WO2025117799A1

WO2025117799A1 - Gradual transition in automated insulin delivery treatment system after a time change

Info

Publication number: WO2025117799A1
Application number: PCT/US2024/057828
Authority: WO
Inventors: Christian Merz
Original assignee: Tandem Diabetes Care Inc
Current assignee: Tandem Diabetes Care Inc
Priority date: 2023-11-27
Filing date: 2024-11-27
Publication date: 2025-06-05
Anticipated expiration: 2026-05-27

Abstract

Embodiments described herein gradually shift a basal rate pattern for a user in time when the time on an insulin pump is changed and use glucose levels from a CGM sensor to coordinate the shift in the basal pattern with the user's actual glucose response to the changing parameters to safely transition the timing of the basal pattern as quickly as possible.

Description

GRADUAL TRANSITION IN AUTOMATED INSULIN DELIVERY TREATMENT SYSTEM AFTER A TIME CHANGE

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of U.S. Provisional Patent Application No. 63/602,997 which is hereby incorporate by reference herein in its entirety.

TECHNICAL FIELD

The present disclosure is directed generally to systems and methods relating to portable infusion pumps and more particularly to continuous glucose monitoring in infusion pump systems.

BACKGROUND

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, are known in the art.

One category of such fluid delivery devices includes insulin injecting pumps developed for administering insulin to patients afflicted with type 1, or in some cases, type 2 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.

Some ambulatory infusion pumps are configured to receive glucose level data of the user from a continuous glucose monitoring (CGM) device that obtains measurements relating to glucose levels in the body. The pump can then use the glucose data in making therapy determinations. Some systems due so in a “closed loop” manner, in which medicament delivery is automatically adjusted based on the glucose levels. In such systems, the closed loop algorithm typically delivers insulin to the user according to a stored basal profile when the user’s glucose levels remain within a target range. The continuous glucose feedback can be used to adjust insulin delivery when the stored baseline basal profile is delivering too much or not enough insulin as reflected by the detected glucose level readings. The stored baseline basal profile provides different basal rates for the user according to the time of day according to the needs of the user at each time of day. If the time on the pump changes due to, e.g., travel to a different time zone, daylight savings time, etc. the basal rate in the basal profile for a given time may not be appropriate as a user’s body will not immediately adjust to the time change.

SUMMARY

Embodiments described herein gradually shift a basal rate pattern for a user in time when the time on an insulin pump is changed and use glucose levels from a CGM sensor to coordinate the shift in the basal pattern with the user’s actual glucose response to the changing parameters to safely transition the timing of the basal pattern as quickly as possible.

In an embodiment, an ambulatory infusion pump system can include a pump mechanism configured to deliver insulin to a user, a communications interface configured to receive data indicative of glucose levels of a user detected by a continuous glucose monitoring sensor and at least one processor configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels. The at least one processor can be configured to cause insulin to be delivered to the user based on a default basal rate pattern that varies a basal rate of insulin being delivered to a patient by a time of day. If time change information indicating a change to the time of day is received, the at least one processor can cause a shift in the default basal rate pattern in time based on the time change information. Glucose levels of the user from the continuous glucose monitoring sensor can be reviewed following the shift in the default basal rate pattern and the shift in the default basal rate pattern in time modified based on the glucose levels.

In an embodiment, an ambulatory infusion pump system can include a pump mechanism configured to deliver insulin to a user and a communications interface configured to receive data indicative of glucose levels of a user detected by a continuous glucose monitoring sensor. At least one processor can be configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels. The at least one processor can be configured to cause insulin to be delivered to the user based on a default basal rate pattern that varies a basal rate of insulin being delivered to a patient by a time of day. Time change information adjusting a current time of day to a new time of day indicating a shift in time of day can be received and the at least one processor can modify the default basal rate pattern in time based on the time change information to gradually align the default basal rate pattern with the shift in time of day. Glucose levels of the user from the continuous glucose monitoring sensor can be reviewed while the default basal rate pattern is being gradually aligned with the shift in time of day. The modification to the default basal rate pattern in time can be selectively altered based on the glucose levels.

In an embodiment, an ambulatory infusion pump system can include a pump mechanism configured to deliver insulin to a user and a communications interface configured to receive data indicative of glucose levels of a user detected by a continuous glucose monitoring sensor. At least one processor can be configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels. The at least one processor can be configured to receive time change information changing a current time of day to a new time of day indicated a shift in time of day. A time-dependent therapy parameter can be modified based on the time change information to gradually align the timedependent therapy parameter with the shift in time of day. Glucose levels of the user from the continuous glucose monitoring sensor can be reviewed while the timedependent therapy parameter is being gradually aligned with the shift in time of day. The modification to the time-dependent therapy parameter in time can be selectively altered based on the glucose levels.

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.

BRIEF DESCRIPTION OF THE DRAWINGS

Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:

FIG. 1 depicts an embodiment of a pump system according to the disclosure.

FIG. 2 depicts a block diagram representing an embodiment of a pump system according to the disclosure.

FIGS. 3A-3B depicts an embodiment of a pump system according to the disclosure.

FIG. 4 depicts a schematic representation of a pump system according to an embodiment of the disclosure.

FIG. 5 depicts a method of transitioning a basal rate pattern of a user following a time change according to the disclosure.

While various embodiments are 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 claimed inventions 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 subject matter as defined by the claims.

DETAILED DESCRIPTION OF THE DRAWINGS

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.

FIG. 1 depicts an exemplary medical device that can be used with embodiments of 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/display 44. The type of output/display 44 may vary as may be useful for a particular application. The output/display 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 include a keyboard, microphone, or other input device known in the art for data entry, which may be separate from the display. The pump 12 may also include a capability to operatively couple to one or more blood glucose meters (BGMs) or continuous blood glucose monitors (CGMs) and/or one or more secondary 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, smart ring, electronic health or fitness monitor, or personal digital assistant (PDA), a CGM display etc.

In one embodiment, the medical device can be a portable 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.

FIG. 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 as shown in FIG. 2 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 one or more input devices, such as sensors that may sense pressure, temperature and/or other parameters.

Figures 3A-3B depict a second infusion pump that can be used in conjunction with one or more embodiments of the ambulatory infusion pump system of the present disclosure. Pump 102 includes a pump drive unit 118 and a medicament cartridge 116. Pump 102 includes a processor that may communicate with one or more processors within the pump 102 and/or one or more processors of other devices such as a remote device (e.g., a CGM device), a remote control device, or a consumer electronic device (e.g., laptop computer, personal computer, tablet computer, smartphone, electronic watch, smart ring, electronic health or fitness monitor, or personal digital assistant). The processor 42 may also include programming to receive signals and/or other data from an input device, such as, by way of example, a pressure sensor, a temperature sensor, or the like. Pump 102 also includes a processor that controls some or all of the operations of the pump. In some embodiments, pump 102 receives commands from a separate device for control of some or all of the operations of the pump. Such separate device can include, for example, a dedicated remote control device or a consumer electronic device such as a smartphone having a processor 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. Such separate device can include any remote display, remote control device, or a consumer electronic device as described above. Pump 102 can also incorporate any or all of the features described with respect to pump 12 in Figure 2. In some embodiments, the communication is effectuated wirelessly, by way of example only, via 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. 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.

FIG. 4 depicts a schematic representation of a pump system 200 according to an embodiment. System 200 includes a user- wearable infusion pump such as pump 12 or pump 102 described above. In embodiments, a user can alternatively wear the pump 102A directly on the body or place the pump 102B in the user's pocket or other location near the body with infusion tubing 144 extending to an infusion set 148 on the user's body. The system 200 also includes a continuous glucose monitoring (CGM) sensor with a corresponding transmitter 208. The CGM sensor obtains measurements relating to glucose levels in the body and the transmitter communicates that information to the pump 102A/B. The pump 208 can then use the glucose data in making therapy determinations. The system can also include a one or more devices such as a smartphone 204 or other multi-purpose consumer electronic device capable of operating a software application to communicate with and/or control the pump and, alternatively or additionally, a dedicated remote control device designed specifically for use with pump 102A/102B. The smartphone 204 or other remote control device can in some embodiments also be capable of communication with CGM sensor/transmitter 208. In addition, the pump 102A/B and/or smartphone 204 or other remote control device can optionally communicate with additional devices such as, for example, a blood glucose meter or other analyte sensing device, an activity or other health monitor, etc.

With the infusion pump and CGM interfaced, the CGM can automatically transmit the CGM data to the pump and/or remote device. The pump can then use this data to automatically determine therapy parameters and suggest a therapy adjustment to the user or automatically deliver the therapy adjustment to the user. These therapy parameters including 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).

In some systems, the closed loop algorithm delivers insulin to the user according to the stored basal profile when the user’s glucose levels remain within a target range. The general concept behind closed loop algorithms such as the algorithm described above is to use continuous glucose feedback to adjust insulin delivery when the stored baseline basal profile is delivering too much or not enough insulin. Because of the ability of the system while in closed loop mode to continually adjust delivery to maintain glucose at a desired level, many users set aggressive basal profiles attempting to maintain the user’s glucose level in a narrower and lower range.

The stored basal profile is a twenty-four hour background infusion of insulin by the insulin pump that is intended to mimic the continuous background release of insulin from a normal pancreas. It is the rate of insulin delivery the patient is estimated to need independent of the consumption of meals. The basal rate is typically specified in insulin units per hour (u/hr). The variation in the rate as a function of time can be referred to as a basal rate pattern or profile. The basal rate pattern will generally vary the delivery rate throughout the day to deliver a different basal rate according to a patient's needs, such as delivering basal insulin at a different rate when the insulin pump user is expected to be sleeping than when the user is awake. Other parameters may also have different optimum values at different times of the day.

A change in the user's schedule may cause the appropriate values of the delivery parameters to change. If the pump user travels and crosses time zones, the user’s circadian clock doesn't immediately adjust to the new time, because, as with jet lag, it takes time for the user's body to adjust. Consequently, the delivery parameters may no longer be programmed appropriately. If the user adjusts the clock on the insulin pump to match the new time zone, it will instantly adjust the basal rate pattern to the new time. This may not be appropriate because the user's body clock will be expecting basal insulin according to the old time zone. For example, if the user travels from the Pacific Time Zone to the Central European Time Zone, there is a nine-hour time change. If the user adjusts the clock on the insulin pump nine hours later, extra basal insulin scheduled for delivery at, for example, 2:00 AM in the Pacific Time Zone will now be delivered at 2:00 AM in the Central European Time Zone while the user's body clock acts as though it is still 5:00 PM. The pump may also be able to automatically adjust its time, which may be even more likely to lead to complications as it may not be top of mind to the user that the change in time will affect the timing of insulin delivery.

A better approach would be to not instantly shift the basal rate pattern to the new time when the insulin pump clock is adjusted. U.S. Patent Publication No. 2022/0230726 to Blomquist et al., owned by the Applicant of the present application, discloses that in such situations the basal rate pattern should be gradually shifted (e.g., once per day) until the basal rate pattern is synchronized to the local time. A similar adjustment would be made on the return home to the original time zone (on a short trip, the basal rate pattern may not be fully adjusted to the new time). Additionally, the basal rate pattern could be gradually adjusted anytime the clock on the insulin pump was changed, such as during a change to or from daylight savings time.

However, different users’ bodies will adjust at different rates such that even a gradual shift as described above may be too quick for some users. Conversely, the goal would be to align the basal pattern with the user’s needs as quickly as possible and for some users the above-described gradual shift may lag and the user’s body would actually benefit from a quicker transition. Embodiments described herein therefore use glucose levels from a CGM sensor as described above to coordinate the shift in the basal pattern according to time with the user’s actual glucose response to the changing parameters to safely transition the timing of the basal pattern as quickly as possible.

For example, in the scenario described above, the basal rate would be shifted by one increment over each set period of time. For example, the delivery pattern of basal insulin may be shifted a specified amount of time per time period (e.g., by a fraction of an hour once or more times per day, or a number of hours once per day) until the delivery pattern matches the new time zone. For example, if the user travels from the Eastern Time Zone to the Central European Time Zone, the delivery pattern of basal insulin can be shifted by one hour per day until the delivery pattern is shifted nine hours later. In embodiments of the present application, this default shift can either be accelerated or slowed down based on glucose feedback. For example, upon arrival in the new time zone the basal pattern may be shifted by one hour. A default transition can be planned, such as shifting the basal pattern by one more hour each day (i.e., 24 hours later). After a predetermined period of time, the system can review a stability of the glucose levels of the user following the previous shift in the basal pattern. 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. The time period may be at the time of the next default shift in the basal pattern (e.g., 24 hours later) or may occur more frequently (e.g., after 6 hours, 12 hours, etc.). More frequent reviews of and modifications to the default transition can serve to both provide a safer transition for users whose bodies are not adjusting as fast as the transition and to provide a quicker transition for users who are able to transition to the new rate more quickly than the default transition.

The system can modify the default 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. For example, if the review is done more frequently than the default transition period (e.g., after 12 hours v. 24 hours), the system can shift the basal rate pattern more frequently when the user’s glucose levels are stable. In such a scenario, after shifting the basal rate pattern by one hour upon arrival, the system may shift the basal rate pattern by another hour after 12 hours rather than waiting 24 hours to the next default transition. If the review is done at the time of the next transition, the system may increase the shift in the basal rate pattern from the default increment. For example, if upon arrival the basal rate pattern was shifted one hour and the user’s glucose levels were stable over the next 24 hours, the pattern may be shifted by two hours for the next adjustment. Similarly, if the user’s glucose levels have not been stable following a shift in the basal pattern, the transition can be slowed. For example, if the basal pattern was shifted by one hour upon arrival and after 12 hours the user’s glucose levels have not been stable, the pattern may be partially shifted back (e.g., by a half hour) or if after 24 hours the user’s glucose levels have not been stable rather than advancing the pattern a second hour the pattern may stay at the same level as the initial shift.

Figure 5 depicts a method of transitioning a basal rate pattern of a user following a time change 300 according to an embodiment. At step 302, the system is delivering insulin to a user based on a default basal rate pattern that varies a basal rate of insulin delivered to the user with an insulin pump over time. Time change information is received changing a time of the insulin pump at step 304. A default gradual transition of the basal rate pattern is initiated at step 306 in response to the time change. At step 308, the basal rate pattern is shifted by a default increment according to the default gradual transition. Glucose levels of the user are reviewed at step 310 following the shift in the basal rate pattern and a measure of stability of the glucose levels is determined. If the glucose levels have been stable, the default transition can be continued or accelerated at step 312. If the user’s glucose levels have not been stable, the default transition can be slowed or paused at step 314. In either scenario, the user’s glucose levels will be continually reviewed at regular levels until the basal pattern has been shifted to match the new time.

In various embodiments, the time change information can be manually entered by the user changing a real time clock of the pump. Alternatively, a pump interfaced with a smartphone, smartwatch or other device may receive the time change information from that device. In some embodiments, pump may be able to communicate with a calendar of the user stored on such a device to determine a time change based on a travel schedule of the user. Similarly, the pump may be able to receive such information from a travel software application downloaded onto the user’s other device. The processor of the pump itself may also be able to detect that a time change has occurred.

The gradual transition of a user’s basal rate pattern described above can also be applied to other therapy parameters that may vary over time. For example, if the user has parameters such as a correction factor, carbohydrate ratio, etc. programmed to be varied throughout the day, those parameters may be gradually transitioned.

In embodiments, an ambulatory infusion pump system can include a pump mechanism configured to deliver insulin to a user and a communications interface configured to receive data indicative of glucose levels of a user detected by a continuous glucose monitoring sensor. At least one processor can be configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels. The at least one processor can be configured to cause insulin to be delivered to the user based on a default basal rate pattern that varies a basal rate of insulin being delivered to a patient by a time of day. Time change information adjusting a current time of day to a new time of day indicating a shift in time of day can be received and the at least one processor can modify the default basal rate pattern in time based on the time change information to gradually align the default basal rate pattern with the shift in time of day. Glucose levels of the user from the continuous glucose monitoring sensor can be reviewed while the default basal rate pattern is being gradually aligned with the shift in time of day. The modification to the default basal rate pattern in time can be selectively altered based on the glucose levels.

In some embodiments, the system further includes a user interface and the time change information is received via the user interface.

In some embodiments, the time change information is received from a separate device.

In some embodiments, the time change information is automatically detected by the at least one processor.

In some embodiments, the at least one processor is configured to modify the default basal rate pattern in time based on the time change information by incrementally shifting the default basal rate pattern in time.

In some embodiments, the at least one processor is configured to incrementally shift the default basal rate pattern in time by shifting the default basal rate pattern by one increment per predetermined unit of time.

In some embodiments, the at least one processor is configured to review glucose levels of the user by determining a stability of the glucose levels.

In some embodiments, the at least one processor is configured to alter the modification to the default basal rate pattern in time based on the glucose levels by maintaining or increasing a rate at which the default basal rate pattern is gradually aligned with the shift in time of day if the glucose levels are considered stable.

In some embodiments, the at least one processor is configured to alter the modification to the default basal rate pattern in time based on the glucose levels by decreasing a rate at which the default basal rate pattern is gradually aligned with the shift in time of day if the glucose levels are not considered stable. In some embodiments, the at least one processor is configured to determine a stability of the glucose levels by comparing an average glucose level of the user to a target level.

In some embodiments, the at least one processor is configured to determine a stability of the glucose levels by determining a number of deviations outside of a target glucose range relative to a threshold number.

In some embodiments, the at least one processor is configured to determine a stability of the glucose levels by reviewing at least one of a maximum or minimum glucose level of the user.

In some embodiments, the at least one processor is configured to determine a stability of the glucose levels by comparing a standard deviation of the glucose levels from a target level to a threshold.

In some embodiments, the at least one processor is configured to continually review the glucose levels of the user at predetermined time intervals until the default basal rate pattern is aligned with the shift in time of day.

In embodiments, an ambulatory infusion pump system can include a pump mechanism configured to deliver insulin to a user and a communications interface configured to receive data indicative of glucose levels of a user detected by a continuous glucose monitoring sensor. At least one processor can be configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels. The at least one processor can be configured to receive time change information changing a current time of day to a new time of day indicated a shift in time of day. A time-dependent therapy parameter can be modified based on the time change information to gradually align the timedependent therapy parameter with the shift in time of day. Glucose levels of the user from the continuous glucose monitoring sensor can be reviewed while the timedependent therapy parameter is being gradually aligned with the shift in time of day. The modification to the time-dependent therapy parameter in time can be selectively altered based on the glucose levels.

In some embodiments, the time-dependent therapy parameter is a basal rate.

In some embodiments, the time-dependent therapy parameter is a correction factor.

In some embodiments, the time-dependent therapy parameter is a carbohydrate ratio.

In some embodiments, the at least one processor is configured to alter the modification to the time-dependent therapy parameter in time based on the glucose levels by maintaining or increasing a rate at which the time-dependent therapy parameter is gradually aligned with the shift in time of day if the glucose levels are considered stable and by decreasing a rate at which the time-dependent therapy parameter is gradually aligned with the shift in time of day if the glucose levels are not considered stable.

Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.

Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein. 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; 9,486,171; 9,486,571; 9,492,608; 9,503,526;

9,555,186; 9,565,718; 9,603,995; 9,669,160; 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; 10/541,987; 10,569,016; 10,736,037; 10,888,655; 10,994,077; 11,116,901; 11,224,693; 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; and 18/896,045.

For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.

Claims

1. An ambulatory infusion pump system, comprising: a pump mechanism configured to deliver insulin to a user; a communications interface configured to receive data indicative of glucose levels of a user detected by a continuous glucose monitoring sensor; and at least one processor configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels, the at least one processor configured to: cause insulin to be delivered to the user based on a default basal rate pattern that varies a basal rate of insulin being delivered to a patient by a time of day; receive time change information adjusting a current time of day to a new time of day indicating a shift in time of day; modify the default basal rate pattern in time based on the time change information to gradually align the default basal rate pattern with the shift in time of day; review glucose levels of the user from the continuous glucose monitoring sensor; and selectively alter the gradual transition of the default basal rate pattern based on the glucose levels.

2. The ambulatory infusion pump system of claim 1, further comprising a user interface and wherein the time change information is received via the user interface.

3. The ambulatory infusion pump system of claim 1, wherein the time change information is received from a separate device.

4. The ambulatory infusion pump system of claim 1, wherein the time change information is automatically detected by the at least one processor.

5. The ambulatory infusion pump system of claim 1, wherein the at least one processor is configured to modify the default basal rate pattern in time based on the time change information by incrementally shifting the default basal rate pattern in time.

6. The ambulatory infusion pump system of claim 1, wherein the at least one processor is configured to incrementally shift the default basal rate pattern in time by shifting the default basal rate pattern by one increment per predetermined unit of time.

7. The ambulatory infusion pump system of claim 1, wherein the at least one processor is configured to review glucose levels of the user by determining a stability of the glucose levels.

8. The ambulatory infusion pump system of claim 7, wherein the at least one processor is configured to alter the gradual transition of the default basal rate pattern based on the glucose levels by maintaining or increasing a rate at which the default basal rate pattern is gradually aligned with the shift in time of day if the glucose levels are considered stable.

9. The ambulatory infusion pump system of claim 7, wherein the at least one processor is configured to alter the gradual transition of the default basal rate pattern based on the glucose levels by decreasing a rate at which the default basal rate pattern is gradually aligned with the shift in time of day if the glucose levels are not considered stable.

10. The ambulatory infusion pump system of claim 7, wherein the at least one processor is configured to determine a stability of the glucose levels by comparing an average glucose level of the user to a target level.

11. The ambulatory infusion pump system of claim 7, wherein the at least one processor is configured to determine a stability of the glucose levels by determining a number of deviations outside of a target glucose range relative to a threshold number.

12. The ambulatory infusion pump system of claim 7, wherein the at least one processor is configured to determine a stability of the glucose levels by reviewing at least one of a maximum or minimum glucose level of the user.

13. The ambulatory infusion pump system of claim 7, wherein the at least one processor is configured to determine a stability of the glucose levels by comparing a standard deviation of the glucose levels from a target level to a threshold.

14. The ambulatory infusion pump system of claim 1, wherein the at least one processor is configured to continually review the glucose levels of the user at predetermined time intervals until the default basal rate pattern is aligned with the shift in time of day.

15. An ambulatory infusion pump system, comprising: a pump mechanism configured to deliver insulin to a user; a communications interface configured to receive data indicative of glucose levels of a user detected by a continuous glucose monitoring sensor; and at least one processor configured to receive the data indicative of glucose levels of the user and to determine therapy parameters for the user based on the glucose levels, the at least one processor configured to: receive time change information changing a current time of day to a new time of day indicated a shift in time of day; modify a time-dependent therapy parameter based on the time change information to gradually align the time-dependent therapy parameter with the shift in time of day; review glucose levels of the user from the continuous glucose monitoring sensor; and selectively alter the gradual alignment of the time-dependent therapy parameter based on the glucose levels.

16. The ambulatory infusion pump system of claim 15, wherein the time-dependent therapy parameter is a basal rate.

17. The ambulatory infusion pump system of claim 15, wherein the time-dependent therapy parameter is a correction factor.

18. The ambulatory infusion pump system of claim 15, wherein the time-dependent therapy parameter is a carbohydrate ratio.

19. The ambulatory infusion pump system of claim 15, wherein the at least one processor is configured to review glucose levels of the user by determining a stability of the glucose levels.

20. The ambulatory infusion pump system of claim 19, wherein the at least one processor is configured to alter gradual alignment of the time-dependent therapy parameter based on the glucose levels by maintaining or increasing a rate at which the time-dependent therapy parameter is gradually aligned with the shift in time of day if the glucose levels are considered stable and by decreasing a rate at which the timedependent therapy parameter is gradually aligned with the shift in time of day if the glucose levels are not considered stable.