Adaptation of Automated Insulin Delivery (AID) for Users with a Discrepancy in the Basal Bolus Ratio

Abstract

The preferred embodiment provides users with a more customized amount of basal insulin to better regulate blood glucose (BG) concentration levels. The preferred embodiment does not statically assume that each user's daily basal amount is 50% of the TDI. Instead, actual TDI data may be collected for each user and used to adjust the user's TDI value to an updated value. In addition, the basal to TDI ratio may be adjusted based on the actual ratio determined from data collected for a user over one or more days. As a result, better BG concentration level control may be achieved.

Description

Technical Field

[0001] Related Applications This disclosure claims the benefit of U.S. Provisional Patent Application No. 63 / 155,555, filed on Mar. 2, 2021, the entire contents of which are hereby incorporated by reference in their entirety.

Background Art

[0002] Conventional automated insulin delivery (AID) systems function under the assumption that basal insulin constitutes 50% of a user's total daily insulin (TDI) requirement. This works well for many users, but equally, does not work for many other users. For example, some users may rely heavily on insulin boluses relative to their daily insulin requirement, such that the amount of basal insulin the user receives from the AID system should be less than 50% of the TDI. Other users may be on a low-carbohydrate diet and thus may not use many insulin boluses. For such users, the basal insulin should be set at a level greater than 50% of the TDI.

[0003] In addition, conventional systems determine a user's TDI according to a standard formula such as setting the TDI as the unit of insulin per day (divided by the user's weight by 4). This standard formula does not provide an accurate estimate of the TDI for many users. For such users, the actual TDI of the user is substantially different from the TDI calculated according to the standard formula.

Summary of the Invention

[0004] According to an aspect of the invention, an insulin delivery device includes a pump for injecting insulin into a user, and a processor for controlling the delivery of basal insulin to the user via the pump. The processor is configured to perform the following, namely, defining the first current basal amount of insulin delivered to the user every time period of up to one day as a part of the user's estimated total daily insulin amount (TDI), determining the average actual TDI of the user over a period of multiple days, where the average actual TDI for each day in the period of multiple days is the sum of the basal insulin and bolus insulin delivered on that day, and updating the current basal amount of insulin delivered to the user over the time period from the first current basal amount to a new basal amount based on the average actual TDI of the user over a period of multiple days.

[0005] The time period may be one day, and the first current basal amount of insulin delivered to the user over the time period may be defined as half of the user's estimated TDI. The update of the current basal amount of insulin delivered to the user every time period may include updating the current basal amount of insulin delivered to the user every time period so as to reduce the difference between the first current basal amount of insulin delivered to the user every time period and a fraction of the average actual TDI of the user over a period of multiple days. How much the difference between the first current basal amount of insulin delivered to the user every time period and a fraction of the average actual TDI of the user over a period of multiple days is reduced may depend on the number of days or the weighting factor in the period of multiple days.

[0006] The processor may further be configured to extend the period of multiple days by additional days, determine the average actual TDI of the user over the extended period of multiple days, and update the current basal amount of insulin delivered to the user every time period to an updated amount as a fractional value of the average actual TDI of the user over the extended period of multiple days.

[0007] The time period may be 1 hour, and the update of the current basal amount delivered to the user to a new basal amount over the time period is, b updated =S·TDI new / 24 TDI new =(1 - X·N days )TDI old +X·N days I total The new basal amount b is calculated so as to be updated and may include calculating N days which is the number of days in a period of multiple days, TDI old which is the estimated TDI of the user, S is a ratio, TDI new which is the average actual TDI of the user over an extended period of multiple days. S can be a constant. S can be a variable having a value based on the ratio of the history of the basal amount delivered per day to the user's TDI. X is a parameter that determines that the weighting of the new insulin delivery history is applied to the previous TDI setting and can range from 0 (no adaptability) to 1 (fully trusting the latest insulin history). This can typically be set to 0.2 for a suitable adaptation to 80% of the new insulin history over a week.

[0008] The current basal amount may be an amount per hour, and the update of the current basal amount delivered to the user to a new basal amount is, b new =S·TDI new / 24 TDI new =(1 - X·N days )TDI old +X·N days I total The new basal amount b is calculated so as to be new and may include calculating N days which is the number of days in a period of multiple days, TDI old which is the estimated TDI of the user, S is a ratio, TDI newis the average actual TDI of the user over an extended multi - day period. S is, S new =(1 - X·N days )S old +X·N days I basal / I total where S is determined as new and may have a value of S, new where S is the newly calculated value of S, old where S is the latest value of S, and I basal is the amount of basal insulin delivered over a multi - day period, and I total is the total amount of insulin delivered to the user over a multi - day period.

[0009] According to another aspect of the invention, the method includes determining, by a processor of an electronic device, an initial current basal amount of insulin delivered to the user every time period of up to one day as a portion of an estimated total daily insulin amount (TDI) of the user. The average actual TDI of the user over a multi - day period is determined by the processor of the electronic device. The average actual TDI for each day in the multi - day period is the sum of the basal insulin and bolus insulin delivered on that day. The current basal amount of insulin delivered to the user over the time period is updated by the processor from the initial current basal amount to a new basal amount based on the average actual TDI of the user over the multi - day period.

[0010] The electronic device can be an insulin delivery device. The time period can be one day, and the first current basal amount delivered to the user over the time period can be defined as half of the user's estimated TDI. Updating the current basal amount of insulin delivered to the user for each time period can include updating the current basal amount of insulin delivered to the user for each time period to reduce the difference between the first current basal amount of insulin delivered to the user for each time period and the fraction of the user's average actual TDI over a period of multiple days. How much the difference between the first current basal amount of insulin delivered to the user for each time period and the fraction of the user's average actual TDI over a period of multiple days is reduced can depend on the number of days and / or weighting factors in the period of multiple days.

[0011] The method can further include extending the period of multiple days by additional days, determining the user's average actual TDI over the extended period of multiple days, and updating the current basal amount of insulin delivered to the user for each time period to the updated amount as the fractional value of the user's average actual TDI over the extended period of multiple days.

[0012] The time period can be one hour, and updating the current basal amount to a new basal amount of insulin delivered to the user over the time period b updated =S·TDI new / 24 TDI new =(1 - X·N days )TDI old +X·N days I total may include calculating a new basal amount b updated such that, where N days is the number of days in the period of multiple days, TDI old is the user's estimated TDI, S is a ratio, and TDI new is the user's average actual TDI over the extended period of multiple days.

[0013] According to an additional aspect of the invention, an insulin delivery device includes a pump that injects insulin into a user, and a processor that controls the delivery of basal insulin to the user via the pump. The processor is configured to determine the current basal amount of insulin delivered to the user every hour, and to determine the average actual TDI of the user over a period of multiple days, where the average actual TDI for each day in the period of multiple days is the sum of the basal insulin and bolus insulin delivered on that day, and the new value of the desired ratio of basal insulin per hour to the one-hour portion of the total daily insulin amount, designated as S new is determined as follows S new =(1 - X·N days )S old + X·N days ·(I basal / I total + 0.5) / 2 where N days is the number of days in the period of multiple days, S old is the latest value of the desired ratio of basal insulin per hour to the one-hour portion of the total daily insulin amount, I basal is the amount of basal insulin delivered over the period of multiple days, and I total is the total amount of insulin delivered to the user over the period of multiple days. The current basal amount of insulin delivered to the user over a time period is updated from the initial current basal amount as b updated = S new ·TDI new / 24 where TDI new =(1 - X·N days )TDI old + X·N days I total and the new basal amount b new is updated to, where TDI new is the average actual TDI of the user over the period of multiple days, and TDI oldconfigured to perform, that is, the latest estimated or actual TDI value of the user.

Brief Description of the Drawings

[0014]

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Modes for Carrying Out the Invention

[0015] Preferred embodiments can provide a user with a more customized basal insulin amount to more adequately regulate blood glucose (BG) concentration levels. Preferred embodiments do not statically assume that a user's daily basal amount is 50% of their total daily insulin (TDI). Instead, actual TDI data may be collected for each user and used to adjust the user's TDI value to an updated value. Additionally, the ratio of basal to TDI can be adjusted based on the actual ratio determined from data collected over one day or multiple days for the user. As a result, more adequate BG concentration level control can be achieved.

[0016] The degree of adaptability of the basal insulin amount for time periods such as daily or hourly can be based on how much historical data is available. The availability of a wider range of historical data can lead to better adaptability of the TDI, better adaptability of the ratio of basal insulin amount to TDI, and ultimately better adaptability of the basal amount. In some preferred embodiments, the degree of adaptability can also be limited to a maximum amount relative to the ideal 50% amount of the TDI. This helps ensure that the adaptation does not result in an inappropriate ratio for the user.

[0017] FIG. 1 depicts an exemplary drug delivery system (100) suitable for delivering insulin to a user (108) in a preferred embodiment. The drug delivery system (100) includes a drug delivery device (102). The drug delivery device can deliver a variety of different drugs including insulin, glucagon, GLP-1, pain management drugs, therapeutic drugs, chemotherapeutic drugs, hormonal drugs, combinations thereof, and the like. However, the methods described below focus on the delivery of insulin, but can be equally applied to other drugs or combinations of insulin with other drugs such as GLP-1. The drug delivery device (102) can be a wearable device worn on the body of the user (108). The drug delivery device (102) can be directly connected to the user (e.g., directly attached to a body part and / or skin of the user (108) via an adhesive or the like). In one example, the surface of the drug delivery device (102) can include an adhesive to facilitate attachment to the user (108).

[0018] The drug delivery device (102) may include a controller (110). The controller (110) may be implemented in hardware, software, or any combination thereof. The controller (110) may be, for example, a microprocessor, a logic circuit, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), or a microprocessor connected to a memory. The controller (110) may maintain a date and time as well as other functions (e.g., calculations or the like). The controller (110) may be operable to execute a control application (116) stored in the storage (114), and the control application (116) enables the controller (110) to command the operation of the drug delivery device (102). The storage (114) may hold user history (113) such as an automatic insulin delivery history, a bolus insulin delivery history, a meal event history, an exercise event history, and the like. In addition, the controller (110) may be operable to receive data or information. The storage (114) may include both primary memory and secondary memory. The storage may include random access memory (RAM), read only memory (ROM), optical storage, magnetic storage, removable storage media, solid state storage, or the like.

[0019] As a guarantee, the drug delivery device (102) may include a storage unit (112) for storing one or more drugs such as insulin to be delivered to the user (108). A fluid path to the user (108) may be provided, and the drug delivery device (102) may release the drug from the storage unit (112) and deliver the drug to the user (108) via the fluid path. The fluid path may include, for example, a tube (e.g., a tube connecting a cannula to the storage unit (112)) that connects the drug delivery device (102) to the user (108).

[0020] For example, there may be one or more communication links with one or more devices physically separated from the drug delivery device (102), including, for example, the user's management device (104) and / or the user's caregiver and / or a sensor (106) that detects an analyte such as BG level concentration. The communication link may include any known communication protocol or standard, for example, any wired or wireless communication link operating according to Bluetooth®, Wi-Fi, a short-range communication standard, a cellular standard, or any other wireless protocol. The drug delivery device (102) may also include a user interface (117), such as an embedded display device, that displays information to the user (108) and, in some embodiments, receives information from the user (108). The user interface (117) may include a touch screen and / or one or more input devices, such as buttons, knobs, or a keyboard.

[0021] The drug delivery device (102) may interface with a network (122). The network (122) may include a local area network (LAN), a wide area network (WAN), or a combination thereof. A computing device (126) may be interfaced with the network and the computing device may communicate with the drug delivery device (102).

[0022] The sensor (106) may be connected to the user (108), for example, by an adhesive or the like, and may provide information or data regarding one or more medical conditions and / or physical characteristics of the user (108). In some preferred embodiments, the sensor (106) may provide periodic BG concentration measurements and may be a continuous glucose monitor (CGM), or another type of device or sensor that provides BG measurements. The sensor (106) may be physically separated from the drug delivery device (102) or may be an incorporated component of the drug delivery device (102). The sensor (106) may provide data indicating the measured or detected BG level of the user (108) to the controller (110). The information or data provided by the sensor (106) may be used to adjust the drug delivery operation of the drug delivery device (102).

[0023] The drug delivery system (100) may also include a management device (104). In some embodiments, the management device (104) is not necessary. Rather, the drug delivery device (102) includes the functions provided by the management device (104). As a result, the drug delivery device (102) can program or adjust the operation of the drug delivery device (102) and / or the sensor (104) without input from a remote management device (104). The management device (104) can be a dedicated device such as a dedicated personal diabetes management (PDM) device. The management device (104) can be a programmed general-purpose device, such as a dedicated controller, a microcontroller, or any portable electronic device including the like, such as a processor. The management device (104) can be used to program or adjust the operation of the drug delivery device (102) and / or the sensor (104). The management device (104) can be any portable electronic device, such as a dedicated device, a smartphone, a smartwatch, or a tablet. In the described example, the management device (104) may include a processor (119) and a storage (118). The processor (119) can execute a process for managing the user's BG level and a process for controlling the delivery of a drug or therapeutic agent to the user (108). The processor (119) can also be operable to execute programming code stored in the storage (118). For example, the storage can be operable to store one or more control applications (120) executed by the processor (119). The storage (118) can store control applications (120), a history (121) such as those described above for the drug delivery device (102), and other data and / or programs.

[0024] The management device (104) may include a user interface (123) for communicating with the user (108). The user interface may include a display such as a touch screen for displaying information. If the user interface is a touch screen, the touch screen may also be used to receive inputs. The user interface (UI) (123) may also include input elements such as a keyboard, buttons, knobs, or the like.

[0025] The management device (104) may interface connect to a network (124) such as a LAN or WAN or a combination of such networks. The management device (104) may communicate on the network (124) with one or more servers or cloud services (128). The roles that one or more servers or cloud services (128) may play in a preferred embodiment are described in more detail below.

[0026] FIG. 2 depicts a block diagram of a device (200) suitable for performing the method described in more detail below. In various preferred embodiments, the device (200) can be a drug delivery device (102), a management device (104), a computing device (126), or one or more servers (128). When the device is a computing device (126) or one or more services (128), the device (200) can function in cooperation with the management device (104) and the drug delivery device (102) to perform the method. The device (200) includes a processor (202) that executes programming instructions. The processor (202) has access to a storage (204). The storage (204) can store an application (206) that performs the method. This application (206) can be executed by the processor (202). The storage (204) can store the user's insulin delivery history (208). The insulin delivery history (208) can include data regarding the amount of insulin delivered and the date and time of delivery. The insulin delivery history (208) can also identify whether each delivery is a basal delivery or a bolus delivery. The storage (204) can store a BG history (210). The BG history (210) can include BG concentration readings and the date and time of the readings. These values can be obtained by a sensor (106). The storage (204) can further store information regarding events (212) such as meal events and exercise events. The storage can hold information regarding a fuzzy set (213), including the membership function of the fuzzy set (213).

[0027] The device (200) may include a network adapter (214) that interfaces with a network such as networks (122 and 124). The device (200) may have a display device (216) for displaying video information. The display device (216) may be, for example, a liquid crystal display (LCD) device, a light emitting diode (LED) device, or the like. The device (200) may include one or more input devices (218) that enable the reception of inputs. Examples of input devices include keyboards, mice, thumb pads, touch screens, microphones, and the like.

[0028] In a preferred embodiment, the controller (110) of the drug delivery device (102) or the processor (119) of the management device (104) that executes the control application (120) may have the role of setting the basal amount of insulin for each time period (e.g., daily, hourly, every 5 minutes). As described above, the preferred embodiment may adapt the basal insulin amount based on the historical TDI data. Additionally, the preferred embodiment may adapt the basal insulin amount based on the historical data of the ratio of basal insulin to the user's TDI.

[0029] Figure 3 depicts a flowchart (300) of exemplary steps that may be performed by a preferred embodiment to adjust the user's basal amount. The basal amount may be for a period of one hour, one day, or even 15 minutes. For illustrative purposes herein, the description relates to an example where the basal amount is for one hour and represents the amount of basal insulin delivered to the user over one hour by the drug delivery device (102) under the control of the AID system. The user's actual TDI data is collected over a period of several days. TDI is the sum of the basal insulin and bolus insulin delivered to the user over one day (i.e., a 24-hour period). Based on the collected data, a new TDI value designated as TDI new is determined.

[0030] Figure 4 shows TDI newDepicts a flowchart (400) of exemplary steps that may be performed to calculate. As described above, actual TDI data is collected (402) over a period of several days for a user. The purpose of collecting this data is to adjust the TDI value to more accurately reflect the user's actual TDI and use the actual TDI when determining the basal amount. The period of several days can be, for example, in the range from 1 day to 3 days, preferably the most recent days. The average TDI is determined from the actual TDI data collected (404). The average can be calculated by summing the TDI values over a period of several days and then dividing the sum by the number of days in the period of several days. Alternatively, in some preferred embodiments, the median of the TDI can be used. The average TDI can be designated as TDI new (406).

[0031] As shown in Figure 3, the ratio of the basal amount for one day to the TDI is determined (304). Conventionally, this ratio has been fixed at 1 / 2, and as a result, the basal amount of insulin delivered to the user in one day is 50% of the TDI. Preferred embodiments correspond to the selection of a fixed value such as 50% or a variable value that can change over time. In some preferred embodiments, the user's actual historical data is used to select the ratio recognized using the historical data. The purpose is to more accurately select the ratio for the user based on the historical ratio.

[0032] Figure 5 depicts a flowchart (500) of exemplary steps that may be taken to select a ratio in a preferred embodiment. A determination is made as to whether the ratio is variable (502). This determination may be based on an assessment of whether a non-variable ratio functions adequately for the user. If a variable ratio is desired, data is collected over a period of multiple days, such as 1 to 3 days. The total basal insulin and total insulin delivered over the period of multiple days are determined, and the ratio of total basal insulin to total insulin over the period of multiple days is determined (504). This ratio constitutes the user's actual ratio over the period of multiple days. Generally, the goal is not to switch the ratio immediately from the old ratio to the actual ratio. Instead, it is more desirable to adapt the ratio more slowly. The reliability of the actual ratio increases with more days of data. Thus, the actual ratio is weighted by the product of the number of days and an adaptation coefficient (506). Thus, a ratio based on 3 days of data is weighted more heavily than a ratio based on 1 day of data. S old The old ratio designated as S is weighted by 1 - (adaptation coefficient * number of days in the period of multiple days) (508). The new ratio S new is defined as the sum of the weighted old ratio S old and the weighted actual ratio.

[0033] S new This formulation of S S new = (1 - X·N days )S old + X·N days I basal / I total can be expressed as. Here, N days is the number of days in the period of multiple days, I basal is the total basal insulin delivered over the period of multiple days, and I totalis the total basal insulin delivered over a period of multiple days. X is an adaptability coefficient that controls how much weight is given to the most recent insulin delivery history relative to the previous settings, and can range from 0 (no adaptability) to 1 (fully trusting the most recent history). The nominal value of this parameter is 0.2.

[0034] As shown in Figure 3, once the ratio of the basal to the TDI is determined, the basal amount can be adjusted to a new value (306) based on the number of days of data, the ratio of the basal to the TDI, and the previous TDI value TDI old The new basal amount is then used when the insulin delivery device delivers basal insulin to the user.

[0035] (b new as designated) for a formulation with a new basal amount is b new =S·TDI new / 24 TDI new =(1 - X·N days )TDI old +X·N days I total is.

[0036] Figure 6 depicts a flowchart (600) of exemplary steps that can be taken to calculate b new . The first product of the number of days in the period of multiple days and TDI (i.e., N new TDI days ) is calculated (602). The first product can be weighted (604) to produce a weighted first product. The weight can be the product of the number of days N new TDI days and the adaptability coefficient X. Thus, TDI new has a greater impact on b new as the number of days of dependent data increases. The adaptability coefficient helps ensure that there is a more gradual impact of TDI new on b new . TDI oldThe weight is based on the product of 1 - adaptation coefficient (0.2) and N days Thus, the product of X·N days is calculated (606), and the product is subtracted from 1 to generate a difference (608). Then, the difference is multiplied to the TDI old to generate a third product (610). The weighted TDI new value is added to the third product (612). The resulting sum is divided by 24 to make it a value per hour rather than a daily value (614). And the value per hour is multiplied by the ratio S new (616).

[0037] This formulation is intended to be illustrative and not limiting. Other formulations such as those using various ratio values and various adaptation coefficients may be used. The alternative formulations may use the historical data to adapt the user's base amount depending on the user's actual historical data.

[0038] It may be desirable to limit the degree of adaptability for the ratio S of the base to the TDI. It may not be desirable for the ratio to be carried out far from 50% of the more ideal ratio. The user may be more adequately adapted by maintaining the ratio S within the allowable range of S. For example, in some cases, the user may be overly dependent on the bolus, and it may be healthier for the user not to be overly dependent on the bolus. More generally, the pattern of the user of insulin delivery may not be very ideal, and the limitation on adaptability helps to regulate the pattern.

[0039] Figure 7 shows a flowchart (700) of exemplary steps that can be taken to limit the degree of adaptability for S. The flowchart is based on the following formulation, namely S new =(1 - X·N days )S old +X·N days ·(I basal / I total +0.5) / 2 S with such a limitation according to new Describe the steps that can be taken to calculate

[0040] Old ratio S old is weighted by the difference between 1 and the product of the number of days (N days ) in a period of several days and the adaptability coefficient (X). This weighting is the same as the formulation of S new described previously (702). The difference in the formulation is how the collected data of I basal and I total is used. Instead of simply weighting the ratio by using the ratio of I basal / I total , the new formulation adds the ratio I basal / I total to 0.5 and then divides by 2 (704). This practical effect is to average I basal / I total and 0.5. The resulting value is weighted by the product of the adaptability coefficient (X) and N days (706). The resulting weighted value is summed with the weighted value of S new to obtain the value of S old (708).

[0041] The practical effect of the change in the formulation is to limit the weighted value. When only I basal / I total is used, the possible range of values extends from 0 to 1, while when (I basal / I total + 0.5) / 2 is used, the possible range of values extends from 0.25 to 0.75. Therefore, the contribution of the actual data regarding insulin is further restricted to a range closer to 0.5.

[0042] Basal amount b newcan be continuously updated, for example, on a daily basis. FIG. 8A depicts a flowchart (800) of exemplary steps that can be taken to effectuate the update. New data, insulin data, is obtained (802). This can include the basal insulin and total insulin for a day (e.g., TDI or I total ). The multi-day period is shifted one day forward to include the new day (804). This can be thought of as shifting the sliding window one day forward. FIG. 8B shows the insulin data (basal and total) for day 1, day 2, and day 3. The multi-day period includes day 1, day 2, and day 3 as shown by the sliding window 820. After the data for day 4 is obtained, the sliding window 820 for the multi-day period can be shifted one day forward as shown in FIG. 8C. Ratio S new can be updated based on the new data within the multi-day period (806) using one of the formulations described above (if the ratio is not fixed). Then, the new value of b new can be determined using the updated data for the multi-day period, for example, using the formulations described above (808).

[0043] Preferred embodiments are described herein, but various changes in form and detail to the preferred embodiments do not depart from the scope of the intended invention as defined in the appended claims.

Claims

**Claim 1** An insulin delivery device comprising: a pump for injecting insulin into a user; a processor for controlling delivery of basal insulin to the user via the pump, the processor being configured to: define an initial current basal amount of insulin delivered to the user per time period of up to one day as a fraction of an estimated total daily insulin amount (TDI) of the user; determine an actual TDI of the user for each day over a period of multiple days and determine an average of the actual TDIs of the user over the period of multiple days, wherein the actual TDI for each day in the period of multiple days is the sum of the basal insulin and bolus insulin delivered on that day; update a current basal amount of insulin delivered to the user per time period to reduce a difference between the initial current basal amount of insulin delivered to the user per time period and the fraction of the average of the actual TDIs of the user over the period of multiple days. **Claim 2** The insulin delivery device according to claim 1, wherein the time period is one day and the initial current basal amount of insulin delivered to the user over the time period is defined as half of the estimated TDI of the user. **Claim 3** The insulin delivery device according to claim 1, wherein how much the difference between the initial current basal amount of insulin delivered to the user per time period and the fraction of the average of the actual TDIs of the user over the period of multiple days is reduced depends on the number of days in the period of multiple days. **Claim 4** The insulin delivery device according to claim 1, wherein how much the difference between the initial current basal amount of insulin delivered to the user per time period and the fraction of the average of the actual TDIs of the user over the period of multiple days is reduced depends on a weighting factor. **Claim 5** The processor is further configured to: extend the period of multiple days by additional days; determine an average of the actual TDIs of the user over the extended period of multiple days; updating the current basal amount of insulin delivered to the user for each of the time periods to an updated amount as a fractional value of the average of the user's actual TDI over the extended multi-day period; The insulin delivery device according to claim 1, which is configured to perform the above. The time period is 1 hour, and the update of the current basal amount to the new basal amount delivered to the user over the time period is the new basal amount b updated being b updated = S · TDI new / 24 TDI new = (1 - X·N days ) TDI old + X·N days I total

6. N days is the number of days in the period of the plurality of days, and TDI old is the estimated TDI of the user, S is a ratio, and TDI new is the average of the actual TDI of the user over the extended plurality of days, and X is an adaptability factor that can range from 0 to 1. The insulin delivery device according to claim 5. including calculating as

7. S is a constant. The insulin delivery device according to claim 6.

8. S is a variable having a value based on the ratio of the history of the basal amount delivered per day to the user's TDI. The insulin delivery device according to claim 6. The current basal amount is an amount per hour, and the update of the current basal amount delivered to the user to the new basal amount is the new basal amount b new to b new = S·TDI new / 24 TDI new = (1 - X·N days ) TDI old + X·N days I total

9. N days is the number of days in the period of the plurality of days, and TDI old is the estimated TDI of the user, S is a ratio, and TDI new is the average of the actual TDI of the user over an extended period of a plurality of days. The insulin delivery device according to claim 1. including calculating as

10. S new = (1 - X·N days ) S old + X·N days I basal / I total S determined as new having a value of, S new is the newly calculated value of S, where S old is the latest value of S, where I basal is the amount of basal insulin delivered over the period of said plurality of days, where I total is the total amount of insulin delivered to said user over the period of said plurality of days. The insulin delivery device according to claim 9 S is

11. determining, by a processor of an electronic device, an initial current basal amount of insulin delivered to the user for each time period up to one day as a part of the user's estimated total daily insulin amount (TDI); determining, by the processor of the electronic device, the actual TDI of the user for each day over a multi-day period and determining the average of the actual TDI of the user over the multi-day period, wherein the actual TDI for each day in the multi-day period is the sum of the basal insulin and bolus insulin delivered on that day; updating, by the processor of the electronic device, the current basal amount of insulin delivered for each time period so as to reduce the difference between the initial current basal amount of insulin delivered to the user for each time period and the fraction of the average of the actual TDI of the user over the multi-day period. A method comprising:

12. The electronic device is an insulin delivery device. The method according to claim 11.

13. The time period is one day, and the initial current basal amount delivered to the user over the time period is determined as half of the user's estimated TDI. The method according to claim 11.

14. How much the difference between the initial current basal amount of insulin delivered to the user for each time period and the fraction of the average of the actual TDI of the user over the multi-day period is reduced depends on the number of days in the multi-day period. The method according to claim 11.

15.

16.

17. The method according to claim 11, wherein how much the difference between the first current basal amount of insulin delivered to the user for each time period and the fraction of the average of the actual TDI of the user over the period of multiple days decreases depends on a weighting coefficient.

16. extending the period of multiple days by additional days, determining the average of the actual TDI of the user over the extended period of multiple days, and further comprising updating the current basal amount of insulin delivered to the user for each time period to an updated amount as a fractional value of the average of the actual TDI of the user over the extended period of multiple days, the method according to claim 11.

17. the time period is 1 hour, and the update of the current basal amount to a new basal amount of insulin delivered to the user over the time period is b updated = S · TDI new / 24 TDI new = (1 - X·N days ) TDI old + X·N days I total calculate the new baseline b so as to updated include N days is the number of days in the period of the plurality of days, and TDI old is the estimated TDI of the user, S is a ratio, and TDI new is the average of the actual TDI of the user over the extended period of the plurality of days, the method according to claim 16.

18. An insulin delivery device, a pump for injecting insulin into a user, a processor for controlling the delivery of basal insulin to the user via the pump, the processor defining a current basal amount of insulin delivered to the user every hour, determining the average actual TDI of the user over a period of multiple days, wherein the average actual TDI for each day in the period of multiple days is the sum of the basal insulin and bolus insulin delivered on that day, S new a new value of the desired ratio of basal insulin per hour to the one-hour portion of the total daily insulin amount, as specified as S new = (1 - X·N days )S old + X·N days ·(I basal / I total + 0.5) / 2 by determining as N days is the number of days in the period of the plurality of days, and S old is the latest value of the desired ratio of basal insulin per hour to the amount of insulin for one hour of the total daily insulin amount, and I basal is the amount of basal insulin delivered over the period of the plurality of days, and I total is the total amount of insulin delivered to the user over the period of the plurality of days, respectively, the current basal amount of insulin delivered to the user over a time period from the first current basal amount, b new = S · TDI new / 24 TDI new = (1 - X·N days ) TDI old + X·N days I total as the new base quantity b new is to update it to TDI new is the average actual TDI of the user over the period of said plurality of days, where TDI old is the most recent estimated or actual TDI value of the user, and is configured to perform. An insulin delivery device

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