Method of individualizing range of analyte values for classifying concentration of analyte

Abstract

The present invention provides: a method of individualizing a range of analyte values for classifying a concentration of an analyte in a sample of a bodily fluid of a subject applied to a reagent test region and determined using a mobile device having a processing device; the invention also relates to a corresponding computer program, a non-transitory computer readable storage medium with corresponding instructions, a corresponding mobile device and a corresponding kit. The method comprises the steps of: determining a numerical analyte result value from an image formed by a color of the reagent test region; attributing the numerical analyte result value to a corresponding analyte value range; and adjusting one or more range limits based on a plurality of numerical analyte result values previously determined for different samples of the bodily fluid of the subject taken at different points in time.

Description

Technical Field

[0001] The present application relates to a method for individualizing analyte value ranges, the method being used to classify the concentration of an analyte in a subject's bodily fluid sample applied to a reagent test area and determined using a mobile device having a processing device. The method comprises the following steps: determining a numerical analyte result value within an overall measurement range by means of an image formed from the color of the reagent test area by means of a processing device; attributing the numerical analyte result value to a corresponding analyte value range in a series of continuous analyte value ranges that divide the overall measurement range, each analyte value range having a range width extending between range limits, each range limit separating adjacent analyte value ranges.

[0002] The present invention further relates to: a computer program comprising computer executable instructions for running the method; a non-transitory computer readable storage medium comprising instructions that, when executed by a mobile device, cause the mobile device to run the method; a mobile device configured to determine the concentration of an analyte in a body fluid; and a kit for determining the concentration of an analyte in a body fluid, the kit comprising at least one mobile device and at least one optical test strip having at least one test area. Background Art

[0003] Many different devices and methods are known from the prior art for determining one or more analytes in body fluids such as blood, urine, interstitial fluid and saliva. Without narrowing the scope, the present invention will be specifically described with respect to blood glucose measurement. However, it should be noted that the present invention can also be used for other types of analytical measurements using test elements.

[0004] Several test elements are known in the art, which comprise at least one test chemical, also called test reagent, which undergoes a color reaction in the presence of at least one analyte to be detected. Some basic principles regarding test elements and reagents, which can also be used within the scope of the present invention, are described in, for example, J. et al.: Diabetes Technology and Therapeutics, Vol. 10, Suppl. 1, 2008, pp. 10-26.

[0005] In analytical measurements based on color-forming reactions, one technical challenge is to evaluate the color change caused by the detection reaction. In addition to the use of dedicated analytical devices such as handheld blood glucose meters, the use of general electronic devices such as smartphones and portable computers has become increasingly popular in recent years. Such a method for detecting analyte concentrations using a mobile device is known from EP 3 591 385 A1.

[0006] WO 2019 / 157102 discloses a system and method for running model-based guidance on patients with diabetes. The model may, for example, include a physiological model or a behavioral model.

[0007] US2020 / 0367808 A1 discloses a post-meal monitoring device for assisting in regulating glucose levels through exercise. The measured glucose level is displayed according to one or more categories to which the measured value conforms.

[0008] WO 2017 / 044654 A1 discloses a calibration method for an analyte concentration sensor and a method for compensating drift of such a sensor. The calibration is based on previously known analyte concentration values ​​for specific repeatable events (e.g., steady states).

[0009] US10,548,537B2 discloses a test system for measuring the concentration of an analyte in a body fluid sample, wherein the system comprises: an input device for receiving information related to the measurement from a user; and a plurality of user-selectable statistical operations for providing enhanced information related to the measurement to the user. The information provided by the user can be categorized, for example by meal tag, and the categorization can be customized for different user groups (such as age groups).

[0010] When a user's target glucose range (e.g., 110 mg / dl to 150 mg / dl) is occasionally centered along an application category boundary (e.g., 131 mg / dl), the user may be confused by perceived "unstable" category results (because the category may easily shift between measurements). Further user category details ("pre-diabetic, athletic, pre-existing conditions, etc., age, diabetes progression" may affect the target range and may even change over time.

[0011] Therefore, it is desirable to provide methods and apparatus that can solve the above-mentioned technical challenges of analytical measurement using mobile devices such as consumer electronic mobile devices, in particular multi-function mobile devices that are not dedicated to analytical measurement (such as smartphones or tablet computers). In particular, methods, computer programs and apparatus that will be widely applicable to available mobile devices and are suitable for improving reliability and safety while allowing users to use them conveniently should be proposed. Summary of the invention

[0012] This problem is solved by a method, a computer program and an apparatus having the features of the independent claims. Advantageous embodiments are listed in the dependent claims, which may be realized individually or in any arbitrary combination.

[0013] As used below, the terms "having", "comprising" or "including" or any grammatical variations thereof are used in a non-exclusive manner. Thus, these terms may refer to the absence of other features in the entity described in this context in addition to the features introduced by these terms, or the presence of one or more other features. As an example, the expressions "A has B", "A includes B" and "A contains B" may refer to the absence of other elements in A in addition to B (i.e., the presence of A solely and exclusively consisting of B); or to the presence of one or more other elements in entity A in addition to B (such as element C, element C and element D, or even other elements).

[0014] Further, it should be noted that the terms "at least one", "one or more" or similar expressions indicating that a feature or element may be present once or more than once are usually used only once when introducing the corresponding feature or element. In the following, in most cases, when referring to the corresponding feature or element, the expression "at least one" or "one or more" is not repeated even though the corresponding feature or element may be present only once or more than once.

[0015] Further, as used hereinafter, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features without limiting the possibilities of alternatives. Therefore, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As the skilled person will recognize, the present invention may be carried out using alternative features. Similarly, the features introduced by "in one embodiment of the present invention" or similar expressions are intended to be optional features without any limitation on alternative embodiments of the present invention, without any limitation on the scope of the present invention, and without any limitation on the possibility of combining the features introduced in this manner with other optional or non-optional features of the present invention.

[0016] In one aspect, a method for individualizing analyte value ranges is disclosed, the method being used to classify the concentration of an analyte in a sample of a subject's bodily fluid applied to a reagent test area and determined using a mobile device having a processing device. The method comprises the following steps: determining, by a processing device, a numerical analyte result value within an overall measurement range from an image formed from the color of the reagent test area; attributing the numerical analyte result value to a corresponding analyte value range in a series of continuous analyte value ranges that divide the overall measurement range, each analyte value range having a range width extending between range limits, each range limit separating adjacent analyte value ranges; adjusting, by a processing device or any other processing device, one or more range limits based on a plurality of numerical analyte result values ​​previously determined for different samples of the subject's bodily fluid taken at different time points.

[0017] "Analyte" refers to a substance or chemical composition of interest during analysis, and is also referred to as a component or chemical substance. As an example, one or more analytes involved in metabolism, such as blood sugar, may be determined. Additionally or alternatively, other types of analytes or parameters, such as pH values, may be determined. The analyte is contained in at least one sample of a subject, i.e., a patient's body fluid, and a test chemical (also referred to as a test reagent) is subjected to a color-forming reaction. In order to induce a reaction, the body fluid is applied to a reagent test area, which may be, but is not limited to, a portion of a test strip or the like.

[0018] "Body fluid" refers to any fluid in the body, such as blood, interstitial fluid, urine, saliva, etc. "Color formation" refers to the color of a reagent test area produced by a color forming reaction, i.e., a chemical, biological or physical reaction during which the color (specifically, reflectivity) of at least one element participating in the reaction changes as the reaction progresses in the test area. Therefore, the concentration of an analyte in a body fluid can be determined by evaluating the color formation in the reagent test area, i.e., the color change caused by the reaction.

[0019] The method is based on the determination of the concentration of the analyte using a mobile device, wherein a "mobile device" refers to a mobile electronic device, i.e. a portable device having at least one processing device and optionally a display device and / or a camera. A mobile device may specifically refer to a mobile communication device, such as a mobile phone or a smartphone. Additionally or alternatively, a mobile device may also refer to a tablet computer or another type of portable computer having at least one camera. A "processing device" refers to any device capable of processing data, such as a data processor.

[0020] "Display device" refers to an output device that communicates information to a user in a visual or tactile form, such as, but not limited to, an LCD display, an LED display, or a tactile electronic display, and the output device can be used to communicate the results, such as the determined analyte value range and / or an associated message to the subject or any other person to whom the message may be important. An associated or corresponding "message" refers to any displayable indicia that can inform a user of the status of the analyte concentration (i.e., the determined analyte value range). The message may include one or more of a range name, a corresponding value such as a range limit, a corresponding recommendation, a symbol, etc.

[0021] A "camera" refers to a device having at least one imaging element configured to record or capture spatially resolved one-dimensional, two-dimensional or even three-dimensional optical data or information. As an example, a camera may include at least one camera chip such as at least one CCD chip and / or at least one CMOS chip configured to record an image.

[0022] Correspondingly, the term "image" refers to data recorded by using a camera, such as a plurality of electronic readings from an imaging device, such as pixels of a camera chip. The image may be taken with a camera included in the mobile device. Alternatively, the image may be taken by any other camera and communicated to the mobile device via a wired or wireless communication path / interface.

[0023] The camera may specifically be a color camera. Thus, for example, for each pixel, color information may be provided or generated, such as color values ​​of three colors R, G, B. A greater number of color values ​​is also feasible, such as four color values ​​per pixel, for example R, G, G, B. Color cameras are generally well known to the technician. Thus, as an example, a camera chip may consist of a plurality of color sensors, each chip containing three or more color sensors, such as color recording pixels, such as one pixel for red (R), one pixel for green (G) and one pixel for blue (B). For each pixel, such as for R, G, B, individual values ​​may be recorded per pixel, such as digital values ​​in the range of 0 to 255, according to the intensity of the corresponding color. As an example, a quaternion, such as R, G, G, B, may be used instead of a color triplet, such as R, G, B. The color sensitivity of a pixel may be generated by a color filter or by the appropriate intrinsic sensitivity of the sensor element used in the camera pixel. These techniques are generally well known to the technician.

[0024] The concentration of the analyte in the subject's bodily fluid is determined by a processing device of the mobile device based on an image of the reagent test area captured by a camera of the mobile device or another camera, wherein a sample of the subject's bodily fluid is applied to the reagent test area before the image is captured, causing a color formation. The color formation in the image, i.e., the color of the reagent test area, is determined by the processing device, and a numerical analyte result value corresponding to the determined color formation is subsequently identified by the processing device, wherein a "numerical analyte result value" refers to a numerical indication of the concentration of the analyte in the subject's bodily fluid sample.

[0025] The processing device then attributes a corresponding analyte value range to the numerical analyte result value determined in step (b) to communicate the measurement result in the form of an analyte value range to the subject or any other person who needs to know.

[0026] "Analyte value range" refers to a portion of a measurement range (i.e., a range of measurable values), wherein each analyte value range has a range width and extends between a lower range limit and an upper range limit, i.e., includes all values ​​of the measurement range between these two range limits and optionally includes one or both of the range limits. The overall measurement range is divided by a series of continuous analyte value ranges. In particular, a series of analyte value ranges can cover the overall measurement range in such a way that adjacent analyte value ranges are separated by range limits and all values ​​of the overall measurement range belong to exactly one of the analyte value ranges. The corresponding analyte value range is a range that includes the corresponding numerical analyte result value, or in other words, the numerical analyte result value falls within the corresponding analyte value range.

[0027] Step (a) and (b) are performed in the listed order, and this order does not exclude the further step carried out between these steps.In addition, in some embodiments, method step (a) and (b) are repeated regularly, for example, by user's requirement, wherein other steps can be carried out before, between or after each iteration of step (a) and (b), or before, between or after certain iterations.For example, these steps are repeated at different time points to assess the analyte concentration of the subject at the different time points.Therefore, at different time points, obtain / produce a sample of the body fluid of the subject and apply it to the reagent test area, produce an image, and determine the numerical analyte result value.It should be understood that, depending on analyte, test reagent and color formation reaction, there is a restriction to the time between the following and / or the condition about the time: obtain a sample of body fluid and / or apply the sample to the reagent test area and / or take an image.

[0028] The analyte value range may be preset by the system (e.g., application code running on a mobile device including the method), or by the HCP, or by a user (such as a subject). Initially or over time, a preset or current analyte value range may not be suitable for a subject. For example, depending on age, health, other conditions, etc., a normal and / or target blood glucose concentration for a subject may be close to one of the preset range limits, which would make it preferable for the subject to shift the range limit.

[0029] "Adjusting" a range limit may refer to changing or moving one or more current range limits, or alternatively, to maintaining or confirming one or more current range limits, or alternatively, to setting one or more new range limits, wherein the "adjusting" depends on an analysis of a plurality of previously determined numerical analyte result values ​​for a subject. It should be understood that the previously determined numerical analyte result values ​​may each be determined for a different sample of a subject's body fluid, and each sample is obtained at a different time point. In addition, it will be understood that the range width of two analyte value ranges separated by the adjusted range limits varies accordingly.

[0030] The adjustment takes into account the previous measurement results of the subject, such as by performing data analysis, and realizes the subjectization of the analyte value range with it. The analyte value range can be adjusted to preferably fit the typical analyte concentration of the subject, such as by moving the range limit when there is a conflict about the restriction. The conflict about the range limit can be, for example, defined as a cluster of concentration measurement values ​​close to or too close to the range limit value. For example, the analysis can determine the distance between each of the considered numerical analyte result values ​​and the range limit value and count the number of distances less than a preset threshold. For example, the preset threshold can consider the error distribution of the measured numerical analyte result value. In particular, the preset threshold can consider the probability of the actual analyte concentration being misclassified in an erroneous, adjacent analyte value range due to the measurement error of the determined numerical analyte value range. Conflict can be defined as the number of determined distances exceeding another preset threshold.

[0031] The adjustment may additionally be based on user input. The user input may include specific range limits and / or analyte value ranges and / or specific information about the subject, such as age, pre-existing conditions, etc. The user input may be used as a basis for determining one or more new shifted range limits and / or as boundary conditions for the adjustment step.

[0032] The analysis may be based on all analyte value ranges previously determined for a subject or on specific selected ones of those analyte value ranges.The analysis may be based on a fixed, unchanging algorithm and / or on a learning algorithm.

[0033] For example, if the analyte concentration of the subject, such as the analyte concentration associated with a particular event (such as fasting, post-meal, or during or after physical exercise), is generally clustered close to one of the range limits, then adjustment may be beneficial. Due to measurement error, this may result in the attribution of adjacent analyte value ranges to some or more of the determined numerical analyte result values, and thus result in constantly shifting analyte value ranges. With the shifting of the range limits, more consistent communication of measurement results is ensured.

[0034] In one embodiment, step (c) is automatically triggered by the amount of iterations of step (a) within a preset time period exceeding a trigger threshold and / or by the amount of numerical analyte result values ​​determined within a preset time period and falling within a preset marginal range around one of the range limits exceeding the trigger threshold.

[0035] "Marginal range" refers to a part of the overall measurement range positioned around the range limit, and therefore refers to the range margin. If the range limit is less than the upper range limit of the marginal range and greater than the lower range limit of the marginal range, the range limit falls within the marginal range. The marginal range can be positioned symmetrically or asymmetrically around the range limit. Due to the criticality of the specific range limit (for example, about the health of the subject) and the criticality of the state of the identification classification in any one of the adjacent analyte value ranges, symmetry can be selected. The marginal range can be preset and / or adjustable, and can be different in width and symmetry for some or all of the range limits. The time period can also be preset by a provider or user or a person associated with the user (such as an HCP) in the setting step, and can be fixed afterwards or can be adjusted by a subject, an HCP and / or any suitable person or facility.

[0036] Counting the values ​​that fall within a marginal range may be a conflict indicator and may therefore represent an appropriate trigger for investigation of at least the affected range limit and, where appropriate, adjustment of the range limit.

[0037] A higher number of range limits provides a more extensive database for the adjustment step (c). For example, a counter may be incremented with each execution of step (a) or with each determined numerical analyte result value falling within any marginal range. Alternatively, there are different counters for each marginal range. When performing the adjustment step, one or more counters may be reset.

[0038] In one embodiment, step (c) is automatically triggered based on analyzing a numerical analyte result value previously determined.

[0039] Thus, previously determined numerical analyte result values ​​are constantly monitored and if analysis of these values ​​reveals any triggering event, such as a violation of one or more of the range limits, step (c) is triggered. The analysis may be identical to the analysis performed in step (c). In particular, the analysis completed prior to the triggering may be used as a basis for adjusting the step itself, and thus for the shifting of the range limits.

[0040] In one embodiment, step (c) is manually triggered via an input device of the mobile device or via a trigger message received by the mobile device through an input port of the mobile device.

[0041] Manual triggering of the adjustment step may be requested, for example, by the subject or another user of the method (eg, a parent), or by the HCP.

[0042] In one embodiment, step (c) comprises analyzing the plurality of numerical analyte result values ​​with respect to distance from one, some, or all of the range limits.

[0043] If too many numerical analyte result values ​​are too close to one of the range limits, this may indicate a conflict and may be a trigger for moving the affected range limit. Therefore, distance is an appropriate measure for range limit adjustment. Distance can be determined by calculating the distance of one of the numerical analyte result values ​​under consideration, or calculating the distance of the mean or median or another representative value determined for the numerical analyte result values ​​under consideration.

[0044] In one embodiment, the adjustment of the range limits is based on numerical analyte result values ​​for the subject determined during a preset time period and / or based on numerical analyte result values ​​for the subject falling within preset marginal ranges around the range limits.

[0045] Limiting the numerical analyte result values ​​used as the basis for adjustment to a preset time period can help exclude data that is too old to be important and / or limit the analysis to more relevant measurements and / or speed up the adjustment process. Limiting the analyte result values ​​that fall within one or more preset marginal ranges, each around a corresponding range limit, can help limit the analysis to the most relevant and / or most critical numerical analyte result values ​​for making decisions about the rationality and / or applicability of the range limits for the subject.

[0046] In one embodiment, the adjustment of the range limits is based on one or more of the group of mean, median, standard deviation, coefficient of variation skewness determined for all or selected ones of previously determined numerical analyte result values ​​for the subject.

[0047] In this embodiment, in order to adjust the range limits based on the numerical analyte result value previously determined, a representative quantity is formed by all or selected persons in the numerical analyte result value previously determined.Representative quantity can represent each value and / or its quality.For example, representative quantity can be the quantity of the numerical analyte result value considered by the mean or standard deviation or any other quantity listed or any other representative as well.For calculation, consider all determined result values, or only consider those result values ​​determined in the preset time period or related to predefined events (such as before or after a meal or after a physical movement or any other event affecting the concentration of the analyte), or consider those result values ​​determined within the preset value range (for example, close to a critical value and / or close to one of the range limits), or consider all those numerical analyte result values ​​or any other suitable selected persons not yet considered by an earlier adjustment step.

[0048] In one embodiment, the adjustment of the range limit is based on satisfying at least one preset boundary condition.

[0049] To set certain limits on the change or movement of the range limits, for example by presetting boundary conditions, can help to enhance the safety of the method and / or prevent malfunction of the method. The boundary conditions can be motivated by the characteristics of the analyte, the function of the analyte for the subject, and / or the characteristics of the determination process (i.e., the measurement process).

[0050] In one embodiment, at least one boundary condition is selected from the group consisting of: not decreasing the range width below a width threshold; not decreasing the upper range limit of the lowest analyte value range below a lower threshold; and not increasing the upper range limit of the lowest analyte value range above an upper threshold.

[0051] If certain concentration values ​​of an analyte are particularly critical, for example with respect to subject health, a shift in the range limits to set the upper or lower limit close to or equal to the critical concentration value may be justified.

[0052] For example, if the analyte is blood glucose, it may be reasonable to ensure that the lowest analyte value range has an upper range limit of at least 70 mg / dl and / or 80 mg / dl or at most 90 mg / dl. In another embodiment where the analyte is glucose, the reduced range width may be limited to a minimum range width of 50 mg / dl or 40 mg / dl.

[0053] Another additional or optional boundary condition may be to always shift the range limits in favor of the "good" category range, thereby shifting the range limits in such a way that the width of the adjacent analyte value ranges classified as more "in range" / "better" is expanded and the width of the adjacent analyte value ranges classified as more "out of range" / "worse" is reduced.

[0054] In one embodiment, adjusting of the range limits includes receiving one or more range limits and / or one or more analyte value ranges and / or other subject-specific information from which the range limits may be derived.

[0055] In addition to the previously determined numerical analyte result value of the subject, further information can be considered when adjusting the range limits. Information can be received via wired or wireless communication or via an input device included in the mobile device. For example, the adjustment can also be based on other subject-specific information, such as age, gender, other health conditions, or any other relevant information about the subject. Deriving the range limits can include selecting or finding a preset adjustment rule from a plurality of preset series of analyte value ranges.

[0056] In one embodiment, the adjusting step includes asking the user to confirm or reject the set range limits.

[0057] The user may be a subject (ie, a patient) or an HCT or any other suitable person (eg, a parent).

[0058] In one embodiment, the corresponding analyte value range and / or a message associated with the corresponding analyte value range is displayed on a display device of the mobile device;

[0059] The associated message (or in other words, the corresponding message) may be any message suitable for informing the user of the determined analyte value range for the subject's current analyte concentration.

[0060] In another aspect, a computer program is disclosed, comprising computer executable instructions for executing the above method.

[0061] In a further aspect, a non-transitory computer-readable storage medium is disclosed, the computer-readable storage medium comprising instructions that, when executed by a mobile device, cause the mobile device to execute the method as described above.

[0062] In another aspect, a mobile device is disclosed, comprising a processing device, a display device, a camera, a display device, and a memory storing instructions, which when executed by the processing device configure the mobile device to perform the method as described above.

[0063] In a further aspect, a kit for determining the concentration of an analyte in a body fluid comprises at least one mobile device as described above and at least one optical test strip having at least one test area.

[0064] Other technical features of different aspects of the present invention will be apparent to those skilled in the art from the following drawings, descriptions and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] To facilitate identification of the discussion of any particular element or act, the most significant digit(s) in a reference number refers to the figure number in which the element is first introduced.

[0066] FIG. 1 illustrates the subject method according to a first embodiment.

[0067] FIG. 2 illustrates a table of analyte value ranges according to one embodiment. DETAILED DESCRIPTION

[0068] In Fig. 1, a first embodiment of a method for individualizing analyte value ranges is shown for classifying the concentration of an analyte in a subject's body fluid sample applied to a reagent test area and determined using a mobile device with a processing device. The method is initiated, for example, as an application on a mobile device such as a smartphone by, for example, a user or by any other trigger (such as a trigger message, a preset schedule, etc.). Application activation is represented by a dot in the figure.

[0069] In the illustrated embodiment, as the first step of each application startup, the amount of the numerical analyte result value determined in the preset previous days (therefore in the preset time period) is checked. If the number of numerical analyte result values ​​in the defined time period does not reach or exceed the preset threshold value number N, the method proceeds to method steps (a) and (b), which are represented as "standard application process" in the diagram. Steps (a) and (b) include determining the numerical analyte result value from the image formed by the color of the reagent test area after applying the body fluid sample of the subject and attributing the numerical analyte result value to the corresponding analyte value range, wherein the analyte value range is one of a series of continuous analyte value ranges that divide the overall measurement range. Each of the analyte value ranges includes a range width extending between a lower range limit and an upper range limit, wherein adjacent analyte value ranges are separated by mutual range limits, and the mutual range limits are included by one of the adjacent analyte value ranges, and other adjacent range limits include all values ​​less than or greater than the range limit, whichever is applicable.

[0070] An example of a range of analyte values ​​for blood glucose is given in FIG2 .

[0071] If the amount of numerical analyte result values ​​determined within the preset time period reaches or exceeds the threshold number N, the method continues with an adjusting step.

[0072] In the illustrated embodiment, the adjustment step begins with an analysis of numerical analyte result values ​​determined within a preset time period, for example (represented by a triangle) including calculating the mean and / or median and / or standard deviation and / or coefficient of variation and / or skewness for all or selected ones of the numerical analyte result values.

[0073] The analysis may also include the handling of outliers. The selection may be made with respect to the distance of the numerical analyte result value from one of the range limits and / or from a numerical analyte result value associated with a particular event (such as before or after a meal) and / or the time at which the numerical analyte result value is determined.

[0074] In the illustrated embodiment, the numerical analyte result values ​​are analyzed with respect to conflicts with one or either of the range limits, wherein conflicts may be identified by over-considered numerical analyte result values ​​being too close to one of the range limits. It should be appreciated that being too close may be defined as a corresponding distance between a numerical analyte result value and a range limit being less than a preset threshold. Correspondingly, "over-considered numerical analyte result values" may be defined as a number that exceeds a corresponding preset threshold.

[0075] If no conflict is detected, the method continues with the standard application flow, ie, performing steps (a) and (b).

[0076] If a conflict is detected, the adjusting step continues by determining an improved set of ranges by moving at least one range limit affected by the conflict. For example, if a large number of previously defined numerical analyte result values ​​are accumulated too close to the lower range limit of the first analyte value range, the lower range limit is reduced to extend the width of the first analyte value range to also cover the lower analyte concentration value. The width of the adjacent lower analyte value range is correspondingly reduced.

[0077] In an adjustment step, for any conflicts detected, the affected range limits are adjusted to produce a new series of analyte value ranges defined by the shifted and unshifted range limits, respectively, such that the new series of analyte value ranges still fully covers and divides the overall measurement range.

[0078] In the illustrated embodiment, the adjustment step further comprises a check for plausibility. Such a plausibility check (semicircle) may include checking boundary conditions, such as ensuring that all range widths still have a preset minimum width and / or that the upper range limit of a certain analyte value range (e.g., the lowest analyte value range) is not below a preset threshold and / or that the range width of a favorable analyte value range (e.g., a range covering those analyte concentration values ​​that are classified as normal) is preferably enlarged rather than reduced.

[0079] In the illustrated embodiment, if the adjusted range limits and / or analyte value ranges fail the plausibility check, these values / ranges are discarded and the method continues with the standard application flow, thereby performing steps (a) and (b) using the old analyte value ranges with the old range limits used prior to the adjustment steps.

[0080] If the adjusted range limits and / or the analyte value ranges defined by the adjusted range limits do pass the plausibility check, the subject or any other user is informed of the newly adjusted analyte value ranges and asked to agree to them. If the user agrees, the method continues with the standard application flow, i.e., steps (a) and (b) are performed using the newly adjusted series of analyte value ranges.

[0081] If the user disagrees with the new series of analyte value ranges, the method continues with the standard application flow, thereby performing steps (a) and (b) using the old series of analyte value ranges and discarding the new series of analyte value ranges with the adjusted range limits.

[0082] Optionally, the adjusted range limits and / or the series of analyte value ranges containing certain adjusted range limits can be permanently rejected by the user when being asked to agree to the adjustment. Thus, the permanently rejected range limit or range limits are saved and added to the rationality check step as another boundary condition.

[0083] In another embodiment, those range limits that the user disagrees with are saved and added as another boundary condition to the rationality check step for a certain preset amount of time.

[0084] In FIG2 , a table is shown listing five different analyte value ranges that divide the overall measurement range from 20 mg / dl to 601 mg / dl according to an embodiment where the analyte is blood glucose. For each numerical analyte result value determined in step (a), a corresponding analyte value range from the table is assigned in step (b). The corresponding range is the range containing the numerical analyte result value.

[0085] The last column gives the numerical analyte result values ​​covered by each analyte value range, wherein each mutual range limit separating adjacent analyte value ranges is contained by one of the adjacent ranges, while the other adjacent range contains all smaller or larger values, respectively. For example, all analyte value ranges contain the corresponding lower range limit given in the fourth column and all values ​​from the lower range limit that are less than a given upper range limit. Thus, the first analyte value range is defined as ≥20 mg / dl to <71 mg / dl.

[0086] In order to communicate the measurement results to the user (and therefore to the subject or any other person), the measurement range is displayed on a display device, such as a display device of a mobile device. The measurement range can be communicated by displaying the corresponding range limits given in the fourth column or by displaying a name, such as given in the second column. Alternatively, a corresponding message, such as the message given in the third column, can be displayed.

Claims

1. A method for individualizing an analyte value range for classifying the concentration of an analyte in a subject's bodily fluid sample applied to a reagent testing area and determined using a mobile device having a processing device, the method comprising the steps of: (a) determining, by the processing device, a numerical analyte result value within an overall measurement range from an image formed from the color of the reagent test area; (b) assigning the numerical analyte result value to a corresponding analyte value range in a series of consecutive analyte value ranges, the series of consecutive analyte value ranges dividing the overall measurement range, each analyte value range having a range width extending between range limits, each range limit separating adjacent analyte value ranges; (c) adjusting, by the processing device or any other processing device, one or more range limits based on a plurality of numerical analyte result values ​​previously determined for different samples of the subject's bodily fluid taken at different time points.

2. A method according to claim 1, wherein step (c) is automatically triggered by the amount of iterations of step (a) exceeding a trigger threshold within a preset time period and / or by the amount of a numerical analyte result value determined within a preset time period and falling within a preset marginal range around one of the range limits exceeding the trigger threshold.

3. The method of claim 1, wherein step (c) is automatically triggered based on analyzing a previously determined numerical analyte result value.

4. The method of claim 1, wherein step (c) is manually triggered via an input device of the mobile device or via a trigger message received by the mobile device via an input port of the mobile device.

5. The method according to any one of claims 1 to 4, wherein step (c) comprises analyzing the plurality of numerical analyte result values ​​with respect to distances from one, some or all of the range limits.

6. A method according to any one of claims 1 to 5, wherein the adjustment of the range limit is based on the numerical analyte result value of the subject determined in a preset time period and / or based on the numerical analyte result value of the subject falling within a preset marginal range around the range limit.

7. A method according to any one of claims 1 to 6, wherein the adjustment of the range limit is based on one or more of the group of means, medians, standard deviations, coefficients of variation, and skewness determined for all or selected numerical analyte result values ​​of the previously determined numerical analyte result values ​​for the subject.

8. The method according to any one of claims 1 to 7, wherein the adjustment of the range limit is based on satisfying at least one preset boundary condition.

9. The method of claim 8, wherein at least one boundary condition is selected from the group consisting of - not reduce the range width below the width threshold, - not reducing the upper range limit of the lowest analyte value range below the lower threshold value; - Not increasing the upper range limit of the lowest analyte value range above the upper threshold value.

10. The method according to any one of claims 1 to 9, wherein the adjusting of the range limits comprises receiving one or more range limits and / or one or more analyte value ranges and / or other subject-specific information from which range limits can be derived.

11. A method according to any one of claims 1 to 10, wherein the adjusting step comprises requiring a user to confirm or reject the set range limits.

12. The method according to any one of claims 1 to 11, wherein the corresponding analyte value range and / or a message associated with the corresponding analyte value range is displayed on a display device of the mobile device.

13. A computer program comprising computer executable instructions for executing the method according to any one of claims 1 to 11.

14. A non-transitory computer-readable storage medium comprising instructions, which, when executed by a mobile device having a camera, a processing device and a display device, cause the mobile device to execute the method according to any one of claims 1 to 11.

15. A mobile device, comprising: Processing device; camera; a display device, and A memory storing instructions which, when executed by a processor, configure the mobile device to execute the method according to any one of claims 1 to 11.

16. A kit for determining the concentration of an analyte in a body fluid, the kit comprising at least one mobile device according to claim 15 and at least one optical test strip having at least one test area.

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