Automatic or manual initiation of meal bolus dispensing and subsequent automatic relaxation of safety constraints

Abstract

Exemplary embodiments may provide a drug delivery device that receives a glucose value of a user (e.g., a diabetic patient) and determines when the user has eaten a meal based on the glucose value. In some embodiments, the drug delivery device may calculate an appropriate bolus dose and automatically deliver the drug bolus to the user. In some embodiments, instead of detecting a meal, the user may announce the meal, such as by activating an element of the drug delivery device or a management unit of the drug delivery device. The drug delivery device may calculate the drug bolus dose and deliver the drug bolus in response to the announcement of the meal. In connection with delivery of the drug bolus, the drug delivery device may relax one or more safety constraints during a relaxation period following delivery of the drug bolus, thereby delivering additional basal medications under the relaxed constraints, if necessary.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 478,842, filed on January 6, 2023, the entire contents of which are incorporated herein by reference.

Summary of the Invention

Problems to be Solved by the Invention

[0002] Diabetic patients need additional insulin to attenuate the rise in glucose levels associated with food intake. Conventionally, such diabetic patients have administered insulin boluses by manual injection in anticipation of eating. Diabetic patients need to determine the dosage of the insulin bolus. This is difficult and error-prone. Diabetic patients need to correctly determine the amount of carbohydrates contained in the meal and accurately determine the appropriate dosage of the insulin bolus to attenuate the rise in glucose levels resulting from ingesting the calculated amount of carbohydrates in the meal. Diabetic patients also need to appropriately determine the time to administer the insulin bolus relative to food intake. Sometimes, diabetic patients even forget to administer the insulin bolus for a meal. Ultimately, glucose level management may not work well. Diabetic patients may become hyperglycemic as a result of choosing a very small insulin bolus or may become hypoglycemic as a result of choosing a very large insulin bolus.

Means for Solving the Problems

[0003] According to a first aspect of the invention, a drug delivery system for delivering a drug such as insulin to a user may include a drug storage unit or tank, and a needle or cannula for puncturing the user's skin to deliver the drug from the storage unit. The drug delivery system may further include a fluid path for the drug between the storage unit and the needle or cannula, and a non-temporary computer-readable storage medium for storing computer program instructions and other historical information. The drug delivery system may further include a processor configured to execute computer program instructions. By executing computer program instructions, the processor may restrict drug delivery to the user, receive the user's glucose level and / or other analyte level values, and determine whether the user has eaten based on the received user analyte level values. The processor may further perform the following actions: to provide an autobolus function that delivers a first portion of a drug bolus to the user in response to the processor's determination that the user has eaten, by executing computer program instructions; and to relax at least one drug safety constraint during the period following the delivery of the first portion of the drug bolus, in order to deliver a larger dose of the automated drug delivery in accordance with at least one relaxed drug safety constraint.

[0004] The processor may further deliver the second portion of a drug bolus by executing a computer program instruction. The processor may further determine the dosage of the second portion of the drug bolus by executing a computer program instruction. The dosage of the second portion may be determined at least in part based on the most recently received glucose value and the user's onboard medication. The processor may further prevent the delivery of another drug bolus during the cool-down period after the delivery of the second portion of the drug bolus by executing a computer program instruction. The processor may further deactivate the autobolus function by executing a computer program instruction if an activity mode is set or the user is in a cool-down period, with the set activity mode indicating that the user is active or will soon be active. The processor may further deactivate at least one drug delivery restriction by executing a computer program instruction if at least one deactivation condition other than the expiration of a period is met. The (one or more) deactivation conditions may include at least one of the difference between consecutively received user blood glucose levels exceeding their respective thresholds or an activity mode being set, with the set activity mode indicating that the user is active or will soon be active.

[0005] In other embodiments of the invention, a method performed by the processor of a drug delivery system may include receiving glucose and / or other analyte level values ​​for a user, and determining whether the user has eaten based on the received analyte level values ​​for the user. The method may further include an autobolus function that determines a first portion of a drug bolus to be delivered to the user in response to the determination that the user has eaten, the drug delivery system determining that the first portion has been delivered to the user, and relaxing at least one drug safety constraint during the period after the determination that the first portion of the drug bolus has been delivered, wherein relaxing at least one drug safety constraint allows for the delivery of a higher dose of the base drug delivery as needed, without adhering to the relaxed at least one drug safety constraint.

[0006] The method may further comprise determining the dosage of a second portion of a drug bolus to be delivered to the user. The dosage of the second portion may be determined at least in part based on the most recently received analyte level value and the user's onboard drug. The method may further comprise determining that the second portion of the drug bolus has been delivered. Furthermore, the method may further comprise sending instructions to the drug delivery device indicating that it should not deliver another drug bolus during the cool-down period after the delivery of the second portion of the drug bolus, and / or that it should not deliver another drug bolus during the cool-down period after it has been determined that the second portion of the drug bolus has been delivered. The method may further comprise deactivating the autobolus function when an activity mode is set or the user is in a cool-down period, the set activity mode indicating that the user is active or will soon be active. The method may release the relaxation of at least one drug delivery constraint when at least one release condition other than the expiration of a period is met. The (one or more) deactivation conditions may include at least one of the following: the difference between consecutively received user blood glucose levels exceeds their respective thresholds, or an activity mode is set, the set activity mode indicating that the user is active or will soon be active.

[0007] In other embodiments of the invention, a drug delivery system for delivering a drug to a user may include a drug storage unit and a needle or cannula for puncturing the user's skin to deliver the drug from the storage unit. The drug delivery system may further include a fluid path for the drug between the storage unit and the needle or cannula. The drug delivery system may further include a non-temporary computer-readable storage medium for storing computer program instructions and a processor configured to execute computer program instructions. By executing computer program instructions, the processor may be made to restrict the delivery of the drug to the user in accordance with current drug safety constraints and to receive instructions for the user's request to deliver a drug bolus to the user. 。 The processor may further perform the following actions by executing computer program instructions: to deliver a first portion of a drug bolus to the user in response to an incoming request; and to relax at least one of the current drug safety constraints during the period following the delivery of the first portion of the drug bolus, so that, if necessary, a larger dose of the base drug delivery can be delivered without being subject to at least one of the relaxed current drug safety constraints.

[0008] The drug delivery system may further include an element that can be activated by the user to request the delivery of a drug bolus. The element may be, for example, a button, knob, switch, lever, or one of a user interface element. The processor may further be instructed to deliver a second portion of the drug bolus by executing a computer program instruction. The processor may further be instructed to determine the dosage of the second portion of the drug bolus by executing a computer program instruction. The processor may further be instructed to prevent the delivery of another drug bolus during the cool-down period after the delivery of the second portion of the drug bolus by executing a computer program instruction. The processor may further be instructed to release the relaxation of at least one drug safety constraint by executing a computer program instruction if the difference between consecutively received user blood glucose levels exceeds their respective thresholds or if an activity mode is set, the set activity mode indicating that the user is active or will soon be active.

[0009] In other embodiments of the invention, a method performed by the processor of a drug delivery system may include receiving instructions for a user's request to immediately deliver a drug bolus to the user. The method may further include, in response to the received request, determining a first portion of the drug bolus to be delivered to the user, determining that the first portion of the drug bolus has been delivered by the drug delivery system, and relaxing at least one of the current drug safety constraints during the period following the delivery of the first portion of the drug bolus, wherein relaxing at least one drug safety constraint allows for the determination of a higher dose of the base drug delivery as needed, without being subject to the relaxed at least one drug safety constraint.

[0010] In other embodiments of the invention, a drug delivery device comprises a drug tank for storing a drug such as insulin, and a needle or cannula for piercing a patient's skin, which is hollow to function as a conduit for delivering the drug to the user. The drug delivery device may have non-temporary computer-readable storage for storing computer program instructions for controlling the operation of the drug delivery device. The drug delivery device may have a processor which, by executing computer program instructions, causes the processor to: restrict the delivery of the drug to the user in accordance with current drug safety constraints; deliver a first portion of a drug bolus to the user; and relax at least one of the current drug safety constraints during the period following the delivery of the first portion of the drug bolus so that a higher dose of the base drug delivery can be delivered as needed, without complying with at least one of the relaxed current drug safety constraints.

[0011] In other embodiments of the invention, a method performed by the processor of a drug delivery system may include: determining a first portion of a drug bolus to be delivered to a user; determining that the first portion of the drug bolus has been delivered by the drug delivery system; and relaxing at least one of the current drug safety constraints during the period following the delivery of the first portion of the drug bolus, wherein relaxing at least one drug safety constraint allows for the determination of a further dose of the base drug delivery as needed, without being subject to the relaxed at least one drug safety constraint.

[0012] Several current drug safety constraints may be relaxed. These drug safety constraints may include at least one of the following: the maximum amount of drug that can be delivered from the drug delivery device to the user in an operating cycle of the drug delivery device; the maximum amount of drug that can be delivered from the drug delivery device to the user in a specified number of operating cycles of the drug delivery device; the current set value of the user's glucose level; the maximum level of drug carried by the user; and a penalty amount in the cost function for extra drug delivery. The processor may further be made to deliver a second portion of the drug bolus at a certain time after the delivery of the first portion of the drug bolus by executing a computer program instruction. The method may further comprise determining the second portion of the drug bolus at a certain time after the delivery of the first portion of the drug bolus. [Brief explanation of the drawing]

[0013] [Figure 1] Figure 1 shows a block diagram of a drug delivery system in an exemplary embodiment.

[0014] [Figure 2] Figure 2 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment having an auto-bolus function.

[0015] [Figure 3A] Figure 3A shows a flowchart of exemplary steps that may be performed in an exemplary embodiment to obtain a meal signal for automated meal detection.

[0016] [Figure 3B] Figure 3B shows an example of a sliding window that, in an exemplary embodiment, slides over time to encompass a two-hour period that is updated when a new glucose value measurement is received for meal detection.

[0017] [Figure 4]Figure 4 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment to calculate a portion of a drug bolus dose.

[0018] [Figure 5] Figure 5 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment to determine a safe drug or IOB such as the insulin carried.

[0019] [Figure 6] Figure 6 shows an example of safety constraints that may be relaxed in an exemplary embodiment.

[0020] [Figure 7] Figure 7 shows an exemplary plot for exemplary autobolus delivery in an exemplary embodiment.

[0021] [Figure 8] Figure 8 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment when restricting a portion of a drug bolus dose.

[0022] [Figure 9] Figure 9 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment to select a portion of a drug bolus dose. [[ID=三十一]]

[0023] [Figure 10] Figure 10 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment for a cool-down period.

[0024] [Figure 11] Figure 11 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment to deactivate the autobolus capability.

[0025] [Figure 12]Figure 12 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment to release one or more safety constraints.

[0026] [Figure 13] Figure 13 shows some exemplary release conditions that may be used in exemplary embodiments.

[0027] [Figure 14A] Figure 14A shows an example of a user interface button on a management device that may be activated by the user to indicate that a meal is being eaten.

[0028] [Figure 14B] Figure 14B shows an exemplary drug delivery device of an exemplary embodiment having a button on the housing that may be pressed by the user to indicate that a meal is being taken.

[0029] [Figure 14C] Figure 14C shows several exemplary triggerable elements that may be activated by the user to indicate that a meal is being eaten.

[0030] [Figure 15] Figure 15 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment to deliver a dietary drug bolus in response to user activation of an activatable element for indicating that a meal is being eaten, and to alleviate at least one safety constraint.

[0031] [Figure 16A] Figure 16A shows a plot illustrating the cooperation between autobolus ability and dietary drug bolus ability induced by manually informing the patient to eat, in an exemplary embodiment. [Figure 16B] Figure 16B shows a plot illustrating the cooperation between autobolus ability and dietary drug bolus ability induced by manually informing the patient to eat, in an exemplary embodiment. [Figure 16C]Figure 16C shows a plot illustrating the cooperation between autobolus ability and dietary drug bolus ability induced by manually informing the patient to eat, in an exemplary embodiment. [Modes for carrying out the invention]

[0032] Exemplary embodiments can reduce the burden on diabetic patients regarding the delivery of meal boluses of drugs such as insulin. Exemplary embodiments may provide a drug delivery device and / or drug delivery system that receives glucose and / or other analyte level values ​​of a user (e.g., a diabetic patient or person with diabetes (PWD)) and determines, based on the glucose or other analyte level values, when the user has eaten a meal. In some embodiments, the drug delivery device and / or drug delivery system may calculate an appropriate bolus dose and automatically deliver the drug bolus to the user. Thus, the user is relieved of the burden of remembering to deliver a drug bolus for a meal and the burden of accurately determining the drug bolus dose. In some embodiments, instead of detecting a meal, the user may be notified of a meal by the activation of an element of the drug delivery device or (e.g., an element of the drug delivery device's control unit if the control unit is part of the drug delivery system). In response to the notification of a meal, the drug delivery device may calculate the drug bolus dose and deliver the drug bolus.

[0033] In connection with drug bolus delivery, the drug delivery device may relax safety constraints during a quiescence period following drug bolus delivery to allow for the delivery of additional basal drugs as needed. The drug bolus dose may be selected conservatively (i.e., less than the dose required to fully compensate for food intake) to reduce the risk of hypoglycemia in the user. The drug delivery device may rely on relaxed safety constraints to enable more aggressive basal drug delivery to complete the necessary compensatory support to bring the user's glucose levels into the desired range after food intake. The quiescence period may be released when the trend in glucose levels shows a substantial downward trend or when the user enters a mode indicating that the user is active, such as exercising. In some embodiments, by relaxing safety constraints, the drug delivery system or device can deliver a larger amount of basal insulin.

[0034] An exemplary embodiment may provide a cool-down phase in which, even if a meal is detected or the user has informed the system of a meal, no additional drug bolus is required during the period following the delivery of the drug bolus.

[0035] Exemplary embodiments may be adapted to both autobolus delivery in response to meal detection with relaxed safety constraints and bolus delivery in response to user notification of a meal with relaxed safety constraints. Exemplary embodiments can provide means for resolving any inconsistencies that may arise from autobolus delivery and meal notification. The drug delivery device may, if necessary, intelligently suspend the relaxation of safety constraints and / or meal detection.

[0036] Figure 1 shows an exemplary drug delivery system 100 suitable for delivering a drug such as insulin to a user 108 according to an exemplary embodiment. The drug delivery system 100 may have a drug delivery device 102. The drug delivery device 102 may be attached to the user 108's body or may be a wearable device carried by the user 108. The drug delivery device 102 may be directly attached to the user (e.g., directly attached to a part of the user's body and / or skin via an adhesive, etc.) or may be carried by the user with the drug delivery device 102 connected to an injection site where the drug is injected using a needle and / or cannula (e.g., placed in a belt or pocket). The surface of the drug delivery device 102 may contain an adhesive to facilitate attachment to the user 108.

[0037] The drug delivery device 102 may have a processor 110. The processor 110 may be, for example, a microprocessor, a logic circuit, a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), or a microcontroller. The processor 110 may maintain the date and time, as well as other functions (e.g., calculations). The processor 110 may be operable to execute a control application 116 encoded with computer program instructions stored in a storage device 114, which enables the processor 110 to direct the operation of the drug delivery device 102. The control application 116 may be a single program, multiple programs, modules, libraries, etc. The processor 110 may execute computer program instructions stored in the storage device 114 for a user interface (UI) 117, which may include one or more display screens displayed on a display 127. The display 127 may display information to a user 108 and, optionally, may receive input from the user 108, such as when the display 127 is a touchscreen.

[0038] The control application 116 may control the delivery of the drug to the user 108 in accordance with a control approach such as those described herein. In an exemplary embodiment, the control application 116 may control the termination of electrical pulses to an SMA (shape memory alloy) element, as will be described later. The storage device 114 may hold user history 111 such as a history of basic deliveries, a history of bolus deliveries, and / or other histories such as a history of meal events, an exercise event, a glucose value history, or other analyte level histories. Furthermore, the processor 110 may be operable to receive data or information. The storage device 114 may include both primary and secondary storage devices. The storage device 114 may include random access memory (RAM), read-only memory (ROM), optical storage devices, magnetic storage devices, removable storage media, solid-state storage devices, and the like.

[0039] The drug delivery device 102 may have a tray or cradle and / or one or more housings that house various components, including a pump 113, a power supply (not shown), and a tank 112 for storing the drug to be delivered to the user 108. A fluid path to the user 108 may be provided, and the drug delivery device 102 may use the pump 113 to drain the drug from the tank 112 to deliver the drug to the user 108 via the fluid path. The fluid path may include, for example, a tube connecting the drug delivery device 102 to the user 108 (e.g., a tube connecting a cannula to the tank 112), or a conduit to a separate injection site. The drug delivery device 102 may have an operating cycle, such as every 5 minutes, during which it calculates and delivers a basic dose of the drug as needed. These steps are repeated in each cycle.

[0040] For example, there may be one or more communication links with one or more devices physically separated from the drug delivery device 102, including a user and / or caregiver management device 104, a sensor 106, a smartwatch 130, a fitness monitor 132, and / or various other wearable devices 134. The communication links may include any wired or wireless communication links operating in accordance with any known communication protocol or standard such as Bluetooth®, Wi-Fi®, a near-field communication standard, a cellular standard, or any other wireless protocol.

[0041] The drug delivery device 102 may communicate with the network 122 via a wired communication link or a wireless communication link. The network 122 may include a local area network (LAN), a wide area network (WAN), or a combination thereof. The computer device 126 may communicate with the network 122, and the computer device may communicate with the drug delivery device 102 or the management device 104.

[0042] The drug delivery system 100 may have one or more sensors 106 that detect one or more analyte levels. The (one or more) sensors 106 may be attached to the user 108 by, for example, an adhesive, and may provide information or data about one or more medical conditions and / or physical attributes of the user 108. The (one or more) sensors 106 may be physically separate from the drug delivery device 102 or may be an integrated component. The (one or more) sensors 106 may include glucose sensors such as a continuous glucose monitor (CGM) and / or a non-invasive glucose monitor. The (one or more) sensors 106 may include ketone sensors, other analyte sensors, heart rate monitors, respiratory rate monitors, exercise sensors, temperature sensors, sweat sensors, blood pressure sensors, alcohol sensors, etc. Some sensors 106 may detect characteristics of components of the drug delivery device 102. For example, the sensors 106 of the drug delivery device may include voltage sensors, current sensors, temperature sensors, etc.

[0043] The drug delivery system 100 may or may not have a control device 104. In some embodiments, the drug delivery device 102 can manage itself, so a control device is not required. The control device 104 may be a dedicated device, such as a dedicated personal diabetes manager (PDM) device. The control device 104 may be a programmed general-purpose device, such as any portable electronic device including a dedicated controller, such as a processor or microcontroller. The control device 104 may be used to program or adjust the operation of the drug delivery device 102 and / or (one or more) sensors 106. The control device 104 may be any portable electronic device, such as a dedicated device, smartphone, smartwatch or tablet. In the example depicted, the control device 104 may have a processor 119 and a storage device 118. The processor 119 may perform processes to manage the user's glucose levels and control the delivery of drugs to the user 108. The drug delivery device 102 may supply data from the sensors 106 and other data to the control device 104. The data may be stored in the storage device 118. The processor 119 may be operable to execute program code stored in the storage device 118. For example, the storage device 118 may be operable to store one or more control applications 120 for execution by the processor 119. The storage device 118 may be operable to store historical information such as drug delivery information, analyte level information, user input information, output information, or other historical information. The control application 120 may play a role in controlling the drug delivery device 102, such as controlling automated drug delivery (ADD) (or, for example, automated insulin delivery (AID)) of the drug to the user 108. In some exemplary embodiments, the control application 120 provides the adaptability described herein. The storage device 118 may store the control application 120, the history 121 described above for the drug delivery device 102, and other data and / or programs. The embodiments described herein may be executed, for example, by multiple processors in a distributed computer system.

[0044] A display 127, such as a touchscreen, may be provided to display information. The display 127 may display a user interface (UI) 123. The display 127 may also be used to receive input, as it would be if it were a touchscreen. The management device 104 may further have input elements 125, such as a keyboard, buttons, knobs, etc., to receive input from the user 108.

[0045] The management device 104 may communicate with a network 124, such as a LAN or WAN or a combination thereof, via a wired communication link or a wireless communication link. The management device 104 may communicate with one or more servers or cloud services 128 via the network 124. In some embodiments, data such as sensor values ​​may be transmitted directly from the drug delivery device 102 to one or more cloud services / servers 128 for storage and processing, or from the management device 104 to one or more cloud services / servers 128.

[0046] Other devices, such as a smartwatch 130, a fitness monitor 132, and a wearable device 134, may be part of the drug delivery system 100. These devices 130, 132, and 134 may communicate with the drug delivery device 102 and / or the control device 104 to receive information and / or issue commands to the drug delivery device 102. These devices 130, 132, and 134 may execute computer program instructions to perform, for example, some of the control functions performed by the processor 110 or processor 119 via control applications 116 and 120. These devices 130, 132, and 134 may have displays for displaying information. The displays may show a user interface for providing user input, such as a request to change or pause the dosage or a request, start, or confirmation of a bolus delivery of the drug, or they may show a user interface for showing output, such as a change in dosage (e.g., base dose) determined by the processor 110 or the control device 104. These devices 130, 132, and 134 may have wireless communication connections with the sensor 106 to directly receive analyte measurement data. Another delivery device 105, such as a drug delivery pen (e.g., an insulin pen), may be configured (e.g., when determining the IOB) or may also be provided to deliver drugs to the user 108.

[0047] The functions described later in exemplary embodiments may be under the control of, or performed by, a control application 116 for the drug delivery device 102 or a control application 120 for the management device 104. In some embodiments, the functions may be under the control of, or performed by, a cloud service or server 128, a computer device 126, or other enumerated devices, including a smartwatch 130, a fitness monitor 132, or another wearable device 134.

[0048] In closed-loop mode, control applications 116,120 continuously determine the amount of drug delivered to user 108 based on a feedback loop. For example, in the case of a drug delivery device using insulin, the objective of closed-loop mode is to bring the user's glucose level to a target glucose level or within a target glucose range. In some embodiments, the target glucose level is between approximately 100 mg / dL and approximately 140 mg / dL, more specifically between approximately 110 mg / dL and approximately 130 mg / dL, and in particular between approximately 115 mg / dL and approximately 120 mg / dL.

[0049] In some embodiments, the drug delivery device 102 does not need to deliver a single drug alone. Instead, the drug delivery device 102 may deliver one drug, such as insulin, to lower the user 108's glucose level, and another drug, such as glucagon, to raise the user 108's glucose level. The drug delivery device 102 may deliver a glucagon-like peptide (GLP)-1 receptor agonist drug to lower blood glucose concentration to delay postprandial glucose spikes or to delay gastric emptying. In other embodiments, the drug delivery device 102 may deliver pramulintide or other drugs that can be substitutes for insulin. In other embodiments, the drug delivery device 102 may deliver concentrated insulin. In some embodiments, the drug or agent delivered by the drug delivery device may be a co-formulation of two or more of these drugs identified above. In a preferred embodiment, the drug delivery device delivers insulin. Thus, although insulin and insulin delivery devices are referred to throughout this application, those skilled in the art will understand that non-insulin drugs can be delivered in place of or in addition to insulin.

[0050] As described above, exemplary embodiments may automatically detect meal intake by user 108 based on glucose levels and automatically deliver an insulin bolus to mitigate the rise in glucose caused by meal intake. The automatic delivery of a bolus is sometimes referred to herein as "autobolus." Figure 2 shows a flowchart 200 of exemplary steps that may be performed in exemplary embodiments when providing the autobolus function. In step 202, the user's glucose level is received. The glucose level may originate from a glucose sensor, such as a CGM, which is one or more sensors 106. If the glucose level originates from a CGM, the glucose level may be received via a wireless connection between the CGM and the drug delivery device 102. The glucose level may be transmitted via an intermediate device, such as a management device 104, on its way to the drug delivery device 102. Furthermore, the glucose level may be stored in a storage device 118 and retrieved from the storage device 118 as needed. The glucose level may be the most recent one obtained for user 100 and may include a value sufficient to detect a meal, as will be described later (e.g., a rolling 15-minute window glucose level). Alternatively, glucose levels may be obtained from a glucose meter that reads a test strip containing a drop of the user's blood, or from another type of glucose sensor. The most recent glucose level may be the one closest to the current time of reception, for example, the time when automatic meal detection occurs.

[0051] In 204, glucose values ​​are processed to detect whether user 108 has consumed a meal. In an exemplary embodiment, meal signals may be collected and used in 203 based on glucose values ​​from the user over a time window to determine whether a meal has been detected. The meal signal represents the probability that a meal was detected in user 108's glucose values ​​over consecutive time intervals. Figure 3A shows a flowchart 300 of exemplary steps that may be performed in an exemplary embodiment to obtain a meal signal. Following this approach, during the training of a machine learning model for meal detection, glucose increases of a specified or predetermined magnitude within each time period are sought. For example, the approach may look for instances of increases of 20 mg / dL or more within 15 minutes, increases of 40 mg / dL or more within 30 minutes, or increases of 60 mg / dL or more within 60 minutes. In one embodiment of the model prediction mode, limited data of 10-minute, 15-minute, and 20-minute glucose values ​​are used to predict whether glucose will increase in the next 30- to 60-minute time window. In 302, user 108's blood glucose data is acquired for 10-minute, 15-minute, and 20-minute periods within a window, such as a 2-hour window ending with the most recent glucose measurement. In some embodiments, glucose values ​​from approximately 5 minutes to 40 minutes prior (relative to the current time), more specifically, glucose values ​​from approximately 10 minutes to 30 minutes prior, and in particular, glucose values ​​from approximately 10 minutes to 20 minutes prior, are used to predict whether glucose will rise in the next 30- to 60-minute time frame.

[0052] In an exemplary embodiment, in 304, the classifier may process glucose values ​​to predict glucose elevation using glucose values ​​in 10-minute, 15-minute, and 20-minute time windows. A separate classifier may be provided for each period. The classifier may be a machine learning model that recognizes patterns of glucose elevation indicating a meal. The classifier may be part of a control application 116 or 120. One classifier may utilize glucose values ​​at 10-minute intervals within a window. Another classifier may utilize glucose values ​​at 15-minute intervals within a window, and a third classifier may utilize glucose values ​​at 20-minute intervals within a window. Each classifier may be, for example, a separate neural network model or a separate decision tree model. The classifier may output the probability that a meal was detected within a window based on computed features within the time window, such as first and second derivatives, mean values, and range values ​​within the window. While 10-minute, 15-minute, and 20-minute time windows are used as exemplary embodiments for predicting the probability of glucose level increases, it should be noted that larger windows utilizing a wider range of glucose levels, such as 30-minute, 60-minute, and 120-minute windows, are other possible embodiments.

[0053] In 306, the classifier may output probabilities, which are used to determine the probability of whether or not a meal event occurred and to determine the maximum allowable insulin bolus dose, as described above. Continuous monitoring of user 108's glucose level data may also be performed.

[0054] Figure 3B shows an example of a sliding window 320 that slides over time to encompass a two-hour period updated when a new glucose value measurement is received. The sliding window 320 may start at a position or window 322 that covers glucose value measurements up to measurement number 20. At a second position or window 324, the window encompasses measurements from measurement 1 to measurement 23, and at a third position or window 326, the window encompasses measurements from measurement 2 to measurement 25. Each measurement occurs at a five-minute interval, and therefore one window may encompass a two-hour period. No meals are detected at window positions or positions 322 and 324, but meals are detected at position or window 326 based on the expected rise in glucose value.

[0055] Referring to Figure 2, at 206, a check may be performed to determine whether a meal has been detected based on the glucose level. If no meal is detected, the process in Figure 2 is completed. If a meal is detected, at 208, the dose of the first portion of the insulin bolus may be determined. In an exemplary embodiment, the first portion of the insulin bolus may be delivered by an autobolus mechanism immediately after a meal is detected. Subsequently, as will be described later, the second portion of the insulin bolus may be delivered, for example, during the next operating cycle. The dose of the first portion of the insulin bolus may be selected to be a safe amount that can be delivered immediately.

[0056] Figure 4 shows a flowchart 400 of exemplary steps that may be performed in an exemplary embodiment to calculate the dose of a portion of an insulin bolus, in particular the first portion. In 402, the current total insulin onboard (IOB) of user 108 is subtracted from the safe required IOB to generate a difference. Total IOB includes all basal and bolus insulin delivered to the user that may still affect the user's glucose level. Safe required IOB represents the IOB level with a safety factor incorporated. In 404, the difference may be added to a preset percentage of the user 108's total daily insulin (TDI). The TDI may be the sum of all basal and bolus insulin delivered to user 108 in a day. The preset percentage may be, for example, in the range of 3 to 8 percent of the TDI. The sum reflects the percentage of the TDI and the extra insulin needed to reach user 108's safe required IOB level. In 406, the dose of a portion of the insulin bolus, in particular the first portion, may be set as the sum. This can also be done as follows:

number

[0057] Figure 5 shows a flowchart 500 of exemplary steps that may be performed to determine the safe required IOB. A preferred formula for calculating the safe required IOB in an exemplary embodiment is as follows:

number

[0058] Referring to Figure 2, at 210, the first portion of the insulin bolus may be delivered to the user 108 by the insulin delivery device 102. At 212, one or more safety constraint relaxations may be initiated during the next cycle after meal detection. One or more safety constraint relaxations may allow for the delivery of more insulin as basal insulin delivery during the relaxation period. The relaxation period may last for a time frame of, for example, six cycles. Figure 6 shows an example of safety constraints that may be relaxed in an exemplary embodiment. The maximum amount of insulin that may be delivered in cycle 602 is a safety constraint that may be relaxed. For example, the maximum amount of insulin that may be delivered in one cycle may be a multiple of the ideal basal delivery amount per cycle, and the multiple may be increased by relaxation. Another safety constraint that may be relaxed is the maximum amount of insulin that may be delivered over multiple cycles 604. Relaxation may simply involve increasing this maximum value. A setpoint 606, also known as a “target” for control application 116 or 120, is a safety constraint. The setpoint 606 may be reduced as part of the relaxation of constraints. For example, in some exemplary embodiments, the larger of the current setpoint minus 20 and a fixed value of 90 mg / dL may be selected as the new setpoint. In embodiments, the fixed value may be between approximately 70 mg / dL and approximately 110 mg / dL, more specifically between approximately 80 mg / dL and approximately 100 mg / dL, and in particular between approximately 85 mg / dL and approximately 95 mg / dL. Another safety constraint is the cost component for insulin 608 (i.e., insulin cost). This penalty for excessive insulin delivery may be reduced as part of the mitigation. A typical cost function for insulin delivery is as follows:

number

[0059] At step 214, taking into account that a new glucose value has been given and the first portion of the insulin bolus has been delivered, the steps in Figure 4 are repeated using the updated total IOB and the updated safe required IOB. Once the dosage, in particular the dosage of the second portion, has been determined, the second portion of the insulin bolus may be delivered at step 216. In some embodiments, the second portion is determined 1 to 5 cycles after the determination of the first portion, more specifically 1 to 3 cycles later, in particular during the cycle immediately following the cycle in which the first portion was determined. In some embodiments, the second portion is determined in the cycle following the calculation of the first portion, in particular the cycle following the cycle in which the first portion was determined, for each calculation identical to that of the first portion, and the current total IOB, safe required IOB and blood glucose level are updated in the cycle following the calculation. Therefore, in some embodiments, the second part is determined by determining the safe required IOB (for the cycle determining the second part), determining the current total IOB (for the cycle determining the second part), adding the safe required IOB to the percentage of total daily insulin (for the cycle determining the second part), and subtracting the current total IOB (for the cycle determining the second part) from there. In some embodiments, the percentage of total daily insulin is calculated by multiplying the user's total daily insulin by a dietary coefficient, the dietary coefficient being between approximately 1% and 10%, and more specifically, between 3% and 8%.

[0060] Figure 7 shows an exemplary plot 700 for exemplary autobolus delivery. Plot 700 shows that a meal is detected at time 702. The first portion of the insulin bolus may be delivered at that time, followed soon by the delivery of the second portion (e.g., in the next cycle). Safety constraints may be immediately relaxed during the 30-minute period 704 between times 706 and 708. Plot 700 also shows a curve 710 of the user's glucose values ​​over time. As will be discussed later, after the delivery of the insulin bolus, there may be a cool-down period of, for example, 90 minutes, as indicated by the arrow 712. During the cool-down period, there may be no detection of a meal, so additional boluses cannot be automatically delivered via the autobolus mechanism.

[0061] There are alternative methods for determining the dosage of a portion of an insulin bolus, different from the approach described above. In some exemplary embodiments, the dosage of each portion of the insulin bolus may be limited. Figure 8 shows a flowchart 800 of exemplary steps that may be performed in exemplary embodiments when limiting the dosage. In 802, the dosage of a portion of the insulin bolus may be calculated as described above. The dosage may be compared to a maximum value, such as one unit of insulin, which acts as a limit in 804. If the dosage is greater than or equal to the limit, the maximum value may be used as the dosage that may ultimately be delivered in 808. Otherwise, the calculated dosage may be used as the dosage that may be delivered.

[0062] In other exemplary embodiments, the dosage is selected from a set of options. Figure 9 shows a flowchart 900 of exemplary steps that may be performed in an exemplary embodiment to select from the options. In 902, the dosage may be determined for autobolus delivery as described above in relation to Figure 4. In 902, the dosage may be determined for a portion of the insulin bolus based on a glucose value prediction. For example, the insulin delivery device 102 may include logic in the control application 116 that determines the bolus amount needed to bring the user 108's glucose value into an acceptable range, taking into account the user 108's current glucose value, dietary intake, and glucose value trends. In 906, the larger of the two determined dosages may be selected for a portion of the insulin bolus. If both dosage sizes are estimated to be safe, the larger dosage may be selected to bring the user 108's glucose value into an acceptable range more quickly.

[0063] As described above, a cool-down period may be provided. The cool-down period helps prevent excessive bolus infusions that could crash or hypoglycemic the user's glucose levels, or more generally, reach undesirable low levels. In some embodiments, hypoglycemia may be defined as a blood glucose level between approximately 40 mg / dL and approximately 80 mg / dL, more specifically between approximately 50 mg / dL and approximately 70 mg / dL, and in particular between approximately 55 mg / dL and approximately 65 mg / dL. The cool-down period may be a fixed number of cycles, such as 12 to 18 cycles (i.e., for a 5-minute cycle, the cool-down period is 1 to 1.5 hours). In some embodiments, the cool-down period has a fixed number of cycles, between approximately 3 to approximately 180 cycles, more specifically between 6 to approximately 60 cycles, and in particular between approximately 10 to approximately 20 cycles. In some embodiments, each cycle has a length between approximately 30 seconds and approximately 30 minutes, more specifically between approximately 1.5 minutes and approximately 10 minutes, and in particular between approximately 3 minutes and approximately 9 minutes. Figure 10 shows a flowchart 1000 of exemplary steps that may be performed in an exemplary embodiment for a cool-down period. In 1002, the cool-down period may be initiated by the delivery of an insulin bolus. The cool-down period may be achieved by stopping meal detection, and therefore stopping any autobolus insulin delivery. In 1004, time progresses until the next cycle is reached. In 1006, a check may be made to see whether the cool-down period has ended. If the cool-down period has not ended, the process may repeat waiting in 1004 until the next cycle is reached. If the cool-down period has ended, in 1008, the cool-down period may be stopped by enabling meal detection. It should be understood that means other than turning meal detection on and off may be used to enable and disable the autobolus function.

[0064] To prevent the user from experiencing excessively low glucose levels, the autobolus function may be disabled when the user exercises. Figure 11 shows a flowchart 1100 of exemplary steps that may be performed in an exemplary embodiment to disable autobolus in such cases. The insulin delivery device 102 may have an activity mode that the user 108 may select when the user 108 starts or is about to start exercising. In 1102, the user 108 turns on the activity mode. In some embodiments, the insulin delivery device 102 automatically detects an activity such as exercise and triggers the activity mode. In 1106, the autobolus function may be disabled as described above. In some embodiments, the autobolus capability may be re-enabled in response to the activity mode being turned off.

[0065] As described above, one or more safety constraints may be relaxed in response to the delivery of an insulin bolus. However, in some exemplary embodiments, this relaxation may be released when a release condition occurs. Figure 12 shows a flowchart 1200 of exemplary steps that may be performed in an exemplary embodiment to release the relaxation of one or more safety constraints. In 1202, the safety constraints are relaxed in response to the delivery of an insulin bolus. In 1204, a release condition occurs. In 1206, the relaxation of one or more safety constraints may be released so that one or more safety constraints return to their default settings or recently established values ​​before relaxation.

[0066] The release conditions may vary. Figure 13 shows some exemplary release conditions 1300. A glucose level crash 1302 may trigger the release of the relaxation so that basal insulin delivery can be reduced and the user 108's glucose level can be stabilized. A glucose level crash 1302 may be defined, for example, when the glucose level falls below a threshold or when the user 108's glucose level falls above a certain rate threshold. In some embodiments, the rate threshold may be between approximately -1 mg / dL / min and approximately -10 mg / dL / min, more specifically between approximately -2 mg / dL / min and approximately -6 mg / dL / min, and particularly between -2.5 mg / dL / min and approximately -4 mg / dL / min. Alternatively or additionally, in some embodiments, a glucose level crash 1302 may be defined as when the glucose level falls for at least 3 cycles. In some embodiments, a glucose level crash may be defined as when the rate threshold is exceeded for the following 2 cycles and / or for the following 3 cycles. In some embodiments, a glucose crash may be determined when a threshold of the rate of change is exceeded during the following two or three cycles, the threshold of the rate of change for the following three cycles being lower than that for the following two cycles when determining a glucose crash over the following three cycles, more specifically about 20% to 70% lower, and in particular about 40% to 60% lower. In some embodiments, a glucose crash may be specified when the glucose level decreases over four following cycles. Another release condition may be that the activity mode is enabled (1304). When in activity mode, in other words, when the user is exercising, the exercise performed by the user lowers the user's glucose level by 108, so there is a risk that the user's glucose level will drop to too low a level due to potentially large insulin delivery under relaxed safety constraints. Therefore, the release of relaxation is justified.

[0067] As described above, the delivery of an insulin bolus and the relaxation of safety constraints for a certain period may also be triggered by the user 108 activating an element of the drug delivery device 102 or the control device to signal a meal. For example, as shown in Figure 14A, the control device 1400 may have a display 1402. The display 1402 may display text instructing the user 108 to press a button 1406 indicating that a meal has been eaten. Pressing the button 1406 signals that the user 108 has eaten, and the drug delivery device may deliver a meal insulin bolus, as described below. The element to be activated to signal a meal may be alternatively or additionally present in the drug delivery device 102. Figure 14B shows a top view of the drug delivery device 1410. The top of the housing 1412 may have a mechanical, electromechanical, or electrical button 1414 that the user may press or touch to signal that a meal has been eaten or is about to be eaten (for example, a physical or alternative "soft" button may be used). The settings for the drug delivery device 102 may include a user-adjustable setting indicating the time required to take a meal after pressing button 1414. For example, the user may set it to "5 minutes," meaning that the meal will be taken approximately 5 minutes after pressing button 1414. In some embodiments, other types of elements may be provided to the user 108 to signal that it is time to eat. Figure 14C shows a diagram listing some types of elements that may be activated to signal that the user 108 has eaten. The activatable elements 1420 may include a button 1422, a knob 1424, a switch 1426, a lever 1428, or a user interface (UI) element 1430. It should be understood that other types of activatable elements may be used and that the depiction in Figure 14C is not intended to be exhaustive.

[0068] Figure 15 shows a flowchart 1500 of exemplary steps that may be performed in an exemplary embodiment when using a manual notification approach for eating. In 1502, the user 108 notifies of eating by activating an activatable element. In response to the activation, in 1504, the drug delivery device 102 may determine the dosage of a portion of the insulin bolus to be delivered as a mealtime insulin bolus. This may be done as described above in relation to Figure 4. In 1506, the drug delivery device 102 delivers the portion of the insulin bolus as described above in relation to Figure 3. In 1508, at least one of the safety constraints is relaxed as described above.

[0069] Once a portion of the insulin bolus has been delivered as described above, a cool-down period may be observed. The relaxation of safety constraints may be lifted as described above in relation to claims 12 and 13.

[0070] In some exemplary embodiments, the autobolus function and manual notification of eating can be used in combination. The drug delivery device 102 may take measures to ensure that these two approaches are compatible for identifying a meal and delivering a meal insulin bolus in response. Figure 16A shows a plot 1600 of the operation when the autobolus effect and the notification of eating effect do not overlap at that time. Plot 1600 plots the amount of insulin delivered 1602 over time 1606 and the user's glucose value 1604 over time 1606. A curve 1608 of the glucose value is shown. Plot 1600 shows where the standard safety setting is effective, as indicated by “Standard Setting” along the time axis. In this figure, at time 1610, the user 108 activates an activatable element to notify of eating. The drug delivery device 102 determines and delivers the first and second portions of the insulin bolus, as described above. At least one safety constraint is relaxed from the "standard setting" during the relaxation period, as indicated by arrow 1612. After the relaxation period ends, the safety constraint is no longer relaxed. A meal is detected at time 1614. The drug delivery device determines and delivers the first and second portions of the insulin bolus to user 108. At least one safety constraint is relaxed during the relaxation period, as indicated by arrow 1616. After the relaxation period, one or more relaxed safety constraints are no longer relaxed.

[0071] Figure 16B shows plot 1620 when the autobolus capability is triggered in response to manual notification of eating, while at least one safety constraint is relaxed from the “standard setting” after insulin bolus delivery. In the example depicted, at time 1620, user 108 notifies of eating by activating an activatable element. Drug delivery device 102 determines the dosage of the first and second portions of the meal insulin bolus and delivers the first and second portions to user 108. At least one safety constraint is relaxed over the period indicated by arrow 1622. At time 1624, eating is detected. The autobolus capability delivers the first and second portions of the insulin bolus in response to the detection of eating. At least one safety constraint is relaxed by the autobolus capability during the relaxation period indicated by arrow 1626. The relaxation of at least one safety constraint resulting from manual notification of eating ends as indicated by “X” 1628. This shows a return to the “standard setting” after the relaxation period indicated by arrow 1626.

[0072] Figure 16C shows a third plot 1630 similar to those in Figures 16A and 16B. However, in this example plot, a meal is detected at time 1632. In response, the autobolus function delivers the first and second portions of the meal insulin bolus and relaxes at least one of the "standard settings" constraints during the period indicated by arrow 1634. At time 1636, user 108 activates an activatable element to signal that they are eating. The first and second portions of the meal insulin bolus are delivered to user 108 by the drug delivery device 102. At least one safety constraint is relaxed in response during the relaxation period indicated by arrow 1640. The previous relaxation of at least one safety constraint resulting from the autobolus insulin bolus delivery is stopped as indicated by "X" 1638. The "standard settings" are re-adopted after the relaxation period 1640 has ended.

[0073] This disclosure also relates to a computer program that includes instructions (also called computer program instructions) for performing the functions described above. The instructions may be executed by a processor. The instructions may be executed, for example, by multiple processors in a distributed computer system. The computer program of this disclosure may be pre-installed or downloaded to, for example, a drug delivery device, a control device, a fluid delivery device, for example, its storage. The computer program may compute the first and second parts to be delivered.

[0074] While exemplary embodiments have been described herein, various modifications of form and detail can be made without departing from the intended scope of the appended claims. The present invention is defined by the appended claims, but it should be understood that the present invention can also be defined (alternatively) according to the following embodiments. 1. A drug delivery system for delivering drugs to users, Drug storage section, A needle or cannula for puncturing the user's skin in order to deliver the drug from the storage unit, A fluid pathway for the drug between the storage section and the needle or cannula, A non-temporary computer-readable storage medium for storing computer program instructions, A processor configured to execute the aforementioned computer program instructions, wherein by executing the aforementioned computer program instructions, Restricting the delivery of drugs to users, Receiving the user's glucose value, Based on the received glucose level of the user, it is determined whether or not the user has eaten a meal. The invention provides an auto-bolus function that delivers a first portion of a drug bolus to the user in response to the processor's determination that the user has eaten a meal. To enable the delivery of higher doses of automated drug delivery in accordance with at least one relaxed drug safety constraint, at least one drug safety constraint is relaxed during the period following the delivery of the first portion of the drug bolus, A processor that causes the aforementioned processor to perform the following, A drug delivery system equipped with the following features. 2. The drug delivery system according to Embodiment 1, further causing the processor to deliver a second portion of the drug bolus by executing the computer program instructions. 3. The drug delivery system according to Embodiment 1 or 2, further comprising causing the processor to determine the dosage of the second portion of the drug bolus by executing the computer program instructions. 4. The drug delivery system according to Embodiment 3, wherein the dosage of the second portion is determined at least in part based on the most recently received glucose value and the user's carried drug. 5. The drug delivery system according to Embodiment 2, wherein the processor is further instructed to prevent the delivery of another drug bolus during the cool-down period following the delivery of the second portion of the drug bolus by executing the computer program instructions. 6. A drug delivery system according to any one of Embodiments 1 to 5, wherein the processor is further instructed to deactivate the autobolus function when an activity mode is set or the user is in a cool-down period by executing the computer program instructions, the set activity mode indicating that the user is active or will soon be active. 7. The drug delivery system according to any one of embodiments 1 to 6, wherein the processor is further instructed to release the relaxation of the at least one drug delivery constraint when at least one release condition other than the expiration of the period is met by executing the computer program instruction. 8. The drug delivery system according to any one of Embodiments 1 to 7, wherein the at least one release condition includes at least one of the difference between consecutively received user blood glucose levels exceeding a threshold or an activity mode being set, and the set activity mode indicates that the user is active or will soon be active. 9. A drug delivery system for delivering drugs to users, Drug storage section, A needle or cannula for puncturing the user's skin in order to deliver the drug from the storage unit, A fluid pathway for the drug between the storage section and the needle or cannula, A non-temporary computer-readable storage medium for storing computer program instructions, A processor configured to execute the aforementioned computer program instructions, wherein by executing the aforementioned computer program instructions, In accordance with current drug safety constraints, the delivery of drugs to users will be restricted, Receiving instructions from the user regarding the delivery of a drug bolus to the user, In response to the received request, the first portion of the drug bolus is delivered to the user, To allow for the delivery of higher doses of the base drug delivery as needed, without adhering to at least one of the relaxed current drug safety constraints, at least one of the current drug safety constraints during the period following the delivery of the first portion of the drug bolus, A processor that causes the aforementioned processor to perform the following, A drug delivery system equipped with the following features. 10. The drug delivery system according to Embodiment 9, further comprising an element which may be activated by a user to request the delivery of the drug bolus. 11. The drug delivery system according to Embodiment 9 or 10, wherein the element is one of a button, knob, switch, or lever. 12. The drug delivery device further comprises a user interface, wherein the element is a user interface element, according to any one of embodiments 9 to 11. 13. A drug delivery system according to any one of embodiments 9 to 12, wherein the processor is further instructed to deliver the second portion of the drug bolus by executing the computer program instructions. 14. A drug delivery system according to any one of embodiments 9 to 13, wherein the processor is further instructed to determine the dosage of the second portion of the drug bolus by executing the computer program instructions. 15. A drug delivery system according to any one of embodiments 9 to 14, wherein the processor is further instructed to prevent the delivery of another drug bolus during the cool-down period following the delivery of the second portion of the drug bolus by executing the computer program instructions. 16. A drug delivery system according to any one of embodiments 9 to 15, wherein the processor is further instructed to release the relaxation of at least one drug safety constraint when the difference between consecutively received user blood glucose levels exceeds the respective threshold or when an activity mode is set, the set activity mode indicating that the user is active or will soon be active. 17. A drug delivery device, Drug tanks for storing drugs, A needle or cannula for piercing a patient's skin, which is hollow to function as a conduit for delivering a drug to the user, A non-temporary computer-readable storage device that stores computer program instructions for controlling the operation of the drug delivery device, A processor that executes the computer program instructions, In accordance with current drug safety constraints, the delivery of drugs to users will be restricted, Delivering the first portion of the drug bolus to the user, To allow for the delivery of higher doses of the base drug delivery as needed, without adhering to at least one of the relaxed current drug safety constraints, at least one of the current drug safety constraints during the period following the delivery of the first portion of the drug bolus, A processor that causes the aforementioned processor to perform the following, A drug delivery device equipped with the following features. 18. A drug delivery device according to Embodiment 17 that alleviates several current drug safety constraints. 19. The drug delivery device according to Embodiment 17 or 18, wherein the drug safety constraints include at least one of the following: the maximum amount of drug that can be delivered from the drug delivery device to the user in an operating cycle of the drug delivery device; the maximum amount of drug that can be delivered from the drug delivery device to the user in a specified number of operating cycles of the drug delivery device; the current set value of the user's glucose level; the maximum level of drug carried by the user; and a penalty amount in the cost function for extra drug delivery. 20. A drug delivery device according to any one of embodiments 17 to 19, wherein the processor is further instructed to deliver a second portion of the drug bolus at a certain time after the delivery of the first portion of the drug bolus by executing the computer program instructions. 21. A method performed by a processor of a drug delivery system, Receiving glucose values ​​and / or other analyte level values ​​for the user, An autobolus function that determines whether a user has eaten based on the analyte level values ​​of the received user, and in response to the determination that the user has eaten, determines the first portion of the drug bolus to be delivered to the user. The drug delivery system determines that it has delivered the first portion to the user, The present invention provides for the relaxation of at least one drug safety constraint during the period following the determination that the first portion of the drug bolus has been delivered, wherein the relaxation of at least one drug safety constraint allows for the delivery of a higher dose of the base drug delivery as needed, without adhering to the relaxed drug safety constraint. A method for providing this. 22. The method according to Embodiment 21, further comprising determining the dosage of a second portion of the drug bolus to be delivered to the user. 23. The method according to Embodiment 22, wherein the dosage of the second portion is determined at least in part based on the most recently received analyte level value and the user's onboard drug. 24. The method according to embodiment 22 or 23, further comprising determining that a second portion of the drug bolus has been delivered. 25. The method according to Embodiment 24, further comprising preventing the delivery of another drug bolus during a cool-down period after the delivery of a second portion of the drug bolus, and / or sending an instruction to the drug delivery device indicating that another drug bolus should not be delivered during the cool-down period after it has been determined that the second portion of the drug bolus has been delivered. 26. The method according to any one of embodiments 21 to 25, wherein the auto-bolus function is deactivated when an activity mode is set or when the user is in a cool-down period, the setting of the activity mode further comprising indicating that the user is active or will soon be active. 27. The method according to any one of embodiments 21 to 26, wherein the relaxation of the at least one drug delivery restriction is released when at least one release condition other than the expiration of the period is met. 28. The method according to Embodiment 26, wherein one or more release conditions include at least one of the following: the difference between consecutively received user blood glucose levels exceeds a threshold, or an activity mode is set, the set activity mode indicating that the user is active or will soon be active. 29. A method performed by a processor of a drug delivery system, To receive instructions from the user requesting immediate delivery of a drug bolus to the user, In response to the received request, determine the first portion of the drug bolus to be delivered to the user, Determining that the first portion of the drug bolus has been delivered by the drug delivery system, To relax at least one of the current drug safety constraints during the period following the delivery of the first portion of the drug bolus, wherein by relaxing at least one drug safety constraint, a higher dose of the base drug delivery can be determined as needed without being subject to the relaxed at least one drug safety constraint, A method for providing this. 30. A method performed by a processor of a drug delivery system, Determining the first portion of the drug bolus to be delivered to the user, Determining that the first portion of the drug bolus has been delivered by the drug delivery system, To relax at least one of the current drug safety constraints during the period following the delivery of the first portion of the drug bolus, wherein by relaxing at least one drug safety constraint, a higher dose of the base drug delivery can be determined as needed without being subject to the relaxed at least one drug safety constraint, A method for providing this.

Claims

1. A drug delivery system that delivers drugs to users, Drug storage section, A needle or cannula for puncturing the user's skin in order to deliver the drug from the storage unit, A fluid pathway for the drug between the storage section and the needle or cannula, A non-temporary computer-readable storage medium for storing computer program instructions, A processor configured to execute the aforementioned computer program instructions, wherein by executing the aforementioned computer program instructions, Constraining the amount of drug that may be delivered to the user by the drug delivery system in accordance with one or more drug safety constraints, including at least one of the following: the maximum amount of drug that can be delivered from the drug delivery system to the user in an operating cycle of the drug delivery system; the maximum amount of drug that can be delivered from the drug delivery system to the user in a specified number of operating cycles of the drug delivery system; the current set value of the user's glucose level; the maximum level of drug carried by the user; and a penalty amount in the cost function for excess drug delivery. Receiving the user's glucose value, Based on the received glucose level of the user, it is determined whether or not the user has eaten a meal. To provide an auto-bolus function that, in response to the processor's determination that the user has eaten, delivers the first portion of a drug bolus, which includes a first portion and a second portion, to the user; Allowable is to increase the dose of automated drug delivery by the drug delivery system by modifying at least one of the one or more drug safety constraints during the period following the delivery of the first portion of the drug bolus, The second portion of the drug bolus is delivered in one to five operating cycles of the drug delivery system after the delivery of the first portion of the drug bolus. To prevent the delivery of another drug bolus during the cool-down period following the delivery of the second portion of the drug bolus, A processor that causes the aforementioned processor to perform the following, A drug delivery system equipped with the following features.

2. The drug delivery system according to claim 1, wherein the dosage of the second portion is determined at least in part based on the most recently received glucose value and the user's carried drug.

3. The drug delivery system according to claim 1, wherein the processor deactivates the autobolus function when an activity mode is enabled or the user is in a cool-down period, and the set activity mode indicates that the user is active or will soon be active.

4. A drug delivery system that delivers drugs to users, Drug storage section, A needle or cannula for puncturing the user's skin in order to deliver the drug from the storage unit, A fluid pathway for the drug between the storage section and the needle or cannula, A non-temporary computer-readable storage medium for storing computer program instructions, A processor configured to execute the aforementioned computer program instructions, wherein by executing the aforementioned computer program instructions, Constraining the amount of drug that may be delivered to the user by the drug delivery system in accordance with one or more drug safety constraints, including at least one of the following: the maximum amount of drug that can be delivered from the drug delivery system to the user in an operating cycle of the drug delivery system; the maximum amount of drug that can be delivered from the drug delivery system to the user in a specified number of operating cycles of the drug delivery system; the current set value of the user's glucose level; the maximum level of drug carried by the user; and a penalty amount in the cost function for excess drug delivery. Receiving instructions from the user requesting delivery of a drug bolus including the first and second parts to the user, In response to the received request, the first portion of the drug bolus is delivered to the user, Allowable is to increase the dose of automated drug delivery by the drug delivery system by modifying at least one of the one or more drug safety constraints during the period following the delivery of the first portion of the drug bolus, The second portion of the drug bolus is delivered in one to five operating cycles of the drug delivery system after the delivery of the first portion of the drug bolus. To prevent the delivery of another drug bolus during the cool-down period following the delivery of the second portion of the drug bolus, A processor that causes the aforementioned processor to perform the following, A drug delivery system equipped with the following features.

5. The drug delivery system according to claim 4, further comprising an element which may be activated by a user to request the delivery of the drug bolus.

6. The drug delivery system according to claim 4, wherein the processor cancels a change to at least one of the one or more drug safety constraints when the difference between consecutively received user blood glucose levels exceeds the respective threshold or when an activity mode is set, and the set activity mode indicates that the user is active or will soon be active.

7. A drug delivery device, Drug tanks for storing drugs, A needle or cannula for piercing a patient's skin, which is hollow to function as a conduit for delivering a drug to the user, A non-temporary computer-readable storage device that stores computer program instructions for controlling the operation of the drug delivery device, A processor that executes the computer program instructions, Restricting the amount of drug that may be delivered to the user by the drug delivery device in accordance with one or more drug safety constraints, including at least one of the following: the maximum amount of drug that can be delivered from the drug delivery device to the user in an operating cycle of the drug delivery device; the maximum amount of drug that can be delivered from the drug delivery device to the user in a specified number of operating cycles of the drug delivery device; the current set value of the user's glucose level; the maximum level of drug carried by the user; and a penalty amount in the cost function for excess drug delivery. Delivering the first portion of a drug bolus, which includes the first and second portions, to the user, Allowable is to increase the dose of automated drug delivery by the drug delivery device by modifying at least one of the one or more drug safety constraints during the period following the delivery of the first portion of the drug bolus, The second portion of the drug bolus is delivered in 1 to 5 operating cycles of the drug delivery device after the delivery of the first portion of the drug bolus. To prevent the delivery of another drug bolus during the cool-down period following the delivery of the second portion of the drug bolus, A processor that causes the aforementioned processor to perform the following, A drug delivery device equipped with the following features.

8. A drug delivery device according to claim 7, which modifies multiple drug safety constraints.

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