US20140351712A1

Movatterモバイル変換

Info

Publication number: US20140351712A1
Application number: US14/455,460
Authority: US
Inventors: Michael L. Blomquist
Original assignee: Tandem Diabetes Care Inc
Current assignee: Tandem Diabetes Care Inc
Priority date: 2006-10-17
Filing date: 2014-08-08
Publication date: 2014-11-27
Also published as: US8961465B2; US20220101978A1; US8734428B2; US20120239362A1; US20120296269A1; US20210012876A1; EP2080131A1; CA2702843A1; US20120232484A1; US20120232521A1; US20180233221A1; US20080172026A1; US8585638B2; US8657807B2; US8998878B2; US20120232485A1; US8821433B2; US11217339B2; US8753316B2; US20120232486A1

Abstract

Methods of monitoring use and displaying information from a medical infusion pump are disclosed. A method includes a computing device receiving information relating to operation of the medical infusion pump and displaying the information. The information can be displayed in a plurality of stacked windows, each having a tab that is selectable to make that window the active window in which a user can view and edit information.

Description

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 13/477,641, filed May 22, 2012, which in turn is a continuation of Ser. No. 13/281,168, filed Oct. 25, 2011, now U.S. Pat. No. 8,657,807, issued Feb. 25, 2014, which in turn is a continuation of Ser. No. 11/582,519 filed Oct. 17, 2006, now abandoned, which is hereby fully incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to insulin pumps, and more particularly, to insulin pumps having correction factors.

BACKGROUND

A large portion of the world's population suffers from diabetes. Many of these people need to take injections of insulin to normalize the level of sugar in their bodies to prevent complications. Such complications can include kidney failure, loss of circulation, and blindness. The need to manually take injections with a syringe and the process of determining the dose for various shots can be a great inconvenience and can limit a diabetic's activities and restrict their movements. Furthermore, it can be difficult to maintain a consistent level of blood glucose because there is a practical limit to the number of injections that most patients can receive.

One solution to reduce some of the problems associated with the manual injection of insulin is an ambulatory pump that delivers insulin to the diabetic user. Such insulin pumps can provide a more consistently normal level of blood glucose, which reduces the risk of complications from diabetes. However, current pumps still have practical limits to their programming that make them cumbersome to program and that limits the potential of the pump to provide even greater control over blood glucose levels.

SUMMARY

According to a first aspect, a method of regulating blood glucose levels using an insulin pump is disclosed. The method includes receiving a current blood glucose level, and determining whether the current blood glucose level is above a threshold value. The method also includes calculating a correction bolus value based upon the current blood glucose.

According to a second aspect, an insulin pump is disclosed. The insulin pump includes a pump mechanism and a memory configured to store one or more blood glucose levels. The insulin pump also includes a programmable circuit arranged to control the pump mechanism and operatively connected to the memory. The programmable circuit is programmed to receive a current blood glucose level and determine whether the current blood glucose level is above a threshold value. The programmable circuit is also programmed to calculate a correction bolus value based upon the current blood glucose.

According to a third aspect, an insulin pump is disclosed. The insulin pump includes a pump mechanism and a memory configured to store one or more rules, each rule including a threshold and a percentage. The insulin pump includes a programmable circuit arranged to control the pump mechanism and operatively connected to the memory. The programmable circuit is programmed to prompt a user to input the threshold value and the percentage for at least one rule. The programmable circuit is further programmed to receive a current blood glucose level, and determine whether the current blood glucose level is above a threshold value. The programmable circuit is also programmed to, upon determining that the current blood glucose level is above the threshold value, alter a correction bolus calculation factor. The programmable circuit is programmed to calculate a correction bolus value based upon the correction factor and deliver the correction bolus to the user.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the architecture of a pump that embodies the present invention;

FIG. 2 is a top view of the pump shown inFIG. 1;

FIG. 3 illustrates setting time and date operating parameters in the pump shown inFIGS. 1 and 2;

FIG. 4 illustrates setting alert styles in the pump shown inFIGS. 1 and 2;

FIGS. 5 and 6 illustrate setting operational parameters related to the pump history for the pump shown inFIGS. 1 and 2;

FIGS. 7-9 illustrate basal rate testing executed by the pump shown inFIGS. 1 and 2;

FIGS. 10-12 illustrate setting operational parameters for the basal rate delivery programs executed by the pump shown inFIGS. 1 and 2;

FIG. 13 illustrates setting the operational parameters for the correction bolus delivery programs executed by the pump shown inFIGS. 1 and 2;

FIGS. 14A-14D illustrate insulin absorption models used in the correction bolus delivery programs executed by the pump shown inFIGS. 1 and 2;

FIG. 15 illustrates setting the operational parameters for the correction bolus delivery programs executed by the pump shown inFIGS. 1 and 2;

FIGS. 16-24 illustrate setting the operational parameters for the meal bolus delivery programs executed by the pump shown inFIGS. 1 and 2;

FIG. 25 illustrates the operations of setting and delivering an audio bolus on the pump shown inFIGS. 1 and 2;

FIG. 26 illustrates the pump shown inFIGS. 1 and 2 communicating with a computer;

FIGS. 27A-27F illustrate a user interface on the computer illustrated inFIG. 26.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Various embodiments of the present invention will be described in detail with reference to the drawings, wherein like reference numerals represent like parts and assemblies throughout the several views. Reference to various embodiments does not limit the scope of the invention, which is limited only by the scope of the claims attached hereto. Additionally, any examples set forth in this specification are not intended to be limiting and merely set forth some of the many possible embodiments for the claimed invention.

The logical operations of the various embodiments of the invention described herein are implemented as: (1) a sequence of computer implemented steps, operations, or procedures running on a programmable circuit within a computer, (2) a sequence of computer implemented steps, operations, or procedures running on a programmable circuit within a pump for delivering insulin; and/or (3) interconnected machine modules or program engines within the programmable circuits.

The various embodiments execute or utilize operating parameters, which customize or personalize operation of the computer implemented steps, machine modules, and programs to meet the requirements of individual pump users. The operating parameters can be numerical values, text strings, flags, argument names, or any other aspect of the insulin pump programming that the user can set to control operation of the pump.

Additionally, the pump generates and presents information and fields in user interfaces, which are also referred to as displays. The user interfaces can include fields, alpha/numeric character strings, times, and dates. The fields, also referred to as cells, prompt users to enter and/or select information. Because there is not an alpha/numeric keyboard on the pump, each of the field is associated with a spin box that includes values the user can enter into the field. The user spins or scrolls through values until the desired value is visible within the field. When the user selects the visible value it is entered into the field. The user selects a value with a Next function, Edit function, or Select function as identified herein. When the pump displays a field and the field has focus, it is said to prompt the user to select a value. Additionally, selecting a value in a field causes the pump to index focus to the next field as defined by the programmed operations or to display the next user interface as defined by the programmed operations. In an alternative embodiment, the pump has an alpha/numeric keyboard from which operating parameters can be typed directly into the pump.

The description set forth herein discusses pumping insulin. One skilled in the art will realize that many of the features, structures, and methods disclosed herein can be used with medical infusion pumps for delivering agents other than insulin. The term “user” generally applies to the person who is receiving insulin from the pump. In many contexts, however, the user could also refer to any other person such as a caregiver that is operating the pump.

A. Pump Architecture

FIG. 1 is a functional block diagram illustrating one of many possible embodiments of an insulin pump, generally identified as100. Amicroprocessor102 is in electrical communication with and controls apump motor104, ascreen106, anaudible alarm108, and avibratory alarm110. Other embodiments can use a microcomputer, or any other type of programmable circuit, in place of the microprocessor.

Thepump motor104 drives adrive mechanism112 that pushes aplunger mechanism114. Theplunger mechanism114 ejects insulin from an insulin cartridge (not shown). The insulin cartridge contains a supply of insulin for delivery to a patient. These mechanical components are illustrated and discussed in commonly assigned U.S. patent application Ser. No. 10/086,646, entitled Cartridge and Pump With Axial Loading, the disclosure of which is hereby incorporated by reference.

Thescreen106 can have many different configurations such as an LCD screen. As explained in more detail herein, thescreen106 displays a user interface that presents various items of information useful to a patient or caregiver. Theaudible alarm108 is a beeper, and an alarm provides actual alarms, warnings, and reminders. Similar to other portable electronic devices such as a cellular telephone, thevibratory alarm110 provides an alarm to either supplement the audio alarms or replace the audio alarm when an audible beep would be disruptive or not heard. A user can selectively enable or disable the audible108 and vibratory110 alarms. In one possible embodiment, however, both the audible108 and vibratory110 alarms cannot be disabled at the same time.

Themicroprocessor102 is in electrical communication with both a random access memory (RAM) I16 and a read only memory (ROM) I18, which are onboard thepump100 but external to themicroprocessor102 itself. Themicroprocessor102 can be any programmable circuit configured to execute instructions stored in the memory devices. In one possible embodiment, themicroprocessor102 includes internal memory as well. TheRAM116 is a static RAM stores that data that can change over time such as pump settings and a historical log of events experienced by theinsulin pump100. TheROM118 stores code for the operating system and the application programs. TheROM118 can be any type of programmable ROM such as an EPROM. In one possible embodiment, theRAM116 has 500 kilobytes of memory capacity and theROM118 has 2 megabytes of memory capacity.

An infrared (IR)port120 is in electrical communication with the microprocessor. As explained in more detail below, theIR port120 provides data communication with an external device such as a computer for programming an application program, programming pump settings, and downloading historical data logs. Theinsulin pump100 can include other types of communication ports in place of or in addition to theIR port120. Examples of other possible communication ports include a radio frequency (RF) port or a port that provides a hard-wired data communication link such as an RS-232 port, a USB port, or the like.

A real-time clock122 provides a clock signal to themicroprocessor102. An advantage of having a real-time clock122 is that it provides the program with the actual time in real-time, including day of the week, so that the programs executed by the insulin pump can track and control the actual time of day that insulin delivery and other events occur. Various durations described here are used for alerts, alarms, reminders, and other functions. In one possible embodiment, the timers are formed by the real-time clock122 and software executed by themicroprocessor102.

A battery123 electrically connects to thereal time clock122 and theRAM116. The battery123 provides an alternate electricity source for the real time clock and theRAM116 to preserve data stored in the RAM in the case of a power interruption, such as during removal of a primary battery.

Akeypad124 also provides input to themicroprocessor102. Although other possible types of keypads are possible, one type of keypad has four buttons and is a membrane-type of keypad, which provides resistance to water and other environmental conditions. Thekeypad124 contains soft keys for which the function of the keys can change as a user executes different menu selections and commands.

Anaudio bolus button125 provides a further input to themicroprocessor102. Theaudio bolus button125 enables a bolus, such as a correction bolus or meal bolus as described herein, corresponding to a specific audible sound. In a possible embodiment, various potential audio bolus amounts correspond to unique audible sounds configured to allow a user to program the audio bolus without requiring the user to visually reference thepump screen106.

Other inputs into themicroprocessor102 include apressure sensor126, which is sensitive to the pressure within a reservoir of insulin; acartridge sensor128, which is sensitive to the presence of an insulin cartridge; and amotion detector130, which detects motion of a gear (not shown) in thedrive mechanism112. Thepressure sensor126,cartridge sensor128, andmotion detector130 are described in more detail in U.S. patent application Ser. No. 10/086,646, which is entitled Cartridge and Pump With Axial Loading, the disclosure of which was incorporated by reference above.

Referring toFIG. 2, thepump100 is packaged in ahousing132. Thekeypad124 is positioned on a first portion of thehousing132, and thescreen106 is positioned on a second portion of thehousing132. Additionally, thescreen106 has two portions, adisplay portion134 and a template portion136. A user interface is presented in thedisplay portion134 of thescreen106.

The template portion136 provides a template that indicates the function assigned to each of the keys on the keypad. In the embodiment illustrated in the drawings, thekeypad124 has afirst function key138 and asecond function key140, and an upkey142 and adown key144. The up and down

keys

142 and144 are for scrolling or spinning through operating parameters that are presented in a spin box associated with a field or between pages present within a user interface such as the home pages as described below. Additionally, afirst portion146 in the template identifies the function assigned to thefirst function key138, and asecond portion148 identifies the function assigned to thesecond function key140. If a variable or menu selection can be scrolled up or down, acorresponding center portion150 of the template presents one or both of an up arrow corresponding to the scroll direction of the upkey142, and a down arrow corresponding to the scroll direction of thedown key144.

B. Home Page

In one possible embodiment, theinsulin pump100 is controlled by a menu-driven application program that is stored in theROM118 and executed by theprocessor102. The application program also is parameter-driven in that the outcome or steps executed by the various application programs depend on the operating parameters set by the user. Examples of outcomes and steps that depend on the operating parameters include delivery rates, delivery schedules, delivery amounts, the generation and presentation of menus, and the like.

Referring still toFIG. 2, the application program presents ahome page152 in thedisplay portion134 of thescreen106. Thehome page152 includes a first icon154 that illustrates the amount of insulin remaining in the insulin cartridge. This first icon154 has the shape of a syringe and abar156 arranged relative to the syringe shape to illustrate the amount of remaining insulin. The amount of remaining insulin also is quantified and listed below the first icon154. Asecond icon158 has the shape of a battery and has abar160 arranged relative to the battery-shape to illustrate the amount of remaining battery life. The percentage of remaining life on the battery is positioned below thesecond icon158.

In one possible embodiment, thehome page152 presents thecurrent status162 of the insulin pump's100 operation. In the example set forth in the illustration, theinsulin pump100 is delivering insulin at a rate of 1.15 units per hour according to a first basal schedule. Thehome page152 also presents thename166 of the active delivery program it is executing andpersonal information168 as programmed by the user. In the illustrated example, the personal information it displays is a banner “Mary's Pump,” which identifies the owner of theinsulin pump100. Other examples of information that might be included in the personal field includes medical information about the pump user similar to that information included on a medical alert bracelet such as allergies and the fact that the patient is diabetic, more detailed information about the patient including the patient's full name, telephone number, and address, detailed information about the user's caregiver such as the name and telephone number of the user's physician, and a warning that thepump100 is an insulin pump and should not be removed from the user.

Furthermore, thepump100 can be configured to present more than one home page. In this embodiment, the user scrolls through the home pages using the up and down

keys

142 and144. For example, other home pages might include the date, time, and amount of the last bolus delivered by the insulin pump; contact information about the patient's caregiver; medical information about the patient such as a list of the user's allergies, a warning that the user is a diabetic, and a warning that the pump is an insulin pump and should not be removed.

Thepump100 displays an icon170 in thehome page152 to identify the displayed page as the home page. Additionally, the icon170 can include a page number to indicate which home page is currently being displayed. One possible shape for the home page icon is an icon having the shape of a house.

C. Main Menu

Referring toFIG. 3, the user accesses amain menu190 by activating amenu function192 assigned to thesecond function key140. Theinsulin pump100 then displays themain menu190, which includes a plurality of menu items that the user can select for setting operation parameters and performing various tasks as described herein. In one possible embodiment, the menu items in the main menu are Basal Programs, New Cartridge, History, and Pump Settings. In other possible embodiments, themain menu190 can be customized to include other menu items such as Correction Bolus, Temporary Rate, Meal Bolus, and others. Furthermore, the user can customize at least some of the labels for various menu items in both themain menu190 and submenus.

The New Cartridge menu item is selected to access the cartridge or syringe of insulin loaded in thepump100. In one possible embodiment, selecting the New Cartridge menu item automatically sequences the user through the steps of loading the new cartridge, priming the tubing for the infusion set, priming the cannula, and setting the site reminder, if the display site reminder is enabled. The site reminder is discussed below in more detail. In yet another embodiment the user will affirmatively acknowledge each of these steps by pressing a predetermined key, either the first or

second function keys

138 or140 on thekeypad124, at the conclusion of each step, which causes the pump to index to the next step. After sequencing through each of these steps, thepump100 prompts the user to enter an instruction whether to resume delivery of insulin.

Accessing the cartridge is discussed in more detail in U.S. patent application Ser. No. 10/086,646, entitled Cartridge and Pump With Axial Loading, the disclosure of which was incorporated by reference above.

The user selects the desired menu item by using the up and down

keys

142 and144 until the desired menu item is highlighted or otherwise marked. The user then activates the highlighted menu item by activating aselect function194 assigned to thesecond function key140.

By selecting the Pump Settings menu item, the pump brings up a Pump Settings submenu196 of several submenu items, including Time and Date, Beep/Vibrate, Program Lock, and Personalize. The Time and Date menu option is selected to set the time and date of the clock. This time and date is set in real time. When the Time and Date menu option is selected, the screen displays the time and date, and focus is placed on thehour field198. The user scrolls through values for the hour until the desired value is set. The user then activates anext function200 assigned to thesecond function key140 to index through the remaining fields for the time and date (e.g., theminute field202, the am/pm field204, themonth field206, the day field208, and the year field210) and set the desired values for each of these fields. The user exits the Time and Date function at any time by activating theDone function212 assigned to thefirst function key138. Activating theDone function212 saves the current time and date settings and returns the pump to thePump Settings submenu196.

D. Beep/Vibrate

Referring toFIG. 4, to configure an alarm function to generate either an audible or vibratory signal, the user selects the Beep/Vibrate menu option within thePump Settings submenu196. Thepump100 then indexes to the next user interface and places focus on a choose-alert field214. The user scrolls to the desired beep setting or vibrate setting and selects that setting by activating theNext function200 to select the desired setting. If the Beep setting is selected, focus changes to a beep-volume field216 and the user scrolls to and selects the desired volume level. In one possible embodiment, the volume levels from which the user can select are low, medium, and high. Other embodiments use a numbered volume scale, labels such as indoor and outdoor, and the like. Upon selecting the desired volume level, the alert and volume settings are saved and thePump Setting submenu196 is displayed on thescreen106. If the user selects vibrate in the choose-alert field214, thepump100 will return directly to thePump Setting submenu196.

E. Navigation Sounds

Audible sounds generated by thepump100 provide assistance to the user in navigating through the pump menus. The audible sounds provide a method by which a user need not rely on visually observing the pump screen while programming the pump. Such a feature can be used by visually impaired users, or users who do not wish to otherwise visually confirm the pump settings. In various embodiments of thepump100, the sounds indicate the current screen displayed by the pump, and also signify buttons depressed on the pump or other pump events.

Thepump100 uses thehome screen152 as a basis for navigating through the pump menus by providing a unique audible sound, such as a beep of a unique pitch as compared with other sounds made by the pump. Additional home screens and menu screens programmed into the pump are associated with beeps of varying pitches. For example, thehome screen152 is associated with a first sound, which is emitted when the pump first displays the home screen, as well as each time a user navigates back to the home screen. Themain menu190 is associated with a second sound different from the first sound, and that second sound is emitted each time a user navigates to themain menu190. Additional sounds, different from the first and second sounds and also different from each other, are associated with other home pages and menu screens as described herein. In one embodiment, the pump emits a sound of a specific pitch upon display of one or more optional setup screens. Associating a sound with an optional screen notifies the user that they are outside the typical pump programming screens. For example, thepump100 can emit the sound upon display of a correction bolus screen, a basal rate confirmation screen, or some other unannounced screen displayed by the pump.

Some screens programmed into the pump revert back to a home screen after a predetermined period of time elapses. A user relying on sounds to navigate through the screens will want to know when this occurs. For such screens, thepump100 can emit a second sound which is either the same as or different from the first sound associated with the screen so as to signify that such a reversion will take place. In one embodiment, thepump100 emits three sounds thirty seconds before the reversion takes place. In such an embodiment, the pump can also optimally emit a single sound fifteen seconds before the reversion takes place. Additional sounds of varying pitch, length, or occurrence can be used as well. For example, the same sound can be used for multiple screens, but be repeated a different number of times to indicate the occurrence of one screen or the other.

Sounds are also associated with the up and down

keys

142,144 on thepump100 to assist in setting pump delivery rates, times, and other settings. A first sound, different from the home screen and menu screen sounds described above, is associated with the upkey142. A second sound, different from this first sound and also different from the home screen and menu screen sounds, can be associated with thedown key144. The pump emits the first or second sounds when the up key142 or downkey144 is depressed, respectively. In one embodiment, the sound associated with the up key is of a higher pitch than the sound associated with the down key. In another possible embodiment, the up key142 or downkey144 repeats operation when held in a depressed position by a user. In this embodiment, the sound associated with the selected

key

142,144 repeats for each instance in which operation of the key repeats. In a further embodiment, sounds of increasing pitch are associated with numerical values scrolled through using the up and down keys, such that lower values are associated with sounds of a lower pitch, and higher values are associated with sounds of a higher pitch.

When scrolling through a range of values to select a setting in a pump, at least two implementations are possible with respect to the boundaries of each range. In one implementation, pressing theup key142 at the top of the range will cause the pump value to wrap around, to the lowest value in the range. Likewise, pressing thedown key144 at the bottom of the range will cause the pump value to wrap around to the highest value in the range. In a second implementation, pressing theup key142 at the top of the range or thedown key144 at the bottom of the range will have no effect, causing the pump setting to remain at that maximum or minimum value. In an embodiment in which the wrap around implementation is used, a sound is emitted by thepump100 when either one of the up or down

keys

142,144 is depressed and the wrap around condition occurs, which is different from the sound emitted when either of the up or down

keys

142,144 are depressed and the condition does not exist. This sound notifies a user that the wrap around condition has occurred without the need for visual confirmation. In an embodiment in which the “wrap around” implementation is not used, a sound is emitted by thepump100 when a user presses the up or down

key

142,144 which is different from the normal sound emitted when one of the keys is depressed. This second sound notifies a user that depressing that key had no effect, again, without the need for visual confirmation. In various additional embodiments in which either the wrap around implementation is or is not used, the unique sound which occurs at the boundary of the range can be different if at the top of the range or at the bottom of the range. In other embodiments, additional unique sounds can be used to denote a position within the range scrolled through. For example, thepump100 can emit a unique sound each time a value is reached that is a multiple of 10. Unique sounds for each multiple of 10, or other notable positions within the range can be used as well.

Sounds are further associated with one or more alerts and/or alarms occurring in thepump100. These sounds can be customized so that the user hears a familiar sound upon occurrence of a specific event or alarm. For example, a missed meal alarm can be associated with a dinner bell or some other sound. In a possible embodiment, the pump emits sounds, such as numerical values or messages, in Morse code or some other audibly encoded format.

The combination of all of the sounds for the screens, menus, and keys allows a user to program thepump100 without relying on either visual confirmation using the pump screen or otherwise having to accurately count the number of times which a key is depressed. In a possible embodiment, one or more of these sound features can be disabled. For example, some or all sounds can be disabled if a user selects the vibrate option in the choose-alert field214 described above.

F. Pump History

Referring toFIG. 5, one possible embodiment of the insulin pump100 tracks historical information related to thepump100 such as delivery information and other events related to thepump100. Historical information can be viewed on thescreen106 of thepump100 or uploaded to a computer as discussed in more detail herein. Thepump100 can be customized to view historical delivery and event information in individual history screens or under the History item of themain menu190. Additionally, thepump100 can display delivery information either as individual events or as averages. These alternatives are only some of the possible embodiments.

Thepump100 can be programmed to track many different types of historical information, to present the historical information in many different ways, and to provide different ways to access historical information. In one possible embodiment, the historical information that thepump100 tracks includes:

- (1) The aggregate insulin delivered by thepump100 as well as the amount of insulin broken down by insulin delivered as a meal bolus, insulin delivered to counteract estimated carbohydrates consumed by the user (if the carbohydrate estimator is used), delivered as a correction bolus, and delivered according to basal delivery protocols. In various embodiments, thepump100 will record delivery according to basal delivery protocols as a total for all basal delivery protocols, or if thepump100 is programmed with multiple delivery basal protocols, the delivered insulin can be broken down by each basal protocol used by thepump100. In one possible embodiment, this data is stored as a daily total and an average daily total for a predetermined number of days. Additionally, in various embodiments, the average data can be recorded as actual average values or the average data can be calculated from the daily totals when requested for display or upon other requests.
- (2) The amount of insulin delivered by thepump100 according to a basal protocol as a percent of the total insulin delivered by thepump100. In one possible embodiment, this data is stored as a daily percentage and an average daily percentage for a predetermined number of days. Additionally, in various embodiments, the average data can be recorded as actual average values or the average data can be calculated from the daily totals when requested for display or upon other requests.
- (3) The date, time, and amount of each bolus delivered.
- (4) The 500-Rule factor, which is used to estimate the grams of carbohydrates that are covered by each unit of insulin. To determine the grams of carbohydrates that are covered by each unit of insulin, the 500-Rule factor is divided by the total daily dose of insulin required to maintain the user blood sugar level in an acceptable range. The typical 500-Rule factor is 500, and hence the ratio is called the 500 Rule. However, the factor may vary for different types of insulin and from user to user and the value for the 500-Rule factor is calculated and stored. In one possible embodiment, the 500-Rule factor is stored as a daily value depending on the total delivery dose and an average value for a predetermined number of days. In an alternative embodiment, the 500-Rule factor is not stored but is calculated as the 500-Rule factor is required for a display, calculation, or other function.
- (5) The 1800-Rule factor, which is used to estimate the drop in blood glucose for every unit of insulin. To determine the drop in blood glucose for each unit if insulin delivered to the user, the 1800-Rule factor is divided by the total daily dose of insulin required to maintain the user blood sugar level in an acceptable range. The typical 1800-Rule factor is 1800, and hence the ratio is called the 1800 Rule. However, the factor may vary for different types of insulin and from user to user and the value for the 1800-Rule factor is calculated and stored. In one possible embodiment, the 1800-Rule factor is stored as a daily value depending on the total delivery dose and an average value for a predetermined number of days. In an alternative embodiment, the 1800-Rule factor is not stored but is calculated as the 1800-Rule factor is required for a display, calculation, or other function.
- (6) The complete history, which in one possible embodiment is the last 2000 events that are experienced by the pump, including all daily delivery totals, all alerts, all errors, all battery changes, all insulin cartridge changes, all changes to the pump program, and the like. Each record of an event includes the date and time that the event occurred. In other embodiments, a predetermined number of events other than 2000 are recorded. In yet another possible embodiment, thepump100 records the events for a predetermined number of days rather than an absolute quantity, although there might be a limit to the total number of events that are recorded depending on available memory and other factors.

In one possible embodiment, as used herein total daily dose, also referred to as Total Daily Dose or TDD, refers to the total amount of insulin delivered during a single day including the amount of insulin delivered as a correction bolus. Other embodiments might include the amount of insulin delivered as a correction bolus in the total daily dose of insulin.

To customize how the historical information is displayed on thepump100, the user selects the History menu item from thePersonalize submenu222. Thepump100 indexes to a delivery-summary field264, which is placed in focus. The user scrolls to and selects the desired yes or no value. The yes value enables the Delivery Summary menu item in the History submenu290 (FIG. 6), and the no value disables the Delivery Summary menu item in the History submenu290. Disabled menu items are not displayed as part of the menu. In one possible embodiment, the delivery summary displayed under this menu item includes the total daily dose of insulin delivered by thepump100 as well as the amount of insulin broken down by insulin delivered as a meal bolus, insulin delivered to counteract estimated carbohydrates consumed by the user (if the carbohydrate estimator is used), delivered as a correction bolus, and delivered according to basal delivery protocols. In an alternative embodiment, the delivery summary includes the total or aggregate amount of insulin, including insulin delivered as a correction bolus.

Upon selecting the yes or no value in the delivery-summary field264, focus indexes to an average-delivery-summary field266, in which the user scrolls to and selects either a yes value or a no value. The yes value enables the Average Delivery Summary menu item in the History submenu290, and the no value disables the Average Delivery Summary menu item in the History submenu290. In one possible embodiment, the Average Delivery Summary displayed under this menu item includes the average daily total for a predetermined number of days for the aggregate insulin delivered by the pump as well as the amount of insulin broken down by insulin delivered as a meal bolus, insulin delivered to counteract estimated carbohydrates consumed by the user (if the carbohydrate estimator is used), delivered as a correction bolus, and delivered according to basal delivery protocols.

Upon selecting the yes or no value in the average-delivery-summary field266, focus indexes to a basal-as-percent-of-TDD field268. In one possible embodiment, basal as a percent of TDD is the amount of insulin delivered by thepump100 according to a basal protocol as a daily percent of the total insulin delivered by thepump100. The user selects whether to display the Basal as a Percent of TDD menu item in the History submenu290 using a procedure similar to that described for the Delivery Summary. Under this menu item, thepump100 lists the total daily amount of insulin delivered as a basal as a percent of the total daily dose of insulin delivered. In an alternative embodiment, thepump100 lists the total daily amount of insulin delivered as a bolus as a percent of the total daily dose of insulin delivered. In various embodiments, the bolus as a percent can be listed as the meal bolus as a percent of the total daily dose of insulin delivered, correction bolus as a percent of the total daily dose of insulin delivered, or total bolus as a percent of the total daily dose of insulin delivered. Thepump100 then indexes focus to an average-basal-as-percent-of-TDD field270. In one possible embodiment, average basal as a percent of total daily delivery (TDD) is the amount of insulin delivered by thepump100 according to a basal protocol as an average daily percent over a predetermined number of days of the total insulin delivered by thepump100. The user selects whether to display the Avg Basal as a Percent of TDD menu item in the History submenu290 using a procedure similar to that described for the Delivery Summary. Thepump100 lists the average basal as a percent of the total daily delivery under this menu item.

Thepump100 then indexes focus to a bolus-history field272. In one possible embodiment, the Bolus History is the date, time, and amount of each bolus delivered. The user selects whether to display a Bolus History menu item in the History submenu290 using a procedure similar to that described for the Delivery Summary. Thepump100 lists the pump's100 Bolus History under the Bolus History menu item.

Thepump100 then indexes focus to an edit-display-of-more-history field274. The user scrolls to a yes value or a no value as desired and then activates the next function. If the user selects the no value, the pump returns to thePersonalize submenu222. If the user selects the yes value, the focus indexes to a carbohydrate-ratio field276 in which the user scrolls to a yes value or a no value as desired and activates the Next function. Selecting the yes value causes thepump100 to display aCalc 500 Rule menu item in the history submenu290 and to display the calculated carbohydrate ratio. The pump indexes focus to a 500-rule-factor field278 when the user selects yes in the 500-rule-factor field276. The user then scrolls to the desired 500-Rule factor to use in various calculations and activates the Next function. In one possible embodiment, the potential factors are in the range from 400 to 600 in increments of 15. Thepump100 then indexes focus from the 500-rule-factor field to an average-carb-ratio field280. Selecting the no value in the 500-Rule-factor field276 disables display of theCalc 500 Rule menu item in the History submenu290 and causes thepump100 to index directly from the 500-rule-factor field276 to the average-carb-ratio field280.

Within the average-carb-ratio field280, the user scrolls to and selects either a yes value or a no value. If the user selects the yes value, thepump100 will enable anAvg Calc 500 Rule menu item in the History submenu290. Under theAvg Calc 500 Rule menu item, the pump displays the average carbohydrate ratio for a predetermined number of days. In one possible embodiment, thepump100 calculates the average carbohydrate ratio for a 7-day period. Upon selecting the yes or no value, the pump indexes focus to a correction-factor field282.

In other embodiments, the pump calculates the average carbohydrate ratio for periods other than 7 days. For example, the range could be in the range from 2 to 90 days. In another possible embodiment, thepump100 calculates the average carbohydrate ratio for however number of days it stores historical data. In yet another embodiment, the user can select a predetermined number of days over which to calculate and average the carbohydrate ratio.

If the user selects the yes value in the correction-factor field282, the focus indexes to an 1800-rule-factor field284. The user then scrolls to and selects the desired 1800-Rule factor to use in various calculations. In one possible embodiment, the potential 1800-Rule factors are in the range from 1500 to 2200 in increments of 100. The pump then indexes focus to an average-correction-factor field286. Selecting the no value in the correction-factor field282 disables display of the Calc 1800-Rule menu item in the History submenu290 and causes the pump to index directly from the correction-factor field282 to the average-correction-factor field286.

Within the average-correction-factor field286, the user scrolls to and selects a yes value or a no value. If the user selects the yes value, thepump100 will enable the Avg. Calc 1800 Rule menu item in the History submenu290. Under the Avg; Calc 1800 Rule menu item, thepump100 displays the average correction factor for a predetermined number of days. In one possible embodiment, thepump100 calculates the average correction factor for a 7-day period. Upon selecting the yes or no value, in the average-correction-factor field286, the pump indexes focus to a complete-history field288.

In other embodiments, the pump calculates the average correction factor for periods other than 7 days. For example, the range could be in the range from 2 to 90 days. In another possible embodiment, thepump100 calculates the average correction factor for however number of days it stores historical data. In yet another embodiment, the user can select a predetermined number of days over which to calculate and average the correction factor.

Within the complete-history field288, the user scrolls between either a yes value or a no value. The user selects yes to enable a Complete History menu item in the History submenu290 and selects the no value to disable the Complete History menu item. Upon selecting either the yes or no value, the pump returns to the Personalize submenu. Under the Complete History menu item, the pump displays the complete body of historical information stored inRAM116.

Referring now toFIG. 6, viewing historical information about thepump100 is accomplished through themain menu190. The user activates theMenu function174 to access themain menu190. Within theMain Menu190, the user selects and activates the History menu item. The pump then indexes to the History submenu290 that lists the historical information that is available to view on thepump100. As described above, the historical information that is available, depending on the setting made within the History item of thePersonalize submenu222 as described above, are Delivery Summary, Avg Delivery Summary, Basal as a Percent of TDD, Avg Basal as a percent of TDD,Calc 500 Rule,Avg Calc 500 Rule, Calc 1800 Rule, and Avg Calc 1800 rule.

If the user selects Delivery Summary, the pump indexes to aDelivery Summary292 that has adate field294 in which the current date is listed and a Total field in which the total number of insulin units delivered is listed, a Meal Bolus field in which the number of insulin units delivered as a meal bolus is listed, a Carbs field in which the total number of carbohydrates that the user entered as an estimate of carbohydrate consumption is listed, Corr. Bolus field in which the total number of insulin units delivered as a correction bolus are listed, and a Basal field in which the total number of insulin units delivered according to the basal protocols employed by the pump are listed.

The user can scroll through dates in thedate field294 and see this historical information for dates other than the current date. In one possible embodiment, the user can scroll through the seven different dates, including the current date and the six previous dates. When the user scrolls to a different date, the pump automatically updates the historical delivery information relating to delivery that occurred on the date now listed in the date field. In an alternative embodiment, the user can scroll through the previous 90 days of data. In yet another possible embodiment, the user can scroll through however many days of data are stored on thepump100.

If the user selects the Avg Delivery Summary menu item in the History submenu290, thepump100 indexes to a display296 entitled “7 Day Average,”293 and displays the same fields (Total field, Meal Bolus field, Carbs field, Con. Bolus field, Basal field) as theDelivery Summary display292. However, rather than daily totals, the fields present that average number of insulin units delivered over a predetermined number of days. Additionally, in place of thedate field294, the screen for the Avg Delivery Summary presents an avg-overfield298, which contains the number of days for which the historical data is being averaged. The user can change the number of days by scrolling up or down using the up or down keys, respectively. In one possible embodiment, the number of days that can be averaged are in the range from 2-30. In another possible embodiment, the number of days that can be averaged are in the range from 2-90 days. In yet another possible embodiment, the number of days that can be averaged are in the range from 2 days to however many days of historical data are stored on thepump100. After scrolling to a new number of days to average, the user activates anUpdate Function300 and thepump100 recalculates the averages.

If the user changes the number of days over which the average data is calculated, the title “7 Day Average”293 changes to “X Day Average,” where X is the selected number of days over which the data is averaged.

If the user selects the Basal as % of TDD item menu from the History submenu290, thepump100 will display a “Basal as % of TDD” display (not shown) and present the percent of total insulin delivered by the pump according to the basal delivery protocols on any given day. The Basal as % of TDD display will present a date field in which the user can change the day for which the historical information is presented in a manner similar to theDelivery Summary display292 as described above.

If the user selects the Avg Basal as % of TDD item menu from the History submenu290, thepump100 will display an “Avg Basal as % of TDD” display (not shown) and present the average percent of total insulin delivered by thepump100 according to the basal delivery protocols for a predefined number of days. The Basal as % of TDD screen will display an avg-overfield298 in which the user can change the number of days for which the historical information averaged in a manner similar to the 7 Day Summary display296 as described above.

If the user selectsCalc 500 Rule, the pump will index to a “Carb Ratio—500 Rule” display and present a table of information. In each row of the table, the pump will list a date and the calculated carbohydrate ratio for that date. The carbohydrate ratio is calculated by dividing the 500-Rule factor by the total number of insulin units delivered for that day. In one possible embodiment, thepump100 will calculate and list the carbohydrate ratio for 30 days and the user can scroll through those values using the up and down keys. However, other embodiments will calculate and list the carbohydrate ratio for any other number of days.

If the user selectsAvg Calc 500 Rule, thepump100 indexes to an “Avg Carb Ratio—500 Rule” display. Thepump100 calculates and presents the average carbohydrate ratio for a predetermined number of days. The “Avg Carb Ratio—500 Rule” display includes an avg-overfield298 in which the user can change the number of days for which the average carbohydrate ratio is averaged in a manner similar to the “Avg Delivery Summary” display as described above.

If the user selects Calc 1800 Rule, thepump100 will index to a “Correction Factor—1800 Rule” display and present a table of information. In each row of the table, thepump100 will list a date and the calculated correction factor for that date. The correction factor is calculated by dividing the 1800-Rule factor by the total daily dose of insulin required to maintain the user blood sugar level in an acceptable range. In one possible embodiment, thepump100 will calculate and list the correction factor for 30 days and the user can scroll through those values using the up and down

keys

142 and144. However, other embodiments will calculate and list the correction factor for other numbers of days.

If the user selects Avg Calc 1800 Rule, thepump100 indexes to an “Avg Correction Factor—1800 Rule” display. Thepump100 calculates and presents the average correction factor for a predetermined number of days. The Avg Correction Factor—1800 Rule screen includes an avg-overfield298 in which the user can change the number of days for which the average correction factor is averaged in a manner similar to the “Avg Delivery Summary” display as described above.

G. Basal Rate Test

In an exemplary embodiment, theinsulin pump100 performs basal testing to determine a proper basal rate for a user of the pump. The basal rate for a pump is the rate at which the pump delivers insulin to a user, and in the exemplary embodiment correlates to the rate at which, independent of meals, the user requires insulin for normal metabolism, based on the user's particular metabolic need for insulin. The user's metabolic need for insulin is determined by testing under a controlled set of circumstances. Basal rate testing aborts under a number of circumstances, for example due to delivery of a correction bolus or a meal bolus as described herein. Also, unusual insulin levels, such as levels falling very far outside of a safe range, can cause interruption of a basal rate test or invalidation of test results for user safety reasons. A blood glucose level that is too high or too low is unsafe to the tested user and will cause thepump100 to abort the basal rate test. Likewise, an initially high or low blood glucose level or high level of insulin on board can prevent the start of a basal rate test. Prior to and during the basal rate tests, thepump100 notifies a user of proper behaviors for a basal rate test, as well as behaviors which can cause test failure, such as eating or delivering a correction bolus.

As described in more detail herein, the basal rate test is performed by measuring the user's blood glucose level at least at the beginning and end of a defined time period. The data representing the measured blood glucose levels and the time at which they were measured can be presented in different formats such as a table or graph.

If the difference between the beginning and ending blood glucose levels falls outside a predetermined range, the user's body is not using insulin at the same rate at which the pump is delivering it and the user can adjust the basal rate accordingly. Since a user's basal insulin needs can vary from hour to hour, the blood glucose level also can be measured at different points throughout the test and compared to the beginning blood glucose level. A difference between any of these intermediate blood glucose levels and the beginning blood glucose level also can indicate that the basal rate needs adjustment. In possible embodiments, this process can be performed iteratively until the difference between the beginning and ending blood glucose levels are within a desired range.

Since a user's basal insulin needs can change over time (weight gain or loss, change in fitness level, etc), basal rate testing may be performed periodically by users of the pump to ensure that the proper basal rate is programmed into the pump for basal delivery, discussed below. The basal testing, in general, enables four sets of scheduled alarms to define a basal test. Each set of alarms corresponds to a time segment during the day in which a user may want to check their basal delivery. For example, the set of alarms can represent times before or after meals, or at other times during a day, week, or other time period.

Referring now toFIG. 7, an exemplary implementation initiating a basal test process is shown. Thepump100 displays a basal test submenu281, which is reached from themain menu190. The basal test submenu281 displays a basal test option listing, which includes a “Start Test” option, a “Set up Test” option, and a “Test History” option. The Start Test option allows the user to initiate a basal test according to the current settings in the pump, and is only visible when no other basal test has been started. The Set up Test option allows a user to set up basal test options, and is discussed in greater detail in conjunction withFIG. 8, below. The Test History option displays a test history from a currently executing or formerly executed basal test. An example of a basal test chart generated from basal test history data is shown inFIG. 9. Using the up and down

keys

142,144, the user chooses one of the options displayed on the basal test submenu281 and chooses aselect option283. In the embodiment shown inFIG. 7, the Start Test option is selected as described.

Upon selection of the Start Test option, thepump100 displays a startbasal test screen285. The startbasal test screen285 allows the user to confirm that a basal test is intended, and may display one or more messages to the user. The messages can include information about the basal test, about activities to avoid during the basal test, or other related information. The user confirms that a basal test is intended by selecting a continueoption287. If the basal test is not intended, a back option returns to the basal test submenu281.

When the user confirms that a basal test is in fact intended, thepump100 displays a basaltest timing screen289. The basaltest timing screen289 displays options for various predefined basal tests, such as an overnight basal test, a daytime basal test, or an evening basal test. The daytime basal test can be, for example, a morning basal test or an afternoon basal test. In the example shown, the overnight basal test is selected using the up and down

keys

142,144 and the continueoption287.

Upon selection of the desired basal test, the pump displays alisting291 of reminder alerts which will be activated to guide the user through the basal testing process associated with that basal test. The reminder alerts represent times during the basal test process at which the user is prompted to enter their current blood glucose level. The reminder alerts can be, for example, times of the day. The listing291 of reminder alerts can be editable by the user, so as to change the times of the day at which the reminders occur, or to change the number of reminders, as shown below inFIG. 8.

A start option295 initiates the basal test. In the embodiment shown, a user can start a basal test at any time. However, thepump100 only enters the basal testing state upon the occurrence of the first programmed reminder alert. Upon initiation of the test, the pump can optionally present one or more prompts or informational screens to the user to assist the user in running the basal rate test. The pump can advise the user as to optimal methods for performing the basal rate test, such as not eating for two hours prior to the test. In one possible embodiment, the one or more prompts includes a series of questions presented to the user prior to initiation of the test. The questions can be related to the user's health or sickness, activity or exercise level, stress levels, and variations of these factors from their normal levels. Other questions can be asked as well. In response to the answers provided by a user, thepump100 may optionally display guidelines for taking a basal rate test or suggest postponement of the basal rate test. The questions and responsive answers can be included in a report, such as the one discussed below in conjunction withFIG. 9.

When the reminder alert occurs, thepump100 prompts the user to test their blood glucose and input the blood glucose reading into the pump. Optionally, the user can select a snooze option to delay the blood glucose test by 15 minutes. The user can repeat selection of the snooze option indefinitely.

Referring toFIG. 8, theinsulin pump100 provides informational and control features related to a basal test. The screens shown inFIG. 8 are available to a user whether or not a basal test is in operation. In the example shown, the information is relates to an overnight basal test.

A basal test submenu281′ corresponds to the basal test submenu281 ofFIG. 7, but includes options related to the currently executing basal test. Basal test submenu items include the current test status, end the current test, set up testing, and test history. Additional submenu items are possible as well.

If the user selects the current test status option, thepump100 indexes focus to atest status screen297. Thetest status screen297 displays information related to the currently scheduled test. The information can include the time remaining in the test, the time of the next reminder alarm, and other information. A back option returns focus to the basal test submenu281′.

If the user selects the end the current test option from the basal test screen281′, thepump100 indexes focus to anend test screen299. Theend test screen299 asks the user to confirm that ending the test before its completion is intended. Anend option301 on theend test screen297 confirms that the test should be aborted. A back option returns focus to the basal test submenu281′.

If the user selects the set up testing option, thepump100 indexes focus to atest setup screen303. Thetest setup screen303 includes navigation options to allow the user to set up a basal test and also to allow the user to set threshold blood glucose levels at which the basal test will be aborted. The user selects one of the listed tests, shown inscreen303 as “Overnight test”, “Daytime test” and “Evening test”. Upon selecting one of the tests, a bloodglucose limit screen305 provides the user with an interface for defining high and low threshold values,307,309. The user selects and edits the high and/or

low threshold value

307,309 using the up and down

arrow keys

142,144. A next option confirms the settings of the threshold values307,309, and causes thepump100 to index focus to a basaltest timing screen287′.

The basaltest timing screen287′ corresponds to the basaltest timing screen287 ofFIG. 7, but relates to the currently selected basal test. The basaltest timing screen287′ presents a list of reminder alarms represented by times of the day at which those alarms occur. The basaltest timing screen287′ also presents additional information, such as the number of blood glucose tests to be performed over the course of the basal rate test, and the total elapsed time of the test. Anedit option311 allows a user to selectively edit the reminder alarms. Upon selection of theedit option311, thepump100 indexes focus to a basal test edit screen315, which allows the user to edit the blood glucose thresholds included in the basal test. The user selects an existing reminder alarm using the up and down

keys

142,144, and a next option activates the alarm for editing using the up and down keys.

Default tests reside within thepump100 and are customizable by a user. In one embodiment, the overnight test includes reminder alerts at 8:00 p.m., 11:00 p.m., 3:00 a.m., and 7:00 a.m. The daytime basal test schedule includes reminder alerts at 9:00 a.m., 12:00 p.m., 2:00 p.m., and 4:00 p.m. The evening basal test schedule includes reminder alerts at 3:00 p.m., 6:00 p.m., 9:00 p.m., and 12:00 a.m. Other times are possible as either default or customized tests as well. In one embodiment, thepump100 does not allow editing of a basal test while the test is in progress.

The basal test terminates upon detection of any of a number of conditions. These conditions include determination that the user's current blood glucose value is outside of the range defined by the high and low threshold values, initiation of a meal bolus, initiation of a correction bolus, changing the insulin cartridge associated with the pump, changing the basal pattern, or initiation of a temporary basal rate.

If the user selects the test history option, thepump100 indexes focus to atest selection screen319. Thetest selection screen319 prompts the user to select the type of test for which to review the test history. Atest listing323 within thetest selection screen319 displays the programmed tests and corresponding radio buttons, allowing the user to select one of the tests by using the up and down

keys

142,144. The test types include the types of tests executable by the pump, such as an overnight test, daytime test (such as a morning or afternoon test), or evening test. Each test differs by the timing of the set of reminder alerts associated with the test. Upon user selection of one of the types of tests, thepump100 indexes focus to atest data screen325 which displays one or more of the tests of that type which have been performed by the pump. In one embodiment, thepump100 displays data related to the last three instances in which the test was run. In a possible embodiment, the data includes the date, the time, and the user's blood glucose level at the time of the last blood glucose test.

Referring toFIG. 9, an exemplary chart graphically displaying three different hypothetical examples of executed overnight basal tests is shown. The chart displays the time of day along the horizontal axis, and the user's blood glucose level along the vertical axis. First, second, and

third data sets

327,329, and331 represent separate hypothetical overnight tests, and include data points at alarm times of 8:00 p.m., 11:00 p.m., 2:00 a.m., 3:00 a.m., and 4:00 a.m., which are, for example, set in the basaltest timing screen307 ofFIG. 8. First data set327 includes only the first three data points, because at 2:00 a.m. thepump100 detected a blood glucose level above the accepted range for the test, and the test aborted. Second data set329 represents a successfully completed test.Third data set331 includes five data points, but did not complete operation due to detection of a blood glucose level below the accepted range for the test, resulting in canceling of the test. Upon detection of a blood glucose reading outside the threshold range programmed into thepump100, the pump displays either an alert indicating that the user's blood glucose is either too high or too low. Thepump100 optionally instructs the user to follow physician's instructions to remedy the abnormal blood glucose value. For example, a user executing a basal rate test resulting in thefirst data set327 might be instructed to increase the basal insulin rate for a subsequent test. Conversely, a user executing a basal rate test resulting in thethird data set331 might be instructed to decrease the basal insulin rate for a subsequent test. In a possible embodiment, thepump100 graphically displays the suggested adjustment to the user's basal profile. Displaying the change in the user's basal profile can show the user the effect of the changed basal rate on blood glucose values.

Referring back toFIGS. 7-9, in one embodiment the basal test process cannot be completed simultaneously with the application of a correction bolus or other non-basal rate effect caused by thepump100. Events that cause the basal test to terminate include a correction bolus, a meal bolus, changing the insulin cartridge, disabling the threshold values, or editing the basal pattern. Additional options can abort the basal test as well.

In one possible embodiment ofpump100, the basal rate testing is performed by prompting a user to input blood glucose values at scheduled times during the test. In an alternate embodiment, thepump100 communicatively links to a blood glucose sensor. In such an embodiment, thepump100 optionally requests blood glucose level information from the blood glucose sensor at various times during the test. The various times during the test can include the scheduled times during which manual or automated blood glucose test result entry would be expected, and can also include a periodic request to a blood glucose sensor. For example, the periodic request can occur every ten minutes or some other period, and may be a user-selectable period. Thepump100 would receive the most recent test result obtained by the blood glucose sensor. In embodiments including a communicative link to a blood glucose sensor, the user need only be interrupted when an abnormal blood glucose level is detected so that appropriate corrective action is taken

H. Basal Rate Delivery

Referring toFIG. 10, theinsulin pump100 can deliver insulin either according to a basal rate or as a bolus. In one possible embodiment, thepump100 can deliver insulin according to four different basal delivery programs. To customize the basal delivery programs, the user accesses thePersonalize Delivery submenu222.

Selecting the Delivery menu item in thePersonalize submenu222 causes the pump to index to aPersonalize Delivery submenu302 in which the user can select the type of bolus or basal delivery protocol to edit. Selecting the Basal Program menu item causes thepump100 to index a maximum-basal-rate field304, which is placed in focus. Within the maximum-basal-rate field304, the user scrolls to and selects the desired maximum basal rate. In one possible embodiment, the maximum basal rate values are in the units of u/hr and the user can scroll through values in the range from 0.5 u/hr to 36 u/hr in increments of 0.5 u/hr. When the desired maximum basal rate is selected, focus indexes to a review/edit-basal-programs field306 in which the user selects either a yes or a no value. If the user selects the no value, theinsulin pump100 returns to thePersonalize Delivery submenu302.

If the user selects the yes value, thepump100 indexes to adisplay308 entitled “Select Program” and lists thename310 for each of the basal programs,Basal 1,Basal 2,Basal 3, andBasal 4. Acheck box312 is also displayed next to eachname310 for the basal delivery programs. If a Basal program is enabled, thecheck box312 next to its name is set. If a Basal program is not enabled, thecheck box312 next to its name is cleared. Thename310 of each enabled basal-delivery program is displayed as a menu item in the Basal Programs submenu318 (FIG. 12) and the user can selectively activate the enabled programs.

To enable or disable a basal program, the user scrolls to the desired basal program and activates theEdit function254. Thepump100 indexes to adisplay313 entitled “Basal 1,” where “Basal 1” is the name of the basal program being edited. The display has two fields, an enablefield314 and aname field316. Within the enablefield314, the user selects either a yes value or a no value. If the user selects the no value, thepump100 disables the basal program associated with the screen313 (Basal Program 1 in the illustrated example) and returns to theSelect Program display308. Thecheck box312 for the disabled program is cleared. In one possible embodiment, if thepump100 is actually executing the basal program that the user attempts to disable, thepump100 will not disable the program and will present an error message stating, “You may not disable the active program.”

If the user selects the yes value in the enablefield314, thepump100 indexes focus to thename field316. Within thename field316, the user can assign a custom name to the basal delivery program. In one possible embodiment, the user can scroll through names that are preloaded into thepump100. Examples of names might include Weekday, Weekend, Sick Day, Travel, Monthly, and the generic names such asBasal 1,Basal 2, etc. When the user has scrolled to the desired name, the user activates the Next function and thepump100 returns to theSelect Program display308. Thecheck box312 for the program that was just edited is set to indicate that the basal program is enabled. Additionally, the name selected in thename field316 is displayed in theSelect Program display308 in place of the previously assigned name. The name selected in thename field316 is also displayed as a menu item in theBasal Programs submenu318.

The user repeats this procedure from theSelect Program display308 for eachbasal program310 for which he or she desires to change the enabled state and/or name. When the user is done changing the enabled states and program names for the variousbasal programs310, the user activates theDone function212. Thepump100 then returns to thePersonalize Delivery submenu302. As described below, the names of the enabled basal delivery programs will then appear theBasal Programs submenu318.

In an alternative embodiment, within the display entitled “My Program X,” the user can access a spin box in which they scroll through a list of optional names and select a custom name for the enabled basal delivery programs. The selected name would then replace the generic name (e.g.,Basal 1,Basal 2,Basal 3, andBasal 4 in the illustrated example) for the program associated with the display. Examples of optional names that might be loaded in thepump100 include weekday, weekend, sick, and monthly (which is to designate a basal delivery program set for a woman's menstrual cycle).

Referring now toFIG. 11, the user can edit the operating parameters for the delivery protocols assigned to each of the enabled basal programs. From the main menu, the user selects the Basal Programs menu item. The pump then indexes to aBasal Programs submenu318 that lists thosebasal programs317 that have been enabled as menu items. Each Basal Delivery program listed in thesubmenu318 is identified by the name assigned to that particular program (e.g., Basal X, Weekend, Weekday, Sick Day, Travel, Monthly). In the illustrated example, all four basal programs are enabled and identified by the generic name Basal X. Additionally, there isbutton320 next to each of the menu items (names for the enabled basal programs). Thebuttons320 associated with the active basal program are set, and the buttons for the other basal delivery programs are cleared.

To edit a basal program, the user scrolls to and selects the desired basal program. Thepump100 indexes to asubmenu322 for which the title is the same name as the selected basal program. The menu has two menu items, an Edit menu item and a Start Using menu item. The user selects the edit menu item and thepump100 indexes to aSummary user interface324 that presents a table in which each row identifies a start time326 and a scheduleddelivery rate328 for each time interval in the basal program. In the illustrated embodiment, there is afirst time interval330 having a start time and a delivery rate, asecond time interval332 having a start time and a delivery rate, and a third time interval having334 a start time and a delivery rate. The start times are listed in a start-time field, and the delivery rates, are listed in a delivery-rate field.

To edit the start times and the delivery rates, the user activates theedit function254 in theSummary user interface324 and thepump100 indexes to an Edit user interface336 and assigns theDone function212 to thefirst function key138. Additionally, thepump100 places focus on the delivery-rate field340 for thefirst interval330. The user scrolls to and selects the desired delivery rate. The user selects the desired delivery by scrolling to the desired value and activating theNext function200. In one possible embodiment, thepump100 scrolls through delivery rates in the range from 0 u/hr to 2 u/hr in increments of 0.05 units per hour. The delivery rate does not exceed the maximum delivery rate (FIG. 10, Item304).

When the desired delivery rate is selected, thepump100 indexes focus to the start-time field342 for thesecond time interval332. The user scrolls to and selects the desired start time. In one possible embodiment, thepump100 scrolls through start times in increments of 30 minutes. In one possible embodiment, the start time cannot be earlier than or equal to the start time of the previous time interval and cannot be later than or equal to the start time of the next subsequent time interval. Other embodiments will implement different scrolling increments and limitations on the start time that can be selected. In another embodiment, if a selected start time is not in sequence, thepump100 will automatically reposition the delivery intervals so they are in chronological order.

When the desired start time is selected, pump100 then indexes focus to the delivery-rate field340 for thesecond time interval332, which the user sets using the procedures described above with respect to thefirst time interval330. The user continues this procedure indexing through the start times for each of the time intervals and their associated delivery rates until the start time for each of the delivery intervals and their associated delivery rates are set. When the user is finished setting and/or editing the start times and delivery rates for the various intervals, he or she activates theDone function212 and thepump100 returns to theSummary Display324.

In one possible embodiment, thefirst time interval330 always starts at 12:00 midnight. In this embodiment, the last time interval will terminate at 12:00 midnight. If, within theSummary Display324, the user highlights and selects thefirst time interval330 for editing, thepump100 indexes to the Edit display336 and initially highlights thedelivery rate328 for thefirst time interval330 rather than the start time326. In another embodiment, however, the user can change thestart time320 for thefirst time interval330. The last time interval would then extend until the start time for thefirst time interval330. Additionally, within theSummary Display324, the user can scroll to a delivery interval other than thefirst interval330 and activate theEdit function254. In this situation, the start-time field342 for the selected interval is initially placed into focus rather than the delivery-rate field340.

To add a time interval to the basal program, the user continues to index through all of the time intervals and associated fields until the pump generates a new delivery interval and displays the characters “--:--”344 in the start-time field342 of the new interval, which occurs after indexing through the delivery-rate field340 for the last time interval. The user then scrolls through desired start times for the new time interval. After the desired start time is selected, the user activates theNext function200 and thepump100 indexes to the delivery-rate field340 for the new time interval, which the user sets by scrolling through available delivery rate values. The user can then activate theNext function200 to add yet another new time interval or can activate theDone function212 to return to theSummary display324. In one embodiment, thepump100 can include up to 48 time segments, although other embodiment will include more or fewer time segments.

To delete a time interval from the basal program, the user places the start-time field342 for the desired interval into focus and scrolls down until the time reads “--:--”344. The user then activates the Next function and the time interval is deleted and the user either activates theNext function200 to index to another time interval for editing or activates theDone function212 to return to theSummary display324.

Additionally, both theSummary user interface324 and the Edit user interface336 include atotal field346 in which the total insulin scheduled to be delivered over a 24-hour period for that basal program is listed. The total insulin scheduled to be delivered is calculated by multiplying the delivery rate by the length of each time interval to calculate the total insulin to be delivered for each time interval by the basal program being edited. The total insulin to be delivered for each time interval is then summed to calculate the total insulin scheduled to be delivered over a 24-hour period.

Referring toFIG. 12, to begin a basal program the user indexes to theBasal Programs submenu318 and selects the name of the desired basal program. The pump indexes to theBasal X submenu322 and selects the Start Using menu item. The pump returns to theBasal Programs submenu318 and sets thebutton320′ for the newly activated basal program. Thepump100 also clears thebutton320 for the previously active basal program.

I. Correction Bolus

In addition to delivering a basal rate thepump100 may administer a bolus to lower the user's blood glucose level. One possible embodiment of thepump100 can deliver two types of boluses, a correction bolus and a meal bolus. The correction bolus delivers a dose of insulin over and above the basal rate to lower or correct the user's blood glucose level if it becomes too high. A meal bolus is a dose of insulin delivered in anticipation of consuming a meal to counteract the effects that the meal may have on the user's blood glucose.

Referring toFIG. 13, the user can personalize or customize the correction bolus program and how the program is presented in the user interface. To personalize the temporary rate programs, the user accesses thePersonalize Delivery submenu302.

Selecting the Correction Bolus menu item causes thepump100 to display a main-menu field388, and places it in focus. The user scrolls to and selects either a yes value or a no value. The yes value enables a Correction Bolus menu item in themain menu190, and a no value disables the Correction Bolus menu item in themain menu190. Upon selecting the yes or no value, focus indexes to a meal-bolus field390 in which the user scrolls to and selects either a yes value or a no value. A yes value enables the user to set a correction bolus through the meal bolus delivery program as described below. A no value disables the ability to set a correction bolus through the meal bolus delivery program.

Upon selecting a yes or no value in the meal-bolus field390, focus indexes to a units field392 in which the user scrolls to and selects units for measuring blood glucose levels in either mg/dL and mmol/L. Upon selecting the units, focus indexes to a correction-bolus-factor field394 in which the user scrolls to and selects a desired correction factor. The correction factor is the amount that the user's blood glucose drops for each unit of delivered insulin. In one possible embodiment, the user scrolls through values ranging from 5 mg/dL to 200 mg/dL (or 0.2 mmol/L to 12 mmol/L). When the desired correction factor is set, focus indexes to a target blood glucose field393.

Additionally, thepump100 calculates the average correction value for a predetermined number of days beginning with the previous day and extending backwards in time, and then displays396 the average correction factor together with the correction-bolus-factor field394. In the illustrated example, thepump100 displays the average correction factor for the previous seven days. As discussed above, other embodiments average the correction factor over other periods of time. In yet other embodiments the user can select the period of time over which to average the correction factor.

The target blood glucose field393 allows a user to edit or review the correction bolus blood glucose targets. An edit option395 allows the user to optionally edit the blood glucose target values. If the user chooses to edit the blood glucose target values, they can optionally choose to set a constant target blood glucose value, or a variable target blood glucose value which changes throughout the day based on expected meal consumption, activity levels, or other factors. When the desired blood glucose targets are set or if the user chooses not to edit the blood glucose target values, focus indexes to a correctionbolus adder field397.

The correctionbolus adder field397 sets one or more correction bolus changes within thepump100. In thefield397 shown, the correction bolus adder field prompts a user to indicate whether to increase the correction bolus delivered by thepump100 based on the user's current blood glucose level. Anedit option399 allows the user to optionally customize the increase amount for the correction bolus based on blood glucose. The addition of insulin to the correction bolus can be a constant amount over a given threshold, can be a graduated increase based on current blood glucose, or a set of stepped increases in insulin based on blood glucose. Once one or more of the desired correction bolus adders are set, focus indexes to a duration-of-activity field398. Within the duration-of-activity field398, the user scrolls to and selects the duration of time over which insulin remains in the user's body. This amount will vary from user to user depending on a variety of factors including physical traits of the user and the type of insulin that is used. In one possible embodiment, the user scrolls through durations in the range from 2 hours to 6 hours. When the duration is set, thepump100 returns to thePersonalize Delivery submenu302.

In a possible embodiment, a user selects an insulin absorption model from among multiple insulin absorption models for application by thepump100. Insulin absorption models are used in the pump to determine the remaining insulin in a user's body a period of time after the insulin is delivered to t he user, whether by a basal rate, a correction bolus, a meal bolus, or another insulin delivery method described herein. To calculate the user's insulin level, the insulin absorption model uses the programmed duration in the duration-of-activity field398. The user optionally selects a linear or non-linear absorption model. A linear absorption model assumes a constant absorption rate of insulin into the body. A nonlinear absorption model assumes a faster absorption rate with higher insulin levels, and a lower absorption rate with lower insulin levels. The user optionally also programs a start time and tail time into thepump100.

FIGS. 14A-14D show graphical representations of four possible insulin absorption models which can be set in the pump. The horizontal axis of the graphs represents the elapsed time since the last measured insulin on board. The vertical axis represents the insulin on board as a percentage of the total delivered insulin at the time represented by the axis.

FIG. 14A shows a linear absorption model in which the programmed duration in the duration-of-activity field398 was set to be 3 hours. The start time and tail time are either not selected or set to be zero. These settings result in a linear decrease in estimated insulin on board over three hours. The equation to be used to determine the current insulin on board (IOB) is:

Current IOB - \frac{Initial Bolus Amount * (\begin{matrix} Duration of Activity - \\ Elapsed Time \end{matrix})}{Duration of Activity}

For example, if a 3 Unit bolus is delivered using this selected model, at a time one and a half hours later the model estimates that the user has 1.5 Unit remaining unabsorbed within their body.

FIG. 14B shows a linear absorption model having a non-zero start time and tail time. In the embodiment shown, the start time is programmed to be 15 minutes and the tail time is programmed to be one hour. Using this model, it is assumed that insulin in a user's body does not decrease for the first 15 minutes after it is introduced. After that start period, insulin levels are assumed to decrease linearly over the set duration to a point at which approximately 5% of the introduced insulin remains. At that point, insulin levels drop to zero (either linearly or non-linearly) over the designated tail time. The equation used to determine current insulin on board using this model is:

Current IOB - \frac{Initial Bolus Amount * (\begin{matrix} Duration of Activity + \\ Start Time - \\ Elapsed Time \end{matrix})}{Duration of Activity}

Note: During Start up Time, current IOB limited to Initial Bolus Amount
until the Current IOB reaches 5% of the Initial Bolus Amount. At that point, the equation used becomes:

Current IOB - \frac{0.05 * Initial Bolus Amount * (\begin{matrix} Elapsed Time Since \\ Tail Time Started \end{matrix})}{Total Tail Time}

More generally, the tail can be affected by changing the percentage of insulin on board at which the tail time occurs. In such an instance, the above equation becomes:

Current IOB = \frac{\begin{matrix} Tail Threshold % * Initial \\ Bolus Amount * (\begin{matrix} Elapsed Time Since \\ Tail Time Started \end{matrix}) \end{matrix}}{Total Tail Time}

FIG. 14C shows a non-linear absorption model in which the programmed duration in the duration-of-activity field398 was set to be 3 hours. The start time and tail time are either not selected or set to be zero. A variety of equations can be used to model the non-linear absorption model, such as an exponentially decreasing, hyperbolic, or other equation. The following is an example of one possible equation used to model non-linear insulin absorption:

y = e^{- (\frac{x^{2} \ln (20)}{T^{2}})}

Where

y=Current IOB
x=Elapse time

T=Duration of Activity

The method of calculating the current insulin on board remains the same, by determining the amount of insulin on board based on the model by using the time elapsed since the insulin is delivered into the user's body.

FIG. 14D shows a non-linear absorption model having a non-zero start time and tail time. In the embodiment shown, the start time is programmed to be 15 minutes and the tail time is programmed to be 2 hours. The start time and tail time are implemented similarly to those described in conjunction withFIG. 14B, while using the non-linear model described in conjunction withFIG. 14C.

Additional methods for varying the absorption model can be incorporated into thepump100 as well. A general method for varying insulin absorption would include incorporation of factors which can affect the rate at which the user would actually absorb insulin, such as due to boluses, activity, or other factors. In one example embodiment, thepump100 varies the insulin absorption model based on a bolus amount. In a further embodiment, thepump100 varies the insulin absorption model based on both a bolus amount and the user's body weight. In a further embodiment, thepump100 varies the insulin absorption model based on the user's anticipated near-future activity level. Other factors can include the user's age, fitness level, body mass index or other user entered health information. In yet a further embodiment, the pump varies the insulin absorption model based on the ambient temperature experienced by the user. In further embodiments, thepump100 varies the insulin absorption model based on other patient-specific parameters.

Referring now toFIG. 15, the user delivers a correction bolus by selecting the correction bolus menu item from themain menu190. Thepump100 then displays anamount field400 in which the user enters the amount by which they would like to lower their blood glucose. The user scrolls to and selects the desired amount. Thepump100 then calculates a recommended bolus and indexes focus to a recommend-bolus field402. Thepump100 also displays abanner403 with the recommend-bolus field402 which reads “Bolus to Lower BG X?” where X is the amount that the user entered to lower his or her blood glucose. Thepump100 calculates the recommended bolus according to the equation:

\begin{matrix} Correction Bolus = \frac{Drop in Glucose Level}{Correction Factor} & (1) \end{matrix}

and displays the recommended correction bolus in the recommend-bolus field402. The user can adjust the recommended correction bolus by incrementing the recommend amount up or down using the up and down

keys

142 and144, respectively.

When the desired correction bolus is displayed in the recommend-bolus field402, the user activates the Deliverfunction384 and thepump100 displays abanner408 in the screen stating the bolus is delivering and the amount of the bolus. Thepump100 then returns to thehome page152 after delivery of the bolus is complete.

Additionally, thepump100 has a duration of activity program that determines whether any bolus that was previously delivered is still active. If a previous bolus is still active, thepump100 calculates the estimated amount of insulin that is still active in the patient's body. In a linear system the pump uses an equation analogous to the Insulin on Board equations above:

\begin{matrix} Residual Insulin = \frac{Last Bolus Amount \times (\begin{matrix} Duration - Time \\ Since Last Bolus \end{matrix})}{Duration} if (Duration - Time Since Last Bolus) \geq 0, otherwise Residual Insulin = 0. & (2) \end{matrix}

where Residual Insulin is the amount of insulin from a previous bolus still active within the user's body, Last Bolus Amount is the amount of the last bolus, Duration is the duration of insulin, which is set as described in conjunction withFIG. 13, and Time Since Last Bolus is the amount of time lapsed since the last bolus was delivered. Additionally, there could be more than one boluses still active within the user's body. In this situation,equation 2 is used to calculate the residual insulin from each of the still active boluses and the amount of residual insulin for each of the previous boluses is summed to determine Residual Insulin. Alternately, a modified version ofequation 2 may be used based on a non-linear insulin absorption model, if selected.

Thepump100 then calculates an adjusted correction bolus according to the equation:

Reduced Correction Bolus=Correction Bolus−Residual Insulin (3)

Thepump100 then displays the reduced recommended corrected bolus in the correction-bolus field402 rather than the recommended correction bolus. The display also presents a banner (not shown) with the recommended-bolus field that indicates that the recommended bolus is reduced to accommodate residual bolus insulin that is still working in the user's body. An example of such a banner is “*reduced for insulin on-board”.

In an alternative embodiment, when the user selects the Correction Bolus menu item from themain menu190, thepump100 indexes to a display that presents the correction factor, displays the user's target blood glucose level, and displays a current-blood-glucose field that prompts the user to enter the user's current blood glucose level. The user scrolls to and selects their current blood glucose level. Thepump100 then calculates the appropriate amount of the bolus to lower the user's blood glucose level to the target value and then presents the verification display. In this embodiment, thepump100 calculates the desired drop in the glucose level, and thepump100 calculates the correction bolus according to the equation:

\begin{matrix} Correction Bolus = \frac{Current Glucose Level - Target Glucose Level}{Correction Factor} & (4) \end{matrix}

In one possible embodiment, thepump100 varies the correction bolus amount based not only upon the time of day, but also the current blood glucose of the user. The user can set one or more rules in thepump100 to change the correction factor applied. These rules can be based on a rules framework programmed into thepump100. For example, the pump can include an additive rule framework of the form “If blood glucose is above X, add Y %”. The user could create a number of personalized rules of the same form, by entering a blood glucose setting and a percentage value. For example, by entering 250 and 20%, respectively, the user tells thepump100 to add 20% to the bolus if the user's blood glucose level is over 250. In a possible embodiment, the effect of these defined rules can be added to the correction bolus after it is initially calculated using equation (4), above. In a second possible embodiment, the correction factor is altered to take into account whether or not a rule applies at the time the correction bolus is calculated.

A plurality of rules can be created in thepump100 with differing glucose values and percentages. In one possible embodiment, up to four rules can be programmed into thepump100. Additionally, the added insulin delivered by thepump100 can be displayed on the pump screen, such as upon selection of the Correction Bolus menu item in themain menu190. These equations can change based on the insulin absorption model selected.

J. Negative Meal Bolus

In a possible embodiment, when the user selects the Correction Bolus menu item from themain menu190 and thepump100 determines that the user's blood glucose is below the target level, the pump indexes to a display that includes a notification message indicating to a user that their blood glucose level is below their target blood glucose level. In a further embodiment, thepump100 includes a negative meal bolus target analogous to the correction bolus target, which is a target level to which the negative meal bolus is configured to aim. The negative meal bolus target can be a different value from the correction bolus target. For example, the correction bolus target can represent a higher level within a range of safe blood glucose levels, such as 130 mg/dl, and the negative meal bolus target can represent a lower level within the range, such as 90 mg/dl. In a possible embodiment, the correction bolus target and negative meal bolus target are user-selectable.

In a possible embodiment, thepump100 deactivates the negative bolus feature based on the occurrence of other events within the pump. For example, the negative bolus feature can be disabled during an extended bolus, or for a predetermined or customizable period of time after delivery of a meal bolus, as described below.

The negative meal bolus feature allows thepump100 to optionally display the amount of carbohydrates necessary to bring the user's low blood glucose back to the target level, consistent with the equations described above. In an embodiment of thepump100 incorporating a food database as described below, the pump optionally displays one or more foods appropriate for treating low blood glucose which contain at least the required number of carbohydrates. In such an embodiment, the pump also optionally displays a minimum serving size to be consumed to reach the required number of carbohydrates.

Thepump100 also optionally displays the user's current blood glucose level or the user's target blood glucose level. Thepump100 optionally executes a meal bolus program which, in one aspect, can calculate and display the number of carbohydrates to bring the user's blood glucose from its current level to the user's target level. The calculated number of carbohydrates is editable by the user, although the number entered by the user may be replaced by the number calculated by thepump100 if the user-entered value is lower.

Once the number of carbohydrates is accepted, raised, or lowered by the user, one of three things may happen. If the user accepts the calculated bolus, thepump100 applies a “zero” bolus. If the user lowers the number of carbohydrates, thepump100 displays a message indicating that the user's blood glucose would still be below target. If the user raises the number of carbohydrates, a meal bolus program, such as those discussed below, calculates the amount of insulin necessary to counteract the extra carbohydrates. This insulin can be delivered to the user at the time the user selects the number of carbohydrates to consume, or can optionally delay the insulin bolus for an amount of time sufficient to ensure that the user's blood glucose level increases quickly back to a normal level. In a possible embodiment, thepump100delays 15 minutes before delivering additional insulin to allow the user a chance to consume some carbohydrates and raise their blood glucose level. In a further possible embodiment, the software prompts the user to perform a blood glucose test to confirm that the bolus is needed. In such an embodiment, the software allows the user to confirm or cancel the bolus as appropriate.

In an embodiment of thepump100 including a food database, as described below, thepump100 can display one or more foods that are good to eat when blood glucose is abnormal, i.e. too high or too low. Additionally, foods which are well-suited for consumption in anticipation of exercise or on sick days can be displayed as well. Thepump100 can present to a user a list of foods which are appropriate under other circumstances as well.

K. Meal Bolus Programs

A meal bolus is a bolus that the pump delivers in anticipation of a meal that the user plans to consume. In one possible embodiment, the amount of the meal bolus is based on how much insulin is required to work against the carbohydrates that the user plans to consume. There are several types of meal bolus programs that thepump100 may include. One type is a standard bolus in which thepump100 delivers the meal bolus a predetermined time prior to when the user consumes the meal or snack. The standard program delivers the bolus at the maximum rate that thepump100 is able to deliver it. As explained below, the standard program can be set for programming in either units of insulin or number of carbohydrates. Another type of meal bolus that thepump100 can be programmed to deliver is an extended bolus in which thepump100 delivers the meal bolus over an extended period. Yet another type of meal bolus that thepump100 can be programmed to deliver is a combination bolus in which thepump100 immediately delivers a portion of the meal bolus and the balance of the meal bolus over an extended period of time.

Referring toFIG. 16, to instruct thepump100 to program the standard meal bolus in units of insulin and to otherwise personalize the meal bolus program, the user accesses thePersonalize Delivery submenu302. From thePersonalize Delivery submenu302, the user selects the Meal Bolus menu item and thepump100

prompts

410 the user to select whether to program in units of insulin or carbohydrates. The user selects units of insulin. Thepump100 then prompts412 the user to select the maximum bolus that can be delivered. In one possible embodiment, the user scrolls through values in the range between 0 units and 40 units of insulin in increments of 1 until the desired value is highlighted. Next, thepump100

prompts

414 the user to select the increments in which the user can select the actual bolus to be delivered. In one possible embodiment, the user scrolls between 0.05 units, 0.10 units, 0.50 units, and 1.00 units.

Thepump100 then prompts416 the user to select whether to enable an extended bolus program and to display an Extended Bolus menu item within a Meal Bolus submenu434 (FIG.18). The extended bolus program is selected by selecting a yes value and disabled by selecting a no value. Thepump100 also prompts418 the user to select whether to enable a combination bolus program and to display a Combo Bolus menu item within theMeal Bolus submenu434. The combination bolus program is activated by selecting a yes value and is disabled by selecting a no value. Thepump100 then prompts420 the user to choose whether to enable an audio bolus program. The user selects a yes value to enable the audio bolus program and selects a no value to disable the audio bolus program.

If thepump100 is preprogrammed with one or more custom meal boluses, the pump prompts422 the user to select whether to review or edit a custom bolus. If the user does not want to review or edit a custom bolus, the user selects no and thepump100 returns to thePersonalize Delivery submenu302. If the user selects yes, thepump100 presents adisplay424 entitled “Custom Bolus,” which lists thenames426 of the available custom meal bolus programs. Thedisplay424 also presents acheck box428 for each of the custommeal bolus programs426. If a custommeal bolus program426 is enabled, thecheck box428 is set. If a custommeal bolus program426 is not enabled, thecheck box428 is cleared. When a custom meal bolus is enabled, it is displayed in the Meal Bolus submenu434 as a separate menu item. If the custom meal bolus program is not enabled, it is not displayed in theMeal Bolus submenu434 and the user cannot execute the program.

To enable or disable a meal bolus program, the user scrolls to the desired custom meal bolus program and activates theEdit function254. Thepump100 presents adisplay430 entitled “Custom Bolus: X,” where X is the name of the selected custom meal bolus program. In the illustrated example, the title of the display is Custom Meal Bolus: Pizza“. Upon activating theEdit function254, thepump100

prompts

432 the user to select either a yes value or no value. If the user selects the yes value, thepump100 enables the custommeal bolus program426 and displays the name of the program as a menu item in theMeal Bolus submenu434. If the user selects the no value, thepump100 disables the custommeal bolus program426 and does not display the name of the program as menu item in theMeal Bolus submenu434. After the yes or no value is selected, thepump100 returns to the “Custom Bolus”display424.

The user repeats this procedure from the “Custom Bolus”display424 for each custommeal bolus program426 for which they desire to change the enabled state. When the user is done changing the enabled states for the available custommeal bolus programs426, the user activates theDone function212 in the “Custom Bolus”display424. Thepump100 then returns to thePersonalize Delivery submenu302.

Additionally, in one possible embodiment, if there are no custom meal bolus programs available for the user to enable, thepump100 automatically returns to thePersonalize Delivery submenu302 after the user instructs420 thepump100 whether to enable an Audio Bolus.

In one possible embodiment, a user can program thepump100 to include a database of foods for which to configure delivery of a custom bolus. A user of thepump100 selects one or more foods from the database of foods to form a meal from which the user's carbohydrate intake is calculated. The database of foods can include a number of records associated with food entries. The food entries each represent a food or a combination of foods. The record includes fields for a name of the food entry, the amount of carbohydrates contained in the food or foods represented by the food entry, and a default serving size for the food entry.

Each entry in the food database is a food entry. The food entry has a number of fields within it. One field can be a name field, and will be the information displayed to the user representing the name or names of the food displayed. The food entries can represent specific foods tracked by a user of the pump. The food entries can also represent meals including a variety of foods typically eaten by the user, and would include combinations of types of foods. Examples of foods displayed could be “pizza” or “apple”, or could also be “Chicken, Potato, and Green Beans” or some other combination commonly consumed by the user, who may wish to store the combination so that they do not have to select each food and serving size each time they consume the common meal.

Additional fields include a carbohydrate field and a serving size field related to the foods displayed. The carbohydrate field contains information related to the number of carbohydrates are contained in the foods, given a default serving size stored in the serving size field. The carbohydrate field and the serving size field are customizable by a user, and can be set independently of each other as well.

In a possible embodiment of the food database, nutritional information is stored in the food database and associated with the one or more food items. The additional nutritional information can be stored in additional fields associated with the food entry, or can be stored separately and referenced by the food entry. The nutritional information includes, for example, additional carbohydrate information, fat information, or protein information. Other nutritional information can be stored as well.

In a further possible embodiment of the food database, thepump100 stores metadata related to one or more user conditions in conjunction with one or more of the foods in the food database. The pump can be configured to display specific foods upon occurrence of the conditions. These conditions include, for example, such as activity levels, sickness, high or low blood glucose levels, or other conditions. For example, in the case of a low blood glucose level, a metadata tag may be associated with a food entry in the food database “orange juice” which will be displayed to the user upon detection of a low blood glucose level. Optionally, thepump100 displays a specific amount of orange juice to consume, as calculated using the negative meal bolus feature, described herein.

In one embodiment, the food database includes 500 or more foods, categories of foods, and/or meals. In a possible embodiment, the food database is a subset of a larger food database that is stored on a computing system that can be interfaced with thepump100, such as the system shown below inFIG. 26.

Referring now toFIG. 17, a meal maker function allows the user to select one or more food entries from the food database to form meals. Meals refer to combinations of one or more food entries selected using the pump which indicate the food or foods which the user plans to consume. In one embodiment, up to 10 food entries are selectable from the food database to form a meal. The food entries in the food database are categorized into one or more hierarchical levels for ease of navigation, and food categories screen405 displays one or more food categories in acategory listing407, allowing the user to navigate to a food or meal to be consumed using the up and down

keys

142,144. The user selects a food or meal category from theoverall food listing407, and confirms the choice using anext option409. Upon activation of the next option, thepump100 indexes focus to a food entries screen411. The food entries screen411 presents a number of foods within the category selected using thefood categories screen405. In the example shown, a fruits category includes single fruits as well as a fruit salad option, which corresponds to a variety of fruits. The user selects at least one food using the up and down

keys

142,144 and uses anext option413 to confirm selection of one of the food entries.

Upon activation of thenext option413, thepump100 indexes focus to aservings screen409. The user selects the number of servings, or “serving size” of the selected food entry that will be consumed, using a servings field417 and the up and down

keys

142,144. The user optionally also defines the default amount of food referred to as the “serving size”, such that a single serving of the food represents the amount of the food that user eats in a single meal. In one particular implementation, the selectable number of servings of the food can be between 0.5 and 3 servings, based on the default food amount. Upon selection of a serving size using aselect option419, the pump calculates the number of carbohydrates to be consumed for the selected food entry, and indexes focus to a confirmation screen421. The confirmation screen421 displays the food or foods selected, as well as a number of informational items related to nutritional aspects of the food, including the serving size of the food, the number of carbohydrates, and the amount of fiber, protein, and fat included in the food. The informational items correspond to the information stored in the food database and associated with the food entry. Other information can be displayed as well, such as by incorporating additional fields into each food entry in the food database. The user can select anadd option423 to add additional food entries to the current meal using the food database, or confirm that the food entries selected represent the meal desired using aset option425. Upon user confirmation using theset option425, thepump100 indexes focus to adelivery screen427. Thedelivery screen427 displays overall meal information, including a total number of carbohydrates consumed, a listing of the foods to be consumed, and other optional nutritional or serving size information. Upon selection of ahome option429 the pump indexes focus to acarbohydrate delivery screen200, such as are shown below inFIG. 20. Using the appropriate screens as described below, the pump delivers an appropriate meal bolus based on the total number of carbohydrates to be consumed in the meal. A back option returns to the confirmation screen421 allowing the user to add additional foods to the meal.

If a food is not selected from the food database, the user can directly enter a number of carbohydrates, as illustrated inFIG. 20 below. However, in any event the pump prevents the user from specifying a serving size for the food item which would cause the total insulin bolus to be greater than the programmed maximum insulin dose, as set using the prompt412.

In the embodiment shown inFIG. 17, the meal maker function provides a hierarchy of menu-based screens configured to organize the foods listed in the food database. The hierarchy of menus includes one or more levels of menus, each menu representing foods, meals, types of foods, types of meals, or other user-selectable navigation or selection criteria. In another embodiment, all foods are displayed in a non-hierarchical listing.

FIG. 18 illustrates administration of a standard meal bolus when thepump100 is set to program meal boluses using units of insulin. The user selects the meal bolus menu item from the main menu, and the pump indexes to aMeal Bolus submenu434. Themeal bolus submenu434 lists the available meal bolus programs. Examples include the standard meal bolus program, the extended meal bolus program, the combination meal bolus program, and any enabled custom meal bolus programs. In the illustrated example, only the extended meal bolus program is enabled and theMeal Bolus submenu434 includes a Standard Bolus and an Extended Bolus. The user highlights the Standard Menu item and thepump100

prompts

436 the user to enter the number of units to deliver. In one possible embodiment, the user can scroll through values in the range from 0 units to 17 units in increments of 0.5 units.

If thepump100 is programmed to enable administration of a correction bolus through the Meal Bolus program, thepump100

prompts

436 the user to enter the number of units to deliver as a meal bolus. The user then activates the Deliverfunction384 and thepump100

prompts

438 the user to enter the amount by which they want to lower their blood glucose level. In one possible embodiment, the user enters the amount by scrolling through values in units of either mg/dL or mmol/L. When the desired drop in blood glucose is entered, the user activates theNext function200, which causes thepump100 to calculate a recommended bolus amount and to display a user interface with thebanner439 stating “Bolus to Lower BG X plus Y meal bolus.” X is the amount the user entered to lower the blood glucose level, and Y is the amount of the meal bolus entered by the user.

The user interface also displays the recommended bolus amount440 to deliver. The recommended bolus amount440 is the recommended correction bolus as calculated above, plus the amount of the meal bolus. This feature allows the user to correct a high blood glucose level and deliver additional insulin to work against carbohydrates that they plan to consume. The user can adjust the recommended bolus amount by increasing or decreasing the recommended bolus amount by scrolling up or down. In one possible embodiment, the user scrolls in increments of 0.5 units. Once the desired bolus amount is set, the user activates the Deliverfunction384.

Activating the Deliverfunction384 causes thepump100 to deliver the correction bolus. Thepump100 will begin to deliver the bolus and display abanner408 stating that the bolus is being delivered. An example of such a banner is “Bolus X is Delivering”, where X is the bolus amount. When delivery of the bolus is complete, thepump100 returns to thehome page152.

In an alternative embodiment, when thepump100 is programmed to enable administration of a correction bolus through a Meal Bolus, thepump100 displays a user interface entitled “Current Blood Glucose.” Thepump100 calculates the current correction factor and displays the correction factor in the user interface. Thepump100 also displays the target blood glucose level. The user then enters his or her current blood glucose level in units of either mg/dL or mmol/L, by scrolling through a range of values until the current blood glucose level is displayed. In this embodiment, the target blood glucose level and the appropriate units are programmed into thepump100 when personalizing the correction bolus program as described herein. After the user enters the current blood glucose level, the user activates theNext function200 and thepump100 calculates a recommended bolus amount, using the equations set forth above, and adds it to the meal bolus. Thepump100 displays the user interface with the banner “Bolus to Lower BG X plus Y Meal Bolus”439. The user can then change the amount440 and activate the Deliverfunction384 to begin delivery of the bolus as described above.

Additionally, in one possible embodiment, thepump100 adjusts the recommended bolus based on the meal bolus or the meal bolus plus the correction bolus to accommodate insulin on board or residual insulin that is still working within the user's body. In this embodiment, the amount of the adjusted correction bolus is adjusted using the equations described above in conjunction with the duration-of-activity function. The methods of adjusting the bolus amount for insulin on board are described above.

Referring toFIG. 19, to instruct thepump100 to program the standard meal bolus in number of carbohydrates consumed and to otherwise personalize the meal bolus program, the user accesses thePersonalize Delivery submenu302. From thePersonalize Delivery submenu302, the user selects the Meal Bolus menu item and thepump100 then prompts442 the user to select whether to program in units of insulin or carbohydrates. The user highlights units of carbohydrates and activates theNext function200. Thepump100

prompts

444 the user to enter one or more carbohydrate ratios, which is the number of grams of carbohydrates that each unit of insulin will counteract. Thepump100 optionally accepts a schedule of carbohydrate ratios as well, allowing the carbohydrate ratio to change based on the time of day. Thepump100 also calculates the historicalaverage carbohydrate ratio445 for a predetermined time-period and displays that historical average with the prompt444. In one possible embodiment, the historical average is for the previous 7-day period. As discussed above, other embodiments average the carbohydrate ratio over other periods of time. In yet other embodiments the user can select the period of time over which to average the carbohydrate ratio.

The user enters the carbohydrate ratio by scrolling through values in a predetermined range such as from 0 gm/u to 50 gm/u in increments of 1. When the desired number of carbohydrates is set, the user activates theNext function200 and thepump100

prompts

446 the user to set the increment by which the user would like to be able to scroll through the number of carbohydrates when programming thepump100 to deliver a meal bolus. In one possible embodiment, the user can set the desired increment between 1 and 15 grams.

Thepump100

prompts

448 the user to enter the maximum bolus that can be delivered. In one possible embodiment, the user scrolls through values in the range between 0 units and 40 units of insulin in increments of 1 until the desired value is highlighted. Thepump100 then prompts450 the user to enter the increments in which the user can select the actual bolus to be delivered. In one possible embodiment, the user scrolls between 0.05 units, 0.10 units, 0.50 units, and 1.00 units and activates theNext function200.

The pump prompts452 the user to select whether to enable an extended bolus program and to display an Extended Bolus menu item within theMeal Bolus submenu434. The extended bolus program is enabled by highlighting and activating a yes value and not enabled by highlighting and selecting a no value. Thepump100 also prompts454 the user to select whether to enable a combination bolus program and to display a Combo Bolus menu item within aMeal Bolus submenu434. The combination bolus program is enabled by highlighting and activating a yes value and not enabled by highlighting and selecting a no value. The user activates theNext function200 to index through these

prompts

452 and454. Thepump100 then prompts456 the user to choose whether to enable an audio bolus program. The user selects a yes value to enable the audio bolus program and selects a no value to not enable the audio bolus program and then activates thenext function200.

If thepump100 is preprogrammed with one or more custom meal boluses, thepump100 then prompts458 the user to select whether to review or edit a custom bolus. If the user does not want to review or edit a custom bolus, the user selects no and thepump100 returns to thePersonalize Delivery submenu302. If the user selects yes, the pump indexes to adisplay460 entitled “Custom Bolus,” which lists thenames462 of the available custom programs. In the illustrated example, there are four custom boluses available on the pump, Breakfast, Lunch, Dinner, and Snack.

The screen also presents acheck box464 for each of the custommeal bolus programs462. If a custom meal bolus program is enabled, thepump100 sets thecheck box464. If a custom meal bolus program is not enabled, thepump100 clears thecheck box464. When a custom meal bolus program is enabled, it is displayed in the Meal Bolus submenu434 as a separate menu item. If the custom meal bolus program is not enabled, it is not displayed in theMeal Bolus submenu434 and the user cannot execute the custom meal bolus program.

To enable or disable a custom meal bolus program, the user selects the desired custom meal bolus program and activates theEdit function254. Thepump100 indexes to a display466 entitled “Custom Bolus: X,” where X is thename462 of the selected custom meal bolus program. In the illustrated example, the title of the display466 is “Custom Meal Bolus: Breakfast”. The user interface466 displays468 a default number of carbohydrates for the custom bolus. For example, the user can create a custom breakfast meal bolus that would have a default value of 90 carbohydrates, equal to the number of carbohydrates in a bowl of cereal and milk normally consumed by the user at breakfast. The pump also prompts470 the user to select either a fixed carbohydrate ratio or the previously entered carbohydrate ratio schedule. If the user selects a fixed carbohydrate ratio, the fixed carbohydrate ratio is used with the custom meal bolus program. The value of thecarbohydrate ratio468 may or may not be the same value as thecarbohydrate ratio444. The user enters the carbohydrate ratio by scrolling through values in a predetermined range such as from 0 gm/u to 50 gm/u in increments of 1. When the desired number of carbohydrate ratio is set, the user activates theNext function200 and thepump100 returns to the “Custom Bolus”submenu434.

The user repeats this procedure from the “Custom Bolus”display460 for each custom bolus program for which they desire to change the enabled state. When the user is done changing the enabled states for the available custom meal bolus programs, the user activates theDone function212. Thepump100 then returns to thePersonalize Delivery submenu302.

Additionally, in one possible embodiment, if there are no custom meal bolus programs available for the user to enable, thepump100 automatically returns to thePersonalize Delivery submenu302 after the user instructs456 thepump100 whether to enable an Audio Bolus.

FIG. 20 illustrates administration of a standard meal bolus when thepump100 is set to program meal boluses using grams of carbohydrates. The user selects the meal bolus menu item from themain menu190, and the pump indexes to theMeal Bolus submenu434. Themeal bolus submenu434 lists the available meal bolus programs. Examples include the standard meal bolus program, the extended meal bolus program, the combination meal bolus program, and any enabled custom meal bolus programs. In the illustrated example, only the extended meal bolus program is enabled and the meal bolus submenu includes a Standard Bolus and an Extended Bolus.

The user selects the Standard Menu item and thepump100

prompts

472 the user to enter the number of carbohydrates that the user plans to consume. The user interface also displays thecurrent carbohydrate ratio473. The user sets the desired number of carbohydrates. In one possible embodiment, the user scrolls through carbohydrates in the range from 0 grams to 225 grams.

The user then activates theNext function200 and thepump100 calculates a recommended size for the meal bolus using the equation:

\begin{matrix} Recommended Meal Bolus = \frac{Grams of Carbohydrates}{Carbohydrate Ratio} & (5) \end{matrix}

Thepump100

displays

474 the recommended meal bolus. The user can then adjust the size of the meal bolus by scrolling up or down. In one possible embodiment, thepump100 scrolls in increments of 1. Once the desired bolus amount is set the user activates the Deliverfunction384.

In a further possible embodiment, the recommended meal bolus is altered based on other nutritional information associated with the selected food entries from the food database. For example, the meal bolus can be increased for foods with a large number of proteins and/or fats in addition to the carbohydrates in the food.

In yet another embodiment, the meal bolus is altered based on other nutritional information associated with the selected food entries from the food database. For example, a combination or extended bolus is optionally recommended for foods having a large number of fats in addition to the carbohydrates in the food.

When thepump100 is programmed to enable administration of a correction bolus through a Meal Bolus, thepump100

prompts

472 the user to enter the number of carbohydrates to be consumed. The user then activates theNext function200, and thepump100

prompts

478 the user to enter the amount by which they want to lower their blood glucose level. The user then activates theNext function200, which causes thepump100 to calculate a recommended bolus amount and to display a user interface with a banner482 stating “Bolus to Lower BG X plus Y grams of carbohydrates.” X is the amount by which the user entered to lower the blood glucose level, and Y is the number of carbohydrates that the user entered.

Thepump100 also displays the recommendedbolus amount480 to deliver. The recommendedbolus amount480 is the recommended correction bolus plus the amount of the meal bolus. This feature allows the user to correct a high blood glucose level and deliver additional insulin to work against carbohydrates that they plan to consume. The user can adjust the recommended bolus amount by increasing or decreasing the recommended bolus amount by scrolling up or down. In one possible embodiment, the user scrolls in increments of 0.5 units. Once the desired bolus amount is set, the user activates the Deliverfunction384.

Activating the Deliverfunction384 causes thepump100 to start the countdown timer and display thebanner404 that states a bolus will be delivered in predetermined time. In one possible embodiment, that time is 5 seconds and thebanner404 also states the bolus amount. An example of apossible banner404 states “Bolus X Delivery Starts in 5 Seconds,” where X is the bolus amount. Thepump100 also assigns aStop function406 to thefirst function key138.

If the user activates theStop function406 before the countdown timer times out, thepump100 will terminate delivery of the bolus and return to thehome page152. If the user does not activate theStop function406, when the timer times out, thepump100 will begin to deliver the bolus and display thebanner408 stating that the bolus is being delivered. An example of such a banner is “Bolus X is Delivering”, where X is the bolus amount. When delivery of the bolus is complete, the pump returns to thehome page152.

In an alternative embodiment, when thepump100 is programmed to enable administration of a correction bolus through a Meal Bolus, thepump100 prompts the user to enter their current blood glucose measurement. Thepump100 calculates the current correction factor and also displays the correction factor and the target blood glucose level with the prompt. The user then enters his or her current blood glucose level in units of either mg/dL or mmol/L, by scrolling through a range of values until the current blood glucose level is displayed. In this embodiment, the target blood glucose level and the appropriate units are programmed into the pump when personalizing or customizing the correction bolus program. Once the user enters the current blood glucose level, the user activates theNext function200 and thepump100 calculates a recommended bolus amount and adds it to the meal bolus. Thepump100 displays the user interface with the banner482 “Bolus to Lower BG X plus Y grams of carbohydrates.” The user can then change the amount and activate the Deliverfunction384 to begin delivery of the bolus as described above.

Additionally, in one possible embodiment, thepump100 adjusts the recommended bolus based on the meal bolus or the meal bolus plus the correction bolus to accommodate insulin on board or residual insulin that is still working within the user's body. In this embodiment, the amount of the adjusted correction bolus is adjusted using the equations described above in conjunction with the duration-of-activity function. The methods of adjusting the bolus amount for insulin on board is described herein.

In a further possible embodiment, thepump100 logs the meals selected by the user and for which meal boluses are delivered. The pump optionally logs nutritional information related to the meals, such as information related to carbohydrates, fats, or proteins. Other nutritional information can be logged as well.

In yet another embodiment thepump100 generates and presents reports to the user. The reports can include historical food intake, as well as cumulative nutritional information of the foods consumed.

FIG. 21 illustrates administration of an extended bolus. The user selects the meal bolus menu item from themain menu190, and thepump100 indexes to aMeal Bolus submenu434. Themeal bolus submenu434 lists the available meal bolus programs including the extended bolus program. In the illustrated example, the extended meal bolus program and the combination bolus program are enabled and the meal bolus submenu includes menu items for a standard bolus, an extended bolus, and a combination bolus.

The user selects the Extended Bolus menu item and, when thepump100 is set to program in units of insulin, the pump prompts484 the user to enter the number of units to deliver. In one possible embodiment, the user can scroll through values in the range from 0 units to 17 units in increments of 0.5 units. When the number of units for delivery are entered, the user activates theNext function200 and thepump100

prompts

486 the user to enter the duration of length of time over which the extended bolus is to be delivered. In one possible embodiment, the user enters a duration in the range of 0 minutes to 6 hours in increments of 30 minutes.

When the duration is set, thepump100 displays auser interface488 that presents the programmedamount490 of the extended bolus and theduration492 over which it is to be delivered. To begin delivery of the extended bolus, the user activates the Deliverfunction384. Thepump100 then begins delivering the extended bolus and will complete delivery upon expiration of the duration.

Alternatively, when thepump100 is set to program in grams of carbohydrates, thepump100

prompts

484′ the user to enter the grams of carbohydrates that the user plans to consume rather than the units of insulin to deliver as an extended bolus. Thepump100 also prompts486 the user to enter the duration for the extended bolus. Thepump100

displays

485 the carbohydrate ratio while prompting the user to enter the grams ofcarbohydrates484′ and theduration486. Thepump100 then calculates a recommendedbolus amount490′ using the carbohydrate ratio as described above and displays the recommendedbolus amount490′, together with theduration492 in a user interface that confirms the parameters for delivery of the extended bolus. The user can adjust the recommendedamount490′ for the extended bolus by scrolling with the up and down

keys

142 and144. The user activates the Deliverfunction384 to begin delivery of the extended bolus using the parameters displayed in the user interface.

After delivery of the extended bolus begins, if thepump100 is programmed to enable administration of a correction bolus through the Meal Bolus program, thepump100

prompts

494 the user to enter the amount by which they want to lower their blood glucose level. The user then activates theNext function200 and thepump100

prompts

496 the user to enter the number of units to deliver as a meal bolus. In one possible embodiment, the user enters the amount by scrolling through values in units of either mg/dL or mmol/L. When the desired drop in blood glucose is entered, the user activates theNext function200, which causes thepump100 to calculate a recommended bolus amount and to display thebanner497 “Bolus to Lower BG X.” X is the amount by which the user entered to lower the blood glucose level.

The prompt496 initially displays the recommended bolus amount to deliver. The recommended bolus amount is the recommended

correction bolus

490 or490′, which thepump100 calculates using the correction factor as discussed above. This feature allows the user to correct a high blood glucose level and deliver additional insulin to work against carbohydrates that they plan to consume. The user can adjust the recommendedbolus amount496 by increasing or decreasing the recommendedbolus amount496 by using the up and down

keys

142 and144. In one possible embodiment, the user scrolls in increments of 0.5 units. Once the desired bolus amount is set, the user activates the Deliverfunction384.

Activating the Deliverfunction384 causes thepump100 to display thebanner404 that states a bolus will be delivered in predetermined time. In one possible embodiment, that time is 5 seconds and thepump100 displays thebolus amount496 in the banner. An example of a possible user interface states “Bolus X Delivery Starts in 5 Seconds,” where X is the amount of the correction bolus. Thepump100 also assigns theStop function406 to thefirst function key138.

If the user activates theStop function406 before the countdown timer times out, thepump100 will terminate delivery of the correction bolus and return to thehome page152. In one possible embodiment, activating theStop function406 will terminate delivery of the correction bolus, but not the extended bolus. If the user does not activate theStop function406, when the timer times out, thepump100 will begin to deliver the bolus and display thebanner408 stating that the bolus is being delivered. An example of such a banner is “Bolus X is Delivering”, where X is the bolus amount. When delivery of the bolus is complete, thepump100 returns to thehome page152. In an alternative embodiment, no timer is included in the pump and thepump100 begins delivering the correction bolus immediately.

In an alternative embodiment, when thepump100 is programmed to enable administration of a correction bolus through a Meal Bolus, thepump100 prompts the user to enter their current blood glucose measurement. Thepump100 calculates the current correction factor and displays the correction factor in the user interface. Thepump100 also displays the target blood glucose level. The user then enters his or her current blood glucose level in units of either mg/dL or mmol/L, by scrolling through a range of values until the current blood glucose level is displayed. In this embodiment, the target blood glucose level and the appropriate units are programmed into thepump100 when personalizing the correction bolus program. Once the user enters the current blood glucose level, the user activates theNext function200 and thepump100 calculates a recommended bolus amount and adds it to the meal bolus. Thepump100 displays the user interface with the banner “Bolus to Lower BG X plus Y Meal Bolus.” The user can then change the amount and activate the Deliverfunction384 to begin delivery of the bolus as described above.

Additionally, in one possible embodiment, thepump100 adjusts the recommended correction bolus based on the meal bolus or the meal bolus plus the correction bolus to accommodate insulin on board or residual insulin that is still working within the user's body. In this embodiment, the amount of the adjusted correction bolus is adjusted using the equations described above in conjunction with the duration-of-activity function. The methods of adjusting the bolus amount for insulin on board is described herein.

Referring toFIG. 22, the user can halt delivery of an extended bolus by activating theStop function172 on thehome page152. As described above, thepump100 prompts the user to halt all delivery or just the extended bolus. The user selects the extended bolus. Thepump100 then prints thebanner386 indicating how much time remains in the duration for the extended bolus and how much of the extended bolus remains to be delivered. Thepump100 also prompts the user to confirm that insulin delivery is to be stopped. The user confirms by activating theYes function178. Thepump100 then stops delivery of the extended bolus and returns to pumping according to the normal basal rate. If the user activates the Nofunction180, thepump100 will continue delivering according to the extended bolus and will return to thehome page152. The user optionally stops all delivery of insulin from thepump100 using the All Delivery option.

Referring toFIG. 23, delivery of a combination bolus is programmed into the pump in a manner similar to that of an extended bolus. However, the pump also prompts498 the user to enter the proportion or percent of the bolus that thepump100 delivers immediately upon activation of the Deliverfunction384. To enter the proportion of the amount that is delivered immediately, the user scrolls through percentages until the desired percentage of the bolus for immediate delivery is set. In one possible embodiment, the user scrolls through percentages in the range from 0% to 100% in increments of 1. Additionally when programming the pump to deliver a combination bolus, thepump100

displays

500 the percentage of the bolus that is to be delivered immediately in theconfirmation user interface488. In an alternative embodiment, the user enters the proportion or percent of the bolus that thepump100 delivers over an extended period.

Referring toFIG. 24, the user can suspend delivery of a combination bolus in a manner substantially similar to that of the extended bolus except that thepump100 displays a combination bolus menu item in the suspend menu. The user selects the combination bolus menu item to suspend delivery of the combination bolus, and then confirms suspension of the combination bolus.

L. Weekly Schedule

A weekly schedule can be created and preprogrammed into thepump100. The weekly schedule allows the user to schedule a pattern of basal rates for individual days of the week, and also allows the user to schedule a set of missed meal bolus alerts for individual days of the week. The weekly schedule allows a user to preprogram one or more basal rates as described above in conjunction withFIGS. 10-11, and to preprogram one or more meal bolus alert sets as described above in conjunction withFIGS. 16-20.

Referring toFIG. 25, thepump100 presents an editable weekly schedule to accommodate a user's specific insulin delivery requirements. For example each user may have varying meal times, activity levels, or insulin absorption rates which will affect the basal rate and bolus timing required of thepump100. In the example shown, the user selects an Edit Schedule item optionally included in themain menu190, and thepump100 indexes focus to anedit schedule submenu500. Theedit schedule submenu500 can be used in addition to or as a substitute for the basal programs option in thePersonalize Delivery submenu302 described above. Theedit schedule submenu500 lists the available editing options for the temporary rates, weekly schedule, basal patterns, and correction boluses. In the example shown, the menu items are displayed as “Temp Basal Pattern”, “Edit Weekly Schedule”, “Edit Basal Patterns”, and “Edit Missed Meal Alert”, respectively. Other menu items or names for menu items are possible as well.

The user selects one of the menu items to edit the corresponding aspect of the weekly schedule. If the user selects the Temp Basal Pattern option in theedit schedule submenu500, thepump100 indexes focus to a start temporarybasal pattern screen502 which allows the user to indicate when to start the temporary basal pattern. A temporary basal pattern is a basal pattern that overrides, for a day, the basal pattern scheduled in the weekly schedule. For example, if a pump user has to occasionally work on Saturday, they can schedule their “Weekday” pattern to temporarily override their “Weekend” pattern for the Saturday they must work. Selecting the Temp Basal Pattern option allows the user to have a temporary basal pattern applied by thepump100 for the remainder of the current day and a second temporary basal pattern programmed to take effect the following day as well. A temp basalpattern start box503 displays the time at which the temporary basal pattern will begin. In the start temporarybasal pattern screen502 shown, the temp basalpattern start box503 indicates that the basal pattern will start immediately. To select a different time at which the temporary basal pattern will begin, the user can change the setting in the temp basalpattern start box503 using the up and down keys. Other start times, such as delayed by an hour, a day, or other time period are possible. A back option returns focus to theedit schedule submenu500.

Upon confirmation of the temp basal pattern start time by selecting a next option, thepump100 indexes focus to a selecttemp pattern screen504. The selecttemp pattern screen504 prompts the user to select the temporary basal pattern that is to be applied. The user selects from the list of basal patterns505 programmed or loaded into and enabled in the pump. In the example shown, “Weekday”, “Weekend”, “Sick Day”, and “Basal Pattern 4” are listed as selectable options. Other lists or combinations of basal patterns can be displayed as well, depending upon the patterns created or loaded into thepump100. The user selects one of the basal patterns using up and down

keys

142,144. Upon selection of a basal pattern and confirmation of the selection with a select option, focus returns to amain menu190. A back option in the selecttemp pattern screen504 returns focus to the start temporarybasal pattern screen502.

If the user selects the Edit Weekly Schedule option in theedit schedule submenu500, thepump100 indexes focus to a day program screen506, which displays the basal pattern and missed meal pattern associated with that day. In the day program screen506 shown, the day displayed is Monday, and the basal pattern isPattern 1. The missed meal bolus alarm set is shown asSet 1. The up and down

keys

142,144 navigate through the days of the week, and an edit option507 indexes focus to a day edit screen508. The day edit screen508 displays the basal pattern assigned to the day in a basal pattern field509, and allows the user to edit the basal pattern for the day selected in the day program screen506. The user changes the basal pattern using the up and down

keys

142,144, among the basal patterns edited using the Edit Basal Patterns option in theedit schedule submenu500. The user also optionally selects a missed meal bolus alert set to associate with the selected day, from a listing of missed meal bolus alert sets programmed using the Edit Missed Meal Alert option in the edit schedule submenu. A back option and a next option both cause thepump100 to index focus back to the day program screen506.

If the user selects the Edit Basal Patterns option in theedit schedule submenu500, thepump100 displays a basal pattern listing510 including basal patterns programmed into the pump. The basal pattern listing510 displays one or more editable basal patterns which are available to be scheduled in the day edit screen509 or used as temporary basal patterns in theselect rate screen504. The basal pattern listing510 displays the defined basal patterns, and allows a user to select one of the predefined basal patterns using the up and down

keys

142,144. The user selects a back option to return to theedit schedule submenu500, or selects aselect option511 to cause thepump100 to index focus to apattern view screen512 related to the selected basal pattern. Thepump100 displays a listing of times and associated delivery rates in thepattern view screen512 for the basal pattern selected in the basal pattern listing510. If the user does not wish to edit the times displayed, the user selects a back option to return to the basal pattern listing510. To edit one or more of the times and/or basal patterns, the user selects anedit option513 to cause thepump100 to index focus to apattern edit screen514. Thepattern edit screen514 displays on thepump100 and allows the user to change the times and basal rates, or add additional times with associated basal rates. The user employs the up and down

keys

142,144 to select and edit the times of the day, as well as to select and edit the basal rates associated with the times of the day. A doneoption515 indicates that the user has completed editing the basal pattern, and causes thepump100 to index focus back to thepattern view screen512. A next option517 indexes focus within thepattern edit screen514.

If the user selects the Missed Meal Alert option in theedit schedule submenu500, the pump indexes focus to a missedmeal alert listing516. The missedmeal alert listing516 includes one or more sets of alerts configured to match the planned meal times of the user. The sets of alerts correspond to the alerts selected using the day edit screen508. If thepump100 does not deliver a meal bolus between the start and end time of a missed meal alert, the user may have forgotten to deliver the meal bolus and is prompted to deliver the meal bolus. The meal bolus can be programmed according to the meal bolus and food database description above. The user can select one or more missed meal alert sets using selection boxes associated with each of the missed meal alert sets. Aselect option519 causes the pump to index focus to an alert enablescreen518.

The alert enablescreen518 displays the enabled or disable status of the missed meal alert set selected in the missedmeal alert listing516, and also displays the name of the alert set. A next option indexes focus to analert listing520 associated with the alert set displayed in the alert enablescreen518. A back option returns focus to the missedmeal alert listing516.

Upon user selection of the next option, thepump100 indexes focus to thealert listing520, which displays all of the defined missed meal alerts associated with a missed meal alert set. The user can select one or more of the alerts in the alert listing which the user wishes to edit. Upon selection of aselect option519, thepump100 indexes focus to analert edit screen522. A back option returns focus to thealert listing screen520.

Thealert edit screen522 allows the user to set a start time and an end time for the selected alert in the missed meal alert set. Upon selection of anext option523 in thealert edit screen522, thepump100 returns focus to the missedmeal alert listing516. A back option in thealert edit screen522 returns focus to thealert listing520.

In a possible embodiment of the weekly schedule, thehome screen152 can be modified to display information related to the weekly schedule as programmed, such as the current day of the week, the type of day or basal rate currently applied, the name of the basal rate pattern, the missed meal alert set applied, or other information related to the weekly schedule.

Although specific examples are illustrated herein, the weekly schedule can be used to schedule basal rates, delivery patterns, and boluses for various events such as different daily meal schedules, upcoming athletic events, travel schedules, work schedules, sick days, parties, and any other type of schedule or event. Additionally, sets of scheduled target blood glucose levels, such as are related to a correction bolus or negative meal bolus, can be created. In an alternative embodiment, a weekly schedule could also be used to remind the user of other events such as testing blood glucose levels.

The weekly schedule disclosed herein is modifiable to provide to a user a monthly or yearly schedule as well. The monthly or yearly schedule can be programmed with monthly or yearly meal boluses, and can track holidays, vacations, or other events which occur outside the user's typical daily or weekly schedule.

M. Disconnect/Suspend Bolus

Referring back toFIG. 3, a disconnect/suspend bolus feature is included in thepump100, and can be added to themain menu190. The disconnect/suspend bolus feature193 allows a user to disconnect from thepump100 for up to two hours without missing delivery of insulin, although other embodiments will permit disconnecting the pump for periods greater than two hours. A user may want to disconnect from thepump100 for a variety of reasons, such as for bathing, high levels of activity, or in other situations in which a pump may be inconvenient or unsafe.

When the user wishes to disconnect from thepump100, the user is first prompted by thepump100 to enter the duration they will be disconnected from the pump. Thepump100 calculates and displays the amount of insulin delivery which will be missed in that time. This includes any basal rate and temporary rate scheduled during that time. Thepump100 prompts the user to enter a percentage of the missed insulin that the user wishes to receive as a bolus prior to disconnecting from the pump, and accepts any percentage value up to 100% of the total insulin delivery that will be missed, although other embodiments might include a limit other than 100%. This percentage bolus delivered prior to disconnection can be referred to as a disconnect bolus.

Thepump100 prompts the user to optionally check their blood glucose level prior to disconnecting from the pump. If the user chooses to check their blood glucose level and requires a correction bolus, the correction bolus is delivered prior to disconnection. If the user chooses to check their blood glucose level and the negative meal bolus feature would normally activate, thepump100 reduces the disconnect bolus to compensate for the user's low blood glucose level.

Upon confirmation by the user, the pump stops all basal rate delivery, logs the disconnection time, the percentage of immediately delivered insulin as selected, and delivers the disconnection bolus, which is the bolus amount calculated by the pump and multiplied by the percentage input by the user. Once the bolus delivery is complete, thepump100 triggers an alarm, such as a visible alarm displayed on the pump or an audible alarm emitted by the pump, indicating to a user that they should disconnect from the pump. In the exemplary embodiment, the pump requests confirmation by the user that they are disconnected from the pump. Once confirmation is received from the user, the pump adds a “reconnect” option into themain menu190. The pump stores its disconnected state and the elapsed disconnection time, such that the pump status is retained during the disconnect/suspend bolus operation even if the pump power is interrupted during the disconnect period, or if the user changes the time or date in thepump100.

When thepump100 remains in the disconnected state, the user can physically reconnect their infusion set and configure the pump to deliver a meal bolus or a correction bolus. Thepump100 maintains the interrupted basal rate during the time that the pump is in the disconnected state.

When the user begins the reconnect process by selecting the reconnect option on the main menu, thepump100 calculates the originally scheduled insulin dose, which is the amount of insulin originally scheduled to be delivered during the elapsed time between the time the pump was disconnected and the time the reconnect option is selected on the main menu. The pump then subtracts the originally scheduled insulin dose from the dose delivered by disconnection bolus the dose. If the difference is a negative number, the user has reconnected before the time they had indicated, and the pump should not deliver additional insulin to the patient upon reconnection. Thepump100 starts a temporary rate of zero units per hour for the time required for the basal rate and boluses to make up for that negative amount. If the amount of insulin owed is a positive number, thepump100 prompts the user to enter the percentage of that “missed” amount that they wish to have delivered, up to 100%. This percentage of missed insulin is referred to as the reconnect bolus.

Thepump100 prompts the user to optionally check their blood glucose level before reconnecting. If the user chooses to check their blood glucose level, any correction bolus deemed necessary will be added to the reconnect bolus. Likewise, if the user chooses to check their blood glucose level, any negative meal bolus will be subtracted from the reconnect bolus.

N. Additional Pump Features

Additional features can be included in the pump consistent with the present disclosure. For example, the pump can include programming for temporary basal rates, an option to include an audio bolus, customized alerts, and lock levels. A temporary rate allows the user to temporarily raise or lower the delivery rate being administered by the active bolus program. The user can personalize or customize the temporary rate programs and how they are present in the user interface. An audio bolus provides for delivery of a standard meal bolus using a single button. A series of sounds, such as beeps, are used to provide an indication of the setting to the user. In a possible embodiment, the beeps are configured analogously to the sounds used to program thepump100 without the need for visual confirmation, such as by a visually impaired user. Customizable alerts allow a user to select specific alerts for various types of events occurring in the pump. Lock levels provide various levels of user rights in the pump based on access codes. Lock levels prevent unauthorized users from entering and changing settings in the pump. These and additional pump features are described in greater detail in U.S. Pat. No. 6,744,350, filed Feb. 28, 2002 and entitled Insulin Pump Having Missed Meal Bolus Alarm, the disclosure of which was incorporated by reference in its entirety above.

O. Computer-Pump Communication and Programming

In one possible embodiment, thepump100 can communicate with a computer. The computer can upload information from thepump100, including the historical information generated by and stored on thepump100. The computer can archive the historical information and maintain a complete historical record about thepump100. Additionally, the computer can generate various reports regarding use of thepump100, including information about delivery rates, bolus amounts, and alarms. Additionally, the computer can operate a program that allows the user to enter operating parameters for the various delivery programs that are loaded on thepump100 and to download those operating parameters to thepump100. In yet another possible embodiment, the computer can be used to download delivery programs and software updates to thepump100.

Referring toFIG. 26, in one possible embodiment, a computer534 is a desktop computer that is IBM PC compatible, although other computers can be used. For example, the computer534 could be an Apple computer, portable computer, a hand-held computer, a mainframe computer, a computer that is connected to a network. The computer534 has amonitor536, astorage device538, and an infrared (IR)communication port540. Thepump100 communicates with the computer through theIR port120 on thepump100 and theIR communication port540 of the computer534. In other embodiments, thepump100 and computer534 communicate through other types of data links such as a wireless or radio frequency (RF) connection or a wired connection such as USB, RS232, Fire wire, etc.

Communication between a medical pump and a computer is also discussed in U.S. Pat. No. 5,935,099, entitled Drug Pump Systems and Methods, the disclosure of which is hereby incorporated by reference.

Referring toFIG. 27A, the software operating on the computer534 generates auser interface542 that allows a user to view, edit, and enter operating parameters for the various delivery programs that are loaded on theinsulin pump100. In one possible embodiment, theuser interface542 has a plurality of stackedprimary windows544a-544e. Each primary window includes a tab546a-546eand data entry features for entering profile settings for the delivery programs. A basal programs primary window544ais associated with the basal delivery programs, and is marked with a tab546abearing the name Basal Programs. A meal bolusesprimary window544bis associated with the meal bolus delivery programs, and is marked with a tab546bbearing the name Meal Boluses. A correction boluses primary window544cis associated with the correction bolus deliver programs, and is marked with a tab546cbearing the name Correction Boluses. A temporary ratesprimary window544dis associated with the temporary rate delivery programs, and is marked with tab546dbearing the name Temporary Rates. Abanner window544ecan include display options for thepump100, and is marked with tab546ebearing the name Banner. A weekly schedules primary window544fis associated with the weekly schedule programs, and is marked with tab546fbearing the name Weekly schedule.

Aprimary window544 can include a variety of different data entry features for entering the operating parameters including text, numbers, flags, or the like. Examples of the data entry features include buttons, check boxes, spin boxes, text fields, numeric fields, and tables. The buttons and check boxes are alternatively set and cleared by clicking on them with a pointing device such as a mouse. Each spin box is associated with up and down buttons and contains a list of values. The user sets the desired value by spinning though the list of values with the up and down keys until the desired value is visible in the spin box. The tables have rows of cells and a scroll bar. The user can manipulate the scroll bar with a pointing device to scroll through the available rows within the table. Additionally, each primary window has a download button, an upload button, and a save button.

The primary window on the top of the stack is active, and the user can enter, edit, and view operating parameters in the active primary window. The user can bring any one of the primary windows to the top of the stack by clicking on the primary window's tab.

Still referring toFIG. 27A, the first primary window544a, which is for setting the operating parameters for the basal programs, has three panels. Thefirst panel548 has a spin box550 for setting the maximum basal rate for the insulin pump. The spin box550 is displayed in a first group box549. The user spins though available values until the desired maximum basal rate is visible within the spin box550. The maximum basal rate set in the spin box will apply to all of the basal delivery programs. In the illustrated example, there are four possible basal delivery programs. The first spin box550 is present in a first group box.

The second panel552 of the screen has one secondary window554a-554dfor each of the basal delivery programs. The secondary windows are stacked and are marked with tabs556a-556d. Each tab556 is marked with the name of the basal program associated with the tab's secondary window554. The secondary window554 on the top of the stack is active, and the user can enter, edit, and view operating parameters in the active secondary window. The user clicks on the tab556 for any given secondary window to bring it to the top of the stack. In the illustrated example, there are four basal delivery programs and hence four secondary windows namedBasal 1554a,Basal 2554b,Basal 3554c, andBasal 4554d.

To display the basal delivery program as a menu item in the Basal Program submenu318 (FIG. 12) on thepump100, the user sets thecheckbox560. When the operating parameters for the basal programs are downloaded to thepump100, the name for the basal program is displayed as a menu item in theBasal Program submenu318.

To customize the name of the basal delivery program, the user types the custom name into thetext field562. The custom name is assigned to the basal delivery program and appears in the tab556 for that program. Additionally, the custom name is the name downloaded into thepump100 and appears in theBasal Program submenu318, if thecheckbox560 is set. In an alternative embodiment, a spin box is associated with thetext field562. The spin box presents preprogrammed, optional names for the basal delivery programs that the user can select. The selected name would then replace the generic name (e.g.,Basal 1,Basal 2,Basal 3, andBasal 4 in the illustrated example) for the program associated with the display. Examples of optional names that might be loaded in thepump100 include weekday, weekend, sick, and monthly (which is to designate a basal delivery program set for a woman's menstrual cycle).

The basal rate table566 or grid has a plurality ofrows572 and each row has twocells574 and576. When a cell within the table566 has focus and the user presses the enter key or the tab key, the focus shifts to the next cell to the right. If the current cell is the last cell in the row, focus shifts to the first cell in the next row. If the user presses the enter key while the last cell in the last row is in focus, a new row is created. In this manner, the user can expand the length of the table572. If the user presses the enter key while the last cell of a row is in focus and there is no data in any cell within that row, the computer will delete the row. The one exception is the first row in the table, which cannot be deleted.

The first cell within a row is a start-time cell574, and the second cell within a row is a delivery-rate cell576. Each row corresponds to a different interval in the delivery protocol for the basal delivery program. To set the delivery protocol for a basal program, the user enters the start time for each delivery interval in the start-time cell574 and the delivery rate in the delivery-rate cell576. Thepump100 will then deliver at the set delivery rate beginning at the set start time and until the start time for the next delivery interval. In one possible embodiment, the start time for the first interval is 12:00 midnight and cannot be changed.

Accordingly, to set the delivery protocol for the basal delivery program, the user types the start time in the start-time cell574, hits the enter key and changes the focus to the delivery-rate cell576 to the right. The user then types in the delivery rate for that interval, hits the cell key, and changes the focus to the start-time cell in the next row (creating the row if the next row does not already exist). A new row will appear in which the user can enter the operating parameters for another delivery interval. The user continues this process until the operating parameters for all of the desired intervals are entered into the table.

In an alternative embodiment, when a cell has focus, a spin box having up and down buttons is presented in that cell. The user can either type a value into the spin box or spin through values until a desired value is visible in the spin box. When the cell and hence the spin box loses focus, the visible value from the spin box is entered into the corresponding cell and the spin box becomes invisible.

The graph568 provides a graphical illustration of the delivery rate for the basal delivery program over a 24-hour period. In one possible embodiment, the graph568 is a bar chart illustrating the delivery rate in a resolution of 30 minutes. In the illustrated example,Basal 1 is set to deliver 2 units/hour from 12:00 midnight to 2:00 am, 2.5 units/hour from 2:00 am to 3:00 am, etc.

In one possible embodiment, the graph568 is automatically updated as the user completes entering the start time and delivery rate for each delivery interval. Additionally, the total daily basal rate is displayed578, and is automatically calculated and updated as the user completes entering the start time and delivery rate for each delivery interval. Entry of data for an interval is complete when the user enters the start time and delivery rate for the interval and exits both the start-time cell574 and the delivery-rate cell576.

The third panel580 presents instructions to the user. In one possible embodiment, the user interface presents a help label582 (e.g., the question mark in the illustrated example) in each of thegroup boxes549,564, and570. When the user clicks on ahelp label582, instructions specific to the group box or other aspects of the user interface associated with the help label are presented in the third panel. Alternatively, the user can point to a particular aspect of the user interface and right click on the mouse to present field-specific instructions in the third panel.

An additional panel (not shown) can include control options for performing a basal test. The additional panel will include options to set up and review the results of the basal test. The additional panel will have analogous functionality to that described above in conjunction withFIGS. 7-9.

FIG. 27B illustrates the secondprimary window544b, which is for setting the operating parameters of the meal bolus delivery programs. The meal bolus primary window includes two panels. Thefirst panel584 has a pair buttons586, a first spin box588, a second spin box590, a third spin box592, a fourth spin box594, afirst check box596, asecond check box598, athird check box600, a fourth check box601 and a meal bolus table602.

The pair of buttons586, spin boxes588,590 and table591 are present in a first group box604. The

check boxes

596,598,600, and601 are presented in a second group box606, and the table602 is present in a third group box608. Spin boxes592 and594 are present in afourth group box610. The pair of buttons586 is for setting the meal bolus delivery program to use either units of insulin or grams of carbohydrates. The pair of buttons586 toggle between set and cleared states so that when one is set the other cleared. The user set the first button to program the meal bolus programs in units of insulin and sets the second button to program the meal bolus programs in grams of carbohydrates

The first spin box588 is for setting the maximum bolus that thepump100 can deliver when executing the meal bolus program. The second spin box590 is for setting the duration of the bolus. The table591 is for setting the user's fixed carbohydrate ratio. The table591 optionally also works in conjunction with functionality to set a schedule of carbohydrate ratios configured to change based on the time of day.

In thefourth group box610, the spin box592 is for programming in units of insulin and is for setting the increments at which a user can spin through bolus amounts. The spin box594 is for programming in grams of carbohydrates and is for setting the increments at which a user can spin through grams of carbohydrates to be consumed in a meal.

When the user sets the first button for programming in units of insulin, the third spin box592 is enabled and the fourth594 spin box is disabled. When the user sets the second button for programming in grams of carbohydrates, the fourth594 spin boxes is enabled, and the third spin box592 is disabled.

To enable the extended bolus program, the user sets thefirst check box596. To enable the combination bolus program, the user sets thesecond check box598. To enable the audio bolus function, the user sets thethird check box600.

To enable to food database, the user sets thefourth check box602. Selection of thefourth check box602 can optionally trigger creation of another window (not shown) used for browsing a food database stored on the computer.

The custom meal bolus table608 has a plurality of rows, and each row has a plurality of cells. The user navigates through the meal bolus table608 using procedures substantially similar to that of the basal rate table. Also similar to the basal rate table, the custom meal bolus table608 can have various spin boxes that become visible when a cell has focus. The spin boxes are for entering values and pre-typed text into the cell with which it is associated.

Within the meal bolus table608, each row has seven cells. The first cell612 has a check box613. To enable the custom meal bolus defined by that row, the user sets the check box613. Thesecond cell614 has a text field in which the user types a name to identify the custom meal bolus defined by that row. An example includes pizza, when the operating parameters for the custom meal bolus are customized to deliver insulin for working against a meal of pizza. Other examples, might include breakfast, lunch, dinner, snack, or any other specific type of food, drink, or meal.

Thethird cell616 contains a text field for entering the type of custom meal bolus, whether it is a standard bolus, an extend bolus, or a combination bolus. In one possible embodiment, a spin box is presented in thethird cell616 when focus is placed on the cell. The user can then spin through the types of bolus (e.g., standard, extended, or combination) and set the desired type. The fourth cell618 is a numeric field for entering the default number of carbohydrates to be delivered by the bolus program defined by that row. Thefifth cell620 is a duration field in which the user enters the duration of the bolus delivery if the bolus program defined by that row is an extended bolus or a combination bolus. Thesixth cell622 is a numeric field in which the user enters the percent of the bolus to be delivered immediately if the bolus program defined by that row is a combination bolus.

If the type of meal bolus set in the third cell (Type of Meal Bolus)616 is standard, the fifth cell (Duration)620 and sixth cell (% as Immediate)622 are disabled and cleared. If the type of meal bolus set in thethird cell616 is an extended bolus, thefifth cell620 is enabled and thesixth cell622 is disabled and cleared. If the type of meal bolus set in thethird cell616 is set as a combination bolus, the fifth620 and sixth622 cells are enabled.

Also, the fourth cell618 allows a default number carbohydrates for the custom bolus to be entered. For example, if a user eats a 40 gram carbohydrate snack before bed each night, a custom meal bolus called “Bedtime Snack” could be created with a default carbohydrate value of 40 grams. The default value can be adjusted before the bolus is delivered.

An optional second panel (not shown) in theprimary window544bfor the meal bolus delivery program presents instructions. It operates in a manner substantially similar to the third, instruction panel580 in the first primary window544afor the basal rate delivery programs as described above.

FIG. 27C illustrates the third primary window544c, which is for setting the operating parameters for the correction bolus delivery program. The primary window544ccan contain two panels. The first panel628 has buttons, check boxes, and spin boxes. Afirst group box630 in the first panel628 has first andsecond check boxes632 and634. To control thepump100 to make the correction bolus delivery program available through themain menu190 and to display a correction bolus menu item in themain menu190, the first check box632 is set. To make the correction bolus program available through the meal bolus delivery programs described above, thesecond check box634 is set.

Atable control638 resides within asecond group box640, and sets a schedule of correction factors. The correction factors define operating parameters used by the correction bolus program. The table control allows the user to define a start time and a Factor, which refers to the amount of correction which could occur at that time of day. Alternately, a pair of buttons set the units for the operating parameters used by the correction bolus program. The pair of buttons toggle between set and cleared states so that when one is set the other is cleared. The first button is set to use mg/dL and the second button is set to use mmol/l. A first spin box is for setting the correction bolus factor. When the first spin box is in focus, the user spins through value until the desired correction factor is set. The pair of buttons and the first spin box are optionally organized into thesecond group box640.

A third group box635 has buttons and a table control. The buttons636 set the method by which blood glucose is measured. In the embodiment shown, the buttons636 allow a user to select between units of mg/dl and mmol/L.The table control637 defines one or more target blood glucose levels and associates the target blood glucose levels with times of the day. In an optional embodiment, thetable control637 allows a user to define a schedule or target blood glucose levels for one or more days.

A fourth group box644 in the first panel628 has buttons and spin boxes. Asecond spin box642 is for setting the duration of activity or action for the insulin. As discussed above, the duration of activity is the length of time that each bolus remains working in the user's body. To enter the duration of activity, the user spins through values in thesecond spin box642 until the desired value is set. Optional spin boxes (not shown) set the start time and tail time of an insulin absorption model. To enter the start and tail times, the user spins through the values in the respective spin boxes until the desired values are set. Buttons may set the insulin absorption model to be used in the pump by toggling between set and cleared states so that when one is set the other two buttons are cleared. Each button can correspond to a linear absorption model such as is shown inFIG. 14A, a nonlinear absorption model, such as is shown inFIG. 14C, or a custom absorption model, using a graphical user interface which optionally appears upon selection of the button (not shown).

Afifth group box631 enables and sets the change in the correction factor based on the user's blood glucose level. Acheck box633 enables changes in the correction factor based on the user's current blood glucose level, of the form “If blood glucose is at least X, add Y %.” A series of spin boxes635 set the threshold blood glucose reading at which the rule takes effect for one or more rules, and represents the “X” value in the above statement for each selected rule. A second series ofspin boxes637 sets the percentage increase in insulin delivery upon reaching the threshold blood glucose level, and represents the “Y” value in the above statement for each corresponding selected rule. In the implementation shown, four separate sets of spin boxes are used to set four blood glucose dependent rules for insulin delivery. However, more or fewer sets of spin boxes are included according to specific implementations of thegroup box631 and correction factors.

An optional second panel (not shown) in the primary window544cfor the correction bolus delivery program presents instructions. It operates in a manner substantially similar to the third, instruction panel580 in the first primary window544afor the basal rate delivery programs as described above.

FIG. 27D illustrates the fourthprimary window544d, which is for setting operating parameters for the temporary rate programs. Theprimary window544dhas two panels. Thefirst panel648 has a first check box650, asecond check box652, athird check box654, a pair ofbuttons656, a spin box658, and a temporary rate table660. The first check box650 and pair ofbuttons656 are in afirst group box662. The second652 and third654 check boxes and the spin box658 are in asecond group box664. The table660 is in athird group box666.

The pair ofbuttons656 sets the temporary rate either as a percentage of the running basal rate or as a new temporary basal rate. The pair ofbuttons656 toggle between set and cleared states so that when one button is set the other button is cleared. The user sets the first button to set the temporary rate as a percent of the basal rate. The user sets the second button to set the temporary rate as a new, temporary basal rate.

To set a reminder so that thepump100 intermittently generates a reminder (audible and/or vibratory) while the temporary rate program is running, the user sets thesecond check box652. When thesecond check box652 is set, the spin box658 is enabled. The spin box658 is for setting the interval between reminders. The spin box658 is disabled when thesecond check box652 is cleared. To set thepump100 to generate a final reminder upon completion of the temporary rate, the user sets thethird check box654.

The temporary rate table660 has a plurality of rows668, and each row668 contains a plurality of cells. The user navigates through the temporary rate table660 using procedures substantially similar to that of the basal rate table. Also similar to the basal rate table602, the temporary rate table660 can have various spin boxes that become visible when a cell has focus. The spin boxes are for entering values and pre-typed text into the cell with which it is associated.

Within the temporary rate table660, each row has six cells. The first cell670 has acheck box672. To enable the temporary rate defined by that row, the user sets thecheck box672. Thesecond cell674 has a text field in which the user types a name to identify the temporary rate defined by that row. Examples might include exercise, 5-mile run, sick, evening, and the like. The third cell676 is a text field to set the temporary rate to be programmed as a percent of current basal rate or as a new rate. In one possible embodiment a spin is present in the third cell676 when focus is place on the cell. The user then spins through the types of temporary rates (e.g., % of Basal or New Rate) and sets the desired type.

Thefourth cell678 is for assigning the percentage of the running basal rate to set as the temporary rate. The fifth cell680 is for setting a new rate for the temporary rate. When the user enters % of basal in the third cell676, thefourth cell678 is enabled and the fifth cell680 is disabled. When the user enters New Rate in the third cell676, thefourth cell678 is disabled, and the fifth cell680 is enabled. Thesixth cell682 is for setting the duration of the temporary rate.

Additionally, in one possible embodiment, when the user sets the first button to adjust the delivery rate as a percent of the basal rate, thecheck box672 is set in the first cell670 for each row668 in which there is a percentage in thefourth cell678. Thecheck box672 in the first cell670 is cleared for each row668 in which there is a delivery rate value in the fifth cell680. Similarly, when the user sets the second button to use a new delivery rate, thecheck box672 is set in the first cell670 for each row668 in which there is a delivery rate value in the fifth cell680. Thecheck box672 in the first cell670 is cleared for each row668 in which there is a percentage value in thefourth cell678.

Thesecond panel684 in theprimary window544dfor the temporary rate delivery programs presents instructions. It operates in a manner substantially similar to the third, instruction panel580 in the first primary window544afor the basal rate delivery programs as described above.

In addition to operating parameters, one possible embodiment of theuser interface542 also enables a user to view, edit, and enter other data, character strings, and settings that are loaded on theinsulin pump100.

For example,FIG. 27E illustrates the fifthprimary window544e, which is for setting the banner displayed in thehome page152 of thepump100.Primary window544eis in the stack ofprimary windows544. The fifthprimary window544eincludes two panels. Thefirst panel690 has afield check box692 and a text field694 mated to thecheckbox692. To enter text into thehome page152, the user sets thecheckbox692 and enters text (numbers and letters as desired) into the text field694. If thepump100 includesmultiple home pages152 through which the user can scroll, an embodiment of theprimary window544eincludes acheckbox692 and mating text field694 for each of thehome pages152. The user can then designate certain text for aparticular home page152 by setting thecheckbox692 associated with thathome page152 and entering text into the mating text field694. In an alternative embodiment, if the text in the text field694 is too long to fit into one display, thepump100 automatically generatesmultiple home pages152 through which the user can scroll and divides the text from the text field694 between themultiple home pages152. In another embodiment, similar text fields and associated checkboxes can be used to customize displays and messages for particular alarms, alerts, and reminders.

The second panel696 in theprimary window544epresents instructions. It operates in a manner substantially similar to the third, instruction panel580 in the first primary window544afor the basal rate delivery programs as described above.

FIG. 27F illustrates the sixth primary window544f, which is for programming basal delivery patterns in a weekly schedule, as described above in conjunction withFIG. 25. The sixth primary window544fincludes two panels. Thefirst panel700 has afirst spin box702 and asecond spin box704 configured to set the basal pattern and missed meal bolus alerts for weekday operation. To select a weekday basal pattern, the user can spin through the listed basal patterns programmed in the basal patterns tab544aand set the desired type. To select a weekday missed meal alert set, the user can spin through the listed alert sets configured in themeal boluses tab544band set the desired type. The first and

second spin boxes

702,704 correspond to agraphical representation710 of the weekday schedule. The graphical representation displays the basal rates and the missed meal bolus alert times that are selected using the

spin boxes

702,704 on an hour by hour basis.

Thefirst panel700 also has a third spin box706 and a fourth spin box708 configured to set the basal pattern and missed meal bolus alerts for weekend operation. To select a weekend basal pattern, the user can spin through the listed basal patterns programmed in the basal patterns tab544aand set the desired type. Likewise, to select a weekend missed meal alert set, the user can spin through the listed alert sets configured in themeal boluses tab544band set the desired type. The first and second spin boxes706,708 correspond to agraphical representation712 of the weekend schedule, which displays the basal rates and meal bolus alerts analogously to the weekday graphical representation706. In an alternative embodiment, thefirst panel700 can include seven spin box controls, corresponding to each day of the week. In a further alternative embodiment, thefirst panel700 can include a graphical calendar display configured to allow monthly programming of the basal pattern and/or missed meal bolus alerts.

A first check box714 enables the weekly schedule option in the software and on thepump100. The first check box714 is by default in a checked, or enabled, state.

One ormore indicators718 correspond to alarms scheduled to occur during the day displayed. The indicators and corresponding alarms can represent appointments, times of the day at which blood glucose values should be checked, or other user reminders.

Thesecond panel716 in the primary window544fpresents instructions. It operates in a manner substantially similar to the instruction panel580 in the first primary window544afor the basal rate delivery programs as described above.

Yet other embodiments of theuser interface542 include various windows, buttons, checkboxes, spin boxes, and fields for setting other parameters used to operate thepump100. Examples of such other parameters that can be set through theuser interface542 include various format settings, alarms, reminders, operating limits, report formats, security settings, character strings, and indeed any other operating parameters, data, settings, and character strings that can be programmed into thepump100.

Referring toFIGS. 27A-27F, to download the operating parameters displayed in an activeprimary window544, the user clicks on thedownload button686. The operating parameters relating to the active primary windows are then downloaded into thepump100 over the communication link. Thepump100 returns the downloaded operating parameters to the computer534, which compares the returned operating parameters to the sent operating parameters. If the returned and sent operating parameters match, the computer534 sends a handshake signal to thepump100 and themicroprocessor102 maps each of the downloaded operating parameters to its designated memory addresses inRAM116 and saves the downloaded operating parameters inRAM116. If the returned and sent operating parameters do not match, the computer534 generates an error signal and sends the error signal to thepump100. Thepump100 then discards the downloaded operating parameters and preserves the preexisting operating parameters already stored inRAM116.

To upload operating parameters from thepump100 into the activeprimary window544, the user clicks the uploadbutton688. The profile settings inRAM116 that correspond to the activeprimary window544 are then retrieved fromRAM116 on thepump100 and are sent to the computer534. The uploaded operating parameters are then populated into the fields of the activeprimary window544, including all secondary windows554. To save the profile settings, the user clicks thesave button690. The profile settings that populate the activeprimary window544 then are saved in thestorage device538. In one possible embodiment, the name of the file that includes the saved data is the name of the pump user.

Furthermore, theuser interface542 can be used on the computer534 to program and managepumps100 for several different pump users. In one such embodiment, the computer534 is programmed with an initial interface that includes a text field in which the name of the pump user is entered either through the computer keyboard or through a spin box. Upon entering the name of the pump user, the computer534 populates the data saved for that pump user'spump100 into theuser interface542. In an alternative embodiment, the computer534 is loaded with a menu in which the name of each pump user having stored data is included as a menu item. Selecting the name/menu item causes the computer534 to populate theuser interface542 with data.

The various embodiments described above are provided by way of illustration only and should not be construed to limit the invention. Those skilled in the art will readily recognize various modifications and changes that may be made to the present invention without following the example embodiments and applications illustrated and described herein, and without departing from the true spirit and scope of the present invention, which is set forth in the following claims.