Abstract: A template sheet is provided for use in the application of a medical grade adhesive to the skin of a user. In one preferred embodiment, the template is fabricated of a flexible plastic material having one or more openings in the sheet and marker openings are provided about the periphery of the one or more openings and through which the skin can be marked with a marking implement. By use of such markers on the skin, the template can be removed after placing the markings on the skin so that adhesive can be applied to the skin within the marked area without need for the template to remain in place during adhesive application. Alternatively, the template may be employed as a mask and the skin adhesive may be applied to the skin while the template is appropriately positioned on the skin of the user.

Abstract: The present invention is directed to an integrated system and a method for utilizing the system to detect and remove blood-borne factors of interest, such as pathogens and/or toxins and/or cytokines, from blood or serum (blood) by contacting the blood with a solid, essentially nonporous substrate which has been surface treated with molecules or chemical groups (the adsorbent media or media) having a binding affinity for the pathogens and/or toxins to be removed (the adsorbents). The invention can be used to remove virulence factors, e.g. toxins, that are released from various pathogens. In one aspect, the invention is for the treatment of sepsis and infection, such as infections associated with battle field trauma.

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 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: 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: 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 continuous glucose monitoring system including a sensor configured to detect one or more glucose levels, a transmitter operatively coupled to the sensor, the transmitter configured to receive the detected one or more glucose levels, the transmitter further configured to transmit signals corresponding to the detected one or more glucose levels, and a receiver operatively coupled to the transmitter configured to receive transmitted signals corresponding to the detected one or more glucose levels, and methods thereof, are disclosed. In one aspect, the transmitter may be configured to transmit a current data point and at least one previous data point, the current data point and the at least one previous data point corresponding to the detected one or more glucose levels.

Abstract: A blood glucose level information processing apparatus, method and program provide blood glucose values and blood glucose value information within a period or range desired by a user without imposing cumbersome operation on the user. The apparatus, method and program provide blood glucose values and blood glucose value information within a period or desired range by acquiring blood glucose levels measured by a blood glucose level measuring device and date/time of measurement at which the blood glucose levels are measured, displaying a line graph obtained by plotting the blood glucose values within a predetermined period. A slide bar can also be provided, for example on a graph display screen image, whereupon if the slide bar is moved, only the blood glucose values corresponding to a preceding period backdating in response to the amount of movement of the slide bar are plotted on a line graph along a time series.

Abstract: An automatic apparatus for obtaining and analyzing a blood sample contains a supply of lancets and test strips, which are located alternately on a carrier band. A lancet or alternatively a test strip may be clamped on a holder, which is mounted so it is movable. The movement controller of the holder comprises a three-dimensional control curve and a guide element, which engages at different depths in the control curve as a function of its relative position. The control curve comprises two guide paths, which run on different parallel planes. The contour of the first guide path determines the movement path of the lancet and the contour of the second guide path determines the movement path of the test strip. The test strip executes a transverse offset perpendicular to the puncture axis of the lancet.

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: 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: A method of delivery of medical data via a trusted end-to-end communication link. The method comprises obtaining a measurement of a parameter of a human being by a first sensor, obtaining a biometric from the human being by a second sensor, receiving input from the first and second sensors by a secure application executing in a trusted security zone of a processor, whereby access to the input from the first and second sensors by applications executing in a normal partition of the processor is blocked, wherein the input from the first and second sensors comprises the measurement of the parameter and the biometric, and transmitting a message based on the input from the first and second sensors via a trusted end-to-end communication link to a medical data server, wherein an application that receives the message executes in a trusted security zone of the server.

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: Method and apparatus for inserting at least a portion of a sensor into a patient is provided.

Abstract: An electronic computing device as presented here includes a device communications layer, a processor device, and a reporting layer. The device communications layer receives sensor data for a user of an insulin infusion device, wherein the sensor data indicates blood glucose levels of the user for a specified period of time, and over a plurality of days. The processor device analyzes the received sensor data to detect an event occurrence indicative of a correctable basal rate setting of the insulin infusion device. The reporting layer generates a report containing a graphical representation of the received sensor data and a recommendation to adjust a basal rate setting of the insulin infusion device, wherein the recommendation is intended to address the detected event occurrence.

Abstract: The present invention relates to a sensor device for measuring tensile variation against a membrane separating a liquid such as the skin on humans and animals and any other membrane separating a liquid on one of its sides.

Abstract: Embodiments described herein relate to an analyte monitoring device having a user interface with a display and a plurality of actuators. The display is configured to render a plurality of display screens, including a home screen and an alert screen. The home screen is divided into a plurality of simultaneously displayed panels, with a first panel displays a rate of change of continuously monitored analyte levels in interstitial fluid, a second panel simultaneously displays a current analyte level and an analyte trend indicator, and a third panel displays status information of a plurality of components of the device. When an alarm condition is detected, the display renders the alert screen in place of the home screen, the alert screen displaying information corresponding to the detected alarm condition. Furthermore, the actuators are configured to affect further output of the analyte monitoring device corresponding to the detected condition.

Abstract: A compact, self-contained apparatus for blood glucose testing, which comprises a blood glucose meter (32), a lancet device (30), and an enclosure for test media with separate compartments for new and used disposable test media (28).

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: 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 medical device and a method for displaying medical data by the medical device are disclosed. In one aspect of the disclosure, a method for displaying medical data by a medical device having a display device and one or more processors is disclosed. The method includes monitoring a condition of the display device and determining, at the medical device, whether the display device is in a failure state based on the monitoring, the failure state being indicative of a malfunction of the display device. When the display device is a failure state, the method includes commanding a slave device to display the medical data and providing the medical data from the medical device to the slave device for display by the mobile device.

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: The object of the invention is a user interface for a device and a system for measuring and monitoring information which relates to diabetes care. The purpose of the invention is to facilitate and motivate a user to perform activities that are required in the care. In a preferred embodiment of the invention user specific information is stored in the measurement device with a user interface, such as a menu-based graphical user interface. The user may input performed activities through the user interface, and to store user's own figurative or sound data to be used by the user interface. The user interface may provide automatically suggestions for a user regarding the input.

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: 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: The object of the invention is a measurement device and a system for measuring and monitoring information which relates to diabetes care. The purpose of the invention is to motivate a user to perform activities that are required in the care. In a preferred embodiment of the invention a performance levels are determined and the level of a user is based on the activities and/or measurement results of the user. Upon increase in the user's level the user is awarded with e.g. new reminder figure in the device. The motivation of a user to follow care activities is thus increased.

Abstract: An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Abstract: A test meter for analyzing a body fluid sample applied to a test strip includes an outer housing having an opening, an actuator, and a cartridge positioned adjacent the outer housing. The cartridge further includes a dispensing member connected to the actuator, a plurality of stacked test strips biased toward the dispensing member, and a cartridge outer housing that is adjacent at least a portion of the dispensing member. Each time the actuator is actuated, the dispensing member is rotated to cause movement of one test strip from the plurality of stacked test strips through the opening, and another test strip is biased toward the dispensing member.

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

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: 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: A system and method described herein simplifies data entry by a subject of a structured blood glucose test as well as helps with dietary compliance by providing specific dietary suggestions to the user. The system includes a portable device configured to be possessed by the subject. The portable device has a location detection system configured to provide data indicative of the location of the subject. A food database provides to the portable device a list of food items that are limited based on foods available at the location, such as a restaurant. The portable device is configured to receive a selection from the list that is indicative of a food consumed by the subject. A blood glucose meter reads blood glucose readings from the subject. The food database is configured to store the blood glucose readings and information about the foods consumed by the subject. Compliance to a prescribed dietary regimen can be monitored by the user and/or a physician.

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: Method and system for providing continuous calibration of analyte sensors includes calibrating a first sensor, receiving data associated with detected analyte levels from the first sensor, and calibrating a second sensor based on a predetermined scaling factor and data associated with detected analyte levels from the first sensor, is disclosed.

Abstract: The invention describes a method of transferring application data (F1, F2) from a first device (Ds) to a second device (DT1, DT2), which method comprises exchanging, through the body of a user (2) touching a touch interface (210) of the first device (Ds), connection-related data (4) between the first device (Ds) and a memory device (1), which memory device (1) is conveyed on the person of the user (2). Application data (F1, F2) is transferred from the first device (Ds) to the memory device (1) over a connection, between the first device (Ds) and the memory device (1), established on the basis of the connection-related data (4), and stored in a memory (220) of the memory device (1).

Abstract: Systems and methods for continuous measurement of an analyte in a host are provided. The system generally includes a continuous analyte sensor configured to continuously measure a concentration of analyte in a host and a sensor electronics module physically connected to the continuous analyte sensor during sensor use, wherein the sensor electronics module is further configured to directly wirelessly communicate displayable sensor information to a plurality of different types of display devices.

Abstract: A system and method are provided whereby periodic measurements of autonomic reflex times of individuals are used as an early-warning indication that an undesirable physical condition, such as an undesirable blood-chemistry condition, may exist. This method correlates measurements of the reaction times of specific autonomic reflexes to more-definitive measurements for the medical condition being monitored for this early-warning assessment.

Abstract: A glucose meter module integrated into a holster device that can securely accommodate another device such as a portable server device or an insulin pump is described. The glucose measuring module and the health device communicate with each other by a short range wireless modality. In the case in which the accommodated device is a server, such as personal digital assistant or cell phone, the device stores data in a memory, displays data on a visual display, and can wirelessly transmit such data to other devices within a personal area network. In the case where the accommodated device is a cell phone, the phone can further transmit data to remote sites. In the case where the accommodated device is an insulin pump, wirelessly received data are stored in a memory, are available for visual display on the insulin pump, and can be incorporated into the electronic processes that regulate the performance of the pump.

Abstract: A closed-loop method for insulin infusion overnight uses a model predictive control algorithm (“MPC”). Used with the MPC is a glucose measurement error model which was derived from actual glucose sensor error data. That sensor error data included both a sensor artifacts component, including dropouts, and a persistent error component, including calibration error, all of which was obtained experimentally from living subjects. The MPC algorithm advised on insulin infusion every fifteen minutes. Sensor glucose input to the MPC was obtained by combining model-calculated, noise-free interstitial glucose with experimentally-derived transient and persistent sensor artifacts associated with the FreeStyle Navigator® Continuous Glucose Monitor System (“FSN”).

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: 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 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: 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: Method and system for providing basal profile modification in insulin therapy for use with infusion devices includes periodically monitoring the analyte levels of a patient for a predetermined period of time in order to determine, based on the monitored analyte levels, an appropriate modification factor to be incorporated into the underlying basal profile which was running at the time the periodic monitoring of the analyte levels were performed.

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.