates the generation or outputting of alerts as a function of the sleep quality metric generated by the sleep detection system. Thus, if the sleep quality metric indicates that the user has been sleeping well (e.g., in deep sleep or REM sleep), then the sleep mode alerting scheme can be adjusted to accommodate that sleeping state. If the sleep quality metric indicates that the user has not been sleeping well or is in a state of shallow or gentle sleep, then the sleep mode alerting scheme can be adjusted in a manner that assumes that the user is not actually sleeping, yet not fully awake. Accordingly, the manner in which different alerts are handled (e.g., silenced, delayed, deleted, queued, repeated) and/or the manner in which different alerts are annunciated or output (e.g., using the native functionality of the medical device  102 , using an escalated or elevated output scheme, and/or using one or more ancillary alerting devices  110 ) can vary in response to the current value of the sleep quality metric. 
     In some embodiments, the user status data provided by the sleep detection system  104  includes a sleep duration metric that measures, quantifies, or otherwise indicates how long the user slept or how long the user has been sleeping. For example, the sleep duration metric may be a time value based on when the sleep detection system  104  determined that the user fell asleep. The sleep duration metric generated by the sleep detection system  104  can be used to regulate or adjust the sleep mode alerting scheme. More specifically, the sleep mode alerting scheme can be designed such that it regulates the generation or outputting of alerts as a function of the sleep duration metric generated by the sleep detection system. Thus, if the sleep duration metric indicates that the user has been continuously sleeping for an extended period of time (e.g., more than two hours), then the sleep mode alerting scheme can be adjusted to accommodate that sleeping state. If the sleep duration metric indicates that the user has only been sleeping for a few minutes, then the sleep mode alerting scheme can be adjusted in a manner that assumes that the user is not actually sleeping, yet not fully awake. Accordingly, the manner in which different alerts are handled (e.g., silenced, delayed, deleted, queued, repeated) and/or the manner in which different alerts are annunciated/output (e.g., using the native functionality of the medical device  102 , using an escalated or elevated output scheme, and/or using one or more ancillary alerting devices  110 ) can vary in response to the current value of the sleep duration metric. 
     As one non-limiting example, a “Low Glucose” alert can be elevated to a higher priority during sleep. Moreover, the output characteristics of a “Low Glucose” alert can change in a dynamic manner if the user does not respond during sleep. As another non-limiting example, an “Occlusion” alarm (which may be utilized by a fluid infusion system) can be elevated to a higher priority during sleep, and its output characteristics can escalate in a dynamic manner if the user does not respond during sleep. As another non-limiting example, a “Low Reservoir” alert can be suppressed or given a lower priority during sleeping periods if the remaining operating time (or amount of fluid remaining in the reservoir) allows the alert to be addressed after the user&#39;s regular wake-up time. As another non-limiting example, a “Low Battery” alert can be suppressed, delayed, or given a lower priority during sleeping periods if the remaining battery time allows the alert to be addressed after the user wakes up. As another non-limiting example, a “High Glucose” alert can remain unchanged (i.e., its priority is not changed and its output characteristics remain the same) during periods of sleep. 
       FIG.  6    is a flow chart that illustrates an alert annunciation/output control process  600  according to certain embodiments. The process  600  may be performed in conjunction with the process  500  described above. Indeed, this description assumes that the process  600  is performed after the system  100  has determined that the user is sleeping. The process  600  outputs a safety alert using a default output type (task  602 ), and checks whether the safety alert has been ignored or attended to (query task  604 ). As used here, a safety alert is any alert that relates to, indicates, or is otherwise associated with a condition, a device state, user status, system state, or environmental condition that implicates the health, well-being, quality of life, or security of the user. In this regard, safety alerts can be distinguished from non-critical alerts, routine reminders, and unimportant messages that have little to no impact on patient health or therapy outcomes and, therefore, can be safely and confidently delayed, ignored, deleted, or disregarded during periods of sleep. 
     If the user responds to the safety alert or if the safety alert is otherwise attended to (the “No” branch of query task  604 ), then the process  600  exits and the system  100  handles the safety alert in an appropriate manner. If the process  600  confirms that the safety alert has been ignored for at least a threshold period of time (the “Yes” branch of query task  604 ), then the process  600  continues by taking appropriate action that is intended to notify or wake up the user. In certain embodiments, the process  600  continues by changing the default output type to an elevated output type that is more aggressive than the default output type (task  606 ), as described above. Next, the process  600  re-outputs the safety alert using the elevated output type (task  608 ). If the user continues to ignore the safety alert, then task  606  and task  608  can be repeated to continue escalating or modifying the output type, mode, or source in an appropriate manner. Thus, additional, different, louder, longer duration, more prevalent, more frequent, or more repetitive alerts or alarms can be used to escalate the manner in which the safety alert is output in an ongoing manner, in an attempt to awaken the user. 
     Referring again to  FIG.  5   , in certain implementations, the medical device  102  receives the user status data, processes the user status data to determine whether the user is sleeping, and activates a native sleep mode alerting scheme. In some embodiments, at least one ancillary control system  108  and/or at least one ancillary alerting device  110  receives the user status data, processes the user status data to determine whether the user is sleeping, and activates or controls a sleep mode alerting scheme for the medical device  102 . In such embodiments, the native alerting functionality of the medical device  102  can be remotely controlled and/or an ancillary alerting device  110  can be controlled to execute the sleep mode alerting scheme. As mentioned above, controllers resident at the different components of the system  100  can be suitably configured and programmed to perform the methods and processes described here, individually or in a distributed or collective manner. 
       FIG.  7    is a flow chart that illustrates an insulin infusion device control process  700  according to certain embodiments. A number of currently available hybrid closed-loop insulin delivery systems use glucose sensor feedback control algorithms to regulate the user&#39;s blood glucose to a fixed “factory setting” setpoint, such as 120 mg/dL or 100 mg/dL. A fixed setpoint at or near 120 mg/dL represents a good target glucose for the vast majority of users that balances effective long term blood sugar control with safety (with respect to hypoglycemia). However, many users may desire a higher or lower setpoint to suit their individual needs. Disclosed here is an insulin infusion system that accommodates a variable target glucose setpoint, which can be adjusted in response to the detected sleeping status of the user. The adjustable glucose setpoint can be programmable to move to different levels at different times, such as a lower setpoint during sleeping periods to give a low fasting glucose, and a higher setpoint when the user is awake. 
     The process  700  represents an automated method of operating a medical device, such as the insulin infusion device  302  depicted in  FIG.  3   . This description assumes that the insulin infusion device is operating in an automatic mode to automatically control delivery of insulin to the user (task  702 ). As explained above with reference to  FIG.  3   , insulin delivery is controlled and regulated in accordance with various factors, sensor data, user-specific settings, etc., including a first or default target glucose setpoint value. The first target glucose setpoint value may be user-configurable, fixed by the manufacturer of the insulin infusion device, set by the user&#39;s physician or caregiver, or the like. In certain embodiments, the first target glucose setpoint value is chosen to be 120 mg/dL, although other values can be used. 
     The process  700  receives user status data (e.g., sleep status data) that indicates the sleeping status of a user of the medical device (task  704 ) and analyzes or processes at least some of the received user status data to determine whether the user is sleeping (query task  706 ). Task  704  is similar to task  502  of the process  500 , and query task  706  is similar to query task  504  of the process  500 , as described above with reference to  FIG.  5   . If analysis of the user status data indicates that the user is awake, then the process  700  maintains the first target glucose setpoint value as the currently active or applicable value for regulating the delivery of insulin during the automatic delivery mode (task  708 ). Accordingly,  FIG.  7    depicts the process  700  leading back to task  702  for continued operation of the insulin infusion device. 
     This example assumes that the process  700  determines, 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 determination that the user is sleeping, the process  700  adjusts the target glucose setpoint value by automatically transitioning (without user input) from the first target glucose setpoint value to a second target glucose setpoint value, different than the first target glucose setpoint value, for use during the automatic mode (task  710 ). In some examples, the second target glucose setpoint value is higher than the target glucose setpoint value. In some examples, the second target glucose setpoint value is lower than the target glucose setpoint value. The process  700  continues to operate the insulin infusion device in the automatic mode to automatically control the delivery of insulin to the user, in accordance with the second target glucose setpoint value (task  712 ). In some embodiments, the process  700  monitors the sleep duration of the user and initiates the transitioning to the second target glucose setpoint value when the sleep duration exceeds a threshold time period (e.g., 30 minutes, 1 hour, 2 hours, or any other period of time). In other words, adjusting the target glucose setpoint value may occur as soon as the user falls asleep, or it may be delayed until the process  700  confirms that the user has been sleeping for at least the threshold time period. In some embodiments, in addition to the duration of the sleep, the user&#39;s glucose condition can be considered. For example, if the duration of sleep is longer than the threshold time period and sensor glucose measurements are stable around the first target glucose setpoint value, then the process  700  can proceed and transition (without user input) to the second target glucose setpoint value. In some embodiments, the process  700  considers an estimated amount of plasma insulin for the user as a factor that influences whether to transition without user input to the second target glucose setpoint value. Other factors, parameters, and data that can be considered before adjusting the target glucose setpoint value include, without limitation: sensor glucose data availability; current or historical sensor glucose levels; and/or the rate of change of sensor glucose readings. 
       FIG.  7    shows the process  700  leading back to task  704  to receive updated or additional user status data for continued monitoring and processing during the automatic mode. If the process  700  determines (from the additional user status data) that the user is no longer sleeping, then task  708  can transition, without user input, from the second target glucose setpoint value to the first target glucose setpoint value, or to another target glucose setpoint value that is appropriate for the current user state. Thereafter, the process  700  continues to operate the insulin infusion device in the automatic mode, using the first target glucose setpoint value as a reference. If the user remains asleep, then the second target glucose setpoint value is maintained for ongoing use during the automatic mode (task  710 ). 
     Transitioning from one target glucose setpoint value to another without user input may be performed gradually or continuously over a predetermined period of time, e.g., 30 minutes, an hour, or the like. Transitioning over time in this manner assumes that the user remains asleep before and during the transition period. In certain embodiments, transitioning from one target glucose setpoint value to another without user input is performed quickly or immediately following the detection of a sleeping state. In other words, the process  700  can simply switch from one setpoint value to another in a stepwise manner. 
     For the example described here, the second target glucose setpoint value is lower than the first (default) target glucose setpoint value. Lowering the setpoint value is appropriate during sleeping hours because the automatic control algorithm need not consider additional factors such as eating, exercise, heartrate variations, etc. As an example, the first value may be 120 mg/dL and the second value may be 100 mg/dL, 80 mg/dL, or any value that is safe and appropriate for the particular user. The second target glucose setpoint value may be a fixed value that is set by the manufacturer of the insulin infusion device, the user, a caregiver, etc. In some embodiments, the second target glucose setpoint value is higher than the first target glucose setpoint value. As an example, the first value may be 120 mg/dL and the second value may be 130 mg/dL or any value that is safe and appropriate for the particular user. 
     In certain embodiments, the second target glucose setpoint value can be variable or dynamic in nature to respond to the particular sleeping status, the current user condition or glucose state, or the like. For example, the user status data provided by the sleep detection system  104  may include a sleep quality metric (as described above with reference to the process  500 ). The sleep quality metric generated by the sleep detection system  104  can be used to regulate or adjust the currently active second target glucose setpoint value without user input. More specifically, the second target glucose setpoint value can be adjusted as a function of the sleep quality metric generated by the sleep detection system. For example, the adjustment amount and/or the adjustment time period may be influenced by the sleep quality metric. In this regard, the target glucose setpoint value can be regulated as a function of sleep quality by monitoring non-diabetic individual(s) and mimicking the manner in which a non-diabetic person regulates glucose. Thus, physiological data, sleep-related data, and glucose response characteristics associated with non-diabetic individuals can be utilized to automatically adjust the target glucose setpoint value for diabetic users, as a function of sleep quality. 
     In some embodiments, the user status data provided by the sleep detection system  104  includes a sleep duration metric (as described above with reference to the process  500 ). The sleep duration metric generated by the sleep detection system  104  can be used to regulate or adjust the currently active second target glucose setpoint value without user input. More specifically, the target glucose setpoint value can be automatically adjusted as a function of the sleep duration metric generated by the sleep detection system. Thus, the adjustment amount and/or the adjustment time period may be influenced by the sleep duration metric. For example, if the user has only been sleeping for one hour, then the setpoint value may be adjusted by only an initial amount. If, however, the sleep duration metric indicates that the user has been continuously sleeping for an extended period of time (e.g., more than two hours or any other period of time), then it may be appropriate to lower the target glucose setpoint value by an additional amount. 
     As explained above, the target glucose setpoint value represents a setting, parameter, or variable of the insulin delivery control algorithm, which can be adjusted or regulated, without user input, as a function of sleep detection and/or certain sleep-related characteristics. In accordance with certain embodiments, one or more additional or alternative settings, parameters, or variables can be adjusted based on sleep detection. For example, controller gain values (which are utilized by the automatic insulin delivery control algorithm) can be adjusted as a function of sleep detection and/or certain sleep-related characteristics. In certain embodiments, the controller of an insulin infusion device employs a proportional-integral-derivative insulin feedback (PID-IFB) control algorithm designed for continuous closed-loop insulin delivery control. Some implementations of the PID-IFB control algorithm include PID gain values that are applied to an error term, a time derivative of sensor glucose term, and an integral error term (which is the integral action on historical errors between sensor glucose readings and the controller setpoint, such as 100 mg/dL). Moreover, certain implementations of the PID-IFB control algorithm calculate the IFB using time constants that can be adjusted based on sleep detection or observed/measured sleeping characteristics. In addition, certain implementations of the PID-IFB control algorithm employ a maximum insulin limit (referred to as “Umax”) that governs the insulin dosage output of the control algorithm—Umax can also be adjusted based on sleep detection or observed/measured sleeping characteristics. In this regard, the controller gain values, Umax, and/or time constants can be regulated to make the controller more or less responsive to changes in sensor glucose measurements during sleeping periods. 
     Referring again to  FIG.  5   , in certain implementations, the medical device  102  receives the user status data, processes the user status data to determine whether the user is sleeping, and adjusts the target glucose setpoint value as needed. In some embodiments, at least one ancillary control system  108  receives the user status data, processes the user status data to determine whether the user is sleeping, and remotely controls the medical device  102  (as needed) to cause the adjustment of the target glucose setpoint value. For example, the ancillary control system  108  can generate and send commands, instructions, and/or control signals to the medical device  102 , wherein the commands, instructions, and/or control signals cause the medical device  102  (e.g., the insulin infusion device) to transition from one target glucose setpoint value to another without user input. In such embodiments, the native insulin delivery control scheme of the insulin infusion device can be remotely controlled to respond to the sleeping status of the user. As mentioned above, controllers resident at the different components of the system  100  can be suitably configured and programmed to perform the methods and processes described here, individually or in a distributed or collective manner. 
     The various tasks performed in connection with a process disclosed herein may be performed by software, hardware, firmware, or any combination thereof. It should be appreciated that an embodiment of an illustrated process may include any number of additional or alternative tasks, the tasks shown in the figures need not be performed in the illustrated order, and a disclosed process may be incorporated into a more comprehensive procedure or process having additional functionality not described in detail herein. Moreover, one or more of the tasks shown in a figure could be omitted from an embodiment of the depicted process as long as the intended overall functionality remains intact. 
     While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application.