Abstract: Methods, devices and systems for receiving an instruction to determine a glycemic variation level, retrieving a stored metric for determining the glycemic variation level, retrieving one or more parameters associated with the retrieved metric analysis, determining the glycemic variation level based on the retrieved one or more parameters for the retrieved metric analysis, and outputting the determined glycemic variation level when it is determined that the retrieved one or more parameters associated with the retrieved metric analysis meets a predetermined condition are disclosed.

Abstract: The present invention relates to an active transdermal analyte detection system performing extraction and detection of body analytes comprising of a patch accepting at least one electrical input; a plurality of transducers configured for converting input electrical energy to different forms of energies for activating extraction procedure; a controller configured for providing the control signals, intensity, sequence, nature, and timing information for the different energies supplied to the said patch vide said transducers; and at least one layer/compartment configured for either collection of extracted fluids and/or delivering at least one reagent formulation that detects the body analyte on activation and a method for performing transdermal extraction and detection of body fluids using said electronic patch.

Abstract: The measuring device of the invention includes: a first container and a second container for holding a sample; and an optical measurement part for carrying out an optical measurement. The first container has a first sample supply inlet for supplying a sample containing an analyte to the first container and at least one electrode. The second container has a second sample supply inlet for supplying the sample to the second container and a reagent holding part for holding a reagent for the optical measurement.

Abstract: Integrated lancing and analyte measurement systems are provided which minimize the number of actions required to operate the systems, accomplished in part by combining two or more user steps into one.

Abstract: The present invention is directed to membranes composed liquid crystals having continuous aqueous channels, such as a lyotropic liquid crystal, including a cubic phase lyotropic liquid crystal, and to electrochemical sensors equipped with such membranes. The membranes are useful in limiting the diffusion of an analyte to a working electrode in an electrochemical sensor so that the sensor does not saturate and/or remains linearly responsive over a large range of analyte concentrations. Electrochemical sensors equipped with membranes of the present invention demonstrate considerable sensitivity and stability, and a large signal-to-noise ratio, in a variety of conditions.

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 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: Aspects of the present disclosure include methods for determining the presence and/or concentration of an analyte. In practicing methods according to certain embodiments, an analyte sensing unit is positioned at a location on the abdomen of a that experiences involuntary movement sufficient to provide for mixing of non-circulating interstitial fluid with circulating interstitial fluid and determining an analyte concentration in the interstitial fluid. Also provided are methods for positioning an analyte sensing unit at a location on the abdomen of a subject, and methods of determining an analyte concentration while the subject is asleep, e.g., during a rapid eye movement (REM) sleep period. Devices and systems for practicing the subject methods also described.

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 glucose monitoring system, includes a glucose sensor strip or package of strips. The strip includes a substrate and a glucose monitoring circuit that has electrodes and a bodily fluid application portion of selected chemical composition. An antenna is integrated with the glucose sensor strip. An RFID sensor chip is coupled with the glucose sensor strip and the antenna. The chip has a memory containing digitally-encoded data representing calibration and/or expiration date information for the strip.

Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the devices include a membrane that has an interference domain designed to reduce the permeation of one or more interferents.

Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the devices include a membrane that has an interference domain designed to reduce the permeation of one or more interferents.

Abstract: The present application provides Ag/AgCl based reference electrodes having an extended lifetime that are suitable for use in long term amperometric sensors. Electrochemical sensors equipped with reference electrodes described herein demonstrate considerable stability and extended lifetime in a variety of conditions.

Abstract: Disclosed herein are systems and methods for calibrating a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes one or more electrodes to measure an additional analyte. Such measurements may provide a baseline or sensitivity measurement for use in calibrating the sensor. Furthermore, baseline and/or sensitivity measurements may be used to trigger events such as digital filtering of data or suspending display of data.

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 apparatus for providing calibration of analyte sensor including applying a control signal, detecting a measured response to the control signal, determining a variance in the detected measured response, and estimating a sensor sensitivity based on the variance in the detected measured response is provided.

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

Abstract: 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 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: 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: 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 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: Body fluid sampling device comprising a sampling element having a fluid pathway (11) for receiving body fluid, at least a portion of the fluid pathway is open to the environment and further comprising a fluid receiving means (40) being spaced from the fluid pathway so that fluid in the pathway will not contact the fluid receiving means initially. The fluid receiving means has two or more test zones (45) for performing analytical reactions. Fluid from the channel is contacted with the fluid receiving means either by bringing the fluid receiving means and the fluid into mechanical contact or by electrically transporting fluid from the channel onto the fluid receiving means.

Abstract: The invention relates to a sensor (2) including: a microelectrode assembly (21); and ?-pancreatic cells (23) or islets (230) of Langerhans in culture on the microelectrode assembly (21); characterized in that the microelectrode assembly (21) is designed to measure dynamically, continuously and in real time, electrical signals (V) produced by the ?-pancreatic cells (23) or the islets of Langerhans (230) upon physiological activation. The invention also relates to the field of devices that can be implantable in the body of a patient, and including an insulin dispenser for dispensing an amount of insulin. The invention also relates to a method for manufacturing such a sensor and to such a device and a use of such a sensor.

Abstract: A biodevice is in an elongated form and has a conductive layer and an insulating layer stacked on a side surface of a shaft member at the center. A cylindrical hollow section is formed through the device, being connected to the exterior at a front end and extending from this front end axially. An electrode section is formed on an inner surface. A sensing substance such as enzyme may be placed at the electrode section to detect a current value corresponding to the concentration or quantity of an object under test placed between a counter electrode and the biodevice.

Abstract: A plug capable of providing information relating to a physical or chemical property of a body fluid, or the presence or amount of a molecular component therein in a living organism is disclosed. Specifically, one embodiment plug is capable of being inserted into a portion of a human eyelid in order to provide information relating to tear fluid is disclosed. This embodiment plug includes a body having a passage which allows for the natural flow of tear fluid therethrough. In addition, a sensing mechanism is provided which is capable of measuring, for example, glucose levels in the body of a patient through the analysis of the tear fluid. Such plug may further be designed so as to double as a punctal plug useful in preventing dry eye. Methods of utilizing and implanting such plugs are also disclosed.

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

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

Abstract: A system and method for transdermal sampling wherein at least one pair of sample electrodes is adapted to provide voltage pulses capable of creating capillary openings in a subject's stratum corneum. Methods for using a transdermal sampling system by creating capillary openings in a subject's stratum corneum via the application of a series of voltage pulses to the stratum corneum and contacting at least a portion of at least one of the sample electrodes with interstitial fluid from the capillary openings are also presented.

Abstract: Systems and methods of use involving sensors having a signal-to-noise ratio that is substantially unaffected by non-constant noise 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: 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 glucose monitoring system, includes a glucose sensor strip or package of strips. The strip includes a substrate and a glucose monitoring circuit that has electrodes and a bodily fluid application portion of selected chemical composition. An antenna is integrated with the glucose sensor strip. An RFID sensor chip is coupled with the glucose sensor strip and the antenna. The chip has a memory containing digitally-encoded data representing calibration and/or expiration date information for the strip.

Abstract: Generally, embodiments of the invention relate to analyte determining devices (e.g., electrochemical analyte monitoring systems) that include an indicator element that provides information relating to service history of the analyte determining devices, including, for example, previous use of the analyte determining devices. Also provided are systems and methods of using the, for example electrochemical, analyte determining devices in analyte monitoring.

Abstract: A method and system for monitoring and/or controlling a glycemic state of a subject, comprising a housing device having one or more chambers, extendable and retractable sensors, extendable and retractable catheters, insulin reservoir, neuroprotective agent reservoir, release mechanism for releasing insulin and neuroprotective agent into the subject, and a control mechanism with a processor for receiving and analyzing outputs from the sensors and for controlling the release mechanism, a clock mechanism for providing logging and/or circadian information to the processor.

Abstract: The invention provides methods and apparatus for detecting an analyte in blood. The apparatus is particularly suited for bringing a sensor into direct contact with blood in vivo. The apparatus comprises a sensor that detects the presence of an analyte and an assembly means. The assembly means has a sensor end, wherein the sensor end of the assembly means is affixed to the sensor, and the assembly means is adapted for coupling with a venous flow device. By coupling with a venous flow device, the assembly means brings the sensor into direct contact with blood flowing through the venous flow device. Examples of venous flow devices that bring the sensor into direct contact with the blood of a subject include, but are not limited to, intravenous catheters and external blood loops, such as are used in extra corporeal membrane oxygenation or hemodialysis.

Abstract: Methods and devices to detect analyte in body fluid are provided. Embodiments include positioning an analyte sensor in fluid contact with an analyte, detecting an attenuation in a signal from an analyte sensor after positioning during a predetermined time period, categorizing the detected attenuation in the analyte sensor signal based, at least in part, on one or more characteristics of the signal, performing signal processing to generate a reportable data associated with the detected analyte sensor signal during the predetermined time period, managing if and when to request additional reference signal measurements, and managing if and when to temporarily not display results.

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 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: In aspects of the present disclosure, a multi compatible or universal blood glucose monitoring unit including a calibration unit is integrated with one or more components of an analyte monitoring system to provide compatibility with in vitro test strip that require calibration code and test strips that do not require calibration code. Also disclosed are methods, systems, devices and kits for providing the same.

Abstract: An analyte sensor including an antiglycolytic agent or a precursor thereof and a chelating agent that stabilizes the antiglycolytic agent positioned proximate to the working electrode of the sensor. Also provided are systems and methods of using the electrochemical analyte sensors in analyte monitoring.

Abstract: An analyte testing device housing a lancet cartridge and a test strip cartridge is described. The testing device simplifies analyte testing/monitoring by providing an actuator and linkage mechanism that: (i) cocks a lancing device, (ii) exposes a test strip for use; and (iii) advances the lancet cartridge. The testing device also includes conversion electronics, which receives a signal from a test trip and converts the signal into readable data.

Abstract: An implantable medical device (IMD) includes an electrode that forms a first snap-fit attachment area and an insulator that forms a through-hole, a second snap-fit attachment area and a third snap-fit attachment area. The second snap-fit attachment area mates with the first snap-fit attachment area of the electrode. The IMD further includes a body including an elongated conductive housing and a feedthrough wire extending therefrom. The body forms a fourth snap-fit attachment area on one end that mates with the third snap-fit attachment area of the insulator such that the feedthrough wire extends through the through-hole of the insulator. The housing encloses at least one of a battery, a sensor, and an electronic circuit. The insulator functions to electrically isolate the electrode from the housing of the body.

Abstract: Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is 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 invention relates to a peritoneal dialysis sampling system to be used together with a peritoneal dialysis system which is programmed to deliver fluid to a peritoneal cavity of a patient and to drain the fluid from the cavity, said peritoneal dialysis system comprising a supplying line and supplying means for supplying dialysis fluid to the peritoneal cavity, a draining line and draining means for draining the fluid from the cavity, said peritoneal dialysis sampling system comprising an automatic sampling system which is able to automatically sample volumic fractions of the dialysate contained in the peritoneum of the patient at specific time intervals in order to evaluate the peritoneal membrane characteristics and/or improve the peritoneal dialysis for a given patient.

Abstract: A system and method for calibrating a sensor of a characteristic monitoring system in real time utilizes a self-calibration module for periodic determination of, and compensation for, the IR drop across unwanted resistances in a cell. A current-interrupt switch is used to open the self-calibration module circuit and either measure the IR drop using a high-frequency (MHz) ADC module, or estimate it through linear regression of acquired samples of the voltage across the sensor's working and reference electrodes (Vmeasured) over time. The IR drop is then subtracted from the closed-circuit value of Vmeasured to calculate the overpotential that exists in the cell (Vimportant). Vimportant may be further optimized by subtracting the value of the open-circuit voltage (Voc) across the sensor's working and reference electrodes. The values of Vmeasured and Vimportant are then controlled by respective first and second control units to compensate for the IR drop.

Abstract: The present invention provides a method for calculating the resolution of blood glucose which corresponding with the peak value of the rising curve. The average peak value is obtained from calculating the plurality of peak value, which determined after the pre-setting sampling time. Then, the average peak value is calculated with the resistance of the measuring circuit, reference resistance, and reference voltage to obtain the resolution of the blood glucose. Furthermore, the mapping table can be fabricated by the different height of maximum peak value and outputted voltage in different presetting sampling time, such that the resolution of blood glucose can be obtained in different outputted voltage values.

Abstract: Devices, systems and methods for accessing bodily fluid beneath the skin surface by abrading the skin, whereby such bodily fluid may be extracted for ex vivo analysis or whereby an in vivo analyte sensor is implanted at the abrasion site.