WO2009034100A1

WO2009034100A1 - User interface for displaying predicted values

Info

Publication number: WO2009034100A1
Application number: PCT/EP2008/061979
Authority: WO
Inventors: Rasmus Panduro; Theresa Rhoades Willerup; Norbert Kurz; Peter Weber; Nina VÖGE
Original assignee: Novo Nordisk A/S
Priority date: 2007-09-10
Filing date: 2008-09-10
Publication date: 2009-03-19

Abstract

System for evaluation of input parameters adapted to receive and store data representing measured analyte level values. The system comprises user input means allowing a user to enter data in the form of one or more input parameter values, display means, and processor means. The display means is controllable by the processor means to graphically display predicted analyte level values as a function of time, the predicted values being calculated on the basis of stored data. The display means is further controllable to display an input parameter value entered by the user and used in the calculation of the predicted analyte level values, the input parameter value and the predicted analyte level values being displayed simultaneously. In this way the user is allowed to directly evaluate the influence of a given input parameter value on the predicted analyte level values.

Description

USER INTERFACE FOR DISPLAYING PREDICTED VALUES

The present invention generally relates to electronically controlled monitoring devices and systems for displaying predicted values to a user, especially for displaying predicted body characteristics. In a specific embodiment the invention relates to a medical device for displaying predicted analyte level values such as blood glucose values. The medical device may be used as part of a continuous analyte level monitoring system.

BACKGROUND OF THE INVENTION

In the disclosure of the present invention reference is mostly made to the treatment of diabetes by monitoring of glucose values and infusion of insulin, however, this is only an exemplary use of the present invention.

Drug delivery devices for delivering a drug such as insulin to a patient are well known and generally comprise a reservoir adapted to contain a liquid drug, a pump assembly for expelling a drug out of the reservoir to the patient. Such devices are often termed infusion pumps and are normally provided with a user interface allowing a user to control the operation of the pump. The user interface provided on some of the first pumps allowed the user to change a basal infusion rate and program a bolus infusion of a desired size. More recent infusion pumps have provided a number of more advanced features such as a number of basal rates to choose among, temporal basal, bolus calculations based on blood glucose (BG) input and/or meal size, diary functions, food data bases, connectivity to external devices, e.g. BG meter (BGM), PC, PDA or mobile phone.

An infusion pump may basically be a remotely controlled implantable pump or an external pump carried outside the human body and connected thereto by a transcutaneous access device such as a soft cannula or a needle. The external pump may be a traditional durable pump adapted to e.g. be worn in a belt at the waist of the user, this allowing the user to op- erate the pump by directly accessing the user interface on the pump, e.g. in order to change infusion rate or to program a bolus infusion. However, the pump may also be worn hidden under clothing this making operation more difficult. Correspondingly, it has been proposed to provide an infusion pump of the durable type with a wireless remote controller allowing the user to access some or all of the functionality of the pump, see for example US patent 6,551 ,276, US 2005/0022274 and US 2003/0065308, which are hereby incorporated by ref- erence, the latter disclosing an ambulatory medical device (MD) adapted to receive control messages from a communication device (CD).

As traditional durable external pumps are relatively expensive it has been proposed to pro- vide disposable pumps which may be attached directly to the skin of the user by means of an adhesive at a lower surface of such a device. A disposable pump may be provided to the user prefilled or it may be adapted to be filled by the user. Correspondingly, the pump may be a unitary fully disposable device or it may comprise two or more portions adapted to be used for different periods of time. Thus, for a skin-mountable device, typically comprising an adhesive allowing the device to be attached directly to the skin of the user, a remote controller would appear even more desirable as it would reduce the cost of providing a full user interface on the pump. Correspondingly, EP 1 177 802 and US patent 6,740,059, which are hereby incorporated by reference, disclose semi-disposable and fully disposable infusion devices (which may be termed a local device or unit) which are intended to be operated primar- ily or entirely by a wireless remote controller (which may be termed a remote device or unit). As the delivery device thus does not have to be provided with a user interface such as a display and keyboard, the semi-disposable or disposable infusion can be provided more cost- effectively.

A drug delivery system, either as a unitary device or as a system comprising e.g. a drug delivery pump and a remote controller, or adapted to communicate with external units, e.g. a PDA or PC, may be provided with a diary function allowing data to be stored, either automatically or by the user. For example, a drug delivery system may be store infusion data such as bolus and temporal basal, blood glucose data such BG values and other data such as meal size and medicine taken. EP 1 494 158 discloses a system and method for managing presentation of medical data, involving presenting medical data, e.g. BG values, downloaded from a device in selected graphical display charts in visual display. US 2005/ 0022274 discloses a drug delivery system comprising a remote controller with a memory and display allowing the user to store and retrieve data, e.g. BG values which can be displayed either as values or as a graph for one or more days.

More recently continuous glucose monitoring (CGM) sensor systems have been introduced allowing a patient to better manage the physiological conditions associated with diabetes by having substantially continuous real time glucose data, see e.g. US 2006/0224141. Such systems may also provide trend information based on measured substantially continuous real time glucose data, such a trend information indicating to the patient in what direction his or her BG level is moving, and accordingly, allowing the patient to modify or adjust the administration of insulin, e.g. by adjusting infusion levels delivered by an infusion device. The amount of insulin to administer may also be suggested by the system based on the trend information and other information known to the system, typically meal information. However, this reduces the patient's willingness to deviate from the suggested amount of insulin as it is not apparent how a different approach for food or insulin intake would influence the BG level.

The trend analysis may also be used to predict undesired events. For example, US 7,022,072 discloses apparatuses and methods for monitoring physiological characteristics such as blood glucose levels. Embodiments of the invention include dynamic monitoring functions that can perform predictive analyses to anticipate harmful conditions, such as hy- per-glycemic or hypo-glycemic incidents, before they occur and thus help the patient avoid such incidents, e.g. by sounding an alarm. Linear or non-linear characteristic curves and functions can be applied in making the prediction. US 2006/0272652, which is hereby incor- porated by reference, discloses a system to assist a user in developing a therapy for a diabetes patient. The system comprises a simulation engine adapted to receive one or more parameters relevant in diabetes therapy and based here upon simulate and display a plurality of blood glucose readings, wherein the system may be adapted to receive values from a CGM system. US 7,188,034, which is hereby incorporated by reference, discloses a system for monitoring an analyte concentration in which predicted values are used to detect measuring errors for later measured values.

Having regard to the above, it is an object of the present invention to provide an analyte monitoring device or system which would allow a user to more individually decide on a num- ber of actions in order to keep the BG level within desired limits. The device or system should allow the user to safely and easily evaluate the consequences of a contemplated action. The device or system should assure one or more of the following: easy to learn and understand, intuitive and easy to use, fast to use, ease of entering data, ease of navigating.

DISCLOSURE OF THE INVENTION

In the disclosure of the present invention, embodiments and aspects will be described which will address one or more of the above objects or which will address objects apparent from the below disclosure as well as from the description of exemplary embodiments. Thus, in a first aspect a system for evaluation of input parameters is provided, comprising means for receiving data representing measured analyte level values, data storage means adapted to store data representing measured analyte level values, user input means allowing a user to enter data to the data storage means in the form of one or more input parameter values, display means, and processor means. The display means is controllable by the processor means to graphically display predicted analyte level values as a function of time, the predicted values being calculated by the processor means on the basis of data stored in the data storage means. The display means is further controllable by the processor means to display an input parameter value entered by the user and used in the calculation of the pre- dieted analyte level values, the input parameter value and the predicted analyte level values being displayed simultaneously. In this way the user is allowed to directly evaluate the influence of a given input parameter value on the predicted analyte level values. The analyte values to be displayed may be for any desired analyte for which the display of predicted values is relevant, e.g. blood glucose for a diabetic patient.

The system in accordance with the invention may have different configurations. For example, the system may be a stand-alone device adapted primarily for receiving analyte data, or it may be provided as part of a device providing further functions, e.g. a drug delivery device, a remote controller for a drug delivery system, a mobile phone, or a PDA to mention some ex- emplary embodiments. In these embodiments the display means is controlled and the predicted values calculated by a processor located in the device and on the basis of stored or received data. The present invention may also be implemented in a handheld or stationary computer device, e.g. in a PC, or the invention may be implemented as a system allowing the different components, e.g. the display and the processor, to be located in different units.

To help indicate to a user that the predicted values are merely predicted, the display means may be controllable by the processor means to graphically display the predicted analyte level values in the form of an interval of uncertainty as a function of time, the interval of uncertainty being calculated by the processor means. To indicate to a user that a predicted value in the near future has a greater certainty than a predicted value for a more distant future, the graphically displayed interval of uncertainty may expand as a function of time, e.g. in a cone- or fan-like fashion.

To allow ease of use the display means may be adapted to display one or more levels of menus and the user input means may be correspondingly adapted to allow the user to select an item on a given menu. When the analyte measured and predicted is blood glucose, at least one input parameter value may be selected from the group consisting of: a meal size, a meal size for a given meal type, an amount of carbohydrates, an amount of exercise, and an amount of insulin, and an amount of insulin for a given infusion profile.

Other analytes that may be monitored and determined by a sensor adapted to work with the present invention include, for example, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, DNA, fructosamine, glutamine, growth hormones, hormones, ketones, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The concentration of drugs, e.g. antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be determined and monitored.

To provided a visual link between the past and the future, the display means may be controllable by the processor means to display measured analyte level values and the predicted analyte level values at the same time. By this arrangement a user is provided at the same time with a presentation of both measured values and calculated predicted values as a function of time, this allowing for ease of evaluation of treatment, both in respect of the past as well as for the future. To emphasize that the measured and predicted values are related to each other, the measured analyte level values and the predicted analyte level values may be shown as an aggregate continuous (including quasi continuous) function of time. The different display areas may be provided by a common or by individual displays, e.g. one or more LCD or OLED screens. When the user is occupied with the entering of parameter values the focus will be on the predicted values. Consequently, in an exemplary embodiment a first display area is used to display the input parameter values instead of measured analyte values.

The information on the display means may be organized in any desirable providing clear and concise communication with the user. In an exemplary embodiment the display means comprises first and second display areas where the first display area is controllable by the processor means to display an input parameter value entered using the user input means, and the second display area is controllable by the processor means to graphically display the predicted analyte level values as a function of time. When the device is not used for manual input of user-generated data the first display area may be controlled by the processor means to graphically display measured analyte level values as a function of time.

A trend indication may be displayed for the most recent measured analyte level value, the trend indication being calculated on the basis of measured analyte level values stored in the data storage means. The most recent measured analyte level value may be indicated graphically as either the last measured analyte level value or the starting point for the predicted analyte level values.

In a further aspect of the invention a medical system is provided, comprising a system for evaluation of input parameters as described above, an analyte sensor adapted to provide data representing analyte level values of a subject, the system being adapted to receive data representing analyte level values from the analyte sensor, e.g. a CGM, wherein data is transmitted from the analyte sensor by either wired or wireless means of communication.

In a yet further aspect of the invention a drug delivery system is provided comprising a system for evaluation of input parameters as described above, a reservoir adapted to contain a drug, an expelling assembly adapted for cooperation with the reservoir to expel drug out of the reservoir, and at least one processor adapted to control the expelling device in accor- dance with a programmed infusion profile. The system may comprise a delivery unit in which the reservoir and the expelling assembly are arranged, and a control unit comprising the display and user input means, the delivery and control units being adapted to communicate with each other. Depending on the system configuration the system may comprises one or more processors wherein the different tasks of supporting the user interface and controlling the delivery means may be performed by a single processor or two or more processors in combination.

In the context of the present application and as used in the specification and claim, the term processor covers any combination of electronic circuitry suitable for providing the specified functionality, e.g. processing data and controlling memory as well as all connected input and output devices. A processor will typically comprise one or more CPUs or microprocessors which may be supplemented by additional devices for support or control functions. For example, in case a communication interface is provided (e.g. wireless), the transmitter and receiver may be fully or partly integrated with a processor, or may be provided by individual units. Each of the components making up the processor circuitry may be special purpose or general purpose devices.

The system may comprise a delivery unit in which the reservoir and the expelling assembly are arranged, and a control unit comprising the display and user input means, the delivery and control units being adapted to communicate with each other, e.g. by wire, RF or IR. Al- ternatively, the system comprises a delivery unit in which the reservoir and the expelling assembly are arranged, the delivery unit further comprising the display and user input means.

The drug may be in the form of a fluid drug or a powder drug. For a fluid drug the expelling assembly may be in the form of a pump forcing or drawing drug from the reservoir and into a patient through a transcutaneous access device. For a fluid drug or a powder drug the expelling assembly may also be semi-automatic dispensing a given amount of drug from a reservoir after which a flow of air created by the person using the system will transport the powder drug to the desired location, e.g. the lungs or other portion of the airways.

The reservoir for a fluid drug may be any suitable structure adapted to hold an amount of a fluid drug, e.g. a hard reservoir, a flexible reservoir, a distensible or elastic reservoir. The reservoir may e.g. be prefilled, user tillable or in the form of a replaceable cartridge which again may be prefilled or fillable. The reservoir may also be in the form of a pressurized aerosol container. For a powder drug the reservoir may in the form of a blister or a plurality of individual blisters.

For a fluid drug the system may comprise or be adapted to cooperate with a transcutaneous access device which may e.g. be in the form of a hollow steel needle, a soft cannula in com- bination with an external or internal introduction needle, or a micro-needle array. The system may further comprise a transcutaneous device unit comprising a transcutaneous access device, and a mounting surface adapted for application to the skin of a subject, wherein the transcutaneous device unit and the delivery unit are adapted to be secured to each other to form a combined device.

The user input means may be in the form of a keyboard comprising one or more user accessible keys, however, alternative a touch display or voice recognition may be used. The user input means may allow a user to e.g. bi-directionally scroll between items in a menu, or enter data information by using bi-directional dial up and down keys. The user input means may also be provided by a four-way rocker switch or a four-way joystick, this allowing bi- directionally scrolling or setting of values in two directions or for two different types of input.

In a further aspect of the invention a program code storage device is provided, comprising a computer-readable storage media (e.g. a hard-drive, memory card, CD, DVD or the like) and computer-readable program code, stored on the computer-readable media, the computer- readable program code including instructions, which when executed cause a computing de- vice to: (i) receive and store data representing input parameter values, (ii) receive and store data representing measured analyte level values, (iii) control display means to graphically display predicted analyte level values as a function of time, the predicted values being calculated by the computing device on the basis of the stored data, and (iv) control display means to display an input parameter value used in the calculation of the predicted analyte level values, the input parameter value and the predicted analyte level values being displayed simultaneously, this allowing the user to directly evaluate the influence of a given input parameter value on the predicted analyte level values.

As used herein, the term "fluid drug" is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a cannula, hollow needle or inhalation conduit in a controlled manner, such as a liquid, solution, gel, fine suspension or a powder. Representative drugs include pharmaceuticals such as peptides, proteins, and hormones, biologically derived or active agents, hormonal and gene based agents, nutri- tional formulas and other substances in both solid (dispensed) or liquid form. In the description of the exemplary embodiments reference will be made to the use of insulin. Correspondingly, the term "subcutaneous" infusion is meant to encompass any method of transcutaneous delivery to a subject.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following the invention will be further described with reference to the drawings, wherein

fig. 1 shows a remote control for a medical system, fig. 2 shows a display view for a CGM display and prediction device, fig. 3 shows a further display view for a CGM display and prediction device, fig. 4 shows a shortcut menu for a CGM display and prediction device, fig. 5 shows how a temporal basal rate is programmed using a dual-mode screen, fig. 6 shows a shortcut menu as in fig. 4 with an item being highlighted, fig. 7 shows a combined display for showing insulin input values and predicted BG values, fig. 8 shows a display as in fig. 7 with a set insulin value and a further menu, fig. 9 shows a combined display for showing meal input values and predicted BG values, fig. 10 shows a display as in fig. 9 with a set meal value and a further menu, fig. 1 1 shows a combined display for showing activity input values and predicted BG values, fig. 12 shows a skin-mountable patch unit, fig. 13 shows the patch unit of fig.12 in an actuated state, fig. 14 shows a patch unit with a pump unit partly attached, fig. 15 shows the pump unit of fig. 14 fully attached to the patch unit, fig. 16 shows in an exploded view a pump unit, and fig. 17 shows a schematic representation of a process unit, a control unit and a sensor unit.

In the figures like structures are mainly identified by like reference numerals.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

When in the following terms such as "upper" and "lower", "right" and "left", "horizontal" and "vertical" or similar relative expressions are used, these only refer to the appended figures and not to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.

The present invention relates to a medical device for displaying predicted analyte level values. The below described embodiment comprises a user operated interface and is adapted to receive BG values wirelessly from a CGM sensor (implanted or skin-mounted), however, alternatively the BG values may be entered manually by a user, e.g. when using the present invention in combination with a conventional strip-based BG meter. The described interface may be implemented in a remote controller for a drug delivery device or it may be a standalone device. The BG values may be provided by a sensor and transmitter unit as disclosed in US 6,175,753 which is hereby incorporated by reference.

Fig. 1 shows a remote control (RC) for a drug delivery system, the RC being adapted to wirelessly communicate with a CGM sensor and incorporating a user interface for displaying measured as well as predicted BG values. Correspondingly, the shown RC has a "pump mode" and a "BG mode" The part of the RC relating to operation of a drug delivery device is described in co-pending application WO 2007/000427 which is hereby incorporated by refer- ence.

More specifically, the RC comprises an LCD display 30 arranged at the upper portion of the unit and buttons arranged beneath the display. The placement close to the centre line is chosen for ergonomic reasons. The remote comprises a rocker switch 10 and a left ACCEPT key 21 as well as a right ESCAPE key 22. The rocker switch is the fundamental navigation button and is a four-way switch having four areas 1 1 , 12, 13, 14 supporting respectively the directions: UP-DOWN and LEFT-RIGHT. Indeed, the four areas of the rocker switch may be replaced with a number of keys arranged in any desired configuration. The vertical axis functions to e.g. (i) scroll up/down in a menu, and (ii) increase or decrease a number. The horizontal axis LEFT RIGHT is used for e.g. (i) scrolling in left/right in a menu, and (ii) changing time related or secondary parameters. The accept button is the fundamental "Yes" button and functions as e.g. a go forth, enter, select, accept or confirm button. The Escape button is the fundamental "No" button and functions as e.g. a no, escape, step back, exit or undo button. Additional functions may be added to the ones described. The display is a dot matrix display and may be a monochrome, greyscale or colour display. The display shows the pump main screen (MS) which normally is displayed when the RC is turned on, however, the RC may turn on showing the BG MS if desired. The BG MS could also be termed a BG status screen. The MS serves to indicate to the user the status of the system controlled by the RC. The screen has a general configuration also used in many other situations of use (see below). More specifically, the MS comprises a central "split screen" display area with left and right portions or sub-areas 31 , 32 as well as upper and a lower information bar areas 33, 34. In the shown view the MS displays in the upper bar the remaining amount of insulin in the insulin pump to which the RC is currently paired as well as the battery status for the RC. The split screen shows the current time and date, and the lower bar shows the current basal infusion rate for the paired pump. Depending on the selected mode of the RC, the screen can have a "dual mode" configuration (see below) used for a number of input screens. Depending on the status of the system other information may be displayed, e.g. status indication for an ongoing bolus and/or an ongoing temporal basal infusion rate.

The RC is further provided with an upper port 40 for a build-in BG meter allowing a BG strip to be inserted and a BG value to be determined. The RC may further be provided with one or more keys at e.g. the sides allowing less commonly used functions to be activated, e.g. on- off and keyboard lock. The RC may be powered by replaceable or rechargeable batteries.

In fig. 2 is shown a BG MS also having a central "split screen" display area with left and right portions or areas 61 , 62. The left portion is adapted to graphically display measured analyte level values (here in mmol/L) as a function of time, and the right portion is adapted to graphically display predicted analyte level values as a function of time, the predicted values being calculated on the basis of data stored in the data storage means. To aid a user to fast capture the displayed information values outside a desired band of BG values may be indicated with a different colour, e.g. red instead of blue. The actual BG value is indicated both with a dot and the actual value just as double arrows indicate that the LEFT-RIGHT keys can be used to move the actual value back and forth and thereby move the division between measured and predicted values in the display, e.g. in order to see older measured values.

As will be described in the following, the right display portion is adapted to graphically display an interval 63 of predicted uncertainty for the predicted BG values as a function of time. The dotted lines mark a possible sample area for future BG values. The area within the cone represents values within a selected confidence interval, e.g. 80%, 90%, 95% or higher. Alternatively, the predicted BG values may be displayed as a simple line without the cone as shown in fig. 3. As appears, in both figs. 2 and 3 the measured analyte level values and the predicted analyte level values are shown as an aggregate continuous function of time.

In the BG MS the top of the screen contains status information on remaining insulin level as a bar and in units. In the middle sensor usage is displayed when the device is used with a CGM unit. Sensor duration is set to 5 days and as days pass the segments are filled. On the right top corner a standard battery indicator for the remote control is placed. The bottom line shows the current basal infusion rate when the device is used also as a RC for a drug delivery unit.

When the remote is turned on it will check whether an initial setup has taken place (e.g. en- tering personal limits and alarm settings) and if so go to the main or "status screen" as described above. From the status screen the user can activate either a pump related shortcut menu (SM) (related to e.g. bolus, profiles, temporal basal) or as shown a BG related SM. The SM screen has a number of items 51 , 52, 53, 54 at predefined locations as shown in fig. 4. Using the rocker switch the user can go directly to any of the four indicated items, i.e. the BG prediction related items meal, insulin, activity, or to a further menu screen.

Before describing specific aspects of the present invention, the "dual mode" input feature will be described with reference to fig. 5 (relating to the setting of a pump feature). A dual mode screen displays two user controllable settings, e.g. two parameters, which at the same time (i.e. using the same screen) can be directly set by the user using a keyboard provided on the remote. In the present embodiment a four-way rocker switch is provided allowing two settings 65, 66 to be controlled in an "up-down" or scrolling fashion. As can be seen, on the screen image two set of arrows 36, 37, 38, 39 are provided to assist the user when operating the four-way switch. As two different settings can be controlled as well as displayed at the same time a user interface providing ease and safety of use is provided. In fig. 6 is shown that the user has selected the "insulin" item in the BG SM. When pressing the ACCEPT key the user is brought directly to a combined input (here: insulin) and BG prediction screen (see fig. 7) allowing the user to enter input parameter values on the basis of which the predicted values are calculated and shown, this allowing a user to graphically evaluate the influence of input parameter values on the predicted values as a function of time. More specifically, the left portion as shown is provided with dual mode setting for a contemplated amount and form of insulin infusion (when using a pump). With the LEFT-RIGHT keys the user can select the type of insulin infusion, e.g. direct or extended, and with the UP- DOWN keys the user can set the contemplated amount of insulin. In the shown embodiment the predicted values as a function of time are calculated dynamically as the amount of insulin is "dialed up", this allowing the user to directly evaluate the predicted result of the contemplated action.

According to an aspect of the invention, the predicted values are displayed as an interval of predicted uncertainty for the predicted BG level values as a function of time, wherein the interval of uncertainty expands cone-like as a function of time, this indicating to a user that a predicted value in the near future has a greater certainty than a predicted value for a more distant future. Alternatively the predicted values may be shown as a normal graph as for the measured values in fig. 2.

The predicted values may be calculated using any suitable algorithm based on a physiological model for calculating BG values as a function of time, such an algorithm being based on a number of patient related constants (e.g. weight, sex, age, time of the day, CIR, ISF, etc.) and at least one variable input parameter value (e.g. a meal size, a meal size for a given meal type, an amount of carbohydrates, an amount of exercise, and an amount of insulin, and an amount of insulin for a given infusion profile). US 2006/0272652 discloses equations for calculating glucose concentrations based on one or more input parameters. The "uncertainty band" may be calculated simply by adding a +/- band as function of time to the calculated values, or it may be based on +/- values used in the algorithm.

In addition to the above-described information, the screen in fig. 7 (and in figs. 2 and 3) also shows the most recent measured BG level value indicated graphically as the starting point for the predicted analyte level values. Further, a trend indication is displayed for the most recent measured analyte level value, the trend indication being calculated on the basis of measured analyte level values stored. When the user has entered the desired amount and type of infusion for insulin the ACCEPT key is activated this prompting a new UP-DOWN "done" menu in which the user can accept "done" (see fig. 8) or dial up or down to "meal" or "activity", this arrangement allowing meal and activity values to be entered without having to return to the BG SM (see fig. 4). As ap- pears, the predicted BG values in fig. 8 are low for the selected insulin amount and the user may desire to immediately evaluate the amount of food that would have to be taken in order to raise the predicted BG level.

In the "meal" dual mode input screen (see fig. 9), the user can with the LEFT-RIGHT keys select the type of meal (e.g. breakfast, lunch, dinner, snack or carbohydrates), and with the UP-DOWN keys the user can set the contemplated amount of food. In the shown embodiment three pre-set size carbohydrate values for each type of meal can be programmed for the individual user. When the type and amount of food has been set the predicted BG values can be evaluated. When the ACCEPT key is activated the "done" menu is shown again, see fig. 10. If no more inputs are desired the ACCEPT key is pressed again which will return the user to the BG MS now being based on the new set values for the predicted values. As an optional feature the meal size may be coupled with a learning algorithm taking into account the achieved BG values as the result of a given standard meal size and then adjust the carbohydrate value of a given standard meal size accordingly.

If the user desires to exercise the "activity" item is chosen in the BG SM which activates a dual mode activity input screen (see fig. 1 1 ). Indeed, the activity input screen could also have been selected directly from the "done" menu, see above. In the activity dual mode screen the LEFT-RIGHT keys select the length of activity, and with the UP-DOWN keys the user can set the activity level. When the ACCEPT key is activated the "done" menu is shown again.

In the above aspects of a user interface for displaying predicted analyte level values have been described. In the following an illustrative drug delivery system suitable to be used in combination with a user interface incorporating one or more of the described aspects or fea- tures will be described. Although the drug delivery system will be described with reference to the pump unit and the remote controller unit disclosed in figs. 12-17, it should be understood that the present disclosure is broadly applicable to any form of system comprising a pump unit in combination with a controller unit or other external unit, e.g. a PC or PDA. For example, aspects of the present invention may be used with programmable ambulatory insulin in- fusion pumps of the sort currently commercially available from a number of manufacturers, including without limitation and by way of example, Medtronic MiniMed under the trademark PARADIGM, lnsulet Corporation under the trademark OmniPod, Smiths Medical under the trademark Deltec COZMO, and others, these pumps either being provided with a remote control or being adaptable to be used with one.

Fig. 12 shows a skin-mountable device in the form of a patch (or cannula) unit 400. The patch unit comprises a relatively rigid body portion 414 arranged on a flexible sheet member 430 with a lower mounting surface 431 provided with an adhesive allowing the sheet to be adhered to a skin surface of a subject. The sheet member comprises a central opening 432 through which a cannula can be inserted. The body portion comprises a housing portion 412 in which a cannula inserting mechanism is arranged, see below. The body portion further comprises two slider leg members 413 extending from the housing, the legs adding stiffness to the patch and further serves as guiding means when a pump/reservoir unit is attached the patch unit, see below. The housing is provided with a set of opposed grooves 420 serving as attachment means for a packaging and subsequently for a pump unit. The housing further comprises a fluid inlet 415 adapted to be mounted in fluid communication with a corresponding fluid outlet from an attached pump unit 450, an actuator 416 for actuating an electrical contact on the attached pump, and a release member 417 adapted to release a cannula inserting mechanism when the pump unit is attached for the first time, the cannula being inserted through the opening 432. The housing portion 412 also comprises a catch 419 adapted to engage a corresponding coupling structure on the pump unit. As appears, when the cannula 951 is inserted (see fig. 13), it is protected by the pump unit, however, the pump unit can be removed for subsequent inspection of the insertion site as shown in fig. 14.

Fig. 14 shows an alternative embodiment of a patch unit 1010 with a pump unit 1050 by its side, and fig. 15 shows the pump unit fully but releasably attached. More specifically, fig. 14 shows an embodiment of a medical device 1000, comprising a cannula unit 1010 of the type shown in fig. 12 and a thereto mountable pump (or reservoir) unit 1050. In the shown embodiment the cannula unit comprises a housing 1015 with a shaft into which a portion 1051 of the pump unit is inserted. The shaft has a lid portion 101 1 with an opening 1012, the free end of the lid forming a flexible latch member 1013 with a lower protrusion (not shown) adapted to engage a corresponding depression 1052 in the pump unit, whereby a snap- action coupling is provided when the pump unit is inserted into the shaft of the cannula unit. Also a vent opening 1054 can be seen. The housing 1015 is provided with a pair of opposed legs 1018 and is mounted on top of a flexible sheet member 1019 with a lower adhesive sur- face 1020 serving as a mounting surface, the sheet member comprising an opening 1016 for the cannula 1017. As appears, from the housing of the cannula unit extends a cannula at an inclined angle, the cannula being arranged in such a way that its insertion site through a skin surface can be inspected (in the figure the full cannula can be seen), e.g. just after insertion. In the shown embodiment the opening in the lid provides improved inspectability of the insertion site. When the pump unit is connected to the cannula unit it fully covers and protects the cannula and the insertion site from influences from the outside, e.g. water, dirt and mechanical forces (see fig. 15), however, as the pump unit is detachable connected to the cannula unit, it can be released (by lifting the latch member) and withdrawn fully or partly from the cannula unit, this allowing the insertion site to be inspected at any desired point of time. By this arrangement a drug delivery device is provided which has a transcutaneous device, e.g. a soft cannula as shown, which is very well protected during normal use, however, which by fully or partly detachment of the pump unit can be inspected as desired. Indeed, a given device may be formed in such a way that the insertion site can also be inspected, at least to a certain degree, during attachment of the pump, e.g. by corresponding openings or transparent areas, however, the attached pump provides a high degree of protection during use irrespective of the insertion site being fully or partly occluded for inspection during attachment of the pump. In the shown embodiment an inclined cannula is used, however, in alternative embodiments a needle or cannula may be inserted perpendicularly relative to the mounting sur- face.

Fig. 16 shows in an exploded view a pump unit 300 of the same type as in fig. 14. The pump unit comprises an upper housing portion 310 and a lower housing portion 320 which in an assembled state provides a water-protected enclosure for the additional components of the reservoir unit: A pump assembly 330, an actuator 340, a reservoir 350, and electronic control means 360. In an initial state as supplied to the user, a protective cap assembly 370 is attached to the unit.

The lower housing portion is made from a transparent material allowing a reservoir (see be- low) to be inspected by a user from the outside, and comprises an opening 321 in which a water repelling vent 322 is arranged. A sheet member 325 with a window opening 326 is attached to the lower surface of the lower housing portion, this masking the transparent portion except for a window over the reservoir. The sheet member may be used to display user information, e.g. type and amount of drug. The pump assembly 330 is in the form of a membrane pump comprising a piston-actuated pump membrane with flow-controlled inlet- and outlet-valves. The pump has a general layered construction comprising a number of body members between which are interposed flexible membrane layers, whereby a pump chamber, inlet and outlet valves, and one or more safety valves can be formed, the layers being hold together with clamps 338. The pump further comprises a fluid connector 335 in the form of hollow connection needle slidably positioned within the pump (for illustrative purposes shown outside of the pump), this allowing the pump to be connected with reservoir when the protective cap assembly 370 is activated. For a more detailed description of such a membrane pump reference is made to applicants co-pending application WO 2006/089958, which is hereby incorporated by reference.

The pump actuator is in the form of a coil actuator to which the pump assembly is attached by a clamp. For a more detailed description of such a coil actuator reference is made to ap- plicants co-pending application WO 2005/094919, which is hereby incorporated by reference.

The drug reservoir is in the form of a flexible, pre-filled collapsible pouch 350 comprising a needle-penetratable septum 354 allowing the fluid connector to be pushed into the reservoir without leakage, thereby providing a fluid communication with the pump. A clip holder 352 is attached to the reservoir, this allowing the reservoir to be attached to the housing without influencing the reservoir per se. Under the reservoir (as seen from the lower surface of the unit) is arranged a sheet (not shown) comprising a contrast-enhancing pattern, e.g. a black line on a white background, allowing for easier visual identification of impurities in the drug, e.g. fibrillation in insulin.

The electronic control means 360 comprises a PCB or flex-print 362 with a processor 361 for controlling the pump assembly, a battery 366, an acoustic transducer 365 providing an alarm and communication interface with the user, as well as a contact mounted on the actuator allowing the control means to be activated by the user when taken into use for the first time (via the actuator 216). The control means may comprise a receiver and/or a transmitter allowing the reservoir to communicate wirelessly with a remote controller.

The protective cap assembly 370 comprises an attachment member 371 initially locked to the reservoir unit and an activation "push button" member 372 slidingly attached to the at- tachment member. When the reservoir unit is removed from its primary packaging (not shown) the user depresses the activation member towards the reservoir unit. This actuation results in three actions taking place: A first protrusion on the activation member will actuate a contact on the reservoir unit, this activating the electronics, and a second protrusion will engage the pump assembly and push the fluid connector 335 out from the pump assembly and into the reservoir, thereby establishing a fluid communication between the reservoir and the pump. Thirdly, depression of the activation member will "unlock" the attachment member and allow it, and thereby the activation member, to be removed from the reservoir unit. Thereafter the reservoir unit can be connected to the patch unit.

Fig. 17 shows a schematic representation of a process unit 200 (here corresponding to the pump unit 1050 of fig. 14) and a controller unit 100 (here in the form of a wireless "remote controller" or "external communication and display device" for the pump unit). It is considered that the general design of such units is well known to the skilled person, however, for a more detailed description of the circuitry necessary to provide the desired functionality of the present invention reference is made to US 2003/0065308 which is hereby incorporated by refer- ence.

More specifically, fig. 17 depicts a simplified block diagram of various functional components or modules (i.e. single components or groups of components) included in the pump unit 200 and remote controller 100. The remote controller unit includes a housing 101 , a remote proc- essor 110 including a CPU, memory elements for storing control programs and operation data and a clock, an LCD display 120 for providing operation for information to the user, a keypad 130 for taking input from the user, an audio alarm 140 for providing information to the user, a vibrator 150 for providing information to the user, a main battery 160 for supplying power to the controller, a backup battery 161 to provide memory maintenance for the control- ler, a remote radio frequency (RF) telemetry transmitter 170 for sending signals to the pump unit, a remote radio frequency (RF) telemetry receiver 180 for receiving signals from the pump unit, and a second transmitter 190. The controller further comprises a port 185, e.g. an infrared (IR) or RF input/output system for communicating with a further device, e.g. a blood glucose meter (BGM), a continuous blood glucose meter (CGM), a PC or a PDA.

As also depicted in fig. 17, the pump unit 200 includes a housing 201 , local processor electronics 210 including a CPU and memory elements for storing control programs and operation data, battery 260 for providing power to the system, a process unit RF telemetry transmitter 270 for sending communication signals to the remote unit, a process unit radio fre- quency (RF) telemetry receiver 280 for receiving signals from the remote unit, a second process unit receiver 240 (which may be in the form of a coil of an acoustic transducer used in an audio alarm for providing feedback to the user), a reservoir 230 for storing a drug, and a pump assembly 220 for expelling drug from the reservoir through a transcutaneous device to the body of a patient. In alternative embodiments the pump unit may also comprise an LCD display for providing information to the user, a keypad for taking input from the user, and a vibrator or other tactile actuator for providing information to the user. RF transmission may be in accordance with a standard protocol such as Bluetooth ®.

As appears, the system of fig. 17 comprises first and second means of communication allowing a first and second group of data types to be transmitted between the two units. In this way different properties of the two means of communication can be used to secure that certain data, e.g. during pairing of the two devices using near-field communication, can be transmitted in a more controlled way whereas other data can be transmitted in a less controlled way using longer-distance communication.

Fig. 17 also shows a CGM sensor and transmitter unit 202 comprising a processor 290, an analyte sensor 291 (e.g. a BG sensor) and a transmitter 285 adapted to transmit analyte data to the control unit via the port 185, e.g. by IR or RF signals. The CGM sensor and transmitter unit may be of the type disclosed in US 6,175,753.

In the above description of the preferred embodiments, the different structures and means providing the described functionality for the different components have been described to a degree to which the concept of the present invention will be apparent to the skilled reader. The detailed construction and specification for the different components are considered the object of a normal design procedure performed by the skilled person along the lines set out in the present specification.

Claims

1. System (1 , 100) for evaluation of input parameters, comprising: means (185) for receiving data representing measured analyte level values, - data storage means (110) adapted to store data representing measured analyte level values, user input means (10, 130) allowing a user to enter data to the data storage means in the form of one or more input parameter values, display means (30, 120), and - processor means (1 10), wherein: the display means is controllable by the processor means to graphically display predicted analyte level values as a function of time, the predicted values being calculated by the processor means on the basis of data stored in the data storage means, and - the display means is controllable by the processor means to display an input parameter value entered by the user and used in the calculation of the predicted analyte level values, the input parameter value and the predicted analyte level values being displayed simultaneously, this allowing the user to directly evaluate the influence of a given input parameter value on the predicted analyte level values.

2. System as in claim 1 , wherein the display means is controllable by the processor means to graphically display the predicted analyte level values in the form of an interval of uncertainty (63) as a function of time, the interval of uncertainty being calculated by the processor means.

3. System as in claim 2, wherein the graphically displayed interval of uncertainty expands as a function of time, this indicating to a user that a predicted value in the near future has a greater certainty than a predicted value for a more distant future.

4. System as in claim 3, wherein the display means is adapted to display at least one level of menus and the user input means is adapted to allow the user to select an item on a given menu, this allowing the user to select between two or more types of input parameter values to be entered.

5. System as in any of claims 1-4, wherein at least one input parameter value is selected from the group consisting of: a meal size, a meal size for a given meal type, an amount of carbohydrates, an amount of exercise, an amount of insulin, and an amount of insulin for a given infusion profile.

6. System as in any of the previous claims, wherein the measured analyte level values and the predicted analyte level values are blood glucose values.

7. System as in any of the previous claims, wherein the display means is controllable by the processor means to display measured analyte level values and the predicted analyte level values as an aggregate continuous function of time.

8. System as in any of the previous claims, the display means (30, 120) comprising first and second display areas (61 , 62), wherein: the first display area (61) is controllable by the processor means to display an input parameter value entered using the user input means, - the second display area is controllable by the processor means to graphically display the predicted analyte level values as a function of time.

9. System as in claim 8, wherein the first display area is controllable by the processor means to graphically display measured analyte level values as a function of time.

10. System as in any of the previous claims, wherein the display means is controllable by the processor means to display a trend indication for the most recent measured analyte level value, the trend indication being calculated on the basis of measured analyte level values stored in the data storage means.

11. System as in any of the previous claims, wherein the most recent measured analyte level value is indicated graphically as either the last measured analyte level value or the starting point for the predicted analyte level values.

12. A medical system comprising: a system (1 , 100) for evaluation of input parameters as in any of the previous claims, an analyte sensor (202) adapted to provide data representing analyte level values of a subject, - the system for evaluation of input parameters being adapted to receive data representing analyte level values from the analyte sensor, wherein data is transmitted from the analyte sensor by either wired or wireless means of communication (185, 285).

13. A drug delivery system comprising: - a system (1 , 100) for evaluation of input parameters as in any of claims 1-11 , a reservoir (350) adapted to contain a drug, an expelling assembly (330) adapted for cooperation with the reservoir to expel drug out of the reservoir, and at least one processor (210, 361 ) adapted to control the expelling device in accor- dance with a programmed infusion profile.

14. A drug delivery system as in claim 13, comprising a delivery unit (1050) in which the reservoir and the expelling assembly are arranged, and a control unit (1 , 100) comprising the display means and the user input means, the delivery and control units being adapted to communicate with each other.

15. A program code storage device, comprising: a computer-readable storage media; and computer-readable program code, stored on the computer-readable media, the computer-readable program code including instructions, which when executed cause a comput- ing device to: receive and store data representing input parameter values, receive and store data representing measured analyte level values, control display means to graphically display predicted analyte level values as a function of time, the predicted values being calculated by the computing device on the basis of the stored data, and control display means to display an input parameter value used in the calculation of the predicted analyte level values, the input parameter value and the predicted analyte level values being displayed simultaneously, this allowing the user to directly evaluate the influence of a given input parameter value on the predicted analyte level values.