Improved method for determining analyte concentrations in body fluids

Abstract

The present invention relates to an analytical method for determining the concentration of an analyte in a bodily fluid by using a mobile device having a camera and a processor, the method comprising: i) capturing an image of an optical test strip with the camera, the test strip having a sample of the bodily fluid applied on a reagent test area; and ii) receiving local temperature information at a current location of the mobile device, wherein the local temperature information is received by the mobile device from at least two of the following temperature source options: a) a remote weather information service; b) a temperature sensor on an external electronic device; and c) a temperature sensor on the mobile device; or the local temperature information is received by the mobile device from a temperature sensor on an external electronic device, the external electronic device being a fitness tracker, a smart watch, smart glasses, a smartphone, or the like. a wearable such as smart clothing, an electronic heating system, a smart temperature measurement unit, a smart home component such as a home weather station, and a body-worn sensor such as a non-invasive analyte measurement sensor; iii) optionally, determining, by the processor, a corrected temperature and / or a corrected temperature function using the local temperature information from step ii); and iv) determining, by the processor, an analyte concentration from the image captured in step i) based on a color reaction in the reagent test area with the sample of bodily fluid applied to the reagent test area, taking into account at least one of the local temperature information from step ii), the corrected temperature from step iii), and the corrected temperature function from step iii).

Description

[Technical Field]

[0001] Technical Field The present invention relates to a method for determining the concentration of an analyte in a body fluid using at least one mobile device having a camera and a processor. Furthermore, the present invention relates to a mobile device having a camera and a processor for performing the method, a kit comprising a mobile device having a camera and a processor, a computer program and a computer-readable storage medium. The method, mobile device, computer program and storage medium can be used in medical diagnostics, in particular for qualitatively or quantitatively detecting one or more analytes in a body fluid, such as for example detecting glucose in blood or interstitial fluid. [Background technology]

[0002] Background technology In the field of medical diagnostics, it is often necessary to detect one or more analytes from a sample of bodily fluid, such as blood, interstitial fluid, urine, saliva, or other types of bodily fluid. Examples of analytes to be detected are glucose, triglycerides, lactate, cholesterol, or other types of analytes commonly present in these bodily fluids. Depending on the concentration and / or presence of the analyte, an appropriate treatment can be selected as needed.

[0003] Generally, devices and methods known to those skilled in the art utilize test elements containing one or more test chemicals, which can perform one or more detectable detection reactions, such as optically detectable detection reactions, in the presence of an analyte to be detected. For test chemicals contained in test elements, reference can be made, for example, to J. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26.

[0004] In analytical measurements, especially those based on colorimetric reactions, one technical challenge lies in the evaluation of the color change resulting from the detection reaction. In addition to using dedicated analytical devices such as handheld blood glucose meters, the use of commonly available electronic devices such as smartphones and portable computers or other mobile devices has become increasingly popular in recent years.

[0005] In contrast to laboratory measurements and measurements performed using dedicated analytical measurement devices, when using a mobile computing device such as a smartphone, various additional influences, such as lighting conditions and positioning aspects, need to be considered, which can be quite difficult to account for. Nevertheless, to improve the accuracy of analyte detection results in these cases, it is beneficial to properly consider any parameters known to be involved in the desired analyte detection or measurement.

[0006] In the case of analytical measurements based on test chemicals, one such parameter is usually the temperature at which the reaction between the analyte and the test chemical occurs; see, for example, J. Hoenes et al., cited above, for a discussion of such test chemicals contained in test elements.

[0007] When using a mobile device, one approach to taking into account the temperature of the reaction on the test element is to provide a temperature sensor or temperature display area on the test strip itself.

[0008] For example, U.S. Patent No. 9,778,200 describes a method for a portable computing device, having an image sensor and a screen on the same side of the portable computing device, to read a reaction area on a test strip located in a peripheral device, the method including, among other things, providing light to illuminate the reaction area, capturing an image with an image sensor that is substantially free of ambient light, and determining an analyte characteristic based on the color of the imaged reaction area in the image. The test strip can include a temperature sensor that can be electrically read to determine the temperature of the test strip, and the analyte characteristic can be corrected based on the temperature of the test strip. Alternatively, the test strip can include a temperature-indicating area, and the analyte characteristic can be corrected based on the imaged temperature-indicating area in the image.

[0009] EP 3018470 A1 describes a method for a terminal for measuring biometric information, which includes receiving an image of a biosensor including a reagent pad on which a sample is collected, and comparing brightness information of a reaction area of ​​the reagent pad in the received image with reference brightness information in the received image to determine a value of a reagent reaction between the reagent pad and the sample. The method can further include determining the temperature of the sample based on temperature information indicated by a temperature measuring device attached to the reagent pad in the received image.

[0010] When using a mobile device to determine ambient temperature, care must be taken to compensate for any effects on the temperature measurement from the mobile device itself, such as heat generated by any components of the mobile device.

[0011] An approach to address this aspect is described, for example, in U.S. Pat. No. 9,784,624, which relates to a portable electronic device comprising a temperature sensor for detecting an ambient temperature, at least one other temperature sensor for detecting an internal temperature of the portable electronic device, a set of components that radiate heat in an active state, a calibration module, and a compensator for determining a compensated ambient temperature that depends at least on the detected ambient temperature and at least one adjusted detected internal temperature, wherein the calibration module is adapted to perform a calibration measurement in response to the portable electronic device being powered on following a power-off or standby state.

[0012] Another approach to address this issue is described in U.S. Pat. No. 7,947,222, which relates to a mobile communications terminal with a temperature compensation function for use in measuring biological information, including a biosensor insertion section into which a biosensor that directly detects biological information of a subject is inserted, a temperature measurement unit, and a controller that analyzes the biological information, wherein the temperature measurement unit measures the temperature of the biosensor housing without directly contacting the biosensor housing and measures the temperature of the biosensor housing without contacting a biosensor completely outside the biosensor housing, and the controller corrects the biological information using the temperature of the biosensor housing measured by the temperature measurement unit.

[0013] Furthermore, U.S. Pat. No. 9,326,097 describes a technique for detecting the surroundings of a mobile device by using information from sensors on the mobile device, which may include temperature sensors, in combination with receiving weather conditions from a remote server to determine whether the mobile device is likely to be indoors or outdoors based on one or more weighted outputs from the sensors, wherein timing is adjusted to determine whether the mobile device is likely to be indoors or outdoors, and a GPS receiver is used to determine the number of receivable satellite signals, and it is determined that the mobile device is likely to be indoors if the number of satellites with receivable signals is below a threshold.

[0014] US Patent Application Publication No. 2013 / 267032 and EP Patent Application Publication No. 3 575 781 relate to analyte test strips for detecting a property of an analyte in a analyte sample, the analyte test strip including a reaction area configured to receive the analyte sample and a color calibration area configured to determine the color of the reaction area after receiving the analyte sample, wherein the analyte test strip may further include a temperature indicating area configured to correct the measurement of the analyte property, and wherein a computing device may use an integrated temperature sensor to approximate or determine the temperature of the reaction area.

[0015] Despite the advantages associated with using mobile computing devices for the purpose of performing analytical measurements, one remaining technical challenge is properly considering the temperature of the reaction involving the analyte being detected and the test chemicals contained in the test element.

[0016] Issues to be resolved It would therefore be desirable to provide devices and methods that at least partially address the above-mentioned challenges, particularly devices and methods that enable efficient, mobile-based determination of analyte concentrations in bodily fluids with reliable accuracy, but with low setup and implementation effort. Summary of the Invention

[0017] overview This problem is addressed by a method for determining the concentration of an analyte in a body fluid by using at least one mobile device having a camera and a processor, by a mobile device having at least one camera and a processor, by a kit comprising a mobile device and an optical test strip, as well as by a computer program and a computer-readable storage medium, with the features of the independent claims. Advantageous embodiments, which can be realized alone or in any combination, are set forth in the dependent claims.

[0018] When used below, the terms "have," "comprise," or "include," or any grammatical variations thereof, are used inclusively. Thus, these terms may refer both to a situation in which, in addition to the features introduced by these terms, no further features are present in the entity described in this context, and to a situation in which one or more additional features are present. For example, the expressions "A has B," "A comprises B," and "A includes B" may both refer to a situation in which, apart from B, no other elements are present in A (i.e., a situation in which A consists solely and exclusively of B), and to a situation in which, apart from B, one or more further elements are present in entity A, such as element C, elements C and D, and even further elements.

[0019] Furthermore, 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 one or more times are typically used only once when introducing each feature or element. In the following, in most cases, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, despite the fact that each feature or element may be present one or more than one time.

[0020] Furthermore, when used hereinafter, the terms "preferably," "more preferably," "particularly," "more particularly," "particularly," "more particularly," or similar terms are used in conjunction with any feature without limiting the possibility of substitution. Therefore, features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. The present invention may also be implemented by using alternative features, as recognized by those skilled in the art. Similarly, features introduced by "in an embodiment of the present invention" or similar expressions are intended to be optional features without limitations on alternative embodiments of the invention, without limitations on the scope of the invention, and without limitations on the possibility of combining the feature introduced in such a way with other optional or non-optional features of the invention.

[0021] In a first aspect of the present invention, a method for determining the concentration of an analyte in a bodily fluid is disclosed, the method comprising using a mobile device having a camera and a processor. The method includes, by way of example, the following steps, which may be performed in a given order. However, it should be noted that different orders are possible. Furthermore, one or more method steps may be performed once or repeatedly. Furthermore, two or more method steps may be performed simultaneously or with overlapping times. The method may include additional method steps not listed. The method includes, in a first step i), capturing at least one image of at least a portion of an optical test strip having a sample of the bodily fluid applied to a reagent test area of ​​the test strip, the capturing comprising using a camera of the mobile device. The at least one captured image includes at least a portion of the reagent test area to which the sample of the bodily fluid has been applied. The method further includes, by the processor, determining the analyte concentration from the captured image based on a color reaction in the reagent test area to which the sample of the bodily fluid has been applied.

[0022] The method comprises: ii) receiving local temperature information at a current location of the mobile device, said local temperature information comprising: a) remote weather information services; b) Temperature sensors in external electronic devices; and c) a temperature sensor on the mobile device, received by the mobile device from at least two of the temperature source options; Alternatively, the local temperature information is received by the mobile device from a temperature sensor of an external electronic device.

[0023] In step ii), the external electronic device is selected from one or more of wearables such as fitness trackers, smart watches, smart glasses, smart clothing, smart home components such as electronic heating systems, smart temperature measurement units, home weather stations, and body-worn sensors such as non-invasive analyte measurement sensors. Further details of some of such external electronic devices are described herein below.

[0024] Optionally, the method further comprises: iii) determining, by the processor, a correction temperature and / or a correction temperature function using the local temperature information from step ii).

[0025] Determining, by the processor, the analyte concentration from the captured image based on a color reaction in the reagent test area where the sample of bodily fluid was applied, takes into account at least one of the local temperature information from step ii), the corrected temperature from step iii), and the corrected temperature function from step iii).

[0026] Without narrowing the scope, the present invention may be specifically described with respect to blood glucose measurements, however, it should be noted that the present invention may also be used for other types of analytical measurements that use test elements.

[0027] As used herein, the term "determining the concentration of an analyte in a bodily fluid," also referred to as "analytical measurement," is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. This term can specifically, but is not limited to, the quantitative and / or qualitative determination of at least one analyte in any sample or aliquot of bodily fluid. For example, the bodily fluid can include one or more of blood, interstitial fluid, urine, saliva, or other types of bodily fluid, particularly blood. The result of the concentration determination can be, for example, the concentration of the analyte and / or the presence or absence of the determined analyte. Specifically, for example, the analytical measurement can be a blood glucose measurement, and thus the result of the analytical measurement can be, for example, a blood glucose concentration. In particular, an analytical measurement result value can be determined by the analytical measurement.

[0028] Thus, the term "analyte concentration value," often also referred to as "analytical measurement value," as used herein, is a broad term and should be given its ordinary and customary meaning to those of skill in the art and should not be limited to any special or customized meaning. This term can specifically, but is not limited to, refer to a numerical representation of the analyte concentration in a sample.

[0029] By way of example, the at least one analyte can be or include one or more specific chemical compounds and / or other parameters. By way of example, one or more analytes involved in metabolism, such as blood glucose, can be determined. Additionally or alternatively, other types of analytes or parameters can be determined, such as, for example, pH value.

[0030] The method outlined above involves the use of at least one mobile device having at least one camera. As used herein, the term "mobile device" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term may specifically refer to, but is not limited to, a portable electronic device, more specifically a portable communication device such as a mobile phone or smartphone. Additionally or alternatively, a portable device may also refer to a tablet computer or another type of portable computer having at least one camera and at least one processor.

[0031] The term "camera," as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term may specifically, but is not limited to, refer to a device having at least one imaging element configured to record or capture spatially resolved one-, two-, or three-dimensional optical data or information. By way of 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. As used herein, but is not limited to, the term "image" may specifically relate to data recorded by using a camera, such as multiple electronic readings from an imaging element, such as pixels of a camera chip.

[0032] In addition to at least one camera chip or imaging chip, the camera may include one or more optical elements, such as one or more lenses. For example, the camera may be a fixed-focus camera with at least one lens that is fixedly adjusted relative to the camera. Alternatively, however, the camera may also include one or more variable lenses that can be adjusted automatically or manually. The present invention should be particularly applicable to cameras typically used in mobile applications, such as notebook computers, tablets, or mobile phones, particularly smartphones. Thus, specifically, the camera may be part of a mobile device that includes, in addition to at least one camera, one or more data processing devices, such as one or more data processors. However, other cameras may also be used.

[0033] The method further includes using at least one optical test strip having at least one reagent test area, also referred to herein as a "test field." The term "optical test strip," as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term can specifically, but not exclusively, refer to any element or device configured to perform a color change detection reaction. Optical test strips can also be referred to as test strips or test elements, and all three terms can refer to the same element. Optical test strips can have, among other things, a reagent test area containing at least one test chemical for detecting at least one analyte. By way of example, optical test strips may comprise at least one substrate, such as at least one carrier, to which at least one reagent test area is applied or incorporated. In particular, optical test strips can further include one or more reference areas, such as a white field and / or a black field. Additionally or alternatively, the substrate or carrier itself may be or include such a reference area. By way of example, at least one carrier can be strip-shaped, thereby making the test element a test strip. These test strips are widely available and in common use. A test strip can carry a single test field or multiple test fields with the same or different test agents contained therein.

[0034] Furthermore, as used herein, the term "reagent test area" (also referred to herein as "test field") is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term can specifically refer to, but is not limited to, a concentrated amount of test chemical, such as a circular, polygonal, or rectangular shaped field having one or more layers of material with at least one layer of the test field containing the test chemical. For test chemicals contained in optical test strips, see, for example, J. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26. Other types of test chemicals are possible and can be used to practice the present invention.

[0035] As outlined above, the method includes using a camera to capture at least one image of at least a portion of a reagent test area to which a sample of bodily fluid has been applied. As used herein, the term "capturing at least one image" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term may specifically refer to, but is not limited to, one or more of imaging, image recording, image acquisition, and image capture. The term "capturing at least one image" may include capturing a single image and / or multiple images, such as a series of images. For example, capturing an image may include continuously recording a series of images, such as a video or motion picture. Capturing at least one image may be initiated by a user action or may be initiated automatically, for example, upon automatic detection of the presence of at least one object within the camera's field of view and / or within a predetermined sector of the field of view. These automatic image capture techniques are known, for example, in the field of automated barcode readers, such as automated barcode reading apps. The image capture may be performed, for example, by a camera capturing a stream or "lifestream" of images, one or more of which are stored and used automatically or by user interaction, such as pressing a button, as at least one first image or at least one second image, respectively. Image capture may be supported by a processor of the mobile device, and image storage may occur within a data storage device of the mobile device.

[0036] Capturing at least one image can include applying a sample of bodily fluid to the test strip and capturing at least one image, and optionally, for example, capturing at least one image without applying the sample of bodily fluid to the test strip before applying the sample to the test strip and capturing the image. The latter image can be specifically used for comparison purposes and can also be referred to as a "blank image" or "dry image." Sample application can generally be performed, for example, directly or indirectly, for example, via at least one capillary element. The at least one image captured after sample application can also typically be referred to as a "wet image," even if the sample may have dried when the image is actually captured. The wet image can typically be captured after waiting at least a predetermined waiting time, for example, 5 seconds or more, to allow a detection reaction to occur. Thus, for example, the method can include waiting at least a predetermined minimum amount of time between capturing at least one optional dry image and at least one wet image. This predetermined minimum amount of time can specifically be sufficient for a detection reaction to occur within the test strip. For example, the minimum waiting time can be at least 5 seconds.

[0037] The method includes determining an analyte concentration, particularly an analyte concentration value, from the color development of the test field. Thus, the method can be an analytical measurement involving a change in at least one optical property of the optical test strip, which can be visually measured or determined using a camera. Specifically, the analytical measurement can be or can include a color reaction in the presence of at least one analyte to be determined. The term "color reaction" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer, but is not limited to, a chemical, biological, or physical reaction in which the color, particularly the reflectance, of at least one component involved in the reaction changes as the reaction progresses. The color development can be detected by a mobile device, such as by a processor in the mobile device, and can be quantitatively evaluated, such as by deriving from at least one image at least one parameter that quantifies or characterizes the color development of the test field due to the presence of the analyte in the bodily fluid. For this purpose, one or more specific color coordinates can be used. Thus, the mobile device, and in particular the processor of the mobile device, can be configured to determine the color change by determining the change in one or more color coordinates that occurs due to the detection response.

[0038] At least one analyte concentration, particularly an analyte concentration value, is determined from the color development of the test field. At least one image is used for this purpose. The analyte concentration value can be a numerical indicator of the result of the analytical measurement, such as indicating the concentration of at least one analyte in the sample, e.g., blood glucose concentration.

[0039] The term “local temperature information” as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. Specifically, the term can refer, but is not limited to, any information regarding the temperature measured or that can be assumed at the current location of the mobile device. Information regarding the local temperature can be expressed numerically in any available, well-known scale, such as Celsius (°C), Fahrenheit (°F), or Kelvin (K). In some cases, the “local temperature information” may alternatively be provided in the form of a temperature range. Furthermore, it should be noted that the “local temperature information” may be received from one or more of the temperature source options in step ii) available at the current location of the mobile device. Thus, the “local temperature information” may be a temperature value received from a single temperature source option or may be a temperature value received from two or more temperature source options. In the latter case, the “local temperature information” may be a temperature value derived from a combination (e.g., an average temperature value) or a weighted combination of two or more temperature values ​​received by the mobile device. The term "local" as used in this context refers to the temperature at the mobile device's current location, e.g., an indoor or outdoor location. Furthermore, as used herein, the term "local" can refer to any place or area that can be designated or defined to adequately represent or approximate the temperature conditions in or within the locally limited surroundings of the mobile device. For example, particularly when the mobile device's current location is outdoors, it may be appropriate to refer to the temperature conditions of a region (e.g., a city, part of a city, a neighborhood, a landscape or part thereof, a county, or federal state, etc.). In this regard, "local temperature information" may relate to information about temperature provided by commonly available online weather services, so long as information about the local temperature is provided. When the mobile device's current location is indoors, it may alternatively or additionally be appropriate to refer to the temperature conditions within a housing or room.

[0040] Similarly, the term "current location of a mobile device" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. This term may specifically refer to, but is not limited to, any place or area that can represent or approximate the locally bounded perimeter of a mobile device. Generally, such a place or area can be identified or described depending on the capabilities of the location technology used. For example, it may be possible to locate the current location of a mobile device in a particular part of a city, a particular neighborhood or portion thereof, a particular street, address, building, or house, a particular piece of land, place, or parcel of land, etc. In particular, if the current location of the mobile device is indoors, it may alternatively or additionally be possible to locate the current location of the mobile device within a particular housing or within a particular room.

[0041] The term "correction temperature" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. This term can specifically refer to, but is not limited to, one or more of a specific temperature value, an average temperature value, a representative temperature value, a reference temperature value, a range of temperature values, and a delta temperature value, particularly a delta temperature value from a reference temperature value. The term "correction temperature function" can refer to a mathematical function, coefficient, formula, or algorithm, each of which can be applied in determining the analyte concentration in step iv) by using local temperature information received by the mobile device as an input or as a trigger for applying the function, coefficient, formula, or algorithm. In general, "correction temperature" and "correction temperature function" can be useful for properly considering the effect of temperature on the chemical reactions used herein in the reagent test area of ​​the optical test strip. Such effects can be described, for example, by the Arrhenius equation, which is well known to those skilled in the art and is an equation for the temperature dependence of reaction rate. In the Arrhenius equation, the variable T is absolute temperature (in Kelvin). In some cases, the determination of the analyte concentration in step iv) based on the color reaction in the reagent test area can be assumed to occur at a typical temperature, e.g., room temperature, e.g., about 20°C. In such cases, the effect of temperature on the chemical reaction may not be explicitly represented by a coefficient, formula, or algorithm that uses the local temperature information received as input. In these cases, the "correction temperature" may be determined to be set to a typical temperature, such as room temperature, e.g., about 20°C. Alternatively, in these cases, the "correction temperature function" may be determined to be a scaling factor equal to "1," i.e., have no effect on the calculation of the analyte concentration.

[0042] The method may further include displaying the analyte concentration values, such as on a display of the mobile device. Additionally or alternatively, the method may include storing the at least one analyte concentration value in at least one data storage device of the mobile device. Again, additionally and alternatively, the method may further include transmitting the at least one analyte concentration value via the at least one interface and / or via at least one data transmission network, e.g., to another computer or the like, for further evaluation.

[0043] Thus, in a first aspect, the present invention relates to an analytical method for determining the concentration of an analyte, in particular blood glucose, in a body fluid, in particular blood, by using a mobile device having a camera and a processor, comprising: i) capturing at least one image of at least a portion of an optical test strip with a camera, the optical test strip having a sample of bodily fluid applied to a reagent test area of ​​the test strip, the image including at least a portion of the reagent test area having the sample of bodily fluid applied to the reagent test area; ii) receiving local temperature information at a current location of the mobile device, said local temperature information comprising: a) remote weather information services; b) Temperature sensors in external electronic devices; and c) a temperature sensor on the mobile device, received by the mobile device from at least two of the temperature source options; Alternatively, the local temperature information is received by the mobile device from a temperature sensor of an external electronic device; receiving, wherein the external electronic device is selected from one or more of a wearable, such as a fitness tracker, a smart watch, smart glasses, smart clothing, a smart home component, such as an electronic heating system, a smart temperature measurement unit, a home weather station, and a body-worn sensor, such as a non-invasive analyte measurement sensor; iii. optionally, determining, by the processor, a correction temperature and / or a correction temperature function using the local temperature information from step ii); and and iv) determining, by the processor, an analyte concentration from the image captured in step i) based on a color reaction in the reagent test area where the sample of bodily fluid was applied, taking into account at least one of the local temperature information from step ii), the corrected temperature from step iii), and the corrected temperature function from step iii).

[0044] The proposed method provides efficient mobile-based determination of analyte concentration in a bodily fluid by taking into account information about the temperature of the current location of the mobile device used to perform the method. Local temperature information is obtained from low-effort available temperature source options at the location. Therefore, reliable accuracy of analyte measurement can be achieved efficiently with particularly low setup and implementation effort.

[0045] In step ii), the method may include at least approximately determining the current location of the mobile device by a location determination means of the mobile device. In particular, said determining is performed automatically by the location determination means. In general, any location determination means available to or applicable to a mobile device may be used for said determining the current location of the mobile device. Useful location determination techniques known to those skilled in the art include global navigation satellite systems (such as the Global Positioning System, GPS), location via mobile communication networks (Global System for Mobile Communications, GSM), and WLAN-based location (which is particularly useful for indoor location determination).

[0046] Typically, determining the current location of the mobile device involves using data from at least one of satellites, assisted GPS (Global Positioning System), Global System for Mobile Communications (GSM), multilateration, triangulation, a subscriber identity module (SIM card), a software-based dedicated tracker, a Wi-Fi positioning system, a Wi-Fi network, a navigation tool, and a navigation system by a positioning means. In particular, the data from the satellites, more specifically, the satellite data, is selected from at least one of GPS signals, Galileo signals, and GLONASS signals. Specifically, it may be beneficial to use first satellite data from a first satellite system and combine the first satellite data with second satellite data from a second satellite system. More specifically, the second satellite data can be used to verify signals from the first satellite system or to adjust the positioning determined from the first satellite data, or vice versa. Thus, for example, first satellite data can be used from Galileo and combined with second satellite data from GPS. Alternatively, first satellite data may be used from GPS and combined with second satellite data from Galileo.

[0047] In particular, determining the current location of the mobile device can include selecting, by the location determination means, whether the current location of the mobile device is indoors or outdoors. More specifically, the selection is performed automatically by the location determination means. Optionally, the selection is performed based on the number and / or strength of satellite signals received by the location determination means. For example, the location determination means can determine that the current location of the mobile device is indoors if the number of satellite signals received by the location determination means is below a threshold, specifically below a predetermined threshold, such as three satellite signals received by the location determination means, for at least one of the satellite systems used, such as Galileo. Additionally or alternatively, the location determination means can determine that the current location of the mobile device is indoors if the strength of the satellite signals received by the location determination means is below a predetermined threshold. As will be apparent to those skilled in the art, alternatively, the location determination means can determine that the current location of the mobile device is outdoors if the number and / or strength of satellite signals received by the location determination means is above a threshold, specifically above a predetermined threshold.

[0048] In an embodiment, step ii) of the method comprises checking, by the mobile device, which of the temperature source options a), b) and c) are available for receiving local temperature information, in particular: aa) checking whether a remote server is available to wirelessly connect to the mobile device; bb) checking whether an external electronic device is available to wirelessly connect to the mobile device; cc) checking whether an ambient temperature sensor and / or a temperature sensor for detecting overheating, in particular local overheating, is available in the mobile device. More specifically, step ii) may include establishing a wireless connection of the mobile device to a remote server and / or an external electronic device, depending on their availability. If the wireless connection of the mobile device to the remote server and / or the external electronic device is established, local temperature information may be received from the temperature source option. Alternatively or additionally, local temperature information may be received from an ambient temperature sensor and / or a temperature sensor for detecting overheating, if such sensors are available in the mobile device.

[0049] Additionally, step ii) may include receiving local temperature information from all of the available temperature source options a), b) and / or c).

[0050] As described herein above, the external electronic device in step ii) is selected from one or more of: a wearable, such as a fitness tracker, a smart watch, smart glasses, or smart clothing; a smart home component, such as an electronic heating system, a smart temperature measurement unit, or a home weather station; and a body-worn sensor, such as a non-invasive or implantable analyte measurement sensor. Suitable wearables, smart home components, and body-worn sensors typically comprise some means for measuring ambient temperature, such as a temperature sensor, and some means for wireless data transmission, such as RFID, Bluetooth or Bluetooth Low Energy (BLE), and Near Field Communication (NFC). Thus, the ambient temperature measured by at least one of the aforementioned devices may be wirelessly transmitted to the mobile device.

[0051] The external electronic device in step ii) may directly provide ambient temperature information, particularly for indoor locations, so that local temperature information can be received by the mobile device and therefore used to determine the analyte concentration in step iv).

[0052] Similarly, if the temperature sensor in step ii) is available in the mobile device and is an ambient temperature sensor, it can directly provide ambient temperature information, particularly for indoor locations, so that local temperature information can be received by the mobile device and thus used to determine the analyte concentration in step iv). If the temperature sensor in step ii) is available in the mobile device and is, for example, a temperature sensor for detecting overheating, particularly local overheating, of any component located in the mobile device, it can indirectly provide local temperature information. For example, particularly in outdoor situations, if the temperature sensor in the mobile device indicates a very low temperature value, e.g., 10°C or below, and the mobile device has been operating for a minimum time, e.g., at least 5 minutes, it can be assumed that the ambient temperature in the outdoor situation is significantly lower, specifically below a moderate room temperature of 20°C, e.g., 15°C or below. This information can then be used, in combination with local temperature information from one or more of the other temperature source options, as local temperature information at the mobile device's current location.

[0053] In an embodiment of the method, step ii) includes receiving, by the mobile device, local temperature information from a remote weather information service. In particular, the local temperature information is received from a remote server connected to the mobile device. Optionally, if the mobile device is not connected to the remote server, the local temperature information may be received from a memory of the mobile device, the memory storing recent local temperature information previously received by the mobile device from the remote server. The recent local temperature information includes local temperature information at the current location of the mobile device that can be used up to a specific time point, calculated from the time the recent local temperature information was received by the mobile device. Thus, if the time up to the specific time point has not yet elapsed, the local temperature information at the current location of the mobile device can be used from the memory of the mobile device.

[0054] In some embodiments of the method, step ii) includes receiving, by the mobile device, local temperature information from at least two of temperature source options a), b) and c), such as from temperature source options a) and b), from options a) and c), or from options b) and c), in particular from temperature source options a) and b), or from temperature source options a) and c), more particularly from all of temperature source options a), b) and c).

[0055] In other embodiments of the method, step ii) includes receiving, by the mobile device, local temperature information only from temperature source option b), i.e., from an external electronic device selected from one or more of: a wearable such as a fitness tracker, a smart watch, smart glasses, smart clothing, etc.; an electronic heating system, a smart temperature measurement unit, a smart home component such as a home weather station, etc.; and a body-worn sensor such as a non-invasive analyte measurement sensor.

[0056] Advantageously, step ii) comprises receiving, by the mobile device, local temperature information from a remote weather information service and from at least one of temperature source options b) and c).

[0057] Optionally, the method further comprises: iii) determining, by the processor, a correction temperature and / or a correction temperature function using the local temperature information from step ii).

[0058] In general, determining a “correction temperature” and / or “correction temperature function” can be useful to properly account for the effect of temperature on the chemical reactions used herein in the reagent test area of ​​the optical test strip. As further described herein, the term “correction temperature” can refer to, for example, one or more of a specific temperature value, an average temperature value, a representative temperature value, a reference temperature value, a range of temperature values, and a delta temperature value, particularly a delta temperature value from a reference temperature value. The term “correction temperature function” can refer to a mathematical function, coefficient, formula, or algorithm, each of which can be applied in determining the analyte concentration in step iv) by using the local temperature information received by the mobile device as an input or trigger. This allows even the fairly complex effect of temperature on a given reagent test chemical and a specific analyte's chemical reaction to be taken into account to determine the analyte concentration.

[0059] For example, if temperature itself is a variable in an equation, formula, or algorithm, each of which can be used to determine analyte concentration by deriving said analyte concentration from a color reaction in a reagent test area, the correction temperature can be a numerical temperature value that is added or subtracted, as appropriate, to the temperature value derived from the local temperature information received by the mobile device in step ii). Alternatively or additionally, the correction temperature function can be a numerical coefficient (e.g., representing a % value, such as 0.9 for 90%) that is used to determine the analyte concentration in step iv), for example, by multiplication with the temperature value derived from the local temperature information or by multiplication with the originally calculated analyte concentration (i.e., before application of the correction temperature function).

[0060] Furthermore, if the local temperature information is assumed to be reliable, the corrected temperature value derived therefrom can be used directly as an input or variable in an equation, formula, or algorithm, which can be used to determine the analyte concentration by deriving said analyte concentration from a color reaction in the reagent test area. The latter scenario can be applied, for example, when the local temperature information received by the mobile device is obtained from a temperature sensor in an external electronic device, such as an electronic heating system or a smart temperature measurement unit.

[0061] Furthermore, the local temperature information received by the mobile device may be subjected to one or more plausibility tests. As an example of an indoor situation, if local temperature information is received by the mobile device from a remote weather information service, and the received local temperature information indicates an (outdoor) temperature around a typical room temperature, e.g., 20°C, a moderate temperature, e.g., above 10°C or above 15°C, can be assumed at the current location of the mobile device. Furthermore, as an example of an outdoor situation, reference is made to the illustrative example given herein above regarding a temperature sensor in a mobile device indicating a very low temperature value, e.g., below 10°C, and the mobile device has been operating for a minimum time, e.g., at least 5 minutes, in which case it can be assumed that the ambient temperature in said outdoor situation is significantly lower, specifically below a typical room temperature of 20°C, e.g., below 15°C.

[0062] In an embodiment of the method, step iii) comprises verifying or adjusting, by the processor, local temperature information received from at least one of temperature source options a), b), and c), in particular from temperature source option a), wherein said verification or adjustment takes into account local temperature information received from at least one of the other two temperature source options.

[0063] In this embodiment, the adjusting in step iii) may further include using a weighted average of local temperature information received from temperature source option a) and from at least one of temperature source options b) and c), thereby determining a corrected temperature or corrected temperature function.

[0064] In another embodiment of the method, step iii) may further comprise using the local temperature information from step ii) to select one of a plurality of temperature ranges, which may be predefined, in particular selecting a temperature range that includes a local temperature derived from the local temperature information from step ii).

[0065] In this embodiment, the plurality of temperature ranges may include 2 to 10, particularly 2 to 5, such as 2, 3, 4 or 5 temperature ranges. In particular, using at least three sets of predetermined temperature ranges, such as 3 or 4, has been found to be particularly useful in carrying out this embodiment of the method.

[0066] Furthermore, multiple temperature ranges can be <T LOW The low temperature range TR(low), which includes temperatures of HIGH and a high temperature range TR(high) including a temperature of T LOW can be a temperature selected from the range of 5°C to 20°C, specifically 10°C to 15°C, and Thigh can be a temperature selected from the range of 20°C to 30°C, specifically 20°C to 25°C. When two predetermined temperature ranges are provided, the first low temperature range TR(low) is T <T LIMIT and a second high temperature range TR(high) can include temperatures T>T LIMIT temperature, T LIMIT may be a temperature selected from the range of 10° C. to 30° C., specifically 15° C. to 25° C., more specifically 20° C. If three predetermined temperature ranges are provided, the first low temperature range TR(low) is T <T LOW and the second intermediate temperature range TR(medium) can include temperatures of TLOW <T<T HIGH can include the temperature of, and the third high temperature range TR(high) is T>T HIGH can include the temperature of, and T LOW can be a temperature selected from the range of 5°C to 20°C, particularly 10°C to 15°C, and Thigh can be a temperature selected from the range of 20°C to 30°C, particularly 20°C to 25°C. Furthermore, for example, if TR(low) includes the temperature of 0°C < T < T LOW and TR(medium) includes the temperature of T LOW <T < T HIGH and TR(high) includes the temperature of T HIGH <T < 40°C, etc., the absolute lower and / or upper limits of the temperature can be defined such that each temperature range is clearly defined by the temperature values of both the lower and upper limits.

[0067] Each of the plurality of temperature ranges may be associated with its own correction temperature or correction temperature function, and the correction temperature or correction temperature function may be selected independently of each other for each temperature range. In particular, a specific correction temperature or correction temperature function may be selected to be different for each temperature range. More specifically, a specific correction temperature or correction temperature function may be able to represent one or more approximate average temperatures or representative temperatures of the temperature range. For example, in the case of three different temperature ranges such as TR(low) including temperatures of T < 15°C, TR(medium) including temperatures of 15°C < T < 25°C, and TR(high) including temperatures of T > 25°C, the first correction temperature of TR(low) can be determined to be 10°C, the second correction temperature of TR(medium) can be determined to be 20°C, and the third correction temperature of TR(high) can be determined to be 35°C. Each of these correction temperatures can be directly used in the determination of the analyte concentration in step iv). Alternatively, a correction temperature function may be determined for each temperature range, such as a correction factor. Thus, in this example, if the local temperature information indicates a temperature value of 12°C, the first correction temperature of TR(low) is determined to be 10°C. This first correction temperature of 10°C can be considered in the determination of the analyte concentration in step iv). Alternatively, the first correction temperature function may be determined for the first temperature range TR(low) by subtracting 10% from the initially calculated (i.e., before applying the temperature correction) analyte value, corresponding to applying a multiplication factor of 0.9, for example.

[0068] In an embodiment, the method may further include, advantageously, enabling measurements only at temperatures within a temperature range from an absolute low temperature limit to an absolute upper temperature, for example, temperatures from 0°C to 40°C. Specifically, determining whether a measurement is permitted can be based on at least one of the local temperature information from step ii) and the correction temperature from step iii).

[0069] Optionally, step ii) of the method can further include receiving additional local temperature information at the current location of the mobile device, the additional local temperature information being received by the mobile device from a thermochromic field. Such a thermochromic field may be provided on the test strip and / or on a color reference card. In such a case, the image of the optical test strip captured by the camera in step i) may include the thermochromic field, or a separate image of the thermochromic field may be captured by the camera. The additional local temperature information can be used in step iii) for determining a correction temperature and / or in step iv) for determining the analyte concentration.

[0070] Optionally, step ii) of the method may further comprise receiving local humidity information at a current location of the mobile device, said local humidity information being received by the mobile device from at least one of the following humidity source options: a) remote weather information services, and / or b) Humidity sensors in external electronic devices, and / or c) A humidity sensor on a mobile device.

[0071] Further, step ii) of the method can include determining, by the processor, a corrected humidity and / or a corrected humidity function using the local humidity information. Further, step ii) of the method can include determining, by the processor, an analyte concentration from the image captured in step i) based on a color reaction in the reagent test area where the sample of bodily fluid was applied, taking into account at least one of the local humidity information, the corrected humidity, and the corrected humidity function.

[0072] In another aspect of the invention, there is provided a mobile device having at least one camera and at least one processor, the mobile device configured to determine a concentration of an analyte in a bodily fluid by using the camera to capture at least one image of at least a portion of an optical test strip having a reagent-testing area, and by determining at least one analyte concentration value from a color reaction in the reagent-testing area of ​​the optical test strip; the mobile device is further configured to receive local temperature information at a current location of the mobile device; The local temperature information is a) remote weather information services; b) Temperature sensors in external electronic devices; and c) a temperature sensor on the mobile device, or Alternatively, the local temperature information is received from a temperature sensor of an external electronic device; There is provided a mobile device, wherein the external electronic device is selected from one or more of a wearable such as a fitness tracker, a smart watch, smart glasses, smart clothing, a smart home component such as an electronic heating system, a smart temperature measurement unit, a home weather station, and a body-worn sensor such as a non-invasive analyte measurement sensor, and wherein the mobile device is further configured to perform at least steps iii) and iv) of the analysis method described herein above.

[0073] In another aspect of the present invention, a kit is provided that includes a mobile device as described hereinabove and an optical test strip.

[0074] In another aspect of the present invention, there is provided a computer program comprising instructions which, when executed by a mobile device as described herein above, cause the mobile device to perform at least steps iii) and iv) of the analysis method as described herein above.

[0075] In another aspect of the present invention, there is provided a computer-readable storage medium comprising instructions that, when executed by a mobile device as described herein, cause the mobile device to perform at least steps iii) and iv) of the analysis method as described herein. [Brief explanation of the drawings]

[0076] Further optional features and embodiments are disclosed in more detail in the subsequent description of the embodiments, preferably in conjunction with the dependent claims. Here, each optional feature may be realized independently as well as in any possible combination, as understood by a person skilled in the art. The scope of the present invention is not limited by the preferred embodiments. The embodiments are illustrated schematically in the figures, where the same reference numerals in these figures refer to identical or functionally comparable elements.

[0077] The diagram is as follows: [Figure 1] 1 shows a flow chart of an embodiment of a method for determining the concentration of an analyte in a bodily fluid. DETAILED DESCRIPTION OF THE INVENTION

[0078] Detailed Description of the Embodiments With reference to Table 1 herein below, an analytical method was used to determine the concentration of an analyte in a body fluid by using a mobile device with a camera and a processor. Instead of a body fluid, in this case a glucose reference solution of known concentration was used, and the analyte to be determined accordingly was glucose. (R) Activated blood glucose test strips have been used to provide blood glucose measurements based on a color reaction in the reagent test area. Typically, such test strips are sold under the corresponding Accu-Chek brand for home use by general users. (R) Used with active handheld blood glucose meters. These blood glucose meters include a temperature sensor to sense the ambient temperature, which is used to calibrate and determine the blood glucose concentration.

[0079] Here, "Moto G6 plus (R) "A mobile phone is provided with software (Accu-Chek) running on said mobile phone. (R) SugarView (R) (corresponding to software sold in some countries under the name Accu-Chek) to evaluate the color development on the reagent test area and determine the blood glucose concentration from said color development. The measurement procedure included a blank measurement of a dry reagent test strip with no sample applied, applying a drop of blood to the reagent test area, waiting a minimum time for a chemical reaction to occur, and taking an image of the reagent test area with the sample applied. From the color formed on the reagent test area, the software determined the resulting blood glucose concentration. (Accu-Chek (R) SugarView (R) The software does not display the concentration value to the user, but does indicate the corresponding blood glucose range.)

[0080] The measurements were performed at a constant relative humidity of rH = 45. The glucose reference solution had a known concentration of 120 mg / dl in each case. However, the temperature was adjusted to 8°C for the first series of measurements, 21°C for the second series, and 40°C for the third series, respectively. Each series included 15 individual measurements. [Table 1]

[0081] Without considering compensation for temperatures deviating from approximately room temperature (e.g., approximately 20°C), it was found that low temperatures resulted in a positive deviation from the expected target concentration (of the glucose reference solution), while high temperatures resulted in a negative deviation from the expected target concentration. Taking into account the average deviation observed in this example, a first compensation temperature function for low temperatures was set to apply a factor of 0.9 to the initially calculated glucose concentration, resulting in a nearly complete reduction in the average deviation. A second compensation temperature function for high temperatures was set to apply a factor of 1.03 to the initially calculated glucose concentration, resulting in a substantial reduction in the average deviation. At room temperature, the average deviation was considered acceptably low. Therefore, a third compensation temperature function for medium or room temperatures was set to apply a factor of 1.0 to the initially calculated glucose concentration, so as not to affect the results.

[0082] 1 , which illustrates a flowchart of an embodiment of a method for determining the concentration of an analyte, such as blood glucose, in a bodily fluid, such as blood, in step 100, a mobile device having a camera and a processor is used to capture at least one image of at least a portion of an optical test strip with the camera. The optical test strip has a sample of the bodily fluid, such as blood, applied onto a reagent test area of ​​the test strip. The captured image includes at least a portion of the reagent test area onto which the sample of the bodily fluid has been applied.

[0083] Also, in step 100, the current location of the mobile device is determined, at least approximately, by the mobile device's positioning means. In particular, the determination may be performed automatically by the positioning means. Here, the determining of the current location of the mobile device includes using data from at least one satellite system by the positioning means. In particular, the satellite data may be selected from at least one of GPS, Galileo, and GLONASS signals, for example, Galileo satellites. Based on the number and / or strength of the satellite signals, an indoor or outdoor situation can be determined. In particular, the positioning means can determine that the current location of the mobile device is indoors if the number of satellite signals received by the positioning means is below a predetermined threshold, for example, three satellite signals received by the positioning means, for one satellite system used, such as Galileo.

[0084] If the number of signals from Galileo satellites received by the position determining means is two, then the position determining means determines that the current location of the mobile device is indoors in step 110. If the number of signals from Galileo satellites received by the position determining means is more than two, then the position determining means determines that the current location of the mobile device is outdoors in step 210. Furthermore, by using the available satellite signals, the current location of the mobile device is determined or approximated as accurately as the satellite signals will allow.

[0085] In either case, in step 300, local temperature information at the mobile device's current location is received by the mobile device from an available temperature source option, such as from a remote weather information service provided on a remote server and accessible via an Internet connection, such as via a WLAN. Such online weather information services are widely available and provide up-to-date weather information, including temperature information, for essentially all identified typical locations, such as countries, regions, cities, parts of cities, streets, neighborhoods, etc. By way of example, in Germany in particular, detailed information can be received from Deutscher Wetterdienst (DWD, German Weather Service), although numerous other online weather services can be used as well.

[0086] If the location determination means determines in step 110 that the current location of the mobile device is indoors, the mobile device checks in step 400 whether an external electronic device having a temperature sensor is available for wireless connection to the mobile device. Such an external electronic device may be a smart temperature measurement unit equipped with wireless transmission means for transmitting the currently measured ambient temperature to the mobile device. In this case, a wireless connection of the mobile device to the smart temperature measurement unit is established, whereby, in addition to the local temperature information from the temperature source (the remote weather information service) in step 300, additional local temperature information from another temperature source (the smart temperature measurement unit) is received by the mobile device. In step 500, the local temperature information from the two temperature sources, i.e., from the remote weather information service and from the smart temperature measurement unit, can be combined; for example, the local temperature information from the two temperature sources can be compared, averaged, verified, and / or adjusted in such a combining step.

[0087] For example, in step 500, an average temperature can be calculated from both temperature values. Alternatively, the local temperature information received from the remote weather information service (which generally indicates an outdoor temperature) can be verified or adjusted by the local temperature information received from the smart temperature measurement unit (which generally indicates an indoor temperature). For example, the local temperature information received from the remote weather information service can indicate a temperature of 32°C, and the local temperature information received from the smart temperature measurement unit can indicate a temperature of 27°C. The processor of the mobile device can then verify the local temperature information received from the remote weather information service without changing the temperature value of 32°C. If the local temperature information received from the remote weather information service indicates a temperature of 32°C and the local temperature information received from the smart temperature measurement unit indicates a temperature of 23°C, the processor of the mobile device can adjust the local temperature information received from the remote weather information service by subtracting one-third of the temperature difference between the two indicated temperature values, such that in this example, 3°C is subtracted from the initial temperature value of 32°C to give a temperature value of 29°C. As a result, a temperature value is determined by the processor from the local temperature information received by the mobile device.

[0088] The temperature value can be used in step 500 as a correction temperature in determining the analyte concentration from the image captured in step 100, based on a color reaction in the reagent test area where the bodily fluid sample is applied. Alternatively, local temperature information, e.g., received from a remote weather information service and verified or adjusted by local temperature information received from the smart temperature measurement unit, can be used to determine a correction temperature function established based on the known temperature dependence of the chemical reaction between the analyte (blood glucose) and the chemical test reagent used in the optical test element. For example, it may be observed that temperatures above and below 30°C affect measurement accuracy significantly differently. In this case, using different correction temperature functions for temperatures above and below 30°C can significantly enhance measurement accuracy. In particular, this aspect can be advantageously employed when the local temperature information received by the mobile device is used to select one of a plurality of predetermined temperature ranges, e.g., three or four temperature ranges, such as 0°C to below 15°C, 15°C to below 25°C, 25°C to below 30°C, and 30°C to 40°C. Here, it may be advantageous if each temperature range is associated with its own specific correction temperature or correction temperature function.

[0089] Furthermore, if the location determination means determines the current location of the mobile device to be indoors in step 110 and the mobile device receives local temperature information from a remote weather information service in step 300 and from a smart temperature measurement unit in step 400, the processor of the mobile device checks in step 600 whether an ambient temperature sensor and / or a temperature sensor for detecting local overheating is available in the mobile device. If so, additional local temperature information can be received by the mobile device from these temperature sources. If an ambient temperature sensor is part of the mobile device, the additional local temperature information received therefrom can be used in the same manner as the local temperature information received from the smart temperature measurement unit, for example, and can be used in determining the analyte concentration in step 500. If a temperature sensor for detecting local overheating is included in the mobile device, one or more plausibility tests can be performed in step 700 using the additional local temperature information received therefrom.

Claims

1. 1. An analytical method for determining a concentration of an analyte in an acquired bodily fluid by using a mobile device having a camera and a processor, comprising: i) capturing at least one image of at least a portion of an optical test strip with said camera; wherein the optical test strip has a sample of the bodily fluid applied to a reagent test area of ​​the test strip, and the image includes at least a portion of the reagent test area with the sample of the bodily fluid applied to the reagent test area; ii) receiving local temperature information at a current location of the mobile device; where: said local temperature information, a) remote weather information services; b) a temperature sensor of an external electronic device; and c) a temperature sensor of the mobile device; and a temperature source option is received by the mobile device from at least two of the following: the external electronic device is selected from one or more of a fitness tracker, a smart watch, smart glasses, smart clothing, a wearable, an electronic heating system, a smart temperature measurement unit, a home weather station, a smart home component, and a non-invasive analyte measurement sensor, a body-worn sensor; iii) determining, by said processor, a correction temperature and / or a correction temperature function using said local temperature information from step ii); iv) determining, by the processor, the concentration of the analyte from the image taken in step i) based on a color reaction in the reagent test area with the sample of the bodily fluid applied to the reagent test area, taking into account at least one of the local temperature information from step ii), the corrected temperature from step iii), and the corrected temperature function from step iii).

2. 2. The method of claim 1, wherein step ii) comprises at least determining the current location of the mobile device by a location determining means of the mobile device.

3. The method of claim 2 , wherein said determining is performed automatically by said location means.

4. 4. The method of claim 3, wherein the determining the current location of the mobile device includes using, by the location means, data from at least one of satellites, assisted GPS, Global System for Mobile Communications (GSM), multilateration, triangulation, a subscriber identity module (SIM card), a software-based dedicated tracker, a Wi-Fi positioning system, a Wi-Fi network, a navigation tool, and a navigation system.

5. 5. The method of claim 3, wherein said determining the current location of said mobile device comprises selecting, by said location determination means, whether said current location of said mobile device is indoors or outdoors.

6. The method of claim 5 , wherein said selecting is performed automatically by said location means.

7. Step ii) is checking, by the mobile device, which of the temperature source options a), b), and c) is available for receiving the local temperature information, and includes at least: aa) checking whether a remote server is available to wirelessly connect to said mobile device; bb) checking whether an external electronic device is available to wirelessly connect to said mobile device; 7. The method according to claim 1, further comprising checking one of the following: cc) checking whether an ambient temperature sensor and / or a temperature sensor for detecting overheating, in particular local overheating, is available in the mobile device.

8. 8. The method of claim 7, wherein step ii) comprises establishing a wireless connection of the mobile device to the remote server and / or the external electronic device, depending on their availability.

9. The method of claim 8 , wherein step ii) further comprises receiving the local temperature information from all of the available temperature source options a), b) and / or c).

10. 9. The method of claim 1, wherein step ii) comprises receiving, by the mobile device, the local temperature information from at least a remote weather information service and also from at least one of the temperature source options b) and c).

11. 11. The method of claim 1, wherein step iii) comprises verifying or adjusting, by the processor, the local temperature information received from at least one of the temperature source options a), b), and c).

12. The method of claim 11 , wherein the verifying or adjusting takes into account the local temperature information received from at least one of the other two temperature source options.

13. 13. The method of claim 1, wherein step iii) further comprises using the local temperature information from step ii) to select one of a plurality of temperature ranges, the temperature ranges being preconfigurable.

14. 14. The method of claim 13, wherein the temperature ranges include two to five temperature ranges.

15. 15. The method of claim 13 or 14, wherein each of the plurality of temperature ranges is associated with its own specific compensation temperature or compensation temperature function, and the specific compensation temperatures or compensation temperature functions can be selected independently of each other for each temperature range.

16. step ii) receiving local humidity information at a current location of the mobile device; determining, by the processor, a corrected humidity and / or a corrected humidity function using the local humidity information; 16. The method of claim 1, further comprising: determining, by the processor, the analyte concentration from the image captured in step i) by considering at least one of the local humidity information, the corrected humidity, and the corrected humidity function.

17. a mobile device having at least one camera and at least one processor, the mobile device configured to determine a concentration of an analyte in a bodily fluid by using the camera to capture at least one image of at least a portion of an optical test strip having a reagent-testing area and determining at least one analyte concentration value from a color reaction in the reagent-testing area of ​​the optical test strip, the mobile device further configured to receive local temperature information at a current location of the mobile device; said local temperature information, a) remote weather information services; b) a temperature sensor of an external electronic device; and c) a temperature sensor of the mobile device; from at least two of the temperature source options, the external electronic device is selected from one or more of a fitness tracker, a smart watch, smart glasses, smart clothing, a wearable, an electronic heating system, a smart temperature measurement unit, a home weather station, a smart home component, and a non-invasive analyte measurement sensor, a body-worn sensor; 17. A mobile device, wherein the mobile device is further configured to perform at least steps iii) and iv) of the analysis method according to any one of claims 1 to 16.

18. 20. A kit comprising the mobile device of claim 17 and an optical test strip.

19. 18. A computer program comprising instructions which, when executed by a mobile device according to claim 17, cause the mobile device to carry out at least steps iii) and iv) of the analysis method according to any one of claims 1 to 16.

20. 18. A computer-readable storage medium comprising instructions that, when executed by a mobile device according to claim 17, cause the mobile device to perform at least steps iii) and iv) of the analysis method according to any one of claims 1 to 16.

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