Abstract: In some aspects, a modular analyte measurement system having a replaceable strip port module is provided to permit contaminated modules to be replaced. Some aspects of the present disclosure related to barriers for strip ports or the sealing of strip ports and/or analyte measurement devices to maintain a clean strip port and/or enable the strip port to be cleaned for reuse. Cleaning tools are also provided. Also provided are strip port interfaces that guide fluid away from the strip port opening, as well as absorptive elements that prevent fluid from entering a strip port. Analyte measurement devices with gravity sensors or accelerometers are also provided, along with methods related thereto. Also provided are docking station that serve as an information server and provides storage and recharging capabilities.

Abstract: Electrode systems are disclosed for measuring the concentration of an analyte under in vivo conditions, where the systems includes an electrode with immobilized enzyme molecules and an improved diffusion barrier that controls diffusion of the analyte from body fluid surrounding the electrode system to the enzyme molecules. Methods of making and using the system also are disclosed.

Abstract: A method and device for warning diabetics of imminent hypoglycaemic attacks. EEG signals are collected from a person using subcutaneously placed electrodes and the signals are led via wires drawn under the person's skin to a subcutaneously placed signal interface unit from where they are transmitted to an externally worn signal processing unit. The signal processing analyzes the EEG signals and when the pre-seizure characteristics signal changes are detected, a warning signal is given to the person from an alarm giver built into the signal processing unit, e.g., in form of a vibrator. When a person detects a warning signal, the person can prevent the hypoglycaemic attack by, e.g., consuming a sugary food.

Abstract: Embodiments of the invention provide methods and materials for making analyte sensors having a plurality of layered elements such as amperometric glucose sensors that are used by diabetic individuals to monitor blood sugar concentrations. Embodiments of the invention utilize plasma deposition technologies to form thin films of adhesion promoting compositions useful in such sensors. Sensors that incorporate the thin film compositions formed by these processes exhibit a number of desirable characteristics.

Abstract: Provided is a living organism information measurement device which users can easily and reliably operate. A living organism information measurement device for acquiring living organism information and generating measurement data relating to the information is provided with a device body, and a panel detachably attached to the device body. The device body comprises a control unit which executes a plurality of functions of the device body, a living organism information measurement unit which is connected to the control unit and generates the measurement data, and a first communication unit connected to the control unit. The panel comprises a second communication unit including a memory storing predetermined information. When the panel is attached to the device body, the first communication unit receives the predetermined information from the second communication unit. The control unit selects and executes a function corresponding to the received predetermined information among the plurality of functions.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: A relay device transfers information between a sensor system, which measures a physiological characteristic level of a user, and a fluid delivery system, which infuses a fluid into a user. The relay device includes a sensor system receiver for receiving communications from the sensor system in a sensor system format. The relay device also includes a processor for processing the communications from the sensor system and converting the communications for transmission in a delivery system format. The relay device further includes a delivery system transmitter for transmitting the converted communications in the delivery system format to the fluid delivery system. The sensor system and delivery system formats may utilize different frequencies and/or different communication protocols for communications transmitted between the sensor system and the fluid delivery system through the relay device.

Abstract: Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.

Abstract: A system and method for receiving and ejecting a test strip of a fluid testing device. The system includes parallel first and second guide rails defining a rail cavity between the guide rails. A sled includes a sled post and opposed first and second side leg sets each having at least one deflectable leg. Each of the deflectable legs is externally slidably engaged to one of the guide rails limiting the sled to only sliding motion in either a loading direction or an opposite ejection direction. An actuator arm is rotatably connected to a mechanism assembly. The sled post is received in an actuator arm slot. Actuator arm rotation in a loading rotational direction displaces the sled in the loading direction in a sliding motion. Subsequent opposite rotation of the actuator arm in an ejection rotational direction displaces the sled in the ejection direction and ejects the test strip.

Abstract: Disclosed herein are devices, systems, and methods for a continuous analyte sensor, such as a continuous glucose sensor. In certain embodiments disclosed herein, various in vivo properties of the sensor's surroundings can be measured. In some embodiments, the measured properties can be used to identify a physiological response or condition in the body. This information can then be used by a patient, doctor, or system to respond appropriately to the identified condition.

Abstract: Devices, systems, and methods for providing more accurate and reliable sensor data and for detecting sensor failures. Two or more electrodes can be used to generate data, and the data can be subsequently compared by a processing module. Alternatively, one sensor can be used, and the data processed by two parallel algorithms to provide redundancy. Sensor performance, including sensor failures, can be identified. The user or system can then respond appropriately to the information related to sensor performance or failure.

Abstract: Systems and methods for compensating for effects of temperature on implantable sensors are provided. In some embodiments, systems and methods are provided for measuring a temperature to determine a change in temperature in a sensor environment. In certain embodiments, a temperature compensation factor is determined based on a change in temperature of the sensor environment. The temperature compensation factor can be used in processing raw data of an analyte signal to report a more accurate analyte concentration.

Abstract: Methods and devices to detect analyte in body fluid are provided. Embodiments include enhanced analyte monitoring devices and systems.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: Devices and methods relating to analyte sensor insertion devices and methods are provided.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: A biosensor comprises a substrate; a reference electrode; a working electrode; a counter electrode; and a plurality of permeability adjusting spacers. The reference electrode, the working electrode and the plurality of permeability adjusting spacers are all being disposed to be substantially parallel to each other to create a plurality of enzyme containing porous sections. The enzyme containing porous sections contain an enzyme; where the enzyme is operative to react with a metabolite to determine the concentration of the metabolite. By combining a number of the aforementioned biosensors, the differential concentration of a target enzyme or protein is determined by monitoring the changes on its metabolite substrates.

Abstract: According to an embodiment of the invention, a method of determining hydration of a sensor having a plurality of electrodes is disclosed. In particular embodiments, the method couples a sensor electronics device to the sensor and measures the open circuit potential between at least two of the plurality of electrodes. Then, the open circuit potential measurement is compared to a predetermined value. In some embodiments, the plurality of electrodes includes a working electrode, a reference electrode, and a counter electrode. In still further embodiments, the open circuit potential between the working electrode and the reference electrode is measured. In other embodiments, the open circuit potential between the working electrode and the counter electrode is measured. In still other embodiments, the open circuit potential between the counter electrode and the reference electrode is measured.

Abstract: Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

Abstract: Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor.

Abstract: A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

Abstract: A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

Abstract: A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

Abstract: Method and apparatus for providing an introducer for transcutaneous placement of at least a portion of an analyte sensor through the skin of a patient is provided.

Abstract: Methods of determining a corrected analyte concentration in view of some error source are provided herein. The methods can be utilized for the determination of various analytes and/or various sources of error. In one example, the method can be configured to determine a corrected glucose concentration in view of an extreme level of hematocrit found within the sample. In other embodiments, methods are provided for identifying various system errors and/or defects. For example, such errors can include partial-fill or double-fill situations, high track resistance, and/or sample leakage. Systems are also provided for determining a corrected analyte concentration and/or detecting some system error.

Abstract: Provided are a measurement device by which the blood-sugar level or the like associated with the living activity of a diabetic patient can be measured easily and precisely and the measured valued associated with the living activity can be clinically applied easily, and an insulin infusion device, a measurement method, a method for controlling an insulin fusion device, and a program. A blood-sugar level measurement device (100) is provided with a blood-sugar level sensor (200) and an acceleration sensor (112) for measuring movement information associated with human body activity, wherein a CPU (110 controls, on the basis of the measured movement information, whether or not the measurement operation of a blood-sugar measurement circuit (113) can be executed.

Abstract: Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: Methods and devices and systems including a data collection module for receiving and storing analyte data over a predetermined time period from a subject, a user interface unit coupled to the data collection module for providing one or more indication related to the analyte data, a control unit coupled to the data collection module and the user interface unit to control, at least in part the operation of the data collection module and the user interface unit, a communication module coupled to the control unit for communicating one or more signals associated with the analyte data to a remote location, where the user interface unit is configured to operate in a prospective analysis mode including substantially real time output of the analyte level received by the data collection module, and a retrospective analysis mode including limited output of information to the subject during the predetermined time period, and further where the communication module is configured to communicate with the remote location afte

Abstract: An apparatus for optimizing a patient's insulin dosage regimen over time, comprising: at least a first computer-readable memory for storing data inputs corresponding at least to one or more components in a patient's present insulin dosage regimen and the patient's blood-glucose-level measurements determined at a plurality of times; a processor operatively connected to the at least first computer-readable memory, the processor programmed at least to determine from the data inputs corresponding to the patient's blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the one or more components of the patient's present insulin dosage regimen in order to maintain the patient's future blood-glucose-level measurements within a predefined range; and a display operative to display information corresponding to at least the patient's present insulin dosage regimen.

Abstract: The methods and apparatus for detecting an analyte in blood are useful for detecting an analyte in tissue of a subject. The apparatus comprises a sensor, which comprises an elongated conductive material having a protrudent end, the protrudent end comprising an electrode that detects the presence of an analyte; a substrate affixed to the conductive material; and a support having an external surface, a proximal end, and a distal end. The conductive material is positioned on the support and the protrudent end of the conductive material protrudes beyond the distal end of the support. Optionally, the sensor is suspended within the lumen of a venous flow device. Typically, only a portion of the sensor is suspended within the lumen of the venous flow device, said portion comprising the protrudent end of the conductive material. Alternatively, the conductive material is positioned on the external surface of the intravenous infusion catheter.

Abstract: Methods and systems for providing data communication in medical systems are disclosed.

Abstract: Membrane systems incorporating silicone polymers are described for use in implantable analyte sensors. Some layers of the membrane system may comprise a blend of a silicone polymer with a hydrophilic polymer, for example, a triblock poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) polymer. Such polymeric blends provide for both high oxygen solubility and aqueous analyte solubility.

Abstract: A method, system, and computer program product related to the detection of physical activity using changes in heart rate. The method, system, and computer program product evaluates short term glucose demand and long term insulin action due to physical activity. The method, system, and computer program product is further related to the improvement of open and closed loop control of diabetes by accounting for the metabolic changes due to physical activity. The method, system, and computer program product is directed to detecting in real time the short and long term effects of physical activity on insulin action via heart rate analysis, and recommending changes in insulin dosing to compensate for the effects of physical activity. With these recommendations, the open and closed loop control of diabetes can be improved and steps can be taken to prevent hypoglycemia that may result from increased insulin sensitivity due to physical activity.

Abstract: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

Abstract: A small diameter flexible electrode designed for subcutaneous in vivo amperometric monitoring of glucose is described. The electrode is designed to allow “one-point” in vivo calibration, i.e., to have zero output current at zero glucose concentration, even in the presence of other electroreactive species of serum or blood. The electrode is preferably three or four-layered, with the layers serially deposited within a recess upon the tip of a polyamide insulated gold wire. A first glucose concentration-to-current transducing layer is overcoated with an electrically insulating and glucose flux limiting layer (second layer) on which, optionally, an immobilized interference-eliminating horseradish peroxidase based film is deposited (third layer). An outer (fourth) layer is biocompatible.

Abstract: A method for calibrating a handheld diabetes managing device based on data generated by a continuous glucose monitor. The method can include sampling a current of the continuous glucose monitor at a sampling interval over a time period to generate a plurality of current samples for the time period. The method can also include determining a mean, median and standard deviation of the plurality of current samples. The blood glucose level of the patient can be measured at a first time and a calibration equation that associates the plurality of current samples with the estimated glucose level of the patient based on the measured blood glucose level and the plurality of current samples can be determined when the standard deviation is less than a first threshold and an absolute value of a difference between the mean and median is less than a second threshold.

Abstract: Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor.

Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the device has a sensing mechanism and a sensing membrane that includes at least one surface-active group-containing polymer and that is located over the sensing mechanism. The sensing membrane may have a bioprotective layer configured to substantially block the effect and/or influence of non-constant noise-causing species.

Abstract: Methods, devices, and systems for calibrating an analyte sensor are provided. Embodiments include determining a sensitivity value associated with an analyte sensor, retrieving a prior sensitivity value associated with the analyte sensor, determining whether a variance between the determined sensitivity value and the retrieved prior sensitivity value is within a predetermined sensitivity range, determining a composite sensitivity value based on the determined sensitivity value and the retrieved prior sensitivity value, and assigning a successful calibration sensitivity value based on the retrieved prior sensitivity value when the variance is within the predetermined sensitivity range.

Abstract: Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor.

Abstract: Novel membranes comprising various polymers containing heterocyclic nitrogen groups are described. These membranes are usefully employed in electrochemical sensors, such as amperometric biosensors. More particularly, these membranes effectively regulate a flux of analyte to a measurement electrode in an electrochemical sensor, thereby improving the functioning of the electrochemical sensor over a significant range of analyte concentrations. Electrochemical sensors equipped with such membranes are also described.

Abstract: Human or animal body fluids can be measured in-vivo to determine analyte concentrations, such as glucose. The measurement system comprises an exchangeable sensor for in-vivo placement, a data carrier with calibration data for the sensor, a housing having a first chamber for receiving a sterile sensor and a second chamber for receiving a data carrier, and a base station that couples to the housing for transmitting measurement signals to an evaluation unit. Replacement sterile sensors can be packaged in a sterile package and the data carrier associated with the replacement sensor can be packaged in a non-sterile package.

Abstract: A device contains individually controllable sites for electrochemically monitoring an analyte in interstitial fluid of a user. The sites include a conductive pattern attached at a first and second ends thereof to electrode material in a closed-circuit configuration for receiving a first predetermined voltage applied thereto in order to thermally ablate a stratum corneum of a user's skin to access the interstitial fluid and form an open-circuit configuration including first and second portions of the electrode material that are electrically isolated from each other; a sensing area deposited on at least one of the first and second portions of the electrode material; and a measuring component for receiving individual measurement data from the sensing area in response to a second predetermined voltage applied to the open circuit configuration. The individual measurement data is indicative of an amount of the analyte in the interstitial fluid.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: Methods and devices and systems for determining an analyte value are disclosed.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.

Abstract: Disclosed herein are systems and methods for a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes first and second working electrodes to measure analyte or non-analyte related signal, both of which electrode include an interference domain.