HK1186368B - Device and method for determining blood glucose characteristics - Google Patents

Description

Apparatus and method for determining blood glucose characteristics

The invention relates to a device and a method for determining blood glucose characteristics.

Background

These techniques are used to determine characteristics of the blood glucose value measured by the patient. The aim is to give the patient and the attending medical staff information which enables the patient to treat his blood glucose value in an improved and appropriate manner.

For people with Diabetes (Diabetes), in particular Diabetes (Diabetes mellitis), it is particularly important for them to keep their blood glucose values constantly at a certain level. This presupposes knowledge of their blood glucose level, which is measured using a blood glucose measuring device provided for this purpose. Blood glucose measuring devices are known in various embodiments.

The international standard method for measuring blood glucose levels is based on molarity, measured in millimoles per liter (millimoles per liter, or millimole, abbreviated to mM). In some countries, mass concentrations are measured in milligrams per deciliter (milligrams per deciliter). Due to glucose C₆H₁₂O₆Is about 180 g/mol, the difference between the two scales is 18-fold for the measurement of glucose, so that 1 mmol/l of glucose equals 18 mg/dl.

On the basis of the measured values, if it is determined that the blood glucose value has exceeded the recommended level, a drug is administered, for example oral antidiabetic drug Metformin (Metformin) by insulin injection or oral administration. If the blood glucose level drops below an ideal or recommended level, the sugar must be taken orally, for example by food or drink. If the ideal level is exceeded for a long period of time, there is a risk of serious health complications, such as blindness, kidney damage, having to amputate limbs or neuropathy. This can lead to nausea, dizziness, sweating or even a delirium if only for a short time but well above the prescribed blood glucose level. It is therefore particularly important for a diabetic to know his blood glucose level at any time so that he can carry out appropriate measures to avoid a deviation of the blood glucose level from the desired level.

Blood glucose measuring devices with which the blood glucose level of a diabetic patient can be measured are known, for example from document US 2007/0293790 a1, and are sold by the applicant under the registered trademark Accu-Chek.

It is known that blood glucose measurements can be made according to a continuous measurement scheme. These measurements are also known as CGM measurements (continuous monitoring blood glucose measurements). In this method, the blood glucose values are measured continuously over successive time periods so that, for example, the progression of blood glucose values can be collected over an entire day. Analysis of the measured blood glucose values may provide for determination of trends over several days. In this way, it is possible to determine blood glucose excursions that are dependent on the time of day. The disadvantage of continuous blood glucose measurement is firstly that it can lead to high costs due to the continuous measurement and secondly that it causes discomfort to the diabetic person, whereby the latter is caused by the permanent wearing of the subcutaneous sensor. This may lead to infections at the entry point, intolerance of the plaster or skin irritation, which prevents the device from being worn for a prolonged or long period of time, e.g. several months. Continuous measurement of blood glucose levels is described, for example, in Gross et al "Performance Evaluation of the MiniMed Continuous Glucose Monitoring System During Patient Home Use”, Diabetes Technology &Therapeutics, 2 (2000) 49.

For continuous monitoring of blood glucose levels, it is proposed in document US 2008/0287755 a1 to perform so-called trend analysis. This may enable the rate of change to be determined based on two or more blood glucose value measurements. The continuous monitoring period may be between 5 and 30 minutes. A measurement period of less than 10 minutes or more than 30 minutes may be provided. The CGM measurement is performed once per second or once per minute during the measurement period, thereby providing a constant or varying cycle length. The known method suggests that the trend thus determined can be displayed as a directional arrow on a display.

And discontinuous or structured blood glucose measurements are known, which are also referred to as SMBG measurements (self-monitoring blood glucose measurements) in particular and are characterized by the fact that the blood glucose values are determined by a single measurement and/or a series of measurements at specific time intervals. In this way, with the help of this blood glucose measurement, which is also referred to as structured blood glucose measurement, it is possible to measure blood glucose values that are in close proximity to a particular event, for example with respect to a meal. The disadvantage of structured blood glucose measurements can arise if blood glucose level related events of a diabetic patient occur between the measurement times, so that they are undetectable. The procedure is described in document US 2009/0054753 Al, whereby a single blood glucose measurement is used within the scope of the discontinuous measurement to determine the time for a subsequent further single measurement according to certain parameters. Parameters considered include patient and environmental conditions.

And it proposes to display measurement related information graphically. Examples can be found in US 2007/0066873 a1, US 2008/0021666 a1, US 2008/0255438 a1, US 2009/0043525 a1 and US 7,399,277B 2. For a graphical display of measurement related information it is suggested to display a trend arrow, which may appear on the display displaying the measurement results to alert the user. Different conditions are shown using trend arrows with different directions: the current blood glucose level rises sharply, rises, has little or no change, falls, or falls sharply as compared to the last blood test (Accu-Check Instant DM, Diabetes Management System, user's manual, Boehringer Mannheim Corporation, 1996).

Summary of The Invention

It is an object of the present invention to provide a device for determining blood glucose characteristics and a method with improved user operation.

According to the present invention, a device for determining blood glucose characteristics and a method of operating a device for determining blood glucose characteristics according to claims 1 and 9, respectively, are provided. Advantageous developments of the invention are disclosed in the dependent claims.

According to one aspect of the present invention, there is provided an apparatus for determining a blood glucose characteristic, comprising a sensor input capable of accepting a signal from a sensor, the signal being based on a sensed blood glucose value of a user; a memory configured to store a plurality of measurements of a sensed blood glucose value of the user from the signal received from the sensor; a display configured to display a graphical representation of a plurality of measurements of a blood glucose characteristic value; and a controller configured to control display of a graphical representation on the display, wherein the graphical representation includes a trend indicator indicating a general numerical trend in the most recent series of sensed blood glucose values over the plurality of measurements, and wherein the trend indicator includes a plurality of graphical portions, each graphical portion being of a different graphical style and assigned to a different range of sensed blood glucose values, thereby indicating a transition from a first range of sensed blood glucose values to a second range of sensed blood glucose values.

According to another aspect of the present invention, there is provided a method of operating a device for determining blood glucose characteristics, the method comprising the steps of: accepting, by the sensor input, a signal from the sensor, the signal being based on a sensed blood glucose value of the user, storing in a memory a plurality of measurements of the sensed blood glucose value from the signal accepted from the sensor, displaying on a display a graphical representation of the plurality of measurements of the blood glucose feature value, and controlling, by the controller, display of the graphical representation on the display, wherein the step of displaying the graphical representation further comprises the step of displaying a trend indicator indicating an approximate numerical trend in a recent series of sensed blood glucose values over the plurality of measurements, the trend indicator comprising a plurality of graphical portions, each graphical portion being of a different graphical style and assigned to a different range of sensed blood glucose values, thereby indicating for the sensed blood glucose values a transition from a first range of sensed blood glucose values to a second range of sensed blood glucose values.

With the aid of the invention, proper operation of the device for determining blood glucose characteristics is improved. The user is provided with the possibility of being able to not only discover the blood glucose values themselves, but also to inform the user about trends in the values over time derived from comparisons of at least two blood glucose measurements. This is displayed on the display with the aid of a trend indicator, depending on whether the blood glucose level is determined to be rising or falling or stable. The graphical trend indicator enables the user to quickly understand the situation with respect to his blood glucose level.

By means of the invention, it is possible to provide information to the patient and/or medical staff about time-dependent changes in the measured blood glucose value, preferably in discrete blood glucose measurement ranges. The time-related changes may indicate an increase or an increase, a decrease or a stable level of the blood glucose value. The information about the time-dependent change, i.e. the blood glucose value trend, may preferably be determined in the form of a positive or negative slope, which corresponds to an increase or decrease. If no time-dependent change in blood glucose level is determined, there is no slope.

The trend indicator contains a plurality of graphical sections that differ in the graphical style used for display. Different graphical portions are assigned or assigned to different ranges of sensed blood glucose values. The range may cover several possible measurements or only one. Due to the fact that the trend indicator contains a plurality of different graphical sections, one or more transitions between different ranges of sensed blood glucose values may be displayed. If, for example, the trend indicator comprises two graphical parts, the trend display will, on the one hand, display a trend, i.e. rising or falling, for example by a change in the slope of a graphical element. And, with the help of the graphical part, it displays, in different graphical styles, also information about the two ranges between which the transition takes place. For example, it may be provided that a first graphical section relating to blood glucose values between 4.0 and 5.5 millimoles per litre is displayed in a first colour in the trend indicator. If subsequent measurements show that the value is now in another range, for example between 5.5 and 7 mmoles/litre, the trend indicator will display the graphical section in a second colour. In this example, in one aspect, the trend display displays a rise, such as with the help of appropriate arrows. In addition, the user can see at a glance in which two ranges the transition occurred as a result of the rise.

According to one embodiment, for the graphic part, the different graphic styles are selected from the group of the following graphic styles: color style and shadow style. It may also be provided that the two graphical parts differ in both colour and shadow styles.

In a further embodiment, the controller is configured to perform a temporal analysis of the measurement time for an early measurement providing a first sensed blood glucose value assigned to the first range of sensed blood glucose values and a later measurement providing a second sensed blood glucose value assigned to the second range of sensed blood glucose values, and if one of the following conditions is derived from the temporal analysis: the time interval between the early and late measurements is shorter than the minimum time interval and the time interval between the early and late measurements is longer than the maximum time interval, the graphical representation of the trend indicator on the display is prevented. In this embodiment, it is also provided that, in addition to trend analysis, the time interval between measurements can be analyzed to determine the blood glucose value from which the graphically displayed trend indicator is derived. If the time interval is shorter than a certain minimum length, the presentation of the trend display is blocked by the controller. If the time interval is too long, the presentation of the trend indicator is also prevented. The values for the minimum and maximum time intervals may be set by the user or predefined by the device. In this way, trend display is prevented in situations where the trend cannot be determined properly for the respective blood glucose values due to too long or too short intervals between measurements.

According to yet a further preferred embodiment, the trend indicator indicates a trend pattern for the sensed blood glucose value selected from the group consisting of: moderate decline, moderate rise, sharp decline, and sharp rise. The difference between steep and medium may be realized for example by the trend indicator showing a vertical or diagonal arrow, whereby a vertical arrow will show a steep change of rise or fall.

In another preferred embodiment, a device integrated sensor is provided. In this embodiment, the device itself is provided with a sensor. Devices for determining blood glucose characteristics based on test element analysis are known as such in different configurations, for example from US 2007/0293790 a 1.

In a further preferred embodiment, the graphical representation comprises a warning symbol indicating that the most recent blood glucose value of the sensed blood glucose values belongs to a risk situation. The risk situation may be determined by the controller by evaluating at least one of: sensed blood glucose values, blood glucose value trends, extrapolation of future blood glucose values, time interval information for blood glucose value measurements, time of day information, and bolus information for injections.

With respect to the method of operating the device for determining blood glucose characteristics, preferred embodiments may be provided as described in detail for the device above.

Description of the preferred embodiments

Hereinafter, the present invention will be described in further detail by way of examples with reference to various embodiments. The attached drawings show that:

FIG. 1 is a schematic view of an apparatus for determining blood glucose characteristics, an

Fig. 2 is a schematic diagram of the device of fig. 1 shown on a display.

Fig. 1 shows a schematic diagram of an apparatus for determining blood glucose value characteristics, with a sensor input 1, a controller 2 and a memory 3. The controller 2 is connected to the display 4 to control the presentation of graphical elements on the display 4. In the case of the embodiment shown in fig. 1, the sensor 5 is shown as an external sensor configured to measure blood glucose values characteristic of the user. The preferred method for sensing blood glucose levels is discontinuous mode. In another embodiment, the sensor 5 may be integrated into the device, shown as a dashed line in fig. 1. This will then be assisted, for example, by a device for determining blood glucose with the aid of a so-called test strip, whereby a blood sample is applied to the test strip to determine the blood glucose value.

The signal of the sensor input 1 is sensed by the sensor 5 in respect of the respective blood glucose level characteristic and is then processed by the controller 2 to generate a control signal for the display 4, in particular for displaying graphical elements representing blood glucose levels and/or information about the change (trend) per time unit.

Fig. 2 shows a schematic view of a display to be displayed on the display 4. In the embodiment shown, the display 4 displays the current blood glucose level 20 and date information 21. Also, a trend indicator 22 is displayed, which in the embodiment shown has the form of an arrow. In each of the two representations in fig. 2, the trend indicator 22 comprises two different graphical parts 23, 24, which differ in the shading used.

By way of its graphical style, the first graphical section 23 shows that the starting point selected for trend analysis is within the initial blood glucose value range, for example in the range of 3.5 and 5 millimoles/liter. The later values of the trend analysis, in the upper representation in fig. 2, lie in another blood glucose value range, which is represented in the second graphic section 24 by means of the lack of shading. For example, the ranges here cover blood glucose values between 6 and 8 millimoles/liter. The slope of the arrow shown in the upper representation in fig. 2 indicates a moderate rise in blood glucose level over the analyzed time period.

In contrast, trend indicator 22 in the lower representation in FIG. 2 shows a sharp drop in blood glucose value derived from measurements used for trend analysis. In the lower representation in fig. 2, the graphical sections 23, 24 also differ in their shading and thus show that a sharp drop results in a transition from one blood glucose value range to another.

The graphical portion at arrow 25 is shown in its graphical style, the range in which the previous blood glucose value for trend analysis has declined. The graphical portion at arrow 26 of trend indicator 22 is displayed in its graphical style, the range in which the blood glucose value of the subsequent blood glucose value for trend analysis has declined.

It may also be provided that the trend indicator 22 comprises more than two different graphical parts, which differ with respect to their graphical style.

With respect to fig. 1, a warning symbol 27 is displayed on the display 4. The warning indicates that the current blood glucose level is within a critical range of blood glucose levels. The controller 2 will generate a control signal for displaying the warning symbol 27 depending on a predefined rule which can be adapted by the user. The following rules may apply:

-the measured blood glucose value is < 60 mg/dl;

-the measured blood glucose value is > 300 mg/dl;

-the measured blood glucose value is obtained after the main meal and the previous blood glucose value is before the main meal and the extrapolated blood glucose value within two hours is < 90 mg/dl or the extrapolated blood glucose value within two hours is > 300 mg/dl;

-the measured blood glucose value is obtained before the main meal and the previous blood glucose value is after the main meal and the extrapolated blood glucose value within one hour is < 60 mg/dl or the extrapolated blood glucose value within one hour is > 250 mg/dl;

-no information above about dietary relationships and an extrapolated blood glucose value within two hours is < 60 mg/dl or an extrapolated blood glucose value within two hours is > 300 mg/dl;

-the measured blood glucose value is < 60 mg/dl and the blood glucose value at the same time of the previous day (23 hours ≦ time interval ≦ 25 hours) is < 60 mg/dl;

-the measured blood glucose value is > 100 mg/dl and goes into low symptoms (hypo symptom);

-the measured blood glucose value is < 50 mg/dl and no low symptoms are set; or

The measured blood glucose values are outside the target range (below/above) and the same trend of blood glucose values occurred the day before (same blood glucose values-differences in blood glucose values ≦ 20 mg/dl and differences in slope ≦ 9 mg/dl × hour and differences in time of day ≦ 1 hour and both values were obtained before or after the main meal).

The features disclosed in the specification, the drawings, and/or the claims may be material for realizing various embodiments of the invention either individually or in various combinations thereof.

Claims (8)

1. An apparatus for determining blood glucose characteristics, comprising:

a sensor input (1) capable of accepting a signal from a sensor (5), the signal being based on a sensed blood glucose value of a user,

a memory (3) configured for storing a plurality of measurements of the sensed blood glucose value of the user from the signal received from the sensor,

-a display (4) configured for displaying a graphical representation of a plurality of measurements of a blood glucose characteristic value, and

a controller (2) configured for controlling the display of graphical representations on the display,

wherein the graphical representation includes a trend indicator (22) indicative of an approximate numerical trend in the most recent series of sensed blood glucose values over the plurality of measurements,

wherein the trend indicator (22) comprises a plurality of graphical portions (23, 24), each graphical portion (23, 24) being of a different graphical style and being assigned to a different range of sensed blood glucose values, thereby indicating a transition from a first range of sensed blood glucose values to a second range of sensed blood glucose values, and

wherein the controller (2) is further configured to

-determining a measurement time for an early measurement providing a first sensed blood glucose value assigned to a first range of sensed blood glucose values and a later measurement providing a second sensed blood glucose value assigned to a second range of sensed blood glucose values for a temporal analysis, and

-blocking the graphical representation of the trend indicator (22) on the display (4) if one of the following conditions is derived from the time analysis:

-the time interval between the early and the later measurement is shorter than the minimum time interval, and

-the time interval between the early and the later measurement is longer than the maximum time interval.

2. The apparatus according to claim 1, wherein for said graphical parts (23, 24) different graphical styles are selected from the group of graphical styles consisting of: color style and shadow style.

3. The apparatus of claim 1 wherein the trend indicator (22) indicates a trend pattern for the sensed blood glucose value selected from the group consisting of: moderate decline, moderate rise, sharp decline, and sharp rise.

4. The device of claim 1, wherein a device-integrated sensor is provided.

5. The device of claim 4, wherein the device incorporates a sensor configured to sense the blood glucose value from analysis by the test element.

6. The apparatus of claim 1, wherein the sensed blood glucose value is provided from a discontinuous mode of blood glucose value measurement.

7. Apparatus according to claim 1, wherein said graphical representation comprises a warning symbol (27) indicating that the most recent blood glucose value of the sensed blood glucose values belongs to a risk situation.

8. A method of operating a device for determining blood glucose characteristics, the method comprising the steps of:

-accepting a signal from a sensor (5) through a sensor input (1), the signal being based on a sensed blood glucose value of the user,

-storing in a memory (3) a plurality of measurements of the sensed blood glucose value of the user from the signal received from the sensor,

-displaying a graphical representation of the plurality of measurements of the blood glucose characteristic value on a display (4),

-controlling the display of the graphical representation on the display by means of a controller (2), and

determining a measurement time for an early measurement providing a first sensed blood glucose value assigned to a first range of sensed blood glucose values and a later measurement providing a second sensed blood glucose value assigned to a second range of sensed blood glucose values,

wherein the step of displaying the graphical representation further comprises the step of displaying a trend indicator (22) indicative of an approximate numerical trend in the most recent series of sensed blood glucose values over the plurality of measurements, said trend indicator (22) comprising a plurality of graphical portions (23, 24), each graphical portion (23) being of a different graphical style and assigned to a different range of sensed blood glucose values, thereby indicating a transition from a first range of sensed blood glucose values to a second range of sensed blood glucose values for the sensed blood glucose values, and wherein the graphical representation of the trend indicator (22) on the display (4) is prevented if one of the following conditions is derived from the time analysis:

-the time interval between the early and the later measurement is shorter than the minimum time interval, and

-the time interval between the early and the later measurement is longer than the maximum time interval.