Systems and methods for monitoring use of a respiratory therapy system by a diabetic patient - Patents.com

Abstract

A method for receiving data related to an individual's diabetes treatment plan, the method further comprising receiving data related to the individual's respiratory therapy plan, the respiratory therapy plan being implementable by a respiratory therapy system during a sleep session, the method further comprising determining a potential interaction between the individual's diabetes treatment plan and the individual's respiratory therapy plan, the method further comprising updating the individual's diabetes treatment plan based on the interaction.

Description

[Technical field]

[0001] The present disclosure relates generally to systems and methods for monitoring a diabetic patient, and more particularly to systems and methods for determining and / or mitigating or optimizing interactions between a diabetic treatment plan and a respiratory therapy plan. [Background technology]

[0002] Many individuals suffer from sleep-related and / or breathing disorders such as obstructive sleep apnea (OSA), central sleep apnea (CSA), other types of apnea such as mixed apnea and hypopnea, and sleep-disordered breathing (SDB), which may include respiratory effort-related arousals (RERA). These individuals may also suffer from other health conditions (which may be referred to as comorbidities) such as insomnia (e.g., difficulty initiating sleep, frequent or prolonged awakenings after initial sleep onset, and / or early awakenings with failure to return to sleep), periodic limb movement disorder (PLMD), restless legs syndrome (RLS), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disorders (NMD), rapid eye movement (REM) behavior disorder (also known as RBD), dream acting out (DEB), hypertension, diabetes, stroke, and chest wall disorders. These individuals are often treated with respiratory therapy systems (e.g., continuous positive airway pressure (CPAP) systems) that deliver pressurized air to help prevent the airway from closing or narrowing during sleep sessions. Diabetic patients who use respiratory therapy systems are often affected, either positively or negatively, by their use of the respiratory therapy system. For example, use of a respiratory therapy system can affect the effectiveness of an individual's diabetes treatment plan. It would therefore be beneficial to be able to monitor diabetic patients who use respiratory therapy systems and adjust their diabetes treatment plan or use of the respiratory therapy system as needed. The present disclosure is directed to solving this problem and others. Summary of the Invention [Means for solving the problem]

[0003] According to some implementations of the present disclosure, a method includes receiving data related to an individual's diabetes treatment plan, receiving data related to the individual's respiratory therapy plan, the respiratory therapy plan being implementable by a respiratory therapy system during a sleep session, determining potential interactions between the individual's diabetes treatment plan and the individual's respiratory therapy plan, and updating the individual's diabetes treatment plan based on the interactions.

[0004] According to some implementations of the present disclosure, a system includes a respiratory therapy system, a memory device, and a control system. The respiratory therapy system includes a respiratory therapy device configured to supply pressurized air and a user interface coupled to the respiratory therapy device via a conduit. The user interface is configured to engage a user and direct the supplied pressurized air to the user's airway. The memory device stores machine-readable instructions. The control system includes one or more processors coupled to the memory device and configured to execute the machine-readable instructions to perform a method. The method includes receiving data related to an individual's diabetes treatment plan, receiving data related to the individual's respiratory therapy plan, the respiratory therapy plan being implementable by a respiratory therapy system during a sleep session, determining potential interactions between the individual's diabetes treatment plan and the individual's respiratory therapy plan, and updating the individual's diabetes treatment plan based on the interactions.

[0005] According to some implementations of the present disclosure, the method includes receiving blood glucose data indicative of one or more blood glucose measurements for the individual; receiving individual sleep data associated with the individual's use of a respiratory therapy system during one or more past sleep sessions; and adjusting the individual's diabetes treatment plan or one or more settings of the respiratory therapy system, or both, based at least in part on the data.

[0006] According to some implementations of the present disclosure, a system includes a respiratory therapy system, a memory device, and a control system. The respiratory therapy system includes a respiratory therapy device that supplies pressurized air and a user interface coupled to the respiratory therapy device via a conduit. The user interface is configured to engage a user and direct the supplied pressurized air to the user's airway. The memory device stores machine-readable instructions. The control system includes one or more processors coupled to the memory device and executes the machine-readable instructions to perform a method. The method includes receiving blood glucose data indicative of one or more blood glucose measurements of the individual, receiving individual sleep data associated with the individual's use of a respiratory therapy system during one or more past sleep sessions, and determining an adjustment to the individual's diabetes treatment plan or one or more settings of the respiratory therapy system, or both, based at least in part on the received data.

[0007] According to some implementations of the present disclosure, the method includes receiving blood glucose data indicative of one or more blood glucose measurements of the individual during a sleep session, receiving sleep data associated with the individual during the sleep session, and causing an action to be performed based at least in part on the received data.

[0008] According to some implementations of the present disclosure, a system includes a respiratory therapy system, a storage device, and a control system. The respiratory therapy system includes a respiratory therapy device that supplies pressurized air and a user interface coupled to the respiratory therapy device via a conduit. The user interface is configured to engage a user and direct the supplied pressurized air to the user's airway. A memory device stores machine-readable instructions. The control system includes one or more processors coupled to the memory device that execute the machine-readable instructions to perform a method. The method includes receiving blood glucose data indicative of one or more blood glucose measurements of an individual during a sleep session, receiving sleep data associated with the individual during the sleep session, and performing an action based at least in part on the received data.

[0009] The above summary is not intended to represent every implementation or every aspect of the present disclosure. Additional features and benefits of the present disclosure will be apparent from the following detailed description and drawings. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is a functional block diagram of a system for monitoring a diabetic user according to some implementations of the present disclosure. [Diagram 2] 2 is a perspective view of at least a portion of the system of FIG. 1, a user of the system, and a bed partner according to some implementations of the present disclosure. [Diagram 3] 1 illustrates an example timeline of a sleep session, according to some implementations of the present disclosure. [Figure 4] 4 illustrates an example hypnogram associated with the sleep session of FIG. 3, in accordance with some implementations of the present disclosure. [Figure 5A] 1 is a graph showing respiratory events and blood glucose levels over time for an individual whose blood glucose levels are controlled. [Figure 5B]FIG. 5B is a graph of respiratory events and blood glucose levels over time in an individual with poorer glycemic control compared to the individual in FIG. 5A. [Figure 6] 1 is a flowchart of a first method for monitoring a diabetic patient according to some implementations of the present disclosure. [Figure 7] 13 is a flowchart of a second method for monitoring a diabetic patient according to some implementations of the present disclosure. [Figure 8] 1 is a flow chart of a third method for monitoring a diabetic patient according to some implementations of the present disclosure. While the present disclosure is susceptible to various modifications and alternative forms, specific implementations and implementations of the present disclosure are shown by way of example in the drawings and are described in detail herein. However, it is not intended to limit the present disclosure to the specific forms disclosed, but rather, it should be understood that the present disclosure covers all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The present disclosure will be described with reference to the accompanying drawings, in which identical or similar components are designated with the same reference numerals in each drawing. The drawings are not drawn to scale and are provided solely to illustrate the present disclosure. Several aspects of the present disclosure are described below with reference to illustrative example applications.

[0012] Many individuals suffer from sleep-related and / or breathing disorders such as Periodic Limb Movement Disorder (PLMD), Restless Legs Syndrome (RLS), Sleep-Disordered Breathing (SDB) such as Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA) and other types of apnea, Respiratory Effort Related Arousals (RERA), Cheyne-Stokes Respiration (CSR), Respiratory Insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disorders (NMD) and Chest Wall Disorders.

[0013] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events such as obstruction or blockage of the upper airway during sleep due to an abnormally small upper airway combined with normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall. Central sleep apnea (CSA) is another form of sleep-disordered breathing. CSA occurs when the brain temporarily stops sending signals to the muscles that control breathing. More generally, apnea refers to the cessation of breathing, typically due to air blockage.

[0014] Other types of apnea include hypopnea, hyperpnea, and hypercapnia. Hypopnea is generally characterized by slow or shallow breathing caused by narrowing of the airway rather than obstruction. Hyperpnea is generally characterized by an increase in the depth and / or rate of breathing. Hypercapnia is generally characterized by a sudden or excessive amount of carbon dioxide in the bloodstream, usually resulting from insufficient breathing.

[0015] Respiratory effort related arousals (RERA) events are generally characterized by an increase in respiratory effort for 10 seconds or more that results in an arousal from sleep, and do not meet the criteria for an apnea or hypopnea event. RERAs are defined as a series of breaths that are characterized by an increase in respiratory effort that results in an arousal from sleep, but do not meet the criteria for an apnea or hypopnea. These events must meet both criteria: (1) a pattern of gradually increasing esophageal negative pressure is terminated by a sudden drop in the negative pressure level and arousal, and (2) the event lasts for 10 seconds or more. In some implementations, a nasal cannula / pressure transducer system is sufficient and reliable for detecting RERA. The RERA detector may be based on an actual flow signal derived from a respiratory therapy device. For example, a flow limitation measure may be determined based on the flow signal. A measure of arousal may then be derived as a function of the flow limitation measure and the measure of ventilation surge. One such method is described in International Patent Publication No. WO 2008 / 138040 and US Patent Publication No. 9,358,353, both issued to ResMed, Inc., the entire disclosures of each of which are incorporated herein by reference.

[0016] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator that results in alternating periods of waxing and waning of ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood.

[0017] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0018] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of diseases of the lower airways that share certain characteristics, such as increased resistance to air movement, a prolonged expiratory phase of breathing, and a loss of normal elasticity of the lungs. COPD encompasses any of a group of diseases of the lower airways that share certain characteristics, such as increased resistance to air movement, a prolonged expiratory phase of breathing, and a loss of normal elasticity of the lungs.

[0019] Neuromuscular disorders (NMDs) encompass a number of diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the rib cage.

[0020] These and other disorders are characterized by specific events that can occur during sleep (e.g., snoring, apnea, hypopnea, restless legs, sleep disturbances, choking, increased heart rate, difficulty breathing, asthma attacks, epileptic episodes, seizures, or any combination thereof).

[0021] Diabetic individuals who also use a respiratory therapy system (e.g., to treat SDB) may experience positive and / or negative interactions. For example, use of the respiratory therapy system may affect the effectiveness of the individual's diabetes treatment plan (which may include a diabetes treatment plan, a diet plan, an exercise plan, etc.). The impact on the effectiveness of the individual's diabetes treatment plan may be positive or negative, making it difficult for these individuals to adhere to their respiratory therapy plan and use the respiratory therapy system and simultaneously adhere to an effective diabetes treatment plan. Thus, it may be advantageous to monitor these individuals and make (and / or determine) various adjustments to their diabetes treatment plan and use of the respiratory therapy system to, e.g., mitigate and optimize the interactions between the diabetes treatment plan and the respiratory therapy plan.

[0022] The apnea-hypopnea index (AHI) is an index used to indicate the severity of sleep apnea during a sleep session. The AHI is calculated by dividing the number of apnea and / or hypopnea events experienced by the user during a sleep session by the total number of sleep minutes during the sleep session. For example, the event may be an apnea lasting at least 10 seconds. An AHI of less than 5 is considered normal. An AHI between 5 and less than 15 is considered to indicate mild sleep apnea. An AHI between 15 and less than 30 is considered to indicate moderate sleep apnea. An AHI of 30 or greater is considered to indicate severe sleep apnea. In children, an AHI greater than 1 is considered abnormal. Sleep apnea can be considered "controlled" when the AHI is normal or when the AHI is normal or mild. The AHI can also be used in combination with oxygen desaturation to indicate the severity of obstructive sleep apnea.

[0023] 1, a system 10 according to some implementations of the present disclosure is shown. The system 10 may include a respiratory therapy system 100, a control system 200, a memory device 204, and one or more sensors 210. The system 10 may additionally or alternatively include a user device 260, an activity tracker 270, and a blood pressure device 280. The system 10 may be used to monitor a diabetic patient using a respiratory therapy system.

[0024] The respiratory therapy system 100 includes a respiratory pressure therapy (RPT) device 110 (herein referred to as respiratory therapy device 110), a user interface 120 (also referred to as a mask or patient interface), a conduit 140 (also referred to as a tube or air circuit), a display device 150, and a humidifier 160. Respiratory pressure therapy refers to the application of air to the entrance of a user's airway at a controlled target pressure that is nominally positive relative to the atmosphere throughout the user's breathing cycle (as opposed to negative pressure therapy such as an iron lung or chest pad, for example). Respiratory therapy system 100 is typically used to treat individuals suffering from one or more sleep-related breathing disorders (e.g., obstructive sleep apnea, central sleep apnea, mixed sleep apnea).

[0025] Respiratory therapy system 100 can be used, for example, as a mechanical ventilator or a positive airway pressure (PAP) system, such as a continuous positive airway pressure (CPAP) system, an automatic positive airway pressure (APAP) system, a bilevel or variable positive airway pressure (BPAP or VPAP) system, or any combination thereof. A CPAP system delivers a predetermined air pressure (e.g., determined by a sleep physician) to a user. An APAP system automatically varies the air pressure delivered to a user, for example, based on respiratory data associated with the user. A BPAP or VPAP system is configured to deliver a first predetermined pressure (e.g., inspiratory positive airway pressure or IPAP) and a second predetermined pressure (e.g., expiratory positive airway pressure or EPAP) that is lower than the first predetermined pressure.

[0026] As shown in FIG. 2, the respiratory therapy system 100 may be used to treat a user 20. In this example, a user 20 and a bed partner 30 of the respiratory therapy system 100 are positioned in a bed 40 and lying on a mattress 42. A user interface 120 may be worn by the user 20 during a sleep session. The respiratory therapy system 100 generally increases air pressure in the throat of the user 20 to help prevent the airway from closing or narrowing during sleep. The respiratory therapy device 110 may be placed on a nightstand 44 directly adjacent to the bed 40 as shown in FIG. 2, or more generally on any surface or structure generally adjacent to the bed 40 and / or user 20.

[0027] Returning to FIG. 1, the respiratory therapy device 110 is typically used to generate pressurized air that is delivered to a user (e.g., using one or more motors driving one or more compressors). In some implementations, the respiratory therapy device 110 generates a continuous constant air pressure that is delivered to the user. In other implementations, the respiratory therapy device 110 generates two or more predetermined pressures (e.g., a first predetermined air pressure and a second predetermined air pressure). In other implementations, the respiratory therapy device 110 is characterized by generating a variety of different air pressures within a predetermined range. For example, the respiratory therapy device 110 can deliver, e.g., at least about 6 cmH2O, at least about 10 cmH2O, at least about 20 cmH2O, between about 6 cmH2O and about 10 cmH2O, between about 7 cmH2O and about 12 cmH2O, etc. The respiratory therapy device 110 can also deliver pressurized air at a predetermined flow rate, e.g., between about -20 L / min and about 150 L / min, while maintaining a positive pressure (relative to ambient pressure).

[0028] The respiratory therapy device 110 includes a housing 112, a blower motor 114, an air inlet 116, and an air outlet 118. The blower motor 114 is at least partially disposed or integrated within the housing 112. The blower motor 114 draws air from outside the housing 112 (e.g., atmosphere) via the air inlet 116 and passes pressurized air to the humidifier 160 and the air outlet 118. In some implementations, the air inlet 116 and / or the air outlet 118 include covers that are movable between a closed position and an open position (e.g., to prevent or block air flow through the air inlet 116 or the air outlet 118). The housing 112 also includes a vent that allows air to pass through the housing 112 to the air inlet 116. As described below, a conduit 140 is coupled to the air outlet 118 of the respiratory therapy device 110.

[0029] The user interface 120 engages a portion of the user's face to deliver pressurized air from the respiratory therapy device 110 to the user's airway to help prevent the airway from narrowing and / or closing during sleep. This may also increase the user's oxygen intake while sleeping. Generally, the user interface 120 engages the user's face to deliver pressurized air to the user's airway through the user's mouth, nose, or both the user's mouth and nose. The respiratory therapy device 110, the user interface 120, and the conduit 140 form an air path fluidly coupled to the user's airway. The pressurized air also increases the user's oxygen intake while sleeping. Depending on the therapy being applied, the user interface 120 may, for example, form a seal with an area or portion of the user's face to facilitate delivery of gas at a pressure sufficiently different from ambient pressure to effect the therapy, for example, a positive pressure of about 10 cmH2O relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the user interface may not include a sufficient seal to facilitate delivery of a gas supply to the airways at approximately 10 cmH2O positive pressure.

[0030] The user interface 120 may include, for example, a cushion 122, a frame 124, a headgear 126, a connector 128, and one or more vents 130. The cushion 122 and the frame 124 define a volume of space around the user's mouth and / or nose. When the respiratory therapy system 100 is in use, this volume of space receives pressurized air (e.g., from the respiratory therapy device 110 via a conduit 140) for passage to the user's airway. The headgear 126 typically serves to position and / or stabilize the user interface 120 on a portion of the user (such as the face) and, together with the cushion 122 (e.g., including silicone, plastic, foam, etc.), serves to provide a substantially airtight seal between the user interface 120 and the user 20. In some implementations, the headgear 126 includes one or more straps (e.g., including hook and loop fasteners). The connector 128 is typically used to couple (e.g., connect and fluidly couple) the conduit 140 to the cushion 122 and / or the frame 124. Alternatively, the conduit 140 may be coupled directly to the cushion 122 and / or frame 124 without the use of the connector 128. The vents 130 may be used to allow escape of carbon dioxide and other gases exhaled by the user 20. The user interface 120 may generally include any suitable number of vents (e.g., 1, 2, 5, 10, etc.).

[0031] 2, in some implementations, user interface 120 is a facial mask (e.g., a full face mask) that covers at least a portion of the nose and mouth of user 20. User interface 120 can optionally be a nasal mask that supplies air to the user's nose, or a nasal pillows mask that delivers air directly to the user's nostrils. In other implementations, user interface 120 includes a mouthpiece (e.g., a night guard mouthpiece molded to fit the user's teeth, a jaw repositioning device, etc.).

[0032] Returning to Figure 1, conduits 140 (also called air circuits or tubing) allow air to flow between components of respiratory therapy system 100, such as between respiratory therapy device 110 and user interface 120. In some implementations, there may be separate branches of the conduit for inhalation and exhalation. In other implementations, a single conduit is used for both inhalation and exhalation.

[0033] A first end is included that is coupled to the air outlet 118 of the respiratory therapy device 110. The first end may be coupled to the air outlet 118 of the respiratory therapy device 110 using various techniques (e.g., a press-fit connection, a snap-fit ​​connection, a threaded connection, etc.). In some implementations, the conduit 140 includes one or more heating elements that heat the pressurized air flowing through the conduit 140 (e.g., heat the air to a predetermined temperature or within a predetermined temperature range). The heating elements may be coupled to and / or embedded in the conduit 140. In such implementations, the first end may include electrical contacts that are electrically coupled to the respiratory therapy device 110 to provide power to the one or more heating elements of the conduit 140. For example, the electrical contacts are electrically coupled to electrical contacts of the air outlet 118 of the respiratory therapy device 110. In this example, the electrical contacts of the conduit 140 could be a male connector and the electrical contacts of the air outlet 118 could be a female connector, or alternatively, the opposite configuration could be used.

[0034] Display device 150 is generally used to display images and / or information, including still images, moving images, or both, related to respiratory therapy device 110. For example, display device 150 can provide information regarding the status of respiratory therapy device 110 (e.g., whether respiratory therapy device 110 is on / off, the pressure of the air being delivered by respiratory therapy device 110, the temperature of the air being delivered by respiratory therapy device 110, etc.) and / or other information (e.g., a sleep score and / or a treatment score (also referred to as a myAir™ score, as described in International Publication No. WO 2016 / 061629 and U.S. Patent Application Publication No. 2017 / 0311879, each of which is incorporated herein by reference in its entirety), the current date / time, personal information of user 20, etc.). In some implementations, display device 150 functions as a human machine interface (HMI) including a graphical user interface (GUI) configured to display images as an input interface. Display device 150 can be an LED display, an OLED display, an LCD display, etc. The input interface may be, for example, a touch screen or touch sensitive board, a mouse, a keyboard, or any sensor system configured to sense input made by a human user interacting with the respiratory therapy device 110.

[0035] The humidifier 160 is coupled or integrated with the respiratory therapy device 110 and includes a reservoir 162 of water capable of humidifying the pressurized air delivered from the respiratory therapy device 110. The humidifier 160 includes one or more heating elements 164 that heat the water in the reservoir to generate water vapor. The humidifier 160 may be fluidly coupled to a water vapor inlet of an air path between the blower motor 114 and the air outlet 118 or may be formed in series with the air path between the blower motor 114 and the air outlet 118. For example, air passes from the air inlet 116 through the blower motor 114, then through the humidifier 160, and out of the respiratory therapy device 110 via the air outlet 118.

[0036] Although respiratory therapy system 100 is described herein as including each of respiratory therapy device 110, user interface 120, conduit 140, display device 150, and humidifier 160, a respiratory therapy system may include more or fewer components according to implementations of the present disclosure. For example, a first alternative respiratory therapy system includes respiratory therapy device 110, user interface 120, and conduit 140. As another example, a second alternative system includes respiratory therapy device 110, user interface 120, and conduit 140, as well as display device 150. Thus, any portion or portions of the components shown and described herein can be used and / or combined with one or more other components to form a variety of respiratory therapy systems.

[0037] The control system 200 includes one or more processors 202 (hereinafter processor 202). The control system 200 is generally used to control (e.g., operate) various components of the system 10 and / or to analyze data acquired and / or generated by the components of the system 10. The processor 202 may be a general-purpose or special-purpose processor or microprocessor. Although one processor 202 is shown in FIG. 1, the control system 200 may include any number of processors (e.g., one processor, two processors, five processors, ten processors, etc.) that may be in a single housing or may be located remotely from one another. The control system 200 (or any other control system) or a portion of the control system 200, such as the processor 202 (or any other processor or portion of any other control system), may be used to perform any one or more steps of the methods described and / or claimed herein. The control system 200 may be coupled to and / or disposed within, for example, a housing of a user device 260, a portion of the respiratory therapy system 100 (e.g., the respiratory therapy device 110), and / or a housing of one or more sensors 210. The control system 200 may be centralized (within one such housing) or distributed (within two or more such housings that are physically separate). In such implementations that include two or more housings that contain the control system 200, the housings may be located proximate to and / or remote from one another.

[0038] The memory device 204 stores machine-readable instructions executable by the processor 202 of the control system 200. The memory device 204 may be any suitable computer-readable storage device or medium, such as, for example, a random or serial access memory device, a hard drive, a solid state drive, a flash memory device, etc. Although one memory device 204 is shown in FIG. 1, the system 10 may include any suitable number of memory devices 204 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). The memory device 204 may be coupled to and / or located within a housing of the respiratory therapy device 110, a housing of the user device 260, a housing of one or more sensors 210, or any combination thereof, of the respiratory therapy system 100. As with the control system 200, the memory device 204 may be centralized (within one such housing) or distributed (within two or more of such physically distinct housings).

[0039] In some implementations, the memory device 204 stores a user profile associated with the user. The user profile may include, for example, demographic information associated with the user, biometric information associated with the user, medical information associated with the user, self-reported user feedback, sleep parameters associated with the user (e.g., sleep-related parameters recorded from one or more past sleep sessions), or any combination thereof. The demographic information may include, for example, information indicative of the user's age, the user's gender, the user's race, the user's geographic location, relationship status, family history of insomnia or sleep apnea, the user's employment status, the user's education status, the user's socio-economic status, or any combination thereof. The medical information may include, for example, information indicative of one or more medical conditions associated with the user, medication usage by the user, or both. The medical information data may further include a Multiple Sleep Latency Test (MSLT) result or score and / or a Pittsburgh Sleep Quality Index (PSQI) score or value. The self-reported user feedback may include information indicative of a self-reported subjective sleep score (poor, fair, good, etc.), the user's self-reported subjective stress level, the user's self-reported subjective fatigue level, the user's self-reported subjective health status, recent life events experienced by the user, or any combination thereof.

[0040] As described herein, the processor 202 and / or memory device 204 can receive data (e.g., physiological data and / or audio data) from one or more sensors 210 and store the data in the memory device 204 or analyze it with the processor 202. The processor 202 and / or memory device 204 can communicate with the one or more sensors 210 using a wired or wireless connection (e.g., using an RF communication protocol, a Wi-Fi communication protocol, a Bluetooth® communication protocol, a cellular network, etc.). In some implementations, the system 10 can include an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof. These components can be coupled to or integrated with a housing of the control system 200 (e.g., the same housing as the processor 202 and / or memory device 204) or the user device 260.

[0041] The one or more sensors 210 may include a pressure sensor 212, a flow sensor 214, a temperature sensor 216, a motion sensor 218, a microphone 220, a speaker 222, a radio frequency (RF) receiver 226, an RF transmitter 228, a camera 232, an infrared (IR) sensor 234, a photoplethysmogram (PPG) sensor 236, an electrocardiogram (ECG) sensor 238, an electroencephalogram (EEG) sensor 240, a capacitance sensor 242, a force sensor 244, a strain gauge sensor 246, an electromyogram (EMG) sensor 248, an oxygen sensor 250, an analyte sensor 252, a humidity sensor 254, a light detection and ranging (LiDAR) sensor 256, or any combination thereof. Generally, each of the one or more sensors 210 is configured to output sensor data received and stored by the memory device 204 or one or more other memory devices.

[0042] Although the one or more sensors 210 are shown and described as including each of a pressure sensor 212, a flow sensor 214, a temperature sensor 216, a motion sensor 218, a microphone 220, a speaker 222, an RF receiver 226, an RF transmitter 228, a camera 232, an IR sensor 234, a PPG sensor 236, an ECG sensor 238, an EEG sensor 240, a capacitance sensor 242, a force sensor 244, a strain gauge sensor 246, an EMG sensor 248, an oxygen sensor 250, an analyte sensor 252, a moisture sensor 254, and a LiDAR sensor 256, more generally, the one or more sensors 210 may include any combination and number of each of the sensors described and / or shown herein.

[0043] As described herein, system 10 may generally be used to generate physiological data associated with a user (e.g., a user of respiratory therapy system 100) during a sleep session. The physiological data may be analyzed to generate one or more sleep-related parameters, which may include any parameter, measurement, or the like, associated with the user during a sleep session. The one or more sleep-related parameters that may be determined for user 20 during a sleep session may include, for example, an apnea-hypopnea index (AHI) score, a sleep score, a flow signal, a respiratory signal, a respiratory rate, an inhalation amplitude, an exhalation amplitude, an inhalation-to-exhalation ratio, a number of events per hour, an event pattern, a stage, a pressure setting of respiratory therapy device 110, a heart rate, a heart rate variability, movement of user 20, a temperature, an EEG activity, an EMG activity, an awakening, a snore, a choking, a cough, a wheezing, a wheezing, or any combination thereof.

[0044] The one or more sensors 210 can be used to generate, for example, physiological data, audio data, or both. The physiological data generated by the one or more sensors 210 can be used by the control system 200 to determine a sleep-wake signal and one or more sleep-related parameters associated with the user during a sleep session. The sleep-wake signal can be indicative of one or more sleep states, including sleep, wakefulness, relaxed wakefulness, micro-arousals, or distinct sleep stages such as a rapid eye movement (REM) stage, a first non-REM stage (often referred to as "N1"), a second non-REM stage (often referred to as "N2"), a third non-REM stage (often referred to as "N3"), or any combination thereof. Methods for determining sleep states and / or sleep stages based on physiological data generated by one or more sensors, such as one or more sensors 210, are described, for example, in International Publication No. WO 2014 / 047310, U.S. Patent Application Publication No. 2014 / 0088373, WO 2017 / 132726, WO 2019 / 122413, WO 2019 / 122414, and U.S. Patent Application Publication No. 2020 / 0383580, each of which is incorporated by reference in its entirety herein.

[0045] In some implementations, the sleep-wake signals described herein may be time-stamped to indicate when the user got into bed, when the user got out of bed, when the user attempted to go to sleep, etc. The sleep-wake signals may be measured by one or more sensors 210 at a predetermined sampling rate, such as, for example, one sample per second, one sample per 30 seconds, one sample per minute, etc., during the sleep session. In some implementations, the sleep-wake signals may also indicate the respiratory signal, respiratory rate, inspiration amplitude, expiration amplitude, inspiration-expiration ratio, number of events per hour, event patterns, pressure settings of the respiratory therapy device 110, or any combination thereof, during the sleep session. The events may include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, mask leak (e.g., from the user interface 120), restless legs, sleep disorder, choking, increased heart rate, labored breathing, asthma attack, epileptic episode, seizure, or any combination thereof. The one or more sleep-related parameters that may be determined for the user during a sleep session based on the sleep-wake signal may include total time in bed, total sleep time, sleep onset latency, wake-after parameter, sleep efficiency, fragmentation index, or any combination thereof. As further detailed herein, the physiological data and / or the sleep-related parameters may be analyzed to determine one or more sleep-related scores.

[0046] The physiological and / or audio data generated by the one or more sensors 210 may also be used to determine a respiratory signal associated with the user during a sleep session. The respiratory signal generally indicates the breathing or breathing of the user during a sleep session. The respiratory signal may be indicative of and / or analyzed (e.g., using the control system 200) to determine one or more sleep-related parameters, such as, for example, respiratory rate, variability in respiratory rate, inhalation amplitude, exhalation amplitude, inhalation-to-exhalation ratio, occurrence of one or more events, number of events per hour, pattern of events, sleep state, sleep stage, apnea-hypopnea index (AHI), pressure setting of the respiratory therapy device 110, or any combination thereof. The one or more events may include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, mask leak (e.g., leak from the user interface 120), coughing, restless legs, sleep disorder, choking, increased heart rate, labored breathing, asthma attack, epileptic episode, seizure, elevated blood pressure, or any combination thereof. While many of the sleep-related parameters described are physiological parameters, some of the sleep-related parameters are considered to be non-physiological parameters. Other types of physiological and / or non-physiological parameters may also be determined based on either data from one or more sensors 210 or other types of data.

[0047] The pressure sensor 212 outputs pressure data that may be stored in the memory device 204 and / or analyzed by the processor 202 of the control system 200. In some implementations, the pressure sensor 212 is an air pressure sensor (e.g., a barometric sensor) that generates sensor data indicative of a user's breathing (e.g., inhalation and / or exhalation) and / or ambient pressure of the respiratory therapy system 100. In such implementations, the pressure sensor 212 may be coupled to or integrated with the respiratory therapy device 110. The pressure sensor 212 may be, for example, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain gauge sensor, an optical sensor, a potential difference sensor, or any combination thereof.

[0048] The flow sensor 214 outputs flow data that can be stored in the memory device 204 and / or analyzed by the processor 202 of the control system 200. Examples of flow sensors (such as, for example, the flow sensor 214) are described in International Publication No. WO 2012 / 012835 and U.S. Patent Application Publication No. 10328219, which are incorporated herein by reference in their entireties. In some implementations, the flow sensor 214 is used to determine the airflow rate from the respiratory therapy device 110, the airflow rate through the conduit 140, the airflow rate through the user interface 120, or any combination thereof. In such implementations, the flow sensor 214 can be coupled to or integrated with the respiratory therapy device 110, the user interface 120, or the conduit 140. The flow sensor 214 can be, for example, a mass flow sensor such as a rotary flow meter (e.g., a Hall effect flow meter), a turbine flow meter, an orifice flow meter, an ultrasonic flow meter, a hot wire sensor, a vortex sensor, a membrane sensor, or any combination thereof. In some implementations, the flow sensor 214 is configured to measure ventilation flow (e.g., intentional "leak"), unintentional leak (e.g., mouth leak and / or mask leak), patient flow (e.g., air entering or leaving the lungs), or any combination thereof. In some implementations, the flow data can be analyzed to determine the user's cardiogenic oscillations. In some examples, the pressure sensor 212 can be used to determine the user's blood pressure.

[0049] The temperature sensor 216 outputs temperature data that may be stored in the memory device 204 and / or analyzed by the processor 202 of the control system 200. In some implementations, the temperature sensor 216 generates temperature data indicative of the core body temperature of the user, the skin temperature of the user 20, the temperature of the air flowing from the respiratory therapy device 110 and / or through the conduit 140, the temperature within the user interface 120, the ambient temperature, or any combination thereof. The temperature sensor 216 may be, for example, a thermocouple sensor, a thermistor sensor, a silicon band gap temperature sensor or semiconductor based sensor, a resistance temperature detector, or any combination thereof.

[0050] The motion sensor 218 outputs motion data that may be stored in the memory device 204 and / or analyzed by the processor 202 of the control system 200. The motion sensor 218 may be used to detect the movement of the user 20 during a sleep session and / or the movement of any of the components of the respiratory therapy system 100, such as the respiratory therapy device 110, the user interface 120 or the conduit 140. The motion sensor 218 may include one or more inertial sensors, such as an accelerometer, a gyroscope and a magnetometer. In some implementations, the motion sensor 218 may alternatively or additionally generate one or more signals representative of the user's body movements and obtain a signal from these signals representative of the user's sleep state, for example via the user's respiratory movements. In some implementations, the motion data from the motion sensor 218 may be used in conjunction with additional data from another sensor 210 to determine the user's sleep state.

[0051] The microphone 220 outputs sound and / or audio data that can be stored in the memory device 204 and / or analyzed by the processor 202 of the control system 200. The sound data generated by the microphone 220 can be played back as one or more sounds (e.g., sounds from the user 20) during a sleep session. As described in more detail herein, the sound data from the microphone 220 can also be used to identify events experienced by the user during a sleep session (e.g., using the control system 200). The microphone 220 can be coupled to or integrated with the respiratory therapy device 110, the user interface 120, the conduit 140, or the user device 260. The microphone 220 can be coupled to or integrated with a wearable device such as a smart watch, smart glasses, earphones, earbuds, or other head wearable device. In some implementations, the system 10 includes multiple microphones (e.g., two or more microphones and / or an array of microphones using beamforming) such that the sound data generated by each of the multiple microphones can be used to identify the sound data generated by other microphones of the multiple microphones.

[0052] The speaker 222 outputs sound waves that are audible to a user of the system 10 (e.g., user 20 of FIG. 2). The speaker 222 can be used, for example, as a wake-up clock or to play alerts or messages to the user 20 (e.g., in response to an event). In some implementations, the speaker 222 can be used to communicate audio data generated by the microphone 220 to the user. The speaker 222 can be coupled or integrated with the respiratory therapy device 110, the user interface 120, the conduit 140, the user device 260, and can be coupled or integrated with a wearable device such as a smart watch, smart glasses, earphones or earbuds, or other head-wearable device.

[0053] The microphone 220 and the speaker 222 can be used as independent devices. In some implementations, the microphone 220 and the speaker 222 can be combined with an acoustic sensor 224 (e.g., a sonar sensor), as described, for example, in International Publication No. WO 2018 / 050913, International Publication No. WO 2020 / 104465, and U.S. Patent Application Publication No. 2022 / 0007965, each of which is incorporated by reference in its entirety herein. In such implementations, the speaker 222 generates or emits sound waves at predetermined intervals, and the microphone 220 detects the reflection of the sound waves emitted from the speaker 222. The sound waves generated or emitted by the speaker 222 have a frequency that is inaudible to the human ear (e.g., below 20 Hz or above about 18 kHz) so as not to disturb the sleep of the user 20 or the bed partner 30. Based at least in part on the data from the microphone 220 and / or the speaker 222, the control system 200 can determine the location of the user 20 and / or one or more of the sleep-related parameters described herein, such as the respiration signal, respiration rate, inhalation amplitude, exhalation amplitude, inhalation-exhalation ratio, number of events per hour, event patterns, sleep states, sleep stages, pressure settings of the respiratory therapy device 110, or any combination thereof. In this context, a sonar sensor may be understood to relate to active acoustic sensing, such as by generating and / or transmitting ultrasonic and / or low frequency ultrasonic sensing signals (e.g., in a frequency range of about 17-23 kHz, 18-22 kHz, or 17-18 kHz) into the air.

[0054] In some implementations, the sensor 210 includes (i) a first microphone that is the same as or similar to the microphone 220 and integrated into the acoustic sensor 224, and (ii) a second microphone that is the same as or similar to the microphone 220 but is independent and separate from the first microphone that is integrated into the acoustic sensor 224.

[0055] The RF transmitter 228 generates and / or emits radio waves having a predetermined frequency and / or a predetermined amplitude (e.g., in a high frequency band, in a low frequency band, long wave signals, short wave signals, etc.). The RF receiver 226 detects reflections of the radio waves emitted from the RF transmitter 228, and this data can be analyzed by the control system 200 to determine the user's location and / or one or more sleep-related parameters described herein. The RF receiver (either the RF receiver 226 and the RF transmitter 228, or another RF pair) can also be used for wireless communication between the control system 200, the respiratory therapy device 110, the one or more sensors 210, the user device 260, or any combination thereof. Although the RF receiver 226 and the RF transmitter 228 are shown in FIG. 1 as separate and distinct elements, in some implementations the RF receiver 226 and the RF transmitter 228 are combined as part of the RF sensor 230 (e.g., a RADAR sensor). In some such implementations, the RF sensor 230 includes control circuitry. The format of the RF communication may be Wi-Fi, Bluetooth (registered trademark), etc.

[0056] In some implementations, the RF sensor 230 is part of a mesh system. An example of a mesh system is a Wi-Fi mesh system, which may include mesh nodes, mesh routers, and mesh gateways, each of which may be mobile / movable or fixed. In such implementations, the Wi-Fi mesh system includes a Wi-Fi router and / or a Wi-Fi controller, and one or more satellites (e.g., access points), each of which includes an RF sensor the same as or similar to the RF sensor 230. The Wi-Fi router and satellite continuously communicate with each other using Wi-Fi signals. The Wi-Fi mesh system can be used to generate motion data based on changes in the Wi-Fi signal between the router and the satellite (e.g., differences in received signal strength) due to the movement of an object or person partially obstructing the signal. This motion data can indicate movement, breathing, heart rate, walking, falls, behavior, etc., or any combination thereof.

[0057] The camera 232 outputs image data reproducible as one or more images (e.g., still images, video, thermal images, or any combination thereof) that may be stored in the memory device 204. The control system 200 can use the image data from the camera 232 to determine one or more of the sleep-related parameters described herein, such as, for example, one or more events (e.g., periodic limb movement or restless legs syndrome), a respiratory signal, a respiratory rate, an inhalation amplitude, an exhalation amplitude, an inhalation-exhalation ratio, a number of events per hour, an event pattern, a sleep state, a sleep stage, or any combination thereof. Additionally, the image data from the camera 232 can be used to, for example, locate the user, determine the movement of the user's chest, determine the airflow of the user's mouth and / or nose, determine the time the user got into bed, or determine the time the user got out of bed. In some implementations, the camera 232 includes a wide-angle lens or a fisheye lens.

[0058] The IR sensor 234 outputs infrared image data that can be played back as one or more infrared images (e.g., still images, moving images, or both) that can be stored in the memory device 204. The infrared data from the IR sensor 234 can be used to determine one or more sleep-related parameters during a sleep session, including the temperature of the user 20 and / or the movement of the user 20. The IR sensor 234 can also be used in combination with the camera 232 in measuring the presence, location and / or movement of the user 20. For example, the IR sensor 234 can detect infrared light having a wavelength between about 700 nm and about 1 mm, while the camera 232 can detect visible light having a wavelength between about 380 nm and about 740 nm.

[0059] The PPG sensor 236 outputs physiological data associated with the user 20 that can be used to determine one or more sleep-related parameters, such as heart rate, heart rate variability, cardiac cycle, respiration rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, estimated blood pressure parameters, or any combination thereof. The PPG sensor 236 is worn by the user 20, may be embedded in clothing and / or fabric worn by the user 20, embedded in and / or coupled to the user interface 120 and / or its associated headgear (e.g., straps, etc.).

[0060] The ECG sensor 238 outputs physiological data related to the electrical activity of the heart of the user 20. In some implementations, the ECG sensor 238 includes one or more electrodes positioned on or around a portion of the user 20 during a sleep session. The physiological data from the ECG sensor 238 can be used to determine, for example, one or more sleep-related parameters described herein.

[0061] The EEG sensor 240 outputs physiological data related to electrical activity of the brain of the user 20. In some implementations, the EEG sensor 240 includes one or more electrodes placed on or around the scalp of the user 20 during a sleep session. The physiological data from the EEG sensor 240 may be used, for example, to determine the sleep state and / or sleep stage of the user 20 at any time during the sleep session. The EEG sensor 240 may be integrated into the user interface 120, associated headgear (e.g., a strap), a headband, or other head-worn sensor device, or the like.

[0062] The capacitance sensor 242, the force sensor 244, and the strain gauge sensor 246 output data that can be stored in the memory device 204 and used / analyzed by the control system 200 to determine, for example, one or more of the sleep-related parameters described herein. The EMG sensor 248 outputs physiological data related to electrical activity produced by one or more muscles. The oxygen sensor 250 outputs oxygen data indicative of the oxygen concentration of a gas (e.g., in the conduit 140 or at the user interface 120). The oxygen sensor 250 can be, for example, an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, a pulse oximeter (e.g., an SpO2 sensor), or any combination thereof.

[0063] The analyte sensor 252 can be used to detect the presence of an analyte in the breath of the user 20. Data output by the analyte sensor 252 can be stored in the memory device 204 and used by the control system 200 to determine the identity and concentration of any analytes in the breath of the user 210. In some implementations, the analyte sensor 252 is placed near the user's mouth to detect the analyte in the breath of the user's mouth. For example, if the user interface 120 is a face mask that covers the user's nose and mouth, the analyte sensor 252 can be placed in the face mask to monitor the user's mouth breathing. In other implementations, if the user interface 120 is a nasal mask or nasal pillows mask, the analyte sensor 252 can be placed near the user's nose to detect the analyte in the breath of the user's nose. In yet other implementations, if the user interface 120 is a nasal mask or nasal pillows mask, the analyte sensor 252 can be placed near the user's mouth. The analyte sensor 252 can be used to detect if air is accidentally leaking from the user's mouth and / or the user interface 120. In some implementations, the analyte sensor 252 is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds. In some implementations, the analyte sensor 252 can also be used to detect whether a user is breathing through their nose or mouth. For example, if the presence of an analyte is detected by data output by the analyte sensor 252 located near the user's mouth or in a facemask (in implementations where the user interface 120 is a facemask), the control system 200 can use this data as an indication that the user is breathing through their mouth.

[0064] The humidity sensor 254 outputs data that may be stored in the memory device 204 and used by the control system 200. The moisture sensor 254 may be used to detect moisture in various areas surrounding the user (e.g., inside the conduit 140 or the user interface 120, near the user's face, near the connection between the conduit 140 and the user interface 120, near the connection between the conduit 140 and the respiratory therapy device 110, etc.). Thus, in some implementations, the moisture sensor 254 may be coupled or integrated with the user interface 120 or integrated with the conduit 140 to monitor the humidity of the pressurized air from the respiratory therapy device 110. In other implementations, the humidity sensor 254 is located near any area where the humidity level needs to be monitored. The humidity sensor 254 may also be used to monitor the humidity of the air in the environment surrounding the user 10, for example, in a bedroom.

[0065] The LiDAR sensor 256 can be used for depth sensing. Such optical sensors (e.g., laser sensors) can be used to detect objects and create a three-dimensional (3D) map of the surrounding environment, such as a living space. LiDARs can generally utilize a pulsed laser to measure time of flight. LiDARs are also referred to as 3D laser scanning. In one use case of such sensors, a fixed or mobile device (such as a smartphone) with a LiDAR sensor 178 can measure and map an area more than 5 meters away from the sensor. LiDAR data can be fused with point cloud data estimated, for example, by an electromagnetic RADAR sensor. The LiDAR sensor(s) 256 can also automatically create a geofence for a RADAR system by using artificial intelligence (AI) to detect and classify features in a space that may pose a problem for the RADAR system, such as glass windows (which may be highly reflective to the RADAR). LiDAR can also be used to estimate, for example, a person's height, as well as changes in height, such as when a person sits down or falls down. LiDAR can be used to create a 3D mesh representation of the environment. In a further application, for solid surfaces through which radio waves pass (e.g., radio-transparent materials), LiDAR allows classification of different types of obstacles due to reflections from such surfaces.

[0066] In some implementations, the one or more sensors 210 include a galvanic skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a blood pressure sensor, an oximetry sensor, a sonar sensor, a RADAR sensor, a blood glucose sensor, a color sensor, a pH sensor, an air quality sensor, a tilt sensor, a rain sensor, a soil moisture sensor, a water flow sensor, an alcohol sensor, or any combination thereof.

[0067] 1, any combination of one or more sensors 210 may be integrated and / or coupled to any one or more of the components of system 10, including respiratory therapy device 110, user interface 120, conduit 140, humidification tank 160, control system 200, user device 260, activity tracker 270, or any combination thereof. For example, microphone 220 and speaker 222 are integrated and / or coupled to user device 260, and pressure sensor 212 and / or flow sensor 214 are integrated and / or coupled to respiratory therapy device 110. In some implementations, at least one of one or more sensors 210 is not coupled to respiratory therapy device 110, control system 200, or user device 260, but is positioned generally adjacent to user 20 during a sleep session (e.g., positioned on or in contact with a portion of user 20, worn by user 20, coupled to or positioned on a nightstand, coupled to a mattress, coupled to a ceiling, etc.).

[0068] One or more of the respiratory therapy device 110, the user interface 120, the conduit 140, the display device 150, and the humidifier 160 may include one or more sensors (e.g., a pressure sensor, a flow sensor, or more generally, any of the other sensors 210 described herein). These one or more sensors may be used, for example, to measure the air pressure and / or flow rate of the pressurized air supplied by the respiratory therapy device 110.

[0069] Data from one or more sensors 210 may be analyzed (e.g., by the control system 200) to determine one or more sleep-related parameters, which may include a respiratory signal, a respiratory rate, a respiratory pattern, an inhalation amplitude, an exhalation amplitude, an inhalation-exhalation ratio, an occurrence of one or more events, a number of events per hour, an event pattern, a sleep state, an apnea-hypopnea index (AHI), or any combination thereof. The one or more events may include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, mask leak, coughing, restless legs, sleep disorder, choking, increased heart rate, labored breathing, asthma attack, epileptic episode, seizure, elevated blood pressure, or any combination thereof. Many of these sleep-related parameters are physiological parameters, but some of the sleep-related parameters are considered non-physiological parameters. Other types of physiological and non-physiological parameters may also be determined based on either the data from one or more sensors 210 or other types of data.

[0070] The user device 260 includes a display device 262. The user device 260 may be, for example, a mobile device such as a smartphone, a tablet, a game console, a smart watch, a laptop, etc. The user device 260 may also be an external sensing system, a television (e.g., a smart television), or other smart home devices (e.g., Google Home (商標) , Google Nest (商標) AmazonEcho TM , Amazon Echo Show (商標) , Alexa (商標)The user device 260 may be a smart speaker, a wearable device, or a smart speaker-enabled device. In some implementations, the user device is a wearable device (e.g., a smart watch). The display device 262 is generally used to display images, including still images, moving images, or both. In some implementations, the display device 262 serves as a human machine interface (HMI) including a graphic user interface (GUI) configured to display the image(s) and an input interface. The display device 262 may be an LED display, an OLED display, an LCD display, or the like. The input interface may be, for example, a touch screen or a touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the user device 260. In some implementations, one or more user devices can be used by and / or included in the system 100.

[0071] In some implementations, the system 10 also includes an activity tracker 270. The activity tracker 270 is generally used to assist in generating physiological data related to the user. The activity tracker 270 may include one or more of the sensors 210 described herein, such as, for example, a motion sensor 218 (e.g., one or more accelerometers and / or gyroscopes), a PPG sensor 236, and / or an ECG sensor 238. Physiological data from the activity tracker 270 can be used to determine, for example, the number of steps, the distance traveled, the number of steps climbed, the duration of physical activity, the type of physical activity, the intensity of physical activity, the time spent standing, the respiration rate, the average respiration rate, the resting respiration rate, the maximum respiration rate, the respiration rate variability, the heart rate, the average heart rate, the resting heart rate, the maximum heart rate, the heart rate variability, the number of calories burned, the blood oxygen saturation, the electrodermal activity (also referred to as skin conductance or galvanic skin response), or any combination thereof. In some implementations, the activity tracker 270 is coupled (eg, electronically or physically) to the user device 260.

[0072] In some implementations, the activity tracker 270 is a wearable device that can be worn by a user, such as a smart watch, wristband, ring, or patch. For example, referring to FIG. 2, the activity tracker 270 is worn on the arm of the user 20. The activity tracker 270 can also be coupled to or integrated with clothing or apparel worn by the user. Further alternatively, the activity tracker 270 can be coupled to or integrated (e.g., within the same housing) with the user device 260. More generally, the activity tracker 270 can be communicatively coupled to or physically integrated (e.g., disposed within a housing) with the control system 200, the memory device 204, the respiratory therapy system 100, and / or the user device 260.

[0073] In some implementations, the system 10 also includes a blood pressure device 280, which is generally used to assist in generating cardiovascular data for determining one or more blood pressure measurements associated with the user 20. The blood pressure device 280 may include at least one of the one or more sensors 210, for measuring, for example, a systolic blood pressure component and / or a diastolic blood pressure component.

[0074] In some implementations, the blood pressure device 280 is a blood pressure monitor that includes an inflatable cuff that can be worn by the user 20 and a pressure sensor (e.g., pressure sensor 212 described herein). For example, in the example of FIG. 2, the blood pressure device 280 can be worn on the upper arm of the user 20. In such implementations in which the blood pressure device 280 is a blood pressure monitor, the blood pressure device 280 also includes a pump (e.g., a manually operated valve) that inflates the cuff. In some implementations, the blood pressure device 280 is coupled to the respiratory therapy device 110 of the respiratory therapy system 100, which in turn delivers pressurized air to inflate the cuff. More generally, the blood pressure device 280 can be communicatively coupled to and / or physically integrated (e.g., within a housing) with the control system 200, the memory device 204, the respiratory therapy system 100, the user device 260, and / or the activity tracker 270.

[0075] In another implementation, the blood pressure device 280 is a portable blood pressure monitor communicatively coupled to the respiratory therapy system 100. The portable blood pressure monitor includes a portable recording device attached to a belt or strap worn by the user 20 and an inflated cuff attached to the portable recording device and wrapped around the arm of the user 20. The portable blood pressure monitor is configured to measure blood pressure about every 15 to about 30 minutes over a 24 or 48 hour period. The portable blood pressure monitor may simultaneously measure the heart rate of the user 20. These multiple measurements are averaged over the 24 hour period. The portable blood pressure monitor determines changes in the measured blood pressure and heart rate of the user 20, as well as distribution and / or trend patterns of the blood pressure and heart rate data during sleep and wake periods of the user 20. The measured data and statistics may then be communicated to the respiratory therapy system 100.

[0076] The blood pressure device 280 may be located external to the respiratory therapy system 100, directly or indirectly coupled to the user interface 120, directly or indirectly coupled to the headgear 126 (if present in the version of the user interface 120 being used), or inflatably coupled to or about a portion of the user 20. The blood pressure device 280 is typically used to assist in generating physiological data for determining one or more blood pressure measurements associated with the user (such as systolic and / or diastolic blood pressure components). In some implementations, the blood pressure device 280 is a blood pressure meter that includes an inflatable cuff that can be worn by the user and a pressure sensor (e.g., pressure sensor 212 described herein).

[0077] In some implementations, the blood pressure device 280 is an invasive device that can continuously monitor the arterial blood pressure of the user 20 and take arterial blood samples as needed to analyze arterial blood gases. In some other implementations, the blood pressure device 280 is a continuous blood pressure monitor that uses a radio frequency sensor and can measure the blood pressure of the user 20 every few seconds (e.g., every 3 seconds, every 5 seconds, every 7 seconds, etc.). The radio frequency sensor may use continuous wave, frequency modulated continuous wave (FMCW using ramp chirp, triangular wave, sine wave), other schemes such as phase shift keying (PSK), frequency shift keying (FSK), pulsed continuous wave, and / or spreading in the ultra-wideband range (which may include spreading, pseudorandom noise (PRN) code, or impulse systems).

[0078] 1 as separate and distinct components of system 10, in some implementations control system 200 and / or memory device 204 are integrated into user device 260 and / or respiratory therapy device 110. Alternatively, in some implementations control system 200, or portions thereof (e.g., processor 202), may be located in the cloud (e.g., integrated into a server, integrated into an Internet of Things (IoT) device, connected to the cloud, subject to edge cloud processing, etc.), located on one or more servers (e.g., remote servers, local servers, etc., or any combination thereof).

[0079] Although system 10 is shown to include all of the components described above, systems according to implementations of the present disclosure may include more or fewer components. For example, a first alternative system includes control system 200, memory device 204, and at least one of one or more sensors 210, but does not include respiratory therapy system 100. As another example, a second alternative system includes control system 200, memory device 204, at least one of one or more sensors 210, and user device 260. As yet another example, a third alternative system includes control system 200, memory device 204, respiratory therapy system 100, at least one of one or more sensors 210, and user device 260. Thus, any portion of the components shown and described herein may be used and / or combined with one or more other components to form a variety of systems.

[0080] Now, referring to FIG. 3, as used herein, a sleep session can be defined in a number of ways. For example, a sleep session can be defined by an initial start time and an end time. In some implementations, a sleep session is the duration during which a user is asleep, i.e., a sleep session has a start time and an end time, and the user does not wake up during the sleep session until the end time. That is, the time during which the user is awake is not included in the sleep session. From this first definition of a sleep session, if a user wakes up and falls asleep multiple times in one night, each sleep period separated by those awake periods will be a sleep session.

[0081] Alternatively, in some implementations, a sleep session has a start time and an end time, and during a sleep session, the user may wake up without the sleep session ending as long as the continuous duration the user is awake is below the wake duration threshold. The wake duration threshold may be defined as a percentage of the sleep session. The wake duration threshold may be, for example, about 20 percent of the sleep session, about 15 percent of the sleep session duration, about 10 percent of the sleep session duration, about 5 percent of the sleep session duration, about 2 percent of the sleep session duration, etc., or any other threshold percentage. In some implementations, the wake duration threshold is defined as a certain amount of time, such as, for example, about 1 hour, about 30 minutes, about 15 minutes, about 10 minutes, about 5 minutes, about 2 minutes, or any other amount of time.

[0082] In some implementations, a sleep session is defined as the total time from when the user first goes to bed at night to when the user last gets out of bed the next morning. In other words, a sleep session can be defined as the time that begins at a first time (e.g., 10:00 PM) on a first date (e.g., Monday, January 6, 2020) that may refer to the current night when the user first goes to bed with the intention to sleep (e.g., not when the user first intends to watch TV or play with their smartphone before going to sleep) and ends at a second time (e.g., 7:00 AM) on a second date (e.g., Tuesday, January 7, 2020) that may refer to the next morning when the user first wakes up with the intention not to sleep again the next morning.

[0083] In some implementations, a user may manually define the start of a sleep session and / or manually end a sleep session. For example, a user may select (e.g., by clicking or tapping) one or more user-selectable elements displayed on the display device 262 of the user device 260 (FIG. 1) to manually start or end a sleep session.

[0084] Generally, a sleep session includes any time after the user 210 lies or sits on the bed 230 (or another area or object on which they intend to sleep), turns on the respiratory therapy device 110, and wears the user interface 120. Thus, a sleep session may include periods of time such as (i) when the user is using the respiratory therapy system 100 but before the user attempts to sleep (e.g., when the user is lying in bed reading a book), (ii) when the user begins to attempt to sleep but is still awake, (iii) when the user is in light sleep (also known as stages 1 and 2 of non-rapid eye movement (NREM) sleep), (iv) when the user is in deep sleep (also known as slow wave sleep, SWS, or stage 3 of NREM sleep), (v) when the user is in rapid eye movement (REM) sleep, (vi) when the user periodically awakens between light sleep, deep sleep, or REM sleep, or (vii) when the user awakens and does not fall asleep again. A sleep session may also be referred to as a therapy session or may include a treatment session, which may be understood to be a period within a sleep session during which an individual is receiving respiratory therapy (e.g., use of a respiratory therapy system).

[0085] A sleep session is typically defined to end when the user removes the user interface 120, turns off the respiratory therapy device 110, and gets out of bed. In some implementations, a sleep session can include additional time periods or be limited to only some of the time periods disclosed above. For example, a sleep session can be defined to encompass the period from when the respiratory therapy device 110 begins to deliver pressurized air to the airway or user to when the respiratory therapy device 110 no longer delivers pressurized air to the user's airway, including any or all of the time during which the user is asleep or awake.

[0086] FIG. 3 illustrates an example timeline 300 of a sleep session. The timeline 300 begins with the time of going to bed (t 就床 ), sleep onset time (t 入眠 ), initial sleep time (t睡眠 ), the first micro-awakening MA1, the second micro-awakening MA2, awakening A, and the awakening time (t 覚醒 ) and wake-up time (t 起床 ).

[0087] bedtime t 就床 is associated with the time when the user first goes to bed (e.g., bed 40 in FIG. 2) prior to falling asleep (e.g., when the user lies or sits in bed). 就床 can be determined based at least in part on a bed threshold duration to distinguish between a time when the user gets into bed to sleep and a time when the user gets into bed for other reasons (e.g., to watch television). For example, the bed threshold duration can be at least about 10 minutes, at least about 20 minutes, at least about 30 minutes, at least about 45 minutes, at least about 1 hour, at least about 2 hours, etc. As used herein, the bed time t is referred to with reference to a bed. 就床 More generally, the time of going to bed t 就床 may refer to the time when a user first goes to sleep in any position (e.g., couch, chair, sleeping bag, etc.).

[0088] Sleep onset time (t 入眠 ) is the time when the user goes to bed (t 就床 ) and the first sleep attempt. For example, after getting into bed, a user may engage in one or more activities (e.g., reading, watching television, listening to music, using the user device 260, etc.) to relax before attempting to sleep. The initial sleep time (t 睡眠 ) is the time when the user first falls asleep. For example, the initial sleep time (t 睡眠 ) may be the time when the user first enters the first non-REM sleep stage.

[0089] Awakening time t 覚醒is a time associated with the time at which the user awakens without returning to sleep (e.g., as opposed to the user waking up in the middle of the night and returning to sleep). The user may experience one of multiple unconscious micro-awakenings (e.g., micro-awakenings MA1 and MA2) having short durations (e.g., 5 seconds, 10 seconds, 30 seconds, 1 minute, etc.) after initial sleep onset. Awakening time t 覚醒 In contrast, the user goes back to sleep after each of the micro-awakenings MA1 and MA2. Similarly, the user may have one or more conscious arousals (e.g., Awakening A) (e.g., waking up to go to the bathroom, caring for a child or pet, sleepwalking, etc.) after initially falling asleep. However, the user goes back to sleep after Awakening A. Thus, the awakening time t 覚醒 may be defined, for example, based at least in part on an awakening threshold duration (e.g., the user is awakened for 15 minutes or more, 20 minutes or more, 30 minutes or more, 1 hour or more, etc.).

[0090] Similarly, the wake-up time t 起床 is associated with the time when the user leaves the bed for the purpose of ending a sleep session (as opposed to, for example, the user getting up during the night to go to the bathroom, caring for a child or pet, sleepwalking, etc.). In other words, the wake-up time t 起床 is the time when the user last left the bed without returning to the bed until the next sleep session (e.g., the next night). Therefore, the wake-up time t 起床 may be defined, for example, based at least in part on a wake threshold duration (e.g., the time the user leaves bed for 15 minutes or more, 20 minutes or more, 30 minutes or more, 1 hour or more, etc.). 就床 may also be defined at least in part based on a wake threshold duration (eg, the user has left bed for 4 hours or more, 6 hours or more, 8 hours or more, 12 hours or more, etc.).

[0091] As mentioned above, the user first 就床 From the last t 起床During the night, the patient may wake up and get out of bed one or more times. In some implementations, the last awakening time t 覚醒 and / or last wake-up time t 起床 is identified or determined based at least in part on a predetermined threshold duration of time following an event (e.g., falling asleep or leaving bed). Such threshold duration may be customized for the user. For a typical user who goes to bed at night and then wakes and gets out of bed in the morning, any period (user wakefulness (t)) between about 12 and about 18 hours may be used. 覚醒 ) or getting out of bed (t 離床 ) and user bedtime (t 起床 ), falling asleep (t 入寝 ) or sleep (t 睡眠 ) may be used. For users who spend a lot of time in bed, a shorter threshold period (e.g., between about 8 hours and about 14 hours) may be used. The threshold period may be initially selected and / or later adjusted based at least in part on the system monitoring the user's sleep behavior.

[0092] Total time in bed (TIB) is the time from the time you get into bed to the time you sleep. 就床 From wake-up time t 起床 t . Total sleep time (TST) is the duration from the initial sleep time to the wake time, excluding conscious or unconscious wakefulness and / or microarousals in between. Typically, the total sleep time (TST) will be shorter (e.g., 1 minute shorter, 10 minutes shorter, 1 hour shorter, etc.) than the total time in bed (TIB). For example, as shown in timeline 300, the total sleep time (TST) is the duration from the initial sleep time t 睡眠 and wake time t 覚醒 , but excluding the periods of the first micro-awakening MA1, the second micro-awakening MA2, and arousal a. In this example, as shown, the total time asleep (TST) is less than the total time in bed (TIB).

[0093] In some implementations, total sleep time (TST) may be defined as total continuous sleep time (PTST). In such implementations, total continuous sleep time excludes a predetermined initial portion or period of the first non-REM stage (e.g., light sleep stage). For example, the predetermined initial portion may be about 30 seconds to about 20 minutes, about 1 minute to about 10 minutes, about 3 minutes to about 5 minutes, etc. Total continuous sleep time is a measure of continuous sleep and smoothes the sleep-wake hypnogram. For example, when a user first falls asleep, the user may enter the first non-REM stage for a very short time (e.g., about 30 seconds), then return to the wake stage for a short time (e.g., 1 minute), before returning to the first non-REM stage. In this example, total continuous sleep time excludes the first instance of the first non-REM stage (e.g., about 30 seconds).

[0094] In some implementations, a sleep session is started by bedtime (t 就床 ) and the time of getting out of bed (t 離床 ), i.e., total time in bed (TIB). In some implementations, a sleep session is defined as a time period beginning with an initial sleep time (t 睡眠 ) and wake-up time (t 覚醒 ) In some implementations, a sleep session is defined as a total sleep time (TST). In some implementations, a sleep session is defined as a sleep session beginning at a sleep onset time (t 入眠 ) and wake-up time (t 覚醒 ) In some implementations, a sleep session is defined as ending at a sleep onset time (t 入眠 ) and the time of getting out of bed (t 離床 ) In some implementations, a sleep session is defined as ending at bedtime (t 就床 ) and wake-up time (t 覚醒 ) In some implementations, a sleep session is defined as ending at an initial sleep time (t 睡眠 ) and the time of getting out of bed (t 離床 ) is defined as ending in

[0095] 4, an example hypnogram 400 corresponding to the timeline 300 (FIG. 3) is shown according to some implementations. As shown, the hypnogram 400 includes a sleep-wake signal 401, a wake stage axis 410, a REM stage axis 420, a light sleep stage axis 430, and a deep sleep stage axis 440. The intersection of the sleep / wake signal 401 with one of the axes 410-440 indicates the sleep stage at any given time during a sleep session.

[0096] The sleep / wake signal 401 may be generated based at least in part on physiological data associated with the user (e.g., generated by one or more of the sensors 210 described herein). The sleep-wake signal may indicate one or more sleep stages including wakefulness, relaxed wakefulness, micro-arousal, REM stage, first non-REM stage, second non-REM stage, third non-REM stage, or any combination thereof. In some implementations, one or more of the first non-REM stage, the second non-REM stage, and the third non-REM stage may be grouped and classified as a light sleep stage or a deep sleep stage. For example, the light sleep stage may include the first non-REM stage, and the deep sleep stage may include the second non-REM stage and the third non-REM stage. Although the hypnogram 400 in FIG. 4 includes a light sleep stage axis 430 and a deep sleep stage axis 440, in some implementations, the hypnogram 400 may include an axis for each of the first non-REM stage, the second non-REM stage, and the third non-REM stage. In other implementations, the sleep-wake signal may indicate a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration / expiration amplitude ratio, an inspiration / expiration duration ratio, a number of events per hour, a pattern of events, or any combination thereof. Information describing the sleep-wake signal may be stored in the memory device 204.

[0097] The sleep history 400 can be used to determine one or more sleep-related parameters, such as, for example, sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE), sleep fragmentation index, sleep blocks, or any combination thereof.

[0098] Sleep onset latency (SOL) is the time when sleep begins (t 入眠 ) and initial sleep time (t 睡眠 ) in the sleep onset latency. In other words, sleep onset latency indicates the time it takes from the user's first attempt to fall asleep to actually falling asleep. In some implementations, sleep onset latency is defined as persistent sleep onset latency (PSOL). The persistent sleep onset latency differs from sleep onset latency in that it is defined as the duration from the time of sleep onset to a predetermined amount of persistent sleep. In some implementations, the predetermined amount of persistent sleep may include, for example, at least 10 minutes of sleep in the second non-REM stage, the third non-REM stage, and / or the REM stage, and 2 minutes or less of awake REM stage, the first non-REM stage, and / or movement therebetween. In other words, persistent sleep onset latency requires, for example, a maximum of 8 minutes of persistent sleep in the second non-REM stage, the third non-REM stage, and / or the REM stage. In other implementations, the predetermined amount of continuous sleep can include at least 10 minutes of sleep in the first non-REM stage, the second non-REM stage, the third non-REM stage, and / or the REM stage following the initial sleep time. In such implementations, the predetermined amount of continuous sleep can exclude any microarousals (e.g., after a 10-second microarousal, the 10 minutes are not resumed).

[0099] A wake-on-sleep onset (WASO) is associated with the total duration that the user is awake between the initial sleep time and the wake-up time. Thus, the wake-onset after sleep includes episodic and micro-awakenings during a sleep session, whether conscious or unconscious (e.g., micro-awakenings MA1 and MA2 shown in FIG. 4). In some implementations, a wake-on-sleep onset (WASO) is defined as a persistent wake-on-sleep onset (PWASO), which includes only total durations of awakenings having a predetermined length (e.g., 10 seconds or more, 30 seconds or more, 60 seconds or more, about 5 minutes or more, about 10 minutes or more, etc.).

[0100] The sleep efficiency (SE) is determined as a ratio between the total time in bed (TIB) and the total sleep time (TST). For example, if the total time in bed is 8 hours and the total sleep time is 7.5 hours, the sleep efficiency of the sleep session is 93.75%. The sleep efficiency indicates the sleep hygiene of the user. For example, if the user goes to bed and spends time on other activities (e.g., watching TV) before going to sleep, the sleep efficiency is reduced (e.g., the user is penalized). In some implementations, the sleep efficiency (SE) can be calculated based at least in part on the total time in bed (TIB) and the total time the user attempts to fall asleep. In such implementations, the total time the user attempts to fall asleep is defined as the duration from the time of sleep onset (GTS) to the time of wake-up as described herein. For example, in an implementation where the total sleep time is 8 hours (e.g., from 11:00 pm to 7:00 am), the time of sleep onset is 10:45 pm, and the time of wake-up is 7:15 am, the sleep efficiency parameter is calculated as approximately 94%.

[0101] The fragmentation index is determined based at least in part on the number of awakenings during the sleep session. For example, if a user has two microawakenings (e.g., microawakenings MA1 and MA2 shown in FIG. 4), the fragmentation index may be expressed as 2. In some implementations, the fragmentation index scales between a predetermined range of integers (e.g., 0 to 10).

[0102] A sleep block is associated with a transition between any sleep stage (e.g., a first non-REM stage, a second non-REM stage, a third non-REM stage, and / or REM) and a wake stage. For example, a sleep block can be calculated with a resolution of 30 seconds.

[0103] In some implementations, the systems and methods described herein generate or analyze a hypnogram including a sleep-wake signal to determine bedtime (t 就床 ), sleep onset time (t 入眠 ), initial sleep time (t 睡眠 ), one or more first microawakenings (e.g., MA1 and MA2), and the awakening time (t 覚醒 ), bed leaving time (t 離床), or any combination thereof, based at least in part on a hypnogram sleep-wake signal.

[0104] In other implementations, one or more of the sensors 210 are used to measure time to bed (t 就床 ), sleep onset time (t 入眠 ), initial sleep time (t sleep ), one or more first microawakenings (e.g., MA1 and MA2), and the awakening time (t 覚醒 ), wake-up time (t 起床 ), or any combination thereof. For example, a sleep session can be defined by determining or identifying a time at which the user goes to bed, t 就床 may be determined based at least in part on data generated by, for example, the motion sensor 218, the microphone 220, the camera 232, or any combination thereof. For example, the time of sleep onset may be determined based at least in part on data from the motion sensor 218 (e.g., data indicating that the user is not moving), data from the camera 232 (e.g., data indicating that the user is not moving and / or data indicating that the user has turned off the lights), data from the microphone 220 (e.g., data indicating that the user has turned off the television), data from the user device 260 (e.g., data indicating that the user is no longer using the user device 260), data from the pressure sensor 212 and / or the flow sensor 214 (e.g., data indicating that the user has turned on the respiratory therapy device 110, data indicating that the user has put on the user interface 120, etc.), or any combination thereof.

[0105] 5A and 5B, individuals who have diabetes and also suffer from SDB (e.g., OSA or CSA) often must address interactions between the two conditions. For example, sleep quality can impact an individual's insulin sensitivity. Negative effects on sleep quality from SDB (e.g., short sleep duration, short time spent in desirable sleep stages during sleep duration, and / or long time spent in undesirable sleep stages during sleep duration, too much low quality sleep, etc.) can negatively impact the effectiveness of a diabetes treatment plan (effectiveness of diabetes, medication, diet, exercise, etc.) that an individual adheres to. Similarly, positive effects on sleep quality from the use of a respiratory therapy system (e.g., long sleep duration, long time spent in desirable sleep stages during sleep duration, and / or short time spent in undesirable sleep stages during sleep duration, limited time of low quality sleep, etc.) can negatively impact the effectiveness of a diabetes treatment plan (effectiveness of diabetes, medication, diet, exercise, etc.) that an individual adheres to. In another example, OSA (or lack of OSA from the use of a respiratory therapy system) can impact an individual's ability to metabolize glucose. Thus, diabetic patients who suffer from OSA often find it very difficult to manage their diabetes. In yet another example, the use of a respiratory therapy system to treat SDB may alter the effectiveness of an individual's diabetes treatment plan. When using a respiratory therapy system intended to treat SDB (or other conditions), a variety of different techniques may be used to assist an individual in managing their diabetes, and vice versa. Further information can be found in paragraphs 2009 / 0007918 of U.S. Patent Application No. 2009 / 0007918, entitled "Respiratory Therapy System for SDB Treatment," in which:

[0106] ~

[0107] and FIGS. 1-3, the specification of which is incorporated herein by reference.

[0106] 5A and 5B illustrate the interaction of a diabetes treatment plan and a respiratory therapy plan. FIG. 5A shows a two-vertical axis plot 500 of blood glucose levels over a 24-hour period and the number of events per hour over the same 24-hour period for an individual whose blood glucose levels and SDB are generally controlled. The horizontal axis of the plot is divided into three time periods. The first time period 502A corresponds to at least a portion of a first sleep session. The second time period 502B corresponds to the following day when the individual is awake / not in a sleep session. The third time period 502C corresponds to at least a portion of a second sleep session after the individual is awake. Typically, the individual is asleep for the majority of the first time period 502A and the third time period 502C that occur during a sleep session, although the individual may be awake for some time within these time periods.

[0107] The graph of the individual's blood glucose levels includes a first portion 504A occurring during a first time period 502A, a second portion 504B occurring during a second time period 502B, and a third portion 504C occurring during a third time period 502C. Similarly, the graph of the number of events per hour includes a first portion 506A occurring during the first time period 502A, and a second portion 506B occurring during a third time period 502C. No portion of the number of events graph occurs during the second time period 502B because the individual did not have a sleep session during the second time period 502B.

[0108] 5A, when an individual is in a sleep session (usually asleep), the individual's blood glucose level is relatively stable in the first portion 504A and the third portion 504C during the first period 502A and the third period 502C. Accordingly, the individual has a relatively low and stable number of events per hour during the first period 502A and the third period 502C. Furthermore, the individual's blood glucose level in the second portion 504B is typically controlled during the second period 502B (e.g., during the day), which may be due to a well-controlled diet and / or exercise.

[0109] FIG. 5B shows a two vertical axis plot 510 similar to plot 500, except that plot 510 is for an individual whose blood glucose levels and / or OSA are less controlled than the individual in FIG. 5A. Plot 510 is divided into three time periods. A first time period 512A corresponds to at least a portion of a first sleep session. A second time period 512B corresponds to the day after the first sleep session. A third time period 512C corresponds to at least a portion of a second sleep session. The individual is typically asleep during the first time period 512A and the majority of the third time period 512C during the sleep session. The graph of the individual's blood glucose levels includes a first portion 514A during the first time period 512A, a second portion 514B during the second time period 512B, and a third portion 514C during the third time period 512C. The graph of the number of events per hour experienced by an individual during a sleep session includes a first portion 516A occurring during a first time period 512A and a second portion 516B occurring during a third time period 512C.

[0110] 5B, during a first time period 512A (e.g., during a first sleep session), the individual's blood glucose level is elevated and unstable as shown in a first portion 514A. In response, the individual experiences an increased number of events per hour as shown in a first portion 516A. During a second time period 512B (e.g., the day after the first sleep session), a diabetes medication is administered to the individual at time 513. Thereafter, during a third time period 512C (e.g., during a second sleep session), the individual's blood glucose level decreases and / or is well controlled.

[0111] Thus, if an individual's SDB is generally not controlled or effectively treated (which may result in poor sleep quality), the individual's blood glucose levels tend to become elevated and / or unstable. This lack of sleep may lead to the individual feeling tired during the day or not adhering to prescribed diets (e.g., eating sugary foods), which if untreated may later cause blood glucose levels to become elevated and / or unstable. Various methods and techniques for monitoring diabetic patients to examine potential interactions between diabetic treatment plans and respiratory therapy plans are described in further detail herein.

[0112] FIG. 6 illustrates a method 600 for monitoring a diabetic patient and updating the individual's diabetes treatment plan in light of interactions with use of a respiratory therapy system. In general, a control system (such as control system 200 of system 10) with one or more processors is configured to execute the steps of method 600. A memory device (such as memory device 204 of system 10) coupled to the control system can be used to store machine-readable instructions executed by the one or more processors of the control system to execute the steps of method 600. The memory device can also store any type of data used in the steps of method 600. In some cases, method 600 can be implemented using a system (e.g., system 10) including a respiratory therapy system (e.g., respiratory therapy system 100) with a respiratory therapy device (e.g., respiratory therapy device 110) configured to deliver pressurized air, a user interface (e.g., user interface 120, etc.) coupled to the respiratory therapy device via a conduit (e.g., conduit 140). The user interface is configured to engage with a user and helps direct the pressurized air to the user's airway. The method 600 may also be implemented using a computer program product (such as a non-transitory computer-readable medium) that includes instructions that, when executed by a computer, cause the computer to perform the steps of the method 600.

[0113] Step 602 of method 600 includes receiving data related to an individual's diabetes treatment plan. The received data is indicative of any characteristic of the diabetes treatment plan, such as a diabetes treatment plan, a meal plan, an exercise plan, a sleep plan, a blood glucose monitoring plan, etc. The data indicative of the diabetes treatment plan may include the type of diabetes medication the individual is taking, the amount of medication prescribed or recommended for the individual, a schedule for taking the diabetes medication, and other information. The diabetes medication may include any suitable diabetes medication, including insulin, metformin, sulfonylureas, meglitinides, glinides, thiazolidinediones, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose transport protein 2 (SGLT2) inhibitors, other drugs, or any combination thereof. The meal plan may include, for example, a desired amount of calories per day, a desired amount of macronutrients per day (e.g., amounts of protein, carbohydrates, fats per day), a meal schedule, desired foods, etc. The exercise plan may include, for example, an exercise schedule, various types of exercise, duration of exercise, and the like.

[0114] Step 604 of method 600 includes receiving data related to the individual's respiratory therapy plan. The respiratory therapy plan may be implemented using a respiratory therapy system (e.g., respiratory therapy system 100) that provides pressurized air to the individual using a respiratory therapy device (e.g., respiratory therapy device 110, etc.) and a user interface (e.g., user interface 120) coupled to the respiratory therapy device via a conduit (e.g., conduit 140). In some cases, the respiratory therapy plan is designed to treat the individual's SDB, which may include OSA, CSA, both, or other types or combinations of SDB.

[0115] The received data may indicate various characteristics of the respiratory therapy plan. The received data may indicate a range of different pressure levels that the pressurized air may have (e.g., minimum pressure, maximum pressure, increments between different pressure levels, start pressure, end pressure, etc.), a ramp time of the pressurized air (e.g., the time it takes for the pressure of the air to rise to a desired therapy pressure from the start of use of the respiratory therapy system), the flow rate of the pressurized air, the humidity level of the pressurized air, whether drugs are delivered or injected into the individual's airway via the pressurized air, whether and how the respiratory therapy device operates in different sleep stages of a sleep session (e.g., different operation in light sleep stages and REM sleep stages), and other characteristics. Data related to the respiratory therapy plan may also include physiological data. This physiological data may relate to past use of the respiratory therapy system by the individual according to the respiratory therapy plan and / or according to other respiratory therapy plans. The physiological data may relate to past use of the respiratory therapy system by other individuals according to the respiratory therapy plan or different respiratory therapy plans.

[0116] Step 606 of method 600 includes determining a potential interaction between the diabetes treatment plan and the respiratory therapy plan. Step 608 of method 600 includes updating the diabetes treatment plan based on the potential interaction. Use of the respiratory therapy system in accordance with the respiratory therapy plan may affect the effectiveness of the diabetes treatment plan in various ways. For example, use of the respiratory therapy system (e.g., treating SBD) may change how the individual's blood glucose levels respond to drugs, diet, exercise, etc., which may make the diabetes treatment plan less effective at treating the individual's diabetes. Use of the respiratory therapy system may also aid in treating the individual's diabetes, e.g., the diabetes treatment plan, when used in conjunction with the respiratory therapy system, is effective at treating the individual's diabetes. In these cases, the diabetes treatment plan may be unnecessarily strict in certain aspects, such as unnecessarily high or frequent dosages. A diabetes treatment plan that is too strict may also unintentionally reduce compliance and negatively impact the individual's diabetes treatment. By determining a potential interaction between the diabetes treatment plan and the respiratory therapy plan, the diabetes plan may be updated to avoid this interaction.

[0117] In some implementations, updating the diabetes treatment plan includes updating various aspects related to the individual's use of the diabetes medication or determining updates to various aspects related to the individual's use of the diabetes medication. The updates may include adjusting the amount of diabetes medication the individual receives, adjusting the frequency at which the individual receives the diabetes medication, adjusting one or more times per day at which the individual receives the diabetes medication, adjusting the type of diabetes medication currently used by the individual, adjusting other aspects related to the individual's diabetes medication, or combinations thereof. In one example, if it is determined that the interaction between the diabetes treatment plan and the respiratory therapy plan reduces the effectiveness of the individual's diabetes medication, the diabetes plan may be adjusted to counter this reduced effectiveness. The adjustments may include increasing the dosage of the diabetes medication the individual receives, increasing the frequency at which the individual receives the diabetes medication, changing the duration at which the individual receives the diabetes medication, changing the type of diabetes medication the individual receives, or other actions. In some cases of this example, the dosage or frequency may also be reduced.

[0118] In another example, if a respiratory therapy plan improves the effectiveness of a diabetic medication, the individual's use of the diabetic medication may be adjusted, including decreasing the dosage of the diabetic medication the individual receives, decreasing the frequency with which the individual receives the diabetic medication, changing the duration over which the individual receives the diabetic medication, changing the type of diabetic medication the individual receives, and other actions. In some cases of this example, the dosage or frequency may also be increased.

[0119] In either example, any aspect related to the individual's diabetes medication that requires updating can be updated over time. For example, the dosage of the individual's diabetes medication can be adjusted initially by a small amount in advance of an anticipated interaction between the diabetes treatment plan and the respiratory therapy plan. As the individual continues to use the respiratory therapy system in accordance with the respiratory therapy plan, the dosage can be updated as needed. In these cases, feedback data related to the effectiveness of the changes can be generated and analyzed so that the interaction can be monitored over time and the changes can be updated.

[0120] In some implementations, adjusting the diabetes treatment plan includes adjusting the individual's meal plan, the individual's exercise plan, or determining to update various aspects related to the individual's meal plan or the individual's exercise plan. For example, if the interaction between the diabetes treatment plan and the respiratory therapy plan causes the diabetes treatment plan to become more or less effective, the meal plan may be adjusted by modifying (e.g., increasing or decreasing) the amount of calories consumed by the individual and / or the amount of carbohydrates consumed by the individual. In another example, the exercise plan may be adjusted by other actions, such as increasing the amount of exercise if the diabetes treatment plan becomes less effective and decreasing the amount of exercise if the diabetes treatment plan becomes more effective.

[0121] In further implementations, a stress event while using the respiratory therapy system according to the respiratory therapy plan may affect the individual's glycemic control (e.g., the individual's ability to naturally control blood glucose levels). In these implementations, determining the potential interaction in step 606 may include determining whether such a stress event is likely to occur during use of the respiratory therapy system. In some examples, if such a stress event is likely to occur, step 608 may include adjusting the diabetes treatment plan to counteract the anticipated decrease in the individual's glycemic control and / or adjusting the respiratory therapy plan to reduce the occurrence and / or severity of the stress event. In other examples, step 606 may result in a determination that a stress event is less likely to occur as a result of future use compared to past use of the respiratory therapy system (e.g., if the respiratory therapy plan is changed). In these examples, step 608 may include adjusting the diabetes treatment plan to counteract the anticipated increase in the individual's glycemic control.

[0122] In some implementations, the determined interaction includes determining that the individual will experience a sleep deprivation when they begin using the respiratory therapy system, for example because the individual may not be accustomed to wearing the user interface during sleep sessions. This predicted sleep deprivation may impact the effectiveness of the diabetic treatment plan. Thus, in some cases, the diabetic treatment plan may be adjusted to account for the predicted sleep deprivation before the individual begins using the respiratory therapy system. In other cases, it may be determined that the individual's diabetic treatment plan should remain the same due to the predicted sleep deprivation even after the individual first begins using the respiratory therapy system. Thus, the diabetic treatment plan may remain unchanged until the individual's sleep improves. The individual's sleep may improve after adjusting the type of user interface used or adjusting the pressure settings.

[0123] A diabetes treatment plan may exist in a variety of different states. A particular state of a diabetes treatment plan may include a particular diabetes medication plan, and / or other plans. When parts of the diabetes treatment plan are changed or adjusted, the diabetes treatment plan may be in a different state. For example, a first state may include a diabetes medication plan that requires an individual to take a particular diabetes medication according to a particular schedule. A second state may include a diabetes medication plan that requires an individual to take a different diabetes medication according to the same schedule, the same diabetes medication according to the same schedule, or a different diabetes medication according to a different schedule.

[0124] Thus, when an individual's diabetes treatment plan is updated to take into account potential interactions between the individual's diabetes treatment plan and the individual's respiratory therapy plan, the update is considered to transition the diabetes treatment plan between different states. In some implementations of the method 600, updating the diabetes treatment plan can include transitioning the diabetes treatment plan from a first state to a second state prior to using the respiratory therapy system in accordance with the respiratory therapy plan. For example, determining the potential interaction can include determining whether future use of the respiratory therapy system in accordance with the respiratory therapy plan will affect the effectiveness of the individual's diabetes treatment plan. If the diabetes treatment plan is currently in a first state, the diabetes treatment plan can be updated from its first state to its second state prior to future use of the respiratory therapy system.

[0125] The diabetes treatment plan may be updated to the second state at a different date / time relative to the future use of the respiratory therapy system. For example, if the future use of the respiratory therapy system is overnight, the diabetes treatment plan may be updated to the second state such that the updated diabetes treatment plan applies to most or all of the day immediately preceding the use of the respiratory therapy system. Also, the diabetes treatment plan may be updated to be in the second stage only after the future use of the respiratory therapy system has ended (e.g., to be in the second stage the day after the first use of the respiratory therapy system).

[0126] In some implementations, the method 600 is used to predict an interaction between an individual's diabetes treatment plan and use of the respiratory therapy system according to a respiratory therapy plan when the individual has never used the respiratory therapy system (or at least has never used the respiratory therapy system according to a current respiratory therapy plan). In some implementations, the future use of the respiratory therapy system is an initial (e.g., first) time that the individual uses the respiratory therapy system according to the respiratory therapy plan. Thus, the diabetes management plan can be generally considered to be in an initial state (e.g., first state) before the individual uses the respiratory therapy system. Once the individual decides to start using the respiratory therapy system according to the respiratory therapy plan (e.g., following the advice of a medical professional), the diabetes treatment plan can be updated to another state (e.g., second state) prior to the first use of the respiratory therapy system. Thus, proactively updating the diabetes treatment plan can avoid potential adverse effects of starting to use the respiratory therapy system according to the respiratory therapy plan.

[0127] In some cases, the different state can be considered a final state. For example, the diabetes treatment plan is updated prior to the first use of the respiratory therapy system and does not need to be updated again thereafter. However, in other cases, the different states are only intermediate states and the diabetes treatment plan is planned to be continually adjusted to different states. For example, the diabetes treatment plan may be updated to an intermediate state (e.g., a second state) prior to the first use of the respiratory therapy system in accordance with the respiratory therapy plan, and then updated to a final state (e.g., a third state) after the respiratory therapy system has been used for one or more sleep sessions to better understand the interaction between the diabetes treatment plan and the respiratory therapy plan.

[0128] In some implementations, the method 600 may further include receiving historical data related to other individuals who have diabetes and have used or will use the respiratory therapy system. Potential interactions between the current individual's diabetes treatment plan and the respiratory therapy plan may be determined based at least in part on the historical data. Updates to the diabetes treatment plan may also be made based at least in part on the historical data. The historical data generally includes any data related to these other individuals, such as age, sex, body mass index (BMI), etc. The historical data also generally includes data related to the other individuals' diabetes treatment plans, data related to the other individuals' respiratory therapy plans, data related to interactions between the diabetes treatment plan and the respiratory therapy plan, data related to changes made to the other individuals' diabetes treatment plans, and other types of data.

[0129] The historical data may be analyzed to determine what interactions may occur between the individual's diabetes treatment plan and the individual's respiratory therapy plan. For example, if the historical data includes data related to individuals similar to the current individual and / or individuals with similar diabetes treatment plans or respiratory therapy plans, method 600 may determine that the interactions between the current individual's diabetes treatment plan and respiratory therapy plan may be similar to other individuals.

[0130] In one example of method 600, use of the respiratory therapy system in accordance with the respiratory therapy plan may result in an individual's sleep duration increasing. However, the increased sleep duration may result in an increase in blood glucose towards the end of the sleep session due to the increased sleep duration and not actively managing the diabetes. Thus, the individual's diabetes treatment plan can be modified to counter this expected increase in blood glucose levels. In another example, use of the respiratory therapy system in accordance with the respiratory therapy plan may result in shorter sleep duration due to insomnia induced by use of the respiratory therapy system. Thus, blood glucose levels may be higher or lower than expected at the end of the sleep session. If blood glucose was not metabolized properly during sleep, this may result in a higher than expected blood glucose level. If the expected increase in blood glucose levels towards the end of the sleep session did not occur, this may result in a lower than expected blood glucose level. In some cases, this expected increase or decrease is evident from the individual's historical blood glucose data. In these cases, the individual's diabetes treatment plan can be modified to counter this expected increase or decrease in blood glucose levels.

[0131] Although the individual's diabetes treatment plan may be updated if it is determined that an interaction will cause the diabetes treatment plan to be less effective than intended or more effective than intended, updating the diabetes treatment plan may also occur for other reasons. For example, determining a potential interaction may reveal that a respiratory therapy plan will be less effective. In this example, the diabetes treatment plan may be updated in a manner that increases the effectiveness of the respiratory therapy plan in treating the individual's SDB without changing the effectiveness of the diabetes treatment plan in treating the individual's diabetes. In some cases in this example, it may be determined that the current diabetes treatment plan makes the individual less likely to comply with the respiratory therapy plan. Thus, the diabetes treatment plan may be updated in a manner that increases the likelihood that the individual will comply with the respiratory therapy plan.

[0132] The interactions between a particular diabetes treatment plan and a particular respiratory therapy plan may be specific to an individual adhering to the plan. Thus, in some cases, the interactions between the plans may be continually learned and updated as an individual is monitored while adhering to the plan over a particular period of time (e.g., one day, two days, one week, one month, etc.). Thus, the potential interactions determined in step 606 may be based, at least in part, on past known interactions.

[0133] In some cases, there may be periods during a sleep session where an individual does not use the respiratory therapy system, e.g., the individual is "off therapy." By comparing the sleep data and blood glucose data (both typically time-stamped), it can be determined how the individual's blood glucose levels (or other relevant markers) are affected (positively or negatively) based on the duration and frequency of respiratory therapy system use during the sleep session. If the potential interaction is based at least in part on past known interactions, updates to the individual's diabetes treatment plan can be based on this determination.

[0134] FIG. 7 illustrates a method 700 for monitoring a diabetic patient and determining whether the individual's use of a respiratory therapy system is positively or negatively impacting the individual's diabetes management. In general, a control system (such as control system 200 of system 10) with one or more processors is configured to execute the steps of method 700. A memory device (such as memory device 204 of system 10) coupled to the control system can be used to store machine-readable instructions executed by the one or more processors of the control system to execute the steps of method 700. The memory device can also store any type of data used in the steps of method 700. In some cases, method 700 can be implemented using a system (such as system 10) that includes a respiratory therapy system (such as respiratory therapy system 100) with a respiratory therapy device (such as respiratory therapy device 110) configured to supply pressurized air, a user interface (such as user interface 120) coupled to the respiratory therapy device via a conduit (such as conduit 140). The user interface is configured to engage with a user and helps direct the pressurized air to the user's airway. The method 700 may also be implemented using a computer program product (eg, a non-transitory computer readable medium) that includes instructions that, when executed by a computer, cause the computer to perform the steps of the method 700.

[0135] Step 702 of method 700 includes receiving blood glucose data indicative of one or more blood glucose measurements of the individual. The blood glucose data can be obtained in any suitable manner. In some implementations, the blood glucose data is obtained from a blood glucose meter or system used by the individual. For example, the individual may use a blood glucose meter to take a single blood glucose measurement. In another example, the individual may use a continuous blood glucose monitor that generates blood glucose measurements periodically. The blood glucose data from these devices can be stored on the meter itself, on one or more devices separate from the user (such as a user device 260, which may be a smartphone, computer, etc.), in cloud storage, or elsewhere. The blood glucose data can generally be obtained from any location where it is stored for use in method 700.

[0136] In some implementations, blood glucose data can be obtained using a sensor located within the respiratory therapy system. For example, an analyte sensor (e.g., analyte sensor 252) can be located in a user interface, a conduit, a respiratory therapy device, or a combination thereof. The analyte sensor can detect and measure one or more indicators of blood glucose in the individual's breath, including, for example, ketones (e.g., acetone) exhaled in the individual's breath.

[0137] Generally, the blood glucose data refers to recently obtained blood glucose measurements. The blood glucose measurements may be taken from the past day, past week, past week, etc. Alternatively or additionally, blood glucose measurements may be taken during a sleep session. For example, one or more blood glucose measurements may be taken at the beginning of a sleep session before the individual falls asleep. If the individual uses a continuous blood glucose monitor, blood glucose measurements may be taken during the day and / or night, including during the portion of the sleep session in which the individual is asleep.

[0138] Step 704 of method 700 includes receiving sleep data for an individual associated with the individual's use of a respiratory therapy system during one or more past sleep sessions. The sleep data may be generated by the respiratory therapy system used by the individual during the sleep session and / or by other devices separate from the respiratory therapy system. For example, a number of different sensors (such as sensor 210 of system 10) may be used to generate physiological data associated with a user, even if they are not an integrated part of the respiratory therapy system.

[0139] The sleep data may consist of various types of data, such as data related to the individual's sleep (e.g., sleep metrics such as sleep quality, sleep hygiene, etc.) and data related to the individual's respiratory therapy (e.g., the individual's use and duration of use of a respiratory therapy system). For example, the sleep data may include the amount of time asleep during one or more past sleep sessions, the amount of time awake during one or more past sleep sessions, the amount of time spent in each of one or more sleep stages (e.g., light sleep stages, deep sleep stages, REM sleep stages) during one or more past sleep sessions, the number of events experienced during one or more past sleep sessions, the type of each event experienced during one or more past sleep sessions (e.g., snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, RERA, flow limitation, mask leak, etc.), pressure data related to the pressure of the pressurized air delivered by the respiratory therapy system during one or more past sleep sessions, flow data related to the flow rate of the pressurized air delivered by the respiratory therapy system during one or more past sleep sessions, physiological data related to the user, other types of data, or any combination thereof.

[0140] Step 706 of method 700 includes adjusting the individual's diabetes treatment plan, the respiratory therapy plan, or both based at least in part on the blood glucose data and the sleep data. Step 706 includes analyzing the blood glucose data and / or the sleep data to determine whether the individual's use of the respiratory therapy system has affected the effectiveness of the individual's diabetes treatment plan in treating diabetes, or whether the individual's adherence to the diabetes treatment plan has affected the effectiveness of the sleep or respiratory therapy system.

[0141] As previously discussed, in some cases, there may be periods during a sleep session during which the individual does not use the respiratory therapy system, e.g., the individual goes "off therapy." By comparing the sleep data with the blood glucose data, it can be determined how the individual's blood glucose levels are affected (positively or negatively) based on the duration and frequency of use of the respiratory therapy system during the sleep session. The individual's diabetes treatment plan and / or respiratory therapy plan can then be modified based on this determination.

[0142] In some implementations, the method 700 can include determining from the blood glucose data whether the individual experienced elevated blood glucose levels during one or more previous sleep sessions and / or during the days (days) following one or more previous sleep sessions. An elevated blood glucose level can be defined in any suitable manner. In some cases, an individual is determined to have experienced elevated blood glucose levels if the individual's average blood glucose level is equal to or exceeds a threshold value for a period of time (e.g., during a sleep session and / or for all or part of a 24-hour period following a sleep session). In other cases, an elevated blood glucose level is indicated if a threshold number of individual blood glucose readings are equal to or exceed a threshold value. In yet other cases, an elevated blood glucose level is indicated if a single blood glucose reading is equal to or exceeds a threshold value.

[0143] In any of these cases, the individual's diabetes treatment plan may be adjusted (or an adjustment to the individual's diabetes treatment plan may be determined) to better control (e.g., lower blood glucose levels, prevent blood glucose spikes, etc.) the individual's blood glucose levels (e.g., during future sleep sessions, during future portion(s) of the current sleep session, and / or during the next day or days following the future sleep sessions). The adjustments may include any of the adjustments described herein, such as increasing the amount of diabetes medication the individual receives, increasing the frequency with which the individual receives the diabetes medication, adjusting the time at which the individual takes the diabetes medication, other adjustments, or combinations thereof. After an adjustment is made to the individual's diabetes treatment plan (such as adjusting the individual's diabetes medication), the individual may be monitored for a period of time (e.g., a day, a week, etc.) to determine the impact of the adjustment. The monitoring may include analysis of sleep data associated with one or more sleep sessions and blood glucose data over a period of time that includes at least one or more sleep sessions to determine the impact of the adjustment. Further adjustments may then be made.

[0144] Additionally or alternatively, settings of the respiratory therapy system may be changed (or changes to the settings of the respiratory therapy system may be determined) to better control (e.g., lower blood glucose levels, prevent blood glucose spikes, etc.) the individual's blood glucose levels (e.g., during future sleep sessions, during future portions of the current sleep session, and / or during the next day or days following a future sleep session). Changes to the respiratory therapy system settings may be used to change the intended therapeutic effect of the respiratory therapy system and / or to change the impact of use of the respiratory therapy system on the individual's sleep (e.g., sleep quality), and may include adjusting the pressure of pressurized air delivered by the respiratory therapy system, adjusting the flow rate of the pressurized air, adjusting the ramp time of the respiratory therapy system, adjusting other settings, or any combination thereof.

[0145] In some cases, changing the settings may increase the intended therapeutic effect of the respiratory therapy system, resulting in a decrease in the number of events the individual experiences during future sleep sessions, a decrease in the severity of events the individual experiences during future sleep sessions, or other effects. In certain cases, the settings of the respiratory therapy system may also be changed to decrease the intended therapeutic effect of the respiratory therapy system.

[0146] In some cases, changes to the settings of the respiratory therapy system improve compliance with the respiratory therapy plan and the respiratory therapy system. As described herein with respect to FIGS. 5A and 5B, use of the respiratory therapy system can reduce events experienced during a sleep session and improve an individual's glycemic control. Thus, compliance with the respiratory treatment plan (e.g., continued use of the respiratory therapy system) can improve glycemic control. Various changes can be made to increase compliance. For example, the pressure of the pressurized air provided by the respiratory therapy system can be changed to reduce the likelihood that an individual will stop using the respiratory therapy system. The type of user interface used by an individual can also be changed if the current type of user interface is uncomfortable and causes the individual to stop using the respiratory therapy system. Location-based events can also be detected, for example, by using data from the motion sensor 218 or other sensors. If it is determined that an individual is experiencing more events in a particular position (e.g., when sleeping on their back), the respiratory therapy system can be modified to increase the air pressure when the individual is in that position. Steps can also be taken to encourage the individual to sleep in other positions, such as on their side.

[0147] In some cases, alterations to the settings of the respiratory therapy system may be made to increase the amount of time an individual is asleep or spends in a particular sleep stage. The sleep stage may be a particular sleep stage (such as a light sleep stage, a deep sleep stage, a REM sleep stage, etc.) or may be a stage in which the user is generally asleep. For example, alterations to the settings of the respiratory therapy system may include limiting the pressure of pressurized air available in response to an individual experiencing an event to reduce the likelihood of the individual waking up.

[0148] In some implementations, if it is determined that an individual experienced a drop in blood glucose levels during one or more past sleep sessions and / or for several days following one or more past sleep sessions, the same or similar adjustments to the user's diabetes treatment plan and respiratory therapy plan may be determined and / or made. A drop in blood glucose level, similar to an increase in blood glucose level, may be defined in any suitable manner. In some cases, a drop in blood glucose level may be determined if the average blood glucose level for a period of time (e.g., all or part of a 24-hour period during and / or following a sleep session) is below a threshold. In other cases, an increase in blood glucose level is indicated if a threshold number of individual blood glucose readings are below the threshold. In yet other cases, an increase in blood glucose level is indicated if a single blood glucose reading is below the threshold.

[0149] In some cases, adjusting the settings of the respiratory therapy system may include changing between different operating modes. As described herein, the respiratory therapy system may be used as different types of systems. In a first operating mode, the respiratory therapy system may operate as a CPAP system. In a second operating mode, the respiratory therapy system may operate as an APAP system. In a third operating mode, the respiratory therapy system may operate as a BPAP or VPAP system. In other operating modes, the respiratory therapy system may operate as different types of systems. The blood glucose data and / or sleep data may reveal that the current operating mode of the respiratory therapy system is not currently controlling the individual's SDB. The blood glucose data and / or sleep data may reveal that the current operating mode of the respiratory therapy system is currently controlling the individual's SDB, but is not adequately controlling the individual's blood glucose levels. In either case, the operating mode of the respiratory therapy system may be changed (e.g., from a CPAP system to an APAP system) to better manage the individual's SDB and / or blood glucose levels. In some cases, a balance must be achieved between managing the individual's SDB and managing the individual's blood glucose levels. In such cases, this balance can be mastered over time.

[0150] In any of these cases, adjustments to the individual's diabetes treatment plan can be used to better control (e.g., increase blood glucose levels, prevent blood glucose spikes, etc.) the individual's blood glucose levels (e.g., during future sleep sessions, during future portions of the current sleep session, and / or during the next day or days following the future sleep sessions). The adjustments may include any of the adjustments described herein, such as reducing the amount of diabetes medication the individual receives, reducing the frequency at which the individual receives the diabetes medication, adjusting the time at which the individual receives the diabetes medication, other adjustments, or combinations thereof. In some implementations, the diabetes treatment plan can be modified to account for a stress event (or lack thereof) experienced by the individual during use of the respiratory therapy system. As discussed herein, a stress event can affect the individual's glycemic control. The sleep data received in step 704 can include data representative of the individual's sympathetic activation during one or more uses of the respiratory therapy system. In step 706, the diabetes treatment plan can be adjusted as necessary. In some cases, the sleep data may indicate that the individual's glycemic control is being adversely affected by a stress event caused by use of the respiratory therapy system. In such cases, the diabetes treatment plan is modified to increase the impact of the diabetes treatment plan on the individual's glycemic control. In other cases, the sleep data may indicate that the individual is experiencing fewer stressful events than expected and that the individual's glycemic control is not being adversely affected by use of the respiratory therapy system as expected, In such cases, the diabetes treatment plan is altered to reduce the impact of the diabetes treatment plan on the individual's glycemic control.

[0151] Settings of a respiratory therapy system used by an individual may also be altered, for example, to alter the intended therapeutic effect of the respiratory therapy system (e.g., increasing or decreasing the intended therapeutic effect) and / or to alter the impact of use of the respiratory therapy system on the individual's sleep (e.g., sleep quality). Alterations may include adjusting the pressure of pressurized air delivered by the respiratory therapy system, adjusting the flow rate of the pressurized air, adjusting the ramp time of the respiratory therapy system, adjusting other settings, or any combination thereof. In one example, if using insulin to treat diabetes, an individual may experience nocturnal hypoglycemia. An alarm associated with the respiratory therapy system (such as an alarm implemented by speaker 222) may be activated to wake the individual and mitigate the hypoglycemic event.

[0152] In some implementations, the method 700 may further include analyzing the sleep data to identify one or more sleep stages of the individual during one or more past sleep sessions and analyzing the blood glucose data to determine blood glucose levels of the individual during the identified sleep stages. Adjustments to the diabetes treatment plan and / or settings of the respiratory therapy system may be based, at least in part, on the blood glucose levels of the individual during the identified sleep stages.

[0153] In some implementations, settings of the respiratory therapy system can be altered to mitigate stress events occurring during use of the respiratory therapy system. If the sleep data indicates that the individual is experiencing an increase in the number and / or severity of stress events, step 706 can include adjusting settings of the respiratory therapy system to mitigate the occurrence and / or severity of such stress events.

[0154] In some cases, adjustments to the diabetes treatment plan and / or settings of the respiratory therapy system may be made or determined if the individual is experiencing high or low blood glucose levels during one type of sleep stage but not another. For example, if analysis of the sleep data and blood glucose data reveals that the individual is experiencing high blood glucose levels during REM sleep stages, the diabetes treatment plan may be modified. Modifications may include increasing or decreasing the amount of diabetes medication the individual receives, increasing or decreasing the frequency with which the individual receives the diabetes medication, adjusting the time at which the individual takes the diabetes medication, other actions, or combinations thereof. Settings of the respiratory therapy system may also be adjusted, for example, by changing the pressure or flow rate of the pressurized air or by modifying the ramp time of the respiratory therapy system.

[0155] Similar to method 600, the diabetes medication can include any suitable diabetes medication, including insulin, metformin, sulfonylureas, meglitinides, glinides, thiazolidinediones, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose transport protein 2 (SGLT2) inhibitors, other drugs, or any combination thereof.

[0156] In some implementations, the method 700 includes analyzing the sleep data and blood glucose data to determine the individual's blood glucose levels associated with events experienced during the sleep session. Modifications to the individual's diabetes treatment plan or settings of the respiratory therapy system can be based in part on how the individual's blood glucose levels respond to events experienced by the individual. For example, if an event causes the individual to experience abnormal (e.g., increased or decreased) blood glucose levels after the event, settings of the respiratory therapy system can be modified to reduce the severity of the event or reduce the likelihood of the event occurring in the future. These reduced severity can reduce or eliminate the abnormal (e.g., increased or decreased) blood glucose levels after the event. Such modifications can include increasing pressure in the pressurizer during and / or prior to the event (or future events) to terminate the event more quickly.

[0157] Generally, if an event causes an increase in blood glucose level, the increase in blood glucose level does not actually occur until a certain time after the event. Thus, the blood glucose level of an individual associated with an event may be the blood glucose level of the individual 10 seconds after the event, 30 seconds after the event, 1 minute after the event, 2 minutes after the event, 5 minutes after the event, 10 minutes after the event, etc. However, in some cases, the blood glucose level of an individual associated with an event may be the blood glucose level of the individual during the event.

[0158] In some cases, the individual's blood glucose level before the event (and a sufficiently long time after the occurrence of other events) can be used to establish a baseline blood glucose level to determine whether the individual's blood glucose level associated with the event is elevated. The individual's blood glucose level associated with the event can then be compared to the baseline blood glucose level. In one example, the baseline blood glucose level can be the baseline blood glucose level for the entire sleep session, and thus the individual's moving average blood glucose level during the sleep session that is not affected by any past events, determined from blood glucose measurements taken during the sleep session. In another example, the baseline blood glucose level can be the baseline blood glucose level when the individual is asleep during the sleep session, and thus the individual's moving average blood glucose level during the sleep session that is not affected by any past events, obtained while the individual is asleep during the sleep session. In yet another example, the baseline blood glucose level can be the baseline blood glucose level when the individual is in the sleep stage that they were in when the event in question occurred, and thus the individual's moving average blood glucose level during the sleep session, determined from blood glucose measurements taken while the individual is in a sleep stage that is not affected by any past events.

[0159] In some implementations, method 700 is implemented outside of a sleep session. For example, after analyzing blood glucose data and sleep data, settings of the respiratory therapy system may be adjusted so that the next time the respiratory therapy system is used during a sleep session, the updated settings are used. However, in some cases, method 700 may be implemented during a sleep session. In these implementations, use of the respiratory therapy system during a sleep session updates the settings of the respiratory therapy system in real time.

[0160] FIG. 8 illustrates a method 800 for monitoring a diabetic patient during a sleep session. In general, a control system (such as control system 200 of system 10) with one or more processors is configured to execute the steps of method 800. A memory device (such as memory device 204 of system 10) coupled to the control system can be used to store machine-readable instructions executed by the one or more processors of the control system to execute the steps of method 800. The memory device can also store any type of data used in the steps of method 800. In some cases, method 800 can be implemented using a system (such as system 10) that includes a respiratory therapy system (such as respiratory therapy system 100) with a respiratory therapy device (such as respiratory therapy device 110) configured to supply pressurized air, a user interface (such as user interface 120) coupled to the respiratory therapy device via a conduit (such as conduit 140). The user interface is configured to engage with a user and helps direct the pressurized air to the user's airway. The method 800 may also be implemented using a computer program product (eg, a non-transitory computer-readable medium) that includes instructions that, when executed by a computer, cause the computer to perform the steps of the method 800.

[0161] Step 802 of method 800 includes receiving blood glucose data indicative of one or more blood glucose measurements of the individual taken during a sleep session. Step 802 may be generally the same as or similar to step 702 of method 700 and may include obtaining the blood glucose data in any suitable manner, although the blood glucose data received in step 802 will typically be received during a sleep session and indicative of blood glucose measurements taken during the sleep session.

[0162] Step 804 of method 800 includes receiving sleep data associated with the individual during a sleep session. Step 804 is generally the same as or similar to step 704 of method 700. However, similar to step 802, the sleep data received in step 804 is typically received during a sleep session and is indicative of various aspects of the sleep session the individual is currently engaged in (which may include sleep quality data, respiratory therapy data, etc.). The sleep data may include data indicative of the current length of the sleep session (e.g., how long the individual has been in the sleep session), whether the individual is currently awake or asleep, the sleep stage the individual is currently in (e.g., light sleep stage, deep sleep stage, REM sleep stage, wake stage, etc.), a history of the sleep stages the individual was in during the sleep session (including the number and duration of each type of sleep stage), time in bed, time onset of sleep, initial sleep time, wake time, wake up time, or characteristics of the sleep session, or any combination thereof.

[0163] Step 806 of method 800 includes performing an action based at least in part on the received blood glucose data and the received sleep data. Generally, the action occurs if the received data indicates that some undesirable event is occurring during the sleep session, and the action is performed during the sleep session to mitigate the undesirable event. In some implementations, the received data may indicate that the individual is experiencing an increase or decrease in blood glucose levels during the sleep session. In these implementations, the action includes administering a dose of a diabetes medication to the individual. For example, if the blood glucose data indicates that the individual is experiencing an increase in blood glucose levels, the individual may be given a medication intended to lower blood glucose levels. Similarly, if the blood glucose data indicates that the individual is experiencing a decrease in blood glucose levels, the individual may be given a medication intended to improve blood glucose levels. The medication may be administered using a device such as an insulin pump that may be implanted within the individual's body. The medication may also be administered in a pill, in which case the individual is typically first woken up before the medication is administered.

[0164] In some cases, the blood glucose data and sleep data may indicate that the individual experiences more events when in a particular position during a sleep session (e.g., on their back), leading to elevated blood glucose levels or other undesirable effects. In these cases, step 806 may include encouraging the individual to sleep in a different position (e.g., on their side), such as by sending a recommendation to the individual. If the individual owns an adjustable mattress with different orientations (e.g., head tilted or down, feet tilted or down, etc.), step 806 may additionally or alternatively include adjusting the orientation of the mattress. The orientation of the mattress may be adjusted to cause the individual to lie in a different position, in which case the individual will likely experience fewer events.

[0165] In some implementations where the individual's blood glucose level is rising or falling, the method 800 includes determining which sleep stage the individual is currently in and administering an amount of a diabetic medication to the individual when the individual is in one sleep stage and not in another sleep stage. For example, administering a diabetic medication during a sleep session may wake the individual. Generally, waking an individual in a light sleep stage has less impact than deep or REM sleep stages, so the diabetic medication may be administered when the individual is in a light sleep stage (or wakefulness stage) and may not be administered when the individual is in a deep or REM sleep stage. However, it has also been found that when a diabetic medication is administered in a deep and / or REM sleep stage, the individual is less likely to wake up than when the individual is in a light sleep stage. Thus, the diabetic medication is only administered when the individual is in a deep and / or REM sleep stage and not administered when the individual is in a light sleep stage. In some implementations, the action additionally or alternatively includes adjusting settings of a respiratory therapy system to mitigate the rise or fall in blood glucose level.

[0166] In some implementations, different actions can be taken to address high or low blood glucose levels depending on the sleep stage the individual is currently in. For example, if a diabetic medication is administered during a light sleep stage, the individual may be awakened compared to a deep or REM sleep stage. Thus, if a high or low blood glucose level is detected when the user is in a light sleep stage, the diabetic medication can be administered. However, if a high or low blood glucose level is detected when the user is in a deep or REM sleep stage, settings of the respiratory therapy system can be adjusted to mitigate the high or low blood glucose level.

[0167] Similar to methods 600 and 700, the diabetes medication can include any suitable diabetes medication, including insulin, metformin, sulfonylureas, meglitinides, glinides, thiazolidinediones, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose transport protein 2 (SGLT2) inhibitors, other drugs, or any combination thereof.

[0168] The blood glucose data received during the sleep session is generated using some automated system that does not require input from the individual. For example, a continuous blood glucose meter can be used to measure the individual's blood glucose during the sleep session and generate the blood glucose data. In some implementations, the blood glucose data may not be received until after the sleep session, but indicates blood glucose measurements made during the sleep session. In that case, a system that does not require input from the individual is used. In other implementations, the blood glucose data may be related to the sleep session and indicates blood glucose measurements made while the user was awake (whether during a sleep session or not). In these implementations, a system that requires input from the individual (such as a blood glucose meter) can be used to generate the blood glucose measurements.

[0169] In some implementations, the blood glucose data and sleep data are received in real time during the sleep session. In these implementations, the received data can be analyzed in real time to determine if immediate action needs to be taken during the sleep session. In other implementations, the blood glucose data and sleep data can be received during and / or after the sleep session, but is analyzed only after the sleep session.

[0170] In some implementations, the actions performed in step 806 are performed in real-time during the sleep session. The blood glucose data and sleep data can be analyzed, and various actions may be performed to address any adverse effects that may occur during the sleep session (e.g., adjusting settings on the respiratory therapy system, administering diabetes medication to the individual, etc.). In other implementations, the actions performed in step 806 occur after the end of the sleep session. For example, the actions include updating the individual's diabetes treatment plan from the day after the sleep session and / or updating settings on the respiratory therapy system from the next sleep session.

[0171] If further implemented, the actions performed in step 806 can be performed during or after the sleep session. For example, the actions can include generating recommendations for the individual based on the blood glucose data and sleep data. The recommendations can be a recommendation to adjust the individual's diabetes treatment plan, a recommendation to adjust one or more settings of the respiratory therapy system for the next sleep session, a recommendation to consult with a medical professional, etc. The actions can also include notifying a third party (e.g., a family member, caregiver, medical professional) of any negative event or events uncovered by the blood glucose data and sleep data. These actions can be performed during or after the sleep session.

[0172] In some implementations, the action of step 806 includes administering a diabetic medication to the individual. This administration can be performed in any suitable manner. For example, in some cases, the individual may have a drug pump (e.g., an insulin pump) configured to administer a medication (e.g., insulin) to the individual and / or the individual's bloodstream, even when the individual is asleep. This action includes operating the drug pump to administer the medication to the individual. In other cases, the diabetic medication can be administered to the individual using a respiratory therapy system, for example, by administering the diabetic medication to pressurized air so that the diabetic medication reaches the individual's airway. Details regarding this technology are described at least in paragraphs

[0110] -

[0196] and Figures 5A-12 of International Publication No. WO 2021 / 084508, which are incorporated herein by reference in their entirety.

[0173] One or more elements, aspects, steps, or any portions thereof, from any one or more of the following claims 1-108 may be combined with one or more elements, aspects, steps, or any portions thereof from any one or more of the other claims 1-108, or combinations thereof, to form one or more further implementations and / or claims of the present disclosure.

[0174] Although the present disclosure has been described with reference to one or more particular embodiments or implementations, those skilled in the art will recognize that many modifications are possible without departing from the spirit and scope of the present disclosure. Each of these implementations and obvious variations thereof are contemplated as falling within the spirit and scope of the present disclosure. Additionally, additional or alternative implementations according to aspects of the present disclosure may combine any features of any of the implementations described herein.

[0175] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 295,259, filed December 30, 2021, the entire contents of which are incorporated herein by reference.

Claims

1. 1. A system comprising: a memory storing machine-readable instructions; a control system coupled to a memory device, said control system executing machine-readable instructions to: receiving data related to an individual's diabetes treatment plan; receiving data related to a respiratory therapy plan for the individual, the respiratory therapy plan implementable by a respiratory therapy system configured to deliver pressurized air to the individual's airway during a sleep session; determining a potential interaction between the individual's diabetes treatment plan and the individual's respiratory therapy plan; one or more processors configured to update the individual's diabetes care plan and the individual's respiratory therapy plan based on the interaction; updating the respiratory therapy plan for the individual includes updating the respiratory therapy plan related to changing one or more settings of the respiratory therapy system. a control system; Including, the system.

2. The change to the one or more settings of the respiratory therapy system comprises: changing the operating mode of the respiratory therapy system; adjusting the pressure of pressurized air supplied by the respiratory therapy system; limiting the pressure of the pressurized air supplied in response to the individual experiencing an event; adjusting the flow rate of the pressurized air; adjusting the ramp time of the pressurized air; adjusting the one or more settings to increase the amount of time the individual spends in a sleep stage during future sleep sessions; modifying the effect that use of the respiratory therapy system has on the individual's sleep; Altering the intended therapeutic effect of the respiratory therapy system; or Any combination of these, Including, The system of claim 1 .

3. The alteration of the intended therapeutic effect may be a reduction in the number of events experienced by said individual during future sleep sessions; a reduction in the severity of events experienced by the individual during future sleep sessions; or Both of these, Including, The system of claim 2 .

4. The alteration to the intended therapeutic effect may be an increase in the intended therapeutic effect, or a reduction in the intended therapeutic effect; Including, The system of claim 2 .

5. The reduction in the intended therapeutic effect may be a decrease in the pressure of the pressurized air supplied by the respiratory therapy system; a reduction in the flow rate of pressurized air delivered by the respiratory therapy system; or Both of these, Including, The system of claim 4.

6. The diabetes treatment regimen comprises: the type of diabetes medication the individual is taking; the amount of the diabetes medication prescribed or recommended for the individual; and a schedule for taking said diabetes medication; Data regarding Including, The system of claim 1 .

7. updating the diabetes treatment plan, determining an adjustment in the amount of diabetes medication the individual receives; determining an adjustment in the frequency with which the individual receives the diabetes medication; determining an adjustment in the time at which the individual receives the diabetes medication; or Combinations of these, Including, The system of claim 1 .

8. 8. The system of claim 7, wherein the diabetes medication comprises insulin, metformin, a sulfonylurea, a meglitinide, a glinide, a thiazolidinedione, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a glucagon-like peptide 1 (GLP-1) receptor agonist, a sodium glucose transport protein 2 (SGLT2) inhibitor, or a combination thereof.

9. the diabetes treatment plan includes a meal plan for the individual; updating the diabetes treatment plan includes determining adjustments to the meal plan; The system of claim 1 .

10. the diabetes treatment plan includes an exercise plan for the individual; updating the diabetes treatment plan includes determining an adjustment to the exercise plan. The system of claim 1 .

11. 2. The system of claim 1, wherein updating the diabetes treatment plan includes updating the diabetes treatment plan from a first state to a second state prior to future use of the respiratory therapy system in accordance with the respiratory therapy plan.

12. 12. The system of claim 11, wherein the diabetes treatment plan is in the first state prior to future use of the respiratory therapy system.

13. 13. The system of claim 12, wherein updating the diabetes treatment plan includes updating the diabetes treatment plan to the second state on a future day of use of the respiratory therapy system.

14. updating the diabetes treatment plan includes: updating the diabetes treatment plan from the first state to the second state on a future day of use of the respiratory therapy system; updating the diabetes treatment plan from the second state to a third state at a later date in a subsequent use of the respiratory therapy system; Including, 14. A system according to claim 12 or 13.

15. The system of claim 11 , wherein the future use of the respiratory therapy system is the first use of the respiratory therapy system.

16. The system of claim 15 , wherein the first state is an initial state.

17. 17. The system of claim 15 or 16, wherein the second state is an intermediate state or a final state.

18. The one or more processors are further configured to execute the machine-readable instructions to receive historical data associated with one or more diabetic patients; The system of claim 1 , wherein the historical data indicates an interaction between the diabetes care plan for each of the individuals and the respiratory therapy plan for each of the individuals.

19. 20. The system of claim 18, wherein the determination of a potential interaction between the individual's diabetes care plan and the individual's respiratory therapy plan is based at least in part on the historical data.

20. 20. The system of claim 18 or claim 19, wherein the historical data includes one or more of the diabetic patient's age, one or more of the diabetic patient's gender, one or more of the diabetic patient's body mass index (BMI), one or more of the diabetic patient's diabetic medication regimen, or a combination thereof.

21. The system of claim 1 , wherein the respiratory therapy plan is used to treat sleep-disordered breathing (SDB).

22. 22. The system of claim 21, wherein the SDB includes obstructive sleep apnea (OSA), central sleep apnea (CSA), or both.

23. the potential interactions include improved blood glucose control in the individual; 23. The system of claim 21 or claim 22, wherein updating the individual's diabetes treatment plan includes determining a reduction in the amount of diabetes medication the individual receives, determining a reduction in the frequency with which the individual receives the diabetes medication, or both.

24. further comprising the respiratory therapy system; The respiratory therapy system comprises: a respiratory therapy device configured to supply the pressurized air; and a user interface coupled to the respiratory therapy device via a conduit; Including, the user interface is configured to engage the individual and assist in directing the supplied pressurized air to the individual's airway; The system of claim 1 .

25. receiving data related to an individual's diabetes treatment plan; receiving data related to a respiratory therapy plan for the individual, the respiratory therapy plan executable by a respiratory therapy system during a sleep session; determining a potential interaction between the individual's diabetes treatment plan and the individual's respiratory therapy plan; updating the individual's diabetes care plan and the individual's respiratory therapy plan based on the interaction; Including, updating the respiratory therapy plan for the individual includes updates related to changes to one or more settings of the respiratory therapy system. method.

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