Abstract: Method and apparatus for performing a discrete glucose testing and bolus dosage determination including a glucose meter with bolus calculation function are provided.

Abstract: Embodiments of methods of querying a diabetic patient regarding compliance with adherence criteria comprises instructing the diabetic patient to collect at least one sample in a sampling set of biomarker data, wherein each sampling set comprises a sufficient plurality of samples recorded over a collection period, comparing the collected samples to an acceptable range, wherein the acceptable range encompasses biomarker values that would be expected upon compliance with the adherence criteria, and informing the diabetic patient if at least one sample is an unacceptable value which falls outside of the acceptable range, and performing at least one additional task after detecting the unacceptable value.

Abstract: The invention relates to a sensor device for in vivo monitoring of glucose in diabetics, wherein the sensor device comprises a micro-array with multiple sensors to be implanted subcutaneously in a patient wherein each sensor may be activated separately for monitoring purposes. Preferably, the sensors in said micro-array are comprised in a mold that is covered by a metal membrane, and even more preferably, the membrane is electrically openable to expose each specific activated sensor in the micro-array separately for monitoring purposes. A transceiver may be provided for monitoring signals obtained by each specific activated sensor to an external receiver and the receiver may be connected to a display means for displaying data representative of the signals obtained by the specific activated sensor.

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 invention relates to a method for calibrating an analyte-measurement device that is used to evaluate a concentration of analyte in bodily fluid at or from a measurement site in a body. The method involves measuring a concentration, or calibration concentration, of an analyte in blood from an “off-finger” calibration site, and calibrating the analyte-measurement device based on that calibration concentration. The invention also relates to a device, system, or kit for measuring a concentration of an analyte in a body, which employs a calibration device for adjusting analyte concentration measured in bodily fluid based on an analyte concentration measured in blood from an “off-finger” calibration site.

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 body fluid testing device has at least one penetrating member and a penetrating member driver configured to be coupled to the at least one penetrating member. A plurality of analyte sensors are coupled to a spoked disk substrate. Each of a penetrating member can pass between spokes of the disk substrate to provide that a used penetrating member can be removed and a new penetrating inserted without removing the disk. A disposable houses the at least one penetrating member and the plurality of analyte sensors.

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 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: This invention relates to a monitoring and/or stabilizing glucose level in the blood stream in a human body signaling the person in the event glucose is at a dangerous level, said method comprising the following steps: (A) implanting a device in the human body wherein a tube from said device is inserted into a blood vessel and in the blood stream of a person; (B) continuously monitoring said glucose level in the blood stream with said implanted device, at a set frequency of time; (C) signaling said person in the event the glucose level drops below a specific level; (D) optionally injecting, at least once, a specified dose of glucagon from a glucagon reservoir, into the subcutaneous tissue of said person; (E) alerting medical providers when the glucose level remains below said specific level for at least two consecutive measurements of said glucose level in the blood stream; provided said signal is not manually silenced by the person.

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

Abstract: Method and apparatus for optimizing analyte sensor calibration including receiving a current blood glucose measurement, retrieving a time information for an upcoming scheduled calibration event for calibrating an analyte sensor, determining temporal proximity between the current blood glucose measurement and the retrieved time information for the upcoming calibration event, initiating a calibration routine to calibrate the analyte sensor when the determined temporal proximity is within a predetermined time period, and overriding the upcoming scheduled calibration event using the current blood glucose measurement are provided.

Abstract: In vitro electrochemical sensor that provide accurate and repeatable analysis of a sample of biological fluid are provided. In some embodiments, the sensors have a measurement zone that has a volume less than the volume of the sample chamber. The measurement zone could have a volume of no more than about 0.2 ?L.

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: In order to increase the accuracy of non-invasive glucose measurement, the device uses a combination of three non-invasive methods: ultrasonic, electromagnetic and thermal. The non-invasive glucose monitor comprises a Main Unit, which drives three different sensor channels (one per technology), located on an external unit configured as an ear clip attached to the subject's ear lobe. To effect the ultrasonic channel, ultrasonic piezo elements are positioned on opposing portions of the ear clip and thus opposite sides of the ear lobe. For implementation of the electromagnetic channel, capacitor plates are positioned on opposing portions of the ear clip and the ear lobe serves as the dielectric. The thermal channel includes a heater and a sensor positioned on the ear clip in close juxtaposition to the ear lobe.

Abstract: A medical workstation is defined by a supporting structure having at least one medical diagnostic instrument disposed thereupon. A first display is further disposed on a first side of the supporting structure and a second display is disposed on a second side of the supporting structure in a manner substantially opposite from the first display. Each of the first and second displays are interconnected to the at least one medical diagnostic instrument to permit at least one of the displays in order to display diagnostic results and are tandemly or independently controllable.

Abstract: Systems and methods for minimizing or eliminating transient non-glucose related signal noise due to non-glucose rate limiting phenomenon such as ischemia, pH changes, temperatures changes, and the like. The system monitors a data stream from a glucose sensor and detects signal artifacts that have higher amplitude than electronic or diffusion-related system noise. The system replaces some or the entire data stream continually or intermittently including signal estimation methods that particularly address transient signal artifacts. The system is also capable of detecting the severity of the signal artifacts and selectively applying one or more signal estimation algorithm factors responsive to the severity of the signal artifacts, which includes selectively applying distinct sets of parameters to a signal estimation algorithm or selectively applying distinct signal estimation algorithms.

Abstract: Systems and methods for non-vascular sensor implantation and for measuring physiological parameters in areas of a body where the physiological parameters are heterogeneous. An implant unit is implanted in an area of a body and a foreign body capsule is allowed to form around the implant unit area. A sensor may be directed into a body cavity such as, for example, the peritoneal space, subcutaneous tissues, the foreign body capsule, or other area. A subcutaneous area of the body may be tunneled for sensor placement. Spatially separated sensing elements may be used for detecting individual amounts of the physiological parameter. An overall amount of the physiological parameter may be determined by calculating a statistical measurement of the individual sensed amounts in the area. Another embodiment of the invention, a multi-analyte measuring device, may include a substrate having an electrode array on one side and an integrated circuit on another side.

Abstract: Method and system for providing diabetes management and insulin therapy based on substantially real time glucose monitoring system is provided.

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: Systems and methods for dynamically and intelligently estimating analyte data from a continuous analyte sensor, including receiving a data stream, selecting one of a plurality of algorithms, and employing the selected algorithm to estimate analyte values. Additional data processing includes evaluating the selected estimative algorithms, analyzing a variation of the estimated analyte values based on statistical, clinical, or physiological parameters, comparing the estimated analyte values with corresponding measure analyte values, and providing output to a user. Estimation can be used to compensate for time lag, match sensor data with corresponding reference data, warn of upcoming clinical risk, replace erroneous sensor data signals, and provide more timely analyte information encourage proactive behavior and preempt clinical risk.

Abstract: Systems and methods for processing sensor data are provided. In some embodiments, systems and methods are provided for calibration of a continuous analyte sensor. In some embodiments, systems and methods are provided for classification of a level of noise on a sensor signal. In some embodiments, systems and methods are provided for determining a rate of change for analyte concentration based on a continuous sensor signal. In some embodiments, systems and methods for alerting or alarming a patient based on prediction of glucose concentration 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: 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: 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: Provided are a measurement device, a sensor unit, and a sensor placement method, which enable the suppression of the occurrence of a situation where a measurement carried out with a sensor implanted under the skin, the implanted sensor becomes faulty. A sensor unit is used for measuring numerical information relating to a substance contained in a body fluid in a body. The sensor unit is provided with a sensor a part of which is placed under the skin and generates a signal according to the state of the substance, a base which is disposed on the skin and holds the sensor, a variable mechanism which is attached to the base and enables the position and/or the direction of the sensor with reference to the base to be varied, and an external terminal which is provided in the base and leads the signal generated by the sensor to the outside.

Abstract: Systems and methods for processing sensor data are provided. In some embodiments, systems and methods are provided for calibration of a continuous analyte sensor. In some embodiments, systems and methods are provided for classification of a level of noise on a sensor signal. In some embodiments, systems and methods are provided for determining a rate of change for analyte concentration based on a continuous sensor signal. In some embodiments, systems and methods for alerting or alarming a patient based on prediction of glucose concentration are provided.

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 second numerical value 246 is shown, which is representative of a variation of the measured analyte value 242. The second numerical value is preferably determined from a variation analysis based on statistical, clinical, or physiological parameters, such as described in more detail elsewhere herein. In one embodiment, the second numerical value 246 is determined based on clinical risk (for example, weighted for the greatest possible clinical risk to a patient). In another embodiment, the second numerical representation 246 is an estimated analyte value extrapolated to compensate for a time lag, such as described in more detail elsewhere herein. In some alternative embodiments, the receiver displays a range of numerical analyte values that best represents the host's estimated analyte value (for example, +/?10%). In some embodiments, the range is weighted based on clinical risk to the patient.

Abstract: A system is provided for monitoring glucose in a host, including a continuous glucose sensor that produces a data stream indicative of a host's glucose concentration and an integrated receiver that receives the data stream from the continuous glucose sensor and calibrates the data stream using a single point glucose monitor that is integral with the integrated receiver. The integrated receiver obtains a glucose value from the single point glucose monitor, calibrates the sensor data stream received from the continuous glucose sensor, and displays one or both of the single point glucose measurement values and the calibrated continuous glucose sensor values on the user interface.

Abstract: One aspect of the invention provides a glucose monitor having a plurality of tissue piercing elements, each tissue piercing element having a distal opening, a proximal opening and interior space extending between the distal and proximal openings; a sensing area in fluid communication with the proximal openings of the tissue piercing elements; sensing fluid extending from the sensing area into substantially the entire interior space of the tissue piercing elements; and a glucose sensor adapted to detect a concentration of glucose in the sensing fluid within the sensing area.

Abstract: Systems and methods for processing sensor data are provided. In some embodiments, systems and methods are provided for calibration of a continuous analyte sensor. In some embodiments, systems and methods are provided for classification of a level of noise on a sensor signal. In some embodiments, systems and methods are provided for determining a rate of change for analyte concentration based on a continuous sensor signal. In some embodiments, systems and methods for alerting or alarming a patient based on prediction of glucose concentration are provided.

Abstract: A body fluid sampling system for use on a tissue site includes a drive force generator and one or more microneedles operatively coupled to the drive force generator. Each of a microneedle has a height of 500 to 2000 ?m and a variable tapering angle of 60 to 90°. A sample chamber is coupled to the one or more microneedles. A body fluid is created when the one or more microneedles pierces a tissue site flows to the sample chamber for glucose detection and analysis.

Abstract: A physiological measuring system is disclosed that monitors certain physiological parameters of an individual through the use of a body-mounted sensing apparatus. The apparatus is particularly adapted for continuous wear. The system is also adaptable or applicable to calculating derivations of such parameters. A oxygen debt measuring embodiment is directed predicting an outcome in response to injury and illness. The technique allows for closed-loop resuscitation, early identification of illness and early corrective action.

Abstract: A method and data processing device for automatically generating a user-specific measuring data recording routine for discontinuous blood glucose measurement with a blood glucose measuring device in a data processing device. The method comprises the steps of providing of process data indicating an expected continuous course of the blood glucose value of a user, in the calculation unit based on blood glucose measuring values from continuous blood glucose measurement, generating of user-specific measuring routine data, which indicate a measuring routine with user-specific measuring events for discontinuous blood glucose measurement with a blood glucose meter taking into account the process data by means of the calculation unit, and providing of the user-specific measuring routine data to the data output interface for data transmission.

Abstract: Analyte monitoring systems, devices, and methods associated with analyte monitoring devices, and devices incorporating the same are provided. Various graphical user interfaces (GUI) and navigation flows are provided for performing various features, activities, functions, etc., associated with the analyte monitoring device or system. Intuitive navigation is provided to enhance the interpretation of analyte measurements.

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: 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: 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 medical device system is disclosed. The medical device system includes a first medical device and a second medical device. A remote interface including a touch screen is also included. The remote interface is in wireless communication with the first medical device and the second medical device. The remote interface is configured to provide a user interface to the first medical device and the second medical device. The remote interface is configured to receive user input through a touch screen. Also, a charging device is included. The charging device is configured to receive at least the first medical device and the remote interface and the charging device is configured to recharge a first medical device battery and the charging device is configured to recharge an interface battery in the remote interface. The charging device is connected to a personal computer wherein the personal computer provides information to the remote interface.

Abstract: Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, and optionally a single point glucose monitor are provided. Manual integrations provide for a physical association between the devices wherein a user (for example, patient or doctor) manually selects the amount, type, and/or time of delivery. Semi-automated integration of the devices includes integrations wherein an operable connection between the integrated components aids the user (for example, patient or doctor) in selecting, inputting, calculating, or validating the amount, type, or time of medicament delivery of glucose values, for example, by transmitting data to another component and thereby reducing the amount of user input required. Automated integration between the devices includes integrations wherein an operable connection between the integrated components provides for full control of the system without required user interaction.

Abstract: An implantable device with in vivo functionality, where the functionality of the device is negatively affected by ROS typically associated with inflammation reaction as well as chronic foreign body response as a result of tissue injury, is at least partially surrounded by a protective material, structure, and/or a coating that prevents damage to the device from any inflammation reactions. The protective material, structure, and/or coating is a biocompatible metal, preferably silver, platinum, palladium, gold, manganese, or alloys or oxides thereof that decomposes reactive oxygen species (ROS), such as hydrogen peroxide, and prevents ROS from oxidizing molecules on the surface of or within the device. The protective material, structure, and/or coating thereby prevents ROS from degrading the in vivo functionality of the implantable device.

Abstract: An insulin injection pen and blood glucose monitoring device is integrated into a single unit that fits in a user's clothing pocket or handbag. The device includes a blood glucose monitoring system for detecting the user's blood glucose level, an insulin injection mechanism, and a microprocessor that calculates an insulin dosage appropriate to the detected blood glucose level of a particular user and sets the insulin injection mechanism to administer the calculated insulin dosage. The device automatically informs a remote emergency service provider if the microprocessor determines that the detected blood glucose level presents a potential danger to the user. The microprocessor also calculates treatment regimens based on the detected blood glucose level and displays the treatment regimens on an LCD display. The device can include a GPS receiver that detects the location of the device, which is transmitted by the device to the remote emergency service.

Abstract: An apparatus comprising a pump, an input configured to receive information related to a user, a user interface, and a controller communicatively coupled to the pump, the input, and the user interface. The controller includes a timing module configured to initiate delivery of a drug in time and to adjust delivery according to the received information. Other devices, systems, and methods are disclosed.

Abstract: A test strip is provided with sample capture that provides for a one step process to achieve a lancing event, sample capture and sample transport in a sensor design that supports one step testing. In various embodiments, the present invention provides for one step testing by, (i) analyte sample capture layout; (ii) analyte sample capture and transport configurations; (iii) structures of sample capture; (iv) processes for forming sample transport, and the like.

Abstract: A blood glucose monitoring kit includes a case constructed in the form of a bi-fold wallet which comprises an upper flap and a lower flap that are connected together through a fold. The case includes an outer layer constructed out of a water resistant and soft fabric and an inner layer constructed out of a water resistant material, the outer and inner layers being sewn together about their peripheries. A layer of cushioned material is preferably disposed between the inner and outer layers to provide the case with a soft feel. Blood glucose monitoring electronics are preferably integrated directly into the upper flap of the case, the electronics including a printed circuit board (PCB), a test port mounted on the PCB and a display mounted on the PCB. Preferably, the upper flap is provided with an opening through which the test port is externally accessible. Additionally, the upper flap is provided with a window through which the display is externally visible.

Abstract: A transdermal test sensor assembly adapted to determine an analyte concentration of a fluid sample is disclosed. The assembly comprises a sensor support including at least one reservoir adapted to hold a liquid. The assembly further comprises a test sensor being coupled to the sensor support. The test sensor forms at least one aperture therein. At least a portion of the at least one aperture is adjacent to the at least one reservoir. The assembly further comprises a hydrogel composition positioned on the test sensor. The hydrogel composition is linked to the at least one reservoir via the at least one aperture.

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 system and method for initiating and maintaining a secure wireless communication between a wireless analyzer and a target network (e.g., a hospital network connected to a LIS and/or HIS). The present disclosure provides novel processes and systems for securely networking a wireless analyzer with a Wi-Fi network without the need for an operator or user to engage in manual initiation steps on, or through, the wireless analyzer.