Medical device and method for administering basal insulin doses and bolus insulin doses

Abstract

A medical device and method for determining a basal insulin dose and a bolus insulin dose to be administered for glycemic control are provided. The medical device comprises: an insulin pump; a control interface comprising a button configured to select one of a plurality of current bolus insulin doses based on input from a user (e.g., a patient); and a controller configured to execute instructions to determine a basal insulin delivery rate based at least in part on a total daily basal insulin dose and to determine the plurality of preset bolus insulin doses based at least in part on a total daily basal insulin dose.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority from European application number 19305725.4 filed on June 5, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to a medical device and method for administering basal and bolus insulin doses. Background Art

[0004] Diabetic patients lack insulin or cannot produce enough insulin to overcome potential insulin resistance or normalize glucose metabolism. Basal insulin or glargine insulin treatment is often used to achieve improved blood sugar control. Although blood sugar levels fluctuate throughout the day, "perfect blood sugar control" will mean that glucose levels are always within the range of 70 to 130 mg / dl or 3.9 to 7.2 mmol / L and cannot be distinguished from people without diabetes. Basal insulin or glargine insulin therapy can be used in combination with bolus insulin doses to achieve improved blood sugar control or as close to "perfect blood sugar control" as possible. In this therapy, basal insulin is provided throughout the day, which is supplemented with bolus insulin doses (e.g., based on the characterization of meals). However, it is more complicated to find the correct bolus dose for meals. The accurate bolus dose depends on the carbohydrate "carb" count, the ratio of insulin to carbohydrates, and the glucose correction factor. Due to these difficulties in determining the accurate bolus insulin dose, patients are unlikely to adopt mealtime bolus doses.

[0005] In addition, the complexity and difficulty of programming the bolus dose in some conventional insulin pumps further reduces the possibility that the patient adopts the mealtime bolus in its treatment. For example, for some conventional insulin pumps, programming the pump to deliver the bolus insulin dose needs to start from zero to the required bolus insulin dose. In some conventional insulin pumps, programming the insulin pump used in the basal insulin therapy to administer the bolus insulin dose requires multi-step programming and / or is relatively time-consuming. In addition, manually programming the pump to administer the bolus insulin dose may cause unexpected dosage errors. For example, the wrong dose may be entered. Summary of the invention

[0006] Some exemplary embodiments of the present disclosure relate to a medical device, which is used to administer daily basal insulin to a user (e.g., a patient) of the medical device based on a determined daily total bolus insulin dose and enables the user to easily and simply select one of a plurality of preset bolus insulin doses. The daily total insulin dose and the determined daily total bolus insulin dose are based on the administration information received for the user (e.g., information received from a health care provider). In some embodiments, the plurality of predetermined bolus insulin doses correspond to the doses required for meals with different amounts of carbohydrates, and correspond to a smaller correction dose. In some embodiments, the user's selection of one of the predetermined bolus insulin doses is performed via a button of the medical device. In some embodiments, the user's selection of one of the preset bolus insulin doses is based on the number of times the user pushes the button. In some embodiments, the medical device is configured to provide information about the selected preset bolus insulin dose (e.g., via the vibration of the medical device or a sound emitted by the medical device). In some embodiments, the medical device is configured to receive input from the user to confirm the selected preset bolus insulin dose. In some embodiments, the input confirmation of the selected preset bolus insulin dose is performed via a second button of the medical device. In some embodiments, the medical device does not include a graphical user interface. In some embodiments, the control interface of the medical device does not include a screen or display.

[0007] Some embodiments provide a medical device that enables selection of only bolus insulin doses to increase compliance with bolus insulin therapy.

[0008] Some embodiments may improve glycemic control by providing a medical device that enables easy characterization of a meal rather than complex carbohydrate counting and complicated calculations for selecting a preset bolus insulin dose.

[0009] Some embodiments may increase adoption of bolus insulin therapy by making it easier for a health care provider (HCP) to program a pump for bolus insulin dosage therapy.

[0010] Some embodiments relate to a medical device, comprising: an insulin pump configured to deliver insulin; a control interface comprising a button configured to select one of a plurality of preset bolus insulin doses based on input from a user; a controller configured to execute instructions stored in a memory. In some embodiments, the controller is configured to execute instructions stored in a memory to determine the user's total daily basal insulin dose and total daily bolus insulin dose based on the received information. In some embodiments, the received information is information about at least two of the following: (i) the user's total daily insulin dose; (ii) the user's total daily basal insulin dose; (iii) the user's total daily bolus insulin dose; and (iv) the user's total daily basal insulin dose to the total daily bolus insulin dose ratio. In some embodiments, the medical device is configured based on the assumption that the total daily basal insulin dose is the same as the total daily bolus insulin dose, in which case the received information may include only one or more of the following: (i) the user's total daily insulin dose; (ii) the user's total daily basal insulin dose; and (iii) the user's total daily bolus insulin dose.

[0011] The controller is configured to execute instructions stored in a memory to determine the plurality of preset bolus insulin doses based at least in part on the total daily bolus insulin dose, and to determine a basal insulin delivery rate based at least in part on the total daily basal insulin dose. The executed instructions further cause insulin to be delivered to the user via the insulin pump at the basal insulin delivery rate. The controller is configured to execute instructions stored in a memory to receive a first input from the user via the button selecting one of the plurality of preset bolus insulin doses, and to deliver the selected bolus insulin dose to the user via the insulin pump.

[0012] In some embodiments, execution of the instructions further causes the controller to: determine a count of the number of times the user activates the button during a selection time period, wherein the selection time period begins when the button is first activated; and select one of the plurality of preset bolus insulin doses based on the count of the number of times the user activates the button during the selection time period.

[0013] In some embodiments, the medical device is configured to select a preset insulin dose among the plurality of preset bolus insulin doses based on the count of activations of the button by the user during the selection time period. In some embodiments, an increase in the count of activations of the button by the user during the selection time period results in selection of a preset bolus insulin dose with progressively larger insulin amounts.

[0014] In some embodiments, execution of the instructions further causes the controller to provide information indicating the selected preset bolus insulin dose to the user via the control interface. In some embodiments, the information indicating the selected preset bolus insulin dose is provided at least in part in the form of a vibration or movement generated via the control interface. In some embodiments, the information indicating the selected preset bolus insulin dose is provided at least in part in the form of a sound generated via the control interface. In some embodiments, the information indicating the selected preset bolus insulin dose is provided via a visual indication.

[0015] In some embodiments, the medical device can receive a second input from the user via the control interface confirming the selected preset bolus insulin dose within a confirmation time period after selecting the preset bolus insulin dose. For example, in some embodiments, the medical device can provide information indicating the selected preset bolus insulin dose, and the user can confirm the selected preset bolus insulin dose in response to the provided information or after receiving the provided information. In some embodiments, the control interface also includes a second button, the second button is configured to confirm the selection of the preset bolus insulin dose, and the user confirms the selected preset bolus insulin dose by pressing or touching the second button. In some other embodiments, the second input for confirming the selected preset bolus insulin dose can be received via the button for initially selecting the preset bolus insulin dose.

[0016] In some embodiments, the user is not required to provide any input or information regarding calories, carbohydrates, glycemic index, or blood glucose levels prior to selecting the preset bolus insulin dose.

[0017] In some embodiments, the doses in the plurality of preset bolus insulin doses are determined as fractions of the total daily bolus insulin dose.

[0018] In some embodiments, the preset bolus insulin doses in the plurality of bolus insulin doses do not increase linearly.

[0019] In some embodiments, the plurality of preset bolus insulin doses include a set of main preset bolus insulin doses and a set of correction preset bolus insulin doses, wherein each correction preset bolus insulin dose is smaller than all of the main preset insulin doses. In some embodiments, the spacing between two preset bolus insulin doses in the set of correction preset bolus insulin doses is smaller than the spacing between any two preset bolus insulin doses in the set of main preset bolus insulin doses. In some embodiments, the main preset bolus insulin doses correspond to meals with different carbohydrate amounts.

[0020] In some embodiments, the plurality of preset bolus insulin doses are not determined based at least in part on a preset daily bolus insulin dose, but are determined at least in part on a total daily insulin dose or a total daily basal insulin dose.

[0021] In some embodiments, execution of the instructions causes the controller to determine a micro-bolus insulin dose and a frequency for administering the micro-bolus insulin dose to the user to achieve a determined basal insulin delivery rate, and to deliver the determined micro-bolus insulin dose to the user via the insulin pump at the determined frequency.

[0022] In some embodiments, execution of the instructions causes the controller to: receive information about the user's insulin administration via an input interface, based on which the user's total daily basal insulin dose and the total daily bolus insulin dose are determined; and store the received information in a memory.

[0023] In some embodiments, the medical device comprises: a control unit, the control unit comprising the controller and the control interface; and a pump unit, the pump unit comprising the insulin pump. In some embodiments, the medical device further comprises a blood glucose measurement unit, the blood glucose measurement unit being configured to determine a blood glucose value corresponding to the current blood glucose level of the user.

[0024] Some embodiments provide a control unit for a medical device. The control unit includes a control interface, the control interface includes a button, the button is configured to select one of a plurality of preset push insulin doses based on input from a user. The control unit also includes a controller configured to execute instructions stored in a memory. The controller executes instructions to determine the user's daily total basal insulin dose and daily total push insulin dose based on the information received about the user. In some embodiments, the received information includes information about at least two of the following: i) the user's daily total insulin dose; ii) the user's daily total basal insulin dose; iii) the user's daily total push insulin dose; and iv) the user's daily total basal insulin dose to the daily total push insulin dose ratio. In some embodiments, the received information includes information about one or more of the following: i) the user's daily total insulin dose; ii) the user's daily total basal insulin dose; iii) the user's daily total push insulin dose, and the assumption that the daily total basal insulin dose is the same as the daily total push insulin dose. The instructions executed by the controller also cause the controller to determine the multiple preset bolus insulin doses based at least in part on the total daily bolus insulin dose, and to determine a basal insulin delivery rate based at least in part on the total daily basal insulin dose. The instructions executed by the controller also cause the controller to actuate the insulin pump of the pump unit via a drive unit to deliver insulin to the user via the insulin pump at the basal insulin delivery rate. In some embodiments, the drive unit is included in the control unit. In some embodiments, the drive unit is included in the pump unit. In some embodiments, the drive unit is not included in the control unit or the pump unit. The instructions executed by the controller also cause the controller to: receive a first input selecting one of the multiple preset bolus insulin doses from the user via the button, and to actuate the insulin pump of the pump unit via the drive unit to deliver the selected bolus insulin dose to the user.

[0025] In some embodiments, the control unit is configured to: determine a count of the number of times the user activates the button during a selection time period, wherein the selection time period starts when the button is first activated; and select one of the multiple preset bolus insulin doses based on the count of the number of times the user activates the button during the selection time period.

[0026] In some embodiments, the control unit selects a preset bolus insulin dose among the multiple preset bolus insulin doses based on the count of the button activations by the user during the selection time period, wherein an increase in the count of the button activations by the user during the selection time period results in selection of a preset bolus insulin dose with progressively larger amounts of insulin.

[0027] Some embodiments provide a method for determining a user's total daily basal insulin dose and a total daily bolus insulin dose based on information received via an input interface of a medical device about at least two of the following: the user's total daily insulin dose, the user's total daily basal insulin dose, the user's total daily bolus insulin dose, and the ratio of the user's total daily basal insulin dose to the total daily bolus insulin dose. The method may include determining a plurality of preset bolus insulin doses based at least in part on the user's total daily bolus insulin dose via the controller of the medical device for selection using a button of a control interface of the medical device. The method may include determining a basal insulin delivery rate based at least in part on the total daily basal insulin dose via the controller of the control unit. The method may include receiving a first input from the user via the button of the control interface of the control unit, the first input selecting one of the plurality of preset bolus insulin doses. In some embodiments, the method also includes providing information indicating the selected preset bolus insulin dose to the user via the control interface. In some embodiments, the method may include receiving a second input confirming the selected preset bolus insulin dose from the user via the control interface within a confirmation time period after selecting the preset bolus insulin dose. In some embodiments, the method further comprises actuating an insulin pump of the medical device via a drive unit of the medical device to deliver insulin to the user via the insulin pump at the basal insulin delivery rate. In some embodiments, the method further comprises actuating the insulin pump via the drive unit to deliver the selected bolus insulin dose to the user.

[0028] Some embodiments provide a method for determining and administering a basal insulin dose and a bolus insulin dose to a user using any of the medical devices described herein.

[0029] Some embodiments provide a method for determining and administering a basal insulin dose and a bolus insulin dose to a user. The method includes determining, by a controller of a medical device, a total daily basal insulin dose and a total daily bolus insulin dose of the user based on information about the administration of the user received via an input interface of the medical device. In some embodiments, the information received about the administration of the user includes information about at least two of the following: i) the total daily insulin dose of the user; ii) the total daily basal insulin dose of the user; iii) the total daily bolus insulin dose of the user; and iv) the ratio of the total daily basal insulin dose of the user to the total daily bolus insulin dose. In some embodiments, the received information about the administration of the user includes information about one or more of the following: i) the total daily insulin dose of the user; ii) the total daily basal insulin dose of the user; and iii) the total daily bolus insulin dose of the user, and the method assumes that the total daily basal insulin dose is the same as the total daily bolus insulin dose. The method also includes determining, by the controller, a plurality of preset bolus insulin doses based at least in part on the total daily bolus insulin dose of the user for selection using a button of a control interface of the medical device. The method also includes determining, by the controller, a basal insulin delivery rate based at least in part on the total daily basal insulin dose. The method also includes delivering insulin to the user at the basal insulin delivery rate using an insulin pump of the medical device. The method also includes receiving a first input from the user via a button of the control interface of the medical device, the first input selecting one of the plurality of preset bolus insulin doses. In some embodiments, the method also includes providing information indicating the selected preset bolus insulin dose to the user via the control interface. In some embodiments, the information indicating the selected preset bolus insulin dose is provided by one or more of a vibration of the medical device, a sound emitted by the medical device, or a visual indication. In some embodiments, the method also includes receiving a second input confirming the selected preset bolus insulin dose from the user via the control interface within a confirmation time period after selecting the preset bolus insulin dose. The method includes delivering the preset bolus insulin dose to the user via the infusion pump. In an embodiment including receiving a second input confirming the selected preset bolus insulin dose via the control interface before delivering the preset bolus insulin dose, the selected preset bolus insulin dose is the confirmed preset insulin dose.

[0030] Some embodiments provide a method for determining a basal insulin delivery rate and a bolus insulin dose for a user. The method includes determining the user's total daily basal insulin dose and total daily bolus insulin dose based on the user's dosing information received via an input interface of a control unit. In some embodiments, the control unit is a reusable control unit. In some embodiments, the dosing information includes information about at least two of the following: i) the user's total daily insulin dose; ii) the user's total daily basal insulin dose; iii) the user's total daily bolus insulin dose; and iv) the user's total daily basal insulin dose to the total daily bolus insulin dose ratio. In some embodiments, the dosing information includes information about one or more of the following: i) the user's total daily insulin dose; ii) the user's total daily basal insulin dose; iii) the user's total daily bolus insulin dose, wherein the method assumes that the user's total daily insulin dose is the same as the user's total daily basal insulin dose. The method includes determining a plurality of preset bolus insulin doses based at least in part on the user's total daily bolus insulin dose via the controller of the control unit for selection using a button of a control interface of the control unit. The method includes determining the basal insulin delivery rate based at least in part on the total daily basal insulin dose via a controller of the control unit. The method includes receiving a first input from the user via the button of the control interface of the control unit, the first input selecting one of the multiple preset bolus insulin doses. In some embodiments, the method includes providing information indicating the selected preset bolus insulin dose to the user via the control interface. In some embodiments, the method may include receiving a second input confirming the selected preset bolus insulin dose from the user via the control interface within a confirmation time period after selecting the preset bolus insulin dose. In some embodiments, the method also includes actuating the insulin pump via the drive unit to deliver the selected bolus insulin dose to the user via the insulin pump.

[0031] In an embodiment including receiving a second input confirming a selected preset bolus insulin dose via the control interface prior to transmitting the second information, the selected preset bolus insulin dose is the confirmed preset bolus insulin dose. In some embodiments in which the insulin pump is actuated, the method is a method of delivering insulin at a basal insulin delivery rate and using the infusion pump of the infusion unit to deliver a bolus insulin dose to a user. In such embodiments, the method further includes: actuating an insulin pump of the medical device via a drive unit of the medical device to deliver insulin to the user at the basal insulin delivery rate, and actuating the insulin pump via the drive unit to deliver the selected bolus insulin dose to the user.

[0032] In some embodiments, any of the methods described herein may include determining a count of the number of times the user activates the button during a selection time period, wherein the selection time period begins when the button is first activated, and selecting one of the plurality of preset bolus insulin doses based on the count of times the user activates the button.

[0033] In some embodiments of any of the methods described herein, confirmation of selection of the preset bolus insulin dose may be performed via receiving user selection of a second button of the control interface.

[0034] In some embodiments of any of the methods described herein, the plurality of preset bolus insulin doses comprises a set of main preset bolus insulin doses and a set of correction preset bolus insulin doses, wherein each correction preset bolus insulin dose is less than all of the main preset insulin doses.

[0035] In some embodiments of any of the methods described herein, the method may further include providing information identifying the selected preset bolus insulin dose based on one or more of a vibration or a sound generated via the control interface prior to confirming the selected preset bolus insulin.

[0036] In some embodiments of any of the methods described herein, the method may include delivering the basal insulin to the user at the basal insulin infusion rate using the insulin pump based on instructions from the controller. In some embodiments of any of the methods described herein, the controller may execute instructions for determining a micro-bolus insulin dose and a frequency for administering the micro-bolus insulin dose to the user to achieve the basal insulin infusion rate and causing the insulin pump to deliver the micro-bolus insulin dose to the user at the determined frequency.

[0037] In some embodiments of the methods and devices described herein, the drug administration information received by the medical device or the control unit is provided by or received from a health care provider (HCP).

[0038] In some embodiments of any of the methods and apparatus described herein, the medical device is a wearable medical device. In some embodiments of any of the methods and apparatus described herein, the medical device is a portable, wearable, or handheld medical device. In some embodiments of any of the methods and apparatus described herein, the medical device is portable, wearable, or handheld, and at least a portion of the medical device is implanted or implantable in the user.

[0039] Some embodiments provide a non-transitory computer-readable storage medium or device configured to store instructions executable by a controller or one or more processors for implementing any of the methods described herein.

[0040] Other objects and features will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed only for the purpose of illustration and not as a definition of the limits of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] FIG1 is a block diagram of an exemplary medical device according to an embodiment;

[0042] 2A is a block diagram of an exemplary medical device including a control unit and a pump unit according to an embodiment;

[0043] 2B is a block diagram of an exemplary medical device including a control unit including a drive unit, according to an embodiment;

[0044] FIG3 is a flow chart of an exemplary method that may be implemented programmatically according to an embodiment; and

[0045] 4 is a block diagram of an exemplary computing device for implementing a method, according to an embodiment. DETAILED DESCRIPTION

[0046] Some exemplary embodiments of the present disclosure relate to a medical device for administering daily basal insulin to a user (e.g., a patient) of the medical device based on a determined total daily bolus insulin dose and enabling the user to easily and simply select one of a plurality of preset bolus insulin doses. Some exemplary embodiments of the present disclosure include methods for determining basal insulin and bolus insulin and delivering them to a user (e.g., a patient) of a medical device. Some methods and devices use a simplified control interface to select a bolus insulin dose from a set of preset bolus insulin doses, which are determined by the device based on received dosing information (e.g., based on dosing information received from the user's HCP). In some embodiments, the set of preset bolus insulin doses includes a set of main doses corresponding to meals with different amounts of carbohydrates and a set of smaller correction doses. In some embodiments, the user's selection of one of the predetermined bolus insulin doses is performed via a button of the medical device. In some embodiments, the user's selection of one of the preset bolus insulin doses is based on the number of times the user pushes the button. In some embodiments, the medical device is configured to provide information about the selected preset bolus insulin dose (e.g., via vibration of the medical device or a sound emitted by the medical device). In some embodiments, the medical device is configured to receive an input from a user confirming a selected preset bolus insulin dose. In some embodiments, the input confirming the selected preset bolus insulin dose is performed via a second button of the medical device. In some embodiments, the medical device does not include a graphical user interface. In some embodiments, the control interface for the user does not include a screen or a graphical display.

[0047] In some embodiments, compared with some other conventional medical devices, medical devices are configured to reduce the complexity and difficulty of user selection of bolus insulin dose by using preset bolus insulin dose and by using simplified control interface. For example, compared with some conventional devices, having a single button for selecting bolus insulin dose from a limited number of preset insulin doses reduces the complexity and time required for user input or setting bolus dose, which can increase the ease of use of the device and reduce the errors associated with some user control interfaces. Many conventional medical devices tend to increase the complexity of control interfaces to include more and more options and controls. In some embodiments, compared with some conventional medical devices, the reduction of control interface options on medical devices is counterintuitive, but can lead to more adoption of bolus dose therapy and increase the compliance to bolus dose therapy and the effectiveness of bolus dose therapy.

[0048] In some embodiments, medical device comprises can be activated (for example, press or touch) repeatedly to select preset push insulin dosage from multiple preset insulin dosage.In some embodiments, the dosage in described multiple preset push insulin dosage is determined as different fractions of user's daily total push insulin dosage by medical device.In some embodiments, user's daily total push insulin dosage is provided to medical device and / or is programmed into medical device by a party except user by health care provider.Described multiple dosage can not be linear increase.For example, in some embodiments, described multiple preset insulin push dosage can be 1 / 10, 1 / 5, 1 / 3 and 1 / 2 of daily total push insulin dosage, to correspond to the characterization of meal and less correction.

[0049] In addition, in the embodiment with the second button for confirming dosage, the second button can reduce the error related to inputting dosage and confirming dosage using the same input mechanism. Other embodiments can adopt the button for selecting preset push insulin dosage to confirm selected preset push insulin dosage (for example, by pressing and keeping or touching and keeping button). Other embodiments can adopt different mechanisms to receive the second input to confirm selected preset push insulin dosage. Therefore, the second button is optional.

[0050] In some embodiments, the user is not required to provide any input or information regarding calories, carbohydrates, glycemic index, or blood glucose measurement before selecting the current bolus insulin dose using the button.

[0051] In some embodiments, medical device can reduce the complexity of user interaction, because medical device can apply bolus dosage scheme when blood glucose measurement is not needed and user input blood glucose measurement is not needed.In some embodiments, medical device receives user input corresponding to simplified characterization of meal or physical activity, and the simplified characterization corresponds to one of preset bolus insulin dosage.For example, medical device can receive pressing button three times to indicate small meal, pressing button four times to indicate medium calorie meal or pressing button five times to indicate large meal.Preset bolus insulin dosage can also include smaller correction dose.For example, in some embodiments, user presses button once to select minimum correction dose, and user presses button twice to select larger correction dose.Therefore, in some embodiments, medical device allows calculating meal instead of simpler method of carbohydrate counting, and provides easy selection of smaller correction bolus.This simplification of interaction with user has amazing and beneficial effect on the success rate of medical compliance and bolus dosage therapy, while reducing human error when user selects dosage.

[0052] In some embodiments, after the medical device receives information about the characterization of the meal (e.g., by the number of times a button is pressed), the medical device can provide an indication of the selection by vibration, sound, and / or visual indication. For example, in some embodiments, if the button is pressed four times to remind the user that the fourth preset push insulin dose is selected, the medical device can vibrate four times. In some embodiments, this indication of the selection via vibration, sound, and / or visual indication can be important because the simplified control interface of the medical device may not include a screen or a graphical display. In some embodiments, after indicating the selection, the medical device may require the user to press the button for selection again to confirm the selection before applying the selected push dose. In some embodiments, the input mechanism for confirming the dose is different from the button for selecting the dose. For example, in some embodiments, the medical device includes a second button activated by the user (e.g., pressed or touched), thereby confirming the selection of the dose before the dose is applied. This confirmation process can reduce errors in dose selection and administration.

[0053] FIG. 1 is a block diagram of a medical device 100 (hereinafter referred to as “device 100”) according to some embodiments. The medical device 100 includes an insulin pump 102 configured to deliver insulin to a user (e.g., a patient), a control interface 108 including a button 109 (e.g., a push button) configured to select one of a plurality of preset push insulin doses based on input from the user, and a controller 104 configured to execute machine-readable instructions stored in a memory 106. In some embodiments, the control interface 108 includes a second button 120 for confirming the selection of the preset push insulin dose. In other embodiments, confirmation of the selection may also be performed via the button 109.

[0054] In some embodiments, the preset bolus insulin dose is determined by the medical device at least in part based on received dosing information about the user (e.g., information received from a health care provider), which is used to determine the user's total daily insulin dose and the total daily bolus insulin dose. In some embodiments, the dose in the multiple preset bolus insulin doses is determined as a fraction of the total daily bolus insulin dose. In some embodiments, the preset bolus insulin doses in the multiple bolus insulin doses do not increase linearly. In some embodiments, the preset bolus insulin doses correspond to meals with different carbohydrate amounts (e.g., large, medium, and small) and smaller correction doses, so that the user can simply and easily select the preset bolus insulin dose corresponding to the meal or select a smaller correction bolus insulin dose.

[0055] In some embodiments, the medical device 100 includes a glucose measurement sensor 112 configured to measure the blood sugar of the user. In other embodiments, the glucose measurement sensor 112 is not included in the medical device, which is why the glucose measurement sensor 112 is indicated in the figure by a box with a dashed line.

[0056] Examples of insulin pump 102 include, but are not limited to, a patch pump worn by a user and an implantable device that delivers a dose of insulin to the bloodstream. In some embodiments, insulin pump 102 is configured to deliver short-acting insulin. In some embodiments, insulin pump 102 is configured to deliver short-acting and / or long-acting insulin.

[0057] In some embodiments, button 109 and / or second button 120 are mechanical switches or electromechanical switches that generate signals when activated. In other embodiments, button 109 and / or second button 120 are capacitive or inductive touch interfaces. In some embodiments, the number of buttons activated by the user during the selection time period determines which of the multiple preset push insulin doses is selected. For example, pressing button 108 five times will select the fifth preset push insulin dose. In some embodiments, the number of preset push insulin doses is five or less than five. In some embodiments, the number of preset push insulin doses is six or less than six. In some embodiments, the number of activations of button 109 for selecting any preset push insulin dose is less than six. In some embodiments, the number of activations of button 109 for selecting any preset push insulin dose is less than seven. Limiting the number of preset push insulin doses simplifies the selection process for the user.

[0058] In some embodiments, the control interface 108 is also configured to provide information indicating the selected preset bolus insulin dose to the user. In some embodiments, the information is provided via the vibration of the medical device. In some embodiments, the information is provided via the sound generated by the medical device.

[0059] In some embodiments, the controller 104 can receive a second input confirming the selected preset push insulin dose from the control interface 108. For example, in some embodiments, the control interface 108 includes a second button 120, and after the preset push insulin dose is selected using the button 108 (e.g., the push button), the user activates the second button 120 (e.g., by pressing or touching the second button), thereby providing a second input to confirm the selected preset push insulin dose. However, some other embodiments of the medical device do not include a second button for confirmation. For example, in some embodiments, the button 108 for selecting the preset push insulin dose can also be used for a second input to confirm the selected preset push insulin dose (e.g., pressing and holding or touching and holding the button 108 for at least a certain period of time can be used to confirm the selected preset push insulin dose). In some embodiments, after the medical device provides information indicating the selected preset push insulin dose to the user (e.g., via one or more of vibration, sound or visual indicators), a second input confirming the selected preset push insulin dose is received.

[0060] In some embodiments, the control interface 108 for the user to use when selecting and confirming the preset bolus insulin dose does not include a graphical user interface. This can be advantageous for users who do not wish to use a separate device (such as a smart phone, etc.). The control and response of the device are greatly simplified. However, in some embodiments, the device can be configured to communicate with a smart phone, etc. while keeping the control interface 108 active.

[0061] In some embodiments, the controller 104 includes a processor, a field programmable gate array, an application specific integrated circuit, a microcontroller, a peripheral interface controller (PIC), etc. In some embodiments, the controller 104 is connected to the memory 106 interface via a bus. The memory 106 can be any form of memory for storing instructions or data. Examples of the memory 106 include, but are not limited to, solid-state memory, computer-readable media such as flash memory, etc.

[0062] In some embodiments, the medical device also includes an input interface for receiving information about the user (e.g., from a health care provider). In some embodiments, the input interface 110 can be configured for wired communication and / or short-range wireless communication (e.g., via Bluetooth connection) or long-range wireless communication (e.g., via cellular). In some embodiments, the input interface 110 is used to receive dosage information to customize the device for the user. In some embodiments, the input interface 110 is an input / output interface for realizing two-way communication (e.g., with a health care provider). In some embodiments, the input interface 110 can be a universal serial bus interface, an IEEE 1394 interface, a wireless interface adapted to send and receive information. In an example, the input interface 110 can be configured to receive input from a health care professional to program the medical device 100.

[0063] For example, in some embodiments, medical device receives information (for example, from HCP) to program medical device 100 with the dosage information of the user.Medical device 100 determines the daily total basal insulin dosage and the daily total push insulin dosage of the user according to the dosage information received.In some embodiments, the information received includes information about at least two of the following: the daily total insulin dosage of the user, the daily total basal insulin dosage of the user, the daily total push insulin dosage of the user and the daily total basal insulin dosage ratio of the user and the daily total push insulin dosage.For example, in some embodiments, the information received (for example, from HCP, for programming the device) includes information about the daily total insulin dosage and about the daily total basal insulin dosage of the user and the daily total push insulin dosage ratio of the user.In some embodiments, include at least one of the following in the information received: the daily total insulin dosage of the user, the daily total basal insulin dosage of the user and the daily total push insulin dosage of the user, and the device assumes that the daily total basal insulin dosage equals the daily total push insulin dosage.

[0064] In some embodiments, the HCP initially interacts with the medical device 100 using a computer or mobile device to program the medical device 100. In some examples, the HCP can provide information to customize the total daily insulin dose and the total daily bolus insulin dose for the user based on the user's (e.g., patient's) profile, etc. In some embodiments, the controller 104 uses the information received from the HCP to reprogram the medical device 100 to customize the treatment for the user.

[0065] In some embodiments, the controller executes instructions stored in the memory to determine the user's daily total basal insulin dose and daily total bolus insulin dose based on the information received about at least two of the following items: the user's daily total insulin dose, the user's daily total basal insulin dose, the user's daily total bolus insulin dose and the user's daily total basal insulin dose and the daily total bolus insulin dose ratio. For example, the received information (e.g., from the HCP) can include the user's daily total insulin dose and the daily total basal insulin dose and the daily total bolus insulin ratio, from which the daily total basal insulin dose and the daily total bolus insulin dose are determined. In the example, based on the received user information, the controller 100 can provide 50% of the user's daily insulin demand via basal insulin delivery, and distribute another 50% for delivery via multiple preset bolus insulin doses that the user can select using button 109.

[0066] In some embodiments, controller 104 determines the basal insulin delivery rate based at least in part on the daily total basal insulin dosage. In some embodiments, controller 104 determines the size of micro-bolus insulin dosage and is used to apply micro-bolus insulin dosage to reach the frequency of determined basal insulin delivery rate. Instruction can include the process of determining the number of times that insulin pump 102 must be operated per hour and the amount of micro-bolus insulin dosage during each operation, the unit time between micro-bolus insulin dosage, etc. In some embodiments, insulin pump 102 can operate continuously to deliver continuous basal insulin rate to the user. For different types of insulin (such as short-acting insulin, long-acting insulin, etc.), the process for determining the basal insulin delivery rate can be different. For example, in some embodiments, the process can be based on the following determination of the number of minutes between micro-bolus:

[0067] Minutes between microboluses=60 min / (TDBasal [μL] / 24 h / Vol microbolus [μL]), where TDBasal is the total daily basal insulin dose and microbolus is the volume of insulin delivered each time the insulin pump 102 is activated.

[0068] Controller 104 determines multiple preset push insulin doses based on total push insulin dose per day at least in part. For example, in some embodiments, instruction includes a process for determining the multiple preset push insulin doses based on total push insulin dose per day. The following includes the non-limiting example of such process. In an embodiment, the process is divided into multiple preset push insulin doses by total push insulin dose per day. In some embodiments, the multiple preset push insulin doses can be five preset push insulin doses, such as 5% of total push insulin dose per day (TDBolus) for slight correction, 12.5% ​​of TDBolus for major correction, 20% of TDBolus for small meals (a small amount of carbohydrates (CHO)), 35% of TDBolus for medium meals (a medium amount of CHO) and 50% of TDBolus for large meals (a large amount of CHO). The preset push insulin doses of other quantities and other divisions of total push insulin dose per day also fall within the scope of the present disclosure. Table 1 below includes non-limiting example segmentation of total push insulin dose per day and the estimated impact on blood glucose level calculated.

[0069] For Table 1, it is assumed that the total daily basal insulin dose is approximately equal to the total daily bolus insulin dose, and the total daily carbohydrate intake is 240 grams. It is assumed that the average expected effect of insulin dose on blood glucose follows the 1600 rule below: dBG = 1600 / DIR,

[0070] Where dBG is the drop in blood glucose in mg / ml and DIR is the daily insulin requirement. Some people have higher insulin or lower insulin sensitivity, which may not be accurately characterized by the "1600 rule" equation above.

[0071] In this example, because the total daily basal insulin dose and the total daily bolus insulin dose are approximately equal, the respective preset sizes also reflect similarly proportioned basal rates.

[0072] In an example, the controller 104 can receive a signal from the push button 108. For example, the user can characterize a meal after a meal, characterize a correction based on exercise before or after a meal, characterize exercise between this meal and the previous meal, etc. by activating the push button 108. The controller 104 can use the number of times the push button 108 is activated within a predetermined time period to characterize a meal, exercise, or both. In an example, the predetermined time period can be a few seconds after the push button 108 is activated for the first time. The controller 104 can determine the number of times the push button 108 is pressed to select a push insulin dose from a set of push insulin presets to be administered. For example, the controller 104 can determine that the push insulin dose to be administered after four activations of the push button is a push insulin dose for the fourth preset push insulin dose, which is a Chinese meal for the example in Table 1. In some embodiments, the controller 104 can receive a signal from the second button 121 to confirm the preset push insulin dose selected using the push button 108. The controller 104 may activate the insulin pump 102 to deliver the selected bolus insulin dose to the user, which in some embodiments is a selected and confirmed preset bolus insulin dose.

[0073] In an example, button 108 may be activated to characterize a meal.

[0074] The use of bolus button 108 allows controller 104 to receive information about a user's meal for selection of a preset bolus insulin dose without requiring the user to categorize the meal using complex methods such as carbohydrate counting, personal dose dials or settings, etc.

[0075] In some embodiments, the activation frequency of the push button 108 is based on the characterization of the meal. For example, as described above, for the embodiments of the preset push insulin dose shown in Table 1, the user can activate the push button 108 four times to indicate a moderate meal. Similarly, the activation frequency of the push button 108 can be based on the characterization of the user's physical activity (e.g., the user's physical activity before a meal, between a previous meal and a current meal, etc.). Similarly, the activation frequency of the push button 108 can be based on the characterization of the user's physical activity and the previous meal.

[0076] In some embodiments, glucose measurement sensor 112 may be interfaced with controller 104 to determine a user's blood glucose level prior to administering a bolus insulin dose to the user.

[0077] In some embodiments, the medical device 100 is configured to receive at least one reservoir containing insulin. In some embodiments, the medical device 100 is configured to receive more than one reservoir, each reservoir containing a different type of insulin.

[0078] Fig. 2A and Fig. 2B schematically depict an exemplary medical device 100 according to some embodiments. The exemplary medical device 100 may include a control unit 202 and a pump unit 204. In some embodiments, the control unit 202 includes a controller 104, a memory 106, and a control interface 108, the control interface including a button 109 (e.g., a push button) for selecting a preset push insulin dose from a plurality of preset push insulin doses. As described above, in some embodiments, the control interface 108 also provides information indicating the selected preset push insulin dose to the user (e.g., via one or more of a vibration, sound, or visual indicator). In some embodiments, the control interface 108 also includes a second button 120 for receiving a second input to confirm the selected preset push insulin dose. For example, in some embodiments, the user activates (e.g., presses or touches) button 108 one or more times to select the current bolus insulin dose, the medical device provides an indication of the selected preset bolus insulin dose (e.g., via one or more of a vibration, sound, or visual indicator), and then the user activates (e.g., presses or touches) second button 120 to confirm the selected preset bolus insulin dose. In some embodiments, the selected dose is confirmed using button 108 or some other element of control interface 108, for example, pressing and holding button 108 can be used to confirm the selected dose. In some embodiments, second button 120 is used as a start / stop button for delivering insulin.

[0079] In embodiments requiring confirmation, the selected preset bolus insulin dose will only be delivered to the user if a second input of confirmation is received. In some embodiments, the second input for confirmation must be received within a preset confirmation time after selecting the preset bolus insulin dose.

[0080] In some embodiments, the control unit 202 includes the glucose measurement sensor 112. However, in other embodiments, no glucose measurement sensor is included, which is why the glucose measurement sensor 112 is indicated by a dashed line in Figures 2A and 2B.

[0081] The pump unit 204 includes at least one insulin pump 102, which may be a patch pump, an implantable pump, or any other pump for delivering insulin to a user. In some embodiments where more than one different type of insulin may be delivered to a user, the pump unit 204 may include more than one pump, each pump dispensing a different type of insulin.

[0082] In some embodiments, the control unit 202 further includes at least one power source 208 (e.g., a battery) and at least one drive unit 206 (see FIG. 2B ) for mechanically actuating at least one insulin pump 102. In other embodiments, at least one drive unit 206 may not be included in the control unit.

[0083] In some embodiments, the control unit 202 is coupled or coupleable by a user to the pump unit 204. In some embodiments, the control unit 202 and / or the pump unit 204 include a coupling for coupling the units together. In other embodiments, the control unit 202 and the pump unit 204 are not intended to be detachable or not detachable by a user without damaging or rendering the medical device inoperable.

[0084] As described above, the controller 104 may determine the basal insulin delivery rate based at least in part on the total daily basal insulin dose. The controller 104 may provide a signal or instruction to the drive unit 206 that causes the drive unit to mechanically actuate the insulin pump 102 of the pump unit 204 to deliver insulin to the user at the basal insulin delivery rate via the insulin pump 102. After selecting the preset basal insulin dose, the controller 104 may provide a signal or instruction to the drive unit 206 that causes the drive unit to mechanically actuate the insulin pump 102 of the pump unit 204 to deliver the selected bolus insulin dose to the user via the insulin pump 102.

[0085] Fig. 3 shows a flowchart 300 of an exemplary method for determining a user's basal insulin delivery rate and a bolus insulin dose. The total daily basal insulin dose and the total daily basal insulin dose are determined by the controller 104 based on the administration information of the user received via the input interface 109 of the control unit 202 (step 302). In some embodiments, the administration information includes at least two of the following: (i) the user's total daily insulin dose; (ii) the user's total daily basal insulin dose; (iii) the daily total bolus insulin dose per user; and (iv) the user's total daily basal insulin dose to the daily total bolus insulin dose ratio. For example, in some embodiments, the administration information includes the user's total daily insulin dose and the user's total daily basal insulin dose to the daily total bolus insulin dose ratio. In some embodiments, the medical device is configured based on the assumption that the total daily basal insulin dose is the same as the daily total bolus insulin dose, in which case the received information may include only one or more of the following: (i) the user's total daily insulin dose; (ii) the user's total daily basal insulin dose; and (iii) the user's total daily bolus insulin dose.

[0086] The controller 104 of the control unit 202 determines a plurality of preset bolus insulin doses based at least in part on the user's determined total daily bolus insulin dose for selection using the button 109 of the control interface 108 of the control unit 202 (step 304).

[0087] The controller 104 of the control unit 202 determines a basal insulin delivery rate based at least in part on the determined total daily basal insulin dose (step 306 ).

[0088] In some embodiments where the method is also a method for delivering basal insulin and delivering bolus insulin, the method further includes: the controller 104 actuates the insulin pump 102 of the pump unit 204 via the drive unit 206 to deliver insulin to the user via the insulin pump 102 at the basal insulin delivery rate (step 308).

[0089] The controller 104 of the control unit 202 receives a first input from a user via a button 109 of a control interface 109 of the control unit, the first input selecting one of the plurality of preset bolus insulin doses (step 310).

[0090] In some embodiments, the controller provides an indication (eg, a vibration, audio, and / or visual indication) of the selected preset bolus insulin dose to the user via the control interface 202 (step 311).

[0091] In some embodiments, the controller 104 receives a second input from the user confirming the selected preset bolus insulin dose via the control interface 108 within the confirmation time period after selecting the preset bolus insulin dose (step 312). For example, the second input can come from the user pressing or touching the second button 120 to confirm the selected preset bolus insulin dose after the medical device provides an indication to the user of the selected preset bolus insulin dose.

[0092] In some embodiments where the method is also a method of delivering basal insulin and delivering bolus insulin, the method further comprises: actuating the insulin pump 102 via the drive unit 206 to deliver the selected bolus insulin dose to the user (step 314). In FIG. 3 , steps that may not be performed in some embodiments are indicated with dashed lines.

[0093] FIG4 is a block diagram of an exemplary computing device 500 that can be used to implement an exemplary embodiment in which the HCP can be used to program the medical device 100. The computing device 500 includes one or more non-transitory computer-readable media for storing one or more computer-executable instructions or software for implementing the exemplary embodiment. Non-transitory computer-readable media may include, but are not limited to, one or more types of hardware memory, non-transitory tangible media (e.g., one or more magnetic storage disks, one or more optical disks, one or more flash drives), etc. For example, the memory 506 included in the computing device 500 can store computer-readable and computer-executable instructions or software for implementing the exemplary embodiment of the medical device 100. The computing device 500 also includes a configurable and / or programmable processor 502 and an associated core 504 and optionally one or more additional configurable and / or programmable processors 502' and one or more associated cores 504' (e.g., in the case of a computer system with multiple processors / cores) for executing computer-readable and computer-executable instructions or software stored in the memory 506 and other programs for controlling the system hardware. The processor 502 and the one or more processors 502' may each be a single core processor or a multi-core (504 and 504') processor.

[0094] Virtualization can be used in computing device 500 so that infrastructure and resources in the computing device can be dynamically shared. A virtual machine 514 can be provided to handle processes running on multiple processors so that the processes appear to use only one computing resource instead of multiple computing resources. Multiple virtual machines can also be used with one processor.

[0095] The memory 506 may include computer system memory or random access memory (such as DRAM, SRAM, EDO RAM, etc.). The memory 506 may also include other types of memory or a combination thereof.

[0096] A user (e.g., a user associated with an HCP) can interact with the computing device 500 through a visual display device 518 (e.g., a computer monitor), which can display one or more user interfaces 520 that can be provided according to exemplary embodiments. The computing device 500 may include other I / O devices for receiving input from the user, such as a keyboard or any suitable multi-touch interface 519, a pointing device 510 (e.g., a mouse). The keyboard 508 and the pointing device 510 may be coupled to the visual display device 520. The computing device 500 may include other suitable conventional I / O peripherals.

[0097] The computing device 500 may also include one or more storage devices 524, such as a hard drive, CD-ROM, or other computer-readable medium, for storing data and computer-readable instructions and / or software implementing an exemplary embodiment of the computing device that the HCP may use to interact with the medical device 100 described herein. The exemplary storage device 524 may also store instructions and / or software implementing an application 550, which may also store one or more databases for storing any suitable information required to program the medical device 100 according to the exemplary embodiments. For example, the exemplary storage device 524 may store one or more databases 526 for storing information, such as information corresponding to one or more commands, operations, passwords, user identifiers, and / or any other information for programming an embodiment of the medical device 100. The database may be manually or automatically updated at any suitable time to add, delete, and / or update one or more items in the database.

[0098] The computing device 500 may include a network interface 512 configured and / or programmed to interface with one or more networks (e.g., a local area network (LAN), a wide area network (WAN), or the Internet) via one or more network devices 513 through various connections, including but not limited to standard telephone lines, LAN or WAN links (e.g., 802.11, T1, T3, 56kb, X.25), broadband connections (e.g., ISDN, Frame Relay, ATM), wireless connections, controller area networks (CAN), or some combination of any or all of the above. The network interface 512 may include a built-in network adapter, a network interface card, a PCMCIA network card, a card bus network adapter, a wireless network adapter, a USB network adapter, a modem, or any other device suitable for connecting the computing device 500 to any type of network interface capable of communicating and performing the operations described herein. In addition, the computing device 500 may be any computer system, such as a workstation, a desktop computer, a server, a laptop computer, a handheld computer, a tablet computer (e.g., tablet computers), mobile computing or communication devices (e.g. communications device) or other form of computing or telecommunications device capable of communications and having sufficient processor power and memory capacity to perform the operations described herein.

[0099] The computing device 500 may run any operating system 516, such as Any version of the operating system, different distributions of Unix and Linux operating systems, Macintosh computers , any embedded operating system, any real-time operating system, any open source operating system, any proprietary operating system, or any other operating system capable of running on a computing device and performing the operations described herein. In an exemplary embodiment, operating system 516 can run in a local mode or in an emulation mode. In an exemplary embodiment, operating system 516 can run on one or more cloud machine instances.

[0100] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. A drug or medicament may be used for a limited duration, or periodically for a chronic disorder.

[0101] As described below, a drug or medicament may include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also contemplated.

[0102] The drug or medicament can be included in a primary package or "drug container" adapted for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir or other solid or flexible vessel, which is configured to provide a suitable chamber for storing (for example, short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (for example, 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can be carried out at room temperature (for example, about 20 ° C) or refrigerated temperature (for example, from about -4 ° C to about 4 ° C). In some cases, the drug container can be or can include a dual-chamber cartridge, which is configured to store two or more components (for example, API and diluent, or two different drugs) of a pharmaceutical preparation to be administered separately, one of which is stored in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during distribution to the human or animal body. For example, the two chambers can be configured so that they are in fluid communication with each other (e.g., through a conduit between the two chambers) and allow the user to mix the two components if desired before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing when dispensing the components into the human or animal body.

[0103] The medicine or medicament contained in the drug delivery device as described herein can be used to treat and / or prevent many different types of medical disorders. The example of obstacle includes, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Another example of obstacle is acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. The example of API and medicine is those as described in the following manual: such as Rote Liste 2014 (for example, but not limited to, main group (main group) 12 (antidiabetic drugs) or 86 (tumor drugs)) and Merck Index, the 15th edition.

[0104] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms "analogs" and "derivatives" refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deleting and / or exchanging at least one amino acid residue present in a naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residues can be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) in which one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Alternatively, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to the naturally occurring peptide.

[0105] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0106] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulin degludec, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0107] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide Exendin-4 Liraglutide (a 39-amino acid peptide produced by the salivary glands of the Gila monster) Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GS K-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0108] Examples of oligonucleotides are e.g. Mipomersen sodium It is a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrome.

[0109] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0110] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), somatropine (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0111] Examples of polysaccharides include glucosaminoglycanes, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 It is a sodium hyaluronate.

[0112] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F (ab) and F (ab') 2 fragments, which retain the ability to bind antigens. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized antibody or a humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has reduced or no ability to bind Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant, which does not support binding to Fc receptors, for example, it has a mutagenic or missing Fc receptor binding region. The term antibody also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0113] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule, which does not include a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide capable of binding an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, although the term is not limited to such cleavage fragments. Antibody fragments that can be used in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, tetravalent and multivalent antibodies), mini antibodies, chelated recombinant antibodies, triabodies or bibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies containing VHH. Other examples of antigen-binding antibody fragments are known in the art.

[0114] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is generally not directly involved in antigen binding, as is known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0115] Examples of antibodies are anti-PCSK-9 mAb (eg, Alirocumab), anti-IL-6 mAb (eg, Sarilumab), and anti-IL-4 mAb (eg, Dupilumab).

[0116] Pharmaceutically acceptable salts of any API described herein are also contemplated for use as drugs or medicaments in drug delivery devices.Pharmacologically acceptable salts are, for example, acid addition salts and basic salts.

[0117] Those skilled in the art will appreciate that various components of the API, formulations, devices, methods, systems, and embodiments described herein may be modified (added and / or removed) without departing from the overall scope and spirit of the invention, and the invention encompasses such modifications and any and all equivalents thereof.

[0118] An example drug delivery device may involve a needle-based injection system as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly distinguished into multi-dose container systems and single-dose (with partial or full discharge) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0119] As further described in ISO 11608-1:2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (preset by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (preset by the user).

[0120] As further described in ISO 11608-1:2014 (E), a single-dose container system can relate to an injection device based on a needle with a replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (complete discharge). In another example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge). As also described in ISO 11608-1:2014 (E), a single-dose container system can relate to an injection device based on a needle with an integrated non-replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (complete discharge). In another example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge).

[0121] When describing exemplary embodiments, specific terms are used for the sake of clarity. For the purpose of description, each specific term is intended to at least include all technical and functional equivalents that operate in a similar manner to achieve similar purposes. In addition, in some cases where a specific exemplary embodiment includes multiple system elements, device components or method steps, these elements, components or steps can be replaced with a single element, component or step. Similarly, a single element, part or step can be used for multiple elements, parts or steps of the same purpose to replace. In addition, although exemplary embodiments have been shown and described with reference to their specific embodiments, it will be appreciated by those of ordinary skill in the art that various substitutions and changes can be made in form and detail without departing from the scope of the present invention. In addition, other embodiments, functions and advantages are still also within the scope of the present invention.

[0122] The exemplary flow chart is provided here for illustrative purposes and is a non-limiting example of a method. One of ordinary skill in the art will recognize that the exemplary method may include more or fewer steps than those shown in the exemplary flow chart, and that the steps in the exemplary flow chart may be performed in a different order than that shown in the illustrative flow chart.

[0123] Reference numerals list

[0124] 102 Insulin Pump

[0125] 104 Controller

[0126] 106 Memory

[0127] 108 Control Interface

[0128] 109 Button

[0129] 110 Input interface

[0130] 112 Glucose Measurement Sensor

[0131] 120 Second button

[0132] 202 Control unit

[0133] 204 Pump unit

[0134] 206 Driver Unit

[0135] 208 Power Supply

[0136] 300-314 Methods

[0137] 500 Computing Devices

[0138] 502 processor

[0139] 502' Virtual Processor

[0140] 504 cores

[0141] 504' Virtual Core

[0142] 506 Memory

[0143] 510 Pointing device

[0144] 512 Network interfaces

[0145] 513 Network Interface Device

[0146] 514 virtual machines

[0147] 516 Operating System

[0148] 518 User Interface

[0149] 519 Multi-touch interface

[0150] 520 Visual Display Device

[0151] 524 Storage

[0152] 526 Database

[0153] 550 Applications

[0154] Table 1

[0155]

Claims

1. A device for administering insulin, comprising: an insulin pump configured to deliver insulin; a control interface comprising a button configured to select one of a plurality of preset bolus insulin doses based on input from a user, the plurality of preset bolus insulin doses being determined by the controller; and The controller is configured to execute instructions stored in the memory to: determining a total daily basal insulin dose and a total daily bolus insulin dose of the user based on information received regarding at least two of: the user's total daily insulin dose, the user's total daily basal insulin dose, the user's total daily bolus insulin dose, and a ratio of the user's total daily basal insulin dose to the user's total daily bolus insulin dose; determining the plurality of preset bolus insulin doses based at least in part on the total daily bolus insulin dose; determining a basal insulin delivery rate based at least in part on the total daily basal insulin dose; delivering insulin to the user via the insulin pump at the basal insulin delivery rate; receiving a first input from the user via the button selecting one of the plurality of preset bolus insulin doses; as well as A selected bolus insulin dose is delivered to the user via the insulin pump.

2. The device according to claim 1, wherein: The controller is further configured to: determining a count of activations of the button by the user during a selection time period, wherein the selection time period begins when the button is first activated; and One of the plurality of preset bolus insulin doses is selected based on the count of activations of the button by the user during the selection time period.

3. The device according to claim 2, wherein: The controller is further configured to select a preset bolus insulin dose among the plurality of preset bolus insulin doses based on the count of the button activations by the user during the selection time period, wherein an increase in the count of the button activations by the user during the selection time period results in selection of a preset bolus insulin dose with progressively larger insulin amounts.

4. The device according to any one of claims 1 to 3, wherein: The controller is also configured to: providing information indicative of the selected preset bolus insulin dose to the user via the control interface; and A second input confirming the selected preset bolus insulin dose is received from the user via the control interface within a confirmation period after selecting the preset bolus insulin dose.

5. The device according to claim 4, wherein: The control interface also includes a second button configured to confirm selection of the preset bolus insulin dose.

6. The device according to claim 4, wherein: The controller is further configured to provide the information indicative of the selected preset bolus insulin dose to the user based on one or more of a vibration or a sound generated via the control interface.

7. The device according to claim 1, wherein: The plurality of preset bolus insulin doses comprises a set of main preset bolus insulin doses and a set of correction preset bolus insulin doses, and wherein each correction preset bolus insulin dose is smaller than all of the main preset bolus insulin doses.

8. The device according to claim 1, wherein: The controller is also configured to: determining a micro-bolus insulin dose and a frequency of administering the micro-bolus insulin dose to the user to achieve the basal insulin delivery rate; and The determined micro-bolus insulin dose is delivered to the user via the insulin pump at the determined frequency.

9. The device according to claim 1, wherein: The controller is also configured to: receiving, via an input interface, said information for determining said total daily basal insulin dose and said total daily bolus insulin dose; and The received information is stored in the memory.

10. The device according to claim 1, comprising: A control unit, the control unit comprising the controller and the control interface; as well as A pump unit comprising the insulin pump. 11 . The apparatus according to claim 1 , further comprising a blood glucose measurement unit configured to determine a blood glucose value corresponding to a current blood glucose level of the user.

12. A control unit for a medical device, the control unit comprising: a control interface comprising a button configured to select one of a plurality of preset bolus insulin doses based on input from a user, the plurality of preset bolus insulin doses being determined by the controller; and The controller is configured to execute instructions stored in the memory to: determining a total daily basal insulin dose and a total daily bolus insulin dose of the user based on information received regarding at least two of: the user's total daily insulin dose, the user's total daily basal insulin dose, the user's total daily bolus insulin dose, and a ratio of the user's total daily basal insulin dose to the user's total daily bolus insulin dose; determining the plurality of preset bolus insulin doses based at least in part on the total daily bolus insulin dose; determining a basal insulin delivery rate based at least in part on the total daily basal insulin dose; actuating an insulin pump of a pump unit via a drive unit to deliver insulin to the user at the basal insulin delivery rate; receiving a first input from the user via the button selecting one of the plurality of preset bolus insulin doses; as well as An insulin pump of a pump unit is actuated via the drive unit to deliver a selected bolus insulin dose to the user.

13. The control unit according to claim 12, wherein: The controller is also configured to: determining a count of activations of the button by the user during a selection time period, wherein the selection time period begins when the button is first activated; and One of the plurality of preset bolus insulin doses is selected based on the count of activations of the button by the user during the selection time period.

14. The control unit according to claim 13, wherein: The controller is further configured to select a preset bolus insulin dose among the plurality of preset bolus insulin doses based on the count of the button activations by the user during the selection time period, wherein an increase in the count of the button activations by the user during the selection time period results in selection of a preset bolus insulin dose with progressively larger insulin amounts.

15. A method for determining a basal insulin dose and a bolus insulin dose, comprising: determining a total daily basal insulin dose and a total daily bolus insulin dose of a user based on information received via an input interface of the medical device regarding at least two of: the user's total daily insulin dose, the user's total daily basal insulin dose, the user's total daily bolus insulin dose, and a ratio of the user's total daily basal insulin dose to the total daily bolus insulin dose; determining, via a controller of the medical device, a plurality of preset bolus insulin doses based at least in part on the total daily bolus insulin dose of the user for selection using a button of a control interface of the medical device; determining, via the controller, a basal insulin delivery rate based at least in part on the total daily basal insulin dose; receiving a first input from the user via the button of the control interface, the first input selecting one of the plurality of preset bolus insulin doses; providing information indicating the selected preset bolus insulin dose to the user via the control interface; as well as A second input confirming the selected preset bolus insulin dose is received from the user via the control interface within a confirmation period after selecting the preset bolus insulin dose.

16. The method according to claim 15, wherein: Receiving the first input from the user via the button of the control interface comprises: determining a count of activations of the button by the user during a selection time period, wherein the selection time period begins when the button is first activated; and One of the plurality of preset bolus insulin doses is selected based on the count of the button activations by the user during the selection time period, wherein increasing count of the button activations by the user during the selection time period results in selection of preset bolus insulin doses with progressively larger insulin amounts.

17. The method according to claim 15 or claim 16, wherein: The plurality of preset bolus insulin doses comprises a set of main preset bolus insulin doses and a set of correction preset bolus insulin doses, and wherein each correction preset bolus insulin dose is smaller than all of the main preset bolus insulin doses.

18. The method of claim 15, further comprising determining a micro-bolus insulin dose and a frequency of administering the micro-bolus insulin dose to the user to achieve the basal insulin delivery rate.

19. The method according to claim 15, wherein: Providing the information indicative of the selected preset bolus insulin dose to the user via the control interface includes generating a vibration, generating a sound, or generating a vibration and a sound.

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