Abstract: Disclosed is a method of using a handheld meter configured for determining an analyte concentration in a body fluid. In the inventive method, a handheld meter with a disposable test element is provided and the test element is positioned at an application site of the meter. A body fluid from a user's body part is applied to a reaction area of the test element and a series of measurement values from the reaction area of the test element is detected. A proximity sensor senses the presence of the body part in a monitored space in proximity to the reaction area of the test element. The measured values are processed as a function of an output signal of the proximity sensor. Consequently, bias in the determination of the analyte concentration caused by the presence of the body portion is reduced or eliminated. An associated handheld meter is also disclosed.

Abstract: Methods are provided for deriving/determining an analyte concentration that include recording measurement values during a time development indicating a progress of a detection reaction of at least one test substance and a body fluid sample and providing at least one measurement curve F(t) containing the measurement values, where the detection reaction is known to be influenced by the analyte concentration and at least one disturbance variable Y. The methods also include deriving an end value of the measurement curve to form a first variable x1, and deriving at least one fit parameter by taking into account an exponential characteristic of the measurement curve, and where the fit parameter forms at least one second variable x2. The methods further include deriving/determining the analyte concentration by using at least one multivariate evaluation algorithm adapted to combine x1 and x2. Also provided are computer programs and devices that incorporate the same.

Abstract: The invention relates to a device for measuring the concentration of an analyte in the blood or tissue of a an animal or a human, particularly a premature infant, wherein for measuring said concentration the device comprises a means (30) comprising at least a first and a second permeability with respect to said analyte, wherein the first permeability for said analyte differs from the second permeability for the analyte. Further, the invention relates to a corresponding method.

Abstract: Methods, devices, and systems are provided for identifying dropouts in analyte monitoring system sensor data including segmenting sensor data into a plurality of time series wherein each time series is associated with a different instance of a repeating event, selecting a first time series to analyze for dropouts from the plurality of time series; comparing the selected first time series to a second time series among the plurality of time series, determining whether the selected first time series includes a portion that is more than a predefined threshold lower than a corresponding portion of the second time series, and displaying, on a computer system display, an indication that the selected first time series includes a dropout if the selected first time series includes a portion that is more than the predefined threshold lower than the corresponding portion of the second time series.

Abstract: A blood glucose sensing device includes a substrate, multiple three-dimensionally (3D) printed electrode leads comprising graphene arranged on or over the substrate, and glucose monitoring chemistry arranged in or on (e.g., adsorbed in) at least one of the 3D printed electrode leads. An end portion of a counter electrode lead may partially surround an end portion of a working electrode lead, and a reference lead may be further provided, Optionally, the 3D printed electrode leads may include a thermoplastic material, such as an aliphatic polyester. The glucose monitoring chemistry may include an enzyme.

Abstract: This invention discloses a method for constructing a set of database of one or more saccharides, a logical procedure for automatic determination of sequential mass spectra, and a method, program and system for determination the structures of oligosaccharides and glycoconjugates by the set of database. In one aspect, the sequential mass spectra measured by the method, program or system of the invention maybe instructed according to the logical procedure automatically or manually determined. By comparing the sequential mass spectra to the set of database, the structure of the carbohydrate comprising linkage position, anomeric configuration, composed monosaccharide and branch location of the carbohydrate sample can be identified. In another aspect, the method, program may be used to control one or more mass spectrometer automatically or manually.

Abstract: A method may include emitting a band of electromagnetic (EM) radiation towards a specimen that covers at least a first and a second wavelength of EM radiation. The method may also include receiving, at a first receiver configured to receive the first wavelength of EM radiation, responses to the EM radiation after the EM radiation interacts with the specimen; and receiving, at a second receiver configured to receive the second wavelength of EM radiation, responses to the EM radiation after the EM radiation interacts with the specimen. The method may also include extracting markers from a combination of first signals representative of the received responses at the first receiver and second signals representative of the received responses at the second receiver, the extracting including replicating and mixing the first signals and the second signals to extract the plurality of markers.

Abstract: Methods, devices, and systems are provided for identifying dropouts in analyte monitoring system sensor data including segmenting sensor data into a plurality of time series wherein each time series is associated with a different instance of a repeating event, selecting a first time series to analyze for dropouts from the plurality of time series; comparing the selected first time series to a second time series among the plurality of time series, determining whether the selected first time series includes a portion that is more than a predefined threshold lower than a corresponding portion of the second time series, and displaying, on a computer system display, an indication that the selected first time series includes a dropout if the selected first time series includes a portion that is more than the predefined threshold lower than the corresponding portion of the second time series.

Abstract: A method for determining the glucose value in blood or in interstitial liquids and to a glucose sensor including a catheter which has one or more openings in the region of the distal end of the catheter; a first optical waveguide which is arranged in the catheter and which includes a coupling surface at the distal end of the optical waveguide; a measuring probe which is arranged in the region of the distal end of the catheter, is coupled to the coupling surface of the first optical waveguide, and has a mirror arranged opposite the coupling surface of the first optical waveguide and a detection chamber between the coupling surface of the first optical waveguide and the mirror; a detection liquid for glucose in the detection chamber; and a membrane which encloses at least the detection chamber filled with the detection liquid and which has a separation capacity of maximally 20 kDA.

Abstract: Methods, devices, and systems are provided for identifying dropouts in analyte monitoring system sensor data including segmenting sensor data into a plurality of time series wherein each time series is associated with a different instance of a repeating event, selecting a first time series to analyze for dropouts from the plurality of time series; comparing the selected first time series to a second time series among the plurality of time series, determining whether the selected first time series includes a portion that is more than a predefined threshold lower than a corresponding portion of the second time series, and displaying, on a computer system display, an indication that the selected first time series includes a dropout if the selected first time series includes a portion that is more than the predefined threshold lower than the corresponding portion of the second time series.

Abstract: Methods, devices, and systems are provided for identifying dropouts in analyte monitoring system sensor data including segmenting sensor data into a plurality of time series wherein each time series is associated with a different instance of a repeating event, selecting a first time series to analyze for dropouts from the plurality of time series; comparing the selected first time series to a second time series among the plurality of time series, determining whether the selected first time series includes a portion that is more than a predefined threshold lower than a corresponding portion of the second time series, and displaying, on a computer system display, an indication that the selected first time series includes a dropout if the selected first time series includes a portion that is more than the predefined threshold lower than the corresponding portion of the second time series.

Abstract: A method implemented on a processor includes emitting a light beam from a light source to a component in an absorption cell, wherein the light beam comprises a plurality of wavelength beams. The method further includes generating a plurality of response signals due to the presence of the component, corresponding to the plurality of wavelength beams of the light beam. The method also includes detecting the plurality of response signals by a photo detector coupled to the absorption cell. The method includes determining a concentration of the component based on the plurality of response signals.

Abstract: Techniques and systems are disclosed for implementing textile-based screen-printed amperometric or potentiometric sensors. The chemical sensor can include carbon based electrodes to detect at least one of NADH, hydrogen peroxide, potassium ferrocyanide, TNT or DNT, in liquid or vapor phase. In one application, underwater presence of chemicals such as heavy metals and explosives is detected using the textile-based sensors.

Abstract: A method of adjusting a final signal value measured on a lateral flow assay test strip, by: identifying a pre-determined calibration method for the test strip, wherein the pre-determined calibration method corresponds to the manufacturing lot from which the test strip has been made; measuring signal values while performing a lateral flow assay reaction on a test strip; determining a final signal value; and adjusting the final signal value based upon the identified pre-selected calibration method for the test strip.

Abstract: Biosensors are made by attaching covalently or non-covalently at least one reporter group to one or more specific positions of a bacterial periplasmic binding protein (bPBP). Upon binding of ligand to the biosensor, there is a change in the signal transduced by the reporter group.

Abstract: Provided is a method for assessing cardiovascular risk in Metabolic Syndrome and Type 2 Diabetes patients. The method involves obtaining data from a Type 2 diabetes patient or a Metabolic Syndrome patient and determining a Fayad/Schentag index which includes a Glucose Supply Index (S) to an Insulin Demand Index (D) ratio. The Fayad/Schentag index is used in scoring cardiovascular risks of Metabolic Syndrome patients and for recommending and implementing therapeutic interventions that can be shown to lower cardiovascular risk.

Abstract: The disclosed subject matter relates to a sensor or system for monitoring a target analyte by using a polymer solution that is capable of binding to the analyte. The sensor of the disclosed subject matter includes a viscosity-based sensor or a permittivity-based sensor. The viscosity-based sensor contains a semi-permeable membrane, a substrate, and a microchamber including a vibrational element. The permittivity-based sensor contains a semi-permeable membrane, a substrate, and a microchamber. The sensor discussed herein provides excellent reversibility and stability as highly desired for long-term analyte monitoring.

Abstract: Provided herein are phenylboronate containing co-polymers (PCC), compositions containing PCC and polyvinyl alcohol (PVA), such compositions further including proteins, methods of making these compositions by water in oil polymerization, and methods of using the protein containing compositions for releasing proteins. Such phenylboronate containing co-polymers are of Formula I: where m, n, p, x, R1-R5, L, X1 and X2 are defined in the application.

Abstract: A biosensor system including the underfill management system determines the analyte concentration in a sample from the at least one analytic output signal value. The underfill management system includes an underfill recognition system and an underfill compensation system. The underfill recognition system determines whether the test sensor initially is substantially full-filled or underfilled, indicates when the sample volume is underfilled so that additional sample may be added to the test sensor, and starts or stops the sample analysis in response to the sample volume. The underfill recognition system also may determine the initial degree of underfill. After the underfill recognition system determines the initial fill state of the test sensor, the underfill compensation system compensates the analysis based on the initial fill state of the test sensor to improve the measurement performance of the biosensor system for initially underfilled test sensors.

Abstract: Various embodiments for methods and systems that allow for detecting of a direction in which a sample is flowing towards a plurality of electrodes and detecting a fill error of an electrochemical test strip.

Abstract: Techniques described herein enable a mobile multifunction device to detect a disposable sensor card at an interface coupled to the mobile multifunction device, wherein the disposable sensor card is mounted inside an opening in the mobile multifunction device, detect analog information associated with the disposable sensor card, and convert analog information to digital information. Detecting analog information comprises detecting a non-transient change in at least a portion of the disposable sensor card, wherein at least a portion of the first disposable sensor card changes form in response to exposure to one or more stimuli from an environment of the first disposable sensor card. A non-transient change may include one or more of changing color, changing shape, changing chemical composition or changing electrical characteristics. Furthermore, the interface may be configured to receive disposable sensor cards with varying sensing capabilities.

Abstract: A device which supports identification of an integrated display and dynamic adjustments to operating parameters thereof includes: a port that receive a test strip having a reaction site for receiving a sample of fluid from a patient, a blood glucose (bG) meter cooperatively operable with a test strip inserted in the port to measure glucose in a sample of fluid on the test strip, and a display device having an electrically resistive component integrated therein and operable to display the glucose measurement in accordance with one or more operating parameters associated with the display device The system also includes a monitoring module electrically connected to the resistive component, wherein the monitoring module determines a type for the display device based on a resistance of the resistive component and a control module that selectively adjusts a given operating parameter of the display device in accordance with the type of display device.

Abstract: The invention provides monoclonal antibody 3H6 and related antibodies. The 3H6 antibody binds to an epitope within residues 28-36 of IAPP. The antibodies of the invention are useful, for example, for treating disorders associated with IAPP accumulation, particularly accumulation of IAPP deposits. Such disorders include type 2 diabetes, metabolic syndrome, impaired insulin tolerance, impaired glucose tolerance, insulinomas, and related conditions.

Abstract: A portable, hand-held glucose testing device includes a housing configured to accommodate a plurality of test sensors in a stacked arrangement and having a wall with an opening defined therein. A plurality of packaged test sensors is stacked in alignment with one another within the housing. Each of the test sensors is packaged within a blister package. The blister package includes a blister package housing and a cover foil overlying a surface of the blister package housing and the test sensor. A drive slide is configured to displace one of the plurality of packaged test sensors out of alignment with other packaged test sensors. A knife mechanism is configured to pierce through the cover foil, and to engage and urge the test sensor to extend through the opening for receiving a sample. A meter contact is configured to engage the test sensor when the test sensor extends through the opening.

Abstract: A method for detecting at least one analyte in at least one sample of a body fluid is disclosed. Therein, at least one test element (124) is used, the at least one test element (124) having at least one test field (162) with at least one test chemistry (154) is used, wherein the test chemistry (154) is adapted to perform at least one optically detectable detection reaction in the presence of the analyte. The method comprises acquiring an image sequence of images of the test field (162) by using at least one image detector (178). Each image comprises a plurality of pixels. The method further comprises detecting at least one characteristic feature of the test field (162) in the images of the image sequence. The method further comprises correcting a relative position change between the image detector (178) and the test field (162) in the image sequence by using the characteristic feature, thereby obtaining a sequence of corrected images.

Abstract: An auto-calibration system for diagnostic test strips is described for presenting data individually carried on each test strip readable by a diagnostic meter. The carried data may include an embedded code relating to data particular to that individual strip. The data is presented so at to be read by a meter associated with the diagnostic test strip in order to avoid manually inputting the information.

Abstract: The present invention relates to a nanoscale or microscale particle for encapsulation and delivery of materials or substances, including, but not limited to, cells, drugs, tissue, gels and polymers contained within the particle, with subsequent release of the therapeutic materials in situ, methods of fabricating the particle by folding a 2D precursor into the 3D particle, and the use of the particle in in-vivo or in-vitro applications. The particle can be in any polyhedral shape and its surfaces can have either no perforations or nano/microscale perforations. The particle is coated with a biocompatible metal, e g gold, or polymer e g parvlene, layer and the surfaces and hinges of the particle are made of any metal or polymer combinations.

Abstract: A method of authenticating includes providing a glucose test strip having a top surface with a reagent thereon that has a structure which chemically reacts with glucose and an anti-counterfeiting identification feature (identification feature) including at least one ink. The glucose test strip is inserted into a glucose meter. The glucose meter includes a light source positioned to shine light on the ink after the inserting, a photodetector positioned to detect a reflected or transmitted signal after interaction with the ink, and stored information that identifies the identification feature. A processor implementing an algorithm automatically analyzes the reflected or transmitted signal by reference to the stored information to determine whether the glucose test strip is authentic.

Abstract: Provided is a method for assessing cardiovascular risk in Metabolic Syndrome and Type 2 Diabetes patients. The method involves obtaining data from a Type 2 diabetes patient or a Metabolic Syndrome patient and determining a Fayad/Schentag index which includes a Glucose Supply Index (S) to an Insulin Demand Index (D) ratio. The Fayad/Schentag index is used in scoring cardiovascular risks of Metabolic Syndrome patients and for recommending and implementing therapeutic interventions that can be shown to lower cardiovascular risk.

Abstract: Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

Abstract: An analytical device for analysis of chemical or biological samples, a method of using such a device, based on rotation of the device, integrated sample dosing and optical detection, and a system comprising such a device are disclosed. The analytical device comprises a device body having a liquid processing unit. The liquid processing unit comprises a mixing chamber for mixing a sample with a reagent, a sample dosing chamber for delivering a defined volume of the sample to the mixing chamber, and a reagent channel for delivering the reagent to be mixed with the sample, wherein the mixing chamber also serves as a detection chamber.

Abstract: A computer-implemented method is provided for displaying glucose measurements of a person on a handheld glucose meter. The method includes: determining a current blood glucose measurement for a person from a test strip inserted into a port of the handheld glucose meter; displaying the current glucose measurement on a result screen of the handheld glucose meter immediately following the measurement of the current glucose measurement by the handheld glucose meter; providing an indicium of a logbook screen on the result screen concurrently with the display of the current glucose measurement on the result screen; and displaying the logbook screen in response to a user input received by the handheld glucose meter, where the logbook screen displays the current glucose measurement along with at least two preceding glucose measurements of the person.

Abstract: The present invention relates to the use of N-linked glycan profiles of blood or blood component proteins as biomarkers for diagnosing diabetes mellitus and for monitoring the efficacy of anti-diabetic therapy. Specifically, the present invention relates to detecting changes in the amounts of N-linked glycans as diagnostic biomarkers for diabetes mellitus and as indicators of the efficacy of anti-diabetic therapy over time.

Abstract: A biosensor calibration method configured to measure a concentration of a specific substance contained in sample liquid to be measured, including: a first step configured to acquire a first output value that is output by the biosensor when first calibration liquid is brought into contact with the biosensor; a second step configured to acquire a second output value that is output by the biosensor when second calibration liquid having a different concentration from that of the first calibration liquid is continuously brought into contact with the biosensor after the first step and determine time for replacement of the biosensor on the basis of the first output value and the second output value.

Abstract: An analytical test cartridge is provided. The analytical test cartridge can be used for medical analyses of liquid samples removed from a patient, for example blood. The analytical test cartridge is configured to provide for titration experiments. An example of a titration experiment that can be performed with the arrangement, is titration of heparin with protamine. Methods of assembly and use are provided.

Abstract: A portable, hand-held glucose testing device includes a housing configured to accommodate a plurality of test sensors in a stacked arrangement and having a wall with an opening defined therein. A plurality of packaged test sensors is stacked in alignment with one another within the housing. Each of the test sensors is packaged within a blister package. The blister package includes a blister package housing and a cover foil overlying a surface of the blister package housing and the test sensor. A drive slide is configured to displace one of the plurality of packaged test sensors out of alignment with other packaged test sensors. A knife mechanism is configured to pierce through the cover foil, and to engage and urge the test sensor to extend through the opening for receiving a sample. A meter contact is configured to engage the test sensor when the test sensor extends through the opening.

Abstract: The present invention relates to an apparatus for quantifying the binding and dissociation kinetics of molecular interactions of small molecular bio materials with high sensitivity almost without the influence of a change in the reflective index resulting from a buffer solution by making polarized incident light incident on the binding layer of a bio material, formed in a thin dielectric film, so that the polarized incident light satisfies a p-wave non-reflecting condition and a quantifying method using the same.

Abstract: A sensor for detecting and/or quantifying the amount of analyte in a sample, the sensor including: a sensing region; and a barrier layer including a reactive oxygen species (ROS)-quenching, analyte-permeable membrane having an ROS-quenching agent adsorbed to the membrane; wherein the sensor is adapted so that the sample enters the sensing region of the sensor through the barrier layer.

Abstract: Systems, techniques and methods for estimating the metabolic state or flux, e.g., the body energy state (“BES”) of a patient, are disclosed. The BES provides deep insight into the nutritional needs of the patient, thus allowing for a sort of exquisite glycemic control with regard to the patient. The invention discloses systems and methods for estimating fractional gluconeogenesis, which is the % of glucose production that comes from gluconeogenesis (“GNG”), as opposed to glycogenolysis (“GLY”), the other form of glucose production. Nutritional formulations, materials, cocktails and methods for feeding patients by parenteral and other means are disclosed. The amount, type and rate of such nutritional feeding are typically based upon the above estimating. The invention discloses formulations that contain labels, such as deuterium, for medical diagnostics, such as for estimating BES and fractional gluconeogenesis.

Abstract: Various systems and methods of operating an analyte measurement device is provided. The device has a display, user interface, processor, memory and user interface buttons. In one example, one of the methods can be achieved by measuring an analyte with the analyte measurement device; displaying a value representative of the analyte; prompting a user to activate a test reminder; and activating the test reminder to remind a user to conduct a test measurement at a different time. Other methods and systems are also described and illustrated.

Abstract: An instrument adapted to determine an analyte concentration of a fluid sample using a test sensor is disclosed. The instrument comprises a display adapted to display information to a user, a user-interface mechanism adapted to allow the user to interact with the instrument, a first test-sensor cartridge, and a body portion including at least a first opening and a second opening formed therein. The first opening is adapted to receive a test sensor from the first test-sensor cartridge. The second opening is adapted to store at least one additional test-sensor cartridge.

Abstract: Apparatus and methods are provided for analyzing a medical condition of a user. The apparatus may include a user interface configured to receive user identification information inputted by the user, an analyzer, and a processor all disposed within a common housing. The analyzer is configured to receive a biological specimen from the user and to analyze the biological specimen to generate analysis information. The processor is configured to store and forward the analysis information and to receive prescription information. The apparatus may include a communication unit configured to transmit the user identification information and the analysis information to a doctor at a remote location for review and to receive the prescription information from the doctor. The apparatus then may dispense the prescribed medication or print a medication prescription.

Abstract: Persons with diabetes often carry a handheld glucose meter as well as a portable computing device, such as a mobile phone. Given the close proximity of these two devices, the portable computing device can serve as a data collector for the glucose measures taken by the glucose meter. Improved techniques are set forth for transferring glucose measures automatically and seamlessly to the patient's portable computing device, including displaying a value for the glucose measure along with an identifier for the portable computing device on a display of the glucose meter during the data exchange with the portable computing device.

Abstract: Persons with diabetes often carry a handheld glucose meter as well as a portable computing device, such as a mobile phone. Given the close proximity of these two devices, the portable computing device can serve as a data collector for the glucose measures taken by the glucose meter. Improved techniques are set forth for transferring glucose measures automatically and seamlessly to the patient's portable computing device, including transmitting a single glucose measure automatically in response to navigating away from an interface which displays to the glucose measure.

Abstract: A diabetes management system includes a handheld medical device, a mobile computing device, and a diabetes management application. The handheld medical device is configured to determine, in response to a port receiving a test strip, whether an auto-send feature is enabled on the handheld medical device, determine whether the handheld medical device is paired with a mobile computing device, and selectively instruct a wireless transceiver to establish a wireless connection and communicate a glucose measurement and identifying information to the mobile computing device. The mobile computing device is configured to execute the diabetes management application. The diabetes management application is configured to process a plurality of glucose measurements and identifying information associated with each of a plurality of glucose measurements.

Abstract: A method of distinguishing a control solution from a sample in an electrochemical test sensor is performed. The method includes adding a control marker to the control solution. The control solution includes the control marker and analyte. The test sensor includes working and counter electrodes, and a reagent. A potential is applied to the test sensor to oxidize the control marker and the analyte. The resulting electrical current is measured. A potential is applied to the test sensor lower than the other potential in which the potential is sufficient to oxidize the analyte and not the control marker. The resulting electrical current is measured. Determining whether a control solution or a sample is present based on the measured electrical currents. To increase the measured current, a salt may be added to the control solution in an amount sufficient to increase the electrical current by at least 5% as compared to a control solution in the absence of a salt.

Abstract: A test tape device is disclosed herein for use with a replaceable analytical tape cassette, where the device includes a housing having a cassette compartment covered by a cassette door and a housing opening for sample application, a protective cover that can be moved between a closed position covering the housing opening and a release position allowing access to the housing opening and a door lock for retaining the cassette door in the closed position, wherein the protective cover is coupled with the door lock via an interlocking mechanism, such that the door lock can only be unlocked in the release position of the cover.

Abstract: A sensor chip is configured to measure the temperature of a blood sample and includes a capillary section and an electrode unit. The capillary section allows the blood sample to be introduced therein. The electrode unit is configured to measure the temperature of the blood sample and includes a working electrode and a counter electrode. The working electrode and the counter electrode respectively include a reaction reagent layer containing an electrolyte. Further, the electrode unit is configured to receive a predetermined voltage to be applied in measuring the temperature of the blood sample for allowing a result of the measurement to be less affected by increase and reduction in a glucose concentration and the like.

Abstract: A biosensor system determines analyte concentration from an output signal generated by an oxidation/reduction reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals at one temperature to determining analyte concentrations from output signals at other temperatures. The temperature-adjusted correlation between analyte concentrations and output signals at a reference temperature may be used to determine analyte concentrations from output signals at a sample temperature.

Abstract: Persons with diabetes often carry a handheld glucose meter as well as a portable computing device, such as a mobile phone. Given the close proximity of these two devices, the portable computing device can serve as a data collector for the glucose measures taken by the glucose meter. Improved techniques are set forth for transferring glucose measures automatically and seamlessly to the patient's portable computing device, including displaying a value for the glucose measure along with an identifier for the portable computing device on a display of the glucose meter during the data exchange with the portable computing device.