Roche Diabetes Care, Inc.

F. Hoffmann-la Roche Ag

Max Berg

Fredrik Hailer

Bernd Limburg

Daniel Sieffert

Volker Tuerck

Bernhard Limburg

Herbert Wieder

Siva Chittajallu

Benhur Aysin

Christian Melchinger

Daria Skuridina

Peter Seelig

Beate Koschorreck

Volker Huellen

Simon Wetzel

Momme Winkelnkemper

Irina Ostapenko

Rudolf Pachl

Hans Kintzig

Alexander Steck

Ingrid Keth

Daniel Kammerer

Christian Hoertz

Ulisse Hohenadel

Miguel Setiabudi

Zied Guermazi

Rolf Hinzmann

Lukas Alperowitz

Frederik Hailer

Diva Chittajallu

An optical test strip () for measuring an analyte concentration in a sample of bodily fluid is disclosed. The optical test strip () comprises:

Devices and method for measuring an analyte concentration in a sample of bodily fluid

Systems and methods for measuring an analyte include devices configured to perform an analyte testing operation. The devices include a wearable electronic device and a remote device operatively connected to each other and each having a processor, the processors cooperating with each other in the execution of program instructions to measure an analyte. The wearable electronic device includes a camera configured to generate a video stream, which is analyzed to identify missing test components, to identify the application of a body fluid on a test strip where the sample undergoes changes in one or more optical properties, the image of which is analyzed to determine a level of the analyte. The wearable electronic device further includes a head-up display (HUD) for providing output messages to the user relating to the performance and status of the analyte testing operation.

System and method for automated optical analyte measurements via wearable smart devices

A method of evaluating suitability of lighting conditions for detecting an analyte in a sample using a mobile device camera. A test strip is provided for detecting the analyte. A first image of the test strip is captured while an illumination source of the mobile device is turned off and a second image of the test strip is captured while the illumination source is turned on. A sample is applied to the test strip and the first and second images are compared to thereby determine the difference in lighting conditions between the first image and the second image. The comparison is used to derive information on suitability of the lighting conditions for analyte detection. The lighting conditions are indicated as suitable when a predetermined threshold amount of light intensity used for illumination of the test strip originates from the illumination source.

Method for evaluating suitability of lighting conditions for detecting an analyte in a sample using a camera of a mobile device

A glucose test arrangement is provided for use in a handheld meter. The arrangement comprises a disposable test pad responsive to glucose in a body fluid, and a supporting member adapted to support the test pad at an application site for applying body fluid from a user's skin onto a receiving area of the test pad. The receiving area faces away from the supporting member. One or more spacer elements are arranged on the supporting member adjacent to the test pad, wherein the one or more spacer elements have a skin-contacting end section which protrudes above the receiving area.

Glucose test arrangement and method

A method of determining concentration of an analyte in a body fluid using a mobile device having a camera is disclosed. In the inventive method, the camera is used to take a series of calibration images of a region of interest of an object. The calibration images differ in their brightness. A key calibration figure is derived from each calibration image, the key calibration images being characteristic for a tone mapping function of the mobile device. A probable tone mapping function of the mobile device is determined by taking into account the key calibration figures. An analysis image is taken of at least part of a test field of an optical test strip, the test field having a body fluid applied thereto. Analyte concentration is determined from the analysis image of the test field by taking into account the probable tone mapping function of the mobile device.

Method of determining a concentration of an analyte in a bodily fluid and mobile device configured for determining a concentration of an analyte in a bodily fluid

A method of evaluating the suitability of a mobile device for performing an analytical measurement based on a color formation reaction. The capability of the mobile device to have relevant settings of the mobile device controlled by software running on the mobile device is evaluated. The relevant settings pertain to image raw data processing steps to be carried out by the mobile device and may include a color space transformation and a tone mapping transformation. When the evaluation indicates that the mobile device is capable of having the relevant settings controlled by the software, control information indicating that the mobile device is suitable for performing the analytical measurement is provided. When the evaluation indicates that the mobile device is not capable of having the relevant settings controlled by the software, control information indicating that the mobile device is unsuitable for performing the analytical measurement is provided.

Methods and devices for performing an analytical measurement

A method is disclosed for determining concentration of an analyte in a body fluid with a mobile device having a camera. The camera captures an image of an optical test strip having a test field. The analyte concentration value is determined from color formation of the test field. Provided in the mobile device is a correlation for transforming color formation of the test field into analyte concentration. Also provided in the mobile device is an item of clearance information indicating a level of confidence for the correlation. When the item of clearance information indicates a sufficient level of confidence for the correlation, the mobile device indicates to a user that the capturing of the image does not require using a color reference card. Further disclosed are a method of controlling analytical measurements, a mobile device, a system for controlling analytical measurements and computer programs for performing and/or controlling analytical measurements.

Method of determining a concentration of an analyte in a bodily fluid

A method for generating a module configured to determine concentration of an analyte in a sample of a body fluid is disclosed. The method includes providing a first set of measurement data derived from images of one or more test strips indicating a color transformation in response to a body fluid containing an analyte. The images can be recorded by multiple devices with differing cameras, software and/or hardware device configurations for image recording and image data processing. A neural network model can be generated in a machine learning process applying an artificial neural network and a module configured to determine concentration of an analyte in a second sample of a body fluid can be generated. Further, the present disclosure includes a system for generating the module as well as a method and a system for determining concentration of an analyte in a sample of a bodily fluid.

Method and system for determining concentration of an analyte in a sample of a bodily fluid, and method and system for generating a software-implemented module

A method of determining analyte concentration in a body fluid with a mobile device having a camera. A user is prompted to apply body fluid to an optical test strip and then waits a predetermined minimum waiting time. The camera captures an image of part of the test field having the body fluid applied thereto. Analyte concentration is determined based on the image captured. The determination includes estimating a point in time of sample application to the test field by taking into account time-dependent information derived from the image captured using a first color channel of a color space. The determination also estimates the concentration of the analyte by taking into account concentration-dependent information derived from the image using a second color channel of the color space.

A method for detecting an analyte in a sample is disclosed. The method includes providing a mobile device having a camera and an illumination source. A test strip having a test field with at least one test chemical for performing an optical detection reaction in the presence of the analyte is provided. The sample is applied to the test field. Several images of a region of the test strip are captured. The region includes at least part of the test field to which sample is applied. The images are captured before and after the sample is applied and with the illumination source turned on and off. The images captured are compared and differences in light intensities are determined. Analyte concentration is determined using the images captured and the determined light intensities.

Detection method for detecting an analyte in a sample

A method for calibrating a camera of a mobile device for detecting an analyte in a sample. An image of an object is captured using the camera with an illumination source turned on. A first area is determined in the image which is affected by direct reflection of light originating from the illumination source and reflected by the object. A second area which does not substantially overlap with the first area is determined as a target area of a test strip. Also disclosed is a detection in which a sample is applied to a test strip and a visual indication is provided to position the test strip relative to the camera to thereby locate the test field of the strip in the target area. An image of the test field is captured using the camera while the illumination source is turned on, and analyte concentration is determined from the image.

Method for calibrating a camera of a mobile device for detecting an analyte in a sample

A calibration method for calibrating a camera for detecting an analyte in a sample is disclosed. A plurality of different color coordinate systems and a set of test samples are provided. The test samples are applied to test elements that have test fields for producing an optically detectable reaction. Images of the colored test fields are acquired using the camera and color coordinates for the images are generated. The color coordinates that are generated are transformed into a set of measured concentrations by using a set of coding functions. The set of measured concentrations is compared with the known concentrations of the test samples and a best match color coordinate system of the plurality of color coordinate systems is determined. A best match coding function of the plurality of coding functions is also determined.

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Mannheim, Germany

Max Berg