Automatic or manually initiated meal bolus delivery followed by automatic safety constraint relaxation

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 January 6, 2023, the entire contents of which are incorporated herein by reference. Summary of the Invention [Problem to be solved by the invention]

[0002] Diabetic patients require additional insulin to counteract the rise in glucose levels associated with meal intake. Traditionally, such diabetics have administered an insulin bolus via manual injection in anticipation of eating a meal. The diabetics must determine the amount of insulin to administer, which is difficult and prone to error. The diabetics must correctly determine the carbohydrate content of the meal and accurately determine the appropriate insulin bolus to counteract the rise in glucose levels caused by consuming the calculated amount of carbohydrates with the meal. The diabetics must also properly time the insulin bolus relative to the intake of the meal. Sometimes, diabetics even forget to administer an insulin bolus for a meal. Ultimately, this can lead to poor glucose management. Diabetic patients can experience hyperglycemia as a result of selecting too small an insulin bolus or hypoglycemia as a result of selecting too large an insulin bolus. [Means for solving the problem]

[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 reservoir or tank and a needle or cannula for piercing the user's skin to deliver the drug from the reservoir. The drug delivery system may further include a fluid path for the drug from the reservoir to the needle or cannula and a non-transitory computer-readable storage medium for storing computer program instructions and other historical information. The drug delivery system may also include a processor configured to execute the computer program instructions. Execution of the computer program instructions may cause the processor to restrict delivery of the drug to the user, receive glucose and / or other analyte level values ​​of the user, and determine whether the user has eaten based on the received analyte level values ​​of the user. Execution of the computer program instructions may further cause the processor to provide an auto-bolus function that delivers a first portion of a drug bolus to the user in response to the processor determining that the user has eaten, and relax at least one drug safety constraint during a period following delivery of the first portion of the drug bolus to enable delivery of a larger dose of the automatic drug delivery in accordance with the relaxed at least one drug safety constraint.

[0004] Execution of the computer program instructions may further cause the processor to deliver a second portion of the drug bolus. Execution of the computer program instructions may further cause the processor to determine a dosage for the second portion of the drug bolus. The dosage for the second portion may be determined based at least in part on recently received glucose values ​​and the user's on-board medication. Execution of the computer program instructions may further cause the processor to prevent delivery of another drug bolus during a cool-down period after delivery of the second portion of the drug bolus. Execution of the computer program instructions may further cause the processor to disable the auto-bolus function if 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. Execution of the computer program instructions may further cause the processor to disable the relaxation of the at least one drug delivery constraint when at least one override condition other than expiration of the period is met. The override condition(s) may include at least one of a difference between consecutively received user blood glucose values ​​exceeding a respective threshold or an activity mode being set, the set activity mode indicating that the user is active or will soon be active.

[0005] According to another inventive aspect, a method executed by a 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 auto-bolus function that determines a first portion of a drug bolus to deliver to the user in response to determining that the user has eaten, determining that the drug delivery system has delivered the first portion to the user, and relaxing at least one drug safety constraint during a period of time after determining that the first portion of the drug bolus has been delivered, wherein relaxing the at least one drug safety constraint allows for delivery of a larger dose of basal drug delivery, if desired, without complying with the relaxed at least one drug safety constraint.

[0006] The method may further comprise determining a dosage of a second portion of the drug bolus to be delivered to the user. The dosage of the second portion may be determined based at least in part on recently received analyte level values ​​and the user's on-board medication. The method may further comprise determining that the second portion of the drug bolus has been delivered. Additionally, the method may further comprise preventing delivery of another drug bolus during a cool-down period after delivering the second portion of the drug bolus and / or transmitting instructions to the drug delivery device indicating that another drug bolus should not be delivered during a cool-down period after determining that the second portion of the drug bolus has been delivered. The method may further comprise disabling the auto-bolus feature if an active mode is set or if 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 also disabling the relaxation of at least one drug delivery constraint if at least one disabling condition other than expiration of a period is met. The (one or more) termination conditions may include at least one of the difference between successively received blood glucose levels of the user exceeding a respective threshold or an activity mode being set, the activity mode being set indicating that the user is active or will soon be active.

[0007] According to another inventive aspect, a drug delivery system for delivering a drug to a user may include a drug reservoir and a needle or cannula for piercing the user's skin to deliver the drug from the reservoir. The drug delivery system may further include a fluid pathway for the drug from the reservoir to the needle or cannula. The drug delivery system may further include a non-transitory computer-readable storage medium storing computer program instructions and a processor configured to execute the computer program instructions. Execution of the computer program instructions may cause the processor to constrain delivery of the drug to the user in accordance with current drug safety constraints and to receive an indication of a user's request to deliver a drug bolus to the user. Execution of the computer program instructions may further cause the processor to deliver a first portion of the drug bolus to the user in response to the received request and to relax at least one of the current drug safety constraints during a period following delivery of the first portion of the drug bolus to allow for delivery of a larger dose of basal drug delivery, if desired, without complying with the relaxed at least one current drug safety constraint.

[0008] The drug delivery system may further comprise an element that may be actuated by a user to request delivery of a drug bolus. The element may be, for example, a button, a knob, a switch, a lever, or one of a user interface elements. Execution of the computer program instructions may further cause the processor to deliver a second portion of the drug bolus. Execution of the computer program instructions may further cause the processor to determine a dosage for the second portion of the drug bolus. Execution of the computer program instructions may further cause the processor to prevent delivery of another drug bolus during a cool-down period after delivery of the second portion of the drug bolus. Execution of the computer program instructions may further cause the processor to release relaxation of at least one drug safety constraint when a difference between successively received blood glucose values ​​of the user exceeds a respective threshold value or when an activity mode is set, the activity mode indicating that the user is active or will soon be active.

[0009] According to another inventive aspect, a method executed by a processor of a drug delivery system may comprise receiving an indication of a user's request to immediately deliver a drug bolus to a user. The method may further comprise, 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 current drug safety constraint during a period following delivery of the first portion of the drug bolus, wherein relaxing the at least one drug safety constraint allows for determining a larger dosage of basal drug delivery, if necessary, without complying with the relaxed at least one drug safety constraint.

[0010] According to another inventive aspect, a drug delivery device includes a drug reservoir for storing a drug, such as insulin, and a needle or cannula for piercing a patient's skin, the needle or cannula being hollow to serve as a conduit for delivering the drug to a user. The drug delivery device may include non-transitory computer-readable storage that stores computer program instructions for controlling operation of the drug delivery device. The drug delivery device may include a processor that executes the computer program instructions to cause the processor to constrain 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 a period following delivery of the first portion of the drug bolus to allow for delivery of a larger dose of basal drug delivery, if desired, without complying with the relaxed at least one current drug safety constraint.

[0011] According to another inventive aspect, a method executed by a 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 current drug safety constraint during a period following delivery of the first portion of the drug bolus, wherein relaxing the at least one drug safety constraint allows for determining a larger dosage of basal drug delivery, if desired, without complying with the relaxed at least one drug safety constraint.

[0012] A plurality of current drug safety constraints may be relaxed. The drug safety constraints may include at least one of a maximum amount of drug that can be delivered to the user from the drug delivery device in an operating cycle of the drug delivery device, a maximum amount of drug that can be delivered to the user from the drug delivery device in a specified number of operating cycles of the drug delivery device, a current set value for the user's glucose value, a maximum level of the user's on-board drug, and a penalty amount in a cost function for excess drug delivery. Execution of the computer program instructions may further cause the processor to deliver a second portion of the drug bolus a fixed time after delivery of the first portion of the drug bolus. The method may further comprise determining the second portion of the drug bolus a fixed time after delivery of the first portion of the drug bolus. [Brief explanation of the drawings]

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

[0014] [Figure 2] FIG. 2 shows a flow chart of exemplary steps that may be performed in an exemplary embodiment having autobolus functionality.

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

[0016] [Figure 3B] FIG. 3B shows an example of a sliding window that slides over time to encompass a two-hour period that is updated upon receiving new glucose readings for meal detection in an exemplary embodiment.

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

[0018] [Figure 5] FIG. 5 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment to determine safe required medication or IOB, such as insulin, on board.

[0019] [Figure 6] FIG. 6 illustrates examples of safety constraints that may be relaxed in an exemplary embodiment.

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

[0021] [Figure 8] FIG. 8 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment in limiting the dosage of a portion of a drug bolus.

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

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

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

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

[0026] [Figure 13] FIG. 13 illustrates some exemplary termination conditions that may be used in an exemplary embodiment.

[0027] [Figure 14A] FIG. 14A shows an example of a user interface button on the management device that may be activated by a user to indicate that they are eating.

[0028] [Figure 14B] FIG. 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 they are eating.

[0029] [Figure 14C] FIG. 14C illustrates a number of exemplary activatable elements that may be activated by a user to indicate that they are eating.

[0030] [Figure 15] FIG. 15 shows a flowchart of exemplary steps that may be performed in an exemplary embodiment to deliver a meal drug bolus and relax at least one safety constraint in response to a user's activation of an activatable element to indicate that they are eating.

[0031] [Figure 16A] FIG. 16A shows a plot illustrating the cooperation of auto-bolus performance and meal drug bolus performance triggered by manually signaling to eat of an exemplary embodiment. [Figure 16B] FIG. 16B shows a plot illustrating the cooperation of auto-bolus performance and meal drug bolus performance triggered by manually signaling to eat of an exemplary embodiment. [Figure 16C]FIG. 16C shows a plot illustrating the cooperation of auto-bolus performance and meal drug bolus performance triggered by manually signaling to eat of an exemplary embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0032] Exemplary embodiments may ease the burden on a diabetic patient regarding the delivery of a meal bolus of a medication, 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 ​​from a user (e.g., a diabetic patient or person with diabetes (PWD)) and determines when the user has eaten a meal based on the glucose or other analyte level values. In some embodiments, the drug delivery device and / or drug delivery system may calculate the 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 of accurately determining the drug bolus dose. In some embodiments, instead of detecting a meal, the user may signal a meal, such as by activating the drug delivery device or an element of the management device of the drug delivery device (e.g., if the management device is part of the drug delivery system). The drug delivery device may calculate the drug bolus dose and deliver the drug bolus in response to signaling the meal.

[0033] In connection with drug bolus delivery, the drug delivery device may relax safety constraints during a relaxation period following drug bolus delivery to allow for the delivery of additional basal drug if necessary. The drug bolus dose may be selected to be conservative (i.e., a dose less than that required to fully accommodate meal intake) to reduce the risk of the user experiencing hypoglycemia. The drug delivery device may rely on the relaxed safety constraints to allow for more aggressive basal drug delivery to complete the compensation required to bring the user's glucose levels into the desired range after meal intake. The relaxation period may be lifted if the glucose value trend indicates a substantial downward trend or if the user enters a mode indicating the user is active, such as exercising. In some embodiments, relaxing the safety constraints allows the drug delivery system or device to deliver a larger amount of basal insulin.

[0034] Exemplary embodiments may provide a cool-down phase during which no additional drug boluses may be delivered for a period following delivery of a drug bolus despite the detection of a meal or user indication of a meal.

[0035] Exemplary embodiments may accommodate both auto-bolus delivery in response to meal detection with relaxation of safety constraints and bolus delivery in response to a user indicating a meal with relaxation of safety constraints. Exemplary embodiments may provide a means for resolving conflicts that may arise from auto-bolus delivery and meal indication. The drug delivery device may intelligently halt relaxation of safety constraints and / or meal detection as needed.

[0036] 1 illustrates 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 include a drug delivery device 102. The drug delivery device 102 may be attached to the body of the user 108 or may be a wearable device carried by the user 108. The drug delivery device 102 may be directly coupled to the user (e.g., attached directly to a body part and / or skin of the user via an adhesive, etc.) or may be carried by the user (e.g., carried on a belt or in a pocket) with the drug delivery device 102 connected to an injection site where the drug is injected using a needle and / or cannula. The surface of the drug delivery device 102 may include an adhesive to facilitate attachment to the user 108.

[0037] The drug delivery device 102 may include a processor 110. The processor 110 may be, for example, a microprocessor, logic circuit, field programmable gate array (FPGA), application specific integrated circuit (ASIC), or microcontroller. The processor 110 may maintain date and time as well as other functions (e.g., calculations, etc.). The processor 110 may be operable to execute a control application 116 encoded with computer program instructions stored in a memory 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 memory 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 the user 108 and, in some cases, 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 medication to the user 108 according to the control approach as 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 described below. The storage device 114 may maintain user history 111, such as basal delivery history, bolus delivery history, and / or other history, such as meal event history, exercise event history, glucose value history, other analyte level history, etc. Additionally, 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, magnetic storage, removable storage media, solid-state storage, etc.

[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 source (not shown), and a reservoir 112 that stores medication for delivery 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 eject medication from the reservoir 112 for delivery to the user 108 via the fluid path. The fluid path may include, for example, tubing connecting the drug delivery device 102 to the user 108 (e.g., tubing connecting a cannula to the reservoir 112) or may include a conduit to a separate infusion site. The drug delivery device 102 may have an operating cycle, such as every five minutes, in which it calculates and delivers a basal dose of medication as needed. These steps are repeated for each cycle.

[0040] For example, there may be one or more communication links with one or more devices physically separate from the drug delivery device 102, including the user's and / or the user's caregiver's management device 104, sensors 106, smart watches 130, fitness monitors 132, and / or various other wearable devices 134. The communication links may include any wired or wireless communication link operating according to 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 or wireless communication link. The network 122 may include a local area network (LAN), a wide area network (WAN), or a combination thereof. A computing device 126 may communicate with the network 122, and the computing device may communicate with the drug delivery device 102 or the management device 104.

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

[0043] The drug delivery system 100 may or may not include a management device 104. In some embodiments, a management device is not required because the drug delivery device 102 can manage itself. The management device 104 may be a dedicated device, such as a dedicated personal diabetes manager (PDM) device. The management device 104 may be a programmed general-purpose device, such as any portable electronic device including a dedicated controller such as a processor, microcontroller, etc. The management device 104 may be used to program or coordinate the operation of the drug delivery device 102 and / or the sensor(s) 106. The management device 104 may be any portable electronic device, including, for example, a dedicated device, a smartphone, a smartwatch, or a tablet. In the depicted example, the management device 104 may include a processor 119 and a memory device 118. The processor 119 may execute processes for managing the user's glucose levels and controlling the delivery of medication to the user 108. The drug delivery device 102 may provide data from the sensors 106 and other data to the management device 104. 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 be responsible for controlling the drug delivery device 102, such as controlling automatic drug delivery (ADD) of a drug to the user 108 (or, for example, automatic insulin delivery (AID)). 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, and other data and / or programs as described above for the drug delivery device 102. The embodiments described herein may be executed by multiple processors, for example, in a distributed computer system.

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

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

[0046] Other devices, such as a smart watch 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 management 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 some of the control functions performed by the processor 110 or the processor 119, for example, via the control applications 116 and 120. These devices 130, 132, and 134 may have a display for displaying information. The display may display a user interface for providing user input, such as a request to change or pause a dosage, or a request, start, or confirm delivery of a bolus of drug, or may display a user interface for displaying output, such as a change in dosage (e.g., basal delivery rate) determined by the processor 110 or the management device 104. These devices 130, 132, and 134 may have a wireless communication connection with the sensor 106 to directly receive analyte measurement data. A separate delivery device 105, such as a drug delivery pen (e.g., an insulin pen), may be configured (e.g., in determining IOB) or may also be provided to deliver drugs to the user 108.

[0047] The functionality described below for the exemplary embodiments may be under the control of or performed by the control application 116 of the drug delivery device 102 or the control application 120 of the management device 104. In some embodiments, the functionality may be under the control of or performed, in whole or in part, by a cloud service or server 128, a computing device 126, or other enumerated device, including a smart watch 130, a fitness monitor 132, or another wearable device 134.

[0048] In closed-loop mode, the control application 116, 120 continuously determines the amount of drug delivery to the user 108 based on a feedback loop. For example, for a drug delivery device that uses insulin, the goal in closed-loop mode is to bring the user's glucose level to a target glucose value or within a target glucose range. In some embodiments, the target glucose value is between about 100 mg / dL and about 140 mg / dL, more specifically between about 110 mg / dL and about 130 mg / dL, and especially between about 115 mg / dL and about 120 mg / dL.

[0049] In some embodiments, the drug delivery device 102 need not deliver a single drug alone. Instead, the drug delivery device 102 may deliver one drug, such as insulin, to lower the user's 108 glucose levels, and another drug, such as glucagon, to raise the user's 108 glucose levels. The drug delivery device 102 may deliver a glucagon-like peptide (GLP)-1 receptor agonist drug to lower blood glucose levels to delay post-prandial glucose spikes or to slow gastric emptying. In other embodiments, the drug delivery device 102 may deliver pramlintide or other drugs that can substitute for insulin. In other embodiments, the drug delivery device 102 may deliver concentrated insulin. In some embodiments, the agent or drug delivered by the drug delivery device may be a co-formulation of two or more of these agents identified above. In a preferred embodiment, the drug delivery device delivers insulin. Thus, although reference is made throughout this application to insulin and insulin delivery devices, those skilled in the art will understand that drugs other than insulin may be delivered instead of or in addition to insulin.

[0050] As described above, exemplary embodiments may automatically detect the ingestion of a meal by the user 108 based on glucose values ​​and automatically deliver an insulin bolus to counteract the rise in glucose caused by the ingestion of a meal. The automatic delivery of a bolus is sometimes referred to herein as an “auto-bolus.” FIG. 2 shows a flowchart 200 of exemplary steps that may be performed by an exemplary embodiment in providing auto-bolus functionality. At 202, a user's glucose value is received. The glucose value may originate from a glucose sensor, such as a CGM, that is one of the sensors 106. If the glucose value originates from a CGM, the glucose value may be received via a wireless connection between the CGM and the drug delivery device 102. The glucose value may be transmitted via an intermediate device, such as the management device 104, on its way to the drug delivery device 102. Additionally, the glucose value may be stored in the memory device 118 and retrieved from the memory device 118 as needed. The glucose value may be the most recent glucose value obtained for the user 100 or may include a value sufficient to detect a meal (e.g., glucose values ​​for a rolling 15-minute window) as described below. Alternatively, the glucose value may be obtained from a glucose meter that reads a test strip onto which a drop of the user's blood is applied, or from another type of glucose sensor. The most recent glucose value may be the glucose value received closest to the current time, for example, the current time is the time at which automatic meal detection occurs.

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

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

[0053] At 306, the classifiers may output respective probabilities, which are used in determining the probability of whether or not a meal event occurred and in determining the maximum allowable insulin bolus dose, as described above. Monitoring of the glucose level data of the user 108 may be performed continuously.

[0054] 3B shows an example of a sliding window 320 that slides over time to encompass a two-hour period that is updated as new glucose readings are received. The sliding window 320 may begin at position or window 322, which covers glucose readings up to reading number 20. At second position or window 324, the window encompasses readings 1 through 23, and at third position or window 326, the window encompasses readings 2 through 25. Readings occur at five-minute intervals, so one window may encompass a two-hour period. At window positions 322 and 324, no meals are detected, but at position or window 326, a meal is detected based on a predicted rise in glucose levels.

[0055] Referring to Figure 2, at 206, a check may be made to determine whether a meal has been detected based on the glucose value. If a meal is not detected, the process of Figure 2 is complete. If a meal is detected, at 208, a dosage of a first portion of an insulin bolus may be determined. In an exemplary embodiment, the first portion of the insulin bolus may be delivered by an auto-bolus mechanism immediately after the meal is detected. This may be followed by delivery of a second portion of the insulin bolus, for example, during the next operating cycle, as described below. The dosage of the first portion of the insulin bolus may be selected to be a safe amount to be delivered immediately.

[0056] FIG. 4 shows a flowchart 400 of exemplary steps that may be performed in an exemplary embodiment to calculate a portion, particularly a first portion, of an insulin bolus dose. At 402, the user's 108's current total insulin on-board (IOB) is subtracted from the safe IOB need to generate a difference. The total IOB includes all basal and bolus insulin delivered to the user that may still affect the user's glucose levels. The safe IOB need represents an IOB level with a safety factor built in. At 404, the difference may be added to a preset percentage of the user's 108's total daily insulin (TDI). The TDI may be the sum of all basal and bolus insulin delivered to the 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 the user's 108's safe IOB need level. At 406, the dose of the portion, particularly the first portion, of the insulin bolus may be set as a sum. This may be done as follows:

number

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

number

[0058] Referring to FIG. 2 , at 210, a first portion of an insulin bolus may be delivered by the insulin delivery device 102 to the user 108. At 212, relaxation of one or more safety constraints may begin during the next cycle after meal detection. Relaxation of one or more safety constraints may allow for more insulin to be delivered as basal insulin delivery during the relaxation period. The relaxation period may last, for example, a time frame of six cycles. FIG. 6 shows an example of a safety constraint that may be relaxed in an exemplary embodiment. The maximum amount of insulin that may be delivered in a cycle 602 is a safety constraint that may be relaxed. For example, the maximum amount of insulin that may be delivered in a cycle may be a multiple of the ideal basal delivery amount per cycle, and relaxation may increase the multiple. Another safety constraint that may be relaxed is the maximum amount of insulin that may be delivered over multiple cycles 604. Relaxation may simply increase this maximum value. A setpoint 606, also known as a “target,” for the control application 116 or 120 is a safety constraint. The setpoint 606 may be reduced as part of the constraint relaxation. For example, in some exemplary embodiments, the new set point may be selected to be the greater of the current set point minus 20 or a fixed value of 90 mg / dL. In embodiments, the fixed value may be between about 70 mg / dL and about 110 mg / dL, more specifically between about 80 mg / dL and about 100 mg / dL, and particularly between about 85 mg / dL and about 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:

number

[0059] At 214, given the new glucose value and considering that the first portion of the insulin bolus has been delivered, the steps of FIG. 4 are repeated using the updated total IOB and updated safe IOB requirement. Once the dosage, particularly the second portion dosage, has been determined, the second portion of the insulin bolus may be delivered at 216. In some embodiments, the second portion is determined 1 to 5 cycles after the determination of the first portion, more particularly 1 to 3 cycles after, and particularly 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, particularly in the cycle following the cycle in which the first portion was determined, for the same calculation as the first portion, and the current total IOB, safe IOB requirement, and blood glucose value are updated in the next cycle of calculation. Thus, in some embodiments, the second portion is determined by determining a safe IOB need (for the cycle determining the second portion), determining a current total IOB (for the cycle determining the second portion), adding the safe IOB need (for the cycle determining the second portion) to a percentage of total daily insulin, and subtracting the current total IOB (for the cycle determining the second portion). In some embodiments, the percentage of total daily insulin is calculated as the user's total daily insulin multiplied by a meal factor, where the meal factor is between about 1% and about 10%, and more specifically, 3%-8%.

[0060] FIG. 7 shows an exemplary plot 700 for an exemplary auto-bolus delivery. Plot 700 shows that a meal is detected at time 702. A first portion of an insulin bolus may be delivered at that time, followed shortly (e.g., on the next cycle) by delivery of a second portion. Safety constraints may be immediately relaxed during a 30-minute period 704 between times 706 and 708. Plot 700 also shows a curve 710 of the user's 108 glucose values ​​over time. As described below, after delivering the insulin bolus, there may be a cool-down period of, for example, 90 minutes, as indicated by arrow 712. During the cool-down period, there may be no meal detection, so no additional boluses can be automatically delivered via the auto-bolus mechanism.

[0061] There are alternative means of determining the dosage of a portion of an insulin bolus that differ from the approach described above. In some exemplary embodiments, the dosage of each portion of an insulin bolus may be limited. FIG. 8 shows a flowchart 800 of exemplary steps that may be performed in an exemplary embodiment when limiting a dosage. At 802, the dosage of a portion of an insulin bolus may be calculated as described above. The dosage may be compared to a maximum value, such as 1 unit of insulin, which serves as a limit at 804. If the dosage is equal to or greater than the limit, the maximum value may be used as the dosage that may ultimately be delivered at 808. Otherwise, the calculated dosage may be used as the dosage that may be delivered.

[0062] In another exemplary embodiment, a dosage is selected from among the options. FIG. 9 shows a flowchart 900 of exemplary steps that may be performed in an exemplary embodiment to select from among the options. At 902, a dosage may be determined for auto-bolus delivery as described above in connection with FIG. 4. At 902, a 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 to determine the bolus amount necessary to bring the user's 108 glucose levels into an acceptable range while taking into account the user's 108 current glucose levels, meal intake, and glucose value trends. At 906, the larger of the two determined dosages may be selected for the portion of the insulin bolus. Both dosage sizes may be presumed to be safe, and therefore the larger dosage may be selected to bring the user's 108 glucose levels 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 injections that could crash the user's 108 glucose levels or cause them to reach hypoglycemia, or more generally, undesirably low levels. In some embodiments, hypoglycemia may be defined as a blood glucose level between about 40 mg / dL and about 80 mg / dL, more specifically, between about 50 mg / dL and about 70 mg / dL, and particularly, between about 55 mg / dL and about 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 hour to 1.5 hours). In some embodiments, the cool-down period has a fixed number of cycles, the number of cycles being between about 3 and about 180 cycles, more specifically, between 6 and about 60 cycles, and particularly, between about 10 and about 20 cycles. In some embodiments, each cycle has a length between about 30 seconds and about 30 minutes, more particularly between about 1.5 minutes and about 10 minutes, and more particularly between about 3 minutes and about 9 minutes. FIG. 10 shows a flowchart 1000 of exemplary steps that may be performed in an exemplary embodiment for a cool-down period. At 1002, the cool-down period may be initiated by delivery of an insulin bolus. The cool-down period may be implemented by stopping meal detection, and therefore any auto-bolus insulin delivery. At 1004, time progresses until the next cycle is reached. At 1006, a check may be made to determine whether the cool-down period has ended. If the cool-down period has not ended, the process may repeat waiting until the next cycle is reached at 1004. If the cool-down period has ended, the cool-down period may be stopped by enabling meal detection at 1008. It should be understood that means other than turning meal detection on and off may be used to enable and disable the auto-bolus feature.

[0064] To prevent the user from experiencing excessively low glucose levels, the auto-bolus function may be stopped when the user exercises. FIG. 11 shows a flowchart 1100 of exemplary steps that may be performed in an exemplary embodiment to stop the auto-bolus in such cases. The insulin delivery device 102 may have an activity mode that the user 108 may select when the user 108 begins or is about to exercise. At 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. At 1106, the auto-bolus function may be stopped as described above. In some embodiments, the auto-bolus 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 delivery of an insulin bolus. However, in some exemplary embodiments, this relaxation may be lifted if a lifting condition occurs. Figure 12 shows a flowchart 1200 of exemplary steps that may be performed in an exemplary embodiment to lift the relaxation of one or more safety constraints. At 1202, a safety constraint is relaxed in response to delivery of an insulin bolus. At 1204, a lifting condition occurs. At 1206, the relaxation of one or more safety constraints may be lifted such that the one or more safety constraints return to default settings or recently established values ​​before the relaxation.

[0066] The termination conditions may vary. FIG. 13 shows some exemplary termination conditions 1300. A glucose value crash 1302 may trigger termination of mitigation so that basal insulin delivery can be reduced and the user's 108 glucose value can stabilize. A glucose value crash 1302 may be identified, for example, as a glucose value falling below a threshold or as the user's 108 glucose value falling by or above a certain rate-of-change threshold. In some embodiments, the rate-of-change threshold may be between about −1 mg / dL / min and about −10 mg / dL / min, more specifically between about −2 mg / dL / min and about −6 mg / dL / min, and particularly between −2.5 mg / dL / min and about −4 mg / dL / min. Alternatively or additionally, in some embodiments, a glucose value crash 1302 may be identified as a glucose value falling for at least three cycles. In some embodiments, a glucose value crash may be identified if the rate-of-change threshold is exceeded for the following two cycles and / or the following three cycles. In some embodiments, a glucose crash may be determined when a rate of change threshold is exceeded over the next two or three cycles, and the rate of change threshold for the next three cycles is lower when determining a glucose crash over the next three cycles compared to the next two cycles, more specifically, about 20% to about 70% lower, and more specifically, about 40% to about 60% lower. In some embodiments, a glucose crash may be identified when the glucose value drops over four subsequent cycles. Another release condition may be that activity mode is enabled (1304). When in activity mode, i.e., when the user is exercising, exercise performed by the user will lower the user's glucose level 108, so there is a risk that potentially greater insulin delivery due to the relaxed safety constraints could lower the user's glucose level to too low a level. Therefore, release of the relaxation is warranted.

[0067] As described above, delivery of the insulin bolus and relaxation of safety constraints for a period of time may also be triggered by the user 108 activating an element of the drug delivery device 102 or management device to signal a meal. For example, as shown in FIG. 14A , the management device 1400 may have a display 1402. The display 1402 may display text instructing the user 108 to press a button 1406 to indicate that they have 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 that is activated to signal a meal may alternatively or additionally be located on the drug delivery device 102. FIG. 14B shows a top view of a 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 indicate that they have eaten or are about to eat (e.g., a physical or alternative "soft" button may be used). The settings of the drug delivery device 102 may include a user-adjustable setting that indicates the amount of time required to consume a meal after pressing the button 1414. For example, the user may set the button 1414 to "5 minutes," meaning that the user typically eats five minutes after pressing the button 1414. In some embodiments, other types of elements may be provided to the user 108 to signal that it is time to eat. FIG. 14C shows a diagram listing some of the types of elements the user 108 may activate to signal that they have eaten. The activatable element 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 the depiction of FIG. 14C is not intended to be exhaustive.

[0068] 15 shows a flowchart 1500 of example steps that may be performed in an example embodiment when using a manual meal notification approach. At 1502, the user 108 signals that they will eat by activating an activatable element. In response to the activation, at 1504, the drug delivery device 102 may determine a dosage of a portion of the insulin bolus to deliver as a meal insulin bolus. This may be done as described above in connection with FIG. 4. At 1506, the drug delivery device 102 delivers the portion of the insulin bolus as described above in connection with FIG. 3. At 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, there may be a cool down period. Relaxation of safety constraints may be lifted as described above in relation to claims 12 and 13.

[0070] In some exemplary embodiments, the auto-bolus feature and manual notification of a meal can be used together. The drug delivery device 102 may take steps to ensure that these two approaches for identifying meals and delivering a meal insulin bolus in response are compatible. FIG. 16A shows a plot 1600 of operation when the auto-bolus effect and the notification to eat effect do not overlap in timing. Plot 1600 plots insulin delivery amount 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 also shows where standard safety settings are in effect, as indicated by "Standard Settings" along the time axis. In this illustration, at time 1610, the user 108 activates an activatable element to signal that a meal is to be eaten. The drug delivery device 102 determines the dosage of the first and second portions of the insulin bolus and delivers the first and second portions of the insulin bolus, as described above. At least one of the safety constraints is relaxed from the "standard setting" for the relaxation period, as indicated by arrow 1612. After the relaxation period ends, the safety constraints are no longer relaxed. A meal is detected at time 1614. The drug delivery device determines and delivers the first and second portion dosages of the insulin bolus to the user 108. At least one safety constraint is relaxed during the relaxation period, as indicated by arrow 1616. After the relaxation period ends, the one or more relaxed safety constraints are no longer relaxed.

[0071] FIG. 16B shows a plot 1620 of triggering the auto-bolus capability during relaxation of at least one safety constraint from a “standard setting” after insulin bolus delivery in response to manually indicating that a meal will be taken. In the depicted example, at time 1620, the user 108 signals that a meal will be taken by activating an activatable element. The drug delivery device 102 determines the dosage of a first and second portion of a meal insulin bolus and delivers the first and second portions to the user 108. The at least one safety constraint is relaxed for a period of time indicated by arrow 1622. At time 1624, a meal is detected. The auto-bolus capability delivers the first and second portions of an insulin bolus in response to detecting the meal. The at least one safety constraint is relaxed by the auto-bolus capability during a relaxation period indicated by arrow 1626. The relaxation of the at least one safety constraint resulting from manually indicating that a meal will be taken ends as indicated by an “X” 1628. A return to a “standard setting” after the relaxation period indicated by arrow 1626 is shown.

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

[0073] The present disclosure also relates to a computer program including instructions (also referred to as computer program instructions) for performing the functions described above. The instructions may be executed by a processor. The instructions may be executed by multiple processors, for example, in a distributed computer system. The computer program of the present disclosure may be pre-installed or downloaded to, for example, a drug delivery device, a management device, or a fluid delivery device, for example, in its storage. The computer program may calculate the first and second portions to be delivered.

[0074] Although illustrative embodiments have been described herein, various changes in form and details may be made therein without departing from the intended scope of the appended claims. While the present invention is defined in the appended claims, it should be understood that the invention can (alternatively) be defined according to the following embodiments. 1. A drug delivery system for delivering a drug to a user, comprising: a drug reservoir; a needle or cannula for piercing the user's skin to deliver the drug from the reservoir; a fluid path for the medication from the reservoir to the needle or cannula; a non-transitory computer-readable storage medium storing computer program instructions; a processor configured to execute the computer program instructions, whereby Constraining delivery of the drug to the user; receiving a glucose value of a user; determining whether the user has eaten based on the received glucose value of the user; providing an auto-bolus function that delivers a first portion of a medication bolus to the user in response to the processor determining that the user has eaten; relaxing at least one drug safety constraint during a period following delivery of the first portion of the drug bolus to allow for delivery of a larger dose of automated drug delivery in accordance with the relaxed at least one drug safety constraint; a processor that causes the processor to perform the following: A drug delivery system comprising: 2. The drug delivery system of 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 of embodiment 1 or 2, further causing the processor to determine the dosage of a second portion of the drug bolus by executing the computer program instructions. 4. A drug delivery system as described in embodiment 3, wherein the dosage of the second portion is determined based at least in part on recently received glucose values ​​and the user's on-board medications. 5. The drug delivery system of embodiment 2, wherein executing the computer program instructions further causes the processor to prevent delivery of another drug bolus during a cool-down period after delivery of a second portion of the drug bolus. 6. A drug delivery system as described in any one of embodiments 1 to 5, wherein executing the computer program instructions further causes the processor to disable the autobolus function when an active mode is set or when the user is in a cool-down period, the active mode being set indicating that the user is active or will soon be active. 7. A drug delivery system described in any one of embodiments 1 to 6, wherein the processor is further caused to release the relaxation of at least one drug delivery constraint when at least one release condition other than expiration of the period is met by executing the computer program instructions. 8. A drug delivery system described in any one of embodiments 1 to 7, wherein the at least one release condition includes at least one of the difference between consecutively received blood glucose levels of the user exceeding a respective threshold or an activity mode being set, the activity mode being set indicating that the user is active or will soon be active. 9. A drug delivery system for delivering a drug to a user, comprising: a drug reservoir; a needle or cannula for piercing the user's skin to deliver the drug from the reservoir; a fluid path for the medication from the reservoir to the needle or cannula; a non-transitory computer-readable storage medium storing computer program instructions; a processor configured to execute the computer program instructions, whereby Constraining delivery of the drug to the user in accordance with current drug safety constraints; receiving an indication of a user's request to deliver a drug bolus to the user; delivering a first portion of the medication bolus to a user in response to the received request; relaxing at least one current drug safety constraint during a period following delivery of the first portion of the drug bolus to allow for delivery of a larger dose of basal drug delivery, if desired, without complying with the relaxed at least one current drug safety constraint; a processor that causes the processor to perform the following: A drug delivery system comprising: 10. The drug delivery system of embodiment 9, further comprising an element that may be actuated by a user to request delivery of the drug bolus. 11. The drug delivery system of embodiment 9 or 10, wherein the element is one of a button, a knob, a switch, or a lever. 12. A drug delivery system described in any one of embodiments 9 to 11, wherein the drug delivery device further comprises a user interface, and the element is a user interface element. 13. A drug delivery system as described in any one of embodiments 9 to 12, further causing the processor to deliver a second portion of the drug bolus by executing the computer program instructions. 14. A drug delivery system as described in any one of embodiments 9 to 13, further comprising causing the processor to determine the dosage of a second portion of the drug bolus by executing the computer program instructions. 15. A drug delivery system as described in any one of embodiments 9 to 14, wherein executing the computer program instructions further causes the processor to prevent delivery of another drug bolus during a cool-down period after delivery of a second portion of the drug bolus. 16. A drug delivery system described in any one of embodiments 9 to 15, wherein executing the computer program instructions further causes the processor to release the relaxation of at least one drug safety constraint when a difference between successively received blood glucose levels of the user exceeds a respective threshold or when an activity mode is set, the activity mode being set indicating that the user is active or will soon be active. 17. A drug delivery device comprising: a drug tank for storing a drug; a needle or cannula for piercing the patient's skin, the needle or cannula being hollow to act as a conduit for delivering the medication to the user; a non-transitory computer readable storage for storing computer program instructions for controlling operation of the drug delivery device; a processor that, by executing the computer program instructions, Constraining delivery of the drug to the user in accordance with current drug safety constraints; delivering a first portion of the drug bolus to a user; relaxing at least one current drug safety constraint during a period following delivery of the first portion of the drug bolus to allow for delivery of a larger dose of basal drug delivery, if desired, without complying with the relaxed at least one current drug safety constraint; a processor that causes the processor to perform the following: A drug delivery device comprising: 18. The drug delivery device of embodiment 17, which alleviates multiple current drug safety constraints. 19. A drug delivery device as described in embodiment 17 or 18, wherein the drug safety constraints include at least one of the maximum amount of drug that can be delivered to the user from the drug delivery device in an operating cycle of the drug delivery device, the maximum amount of drug that can be delivered to the user from the drug delivery device in a specified number of operating cycles of the drug delivery device, the current set value of the user's glucose value, the maximum level of the user's onboard drug, and a penalty amount in a cost function for excess drug delivery. 20. A drug delivery device as described in any one of embodiments 17 to 19, wherein executing the computer program instructions further causes the processor to deliver a second portion of the drug bolus at a certain time after delivery of a first portion of the drug bolus. 21. A method performed by a processor of a drug delivery system, comprising: receiving glucose and / or other analyte level values ​​for a user; determining whether the user has eaten based on the received analyte level value for the user, wherein an auto-bolus function determines a first portion of a drug bolus to be delivered to the user in response to determining that the user has eaten; determining that the drug delivery system has delivered the first portion to a user; relaxing at least one drug safety constraint during a period of time after determining that a first portion of the drug bolus has been delivered, wherein relaxing the at least one drug safety constraint allows for delivery of a larger dose of basal drug delivery, if desired, without complying with the relaxed at least one drug safety constraint; A method for providing 22. The method of embodiment 21, further comprising determining a dosage of a second portion of the drug bolus to be delivered to a user. 23. The method of embodiment 22, wherein the dosage of the second portion is determined based at least in part on recently received analyte level values ​​and the user's on-board medications. 24. The method of embodiment 22 or 23, further comprising determining that a second portion of the drug bolus has been delivered. 25. The method of embodiment 24, further comprising preventing delivery of another drug bolus during a cool-down period after delivering a second portion of the drug bolus, and / or sending instructions to the drug delivery device indicating that another drug bolus should not be delivered within the cool-down period after determining that the second portion of the drug bolus has been delivered. 26. A method as described in any one of embodiments 21 to 25, further comprising disabling the autobolus function when an activity mode is set or when the user is in a cool-down period, the activity mode being set indicating that the user is active or will soon be active. 27. A method according to any one of embodiments 21 to 26, wherein the relaxation of said at least one drug delivery constraint is lifted when at least one lifting condition other than the expiration of said period is met. 28. The method described in embodiment 26, wherein the (one or more) termination conditions include at least one of the difference between successively received blood glucose values ​​of the user exceeding a respective threshold or an activity mode being set, the activity mode being set indicating that the user is active or will soon be active. 29. A method performed by a processor of a drug delivery system, comprising: receiving an indication of a user's request to immediately deliver a drug bolus to the user; determining a first portion of a medication bolus to be delivered to a user in response to receiving the request; determining that a first portion of the drug bolus has been delivered by a drug delivery system; relaxing at least one current drug safety constraint during a period following delivery of the first portion of the drug bolus, whereby relaxing the at least one drug safety constraint allows for determining a larger dose of basal drug delivery, if desired, without complying with the relaxed at least one drug safety constraint; A method for providing 30. A method performed by a processor of a drug delivery system, comprising: determining a first portion of a medication bolus to be delivered to a user; determining that a first portion of the drug bolus has been delivered by a drug delivery system; relaxing at least one current drug safety constraint during a period following delivery of the first portion of the drug bolus, whereby relaxing the at least one drug safety constraint allows for determining a larger dose of basal drug delivery, if desired, without complying with the relaxed at least one drug safety constraint; A method for providing

Claims

1. A drug delivery system for delivering a drug to a user, comprising: a drug reservoir; a needle or cannula for piercing the user's skin to deliver the drug from the reservoir; a fluid path for the medication from the reservoir to the needle or cannula; a non-transitory computer-readable storage medium storing computer program instructions; a processor configured to execute the computer program instructions, whereby executing the computer program instructions Constraining delivery of the drug to the user; receiving a glucose value of a user; determining whether the user has eaten based on the received glucose value of the user; providing an auto-bolus function that delivers a first portion of a medication bolus to the user in response to the processor determining that the user has eaten; relaxing at least one drug safety constraint during a period following delivery of the first portion of the drug bolus to allow for delivery of a larger dose of automated drug delivery in accordance with the relaxed at least one drug safety constraint; a processor that causes the processor to perform the following: A drug delivery system comprising:

2. 10. The drug delivery system of claim 1, wherein execution of the computer program instructions further causes the processor to deliver a second portion of the drug bolus.

3. 3. The drug delivery system of claim 1, wherein execution of the computer program instructions further causes the processor to determine a dosage of a second portion of the drug bolus.

4. 4. The drug delivery system of claim 3, wherein the dosage of the second portion is determined based at least in part on recently received glucose values ​​and the user's on-board medications.

5. 3. The drug delivery system of claim 2, wherein execution of the computer program instructions further causes the processor to prevent delivery of another drug bolus during a cool-down period after delivery of a second portion of the drug bolus.

6. 6. The drug delivery system of claim 1, wherein execution of the computer program instructions further causes the processor to disable the auto-bolus function when an active mode is set or when the user is in a cool-down period, the active mode being set indicating that the user is active or will soon be active.

7. The drug delivery system of any one of claims 1 to 6, wherein the execution of the computer program instructions further causes the processor to release the relaxation of the at least one drug delivery constraint when at least one release condition other than expiration of the period is met.

8. The drug delivery system of any one of claims 1 to 7, wherein the at least one release condition includes at least one of the difference between successively received blood glucose levels of the user exceeding a respective threshold or an activity mode being set, the activity mode being set indicating that the user is active or will soon be active.

9. 1. A drug delivery system for delivering a drug to a user, comprising: a drug reservoir; a needle or cannula for piercing the user's skin to deliver the drug from the reservoir; a fluid path for the medication from the reservoir to the needle or cannula; a non-transitory computer-readable storage medium storing computer program instructions; a processor configured to execute the computer program instructions, whereby executing the computer program instructions Constraining delivery of the drug to the user in accordance with current drug safety constraints; receiving an indication of a user's request to deliver a drug bolus to the user; delivering a first portion of the medication bolus to a user in response to the received request; relaxing at least one current drug safety constraint during a period following delivery of the first portion of the drug bolus to allow for delivery of a larger dose of basal drug delivery, if desired, without complying with the relaxed at least one current drug safety constraint; a processor that causes the processor to perform the following: A drug delivery system comprising:

10. 10. The drug delivery system of claim 9, further comprising an element that may be actuated by a user to request delivery of the drug bolus.

11. 11. The drug delivery system of claim 9 or 10, wherein the element is one of a button, a knob, a switch or a lever.

12. The drug delivery system according to any one of claims 9 to 11, wherein the drug delivery device further comprises a user interface, and the element is a user interface element.

13. 13. The drug delivery system of any one of claims 9 to 12, wherein executing the computer program instructions further causes the processor to deliver a second portion of the drug bolus.

14. 14. The drug delivery system of claim 9, further comprising: executing the computer program instructions to cause the processor to determine a dosage of a second portion of the drug bolus.

15. 15. The drug delivery system of claim 9, wherein executing the computer program instructions further causes the processor to prevent delivery of another drug bolus during a cool-down period after delivery of a second portion of the drug bolus.

16. 16. The drug delivery system of claim 9, wherein the execution of the computer program instructions further causes the processor to remove the relaxation of the at least one drug safety constraint when a difference between successively received blood glucose levels of the user exceeds a respective threshold or when an activity mode is set, the activity mode being set indicating that the user is active or will soon be active.

17. 1. A drug delivery device comprising: a drug tank for storing a drug; a needle or cannula for piercing the patient's skin, the needle or cannula being hollow to act as a conduit for delivering the medication to the user; a non-transitory computer readable storage for storing computer program instructions for controlling operation of the drug delivery device; a processor that, by executing the computer program instructions, Constraining delivery of the drug to the user in accordance with current drug safety constraints; delivering a first portion of the medication bolus to a user; relaxing at least one current drug safety constraint during a period following delivery of the first portion of the drug bolus to allow for delivery of a larger dose of basal drug delivery, if desired, without complying with the relaxed at least one current drug safety constraint; a processor that causes the processor to perform the following: A drug delivery device comprising:

18. 18. The drug delivery device of claim 17, which relaxes several current drug safety constraints.

19. The drug delivery device of claim 17 or 18, wherein the drug safety constraints include at least one of a maximum amount of drug that can be delivered to a user from the drug delivery device in an operating cycle of the drug delivery device, a maximum amount of drug that can be delivered to a user from the drug delivery device in a specified number of operating cycles of the drug delivery device, a current set value for the user's glucose value, a maximum level of the user's loaded drug, and a penalty amount in a cost function for excess drug delivery.

20. 20. The drug delivery device of claim 17, wherein executing the computer program instructions further causes the processor to deliver a second portion of the drug bolus at a fixed time after delivery of a first portion of the drug bolus.

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