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: A mobile analyte monitoring system may include an implantable sensor and a reader device with an optical sensor. The implantable sensor may be implanted into the dermis of an animal, and may exhibit a color change in response to the presence of a target analyte or reaction product thereof. The reader device may be configured to capture an image of the implanted sensor and to determine the concentration of the target analyte based at least in part on the image. One or more portions of the implantable sensor or components thereof may be configured to facilitate calibration of the sensor, correction of an optical signal obtained from the sensor by a reader device to accommodate variations in the surrounding tissues, and/or calculation of a representative value by a reader device. The reader device may be a personal electronic device such as a cell phone, PDA, or personal computer.

Abstract: A detection device for detecting a blood count parameter in a blood vessel, comprising a transmitter having a number of transmit antennas for transmitting at least one transmit signal, a receiver having a number of receive antennas for receiving at least one receive signal, a processor to select a detection configuration comprising one of the transmit antennas and one of the receive antennas and select a second detection configuration comprising one of the transmit antennas and one of the receive antennas, and a loss detector that is designed, when the first detection configuration is selected to transmit a transmit signal, to detect a first loss value on the basis of the transmit signal and a receive signal, and, when the second detection configuration is selected to transmit a transmit signal, detect a second loss value on the basis of the transmit signal and a receive signal. The processor is designed to select the detection configuration having the lower loss value to detect the blood count parameter.

Abstract: A device, method, and graphical user interface for displaying diabetes related information sets aligned by the occurrence of a particular event are disclosed. After receiving a request for an event-aligned display of diabetes related information based on an event, a search for a plurality of tagged occurrences of the event and retrieval of an information set for each of the plurality of tagged occurrences is provided. Each information set may include diabetes related information chronologically related to the tagged occurrence. The retrieved information sets is displayed on a display, wherein the retrieved information sets are shown on the display aligned by their tagged occurrences such that all diabetes related information is positioned relative the event based on its chronological relationship with the event.

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: 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: 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: The present invention describes an active overlay of real-time glucose and/or insulin information on a display for convenient monitoring and control of information for the management of diabetes. The superimposed images on display can be varied based on automated and/or programmable processes and/or alerts of the system. In various embodiments, the system can include a console and/or remote control to allow the user to control the overlay display. In specific embodiments, the system can communicate with a glucose sensor and/or insulin infusion device.

Abstract: An implantable physiologic sensor assembly is configured to be implanted within a patient. The assembly includes a module that houses an internal operative chamber, and a flexible pressure-detecting member connected to the module. The module and the pressure-detecting member are separated before implantation into the patient. At least a first end of the pressure-detecting member is configured to be inserted into an artery of the patient and a second end of the pressure-detecting member is connected to the module. The module is configured to be subcutaneously positioned within the patient.

Abstract: An armband comprising a detection device for detecting a blood count parameter in a blood vessel of the arm and an adjustment device for adjusting a predefined contact pressure of the armband on the arm.

Abstract: An infusion system includes a characteristic determining device and an infusion device. The characteristic determining device includes a receptacle for receiving and testing an analyte from the user to determine a concentration of the analyte in the user. The characteristic determining device also includes a communication system for transmitting a communication including data indicative of the determined concentration of the analyte in the user, and the infusion device includes a communication system for receiving the communication from the characteristic determining device. The infusion device further includes a bolus estimator for calculating an estimated amount of fluid to be infused into the body of the user based upon the received data indicative of the determined concentration of the analyte in the user and a target concentration of the analyte in the user, and an indicator to indicate when the estimated amount of fluid to be infused has been calculated.

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 system for providing a fault tolerant data receiver unit configured with a partitioned or separate processing units, each configured to perform a predetermined and/or specific processing associated with the one or more substantially non-overlapping functions of the data monitoring and management system is provided

Abstract: The present invention relates to a blood component detection unit, which comprises: a capsule body having a first surface; a needle array including a plurality of needles, each of the needles have an opening and an inner hollow space, and each of the needles protrudes out of the first surface; a detection chamber disposed inside the capsule body and connected with the inner hollow space; a sensing chip disposed inside the capsule body; and a plurality of sensing elements disposed on the sensing chip.

Abstract: In aspects of the present disclosure, an auto turn on blood glucose monitoring unit including a calibration unit integrated with one or more components of an analyte monitoring system is provided. Also disclosed are methods, systems, devices and kits for providing the same.

Abstract: A wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user. Said wearable monitoring apparatus comprises at least one transducer configured for delivering electromagnetic (EM) radiation to said internal tissue and intercepting a reflection of said EM radiation said reform in a plurality of transmission sessions during at least 24 hours, a processing unit configured for analyzing respective said reflection and identifying a change in said at least one biological parameter accordingly, a reporting unit configured for generating a report according to said change, and a housing for containing said at least one transducer, said reporting unit, and said processing unit, said housing being configured for being disposed on said body of said ambulatory user.

Abstract: Provided is a non-transitory machine readable medium on which is stored a computer program for non-invasive determination of glycogen stores including, the computer program including instructions which when executed by a computer system perform the steps of: receiving an ultrasound scan of a target muscle; and evaluating at least a portion of the ultrasound scan to determine glycogen store within the target muscle.

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: 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 medication delivery system for delivering medicament to a body of a user. The medication delivery system may include a housing having a plurality of medicament reservoirs therein, a first sensor configured to continuously monitor a parameter of the body, and a pump mechanism configured to pump medicament from each of the plurality of medicament reservoirs to a delivery mechanism having a portion disposed within the body of the user.

Abstract: An implant system and a method for controlling the natural and artificial microenvironments surrounding an implanted device using an artificial tissue system (ATS) and includes methods of diagnostic and testing related thereto. The ATS, among other things, induce better integration, function, and extended lifespan of the devices at the site of implantation. The ATS includes cells, such as naturally occurring, engineered, and/or artificial cells; matrices such as natural, engineered, artificial and/or hybrid matrices; tissue response modifiers (TRM); and/or cell response modifiers (CRM). The specific composition of the ATS is based on the nature of the tissue in which ATS-device combination is implanted and the nature of the implant device, as well as the required function and lifespan of the implanted device. Additionally, the ATS, as well as ATS-device combinations can be utilized in vitro to aid in the design of improved ATS, devices and ATS-device combinations for in vivo uses.

Abstract: Embodiments of the disclosure relate to medical devices and, in particular, to devices for delivery of basal and/or bolus doses of one or more medicaments to a patient. In one embodiment, a medical device for delivering a medicament to the body of a user may include a reservoir configured to contain the medicament, a delivery mechanism for channeling the medicament from the reservoir to the user, a pumping mechanism for pumping the medicament from the reservoir, through the delivery mechanism, and to the user, wherein the medical device may be configured to deliver a dose of the medicament to the user. The medical device may also include a sensor for monitoring a parameter of the body and a display of information to alert and keep the user informed.

Abstract: Disclosed herein are a blood glucose measurement module, a smart phone combinable with the blood glucose measurement module, and a blood glucose measurement method using the same. The blood glucose measurement module includes a body, a strip reception slit, and a plug. The body includes a blood glucose measurement unit for measuring a blood glucose level of blood absorbed into a test strip and a CPU for calculating and transmitting the results of the measurement of the blood glucose level. The strip reception slit is formed in a part of the body, and receives the test strip. The plug is formed on one end surface of the body, and is easily fitted into the socket of a smart phone.

Abstract: An apparatus and a method for measuring a property of a blood sample is shown. The apparatus comprises of a housing having an aperture; a shaft mounted inside the housing; a testing member rotatably mounted on the shaft; an actuating member coupled to the housing and configured to exert a force against the testing member; and a lancet for eliciting a blood sample fixedly coupled to and protruding substantially radially from the testing member and configured to co-rotate with the testing member. The apparatus is further configured such that the lancet is aligned with the aperture in the housing when the testing member is in a first position. The testing member is configured, in the presence of a force exerted against the testing member by the actuator member, to translate to a second position in which the lancet is in a skin penetrating position.

Abstract: Apparatus for detecting hypoglycemia or impending hypoglycemia by analysis of an EEG comprises at least one EEG measuring electrode (10) for gathering an EEG signal and a computer (12) for receiving said EEG signals programmed to obtain a plurality of signal components each comprising a different band of frequencies, obtain a measure of the varying intensity of each said component, obtain a long time estimate of the mean of each intensity measure, obtain a long time estimate of the variability of each intensity measure, normalise each intensity measure e.g.

Abstract: Systems and methods of use involving sensors having a particle-containing domain are provided for continuous analyte measurement in a host. In some embodiments, a continuous analyte measurement system is configured to be wholly, transcutaneously, intravascularly or extracorporeally implanted.

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: 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: The present embodiments relate generally to systems and methods for measuring an analyte in a host. More particularly, the present embodiments provide sensor applicators and methods of use with pushbutton activation that implant the sensor, withdraw the insertion needle, engage the transmitter with the housing, and disengage the applicator from the housing, all in one smooth motion. Some embodiments contemplate engagement of the transmitter with the housing after release of the applicator.

Abstract: Embodiments of the present invention relate to analyte sensors comprising a heparin coating, and methods of coating analyte sensors. The heparin can be stably associated with at least a portion of a porous membrane that covers a portion of the analyte sensors. The heparin can be photochemically linked to the coating through the formation of covalent bonds.

Abstract: To provide a fluorescent hydrogel having superior detectability of saccharides such as glucose and minimal invasiveness, a method for producing the same, and a sensor for measuring saccharides using the same. A florescent hydrogel having a structure represented by the following chemical formula 1, a method for producing the same, and a sensor for measuring saccharides using the same.

Abstract: Apparatus for eliciting a blood sample comprises: a member rotatably mounted on a shaft and configured to rotate between a first position and a second position; and a curved lancet protruding from the member and configured to co-rotate with the member such as to provide skin penetration by the lancet when the member is in the second position. At least 1 mm of the end portion of the curved lancet is coincident with a line that is concentric with respect to the shaft.

Abstract: The present embodiments relate generally to systems and methods for measuring an analyte in a host. More particularly, the present embodiments provide sensor applicators and methods of use with pushbutton activation that implant the sensor, withdraw the insertion needle, engage the transmitter with the housing, and disengage the applicator from the housing, all in one smooth motion. Some embodiments contemplate engagement of the transmitter with the housing after release of the applicator.

Abstract: The present embodiments relate generally to systems and methods for measuring an analyte in a host. More particularly, the present embodiments provide sensor applicators and methods of use with pushbutton activation that implant the sensor, withdraw the insertion needle, engage the transmitter with the housing, and disengage the applicator from the housing, all in one smooth motion. Some embodiments contemplate engagement of the transmitter with the housing after release of the applicator.

Abstract: Lancet device including a skin engaging end that includes a lancet opening through which a lancet needle may extend, a movably mounted holding member configured to receive a lancet, and a combined triggering and cocking system structured and arranged to move the holding member to a retracted position during a cocking phase and to cause the holding member to move to an extended position during a triggering phase. A method of puncturing a surface of skin using the lancet device includes disposing the skin engaging end against a user's skin and manually activating the combined triggering and cocking system. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

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

Abstract: A monitor system is disclosed. The monitor system includes a sensor with a sensor port. The monitor system further includes a recorder with a recorder port within a recording housing. The recorder port interfaces with the sensor port to receive signals from the sensor port. A recorder clock is defined within the recorder housing, with a recorder processor to store signals from the sensor. The recorder includes a data port to interface with a dock receiver. The monitor system includes a dock remotely located from the sensor and the recorder. The dock receiver couples the recorder to the dock. The monitor system further includes a data processor to analyze the sensor signals from the recorder. The data processor includes memory and a clock. Further included with the data processor are program instructions to assign the time and date of the sensor signals.

Abstract: A urine shield comprises an elongate base and side walls connected to the base. At least one of the sides and base is absorbent. The shield further comprises at least one attachment tab for releasably attaching the shield to a user's skin The shield has an hourglass shaped cross-section. A method and device for the collection of a urine sample from an individual is also provided.

Abstract: An apparatus and method for easily and accurately measuring a biological signal by using a wristwatch-type measurement module. After a band of the wristwatch-type measurement module is tightened to wear on a user's wrist, the band is further tightened to make the wristwatch-type measurement module closely contact the user's wrist. An operation mode of the wristwatch-type measurement module closely contacting the user's wrist is switched from a normal mode to a measurement mode, and a user's biological signal is measured from the user's wrist through the wristwatch-type measurement module in the measurement mode. The user's biological signal is then displayed through the wristwatch-type measurement module.

Abstract: A measuring apparatus (10) for measuring the condition of a measurement subject includes: a recording unit (11) configured to record a plurality of behaviors that can be set in the measuring apparatus (10), and pieces of identification information that are associated with the plurality of behaviors; an output unit (13) configured to output the behaviors; and a setting unit (12) configured to specify a piece of identification information that is correlated with a measurement result in accordance with external input, and to set the specified piece of identification information and a behavior associated therewith, as identification information and a behavior that are to be used.

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 system and method for automatically adjusting parameters for predicting blood glucose levels and/or controlling the dispensing of insulin. In one embodiment, the system is a stand-alone system. In one embodiment, the system is part of a system for controlling the dispensing of insulin.

Abstract: Devices and methods for inserting at least a portion of a medical device in a patient are provided. Embodiments include medical device insertions that employ a plurality of insertion stages. Also provided are systems and kits for use in analyte monitoring.

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: Implantable self-calibrating biosensor Subcutaneously or intracorporeally implantable biosensor, characterized by a closed microfluidic circuit with calibrating fluids, which communicates by a backward micro-dialysis logic with the exterior of said circuit, an open and in contact with the tissues and the interstitial fluid working electrode, for its self-calibration. One or more working electrodes may be positioned inside openable boxes from EAP, and be opened for the duration of the measurement and closed immediately after, succeeding one another in the measurement, as their sensitivity is diminished.