System and method for incorporating exercise into closed-loop diabetes therapy

Abstract

Disclosed herein are apparatuses and methods that account for exercise in closed loop insulin delivery systems. The apparatuses and methods disclosed herein address exercise-induced glucose level increases by reducing the target IOB within the closed loop. By reducing the target IOB, the algorithm responds less aggressively to pre-exercise food, and does not build up the IOB that could potentially contribute to undesirably low glucose levels once the exercise also begins lowering glucose levels. Following exercise, because the user's body will not immediately transition to a pre-exercise state, the algorithm will gradually transition back to the initial target IOB.

Description

[0001] SYSTEM AND METHOD FOR INCORPORATING EXERCISE INTO CLOSED-LOOP DIABETES THERAPY

[0002] PRIORITY CLAIM

[0003] The present application claims the benefit of U.S. Provisional Application No. 63 / 615,579 filed December 28, 2023, which is hereby incorporated herein by reference in its entirety.

[0004] FIELD OF THE INVENTION

[0005] The present invention relates generally to ambulatory infusion pumps and, more particularly, to operation of ambulatory infusion pumps in a closed-loop or semi-closed-loop fashion.

[0006] BACKGROUND OF THE INVENTION

[0007] There are a wide variety of medical treatments that include the administration of a therapeutic fluid in precise, known amounts at predetermined intervals. Devices and methods exist that are directed to the delivery of such fluids, which may be liquids or gases, which are known in the art.

[0008] One category of such fluid delivery devices includes insulin injecting pumps developed for administering insulin to patients afflicted with type I, or in some cases, type II diabetes. Some insulin injecting pumps are configured as portable or ambulatory infusion devices can provide continuous subcutaneous insulin injection and / or infusion therapy as an alternative to multiple daily injections of insulin via a syringe or an insulin pen. Such pumps are worn by the user and may use replaceable cartridges. In some embodiments, these pumps may also deliver medicaments other than, or in addition to, insulin, such as glucagon, pramlintide, and the like. Examples of such pumps and various features associated therewith include those disclosed in U. S. Patent Publication Nos. 2013 / 0324928 and 2013 / 0053816 and U.S. Patent Nos. 8,287,495; 8,573,027; 8,986,253; and 9,381,297, each of which is incorporated herein by reference in its entirety.

[0009] Ambulatory infusion pumps for delivering insulin or other medicaments can be used in conjunction with blood glucose monitoring systems, such as blood glucose meters (BGMs) and continuous glucose monitoring devices (CGMs). A CGM provides a substantially continuous estimated blood glucose level through a transcutaneous sensor that estimates blood analyte levels, such as blood glucose levels, via the patient’s interstitial fluid. CGM systems typically consist of a transcutaneously-placed sensor, a transmitter and a monitor.

[0010] Ambulatory infusion pumps typically allow the patient or caregiver to adjust the amount of insulin or other medicament delivered, by a basal rate or a bolus, based on blood glucose data obtained by a BGM or a CGM, and in some cases include the capability to automatically adjust such medicament delivery. Some ambulatory infusion pumps may include the capability to interface with a BGM or CGM such as, e.g., by receiving measured or estimated blood glucose levels and automatically adjusting or prompting the user to adjust the level of medicament being administered or planned for administration or, in cases of abnormally low blood glucose readings, reducing or automatically temporarily ceasing or prompting the user temporarily to cease or reduce insulin administration. These portable pumps may incorporate a BGM or CGM within the hardware of the pump or may communicate with a dedicated BGM or CGM via wired or wireless data communication protocols, directly and / or via a device such as a smartphone. One example of integration of infusion pumps with CGM devices is described in U.S. Patent Publication No.

[0011] 2014 / 0276419, which is hereby incorporated by reference herein.

[0012] As noted above, insulin or other medicament dosing by basal rate and / or bolus techniques could automatically be provided by a pump based on readings received into the pump from a CGM device that is, e.g., external to the portable insulin pump or integrated with the pump as a pump- CGM system in a closed-loop or semi-closed-loop fashion. With respect to insulin delivery, some systems including this feature can be referred to as artificial pancreas systems because the systems serve to mimic biological functions of the pancreas for patients with diabetes.

[0013] Exercise is known to affect glucose levels in unpredictable ways and can cause challenges for accurate closed-loop or semi-closed loop treatment of diabetes even with use of a CGM. The body’s response to exercise varies depending upon a number of factors, including intensity of exercise. For example, aerobic exercise tends to lower blood glucose while anaerobic exercise tends to increase blood glucose. With closed-loop therapy, the control algorithm will generally increase the delivery of insulin upon detecting a rise in glucose level after the user eats. If a user then begins to exercise aerobically after eating, the exercise plus the increase in insulin can cause a severe drop in blood glucose. The variability of the body’s response to exercise makes accounting for such circumstances with closed loop therapy challenging. In addition, while some pumps include an exercise mode that can be turned on and off to modify settings while a user is exercising, the user’s body does not simply turn exercise on or off so these modes may still not accurately meet the user’s needs. SUMMARY

[0014] Disclosed herein are apparatuses and methods that account for exercise in closed loop insulin delivery systems. The apparatuses and methods disclosed herein address exercise-induced glucose level increases by reducing the target IOB within the closed loop. By reducing the target IOB, the algorithm responds less aggressively to pre-exercise food, and does not build up the IOB that could potentially contribute to undesirably low glucose levels once the exercise also begins lowering glucose levels. Following exercise, because the user’s body will not immediately transition to a pre-exercise state, the algorithm will gradually transition back to the initial target IOB.

[0015] In an embodiment, a system for closed loop diabetes therapy can include a pump mechanism configured to facilitate delivery of insulin to a user, a user interface, a communications interface adapted to receive glucose levels from a continuous glucose monitor and a processor functionally linked to the pump mechanism, the user interface and the communications device. The processor can be configured to calculate and deliver insulin doses to the user based on a closed loop insulin delivery algorithm. An indication may be received that the user will be exercising. An exercise mode for the closed loop insulin delivery algorithm can be activated in response to the indication that the user will be exercising. The exercise mode can modify a variable of the closed loop insulin delivery algorithm from a non-exercise value to an exercise value. Insulin doses can be calculated and delivered to the user based on glucose levels from the continuous glucose monitor according to the exercise mode of the closed loop insulin delivery algorithm following the indication that the user will be exercising. Upon receiving an indication that the user is no longer exercising the variable can be gradually returned from the exercise value to the nonexercise value.

[0016] In an embodiment, a system for closed loop diabetes therapy can include a pump mechanism configured to facilitate delivery of insulin to a user, a user interface, a communications interface adapted to receive glucose levels from a continuous glucose monitor and a processor functionally linked to the pump mechanism, the user interface and the communications device. The processor can be configured to calculate and deliver insulin doses to the user based on a closed loop insulin delivery algorithm. If it is determined that the user is exercising, an exercise mode for the closed loop insulin delivery algorithm can be activated the closed loop insulin delivery algorithm. Insulin doses can be calculated and delivered to the user based on glucose levels from the continuous glucose monitor according to the exercise mode while the user is exercising. When it is determined that the user is no longer exercising the system gradually returns to the closed loop insulin delivery algorithm from the exercise mode.

[0017] The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.

[0018] BRIEF DESCRIPTION OF THE DRAWINGS The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:

[0019] Figure 1 is a medical device that can be used with embodiments of the disclosure.

[0020] Figure 2 is a block diagram representing a medical device that can be used with embodiments of the disclosure.

[0021] Figures 3A-3B depict an embodiment of a pump system according to the disclosure.

[0022] Figure 4 is a schematic representation of a system according to the disclosure.

[0023] Figure 5 is flowchart of a method of modifying insulin therapy for an exercise activity according to the disclosure.

[0024] While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

[0025] DETAILED DESCRIPTION OF THE INVENTION

[0026] The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0027] Figure 1 depicts an embodiment of a medical device according to the disclosure. In this embodiment, the medical device is configured as a pump 12, such as an infusion pump, that can include a pumping or delivery mechanism and reservoir for delivering medicament to a patient and an output / di splay 44. The output / di splay 44 may include an interactive and / or touch sensitive screen 46 having an input device such as, for example, a touch screen comprising a capacitive screen or a resistive screen. The pump 12 may additionally or instead include one or more of a keyboard, a microphone or other input devices known in the art for data entry, some or all of which may be separate from the display. The pump 12 may also include a capability to operatively couple to one or more other display devices such as a remote display, a remote control device, a laptop computer, personal computer, tablet computer, a mobile communication device such as a smartphone, a wearable electronic watch or electronic health or fitness monitor, or personal digital assistant (PDA), a CGM display etc.

[0028] In one embodiment, the medical device can be an ambulatory insulin pump configured to deliver insulin to a patient. Further details regarding such pump devices can be found in U.S. Patent No. 8,287,495, which is incorporated herein by reference in its entirety. In other embodiments, the medical device can be an infusion pump configured to deliver one or more additional or other medicaments to a patient.

[0029] Figure 2 illustrates a block diagram of some of the features that can be used with embodiments, including features that may be incorporated within the housing 26 of a medical device such as a pump 12. The pump 12 can include a processor 42 that controls the overall functions of the device. The infusion pump 12 may also include, e.g., a memory device 30, a transmitter / receiver 32, an alarm 34, a speaker 36, a clock / timer 38, an input device 40, a user interface suitable for accepting input and commands from a user such as a caregiver or patient, a drive mechanism 48, an estimator device 52 and a microphone (not pictured). One embodiment of a user interface is a graphical user interface (GUI) 60 having a touch sensitive screen 46 with input capability. In some embodiments, the processor 42 may communicate with one or more other processors within the pump 12 and / or one or more processors of other devices, for example, a continuous glucose monitor (CGM), display device, smartphone, etc. through the transmitter / receiver. The processor 42 may also include programming that may allow the processor to receive signals and / or other data from an input device, such as a sensor that may sense pressure, temperature or other parameters.

[0030] Figures 3A-3B depict another pump system including a pump 102 that can be used with embodiments. Drive unit 118 of pump 102 includes a drive mechanism 122 that mates with a recess in disposable cartridge 116 of pump 102 to attach the cartridge 116 to the drive unit 118. Pump system 100 can further include an infusion set 145 having a connector 154 that connects to a connector 152 attached to pump 102 with tubing 153. Tubing 144 extends to a site connector 146 that can attach or be pre-connected to a cannula and / or infusion needle that punctures the patient’s skin at the infusion site to deliver medicament from the pump 102 to the patient via infusion set 145. In some embodiments, pump can include a user input button 172 and an indicator light 174 to provide feedback to the user.

[0031] In one embodiment, pump 102 includes a processor that controls operations of the pump and, in some embodiments, may receive commands from a separate device for control of operations of the pump. Such a separate device can include, for example, a dedicated remote control or a smartphone or other consumer electronic device executing an application configured to enable the device to transmit operating commands to the processor of pump 102. In some embodiments, processor can also transmit information to one or more separate devices, such as information pertaining to device parameters, alarms, reminders, pump status, etc. In one embodiment pump 102 does not include a display but may include one or more indicator lights 174 and / or one or more input buttons 172. Pump 102 can also incorporate any or all of the features described with respect to pump 12 in Figure 2. Further details regarding such pumps can be found in U.S. Patent No. 10,279,106 and U.S. Patent Publication Nos. 2016 / 0339172 and 2017 / 0049957, each of which is hereby incorporated herein by reference in its entirety.

[0032] Pump 12 or 102 can interface directly or indirectly (via, e.g., a smartphone or other device) with a glucose meter, such as a blood glucose meter (BGM) or a continuous glucose monitor (CGM). Referring to Figure 4, an exemplary CGM system 100 according to an embodiment of the present invention is shown (other CGM systems can be used). The illustrated CGM system includes a sensor 101 affixed to a patient 104 that can be associated with the insulin infusion device in a CGM-pump system. The sensor 101 includes a sensor probe 106 configured to be inserted to a point below the dermal layer (skin) of the patient 104. The sensor probe 106 is therefore exposed to the patient’s interstitial fluid or plasma beneath the skin and reacts with that interstitial fluid to produce a signal that can be associated with the patient’s blood glucose (BG) level. The sensor 101 includes a sensor body 108 that transmits data associated with the interstitial fluid to which the sensor probe 106 is exposed. The data may be transmitted from the sensor 101 to the glucose monitoring system receiver 100 via a wireless transmitter, such as a near field communication (NFC) radio frequency (RF) transmitter or a transmitter operating according to a “Wi-Fi” or Bluetooth® protocol, Bluetooth® low energy protocol or the like, or the data may be transmitted via a wire connector from the sensor 101 to the monitoring system 100. Transmission of sensor data to the glucose monitoring system receiver by wireless or wired connection is represented in Figure 4 by the arrow line 112. Further detail regarding such systems and definitions of related terms can be found in, e.g., U.S. Patent Nos. 8,311,749, 7,711,402 and 7,497,827, each of which is hereby incorporated by reference in its entirety.

[0033] In an embodiment of a pump-CGM system having a pump 12, 102 that communicates with a CGM and that integrates CGM data and pump data as described herein, the CGM can automatically transmit the glucose data to the pump. The pump can then automatically determine therapy parameters and deliver medicament based on the data. Such an automatic pump-CGM system for insulin delivery can be referred to as an automated insulin delivery (AID) or an artificial pancreas system that provides closed-loop therapy to the patient to approximate or even mimic the natural functions of a healthy pancreas. In such a system, insulin doses are calculated based on the CGM readings (that may or may not be automatically transmitted to the pump) and are automatically delivered to the patient at least in part based on the CGM reading(s). In various embodiments, doses can be delivered as automated correction boluses and / or automated increases or decreases to a basal rate. Insulin doses can also be administered based on current glucose levels and / or predicted future glucoses levels based on current and past glucose levels.

[0034] For example, if the CGM indicates that the user has a high blood glucose level or hyperglycemia, the system can automatically calculate an insulin dose necessary to reduce the user’s blood glucose level below a threshold level or to a target level and automatically deliver the dose. Alternatively, the system can automatically suggest a change in therapy upon receiving the CGM data such as an increased insulin basal rate or delivery of a bolus, but can require the user to accept the suggested change prior to delivery rather than automatically delivering the therapy adjustments. If the CGM data indicates that the user has a low blood glucose level or hypoglycemia, the system can, for example, automatically reduce a basal rate, suggest to the user to reduce a basal rate, automatically deliver or suggest that the user initiate the delivery of an amount of a substance such as, e.g., a hormone (glucagon) to raise the concentration of glucose in the blood, automatically suggest that the user, e.g., ingest carbohydrates and / or take other actions and / or make other suggestions as may be appropriate to address the hypoglycemic condition, singly or in any desired combination or sequence. Such determination can be made by the infusion pump providing therapy or by a separate device that transmits therapy parameters to the infusion pump. In some embodiments, multiple medicaments can be employed in such a system as, for example, a first medicament, e.g., insulin, that lowers blood glucose levels and a second medicament, e.g., glucagon, that raises blood glucose levels.

[0035] As with other parameters related to therapy, such thresholds and target values can be stored in memory located in the pump or, if not located in the pump, stored in a separate location and accessible by the pump processor (e.g., “cloud” storage, a smartphone, a CGM, a dedicated controller, a computer, etc., any of which is accessible via a network connection). The pump processor can periodically and / or continually execute instructions for a checking function that accesses these data in memory, compares them with data received from the CGM and acts accordingly to adjust therapy. In further embodiments, rather than the pump determining the therapy parameters, the parameters can be determined by a separate device and transmitted to the pump for execution. In such embodiments, a separate device such as the CGM or a device in communication with the CGM, such as, for example, a smartphone, dedicated controller, electronic tablet, computer, etc. can include a processor programmed to calculate therapy parameters based on the CGM data that then instruct the pump to provide therapy according to the calculated parameters.

[0036] Applicant has determined that the difficulties in accounting for exercise in such closed loop controls are caused by an estimated insulin on board (IOB) for the algorithm. For example, when the user consumes food, the algorithm increases the estimated IOB in response to the increase in insulin delivered to address rising blood glucose, and that increased estimated IOB can cause blood glucose to go low during exercise. For example, for an individual with a total daily insulin (TDI) of 50 units, a typical closed loop algorithm would generally respond to a very high glucose level (e.g., 250 mg / dL) by increasing insulin delivery to maintain an estimated target IOB of three units. The goal of maintaining this IOB target is ultimately the problem when exercise is involved.

[0037] U.S Patent Publication No. 2020 / 0368430, which is incorporated herein by reference, addresses this issue by modifying the IOB estimate / target in the closed loop algorithm disclosed therein. During exercise, the algorithm can be altered to reduce the IOB target. For example, in the above example for the individual with a TDI of 50 units, the IOB target can be reduced, such as, for example, by 50%. The IOB target can be reduced on either a linear or non-linear schedule based on the intensity of the exercise. For example, for intense exercise such as running a marathon the IOB target could be reduced by 80% whereas for more casual exercise such as a hike along the coast, the target could be reduced by 20%. This type of modification can also be applied to other closed loop control algorithms. For example, PCT Application No. PCT / US23 / 82084 filed December 1, 2023 and entitled Devices, Systems and Methods for Closed and Semi Closed Loop Operation of Infusion Pumps, which is incorporated herein by reference, discloses a closed loop algorithm employing a model predictive control that generates dosing policies or functions for determining therapy doses. When a user is exercising, the dosing policy or function can similarly be reduced by a predetermined percentage. As such, embodiments disclosed herein address exercise and the potential for low glucose levels by focusing the therapy adjustment on insulin in the body rather than on the glucose levels of the user.

[0038] However, even though the approaches above provide improved outcomes for therapy being provided during exercise, when a user is done exercising, the user’s body does not immediately return to a pre-exercise state. As such, if the algorithm reverts directly back to the default nonexercise approach immediately following exercise, there is a risk that increases in insulin can cause low glucose levels even once the exercise event itself has concluded. As such, embodiments disclosed herein can provide a “cool down” period in which the algorithm gradually transitions from an exercise state back to a pre-exercise state, much like how the body gradually cools down after exercising.

[0039] Figure 5 depicts a flowchart of algorithm logic 50 for transitioning into an exercise mode and gradually transitioning back out of exercise mode when the user is cooling down following exercise. The algorithm is initially in a pre-exercise state at step 52 in which the IOB target is at the default value for the algorithm (e.g., at 100% or 1.0). This is maintained while the user is in a NOT EXERCISING state 54. When an indication is received that the user is exercising, the system can immediately modify the IOB factor to an exercise ratio at step 56 that reduces the IOB target. For example, as noted above, a factor of 0.5 may be applied to reduce the target to 50% of the nonexercise value. This factor can be maintained for the entirety of when the user is in an EXERCISING state 58. When the user has finished exercising, the algorithm can transition to a cooling phase 60 while the user is in a COOLING DOWN state 62. During the cooling phase, the algorithm can gradually transition the IOB factor from the exercise ratio back to the default, 100% value in a series of cooling steps at step 64. If at any point during this cooling phase the user begins exercising again, the algorithm can immediately revert back to the exercise ratio at step 66 while the user is again in the EXERCISING state 58. Otherwise, once the series of cooling steps has raised the IOB factor from the exercise ratio to the default value, the algorithm returns to the pre-exercise state at step 68 and will remain in that state as long as the user remains in the NOT EXERCISING state 54. It should be noted that if a cooling step raising the IOB target would result in the IOB target being greater than the default value (e.g., greater than 1.0), at step 68 that IOB target is set to the default, 100% value prior to transitioning to the NOT EXERCISING state 54.

[0040] In some embodiments, the cooling steps employed in the cooling phase of the algorithm can be linear such that each cooling step transitions the IOB factor the same amount towards the default value each interval of time. For example, in the example in which the exercise ratio is 50%, the algorithm could transition 5% upon entering the cooling phase and another 5% every 5 minutes such that the algorithm will return to the default value after 45 minutes. Similarly, the algorithm can be designed to return to the default target after a predetermined amount of time, such as, for example 30 minutes, with linear steps beginning when the cooling phase is entered. In the above example, the algorithm would increase the factor by about 7.1% in each cooling step to transition from 50% to 100% over 30 minutes.

[0041] In other embodiments, the cooling steps employed in the cooling phase of the algorithm can be nonlinear. For example, in some embodiments the first cooling step may be larger with each cooling step becoming smaller until the default target IOB is reached. Alternatively, the first cooling step may be smaller with each cooling step increasing until the default target IOB is reached. The nonlinear transition can also be time-based, meaning that each cool step can increase the IOB target the same amount, but the interval between cooling steps can become faster or slower as the default target IOB is approached. Such nonlinear transitions can be based on, for example, a lookup table, an equation, etc. In embodiments, the nonlinear transition can be designed to arrive at the default target rate a predetermined amount of time after entering the cooling phase, such as, for example, 30 minutes.

[0042] In embodiments, the rate of the transition from the exercise value to the default value can be varied based on glucose level feedback for the user. For example, if the user’s glucose levels are stable during the transition the system can speed up the gradual transition to the default value. If the user’ s glucose levels are not stable, the system can pause or slow the transition. The stability of the user’s glucose levels can be determined in various ways, such as, for example, by comparing an average glucose level of the user to a target level, determining a number of deviations outside of a target glucose range relative to a threshold number, reviewing a maximum and / or minimum glucose level over the time period, calculating a standard deviation from a target level, etc.

[0043] The system can modify the default gradual transition in various ways based on the stability of the user’ s glucose levels. If the user’s glucose levels are stable, the system may simply continue with the default transition. Alternatively, if the user’s glucose levels are stable, the system may accelerate the transition. This could be done by increasing the increment at the next step in transition and / or decreasing the amount of time until the next increment. Similarly, if the user’s glucose levels are not stable, the system can skip an increment in the transition, decrease the next increment, and / or increase the amount of time until the next increment. In some embodiments, a single exercise ratio and / or exercise logic 50 can be employed any time the user is exercising. In other embodiments, different exercise ratios and / or exercise logic can be employed based on the type of exercise. For example, depending on whether the user is exercising aerobically or anaerobically, doing high intensity interval training, etc. different exercise ratios, cooling steps (e.g., step size / speed or linear / nonlinear), etc., can be employed. Parameters can also be varied based on an intensity of exercise.

[0044] Although described herein as providing a gradual transition from an exercise target IOB to a default target IOB while the user is “cooling down” after exercise, it should be understood that the algorithm logic described herein can be applied to any other circumstance in which the target IOB in the algorithm is modified. For example, a temporary basal rate that modifies the IOB target can be employed by the algorithm for a number of reasons. The algorithm can gradually transition from the modified IOB target to the default IOB target as described herein in these scenarios as well. Such a gradual transition can also be applicable to any other variable in a closed loop algorithm that is temporarily modified.

[0045] In some embodiments, a user will indicate to the system that the user will be exercising, such as, for example, by selecting to enter an exercise mode through a user interface of a pump, remote control, etc. In other embodiments, the system can automatically determine that the user is exercising. In some embodiments, the system can make this determination based on information from one or more additional devices, such as, for example, a fitness or health monitoring device or application. The system may remain in exercise mode for a predetermined time that can be determined in various ways. For example, a user may enter or select an amount of time that the user will exercise or starting time and an ending time for exercise. The user may also be able to disable or close the exercise mode following the exercise through a user interface of a pump, remote control etc. In embodiments that automatically determine when the user is exercising based on information from one or more additional devices, the system can automatically determine when the user has stopped exercising based on the information from the one or more additional devices.

[0046] In embodiments, a system for closed loop diabetes therapy can include a pump mechanism configured to facilitate delivery of insulin to a user, a user interface, a communications interface adapted to receive glucose levels from a continuous glucose monitor and a processor functionally linked to the pump mechanism, the user interface and the communications device. The processor can be configured to calculate and deliver insulin doses to the user based on a closed loop insulin delivery algorithm. An indication may be received that the user will be exercising. An exercise mode for the closed loop insulin delivery algorithm can be activated in response to the indication that the user will be exercising. The exercise mode can modify a variable of the closed loop insulin delivery algorithm from a non-exercise value to an exercise value. Insulin doses can be calculated and delivered to the user based on glucose levels from the continuous glucose monitor according to the exercise mode of the closed loop insulin delivery algorithm following the indication that the user will be exercising. Upon receiving an indication that the user is no longer exercising the variable can be gradually returned from the exercise value to the non-exercise value.

[0047] In some embodiments, the variable is a target insulin on board for the user at which the closed loop insulin delivery algorithm attempts to maintain an insulin on board for the user.

[0048] In some embodiments, the at least one processor is configured to gradually return the variable from the exercise value to the non-exercise value by incrementally returning to variable from the exercise value to the non-exercise value. In some embodiments, the at least one processor is configured to incrementally return the variable from the exercise value to the non-exercise value by modifying the exercise value by one increment per predetermined unit of time.

[0049] In some embodiments, the at least one processor is configured to modify the incremental returning of the exercise value to the non-exercise value based on glucose levels of the user.

[0050] In some embodiments, the at least one processor is configured to modify the incremental returning of the exercise value to the non-exercise value based on glucose levels of the user by increasing the increment and / or decreasing the predetermined unit of time if the glucose levels of the user are stable.

[0051] In some embodiments, the at least one processor is configured to modify the incremental returning of the exercise value to the non-exercise value based on glucose levels of the user by skipping a subsequent increment, decreasing the increment and / or increasing the predetermined unit of time if the glucose levels of the user are not stable.

[0052] In some embodiments, the at least one processor is configured to gradually return the variable from the exercise value to the non-exercise value nonlinearly.

[0053] In some embodiments, the at least one processor is configured to nonlinearly return the variable from the exercise value to the non-exercise value by accelerating the return over time.

[0054] In some embodiments, a rate at which the variable is returned from the exercise value to the non-exercise value is varied based on a type of exercise.

[0055] In some embodiments, a rate at which the variable is returned from the exercise value to the non-exercise value is varied based on an intensity level of the exercise. In some embodiments, the indication that the user will be exercising and / or the indication that the user is no longer exercising is received through the user interface.

[0056] In some embodiments, the indication that the user will be exercising and / or the indication that the user is no longer exercising is received from a smartphone.

[0057] In some embodiments, the indication that the user will be exercising and / or the indication that the user is no longer exercising is received from an activity monitoring device.

[0058] In embodiments, a system for closed loop diabetes therapy can include a pump mechanism configured to facilitate delivery of insulin to a user, a user interface, a communications interface adapted to receive glucose levels from a continuous glucose monitor and a processor functionally linked to the pump mechanism, the user interface and the communications device. The processor can be configured to calculate and deliver insulin doses to the user based on a closed loop insulin delivery algorithm. If it is determined that the user is exercising, an exercise mode for the closed loop insulin delivery algorithm can be activated the closed loop insulin delivery algorithm. Insulin doses can be calculated and delivered to the user based on glucose levels from the continuous glucose monitor according to the exercise mode while the user is exercising. When it is determined that the user is no longer exercising the system gradually returns to the closed loop insulin delivery algorithm from the exercise mode.

[0059] In some embodiments, the at least one processor is configured to gradually return to the closed loop insulin delivery algorithm from the exercise mode incrementally.

[0060] In some embodiments, the at least one processor is configured to incrementally return to the closed loop insulin delivery algorithm from the exercise mode by modifying a value by one increment per predetermined unit of time. In some embodiments, the at least one processor is configured to modify the incremental returning to the closed loop insulin delivery algorithm based on glucose levels of the user.

[0061] In some embodiments, the at least one processor is configured to gradually return to the closed loop insulin delivery algorithm from the exercise mode nonlinearly.

[0062] In some embodiments, a rate of the gradual return to the closed loop insulin delivery algorithm from the exercise mode is varied based on one or more of a type of exercise and an intensity level of the exercise.

[0063] Although embodiments described herein may be discussed in the context of the controlled delivery of insulin, delivery of other medicaments, singly or in combination with one another or with insulin, including, for example, glucagon, pramlintide, etc., as well as other applications are also contemplated. Device and method embodiments discussed herein may be used for pain medication, chemotherapy, iron chelation, immunoglobulin treatment, dextrose or saline IV delivery, treatment of various conditions including, e.g., pulmonary hypertension, or any other suitable indication or application. Non-medical applications are also contemplated.

[0064] With regard to the above detailed description, like reference numerals used therein may refer to like elements that may have the same or similar dimensions, materials, and configurations. While particular forms of embodiments have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the embodiments herein. Accordingly, it is not intended that the invention be limited by the forgoing detailed description.

[0065] Also incorporated herein by reference in their entirety are commonly owned U.S. Patent Nos. 6,999,854; 8,133,197; 8,287,495; 8,408,421 8,448,824; 8,573,027; 8,650,937; 8,986,523; 9,173,998; 9,180,242; 9,180,243; 9,238,100; 9,242,043; 9,335,910; 9,381,271; 9,421,329;

[0066] 9,486,171; 9,486,571; 9,492,608; 9,503,526; 9,555,186; 9,565,718; 9,603,995; 9,669,160;

[0067] 9,715,327; 9,737,656; 9,750,871; 9,867,937; 9,867,953; 9,940,441; 9,993,595; 10,016,561; 10,201,656; 10,279,105; 10,279,106; 10,279,107; 10,357,603; 10,357,606; 10,492,141;

[0068] 10 / 541,987; 10,569,016; 10,736,037; 10,888,655; 10,994,077; 11,116,901; 11,224,693;

[0069] 11,291,763; 11,305,057; 11,458,246; 11,464,908; 11,654,236; 11,911,595; 12,138,425 and commonly owned U.S. Patent Publication Nos. 2009 / 0287180; 2012 / 0123230; 2013 / 0053816; 2014 / 0276423; 2014 / 0276569; 2014 / 0276570; 2018 / 0071454; 2019 / 0307952; 2020 / 0206420; 2020 / 0329433; 2020 / 0372995; 2021 / 0001044; 2021 / 0113766; 2022 / 0062553; 2022 / 0139522; 2022 / 0223250; 2022 / 0233772; 2022 / 0233773; 2022 / 0238201; 2022 / 0265927; 2023 / 0034408; 2022 / 0344017; 2022 / 0370708; ; 2022 / 0037465; 2023 / 0040677; 2023 / 0047034; 2023 / 0113545; 2023 / 0113755; 2023 / 0166033; 2023 / 0166037; 2023 / 0173170; 2023 / 0201452; 2023 / 0241314; 2023 / 0277765; 2023 / 0338653; 2023 / 0381406; 2024 / 0050650; 2024 / 0226423; 2024 / 0226424 and 2024 / 0277924 and commonly owned U.S. Patent Applications Nos. 17 / 368,968; 17 / 896,492; 18 / 207,094; 18 / 398,543; 18 / 441,735; 18 / 474,839; 18 / 475,916; 18 / 478,552; 18 / 678,130; 18 / 700,168; 18 / 891,482; 18 / 896,045; and 18 / 962,169.

[0070] The entirety of each patent, patent application, publication, and document referenced herein is hereby incorporated by reference. Citation of the above patents, patent applications, publications and documents is not an admission that any of the foregoing is pertinent prior art, nor does it constitute any admission as to the contents or date of these documents.

[0071] Modifications may be made to the foregoing embodiments without departing from the basic aspects of the technology. Although the technology may have been described in substantial detail with reference to one or more specific embodiments, changes may be made to the embodiments specifically disclosed in this application, yet these modifications and improvements are within the scope and spirit of the technology. The technology illustratively described herein may suitably be practiced in the absence of any element(s) not specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation and use of such terms and expressions do not exclude any equivalents of the features shown and described or portions thereof and various modifications are possible within the scope of the technology claimed. Although the present technology has been specifically disclosed by representative embodiments and optional features, modification and variation of the concepts herein disclosed may be made, and such modifications and variations may be considered within the scope of this technology.

Claims

CLAIMS1. A system for closed loop diabetes therapy, comprising: a pump mechanism configured to facilitate delivery of insulin to a user; a user interface; a communications interface adapted to receive glucose levels from a continuous glucose monitor; a processor functionally linked to the pump mechanism, the user interface and the communications device, the processor configured to: calculate and deliver insulin doses to the user based on a closed loop insulin delivery algorithm; receive an indication that the user will be exercising; activate an exercise mode for the closed loop insulin delivery algorithm in response to the indication that the user will be exercising, the exercise mode modifying a variable of the closed loop insulin delivery algorithm from a non-exercise value to an exercise value; calculate and deliver insulin doses to the user based on glucose levels from the continuous glucose monitor according to the exercise mode of the closed loop insulin delivery algorithm following the indication that the user will be exercising; receive an indication that the user is no longer exercising; and gradually return the variable from the exercise value to the non-exercise value when the user is no longer exercising.

2. The system of claim 1 , wherein the variable is a target insulin on board for the user at which the closed loop insulin delivery algorithm attempts to maintain an insulin on board for the user.

3. The system of claim 1, wherein the at least one processor is configured to gradually return the variable from the exercise value to the non-exercise value by incrementally returning to variable from the exercise value to the non-exercise value.

4. The system of claim 3, wherein the at least one processor is configured to incrementally return the variable from the exercise value to the non-exercise value by modifying the exercise value by one increment per predetermined unit of time.

5. The system of claim 4, wherein the at least one processor is configured to modify the incremental returning of the exercise value to the non-exercise value based on glucose levels of the user.

6. The system of claim 5, wherein the at least one processor is configured to modify the incremental returning of the exercise value to the non-exercise value based on glucose levels of the user by increasing the increment and / or decreasing the predetermined unit of time if the glucose levels of the user are stable.

7. The system of claim 5, wherein the at least one processor is configured to modify the incremental returning of the exercise value to the non-exercise value based on glucose levels ofthe user by skipping a subsequent increment, decreasing the increment and / or increasing the predetermined unit of time if the glucose levels of the user are not stable.

8. The system of claim 1, wherein the at least one processor is configured to gradually return the variable from the exercise value to the non-exercise value nonlinearly.

9. The system of claim 8, wherein the at least one processor is configured to nonlinearly return the variable from the exercise value to the non-exercise value by accelerating the return over time.

10. The system of claim 1, wherein a rate at which the variable is returned from the exercise value to the non-exercise value is varied based on a type of exercise.

11. The system of claim 1, wherein a rate at which the variable is returned from the exercise value to the non-exercise value is varied based on an intensity level of the exercise.

12. The system of claim 1, wherein the indication that the user will be exercising and / or the indication that the user is no longer exercising is received through the user interface.

13. The system of claim 1, wherein the indication that the user will be exercising and / or the indication that the user is no longer exercising is received from a smartphone.

14. The system of claim 1, wherein the indication that the user will be exercising and / or the indication that the user is no longer exercising is received from an activity monitoring device.

15. A system for closed loop diabetes therapy, comprising: a pump mechanism configured to facilitate delivery of insulin to a user; a user interface; a communications interface adapted to receive glucose levels from a continuous glucose monitor; a processor functionally linked to the pump mechanism, the user interface and the communications device, the processor configured to: calculate and deliver insulin doses to the user based on a closed loop insulin delivery algorithm; determine that the user is exercising; activate an exercise mode for the closed loop insulin delivery algorithm in response to the user exercising, the exercise mode modifying the closed loop insulin delivery algorithm; calculate and deliver insulin doses to the user based on glucose levels from the continuous glucose monitor according to the exercise mode while the user is exercising; determine that the user is no longer exercising; and gradually return to the closed loop insulin delivery algorithm from the exercise mode.

16. The system of claim 15, wherein the at least one processor is configured to gradually return to the closed loop insulin delivery algorithm from the exercise mode incrementally.

17. The system of claim 16, wherein the at least one processor is configured to incrementally return to the closed loop insulin delivery algorithm from the exercise mode by modifying a value by one increment per predetermined unit of time.

18. The system of claim 17, wherein the at least one processor is configured to modify the incremental returning to the closed loop insulin delivery algorithm based on glucose levels of the user.

19. The system of claim 15, wherein the at least one processor is configured to gradually return to the closed loop insulin delivery algorithm from the exercise mode nonlinearly.

20. The system of claim 15, wherein a rate of the gradual return to the closed loop insulin delivery algorithm from the exercise mode is varied based on one or more of a type of exercise and an intensity level of the exercise.

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