Method and apparatus for determining device dosage

Abstract

The technology described herein relates to a computerized method and apparatus for determining a dose injected into a user by one or more drug delivery devices. Data indicating an injection event group is accessed, the injection event group including one or more injection events associated with the one or more drug delivery devices. The injection event group is processed to determine the dose injected into the user based on one or more of the following: whether the injection event is associated with a drug delivery device change, the dose size of the one or more injection events, the position of the one or more injection events in the injection event group, and / or the time period between the one or more injection events and the next injection event in the injection event group.

Description

Background Art

[0001] Drug delivery devices include injection-type delivery devices that inject doses of drug. Multiple-use injection devices typically include a reservoir to hold the drug, and a dose setting mechanism that allows the user to set the desired dose size for each injection. An insulin pen is an example of a multiple-use injection device. The insulin pen includes a reservoir of insulin sufficient for multiple doses over an extended period of time (e.g., over several days or weeks). The insulin pen also allows the user to specifically adjust the unit amount to be delivered with each injection.

[0002] Patients using drug delivery devices (e.g., insulin pens) are typically required to follow a prescribed dosage schedule, which may include multiple injections throughout the course of each day, as well as the dosage size of each injection. Patients must manually keep track of each injection and dosage size, which can be cumbersome, tedious, and prone to human error. Summary of the invention

[0003] The present disclosure relates to techniques for determining injected dose information. In some embodiments, the techniques may process multiple injection events to distinguish non-events (e.g., priming events) from actual injected doses. In some embodiments, the techniques may incorporate change information (e.g., cartridge changes and / or switching drug delivery devices) into the analysis to determine injected doses taking into account change events.

[0004] Various aspects are described in this disclosure, including but not limited to the following:

[0005] 1. A computerized method for determining a dose to be injected into a user by one or more drug delivery devices, the method comprising:

[0006] Accessing data indicative of an injection event group, the injection event group comprising one or more injection events associated with one or more medication delivery devices, wherein each of the one or more medication delivery devices comprises:

[0007] a dose adjustment mechanism that allows a user to adjust the amount of a dose for injection by the drug delivery device;

[0008] a reservoir of sufficient size to hold the drug for multiple doses;

[0009] one or more sensors for detecting the amount of the dose dispensed for each injection; and

[0010] a wireless communication unit that communicates the amount of the dose dispensed and the time at which it was dispensed;

[0011] determining whether the group of injection events is associated with a drug delivery device change;

[0012] Upon determining that the group of injection events is not associated with a change in the drug delivery device, analyzing the group of injection events based on a first dose detection algorithm to determine a dose to be administered to a user; and

[0013] Upon determining that the group of injection events is associated with a change in the drug delivery device, the group of injection events is analyzed based on a second dose detection algorithm to determine a dose to be administered to a user.

[0014] 2. The computerized method of aspect 1, wherein:

[0015] The one or more drug delivery devices include a previous drug delivery device and a new drug delivery device; and

[0016] Determining whether the group of injection events is associated with the drug delivery device change includes determining whether a user switches from using the previous drug delivery device to using the new drug delivery device within a predetermined time window of the group of injection events.

[0017] 3. The computerized method of aspect 1, wherein:

[0018] The one or more drug delivery devices include a drug delivery device; and

[0019] Determining whether the group of injection events is associated with a change of the drug delivery device includes determining whether there is a change of a replaceable cartridge of the one drug delivery device within a predetermined time window of the group of injection events.

[0020] 4. The computerized method of aspect 1, wherein analyzing the group of injection events based on a first dose detection algorithm comprises:

[0021] determining that the number of injection events in the group of injection events is greater than two; and

[0022] The dose is determined to be equal to an injection volume associated with a most recent injection event in the group of injection events, wherein the most recent injection event occurs later in time than any other injection event in the group of injection events.

[0023] 5. The computerized method of aspect 4, wherein the most recent injection event is designated as a true injection event and all other injection events in the group of injection events are each designated as a priming injection event.

[0024] 6. The computerized method of aspect 1, wherein analyzing the group of injection events based on a first dose detection algorithm comprises:

[0025] Determining that the number of injection events in the injection event group is equal to two, wherein the injection event group includes:

[0026] a first injection event associated with the first time; and

[0027] a second injection event associated with a second time later than the first time; and

[0028] A determination is made as to whether a first injection volume associated with the first injection event is greater than a second injection volume associated with the second injection event.

[0029] 7. The computerized method of aspect 6, further comprising determining the dose based on a sum of the first injection volume and the second injection volume upon determining that the first injection event is greater than the second injection event.

[0030] 8. The computerized method of aspect 6, further comprising determining that the dose is equal to the second injection volume upon determining that the first injection event is not greater than the second injection event.

[0031] 9. The computerized method of aspect 8, wherein the first injection event is designated as a priming injection event.

[0032] 10. The computerized method of aspect 1, wherein analyzing the group of injection events based on a second dose detection algorithm comprises determining whether a change time associated with a change to the drug delivery device is (i) later than or earlier than each time associated with each injection event in the group of injection events, or (ii) later than a time associated with at least one injection event in the group of injection events and earlier than another time associated with at least one other injection event in the group of injection events.

[0033] 11. The computerized method of aspect 10, further comprising: determining that the dose is equal to an injection volume associated with a latest injection event in the group of injection events when determining that the change time is later than or earlier than each time associated with each injection event in the group of injection events, wherein the latest injection event occurs later in time than any other injection event in the group of injection events.

[0034] 12. The computerized method of aspect 11, wherein the remaining injection events are designated as priming injection events.

[0035] 13. The computerized method of any one of aspects 10 or 11, further comprising, upon determining that the change time is later than a time associated with at least one injection event in the group of injection events and earlier than another time associated with at least one other injection event in the group of injection events, determining:

[0036] a first sub-injection event group including each injection event in the injection event group associated with a time occurring before the change time; and

[0037] A second sub-injection event group includes each injection event in the injection event group that is associated with a time that occurs after the change time.

[0038] 14. The computerized method of aspect 13, further comprising determining the dose based on the sum of:

[0039] a first latest injection event in the first sub-group of injection events, wherein the first latest injection event occurs later in time than any other injection event in the first sub-group of injection events; and

[0040] A second most recent injection event in the second sub-group of injection events, wherein the second most recent injection event occurs later in time than any other injection event in the second sub-group of injection events.

[0041] 15. The method according to aspect 14, wherein the remaining injection events in the first sub-group of injection events and the remaining injection events in the second sub-group of injection events are designated as priming injection events.

[0042] 16. The method according to aspect 1 also includes determining the injection event group.

[0043] 17. The method according to aspect 16, wherein:

[0044] Determining the set of injection events includes determining that a plurality of injection events satisfy a predetermined criterion; and

[0045] Determining that the plurality of injection events meets the predetermined criteria includes, for each injection event in the plurality of injection events, determining that a time associated with the injection event is within a predetermined time period of a previous injection event in the plurality of injection events.

[0046] 18. A non-transitory computer-readable medium comprising instructions which, when executed by one or more processors on a computing device, are operable to cause the one or more processors to perform the method of any one of aspects 1-17.

[0047] 19. A system comprising a memory storing instructions and a processor, the processor being configured to execute the instructions to perform the method according to any one of aspects 1-17.

[0048] 20. A computerized method for determining a dose to be injected into a user by one or more drug delivery devices, the method comprising:

[0049] accessing data indicative of an injection event group, the injection event group comprising one or more injection events associated with one or more medication delivery devices, wherein each of the one or more injection events occurs within a predetermined time period, and wherein each of the one or more medication delivery devices comprises:

[0050] a dose adjustment mechanism that allows a user to adjust the amount of a dose for injection by the drug delivery device;

[0051] a reservoir of sufficient size to hold the drug for multiple doses;

[0052] one or more sensors for detecting the amount of the dose dispensed for each injection; and

[0053] a wireless communication unit that communicates the amount of the dose dispensed and the time at which it was dispensed;

[0054] Determine the dosage to be given to the user, including:

[0055] determining whether the group of injection events includes a first injection event and a second injection event occurring after the first injection event; and

[0056] Upon determining that the injection event group includes the first injection event and the second injection event, determining whether the first injection event is associated with a dose administered to a user or a priming dose not administered to a user based on a time period between the first injection event and the second injection event.

[0057] 21. The computerized method of aspect 20, wherein the predetermined time period is between four minutes and six minutes.

[0058] 22. The computerized method of aspect 20, wherein determining the dose administered to the user comprises determining whether the injection event is associated with a dose administered to the user or a priming dose not administered to the user based on a dose size of an injection event in the group of injection events.

[0059] 23. The computerized method of aspect 22, further comprising:

[0060] determining whether the dose size is greater than a first predetermined threshold;

[0061] Upon determining that the dose size is greater than the first predetermined threshold, determining that the injection event is associated with a dose administered to a user; and

[0062] When it is determined that the dose size is not greater than the first predetermined threshold, a dose to be administered to the user is determined based on whether there is a next injection event occurring after the injection event in the group of injection events.

[0063] 24. The computerized method of aspect 23, wherein the first predetermined threshold is a dose size between nine units and eleven units.

[0064] 25. The computerized method of aspect 23, further comprising: upon determining that the dose size is not greater than the first predetermined threshold:

[0065] determining whether there is a next injection event occurring after the injection event in the injection event group;

[0066] Upon determining that there is no next injection event in the group of injection events, determining that the injection event is associated with a dose administered to a user; and

[0067] Upon determining that there is a next injection event in the group of injection events, a dose to be administered to the user is determined based on a time period between the injection event and the next injection event in the group of injection events.

[0068] 26. The computerized method of aspect 20, wherein determining a dose to administer to the user based on a time period between the first injection event and the second injection event comprises:

[0069] determining whether the time period is less than a second predetermined threshold;

[0070] Upon determining that the time period is less than the second predetermined threshold, determining that the first injection event is associated with a priming dose that was not administered to a user; and

[0071] Upon determining that the time period is not less than the second predetermined threshold, a dose to be administered to the user is determined based on the dose size of the first injection event.

[0072] 27. The computerized method of aspect 26, wherein the second predetermined threshold is a time period between 75 seconds and 85 seconds.

[0073] 28. The computerized method of aspect 26, wherein determining a dose to administer to a user based on a dose size of the first injection event comprises:

[0074] determining whether the dose size is greater than a third predetermined threshold;

[0075] upon determining that the dose size is greater than the third predetermined threshold, determining that the first injection event is associated with a dose administered to a user; and

[0076] Upon determining that the dose size is not greater than the third predetermined threshold, it is determined that the first injection event is associated with a priming dose that was not administered to the user.

[0077] 29. The computerized method of aspect 28, wherein the third predetermined threshold is a dose size between four units and five units.

[0078] 30. A non-transitory computer-readable medium comprising instructions which, when executed by one or more processors on a computing device, are operable to cause the one or more processors to perform the method of any of aspects 20-29.

[0079] 31. A system comprising a memory storing instructions and a processor, the processor being configured to execute the instructions to perform the method according to any one of aspects 20-29. BRIEF DESCRIPTION OF THE DRAWINGS

[0080] Additional embodiments of the present disclosure and their features and advantages will become more apparent by reference to the description herein in conjunction with the accompanying drawings. The components in the figures are not necessarily to scale. In addition, in the accompanying drawings, the same reference numerals represent corresponding parts in different views.

[0081] Figure 1 are illustrative examples of drug delivery devices according to some examples;

[0082] Figure 2 is a flow chart illustrating an exemplary computerized process for determining injection event groups according to some embodiments;

[0083] Figure 3A-3B is a table showing examples of injection event groups according to some embodiments;

[0084] Figure 4A-4B is a flow chart illustrating an exemplary computerized process for determining a dosage based on a group of injection events according to some embodiments;

[0085] Figures 5A-5C is a table illustrating an example of dose determination for a group of injection events not associated with a drug delivery device change according to some embodiments;

[0086] Figure 6A-6B is a table showing an example of dose determination for an injection event group associated with a drug delivery device change according to some embodiments;

[0087] Figure 7 is a flow chart illustrating an exemplary computerized process for determining a dosage based on an injection event group including one or more injection events occurring within a predetermined time period according to some embodiments;

[0088] Figures 8A-8E is a table illustrating an example of dose determination for an exemplary group of injection events in which the injection events occur within a predetermined time period of five minutes according to some embodiments;

[0089] Fig. 9 is a flow chart illustrating an exemplary computerized process for determining a dosage based on a group of injection events according to some embodiments;

[0090] Figures 10A-10C is a table showing an example of dose determination for an exemplary injection event group according to some embodiments; and

[0091] Fig.11 is a diagram of an exemplary system for implementing the computerized processes described herein, according to some embodiments. DETAILED DESCRIPTION

[0092] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe these embodiments. It will be understood, however, that no limitation of the scope of the invention is thereby intended.

[0093] The present disclosure relates to a technology for accurately determining dosage injection information. Drug delivery devices (e.g., insulin pens) can be disposable or reusable. When a user runs out of insulin in a reservoir, the disposable pen is discarded and replaced as a whole. The reusable pen has a port for receiving an insulin cartridge. Once the cartridge runs out, the user can discard the old cartridge and insert a new one. For example, U.S. Patent No. 7,195,616, entitled MEDICATION INJECTOR APPARATUS WITH DRIVE ASSEMBLY THAT FACILITATES RESET, issued on March 27, 2007, describes an example of a reusable insulin pen, which is incorporated herein by reference in its entirety.

[0094] Insulin pens typically require periodic priming prior to use. Priming typically involves the user intentionally injecting a small amount of insulin (e.g., into air) to purge excess air trapped in the needle or elsewhere in the fluid path between the pen's insulin reservoir and the needle tip. If the pen is not properly primed prior to use, air in the needle and / or fluid path may cause the pen to inject less than the requested amount of insulin.

[0095] Because manual tracking of injection and dosage by the user may be troublesome and prone to error, the drug delivery device may include a wireless function (e.g., WiFi, Bluetooth, NFC, etc.), which can wirelessly report injection event information, including the time and dosage size of insulin injection. As used herein, "injection event" may refer to a discrete dose of insulin delivered at a specific time. The injection event information may be transmitted to a remote device, such as a smart phone (e.g., running a mobile application) or a cloud server. It is necessary to distinguish between the real injection dose of insulin injected into the patient's body and the filling dose that is not injected into the patient's body. If the filling dose is mistaken for the real dose, the remote device and / or the cloud server may incorrectly determine that the user has injected more insulin than the insulin he / she actually injected. This incorrect determination may affect the validity of the user's insulin dosage log and the calculation of the amount of onboard insulin (e.g., the amount of effective, unused insulin circulating through the user's body). Incorrect onboard insulin calculation may affect the validity of subsequent push calculations.

[0096] There is also a need to identify split doses, where a user splits a single dose across two or more pens (eg, disposable insulin pens), or changes the insulin cartridge of a reusable pen in the middle of a dose.

[0097] The following example illustrates the need for detecting both filling doses and split doses. Assume that a user needs to take 15 units of insulin, but only 7 units are left in her pen. The user can fill her pen by expelling a small dose of 2 units into the air. The user then injects the remaining 5 units. The user then discards the empty pen and selects a new pen (or replaces the used insulin cartridge if the pen is a reusable pen). The user fills a new pen (or a new insulin cartridge) by expelling 3 small doses of 2 units each time until the user feels that there is no air left in the needle. Once the new pen or cartridge is properly filled, the user injects the remaining 10 units.

[0098] In this example, a device receiving injection event data will receive data indicating the following sequence of injected doses: 2, 5, 2, 2, 2, and 10 units of insulin. If the device assumes that all of these doses are true doses, it will overestimate the amount of insulin actually taken by the user (e.g., it will determine that the user injected 23 units of insulin when in fact the user only injected 15 units). Therefore, there is a need to distinguish between true doses actually injected into the patient and priming doses, and also to identify when doses are split across two separate pens or cartridges.

[0099] The technology described herein provides a computer-implemented technology (e.g., a computer application, such as a mobile phone application or a cloud-based application) that provides accurate determination of the dose injected into a patient by a drug delivery device. In some embodiments, the technology can be configured to determine an injection event group based on the injection event time, for example (e.g., by grouping injection events that occur within five minutes of each other). Such an injection event group may include any group of one or more injection events. In some embodiments, the technology can be configured to process the injection event group based on whether the injection event group is associated with a device change (e.g., a user switches to a new disposable drug delivery device and / or changes the cartridge of a reusable drug delivery device). If the injection event group is not associated with a device change, the technology can process the injection event group according to a first algorithm that is configured to determine the dose information of the injection event group that is not associated with the device change. If the injection event group is associated with a device change, the technology can process the injection event group using a second algorithm that is configured to determine the dose information of the injection event group associated with the device change.

[0100] In some embodiments, the technology can be configured to determine a group of injection events that occur within a certain time period (e.g., injection events that occur within a five-minute period). In some embodiments, the dose administered to the user can be determined by determining whether each injection event is associated with a dose administered to the user or a fill dose that is not administered to the user. The determination can include determining whether the group of injection events includes a first injection event and a second injection event that occurs after the first injection event. When determining that the group of injection events includes a first injection event and a second injection event, the determination can also be based on a time period between the first injection event and the second injection event.

[0101] Although various embodiments have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible. Therefore, the embodiments described herein are examples, rather than the only possible embodiments and implementations. Furthermore, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all described advantages will be achieved by each embodiment.

[0102] Figure 1is an illustrative example of a drug delivery device 20 according to some examples. The drug delivery device 20 is a reusable drug injection pen. As is well known in reusable devices of its type, the injection pen 20 includes a cartridge or reservoir 22 filled with a drug as part of a cartridge assembly, generally designated 24, which is connected to a reusable pen base, generally designated 26. The cartridge or reservoir 22 is sized sufficient to contain the drug for a plurality of doses. The pen base 26 preferably includes a dose setting and injection mechanism that functions to allow a certain amount of drug to be selected and then expelled from the cartridge assembly 24 through an injection needle assembly 27 shown as being connected thereto. As shown, an exposed knob 28 having a rotatable button 30 thereon at the rear end or proximal end of the pen base 26 is a manually operated portion of the dose setting and injection mechanism that is otherwise contained within the pen base 26. During the dose setting process, the knob 28 is designed to be rotatable to set a dose, and when the knob 28 is so rotated to increase the selected dose, the knob 28 and button 30 are rotated from the cartridge assembly 24 to increase the selected dose. Figure 1 The axial position shown is translated out of the pen base 26, or from Figure 1 During the dose injection process that occurs after the dose setting process, when a push force is applied to the button 30 that rotates freely relative to the knob 28, the button 30 and the knob 28 are designed to shift to the left and return to the Figure 1 The axial position shown allows the injection mechanism assembly housed in the pen base to operate, thereby allowing the drug in the cartridge to be injected.

[0103] In some embodiments, the drug delivery device may include one or more sensors for detecting the dose allocated for each injection. For example, the drug delivery device may include one or more sensors configured to detect movement and / or changes of components of the drug delivery device. Examples of such sensors may include magnetic field sensors, switches, accelerometers, gyroscopes, etc. As another example, the drug delivery device may include a sensor for determining the setting of a dose setting member. U.S. Patent No. 7,195,616, incorporated by reference in its entirety above, contains some non-limiting examples of such sensors.

[0104] In some embodiments, the drug delivery device may include one or more sensors for detecting when a user changes a cartridge (e.g., when a user changes reservoir 22). For example, the drug delivery device may include one or more switches and / or pressure sensors for detecting removal of a cartridge from the drug delivery device and / or insertion of a cartridge into the drug delivery device.

[0105] In some embodiments, the drug delivery device may include a processing unit (or multiple processing units), such as a central processing unit (CPU), a microcontroller unit (MCU), an application specific integrated circuit (ASIC), etc. In some embodiments, the processing unit can be configured to use data generated from the sensor to determine the injection dose and / or the insertion / removal of the cartridge. In some embodiments, the processing unit can be configured to perform the techniques described herein, including determining the injected dose.

[0106] In some embodiments, the drug delivery device may include a communication unit. The communication unit may be a wired communication unit (e.g., Universal Serial Bus (USB), FireWire, Serial, etc.) and / or a wireless communication unit (e.g., Bluetooth, WiFi, Near Field Communication (NFC), etc.). For example, the communication unit may be a WiFi transceiver, a Bluetooth transceiver, an RFID transceiver, a USB transceiver, a Near Field Communication (NFC) transceiver, a combination chip, etc. The processing unit may be configured to send injection event information (e.g., including the dose dispensed and the time dispensed), cartridge change information, and / or other information to a separate device using the communication unit.

[0107] Figure 2 2 is a flow chart illustrating an exemplary computerized process 200 for determining a group of injection events according to some embodiments. The process 200 may be performed, for example, by a medication delivery device, a smart phone, a server, etc. At step 202, the device accesses data indicating injection events. For example, the device may receive a group of injection events from the medication delivery device substantially simultaneously (e.g., in a batch report), or the device may receive each injection event individually from the medication delivery device as each injection event occurs.

[0108] In step 204, the device adds the received injection event to the currently opened injection event group. If there is no currently opened injection event group, the device creates a new currently opened injection event group.

[0109] At step 206, the device opens an injection event window. The injection event window may include a time period during which the device will add any newly received injection events to the currently opened injection event group. In some embodiments, opening the injection event window may include starting a timer.

[0110] At step 208, the device determines whether it has accessed data indicating a new injection event within the injection event window (e.g., before the timer expires). If so, the device returns to step 204 (where it adds the new injection event to the currently open injection group), to step 206 (where it restarts the injection event window), and to step 208 (where it determines whether it has accessed data indicating a new injection event within the newly restarted injection event window). If no new injection event is received within the injection event window, the device proceeds to step 210 and closes the injection event group. If an additional new injection event is received within the newly restarted injection event window, the device returns to step 204. In this way, the device repeats steps 204, 206, and 208 until no new injection event is received within the then-current injection event window.

[0111] In operation, for example, if each injection is delivered within (e.g., less than or equal to) 5 minutes in time from the previous injection (in this example, the injection event window has a duration of 5 minutes), the device may group one or more injection events into a single injection event group. Thus, for example, if the injection event data shows that the pen delivered a second injection 4 minutes after the first injection, and then delivered a third injection 3 minutes after the second injection, the device groups all three injections into the same injection event group (e.g., even if the elapsed time between the first and third injection events is 7 minutes).

[0112] Process 200 may be modified in various ways. For example, in some embodiments, the device may not restart the injection event window each time a new injection event is received. In such an embodiment, all injection events must be received within a certain time period of the first injection event in order to be grouped into the same injection event group. In some embodiments, the device may optionally determine whether the injection event meets a certain predetermined criterion before adding the injection event to the currently opened injection event group. For example, the device may be configured to only add injection events that are greater than a certain minimum dose size (e.g., 1 unit), have a duration greater than a certain minimum duration, or have a duration less than a certain maximum duration to the currently opened injection event group. Any injection event that does not meet the predetermined criterion may not be added to the currently opened injection event group.

[0113] Figure 3A-3B300, 350 are tables showing examples of injection event groups according to some embodiments. As shown in table 300, an injection event 302 occurs at 4:42:03 p.m., where the dose is two units, and five minutes later at 4:47:03 p.m., no additional injection events occur, so injection event 302 is the only injection event in the injection event group. In this example, injection event 302 is determined to be an injection event (e.g., as opposed to a fill event) because it is the only injection event in the injection event window. As shown in table 350, the injection event group (in this example, group 1) includes five different injection events 352-360. As shown, each injection event is within five minutes of the previous injection event. For example, injection event 354 occurs at 4:55:19 p.m., which is within five minutes of injection event 352, which occurs at 4:55:14 p.m.

[0114] Figure 4A 4 is a flow chart illustrating an exemplary computerized process 400 for determining a dose based on an injection event group according to some embodiments. At step 402, a device (e.g., a drug delivery device, a smart phone, a server, etc.) accesses an injection event group including one or more injection events. As described herein, an injection event group can include injection events associated with (e.g., delivered by) one or more drug delivery devices.

[0115] In step 404, the device determines whether the injection event group is associated with a drug delivery device change. In some embodiments, the device change may include switching from a single-use drug delivery device to another single-use drug delivery device and / or changing the cartridge of a reusable drug delivery device. In some embodiments, the drug delivery device may store and / or report data indicating when the cartridge changes, when the disposable drug delivery device runs out of the drug in the reservoir, and / or when the new disposable drug delivery device replaces the previous disposable drug delivery device. In some embodiments, the device change can be determined based on other information. For example, when a user selects a new disposable drug delivery device, the user may need to first pair the drug delivery device with another device (e.g., an attachable module, an application running on a smart phone, a server, etc.). When the new drug delivery device is paired with the device and / or paired with another device in the system, the device can determine that there is a device change.

[0116] In some embodiments, an injection event group may be determined to be associated with a device change if the time of the change is within a predetermined amount of time for the injection event group, within a time window determined based on the injection event group, etc. For example, the device may determine that an injection event group is associated with a device change if the user changes pens or changes replaceable cartridges during a time period that begins 5 minutes before the first injection event in the group and ends at the time of the last injection event in the group. As another example, the device may determine that an injection event group is associated with a device change if the user changes pens or changes replaceable cartridges during a time period that begins 5 minutes before the first injection event in the group and ends 5 minutes after the time of the last injection event in the group.

[0117] If the injection event group is not associated with a change, the method proceeds to step 406 to analyze the injection event group based on the first dose detection algorithm shown in steps 406 to 414 to determine the dose administered to the user. If the injection event group is associated with a drug delivery device change, the method proceeds to the step described further below. Figure 4B The method shown is to analyze the group of injection events based on a second dose detection algorithm to determine the dose administered to the user.

[0118] At step 406, the device determines whether there are three or more injection events in the group of injection events. If there are three or more injection events, the method proceeds to step 408, and the device determines that the dose administered to the patient is equal to the dose associated with the last injection event in the group (which is the injection event that occurs later in time than any other injection event). The device may designate the remaining injection events as priming injection events.

[0119] If there are not three or more injection events, the method proceeds to step 410. Figure 4A Although not shown in the flowchart of , if the injection event includes only one event, the system can be configured to determine that the injection event includes an injection dose. At step 410, if there are two injection events in the injection event group, the device determines whether the dose of the injection event that occurs first in time is greater than the dose of the second injection event that occurs later in time. If the dose of the first injection event is greater than the dose of the second injection event, the method proceeds to step 412, and the dose is determined based on the sum of the doses of the two injection events. If the dose of the first injection event is not greater than the dose of the second injection event, the method proceeds to step 414, and the device determines that the dose administered to the patient is equal to the dose of the second injection event. The device can designate the first injection event as a priming injection event.

[0120] In some embodiments, step 410 may be modified such that the method proceeds to step 412 only if the dose of the first injection event is greater than the dose of the second injection event by a predetermined threshold. If the dose of the first injection event is not greater than the dose of the second injection event by the predetermined threshold, the method may proceed to step 414. The predetermined threshold may be an absolute number of units of insulin (e.g., 7 units), or a required minimum ratio of the first injection dose to the second injection dose may be specified (e.g., the ratio of the first injection dose to the second injection dose must exceed 5:1).

[0121] Figures 5A-5C 5 are tables 500, 530, and 560, respectively, illustrating examples of dose determination for a group of injection events not associated with a drug delivery device change according to some embodiments. Figure 5A In table 500, the injection event group includes two injection events 502 and 504. Since there are only two injection events, the device compares the doses of the two injections. Since the dose of injection two 504 (33 units) is greater than the dose of injection one 502 (2 units), the device determines that the injection dose is 33 units and the first injection event is a priming event that does not count the amount injected by the user.

[0122] refer to Figure 5B According to the table 530, the injection event group includes three injection events 532, 534, and 536. Since there are three injection events, the device determines that the last injection event 536 is an injection event, and the other two injection events 532 and 534 are priming events.

[0123] refer to Figure 5C In table 560, the injection event group includes two injection events 562 and 564. Since there are only two injection events, the device compares the amount of the two injected doses. Since the dose of the first injection event 562 (12 units) is greater than the dose of the second injection event 564 (2 units), the device determines that each injection event is an injection, and therefore the amount injected is equal to the combination of the two doses, i.e., 14 units.

[0124] Figure 4B4 is a flowchart illustrating an exemplary computerized process 450 for determining a dose based on an injection event group associated with a drug delivery device change according to some embodiments. In step 452, the device determines whether a drug delivery device change occurs between injection events in the injection event group. If the change time is sent before or after all injection events in the injection event group, the device proceeds to step 454 and determines that the last injection event (an event that occurs after other injection events in the group) is an injection dose, while the remaining injection events are filling events. For example, as described herein, if the change event occurs within a certain time period after the injection events in the injection event group (e.g., within five minutes after the last injection event), the injection event group can be associated with the change event. As another example, as described herein, if the change event occurs within five minutes before all injection events in the injection event group, the injection event group can be associated with the change event. If all injection events in the injection event group occur before or after the change, the method can proceed to step 454 and determine that the last injection event is an injection dose, while the remaining injection events are filling events. Otherwise, the method can proceed to step 456, as described below.

[0125] If the change time occurs between injection events, the device proceeds to step 456 and determines two sub-injection groups. The first sub-injection event group includes each injection event in the injection event group that occurs before the change time. The second sub-injection event group includes each injection event in the injection event group that occurs after the change time. In step 458, the device determines the injection dose based on the last injection event in each sub-injection event group. In particular, for the first sub-injection event group, the device determines that the latest injection event (which occurs after other injection events in the first sub-injection event group) is the injection dose, and the remaining injection events (if any) are filling events. Similarly, for the second sub-injection event group, the device determines that the latest injection event is the injection dose, and the remaining injection events (if any) are filling events. Therefore, the device can determine the total injection dose by adding the dose of the last injection event in each sub-injection event group.

[0126] Figure 6A-6B 600, 650 are tables illustrating examples of dose determination for a group of injection events associated with a drug delivery device change according to some embodiments. Fig. 6A6, which includes five injection events 602-610. As shown in the third column of table 600, the change time (e.g., the time when the user changed the cartridge and / or the time when the user switched to a new pen) is 4:54:56 p.m. Since the change time occurs before all injection events 602 and 610 (which occur between 4:55:14-4:55:34 p.m.), the device determines that the last injection event 610 represents an injected dose, resulting in an injected dose of 4 units), and the remaining injection events are priming events.

[0127] refer to Figure 6B 650, which includes two injection events 652 and 654. As shown in the third column, the change time is 7:41:55 p.m., which occurs between the first injection event 652 time at 7:39:31 p.m. and the second injection event 654 time at 7:42:10 p.m. Therefore, the system will determine two different sub-injection event groups. In this example, each sub-injection event group includes only one injection event: the first sub-injection event group includes injection event 652, and the second sub-injection event group includes injection event 654. The last (and only) injection event in each sub-injection event group is identified as including an injection dose. Therefore, the injection dose of the example shown in table 650 is six units.

[0128] In some embodiments, other methods that do not require determining whether the injection event group is associated with a drug delivery device change can be used to determine the dose given to the patient. Such methods can be used when no drug delivery device change information is available. Such methods can determine the dose given to the patient by using an injection event group that includes injection events within a specific time period (e.g., injection events that occur within a specific number of minutes, seconds, etc.). The technology can include determining the dose given to the user by determining whether each of one or more injection events is associated with a dose given to the user or a fill dose that is not given to the user. The determination may include determining whether the injection event group includes a first injection event and a second injection event that occurs after the first injection event. When determining that the injection event group includes the first injection event and the second injection event, the determination may be based on the time period between the first injection event and the second injection event (e.g., the ranking of the time period with the time periods of other sequential injection events, and / or whether the time period is greater than a predetermined time period). The determination may also be optionally based on one or more of the following: the dose size of the injection event (e.g., whether the dose size is greater than a single number) and the position of the injection event in the injection event group (e.g., whether the injection event is the only remaining injection event in the injection event group, or whether there are more injection events).

[0129] Figure 7700 is a flowchart illustrating an exemplary computerized process 700 for determining a dose based on an injection event group including one or more injection events occurring within a predetermined time period according to some embodiments. In step 702, the device selects an injection event from the injection event group. The injection event group may include one or more injection events. In some embodiments, the injection event group is a group of one or more injection events occurring during a predetermined time period. For example, the injection event group may include all injections occurring within three minutes, five minutes, seven minutes, and / or other time periods after the first injection event in the injection event group. In some embodiments, the device may access data related to multiple injection events of the injection event group substantially simultaneously (e.g., as a batch download of pre-recorded data of some or all of a group of injection events in the injection event group). In some embodiments, the device accesses one or more injection events of the injection event group individually, for example, by receiving data indicating each injection event individually in time (e.g., when each injection event occurs and / or shortly after each injection event occurs). Therefore, step 702 may include selecting an injection event from a plurality of injection events and / or processing a single injection event (e.g., when received from a drug delivery device and / or when an injection event occurs).

[0130] At step 704, the device determines whether the dose size of the selected injection event is greater than a first predetermined threshold. For example, the predetermined threshold may be 6 units, 7 units, 9 units, 10 units, 11 units, etc. If the dose size is greater than the threshold, the method proceeds to step 706, where the device determines that the selected injection event is associated with an injection dose given to the user. If the dose size is not greater than the first predetermined threshold, the method proceeds to step 708 and determines whether there is a next injection event in the injection event group that occurs after the selected injection event. If there are no other injection events, the method proceeds to step 706, in which the device determines that the selected injection event is associated with an injection dose given to the user. After step 706, the method proceeds to step 718 as described below. If at step 708, the method determines that there is a next injection event, the method proceeds to step 710.

[0131] As described herein, the injection events of the injection event group may be accessed as a group of injection events (e.g., a batch of pre-recorded data indicative of the injection events is received and / or accessed substantially simultaneously) and / or may be accessed individually (e.g., received individually in time at or shortly after each injection event occurs). In some embodiments, when the injection events are accessed individually, step 708 may include the device determining whether the device receives the next injection event within an injection event window (e.g., within a predetermined time period, such as three minutes, five minutes, seven minutes, or some other time period) of the first injection event (e.g., the injection event selected in step 702). In some embodiments, when one or more injection events are accessed as a group of events, step 708 may include analyzing the data of the group of events to determine whether there is a next injection event.

[0132] At step 710, the device determines whether the time between the selected injection event and the next injection event is greater than a second predetermined threshold. For example, the device may determine whether the next injection event occurs more than a predetermined number of seconds (e.g., greater than 59.5 seconds, 60 seconds, 60.5 seconds, 79.5 seconds, 80 seconds, etc.) after the selected injection event. If the time between events is not greater than the threshold, the method proceeds to step 712, where the device determines that the selected injection event (i.e., the injection event selected at step 702) is associated with a priming dose that was not administered to the user. After step 712, the method proceeds to step 718.

[0133] If the time between injection events is greater than the second predetermined threshold, the method proceeds to step 714, and the device determines whether the dose size of the selected injection event is greater than a third predetermined threshold. For example, the device may determine whether the dose size is greater than 3 units, 3.5 units, 4 units, 4.5 units, 5 units, 5.5 units, etc. If the dose size is not greater than the threshold, the method proceeds to step 712, where the device determines that the selected injection event is associated with a priming dose that was not administered to the user, and then the method proceeds to step 718. If the dose size is greater than the third predetermined threshold, the method proceeds to step 706, and the device determines that the selected injection event is associated with an injection dose that was administered to the user.

[0134] After steps 706 and 712, the method proceeds to step 718, where the device determines whether there are any additional injection events in the injection event group that need to be classified as an injection dose or a filling dose. If there are no additional events, the method proceeds to step 720, where the device ends the dose detection process. If there are additional injection events, the method returns to step 702, selects the next injection event in the injection event group, and repeats the process as described herein.

[0135] Figures 8A-8E800, 820, 840, 860, and 880, respectively, illustrate examples of dose determination for an exemplary group of injection events in which the injection events occur within a predetermined time period of 5 minutes, according to some embodiments. For these examples, the dose size for the first threshold is 10 units, the time between injection events for the second threshold is 79.5 seconds, and the dose size for the third threshold is 4.5 units.

[0136] refer to Fig. 8A 800, the device selects the first injection event 802 and determines that the corresponding dose size of 11 units is greater than the predetermined threshold of 10 units. Therefore, the device determines that the first injection event 802 is associated with the dose administered to the user. Then, the device selects the second injection event 804 and determines that the corresponding dose size of 3 units is not greater than the predetermined threshold of 10 units. Therefore, the device continues to determine that there are no other injection events in the injection event group after the second injection event 804, and determines that the second injection event 804 is associated with the injection dose administered to the user. Therefore, the injection dose of the injection event group shown in Table 800 is 14 units.

[0137] refer to Figure 8B 820, the device selects the first injection event 824 and determines that the corresponding dose size of 3 units is not greater than the predetermined threshold of 10 units. The device then determines that there are no other injection events in the group of injection events after the first injection event 824, and therefore determines that the first injection is associated with an injection dose administered to the user. Therefore, the injection dose of the group of injection events shown in table 820 is 3 units.

[0138] refer to Figure 8C 840, the device selects the first injection event 842 and determines that the corresponding dose size of 5 units is not greater than the predetermined threshold of 10 units. Then, the device determines that the second injection event 844 occurs after the first injection event 842, and further determines that the time period of 60 seconds between the first injection event 842 and the second injection event 844 is not greater than the threshold of 79.5 seconds. Therefore, the device determines that the first injection event 842 is associated with a fill dose that was not given to the user. Since there is a second injection event 844 that occurs after the first injection event 842, the device then selects this event for analysis. The device determines that the dose size of 3 units is not greater than the threshold of 10 units, and no other injection events occur within five minutes of the second injection event 844. Therefore, the second injection event 844 is associated with an injection dose given to the user. Therefore, the injection dose of the injection event group shown in Table 840 is 3 units.

[0139] refer to Fig.8D860, the device selects the first injection event 862 and determines that the corresponding dose size of 5 units is not greater than the predetermined threshold of 10 units. Then, the device determines that the second injection event 864 occurs after the first injection event 862, and further determines that the time period of 81 seconds between the first injection event 862 and the second injection event 864 is greater than the threshold of 79.5 seconds. In addition, the device determines that the dose size of the first injection event 862 of 5 units is greater than the predetermined threshold of 4.5 units. Therefore, the device determines that the first injection event 862 is associated with an injection dose administered to the user. Then, the device selects the second injection event 864, and after determining that the corresponding dose size of 3 units is not greater than the threshold of 10 units, determines that there are no other injection events after the second injection event 864. Therefore, the device determines that the second injection event 864 is also associated with an injection dose administered to the user. Therefore, the injection dose of the injection event group shown in Table 860 is 8 units.

[0140] refer to Fig. 8E 880, the device selects the first injection event 882 and determines that the corresponding dose size of 2 units is not greater than the predetermined threshold of 10 units. Then, the device determines that the second injection event 884 occurs after the first injection event 882, and further determines that the time period of 81 seconds between the first injection event 882 and the second injection event 884 is greater than the threshold of 79.5 seconds. In addition, the device determines that the corresponding dose size of 2 units is less than the threshold of 4.5 units. Therefore, the device determines that the first injection event 882 is associated with a priming dose that is not given to the user. Then, the device selects the second injection event 884, and after determining that the corresponding dose size of 3 units is less than the threshold of 10 units, determines that there is a third injection event 886 that occurs after the second injection event 884. The device determines that the time period of 40 seconds between the second injection event 884 and the third injection event 886 is not greater than the threshold of 79.5 seconds. Therefore, the device determines that the second injection event 884 is also associated with a priming dose that is not given to the user. Finally, the device selects the third injection event 886 and, after determining that the corresponding dose size of 3 units is not greater than the threshold of 10 units, determines that no other injection events occurred after the third injection event 886. Therefore, the third injection event 886 is associated with an injection dose administered to the user. Therefore, the injection dose of the group of injection events shown in table 880 is 3 units.

[0141] One advantage of the process 700 for determining a dose is that it does not require medication delivery device change information, which may not always be available. Another advantage of the process 700 is that any given injection event can be classified as being associated with an injection dose given to a user or a priming dose not given to a user within five minutes of the occurrence of the given injection event. The process 700 does not require the user to wait until all injection events within a group of injection events are known before making a classification decision.

[0142] In some embodiments, process 700 can be modified by simplifying steps 710 and 714. For example, if process 700 determines at step 708 that there is a next injection event within a certain time period after the selected injection event (e.g., there is a next injection event within three minutes, five minutes, seven minutes, or some other predetermined time period of the selected injection event), then process 700 can automatically classify the selected injection event as a priming dose without going through steps 710 and / or 714. In such an embodiment, process 700 can classify the selected injection event as an injection dose while waiting for a predetermined time period after the selected injection event has passed. If the next injection event is received before the expiration of the predetermined time period, the selected injection event can be reclassified from an injection dose to a priming dose.

[0143] This modified embodiment of process 700 will produce Fig. 8A -C and 8E present the same fill-in injection event classification, but will produce the same Fig.8D The classification presented in the different categories. Specifically, refer to Fig.8D 860, under a modified embodiment of process 700, the device selects the first injection event 862 and determines that the corresponding dose size of 5 units is not greater than the predetermined threshold of 10 units. The device then determines that the second injection event 864 occurred within five minutes (a predetermined time period) after the first injection event 862. Without further querying the time interval between injection events 862 and 864, and without further querying the dose size of injection event 864, the device classifies injection event 862 as a filling dose. The device then selects injection event 864 for analysis. After determining that no additional injection events occurred within five minutes of injection event 864, the device classifies injection event 864 as an injection dose administered to the user.

[0144] Fig. 99 is a flow chart illustrating another exemplary computerized process 900 for determining a dose based on a group of injection events according to some embodiments. At step 902, the device selects an injection event from the group of injection events and proceeds to step 904. As described herein, an injection event group may include one or more injection events associated with one or more drug delivery devices. Also as described herein, an injection event may include injection events that occur within a predetermined time period, such as a single time period (e.g., a total of five minutes, a total of ten minutes, etc.) and / or a certain time period from each injection (e.g., within five minutes of each injection).

[0145] At step 904, the device determines whether the selected injection event is the last injection event in the group of injection events. If the selected injection event is the last injection event, the method proceeds to step 906, and the device determines that the selected injection event is an injection dose administered to the user. If the selected injection event is not the last injection event in the group of injection events, the method proceeds to step 908.

[0146] At step 908, the device determines whether the time between the selected injection event and the next injection event in the event group is greater than a first predetermined threshold (e.g., greater than 58.5 seconds, 60 seconds, 60.5 seconds, 73.5 seconds, 80 seconds, etc.) Upon determining that the time between injection events is not greater than the threshold, the method proceeds to step 910 and determines that the selected injection event is a priming dose that was not administered to the user.

[0147] If the time period is greater than the first predetermined threshold, the method proceeds to step 912, and the device determines whether the time interval ranking associated with the selected injection event is greater than or equal to a second predetermined threshold. The time interval ranking can be, for example, a ranking of the amount of time between each sequential pair of injection events in the injection event group, as further discussed herein. The second predetermined threshold can be, for example, 2, 3, 4, etc. Upon determining that the time interval ranking is not greater than or equal to the second predetermined threshold, the method proceeds to step 912, in which the device determines that the selected injection event is a filling dose that was not administered to the user. However, if the time interval ranking is greater than or equal to the second predetermined threshold, the method proceeds to step 914, in which it is determined that the selected injection event is an injection event associated with an injection dose administered to the user.

[0148] After steps 910 and 914, the method returns to step 902, selects the next injection event in the group of injection events, and repeats the process described herein.

[0149] In some embodiments, if no other injection events occur within a predetermined time period after the selected injection event, it can be determined that the selected injection event is the last injection event of the injection event group (step 904). For example, if no other injection events occur within 4 minutes, 5 minutes, 6 minutes, etc. after the selected injection event, the device can determine that the injection event is the last injection event of the injection event group. When making this determination, the device can close the injection event group.

[0150] In some embodiments, the time interval ranking can be determined by evaluating and comparing the time periods between consecutive injection events in the injection event group. The time periods between consecutive injection events can be sorted, for example, from the shortest time period between consecutive injection events to the longest time period between consecutive injection events, and the corresponding rankings are assigned in ascending order. Consider an example with a first, second, and third injection event, where the time period between the first and second injection events is 5 seconds, and the time period between the second and third injection events is 3 seconds. Since there are no other injection events in the injection event group, the time period associated with the third injection event can be set to zero. For this example, the corresponding time interval ranking is 3 for the first injection event (because the time interval of 5 seconds is the largest of all three time intervals), 2 for the second injection event (because the time interval of 3 seconds is less than the time interval of the first injection event, but greater than the time interval of the third injection event), and 1 for the third injection event (because the time interval of 0 seconds is the smallest of all three time intervals). This is shown in the further discussion below. Fig. 10A In the example.

[0151] Figures 10A-10C 1000, 1030, and 1060, respectively, illustrate examples of dose determination for an exemplary group of injection events, according to some embodiments. For these examples, the time period between injection events for the first threshold is 73.5 seconds and the time interval rank for the second threshold is 3.

[0152] refer to Fig. 10A1000, the injection event group includes three injection events 1002-1006. The device selects the first injection event 1002 and determines that it is not the last injection event in the injection event group. Therefore, the device then compares the time period of 5 seconds between the first injection event 1002 and the second injection event 1004 with the predetermined time period of 73.5 seconds. When determining that the time period of 5 seconds is not greater than the predetermined time period, the device determines that the first injection event 1002 is associated with a priming dose that is not given to the user, and selects the second injection event 1004. The device determines that the second injection event 1004 is not the last injection event, and the time period of 3 seconds between the second injection event 1004 and the third injection event 1006 is not greater than the predetermined threshold of 73.5 seconds. Therefore, the device determines that the second injection event 1004 is associated with a priming dose that is not given to the user. Then the third injection event 1006 is selected and determined as the final injection event of the injection event group. Therefore, the device determines that the third injection event is the injection dose given to the user. Therefore, the injection dose of the injection event group shown in Table 1000 is 4 units.

[0153] refer to Fig. 10B 1030, the injection event group includes five injection events 1032-1038. The first injection event 1032 is selected, and the device determines that it is not the final dose in the injection event group. Therefore, the time period (5 seconds) before the second injection event 1034 is compared with the predetermined threshold of 73.5 seconds. Since the time period of the selected injection event is not greater than the threshold, the device determines that the first injection event 1032 is a priming dose that is not given to the user. The second injection event 1034 is then selected, and the device determines that it is not the final injection event of the injection event group. The time period of 81 seconds between the second injection event 1034 and the third injection event 1036 is determined to be greater than the predetermined threshold of 73.5 seconds. The device then determines that the time interval ranking 4 associated with the time period between the second and third injection events 1034-1036 is greater than or equal to the predetermined threshold 3. The device determines that the second injection event is associated with the injection dose given to the user. The third injection event 1036 is then selected by the device, and the device then determines that it is not the final injection event of the injection event group. Since the time period of 48 seconds between the third injection event 1036 and the fourth injection event 1038 is not greater than the 73.5 second threshold, the device determines that the third injection event 1036 is a priming dose that was not administered to the user. Finally, the device determines that the fourth injection event 1038 is associated with an injection dose administered to the user because it is the final injection event of the group of injection events. Therefore, the injection dose of the group of injection events shown in table 1030 is 5 units.

[0154] refer to Fig. 10C, the injection event group includes two injection events 1062 and 1064. The first injection event 1062 is selected by the device and is determined not to be the final injection event in the injection event group. The time period (81 seconds) between the first injection event 1062 and the second injection event 1064 is greater than the predetermined threshold of 73.5 seconds, so the device proceeds to evaluate the time interval ranking. The time interval ranking 1 associated with the time period discussed previously is not greater than or equal to the predetermined threshold 3. Therefore, the device determines that the first injection event 1062 is a priming dose that was not given to the user. The second injection event 1064 is then selected and determined to be the injection dose delivered to the user because it is the final injection event of the injection event group. Therefore, the injection dose of the injection event group shown in Table 1060 is 3 units.

[0155] According to some embodiments, the dose determination of the injection event may be performed in real time (e.g., when information of one or more doses is received, rather than generating an injection event group). The device may select the current injection event and compare the dose size with a first predetermined threshold (e.g., a dose size of 8 units, 9 units, 10 units, 11 units, etc.). If the dose size is greater than or equal to the first predetermined threshold, the device may determine that the current injection event is associated with a dose administered to the user. However, if the dose size is not greater than or equal to the first predetermined threshold, the device may compare the dose size with a second predetermined threshold. For example, the second predetermined threshold may be a dose size of 3 units, 4 units, 5 units, etc. In the event that the dose size exceeds the second predetermined threshold, the method may proceed to compare the time period since the last dose with a predetermined time period (e.g., a time of 8 seconds, 9 seconds, 10 seconds, 11 seconds, etc.). When it is determined that the time period since the last dose is greater than the predetermined time period, the device may determine that the current injection event is associated with an injection dose administered to the user. The device may determine that all other injection events (eg, if the dose size does not exceed a second predetermined threshold and / or if the time period since the last dose is not greater than a predetermined time period) are priming doses that were not administered to the user.

[0156] Fig.111 is a diagram of an exemplary system 1100 for implementing the computerized process described herein, according to some embodiments. The terms "logic", "control logic", "application", "process", "method", "algorithm" and "instructions" as used herein may include software and / or firmware executed on one or more programmable processors, application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), digital signal processors (DSPs), hardwired logic, or a combination thereof. Therefore, depending on the embodiment, the various logics may be implemented in any appropriate manner and will remain consistent with the embodiments disclosed herein. The system 1100 includes a computing device 1110 that wirelessly communicates with a drug delivery device 1140. The computing device 1110 may also communicate with a server 1160 via a network 1150.

[0157] Computing device 1110 illustratively includes a mobile device, such as a smart phone. Alternatively, any suitable computing device may be used, including but not limited to, for example, a laptop computer, a desktop computer, a tablet computer, or a server computer. Computing device 1110 includes a processor 1112, a memory 1116, a display / user interface (UI) 1118, and a communication device 1119.

[0158] The processor 1112 includes at least one processor that executes software and / or firmware stored in the memory 1116 of the computing device 1110. The software / firmware code contains instructions that, when executed by the processor 1112, cause the processor 1112 to perform the functions described herein. Such instructions illustratively include control logic / applications 1114 that are operable to implement the functions described herein. The memory 1114 is any suitable computer-readable medium that can be accessed by the processor 1112. The memory 1114 can be a single storage device or multiple storage devices, can be located internal or external to the processor 1112, and can include both volatile and non-volatile media. Exemplary memory 1114 includes random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, magnetic storage devices, optical disk storage, or any other suitable medium that is configured to store data and can be accessed by the processor 1112.

[0159] The computing device 1110 includes a display / user interface 1118 that communicates with the processor 1112 and is operable to provide user input data to the system and to receive and display data, information, and prompts generated by the system. The user interface 1118 includes at least one input device for receiving user input and providing the user input to the system. In the illustrated embodiment, the user interface 1118 is a graphical user interface (GUI) including a touch screen display that is operable to display data and receive user input. The touch screen display allows the user to interact with the presented information, menus, buttons, and other data to receive information from the system and provide user input to the system. Alternatively, a keyboard, keypad, microphone, mouse pointer, or other suitable user input device may be provided.

[0160] The computing device 1110 also includes a communication device 1119 that allows the computing device 1110 to establish a wired or wireless communication link with other devices. The communication device 1119 may include one or more wireless antennas and / or signal processing circuits for sending and receiving wireless communications, and / or one or more ports for receiving physical lines for sending and receiving data. Using the communication device 1119, the computing device 1110 can establish one or more short-range communication links, including a communication link 1103 with the drug delivery device 1140. Such short-range communication links can utilize any known wired or wireless communication technology or protocol, including but not limited to radio frequency communication (e.g., Wi-Fi; Bluetooth, Bluetooth Low Energy (BLE), Near Field Communication (NFC), RFID, etc.), infrared transmission, microwave transmission, and light wave transmission. Such a short-range communication link can be a unidirectional link (e.g., data flow only from the device 1140 to the computing device 1110) or a bidirectional link (e.g., bidirectional data flow). The communication device 1119 may also allow the computing device 1110 to establish a long-distance communication link with the server 1160 via the network 1150 and the communication links 1104 and 1105. The server 1160 may be located at a location remote from the computing device 1110, for example, in another building, in another city, or even in another country or continent. The network 1150 may include any cellular or data network suitable for relaying information from the computing device 1110 to and / or from the server 1160, potentially via one or more intermediate nodes or switches. Examples of suitable networks 1150 include cellular networks, metropolitan area networks (MANs), wide area networks (WANs), and the Internet.

[0161] The drug delivery device 1140 illustratively includes any device configured to deliver one or more drug doses to a patient, measure and / or record the time and amount of each dose, and transmit this information to the computing device 1110. In some embodiments, the drug delivery device 1140 may be configured to store and / or deliver one or more drug doses to a person. As used herein, the term "drug" or "drug" may refer to insulin, insulin analogs (e.g., insulin lispro or insulin glargine), and / or insulin derivatives, but may also refer to one or more other therapeutic agents, including but not limited to GLP-1 receptor agonists (e.g., dulostat or liraglutide), glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and any therapeutic agent capable of being delivered by the above-mentioned device. The drug used in the device may be formulated with one or more excipients. The device is operated by a patient, a caregiver, or a health care professional to deliver the drug to a person. The drug delivery device 1140 can be configured as a reusable device that can be refilled with a drug once its drug storage is exhausted, or can be configured as a disposable device designed to be discarded and replaced once its drug storage is exhausted. The drug delivery device 1140 includes a processing circuit 1142, a dose detection sensor 1144, a communication device 1146, a drug reservoir 1148, and a dose adjustment mechanism 1149. The processing circuit 1142 may include any possible type of processing circuit described previously. The dose detection sensor 1144 may include any suitable sensor for detecting and / or recording the time and amount of the delivered dose. The communication device 1146 enables the drug delivery device 1140 to communicate with the computing device 1110 via the communication link 1103. The size of the drug reservoir 1148 can be designed to be sufficient to accommodate sufficient drug for multiple doses, while the dose adjustment mechanism 1149 allows the user to adjust the amount of the dose for injection of the drug delivery device.

[0162] The server 1160 illustratively includes any computing device configured to receive information about a patient from the computing device 1110 via the network 1150, process the information, and optionally send a response, notification, or instruction to the computing device 1110 in response to the information. The server 1160 includes a processing circuit 1162, a memory 1164, and a communication device 1166. The processing circuit 1162 may include any possible type of processing circuit described previously. The processing circuit 1162 may execute software and / or firmware stored in the memory 1164 of the server 1160. The software / firmware code contains instructions that, when executed by the processing circuit 1162, perform the functions described herein. The memory 1164 may also be configured to store information about one or more patients, such as biological information and / or medical information (e.g., medication dosage records, medical history, etc.). Information received from or sent to the computing device 1110 may also be stored in the memory 1164. The memory 1164 may include any possible type of memory described previously. Communication device 1166 enables server 1160 to communicate with computing device 1110 via communication link 1105 , network 1150 , and communication link 1104 .

[0163] In some embodiments, computing device 1110 may operate without being connected to any network 1150 and / or server 1160 .

[0164] In other embodiments, the system 1100 can be modified by adding components. For example, the server 1160 can be configured as a plurality of networked servers 1160 that collaborate to process information. This configuration of networked servers can be referred to as a "cloud" of servers that perform the functions described herein. The server(s) 1160 can communicate with a plurality of computing devices 1110 via a network 1150, and each computing device 1110 can in turn optionally connect to one or more drug delivery devices 1140.

[0165] In some embodiments, the technology described herein can be used with a reusable drug device, such as a reusable insulin pen, including a reusable insulin pen that reports a cartridge change event. In some embodiments, the reusable drug delivery device can generate data indicating a cartridge change time as described herein, which can be used to process injection data based on a reservoir change.

[0166] In some embodiments, some or all of the techniques described herein (e.g., processes 200, 400, 450, 700, and / or 900) may be performed by a drug delivery device. For example, the drug delivery device may include a processing circuit configured to determine an injection event group and / or determine an injection dose (e.g., by distinguishing between a fill and an injection event, including appropriately handling a cartridge change). In some embodiments, the drug delivery device may be configured to transmit the determined information (e.g., an injection event group and / or an injection dose) to a separate device, such as a smartphone or a module that may be attached to the drug delivery device.

[0167] In some embodiments, some or all of the techniques described herein (e.g., processes 200, 400, 450, 700, and / or 900) may be performed by a device separate from the drug delivery device, such as by an application running on a smartphone or other device communicatively coupled to the drug delivery device (e.g., computing device 1110), a remote server (e.g., server 1160), etc. The drug delivery device may be configured to transmit injection data and / or processing data (e.g., injection event groups and / or device change information) to a separate device. In some embodiments, the drug delivery device may be a disposable drug delivery device. Some illustrative examples of such disposable drug delivery are further described in detail in International Publication No. WO 2019 / 040313, entitled MEDICATION DELIVERY DEVICE WITH SENSING SYSTEM and having an international filing date of August 14, 2018, the contents of which are incorporated herein in their entirety.

[0168] In some embodiments, the drug delivery device may not include wireless transmission function, dosage detection function and / or processing function. In some embodiments, a reusable electronic module can be attached to / detached from the drug delivery device to add one or more such features to the drug delivery device. For example, a reusable electronic module can be configured to sense the amount of the dosage associated with each injection event, and report the information to a second device that processes the injection event data. Some illustrative examples of such reusable electronic modules are further described in detail in International Publication No. WO 2018 / 160425, entitled DOSE DETECTION AND DRUG IDENTIFICATION FOR AMEDICATION DELIVERY DEVICE and International Application Date February 22, 2018, and its contents are incorporated herein as a whole. As another example, a reusable electronic module can be configured to report information when the device is attached to and / or removed from the drug delivery device, and the receiving device can use the information to determine the change information.

[0169] In some embodiments, the above-described processes 200, 400, 450, 700, and / or 900 may be refined based on user feedback. As described above, the processes 200, 400, 450, 700, and / or 900 may classify each received injection event as being associated with a dose administered to a user or as a priming dose not administered to a user. In some embodiments, a user may manually provide feedback indicating whether the classification applied by the processes 200, 400, 450, 700, and / or 900 to a particular injection event is correct. For example, a user may confirm that a particular injection event is correctly classified as an administered dose versus a priming dose, or a user may modify and / or correct the label applied by the processes 200, 400, 450, 700, and / or 900. When a user provides feedback confirming or correcting a classification output by the processes 200, 400, 450, 700, and / or 900, the feedback may be used to modify the process to more accurately classify future injection events. For example, once sufficient user feedback is collected over a specified period of time (e.g., a few days, a week, a few weeks, or a month), the user feedback may be used to train a machine learning model that adjusts thresholds or timers in the process to increase the accuracy of the process. The user feedback used to train the machine learning model may be obtained from a single user or from a group of users. A non-limiting set of thresholds and / or timers that may be adjusted by such a machine learning model may include (i) the duration of the injection event window in step 206, (ii) the first threshold referenced in step 704, (iii) the duration of the second threshold referenced in step 710, (iv) the magnitude of the third threshold referenced in step 714, (v) the first predetermined threshold referenced in step 908, and / or (vi) the second predetermined threshold referenced in step 912. The machine learning model and / or the adjustment of the thresholds and / or timers may be implemented on the computing device 1110, but may also be implemented on the drug delivery device 1140 and / or the server 1160. By continuously learning from user feedback, such a machine learning model can continuously improve and enhance the accuracy of processes 200, 400, 450, 700 and / or 900.

[0170] Although adjusting the thresholds and / or timers in the process changes certain programmable features in such a process, the data flow in such a process remains substantially the same. However, in some embodiments, in addition to adjusting the thresholds and / or timers in certain process steps, such user feedback can also be used to modify the process 200, 400, 450, 700 and / or 900 by adding, deleting, rearranging and / or editing any of the steps of the process. For example, such user feedback can be used to derive new data features (e.g., in addition to data features such as dose size, time between doses, dose order and / or time interval ranking of the above doses) and incorporate such new data features into a completely new process. Such user feedback can also be used to prompt a switch from one of the above processes 200, 400, 450, 700 and / or 900 to another of the above processes.

[0171] A machine learning model capable of making these more extensive adjustments to a process may require a greater amount of training data, computing resources, and / or memory than a model that simply adjusts thresholds and / or timers. Therefore, some embodiments may employ a two-level model to adjust a process. First, a simpler machine learning model may be used to adjust thresholds and / or timers. This simpler machine learning model may be implemented relatively frequently (e.g., weekly) and on a device (e.g., computing device 1110) with relatively modest computing resources and / or memory. The user feedback group used to train such a model may also be obtained from only a single user, or from a smaller user group. Second, a more complex machine learning model may be used to implement the aforementioned more extensive modifications to processes 200, 400, 450, 700, and / or 900. This more complex machine learning model may be implemented relatively less frequently (e.g., monthly) and / or on a device (e.g., server 1160) using a greater amount of training data (e.g., from a larger user group) and / or on a device (e.g., server 1160) with a greater amount of computing resources and / or memory. Once the second machine learning model outputs a revised process, the revised process may be distributed to one or more computing devices 1110 and / or drug delivery devices 1140 to classify further injection events.

[0172] The various methods or processes outlined herein may be encoded as software that can be executed on one or more processors using any of a variety of operating systems or platforms. In addition, such software may be written using any of a variety of suitable programming languages ​​and / or programming or scripting tools, and may also be compiled into executable machine language code or intermediate code that is executed on a virtual machine or a suitable framework.

[0173] In this regard, various inventive concepts may be implemented as at least one non-transitory computer-readable storage medium (e.g., computer memory, one or more floppy disks, compressed disks, optical disks, tapes, flash memory, circuit configurations in field programmable gate arrays or other semiconductor devices, etc.) encoded with one or more programs, which, when executed on one or more computers or other processors, implement various embodiments of the present invention. One or more non-transitory computer-readable media may be transportable, so that one or more programs stored thereon may be loaded into any computer resource to implement various aspects of the present invention as described above.

[0174] The terms "program", "software" and / or "application" are used herein in a general sense to refer to any type of computer code or computer executable instruction set that can be used to program a computer or other processor to implement various aspects of the embodiments as described above. In addition, it should be understood that according to one aspect, one or more computer programs that perform the methods of the present invention when executed do not need to reside on a single computer or processor, but can be distributed in a modular manner between different computers or processors to implement various aspects of the present invention.

[0175] Computer executable instructions can be in many forms such as program modules that are executed by one or more computers or other devices. Typically, program modules include routines, programs, objects, components, data structures, etc. that perform specific tasks or implement specific abstract data types. Typically, the functionality of program modules can be combined or distributed in various embodiments as desired.

[0176] In addition, the data structure may be stored in a non-transitory computer-readable storage medium in any suitable form. The data structure may have fields that are related by location in the data structure. This relationship may also be achieved by assigning locations in the non-transitory computer-readable medium that convey the relationship between the fields for storage of the fields. However, any suitable mechanism may be used to establish the relationship between the information in the fields of the data structure, including through the use of pointers, tags, or other mechanisms that establish relationships between data elements.

[0177] Various inventive concepts may be embodied as one or more methods, examples of which have been provided. The actions performed as part of a method may be ordered in any suitable manner. Thus, embodiments may be constructed in which the actions are performed in an order different from that shown, which may include performing some actions simultaneously, even though shown as sequential actions in an illustrative embodiment.

[0178] Unless expressly indicated to the contrary, the indefinite articles "a" and "an" as used in this specification and claims should be understood to mean "at least one". As used in the specification and claims, the phrase "at least one" referring to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the list of elements, but not necessarily including at least one of each element specifically listed in the list of elements, and not excluding any combination of elements in the list of elements. This allows for the optional presence of elements other than the elements specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified.

[0179] The phrase "and / or" as used in the specification and claims should be understood to mean "either or both" of the elements so combined, i.e., elements that are present in combination in some cases and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so combined. In addition to the elements specifically identified by the "and / or" clause, other elements may optionally be present, whether related or unrelated to those specifically identified. Thus, as a non-limiting example, a reference to "A and / or B", when used in conjunction with open language such as "comprising", may refer to A only (optionally including elements other than B) in one embodiment; to B only (optionally including elements other than A) in another embodiment; to both A and B (optionally including other elements) in yet another embodiment; and so on.

[0180] As used in the specification and claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when listing items in a list, "or" or "and / or" should be interpreted as inclusive, i.e., including at least one of a plurality of elements or a list of elements, but also including more than one, and optionally, including additional unlisted items. Only terms that clearly indicate the opposite (such as "only one" or "exactly one") or "consisting of" when used in the claims will refer to including exactly one element in a plurality of elements or a list of elements. Generally, when there are exclusive terms before the term "or", such as "either", "one of them", "only one of them" or "exactly one of them", the term "or" as used herein should only be interpreted as indicating exclusive alternative elements (i.e., "one or the other, but not both"). When used in the claims, "essentially consisting of" should have its ordinary meaning used in the field of patent law.

[0181] The use of ordinal terms such as "first," "second," "third," etc. in the claims to modify claim elements does not by itself imply any priority, precedence, or sequence of one claim element with respect to another, or a temporal order of the acts of performing a method. These terms serve merely as labels to distinguish one claim element with a particular name from another element with the same name (but using an ordinal term).

[0182] The phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," "having," "containing," "involving," and variations thereof, is meant to encompass the items listed thereafter and additional items.

[0183] Having described several embodiments of the present invention in detail, those skilled in the art should be able to easily conceive of various modifications and improvements. These modifications and improvements are within the spirit and scope of the present invention. Therefore, the foregoing description is only exemplary and not restrictive.

Claims

1. A computerized method for determining a dose to be injected into a user by one or more drug delivery devices, the method comprising: Accessing data indicative of an injection event group, the injection event group comprising one or more injection events associated with one or more medication delivery devices, wherein each of the one or more medication delivery devices comprises: a dose adjustment mechanism that allows a user to adjust the amount of a dose for injection by the drug delivery device; a reservoir of sufficient size to hold the drug for multiple doses; one or more sensors for detecting the amount of the dose dispensed for each injection; and a wireless communication unit that communicates the amount of the dose dispensed and the time at which it was dispensed; determining whether the group of injection events is associated with a drug delivery device change; Upon determining that the group of injection events is not associated with a change in the drug delivery device, analyzing the group of injection events based on a first dose detection algorithm to determine a dose to be administered to a user; and Upon determining that the group of injection events is associated with a change in the drug delivery device, the group of injection events is analyzed based on a second dose detection algorithm to determine a dose to be administered to a user.

2. The computerized method of claim 1, wherein: The one or more drug delivery devices include a previous drug delivery device and a new drug delivery device; as well as Determining whether the group of injection events is associated with the drug delivery device change includes determining whether a user switches from using the previous drug delivery device to using the new drug delivery device within a predetermined time window of the group of injection events.

3. The computerized method of claim 1, wherein: The one or more drug delivery devices include a drug delivery device; as well as Determining whether the group of injection events is associated with a change of the drug delivery device includes determining whether there is a change of a replaceable cartridge of the one drug delivery device within a predetermined time window of the group of injection events.

4. The computerized method of claim 1, wherein: Analyzing the injection event group based on a first dose detection algorithm includes: determining that the number of injection events in the group of injection events is greater than two; and The dose is determined to be equal to an injection volume associated with a most recent injection event in the group of injection events, wherein the most recent injection event occurs later in time than any other injection event in the group of injection events.

5. The computerized method of claim 4, wherein: The most recent injection event is designated as a true injection event, and all other injection events in the group of injection events are each designated as a priming injection event.

6. The computerized method of claim 1, wherein: Analyzing the injection event group based on a first dose detection algorithm includes: Determining that the number of injection events in the injection event group is equal to two, wherein the injection event group includes: a first injection event associated with the first time; and a second injection event associated with a second time later than the first time; and A determination is made as to whether a first injection volume associated with the first injection event is greater than a second injection volume associated with the second injection event.

7. The computerized method of claim 6, further comprising determining the dose based on a sum of the first injection volume and the second injection volume upon determining that the first injection event is greater than the second injection event.

8. The computerized method of claim 6, further comprising determining that the dose is equal to the second injection volume upon determining that the first injection event is not greater than the second injection event.

9. The computerized method of claim 8, wherein: The first injection event is designated as a priming injection event.

10. The computerized method of claim 1, wherein: Analyzing the group of injection events based on a second dose detection algorithm includes determining whether a change time associated with the drug delivery device change is (i) later than or earlier than each time associated with each injection event in the group of injection events, or (ii) later than a time associated with at least one injection event in the group of injection events and earlier than another time associated with at least one other injection event in the group of injection events.

11. The computerized method of claim 10, further comprising: When it is determined that the change time is later than or earlier than each time associated with each injection event in the group of injection events, the dose is determined to be equal to the injection amount associated with the latest injection event in the group of injection events, wherein the latest injection event occurs later in time than any other injection event in the group of injection events.

12. The computerized method of claim 11, wherein: The remaining injection events in the group of injection events are designated as priming injection events.

13. The computerized method of any one of claims 10 or 11, further comprising: Upon determining that the change time is later than a time associated with at least one injection event in the group of injection events and earlier than another time associated with at least one other injection event in the group of injection events, determining: a first sub-injection event group including each injection event in the injection event group associated with a time occurring before the change time; and A second sub-injection event group includes each injection event in the injection event group that is associated with a time that occurs after the change time.

14. The computerized method of claim 13, further comprising determining the dose based on the sum of: a first most recent injection event in the first sub-group of injection events, wherein, The first latest injection event occurs later in time than any other injection event in the first sub-group of injection events; as well as A second most recent injection event in the second sub-group of injection events, wherein the second most recent injection event occurs later in time than any other injection event in the second sub-group of injection events.

15. The computerized method of claim 14, wherein: The remaining injection events in the first sub-group of injection events and the remaining injection events in the second sub-group of injection events are designated as priming injection events.

16. The computerized method of claim 1, further comprising determining the set of injection events.

17. The computerized method of claim 16, wherein: Determining the group of injection events includes determining that a plurality of injection events satisfy a predetermined criterion; as well as Determining that the plurality of injection events meets the predetermined criteria includes, for each injection event in the plurality of injection events, determining that a time associated with the injection event is within a predetermined time period of a previous injection event in the plurality of injection events.

18. A non-transitory computer-readable medium comprising instructions that, when executed by one or more processors on a computing device, are operable to cause the one or more processors to perform the method of any one of claims 1-17.

19. A system comprising a memory storing instructions and a processor, the processor being configured to execute the instructions to perform the method according to any one of claims 1-17.

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