Abstract: A portable insulin pump can utilize readings from a sensor incorporated into an infusion set used with the pump to deliver insulin to a patient to determine if the infusion set is or is likely to become dislodged from the patient. Readings from the sensor that are inconsistent with expected readings or a range of expected readings can indicate that the infusion set has become dislodged from the patient.

Abstract: A new biostable glucose permeable polymer has been developed which is useful, for example, in implantable glucose sensors. This biostable glucose permeable polymer has a number of advantageous characteristics and, for example, does not undergo hydrolytic cleavage and degradation, thereby providing a composition that facilitates long term sensor stability in vivo. The versatile characteristics of this polymer allow it to be used in a variety of contexts, for example to form the body of an implantable glucose sensor. The invention includes the polymer composition, sensor systems formed from this polymer composition, and methods for making and using such sensor systems.

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: This disclosure provides systems, methods and apparatus for processing, transmitting and displaying data received from an analyte sensor, such as a glucose sensor. The system may include a display device with at least one input device. In response to movement of or along the input device, the display device may change a glucose data output parameter and update an output of the display device using the changed output parameter.

Abstract: Methods, systems, and devices for short-range low-power wireless communication of analyte information are provided. In some implementations, short-range low-power wireless communication of analyte information may include receiving an electromagnetic wireless communication signal and harvesting energy from the electromagnetic wireless communication signal. In some implementations, short-range low-power wireless communication of analyte information may include enabling capabilities associated with an external sensor in response to detecting the external sensor. In some implementations, short-range low-power wireless communication of analyte information may include detecting an analyte sample; determining an analyte concentration associated with the detected analyte sample; and transmitting an indication of the analyte concentration to an external device.

Abstract: Low profile continuous analyte measurement systems and systems and methods for implantation within the skin of a patient are provided.

Abstract: Methods and systems for biochemical data analysis are provided. A dataset can be received and a selection of a compare field can be used for creation of sub-groups of data to run statistical analysis on. The sub-groups of the dataset can be created based on the selection of the compare field. Statistical information about each sub-group of data can be calculated and displayed on a user display. Other information can be provided for further dataset refinements. A user may supply a control group selection, and such a selection may then result in an indication on the display of which population represents the control group. A user may supply information for further dataset filtering. Such information may be used to filter data, prior to creating the sub-groups for statistical analysis.

Abstract: Embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have a membrane with low temperature sensitivity. The sensing layer is disposed on a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

Abstract: Disclosed herein are membrane structures for use in analyte sensors, where the membrane structures exhibit low temperature sensitivity.

Abstract: A composition which can be used as an organic water/oxygen barrier material, an OLED display device and manufacturing method thereof are disclosed. The composition includes: 15-25 wt % of parylene, 15-25 wt % of polyvinyl chloride, 5-15 wt % of acetone, 5-15 wt % of trichloroethylene, 10-20 wt % of polyvinyl acetate, 5-15 wt % of polyvinyl alcohol, 0-5 wt % of SiO2 nanoparticles, and 8-12 wt % of an organic solvent, wherein all weight percent values are based on the total weight of the composition. When a water/oxygen barrier layer fabricated by the composition is disposed between a luminescent layer of OLED and a light extraction layer, water vapor and oxygen gas can be prevented from entering the OLED luminescent layer, thereby prolonging the service life of the OLED luminescent layer.

Abstract: Method and apparatus for determining and outputting projected alarms or notifications associated with anticipated hyperglycemic or hypoglycemic conditions are provided. Systems and kits employing the devices described herein executing the one or more routines described are also provided.

Abstract: Disclosed herein are systems and methods for providing a compressible interconnect for allowing electrical communication between an electronics unit and an analyte sensor in an on-body analyte monitoring device. In other embodiments, systems and methods are provided for reducing the Z-height of an on-body analyte monitoring device by utilizing novel interconnects.

Abstract: Methods and apparatus including determining a rate of occurrence of a glycemic excursion event, determining a frequency of an alarm activation associated with the glycemic excursion event, determining an analyte level associated with the alarm activation, and setting an alarm parameter based on one or more of the determined rate of occurrence of the glycemic excursion event, the frequency of the alarm activation associated with the glycemic excursion event or the determined analyte level are provided.

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: Disclosed are a method and/or system for determining a suggested change in a recommended therapy for a patient based, at least in part, on sensor measurements, and generating an alert to an attendant in a hospital environment upon detection of the suggested change. In another embodiment, a method and/or system is directed to automatically determining a maximum interval to alert an attendant following receipt of a measurement at an operator interface. In yet another embodiment, a method and/or system is directed to blood-glucose sensor calibration.

Abstract: A monolithically integrated sensor assembly is for detecting molecules that are potentially contained in an analyte. The assembly includes: a substrate; at least one sensor electrode, which is located on or in the substrate and is coated with a sensor-active layer, on which electrochemically active particles are generated in the present of the molecules to be detected, the particles being detected via an electric sensor signal on the sensor electrode(s); at least one additional electrode that is located on or in the substrate; and an operating circuit that is integrated into the substrate for controlling the sensor electrode and the additional electrode(s).

Abstract: Methods, systems, and devices are provided for monitoring and displaying medical parameters for a patient. In one embodiment, a display screen can include information related to a physiological parameter being measured from a patient. The information can include a current value based on values of the physiological parameter gathered from the patient over a period of time. The display screen can indicate whether or not the current value is within a predetermined normal range for the physiological parameter and whether or not the current value is within a predetermined goal range for the physiological parameter. The goal range can be nested within the normal range. If the current value moves outside the normal range, an alarm can be triggered. A goal alarm can be triggered if the current value is within the normal range but falls outside the goal range.

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 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 including a sensor; a mounting unit for placement on the skin of a host; a sensor introducer coupled to the sensor and to the mounting unit, the sensor introducer configured to transcutaneously introduce a portion of the sensor through a skin of the host to a first position relative to the mounting unit, and a data processing unit configured to couple to the mounting unit, the data processing unit displacing the sensor to a second position relative to the mounting unit upon coupling to the mounting unit.

Abstract: A system and method are described herein for detecting a user's transition between sitting and standing postures. Transitions between sitting and standing states are reliably detected using an accelerometer attached to the user. By modeling error introduced by the accelerometer, and correcting for this error, transitions between sitting and standing states are reliably detected. A microprocessor coupled to the accelerometer converts the captured accelerometer data to approximate vertical acceleration. Vertical velocity, which includes accelerometer error, is determined from the approximate vertical acceleration. The vertical velocity is corrected, and the corrected vertical velocity used to determine vertical displacement. Transitions between sitting and standing states are determined from the vertical displacement.

Abstract: Methods and devices for determining sensing device usability, e.g., for self-monitoring and point of care devices. In one embodiment, the invention is to a method of determining device usability, comprising the steps of providing a device comprising a first electrical pad; a second electrical pad; and a humidity-responsive polymer layer contacting at least a portion of the first and second electrical pads; applying a potential across the first and second electrical pads; measuring an electrical property associated with the humidity-responsive polymer layer; and determining whether the measured electrical property associated with the humidity-responsive polymer layer has exceeded a humidity threshold level associated with the device usability.

Abstract: Provided is an analysis apparatus capable of acquiring a measurement result with high reliability that includes: a signal detection unit; a measuring unit; a first temperature detection unit; a second temperature detection unit; and a calculation unit.

Abstract: A system and method for reducing the number of hypoglycemic alarms presented to a user is presented. The system and methods include use of model based state estimation and variable-delayed threshold values to balance the risk of not presenting an alarm caused by an actual hypoglycemic state with the presentation of alarms caused by artifacts in the signals produced by a continuous glucose monitor.

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: 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: 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: A substrate etching system includes an etching control module, a filtering module, and an endpoint module. The etching control module selectively begins plasma etching of a substrate within an etching chamber. The filtering module, during the plasma etching of the substrate: receives a signal including endpoint information; decomposes the signal using empirical mode decomposition (EMD); and generates a filtered signal based on results of the EMD. The endpoint module indicates when an endpoint of the plasma etching of the substrate has been reached based on the filtered signal. The etching control module ends the plasma etching of the substrate in response to the indication that the endpoint of the plasma etching of the substrate has been reached.

Abstract: Method and apparatus for providing a retention mechanism to retain the sensor in pre-deployment position within the introducer when the sensor insertion mechanism is activated so as to facilitate the sensor insertion process is disclosed.

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: The disclosure provides a sensor including a sensor having an external surface and a cannula. The cannula comprises a substantially cylindrical wall encircling a lumen, at least one aperture and a distal end. The sensor is positioned within the lumen and the distal end of the cannula extends beyond the sensor. This configuration functions for example to stabilize chemical reactions associated with the sensor by creating a buffer zone between the sensor and the surrounding tissues at the site of implantation. In certain embodiments, the sensor can further comprise an accessory material in proximity to the external surface, wherein the accessory material modifies the biological response of a tissue that is in contact with the sensor. The sensor can also comprise anchors that keeps the sensor in contact with subcutaneous tissue of a subject upon insertion of the sensor into the body of the subject.

Abstract: Apparatus and methods are described, including a method that includes (i) identifying that it is desired to apply electrical stimulation to a pancreas of a subject, and (ii) in response to the identifying, placing an intravascular support structure within a blood vessel of the subject. The intravascular support structure has at least one electrode coupled thereto, the at least one electrode being configured to stimulate the pancreas of the subject by driving an electric current through tissue of the pancreas of the subject. Other applications are also described.

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 for processing, transmitting and displaying data received from an analyte sensor, such as a glucose sensor, are provided. In an embodiment, a method for transmitting data between a first communication device associated with an analyte sensor and a second communication device configured to provide user access to sensor-related information comprises: activating a transceiver of a first communication device associated with an analyte sensor at a first time; and establishing a two-way communication channel with the second communication device; wherein the activating comprises waking the transceiver from a low power sleep mode using a forced wakeup from the second communication device.

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: An implantable sensor array incorporates active electronic elements to greatly increase the number of sensors and their density that can be simultaneously recorded and activated. The sensors can be of various configurations and types, for example: optical, chemical, temperature, pressure or other sensors including effectors for applying signals to surrounding tissues. The sensors/effectors are arranged on a flexible and stretchable substrate with incorporated active components that allow the effective size, configuration, number and pattern of sensors/effectors to be dynamically changed, as needed, through a wired or wireless means of communication. Active processing allows many channels to be combined either through analog or digital means such that the number of wires exiting the array can be substantially reduced compared to the number of sensors/effectors on the array.

Abstract: Systems and methods for minimizing or eliminating transient non-glucose related signal noise due to non-glucose rate limiting phenomenon such as interfering species, ischemia, pH changes, temperatures changes, known or unknown sources of mechanical, electrical and/or biochemical noise, 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 processes some or the entire data stream continually or intermittently based at least in part on whether the signal artifact event has occurred.

Abstract: Methods and devices for determining sensing device usability, e.g., for self-monitoring and point of care devices. In one embodiment, the invention is to a method of determining device usability, comprising the steps of providing a device comprising a first electrical pad; a second electrical pad; and a humidity-responsive polymer layer contacting at least a portion of the first and second electrical pads; applying a potential across the first and second electrical pads; measuring an electrical property associated with the humidity-responsive polymer layer; and determining whether the measured electrical property associated with the humidity-responsive polymer layer has exceeded a humidity threshold level associated with the device usability.

Abstract: Method and apparatus for integrated sensor and data processing assembly is provided.

Abstract: Methods and apparatus for providing data processing and control for use in verifying the stability of sensor sensitivity of an analyte sensor.

Abstract: A sensor inserting device includes a device main body and a push handle for moving a detector of a sensor and an insertion needle, with the sensor held coupled to the insertion needle, into the body of a patient. A transmitter, for processing a signal from the sensor, is set in the device main body. A cable, allowing transmission of a signal between the sensor and the transmitter, is connected to the sensor (12) and the transmitter.

Abstract: Embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have a membrane with low temperature sensitivity. The sensing layer is disposed on a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

Abstract: A modular, multifunction dock system is disclosed. The dock system includes a dock housing with a dock receiver to interface with a data port for both a recorder and a transmitter. The dock system further includes a logic board that is contained within the dock housing. The logic board couples a memory and a processor to the dock receiver to enable dock functionality with both the recorder and the transmitter. Further included with the dock system is a coupling port to provide access through the dock housing to a socket coupled to the logic board and an input/output port to enable power and data transmission from the logic board to a data processor. The dock housing includes a mating arm that moves between a retracted and extended position. The mating arm fits within the coupling port and is terminated by a plug that couples with the socket.

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

Abstract: A transcutaneous sensor device configured for continuously measuring analyte concentrations in a host is provided. In some embodiments, the transcutaneous sensor device 100 comprises an in vivo portion 160 configured for insertion under the skin 180 of the host and an ex vivo portion 170 configured to remain above the surface of the skin 180 of the host after sensor insertion of the in vivo portion. The in vivo portion may comprise a tissue piercing element 110 configured for piercing the skin 180 of the host and a sensor body 120 comprising a material or support member 130 that provides sufficient column strength to allow the sensor body to be pushable in a host tissue without substantial buckling. The ex vivo portion 170 may be configured to comprise (or operably connect to) a sensor electronics unit and may comprise a mounting unit 150. Also described here are various configurations of the sensor body and the tissue piercing element that may be used to protect the membrane of the sensor body.

Abstract: Methods, systems, and devices for short-range low-power wireless communication of analyte information are provided. In some implementations, short-range low-power wireless communication of analyte information may include receiving an electromagnetic wireless communication signal and harvesting energy from the electromagnetic wireless communication signal. In some implementations, short-range low-power wireless communication of analyte information may include enabling capabilities associated with an external sensor in response to detecting the external sensor. In some implementations, short-range low-power wireless communication of analyte information may include detecting an analyte sample; determining an analyte concentration associated with the detected analyte sample; and transmitting an indication of the analyte concentration to an external device.

Abstract: In particular embodiments, methods, devices and systems including calibrating analyte data associated with a monitored analyte level received from an analyte sensor based on a reference measurement, determining a lag time constant associated with the calibrated analyte data, and performing lag correction of the calibrated analyte data based on the determined time lag constant are disclosed.

Abstract: Method and apparatus for determining and outputting projected alarms or notifications associated with anticipated hyperglycemic or hypoglycemic conditions are provided. Systems and kits employing the devices described herein executing the one or more routines described are also provided.

Abstract: An embodiment may be in the field of glycemic analysis and control. More specifically, an embodiment or approach may provide a novel method, system, and computer program for the visual and quantitative tracking of blood glucose variability in diabetes from self-monitoring blood glucose (SMBG) data and/or continuous glucose monitoring (CGM) data. More particularly, an embodiment or aspects thereof may use glucose measurements obtained from self-monitoring data and/or CGM data of an individual or a group of individuals to track and analyze blood glucose variability.

Abstract: A sensor utilizing a non-leachable or diffusible redox mediator is described. The sensor includes a sample chamber to hold a sample in electrolytic contact with a working electrode, and in at least some instances, the sensor also contains a non-leachable or a diffusible second electron transfer agent. The sensor and/or the methods used produce a sensor signal in response to the analyte that can be distinguished from a background signal caused by the mediator. The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is typically provided as a second electron transfer agent.

Abstract: Generally, methods, devices, and systems for generating a hybrid analyte level output are provided. The uncompensated analyte levels lag in time with respect to the lag-compensated analyte levels, and the hybrid analyte level output tracks between the uncompensated analyte levels and the lag-compensated analyte levels according to predetermined criteria.