Definitions

• the invention relates to the field of physiological monitoring and diagnostic devices and more particularly, to the provision of information for use in connection with personal monitoring devices.
• monitoring devices e.g. meters
• point of care has become increasingly common and prevalent over the last few years with the development of electronic miniaturisation techniques, improved test element technology, and the increasing number of individuals eager to self- manage their diseases.
• test element is used in combination with a monitoring device to determine the presence and concentration of an analyte in a sample of physiological fluid utilising one of several detection principles (e.g. electrochemical, photometric to name but a few). The user may then be informed, typically by means of a displayed numerical value, of the concentration of an analyte under investigation.
• detection principles e.g. electrochemical, photometric to name but a few.
• the user interface includes an input console as well as a display screen on which a menu and test results are displayed.
• the input console may include a number of manual controls such as switches and/or jog- wheels that may allow a user to manipulate the information displayed on the display screen, e.g. for operating the device, for viewing results, and optionally for configuring a health management plan.
• Such personal diagnostic devices e.g. for operating the device, for viewing results, and optionally for configuring a health management plan.
• easy navigation of a user interface is of paramount consideration when designing such personal diagnostic devices and some consideration is therefore given to their utilisation, for providing accessibility to as broad a demographic range as possible. For instance, designers of devices earmarked for the diabetes market face several challenges, not least due to the elevated risk of cerebrovascular accidents (e.g.
• averaging or mean function a function which is an important parameter in aiding a user during management of a disease
• averaging functions are considered impractical to use since they do not relate to user specific events or highlight deviations from target measurements.
• some users may try to manipulate their mean concentration measurement values by systematically repeating good measurements such that the mean values are improved.
• WO2005001680 published 6 th January to Hansen, discloses a user interface for a portable medical device, including a display screen and virtual switches, with a user input device allowing the virtual switches of the GUI to be selected. Similarly, the manipulation and navigation of the user interface of such a medical device depends on the user being able to use a pointing device;
• WO2005009205 published 3 rd February 2005 to Anderson et al., discloses a system and method for self management of health using natural language interface, initiating dialogue with a user to solicit health information from the user using a natural language interface and may respond unsolicited health information from the user provided via the natural language interface.
• the health information from the user is semantically processed in accordance with pre-specified health management rules to facilitate user self management of health.
• the natural language interface is a constrained natural language. However, such a system requires connection to a cell phone for instance.
• the invention aims to alleviate at least some of the above identified problems and/or needs.
• a monitoring device comprises a processor, and a built-in sensor or a port equipped with a disposable sensor.
• the monitoring device is adapted for relating the stored measurement values of the sensor to a medical useful compliance range.
• the user may immediately recognize how an actual measurement value determined by the sensor is located relative to a predefined compliance range of medical useful values. Thus, the user may judge how good or bad the actual measurement value is.
• evaluation of measurement values is performed with regard to a predefined set of specific events that occur periodically during a period of 24 hours, i.e. during a period of time comprising one day and one night.
• the specific events may e.g. comprise meal type events. These meal type events comprise pre-prandial and post-prandial events such as e.g. pre-breakfast, post-breakfast, pre-lunch, post- lunch, pre- dinner, post-dinner, etc.
• the specific events may e.g. comprise events related to medication
• an event is defined by a characteristic time frame, e.g. the event "post- breakfast" might range from 9 AM to 11 AM.
• analysis of the measurement values is performed in accordance with the respective event. For example, a mean value of measurement values acquired during the last few days might be determined, whereby only those stored measurement values with a time stamp that lies within the time frame related to the respective event are considered. Thus, for each of the time frames related to a specific event, a separate mean value may e.g. be determined.
• the set of specific events and the related time frames together form a compliance management profile that reoccurs every 24 hours.
• a current measurement value maybe compared with the statistical properties of former measurement values that belong to the same event, like e.g. pre- lunch.
• a current measurement value that has been acquired in the time frame "pre- lunch” maybe compared with a mean value of the "pre- lunch” measurements acquired during the past days.
• a set of mean values and statistical properties is built up automatically. This "data base" of former values is the base point for analysis of the current measurement.
• the advantage of using compliance management profiles comprising a set of predefined specific events is that the dependence of the measurement values on the respective time of day can be considered.
• a user may compare an actual measurement value both with a compliance window and with a mean value of the time frame the actual measurement value belongs to.
• the position of the actual measurement value relative to the mean value of the past few days can be shown to the user. This provides for a more thorough understanding of the measurement values, which are perceived together with a context of former values.
• Figure 1 shows a simplified block diagram of a first main element of the diagnostic device according to an embodiment of the present invention
• Figure 2 shows a simplified block diagram of the first main element in electrical connection to a second main element according to an embodiment of the present invention
• Figure 3 shows a display screen with an example screen layout providing a numerical result area, several information icons, and an information section according to an embodiment of the present invention
• Figure 4 shows a display screen with an example screen layout, providing a numerical result area, several information icons, and an information section depicting a disease management compliance window;
• Figure 5 shows an enlarged view of the information section of Figure 4 showing a disease management compliance window in greater detail
• Figure 6 shows an enlarged view of the information section of Figure 3 showing a disease management compliance alphanumerical message
• Figure 7 shows a display screen with an example screen layout providing a numerical result area, several information icons and several disease compliance indicators, according to another embodiment of the present invention.
• Figure 8a shows an enlarged view of the information section of Figure 3 showing an interactive user navigational area of an interface program according to an embodiment of the present invention
• Figure 8b shows a first level menu of an interface program of a personal diagnostic device according to the embodiment of Figure 8a;
• Figure 8c shows a second level menu of an interface program of a personal diagnostic device according to the embodiment of Figure 8a.
• Figure 9a shows a flow chart showing the steps of meal marking in relation to a measurement sequence.
• Figure 9b shows a schematic view of a user selectable menu for a pre or post prandial meal event.
• Figure 9c shows a display screen showing a result screen populated with a meal category and a graphical tool.
• Figure 9d shows a display screen showing a result screen populated with a meal category.
• the disclosed invention provides a useful tool for a user to follow a predetermined schedule with a predetermined set of events and relating this schedule to the acquired diagnostic measurement data.
• the patient will keep always an overview over certain behavioural manners connected to a certain event i.e. if the "style of eating" at dinner time may cause a satisfying or non satisfying compliance.
• the disclosed invention in form of the monitoring device provides the possibility to calculate average and/ or statistical representations of measurement values according to a "compliance management profiles", which represents a plurality of periodically reoccurring special events such as a mealtime i.e. breakfast, lunch, dinner, or other events which influences the "life style" of a person Le. wake-up time or bed-time. All these events in terms of the activity such as food in- take, exercise or administration of medicine are of central importance for the compliance of the patient.
• the personal monitoring device has the means to single out certain measurement values and provides due to the connection of this data point to a specific event a highly improved interpretation of the diagnostic result for the user or the physician.
• this type of monitoring device has a great advantage over a manually kept diary, which is currently the common praxis for many (diabetes) patients.
• the utility of the compliance management profile can be appreciated easily if its function is understood as an automatic filter or sorting algorithm, which processes certain measurements values due to a predetermined time scheme (understood and described below as management time frame), whereas such functionality is activated or deactivated by die real time clock (RTQ of a host processor.
• RTQ die real time clock
• the discussed algorithm would label the measurement value with a specific event label in this case a meal type identifier such as "Breakfast” or “Dinner " depending on the preset of the compliance management profile and the RTC of a host processor.
• a further aspect of the invention is the provision of a self-learning mode of the disclosed monitoring device.
• the user can label a measurement value specifically as “Breakfast”, “Dinner”, “Exercise”, or “Administration of insulin” and optionally with one of the additional event labels "Pre” or "Post” to generate for example the event "Pre- Breakfast” to indicate a measurement value before breakfast.
• a host processor is configured in a way diat the compliance management profile is automatically updated and the monitoring device will learn the daily routine of the patient or the device user, respectively.
• the compliance management profile can be understood as a instruction set for a host processor to link certain measurement values to specific and/or reoccurring events as described above, whereas the disease management compliance window or simply the compliance window can be understood as "look- up indicator" allowing the user a brief orientation of his current compliance compared to the long-term compliance i.e. over the last 7, 14 or 30 days at specific events such as "Pre-Breakfast” or alternatively for the entire day.
• FIG. 1 a simplified block diagram of a system 2 according to an embodiment of the present invention is shown.
• Block diagram depicts two main elements 2a, 2b, electrically connected to each other.
• the two main elements 2a, 2b may conveniently be housed in a housing (not shown) of suitable size and shape to be grasped by a user's hand, and made from a polymeric material.
• the first main element 2a shows a microprocessor 6 electrically connected to a storage device 8 such as a ROM and RAM, an analogue input device 10, a display screen 12, an analyte test element port 14, an output connector, a power supply 18, an oscillator circuit 20 and a bus 22.
• the microprocessor 6 of the first main element 2a will be regarded, according to the present invention, as a host processor 6.
• the microprocessor is a 16 bit microprocessor such as the MAXQ2000 microprocessor available from Dallas Semiconductor Corporation, 4401 South Beltwood Parkway, Dallas, Texas, USA.
• host processor 6 has several input and output ports operating in conjunction with additional circuits such as analogue to digital converters, storage devices (e.g. RAM and ROM), and the oscillator circuit 20 for maintaining correct timing of digital signals. Additionally a low power circuit configuration maybe provided as part of host processor 6, for allowing the system 2 to conserve battery power during idle moments. Such a circuit generally controls analogue circuits thereby shutting them off when not in use.
• additional circuits such as analogue to digital converters, storage devices (e.g. RAM and ROM), and the oscillator circuit 20 for maintaining correct timing of digital signals.
• a low power circuit configuration maybe provided as part of host processor 6, for allowing the system 2 to conserve battery power during idle moments. Such a circuit generally controls analogue circuits thereby shutting them off when not in use.
• host processor 6 additionally has the capability for storing of operational software that controls standard operation of the diagnostic device, for storing software to operate a user interface, and for storing several algorithms which evaluate several input signals (e.g. from sensors and/or interfaced signals) as will be described in greater detail below. Examples of such algorithms include statistical analysis algorithms, data analysis algorithms and so on.
• Host processor 6 may additionally store test measurement data in the form of analyte test result records, or such data maybe stored on the aforementioned external storage devices 8.
• Such external storage devices can include static or dynamic RAM, non-static RAM, rewritable ROMs, flash memory, or the like. Electrical Static Discharge protection maybe provided by an integrated circuit 21 such as those provided by Dallas Semiconductor Corporation such that uncontrolled microprocessor operation is minimized.
• the analyte test element port 14 can take various forms and may include electrical connectors, a microswitch, and/or sensors (not shown) for cooperating with an inserted test element.
• the electrical connectors of the test element port 14 may correspond to electrical contacts of an electrochemical test element for example.
• the port 14 houses an optical system.
• an optical system includes but not limited to, at least one light source (e.g. LED) and at least one optical sensor (e.g. photodiode), and configured such that the optical system corresponds to at least one reaction area of an optical test element.
• test element of Co- Pending Patent Application PCT/EP2005/009382 and herein incorporated by reference alternatively embedded data analysis algorithm maybe adapted to cooperate with an immunoassay test sensor of Co- Pending Patent Application PCT/EP2005/009381 and herein incorporated by reference.
• the signals are received on an input/ output (I/O) port of die host processor 6 after processing by sub-circuits such as converter circuitry, filter circuitry and/or amplifiers.
• the analogue input device 10 may encompass manual switches (not shown). As will be briefly described later, analogue input device may take other forms 30.
• the manual switches maybe constituted by scroll switches, a rotary wheel, and/ or a confirmation switch. Additionally, alphanumerical or non- alphanumerical characters (not shown) may form part of the manual switches for aiding the user in correct displacement thereof.
• the manual switches may be backlit by means of LED's for further aiding the user in the displacement of the switches, especially in low light conditions.
• the display screen 12 may be implemented by a commonly sourced colour or monochromatic dot matrix type, and/or segmented type display, and/or hybrid segmented-dot matrix type, and/ or organic LED type display screen, or any other display screen available presendy or in the future, and connected to an output port of the host processor.
• Driving circuit for the display screen 12 is provided by the host processor 6 such that only minimal additional components are required to realise the functionality of the display screen 12.
• the display screen 12 may however include its own driving circuitry.
• the display screen 12 forms part of the user interface 4 and as such provides information to the user for navigating the operational menus of an interface program and for providing a means of reporting information to a user (e.g. information relating to an analyte under investigation).
• Analyte test result data may optionally be downloaded to a peripheral device (e.g. Personal Computer) for further processing and analysis by utilizing the output connector of the system.
• a peripheral device e.g. Personal Computer
• output connector connected to the host processor 6 allows connectivity and data download by wire to a personal computer, mobile telephone and so on.
• Such downloaded data maybe manipulated by a user using commercially available data management software, widely known in the art with no further details required herein.
• a beeper 23 such as a piezoelectric transducer may be provided and connected by means of an operational amplifier circuit to the host processor 6 as would be known to persons skilled in the art.
• Beeper 23 is for providing a response to a user for alerting of various functional features (e.g. meal time, alarm, incorrect analogue input device usage and so on of the device). User may control whether to utilize such a response by means of interface program as will be described later.
• the block diagram also includes a power supply 18 such as at least one commonly sourced battery.
• a battery maybe a Lidiium CR2032 type battery, an AA type battery or an AAA type battery.
• a low battery alarm (such as display of a graphical symbol on the display screen and/or driving of the beeper) maybe included with the main operating program with a threshold trigger optionally configured by a user.
• beeper 23 may provide a beep to a user when such a threshold has been reached.
• the second main element 2b provides an alternative configuration for analogue input device, and is depicted in a simplified block diagram.
• Second main element is electrically connected by means of bus 22 to the first main element 2a.
• Alternative analogue input device may comprise a microphone circuit and/or a touch sensitive area(s) and/ or additional switches.
• first and second main elements 2a, 2b are described in the context of a shared integrated housing, it should be noted that the second main element 2b maybe separate and external to the housing and connected to the first main element by means of the bus 22 cooperating with an interface 22a, as depicted in Figure 2.
• Figure 3 shows, and admittedly in somewhat schematic fashion, an example layout of the display screen 12 forming part of the user interface 4 of the system.
• User operation of the device maybe performed by navigating several different menu items as will be described in great detail later.
• the display screen 12 forming part of the user interface 4 is divided into several sections (e.g. uppermost 34, middlemost 36, and lowermost 38) and arranged byway of example, for providing information to a user.
• Such divisions may include information icons 40, analyte measurement results area 42, and a lowermost information area 38a.
• the number of icons shown is purely by way of example and maybe varied to suit ones desires for performance of the device.
• the display screen 12 maybe implemented by a commonly sourced colour or monochromatic dot matrix type, a segmented display and/or OLED display, and connected to an output port of the host microprocessor, as shown in Figure 1.
• the display screen 12 is provided as a hybrid segmented-dot matrix type.
• the information displayed on display screen 12 is calculated based on data manipulation algorithms embedded within the host processor 6 for data analysis and statistical analysis.
• the algorithms maybe pre-programmed on the host processor during device set-up and/or may be programmed on the host processor during device upgrade for instance.
• the parameters of the embedded algorithms can be updated or optimized by the user or by utilising the self- learning mode of the device.
• the utilisation of such algorithms is for allowing an easy, informative and convenient means of aiding the user in managing a condition for which the device of die present invention is being utilized e.g. for determining the concentration of an analyte (e.g. glucose) in a sample of physiological fluid.
• an analyte e.g. glucose
• an uppermost section 34 of display screen 12 constitutes time 40a and date 40b indicators, utilising for instance, a segmented part of the hybrid display screen 12.
• the format of the displayed time 40a maybe configurable by the user via navigation (as will be described in detail later) and selection of an appropriate menu item of the interactive navigational area of the interface program by means of the analogue input device 10, 30 such that a 12- hour or 24- hour format is assured.
• indication of the date 40b may be in the form day/ month/year or user configurable as year/ month/ day, again by selection of an appropriate menu item of the interactive navigational area of the interface program by means of the analogue input device 10, 30.
• General information icons 40 are further provided on the display screen 12 and as shown these maybe provided as a 'low battery 5 icon 40c, a 'temperature' icon 4Od, a 'clean test element port' icon 4Oe, and an 'apply physiological fluid now" icon 4Of.
• Other icons may be provided as required or being specific to an analyte under investigation.
• analysis of an analyte under investigation is a process undertaken by several components of the system e.g. test element, host processor, data analysis algorithm and so on, and provision is therefore made for displaying the results
• the result of the analysis maybe reported to a user on a segmented area of the display screen.
• the result 42 of the analysis is presented at the middlemost section 36 of the display screen 12, utilising 3 x 7 segments thus forming a numerical value.
• the segments utilised for displaying the analyte result 42 are of greater size than the segments utilised for displaying the time and date 40a, 40b information.
• the measurement results 42 maybe stored in the form of analyte measurement result records on the host processor 6 and/ or maybe stored on a separate storage device 8 such as a ROM. Indeed it would be obvious to those skilled in the art that such resulting data maybe transferred by wire or wirelessly to a personal computer for further analysis for instance.
• the unit(s) of measure 42a for the analyte under investigation is allocated an area to the right of the numerical analyte result 42.
• the unit of measure 42a may in part be user configurable such that accessing an appropriate menu item of the interface program would result in a preferred unit of measure 42a being displayed on display screen 12.
• the user may have the option of selecting between the units mg/dL or mmol/L.
• the unit of measure 42a may also be preset during manufacture depending on the geographical market destination of the device e.g. mg/dL being the preferred unit of measure in North America.
• analytes require different units of measure and as such these are flavoured depending upon the utilised data analysis algorithm(s) hosted by the host processor 6.
• a device earmarked for evaluating coagulation properties of a physiological sample would require the unit of measure to be displayed as an International Normalised Ratio (INR).
• INR International Normalised Ratio
• a meal type identifier 44 is displayed on display screen.
• the meal type identifier 44 is a specific type of an event label of the compliance management profile, which indicates and links the management time frame for different meal events e.g. Pre- Prandial, Post- Prandial, occurring during the course of any 24 hour period of performed measurement values e.g. blood glucose values in case of a monitoring device for diabetes patients.
• the meal type identifier 44 maybe displayed during the occurrence of an analyte measurement and/or may be displayed simultaneously when viewing a stored analyte result 42 record.
• the meal type identifier 44 is provided as alphanumeric characters (i.e.
• non- alphanumeric characters may represent each meal type.
• several meal type identifiers maybe printed on a surface of a display viewing lens with an appropriate indicator activated on the display screen, juxtaposing the appropriate meal type identifier. Further, use of the system clock governs the displayed meal type, such that the indication of a meal type changes automatically during the course of any 24 hour period.
• the lowermost information area 38a is an area dedicated for delivering two forms of information. In a first form, provision is made for display information relating to analysis of data. In a second form, menu navigation information of the user interface of the device is provided. Navigation within the user interface of the device is realised by a multipurpose interactive navigational area 80 of the interface program which will be described in great detail later.
• the lowermost information area 38a utilises a dot-matrix area under the control of the host processor to generate non- alphanumeric characters and alphanumerical characters.
• the data analysis information area 38a in the first information form, is for providing an intuitive representation pertaining to user compliance to a treatment regimen.
• the representation maybe alphanumeric and/or non- alphanumeric.
• the representation maybe a bar graph and/or pie chart and/or any graphical or iconic way to display statistical summary of a disease state.
• the representation is presented as a compliance window, as shown in Figure 4.
• the representation calculated using the aforementioned statistical and data analysis algorithms of the host processor 6, includes the provision of elements such that several graphical indicators are presented on the display screen 12 thus forming a disease management compliance window 50 for aiding a user in the management of a disease of interest.
• user compliance to a treatment regimen maybe provided as text information and shown later in Figure 6.
• the text information scrolls from right to left across the width of the display screen.
• the disease management compliance window 50 maybe defined as a geometric shape, by activated pixels and shown more clearly in Figure 5.
• the geometric shape is provided by two pairs of opposing sides 52, 54, 56, 58, being of unequal length, defining a rectangular shape.
• a horizontally aligned rectangle depicts the outer frame of the disease management compliance window 50 and as previously discussed arranged on the lower most section 38 of the display screen 12. It would be obvious to those skilled in the art however that the window 50 may be in the form of a circle, a triangle, a square and so on, and disposed on any area of the display screen 12.
• the disease management compliance window 50 further includes several activated pixels forming several category indicators.
• the category indicators represent several different information categories. Such information categories may represent a 'target indicator * 60, and/or a 'low and high threshold indicator 5 62, 64 and/ or a 'mean indicator" 66 and/or a 'current measurement indicator 5 68, and/or any other indicator deemed relevant to aid a user in the management of his disease.
• the indicators may be arranged vertically, and/ or horizontally, and/or diagonally, although one of skill in the art, given the teaching of this invention, will recognize that deviations from this may be accomplished without varying from the scope of the present embodiment.
• the disease management compliance window is not limited to a glucose analyte, and many several other analytes e.g. cholesterol, tri-glycerides, lactate, or drugs with a narrow therapeutic range i.e. Coumarin as well known as Coumadine (RIM) or Warfarin (RTM) and so on could validly use such a window utilising appropriate and/ or specific compliance information and feedback to the user.
• the aforementioned can be displayed either as a graphical compliance window or with aid of category indicator ⁇ ).
• the disease management compliance window 50 may allow a user to visually compare an indicator (or icon) representing a current measurement 68 with indicators (e.g. icons) representing threshold 62, 64, target 60 or mean measurements 66, based on their appearances and locations about the compliance window. According to the comparison the user may elect to modify his lifestyle (e.g. increase exercise, reduce certain food types and so on), to make it more likely that a current measurement indicator 68 will closer correlate with one or more of the other indicators.
• the compliance window 50 may display information that changes in substantially real time as the current measurement indicator 68 moves within or outside of the compliance window 50 to provide a substantially accurate display of the values associated with the indicators at all times, for example in the case of a continuous analyte (e.g. glucose) sensor.
• a continuous analyte e.g. glucose
• the upper and lower compliance threshold indicators 62, 64 are represented by one pair of opposing sides 52, 54 of the disease management compliance window 50 i.e. the vertically arranged sides.
• the location of the indicators (e.g. thresholds, targets) relative to the disease management compliance window 50 may be predetermined by the user or HCP during device set up, utilising the analogue input device in form of buttons and/ or switches 10 and/or touch sensitive area(s) 30 which does not require a mechanical activation for selecting an appropriate menu item of the interactive user navigational area.
• a numerical value 42 e.g.
• the numerical value 42 maybe presented on the middlemost section 36 of the display screen 12 utilising 3 x 7 segments or such values maybe presented utilising the segments partly reserved for displaying the current date and time information.
• the analyte measurement target indicator 60 is the analyte measurement target indicator 60.
• the position of the target indicator 60 is again predetermined by the user and/ or HCP and it is generally considered that such an indicator 60 shall be positioned within the disease management compliance window 50, that is between the lower and upper threshold indicators 62, 64.
• the pixels activated to display the target indicator 60 are depicted and arranged as a vertical line, being aligned parallel to die lower and upper threshold indicators, although it would obvious to those skilled in the art that deviations from this maybe accomplished without varying from the scope of die present embodiment.
• die user may alter the position of the target indicator 60 depending on his health status and/or maybe prompted, by means of the piezo transducer (beeper) 23, to alter the target indicator at a predetermined frequency Le. once a month.
• a mean indicator 66 allows for representative indication of all analyte measurements in relation to a specific meal type 44 e.g. pre-prandial, postprandial occurring during the course of any 24 hour period.
• other category indicators e.g. current measurement
• the x axis (and/ or y axis in the case of vertically arranged compliance window) of the activated pixels (Le. indicators) are correctly positioned about the compliance window 50. That said, the aforementioned category indicators are thus arranged in the context of one another and 'move' depending on a result of several factors such as the calculated analyte result for instance.
• Analyte mean is the mean analyte value of all* measurements over a time frame of interest, and N is the number of data points (or measurement).
• the mean analyte value is determined for one specific meal time category, like e.g. "pre lunch” or "after dinner". For determining a mean value for the meal time category "pre lunch”, only former measurement values of this specific meal time category are taken into account. Thus, specific mean values corresponding to each of the meal time categories may be determined.
• the respective mean values are determined as mean values of the measurements of the last n days, and further preferably, n is set to 14, which means that an average value of the measurements of the last 14 days is determined for a respective meal time category.
• n is set to 14 which means that an average value of the measurements of the last 14 days is determined for a respective meal time category.
• each time a test result is calculated a new average for that mealtime is also calculated, with the new average being stored together with that result.
• the location of the mean category 66 indicator is at a position between the target and upper threshold indicators 60, 64. Indeed it is generally considered that effective disease management ensures that a mean category indicator 66 is as close as possible to a target category indicator 60.
• the mean value for each specific meal type frames may be stored in the storage device of the first main element, such that the value(s) maybe utilized for subsequent statistical calculations and/or recalled for presentation to the user in the future such as for comparison with other date specific time events.
• the current measurement indicator 68 i.e. the indication of an analyte measurement relative to a target 60 and/ or mean indicator 66.
• the current measurement indicator 68 maybe provided by several activated pixels forming a geometric shape (e.g. square, circle, triangle, and so on) or an icon, although one of skill in the art, given the teaching of this invention, will again recognize that deviations from this maybe accomplished without varying from the scope of the invention.
• the position of the current measurement indicator 68 relative to the target measurement indicator 60 is, of course a direct consequence of the concentration of an analyte under investigation and therefore determined by an analysis algorithm hosted on the host processor.
• An alarm may additionally be triggered to alert the user that a current measurement (or a series of measurements) is/ are outside of the upper and/or lower thresholds.
• Such an alarm may be audible 23 (by means of the beeper), iconic 40 (by means of the display), or vibratory (by means of a vibrator) (not shown).
• each time a test result is calculated a new average for that mealtime category is also calculated, and the new average is stored with that result.
• the monitoring device displays the last record made for that mealtime category, like e.g. "before breakfast”, “after breakfast”, “before lunch”, “after lunch”, etc..
• the user may scroll back through the records for that mealtime category, one result at a time.
• the mean indicator 66 move within the compliance window 50.
• the user sees that the mean indicator 66 moves towards the target 60 or away from the target 60.
• the monitoring device displays the records in the selected mealtime category.
• the mean indicator 66 indicates the 14-day average at the time when the record was made.
• the user can see the 14-day mean indicator 66 move within the compliance window as he or she scrolls backwards and forwards through the records a in the selected mealtime category.
• the movement of the mean indicator 66 indicates to the user whether his or her lifestyle is correct or incorrect.
• Such a trending function is particularly useful to be displayed in combination with the averages of the different categories to indicate to the user his on-going compliance state and/ or states.
• the monitoring device will use simple routines to make comparisons between elements of a record, using the compliance window settings as benchmarks. In particular, the following three comparisons maybe performed: [00085] First Test: Comparing the Target Value with the Updated 14- Day Average
• the target value is set as one of the compliance window parameters. This value will not vary from record to record unless the user adjusts his or her personal parameters. This is also true for the low limit and high limit parameters. Every time the user makes a new blood glucose measurement for a particular meal memo category, the monitoring device will use the new result to calculate a revised 14-day average.
• the average value is stored as part of the glucose result record which means that each record contains a 14- day average value that was true at the time the measurement was made. This provides a simple trending tool that allows the user to see through a graphical display how his or her average is changing over time. This feature is further enhanced by making a basic numerical comparison between the 14- day average value and the target.
• the monitoring device will display an advice screen like e.g. "YOUR AVERAGE IS TOO LOW COMPARED TO YOUR TARGET" or "YOUR
• Second Test Comparing the Target Value to the Current Result
• a simple numerical comparison between the result just calculated and the target value can be made. If the net difference between the two values is greater than a pre-set value, say ⁇ 50 mg/dL for example, the monitoring device will display an advice screen like for example "YOUR RESULT IS LOW COMPARED TO YOUR TARGET" or "YOUR RESULT IS HIGH COMPARED TO YOUR TARGET':
• a simple numerical comparison between the result just calculated and the new 14-day average can be made. If the net difference between the two values is greater than a pre-set value, say ⁇ 50 mg/dL for example, the monitoring device will display an advice screen such as for example "YOUR RESULT IS LOW COMPARED TO YOUR AVERAGE” or "YOUR RESULT IS HIGH COMPARED TO YOUR AVERAGE”.
• a pre-set value say ⁇ 50 mg/dL
• the monitoring device will display an advice screen such as for example "YOUR RESULT IS LOW COMPARED TO YOUR AVERAGE” or "YOUR RESULT IS HIGH COMPARED TO YOUR AVERAGE”.
• an indication of the variance (not shown) of analyte measurement over a selected time frame may additionally be displayed about the compliance window.
• the data analysis information area has, so far been described in relation to non- alphanumeric representation of user compliance of a treatment regimen, and as such to further aid the user to understand his compliance to a disease, die provision of alphanumerical information, in the form of scrolling text 70 or messages, maybe provided.
• the lower most information area 38a is utilised to provide the scrolling text information 70, by rapid host processor 6 activation and deactivation of appropriate pixels.
• the scrolling text 70 may further be provided elsewhere about the display if a full dot matrix display screen is utilised.
• the messages 70 exhibited on the display screen 12 maybe pre-programmed and stored on the host processor 6 or on the storage device external 28 to the host processor 6, providing useful information to a user.
• the exhibited message may relate to compliance of a treatment regimen, and/or advertisements from sponsors, and/ or company logos, and/ or motivational messages, and/ or personal information (e.g. Name, allergies, contact person and so on) and/or general information relating to a disease for which the device is implemented.
• the provision of the messages 70 relating to disease management compliance information is automatically prompted in relation to measurement values and their comparison to predetermined diresholds, as will be described below.
• a provision is made for user control of the rate of text scrolling such as by selection and manipulation 10, 30 of function menu items of the interface program.
• An example pre-programmed message which maybe conveyed to a user in a scrolling fashion maybe 'YOURMEAN GLUCOSE VALUE DURING BREAKFAST IS ON TARGET.
• a message indicating an elevated glucose levels between different meal types could be displayed such as ⁇ OUR MEAN GLUCOSE VALUE
• DURING BREAKFAST IS HIGHER THAN DINNER'. Indeed, such a message may additionally be conveyed to the user by means of the analogue output such as a speech digitizer and a speaker.
• the analogue output such as a speech digitizer and a speaker.
• Equation 2 describes the standard deviation of measurements over a predetermined time frame.
• Equation 2 the standard deviation of measurement values can be calculated for indicating the spread of data about the mean value. For example using the above examples would return a standard deviation value of 9.8 for the former set of results and in turn, a standard deviation of 2.3 for the latter set of results. The result of using Equation 2 therefore indicates the spread of the measured values for each meal type suggesting that the former set of results are variable.
• JC is the mean (from Equation 1)
• JC is the glucose value for each data point and N is the number of samples.
• Even more powerful is the possibility of a comparison between the spread of data of at least two separate data sets (e.g. meal types, i.e. breakfast, lunch, and pre and post prandial) that have approximately the same mean.
• the mean value during breakfast measurements might be the same (or near) as the mean value for the dinner measurements, potentially mis- leading the user that preceding actions (e.g. exercise, diet) has been conducive in providing disease management compliance information, or that both data sets are the same.
• the breakfast measurements may have high variability of measurements as compared to the dinner measurements.
• a relatively small standard deviation in this case 2.3 is indicative of a narrow spread of measurements around the mean and therefore has comparatively fewer high or low value measurements.
• a relatively large standard deviation in this case 9.8 is indicative of a wide spread of measurement around the mean.
• the more widely spread the values are the larger the standard deviation.
• the high spread of data during breakfast time frames might indicate that his previous insulin dosage maybe too high or low.
• the resulting analysis may be provided to the user by means of scrolling text with such a message being 'YOUR BREAKFAST READINGS ARE VARIABLE AND SOMETIMES OUT OF THE NORMAL RANGE. PLEASE CONSULT YOUR
• the standard deviation for each meal type is stored in the storage device 8 as a running value, after the user has performed an analyte measurement.
• a comparison is performed by operational software of the host processor 6 of outlying returned results, that is, results of Equation 2 which provide the largest range. For instance, if four standard deviation results (i.e. corresponding to four different meal events) are computed using Equation 2, then the results of the comparison may be utilised to return a message to a user (e.g. as pixeiated scrolling text). Messages returned to the user may include 'GLYCEMIC CONTROL DURING BREAKFAST HAS A
• trends of a patient compliance to a treatment regimen may additionally be provided such that a determination is made whether an overall increase (or decrease) in the control and variability of the measurement values over a predetermined time frame.
• Messages may be provided to the user and displayed in text box such as 'OVER THE PASTMONTHYOURDINNER GLUCOSE VALUES ARE MUCH BETTER CONTROLLED', thus providing a motivation message to the user.
• FIG. 7 shows and again in a somewhat schematic fashion, an alternative configuration of the disease compliance reporting aspect of the user interface.
• the figure shows a display lens 72 positioned above a display screen 12 and within an aperture of an upper housing of the device.
• the display screen 12 is divided into several sections or areas and arranged by way of example, for providing information to a user.
• Such divisions may include information icons 40, a results data area 36, and meal event indicators 44.
• icons 74 preferably on the lowermost part of the display screen 12 are icons 74, earmarked for disease compliance notification.
• the display screen 12 maybe implemented by a commonly sourced colour or monochromatic dot matrix type, a segmented display and/ or OLED display, and connected to an output port of the host processor 6, as shown in Figure 1.
• the display screen 12 is provided as a segmented type.
• the display lens 72 being transparent in nature, maybe of various sizes and shapes and includes an inner surface and an outer surface.
• the display lens 72 may form part of the outer casing (not shown) of the device or maybe connected, by means of snap fitments for example, to the outer casing of the device. Such connection generally is for providing a contiguous fitment between an outer surface of the display lens 72 and an outer casing of the device.
• Either the inner and/or outer surfaces of the display lens 72 may be coated with a coating having antireflective properties, such as that undertaken by a chemical and/or physical process as would be known to persons skilled in the art. Such properties aid a user when viewing the contents of the display screen 12 under bright light conditions e.g. sun, and/or lamps.
• a non transparent circumferential border 73 maybe provided by printing or coating of the inner surface display lens 72 with a non- transparent material.
• a cell matrix 76 comprising of individually separated geometric shapes or cells 76a-i and preferably defining a graduated chromatic scale (e.g. colour or mono), by further printing or coating techniques.
• the chromatic scale is provided behind the glass of the liquid crystal display (LCD) with individual activated segments of the display appearing in front of the chromatic scale.
• Each individual geometrically shaped cell 76a-i may however comprise an individual patterned marking.
• the scaling may vary in a linear or non- linear manner in order to cause the graded effect to be accentuated or attenuated.
• a 9 x 1 cell matrix 76 is utilized, with the cells 76a- ic being rectangular in shape.
• cells 76a-i may have any suitable size and shape according to particular needs.
• the cells 76a-i maybe disposed elsewhere about the border 73 such as the uppermost and/or on the sides and arranged either horizontally or vertically.
• the cells 76a- i are clustered around the lowermost peripheral border 73 in a horizontal arrangement that together with suitably activated symbols 74a, 74b provide a compliance indicator, as will be described below.
• Cells within the matrix are scaled such that in combination with the activated symbols represent 'ELEVATED', and/or 'SLIGHTY ELEVATED' and/or 'NORMAL' current measurement and/or statistically enhanced measurements (e.g. mean).
• the number and form of the symbols 74a, 74b depicted in the current illustration are purely provided by way of example and varied to suit ones desires, however the number of symbols 74a, 74b available for display on the display screen 12 is equal to twice the number of cells 76a-i in the matrix 76.
• the symbols 74a, 74b maybe provided by way of segments (e.g. in a segmented type display, and pixels in a hybrid and/or dot- matrix display). Alternatively, pixels that define alphanumerical and/or non- alphanumerical characters may be utilised if a pixelated type display is utilised.
• matrix contains nine cells, with nine pairs of concentric circles provided. Each circle within a pair are distinguished by having an inner circle and outer circle of different diameter and separated by a gap. Each circle may be independently activated.
• Each activated symbol 74a, 74b (i.e. circle) maybe representative of statistical evaluations performed by the host processor 6.
• an inner activated circle may represent a 'current' measurement
• an outer activated circle may represent a
• Such an outer circle maybe activated and controlled by Equation 1. Furthermore, the position of each circle in relation to the cell matrix is dependent and/or activated depending on predetermined analyte measurement targets. Such targets may be user defined and/ or HCP defined, each user accessing a set-up mode of the interface program by manipulation of the analogue input device 10, 30.
• the activated symbols 74a, 74b on the display screen appear in front, in a preferred configuration, of the display lens cell matrix 76.
• compliance indicator 75 enabling a user to readily visualize and compare among the cell markings 76a-i the different status of his compliance to a disease regimen, without needing to conduct a detailed evaluation of the actual values associated with the analyte measurement as in known techniques.
• an activated inner circle 74a on the display screen 12 appearing in front of a coloured cell 76a or 76i may indicate to a user that his current analyte measurement is 'ELEVATED'.
• an activated outer circle 74b appearing in front of a coloured cell 76d-f may indicate that his mean analyte measurement for a particular meal type 'NORMAL'.
• indication of a specific time frame is also provided on the display screen 12, further enhancing the information provided to the user.
• Users who improve their compliance to a treatment regimen may suitably alter their targets, again by accessing an appropriate menu item of the interface program and manipulation of the analogue input device 10, 30.
• the host processor by means of the interface program, is configured to present a navigational interface on the display screen 12 to a user.
• the navigational interface comprises a menu interface 82 such as a list menu and a navigation decision area.
• the navigation decision area is provided by a
• the selection window 80 is displayed at the lowermost section 38 of the display screen 12, that is the lowermost information area.
• the selection window 80 maybe provided as a geometric shape having an outer frame provided by the activated pixels.
• the geometric shape maybe in the form of a circle, a triangle, a square, a rectangle.
• a horizontally aligned rectangle is provided, although it will be apparent that the selection window 80 can be readily arranged in any other orientation on the display screen 12.
• apparent to those skilled in the art would be the provision of a selection window 80 on a surface of a display lens 72, provided by means of a coating for example.
• the analogue input device 10, 30 can take the form of control switches 10, touch sensitive areas 30, jog wheels.
• User input to the host processor 6 may be effected by manipulation (or instructing) of the analogue input device 10 (e.g. manual buttons, confirmation button) which in turn signals the host processor 6.
• the analogue input device 10 e.g. manual buttons, confirmation button
• the list formation of the menu consists of a set of individual menus logically organized in a hierarchical fashion, such that the selection of a first level menu item from a first level menu causes a second level menu to be displayed.
• the second level menu includes several second level menu items associated with the selected first level menu item.
• Menu items at any level in the hierarchy can be provided to cause another menu level to be displayed, to set targets or thresholds, to view stored analyte measurement result records, or to cause a particular function to execute.
• the menu 82 of the present invention is described herein with respect to an exemplary implementation that allows a user to select a function from several available functions.
• Figure 8b shows a top level menu 82a which maybe presented on the lowermost information section 38 of the display screen 12.
• the top level menu 82a includes a set of top level menu items 82aa-82ae in a sequential arrangement. While five menu items are depicted, it should be recognised that a greater or lesser number of menu items can be used without departing from the scope of the present embodiment.
• a user selected menu item (82aa of Figure 8a) is set within the selection window 80. Further, and at anytime at least three menu items are displayed on the display screen 12 arranged in a sequential arrangement (e.g. row or column).
• the menu items are provided in the context of the selection window 80, such that manipulation of the analogue input device 10 scrolls the menu items 82aa-82ae (of Figure 8b) in a left or right direction (or up and down), depending on the direction in which the user urges the analogue input device 10 such that a required menu item 82aa is positioned within the selection window 80 as shown in Figure 8a. Further, either side of the selection window 80 is a pre and post menu item 82ab, 82ae, for providing a preview (or post view) of the next menu item a user maybe able to select.
• Each menu item represents a link to another menu level, a feature, an application, and so on. Further, each menu item includes text and/ or a graphical icon to present the function of the link.
• the text and/or graphical icon maybe represented by pixels under the control of the host processor 6.
• the links are labelled in the following categories: 'set-up' 82aa, 'lifestyle' 82ab, 'memory' 82ac, 'medication' 82ad, 'module' 82ae.
• the menu items maybe arranged according to a default configuration as maybe specified by a manufacturer. Indeed, further first level menu items maybe added to the first level menu 82a on connection to the device of appropriate functional hardware modules. Similarly, first level menu items seldom used by user maybe 'removed' therefrom. Such operations are performed by accessing first level items such as the 'set-up' item.
• a second level menu 82b is generated and displayed on the lowermost section 38 of the display screen 12, shown in Figure 8c.
• the second level menu 82b comprises several second level menu items, and the second level menu items replace the first level menu items in the row (or column) arrangement.
• at least three second level menu items may be displayed on the display screen 12, one of which being inside the selection window 80.
• the remaining second level menu items appear either side of the selection window 80 allowing a user a pre or post view of such menu items.
• Figure 8c depicts an example of a second level menu displayed in response to a selection of a 'set-up' menu item 82aa (of the first level menu 82a).
• the second level menu 82b includes several second level menu items 82b, arranged in a row (or column) arrangement.
• all of the second level menu items 82aal-82aa4 include text and/or a graphical icon to represent the function of the item.
• selection of any second level menu items 82aal-82aa4 as in the selection of items from the first level menu, utilises other parts of the display screen 12 such that stored records, set-up information (e.g.
• a means 200 of navigating back from the second level menu to the first level menu or from the first level menu to the main screen is provided by an "Escape” or a "Go- Back" menu item. ] Selecting a menu item can be accomplished in a number of different ways.
• the menu item can be selected by navigating through the menu items of each menu by the analogue input device 10 until the desired menu item appears in the selection window.
• the analogue input device 10 is urged by the user in a general left or right direction, causing the menu items to move in a corresponding fashion through the selection window 80, until the required item (i.e. set-up) is within the window 80.
• the desired menu item is then selected by the user by performing an action e.g. depression of the confirmation switch.
• the analogue input devices i.e. control switches
• the second menu level 82b is then entered and associated further menu items are presented on the display screen. Further urging and depression of the input device 10 allows the user to select the desired menu item.
• the information provided on other parts of the display screen are changed as appropriate. For example, in the memory menu 82ac, previous generated analyte results 42 can be viewed on die display screen 12 (e.g. upper and middlemost area) by control of the analogue input device 10.
• the previously generated analyte result records (e.g. for each meal event, or particular date) can be viewed in a sequential fashion, die desired record being viewed by appropriate urging of the analogue input device 10.
• the disease management compliance window is a graphical tool aiding a person to visually compare an indicator such as for a current measurement value with other indicators deemed important for the management of a disease. These other indicators may include high and low markers and/or average markers and/or other statistical relevant markers.
• other indicators may include high and low markers and/or average markers and/or other statistical relevant markers.
• Step 1 the user inserts an unused test element into an appropriately designed receptacle.
• a receptacle maybe configured to receive a photometric based test element such as the analyte test element of European Patent Specification 1574858, or the receptacle maybe configured to receive an analyte test element of Co-Pending Patent Application PCT/EP2004/009113.
• the meter is automatically activated (Step 1)
• Step 3 the display screen of the meter prompts the user to select a meal time from a pre-programmed list of possible meal time categories (e.g. Breakfast, Lunch, Dinner, Night, Odier).
• the list may be in the form of text based messages and/or iconic based messages and/or a combination of text and iconic based messages.
• a switch e.g. mechanical and/ or touch sensitive and/or voice control
• the user selects and confirms an appropriate meal time category to conclude the next step (Step 4).
• the automatic prompting of the meal time is based on operating parameters such as e.g. 6am to 11am equating to 'Breakfast', 1 lam to 3pm equating to 'Lunch' , 3pm to 8pm equating to 'Dinner', and any other time equating to 'Night' or 'Other'.
• operating parameters e.g. 6am to 11am equating to 'Breakfast', 1 lam to 3pm equating to 'Lunch' , 3pm to 8pm equating to 'Dinner', and any other time equating to 'Night' or 'Other'.
• Such operating parameters maybe stored on a storage device of the meter for example. It is important to stress, that these operating parameters are not fixed and that the user can select which ever meal event which is most apt for a particular time of day.
• Step 5 the content of the display screen is automatically changed to display a further user selectable list.
• the changes to the display screen is to allow the user to select whether the previously selected meal category should be marked as pre or post prandial type.
• the list maybe in the form of text based messages and/ or iconic based messages and/or a combination of text and iconic based messages.
• the display screen may indicate the previously selected time, in this case, 'Breakfast' in a header part of the display and in the centre thereof the user selectable pre and post list ('Before' or 'After'), as is shown in the schematic diagram of Figure 9b.
• a footer part of the display screen is an information area to indicate which menu level and/or action the user must perform.
• a next step the user categorises the previously selected meal category into a pre or post prandial type by navigating to the appropriate event. Again, navigation to the appropriate event is performed by using input devices such as mechanical and/or touch sensitive and/or voice control parts.
• Step 7 the content of the display screen is automatically changed to prompt the user to apply a sample of blood on an application area of an appropriate test element. After a few moments, the concentration of blood glucose in a sample of blood is displayed on the display screen (Step 8).
• the meal event category is displayed together with the optionally activated disease management compliance window thus forming a comprehensive tool for aiding a patient in managing a disease of interest.
• the above steps is entirely relevant for the above steps to be performed without the disease management compliance window to be switched on, i.e. that meal category selection is displayed without the graphical tool being displayed such as displayed on Fig 9d.
• die present invention may have particular applicability to personal glucose diagnostic devices, it is should be noted that the present invention is also applicable to other types of analytes e.g. cholesterol, alcohol, lactate and the like, and to sensors such as immunoassay sensors, coagulation sensors and the like.
• analytes e.g. cholesterol, alcohol, lactate and the like
• sensors such as immunoassay sensors, coagulation sensors and the like.

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• 2007
  • 2007-12-14 EP EP07856764A patent/EP2113110A1/de not_active Withdrawn

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