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.

Abstract: An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

Abstract: Analyte sensors and methods of manufacturing same are provided, including analyte sensors comprising multi-axis flexibility. For example, a multi-electrode sensor system 800 comprising two working electrodes and at least one reference/counter electrode is provided. The sensor system 800 comprises first and second elongated bodies E1, E2, each formed of a conductive core or of a core with a conductive layer deposited thereon, insulating layer 810 that separates the conductive layer 820 from the elongated body, a membrane layer deposited on top of the elongated bodies E1, E2, and working electrodes 802?, 802? formed by removing portions of the conductive layer 820 and the insulating layer 810, thereby exposing electroactive surface of the elongated bodies E1, E2.

Abstract: A method for evaluating a sensor array includes providing software having the sensor array topology, relating array elements to hardware components. Data from the array elements is collected and evaluated to determine operative components. Displays of the determinations are generated allowing a user to diagnose sensor array failures. Other aspects of the invention provide for automatic array failure diagnosis and improvement of sensor array directivity. An additional aspect provides a system for evaluating a sensor array incorporating a computer with a database and a display.

Abstract: A method for operating measuring equipment for detecting an analyte in a bodily fluid by means of a continuously measuring blood glucose sensor. A calibration method is carried out for the prospective calibration of the measuring equipment. At least three calibration points are detected in the calibration method, wherein each calibration point comprises a measurement signal from the measuring equipment and a reference value of an associated reference measurement. A plurality of possible slopes are established between the calibration points. At least one robust estimation method using a formation of at least one median is used to determine a probable slope from the plurality of possible slopes. Furthermore, a measurement is carried out. During the measurement and using the probable slope, a concentration of the analyte in the bodily fluid is deduced from a measurement signal from the measuring equipment and the probable slope.

Abstract: Embodiments of the invention provide amperometric analyte sensors having multiple related structural elements (e.g. sensor arrays comprising a working, counter and reference electrode) and algorithms designed for use with such sensors. While embodiments of the innovation can be used in a variety of contexts, typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: An analyte sensor is provided for detecting an analyte concentration level in a bio-fluid sample. The analyte sensor has a base, a first electrode and a second electrode wherein a thermocouple portion is provided integral with the second electrode thereby enabling on-sensor temperature measurement capability. In some embodiments, two and only two electrical contact engagement portions are provided thereby simplifying electrical contact. Manufacturing methods and systems utilizing the analyte sensors are provided, as are numerous other aspects.

Abstract: An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

Abstract: A fully integrated small size implantable sensing device is described, which can include a sensor and an electronic circuit to interface with the sensor and communicate with an external device. Various fabrication methods for the sensing device are described, including provision of wells, created using same fabrication technology as the electronic circuit, to contain electrodes of the sensor and corresponding functionalization chemicals. Such implantable sensing device can be used for a variety of electrochemical measuring applications within a living body as well as actuation by injecting a current into the living body.

Abstract: A wireless communication terminal may include a first interface that receives urgency data indicating urgency of an event detected by an implantable medical device and being transmitted from the implantable medical device using a first wireless communication protocol, and detailed data indicating details of the event and having a greater data size than the urgency data and being transmitted from the implantable medical device using a second wireless communication protocol, a second interface that transmits the detailed data to an external device using the second wireless communication protocol, a display unit that displays information, and a control unit that performs control to cause the display unit to display summary information based on the urgency of the event, and the second interface to transmit the detailed data received by the first interface to the external device based on the urgency data received by the first interface.

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: Methods and apparatuses for monitoring the level of glucose or other constituents in live subjects are disclosed. Stem cells are obtained from the subject and processed into cells that change their optical characteristics in response to a level of the constituent. The responsive cells are formed into clusters and implanted into in the subject's body at locations that permit optical monitoring from outside the subject's body. The implanted cell clusters are illuminated and the reflected illumination from each of the cell clusters is detected. Changes in the optical characteristics of the cell clusters that correspond to the responses of the cell clusters are identified, and the identified changes are mapped to a constituent level based on calibration data for each cell cluster. An indication of the constituent level in the subject is then output.

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: Analyte sensors and methods of manufacturing same are provided, including analyte sensors comprising multi-axis flexibility. For example, a multi-electrode sensor system 800 comprising two working electrodes and at least one reference/counter electrode is provided. The sensor system 800 comprises first and second elongated bodies E1, E2, each formed of a conductive core or of a core with a conductive layer deposited thereon, insulating layer 810 that separates the conductive layer 820 from the elongated body, a membrane layer deposited on top of the elongated bodies E1, E2, and working electrodes 802?, 802? formed by removing portions of the conductive layer 820 and the insulating layer 810, thereby exposing electroactive surface of the elongated bodies E1, E2.

Abstract: Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

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 measuring system for measuring the concentration of substances or analytes in a body fluid or in a body tissue comprises a microdialysis probe comprising a microdialysis membrane, the probe being adapted to be placed in blood or in tissue, a flow through sensor for analysing a fluid having passed the microdialysis probe, a pump for pumping the fluid to and through the microdialysis probe and further to and through the sensor, and tubing connecting the pump to the microdialysis probe and the microdialysis probe to the sensor. The pump effects a flow rate in the system in the interval 0.2-15 microliters per minute. The sensor comprises a flow channel having a flow resistance or pressure drop adapted to the characteristics of the microdialysis membrane so as to eliminate, or at least substantially reduce, ultra filtering in the microdialysis membrane.

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 present disclosure relates to an electrode strip, a sensor strip, a system thereof and a manufacturing method thereof. The sensor strip includes a first reactive film, a second reactive film and a vent hole. The first reactive film includes a substrate, a first electrode layer and a first insulation layer. The first end of the first insulation layer is concaved to a first depth to form a first reactive area. The second reactive film includes a second electrode layer and a second insulation layer. The first end of the second insulation layer is concaved to a second depth to form a second reactive area. The vent hole penetrates the second insulation layer, the second electrode layer and the first insulation layer so as to connect the first reactive area and the second reactive area.

Abstract: Disclosed are methods, apparatuses, etc. for glucose sensor signal reliability analysis.

Abstract: An electrochemical test sensor for detecting the concentration of an analyte in a fluid sample. The electrochemical test sensor includes a housing that has a first end and a second opposing end. The housing includes an opening at the first end to receive a fluid test sample. An electrode assembly includes a substrate, a working electrode, a counter electrode and a reagent. The substrate has a first surface and an opposing second surface. The working electrode is disposed on the first surface of the substrate, and the counter electrode is disposed on the second surface of the substrate. The electrode assembly is positioned within the housing to define a reaction channel. The electrochemical test sensor may be used with a removable lancet mechanism or integrated within a lancet mechanism to form one integral unit.

Abstract: Correction for initial variation in thickness of a polymer layer and for changes in the coating thickness that occur after implantation of a biosensor and therefore provides substantial increase in the accuracy and lifetime of implantable sensors is done using a factor derived from the decay of potential.

Abstract: One or more therapeutic fluids, such as for example insulin can be delivered to a body. In addition or alternatively, the concentrations of one or more analytes can be measured in vivo. A feedback process can be used to regulate levels of the one or more analytes based on the measurements via delivery of the one or more therapeutic fluids. Related systems, apparatus, methods, and/or articles are also described.

Abstract: An analyte sensor system including a substrate, a first electrode disposed on a first surface of the substrate, a second electrode disposed on a second surface of the substrate, a third electrode provided in electrical contact with at least one of the first or second electrodes, where at least a portion of the first electrode and the second electrode are subcutaneously positioned in a patient, and where the third electrode is substantially entirely positioned external to the patient, and corresponding methods are provided.

Abstract: Methods and apparatus for providing multi-stage signal amplification in a medical telemetry system are 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: A method and an apparatus for measuring glucose level in the body fluid of a subject, typically blood glucose level, by measuring impedance of a body tissue, with two pairs of electrodes, two electrodes for injecting current into a body tissue and two electrodes for detecting the ensuing voltage of the body tissue. The body tissue is typically a sub-dermal or sub-cutaneous tissue. The measured impedance of the body tissue is used to correlate with directly determined glucose levels to determine the glucose level from the measured impedance. It is thus possible to determine body fluid glucose levels in a reliable and reproducible manner.

Abstract: A device for detection or measurement of a carbohydrate analyte in fluid comprises: an optical sensor comprising components of an assay for carbohydrate analyte, the readout of which is a detectable or measurable optical signal, and a light guide having a distal portion optically coupled to the assay components and a proximal portion; and a reader for interrogating the optical sensor, the reader comprising an assay interrogating system including a lens; and an interface portion forming part of at least one of the optical sensor and the reader, the interface portion being capable of removably constraining the proximal portion of the light guide and the lens of the assay interrogating system in an optically coupled arrangement. The device may be combined with an insulin-infusion system.

Abstract: A region of skin, other than the fingertips, is stimulated. After stimulation, an opening is created in the skin (e.g., by lancing the skin) to cause a flow of body fluid from the region. At least a portion of this body fluid is transported to a testing device where the concentration of analyte (e.g., glucose) in the body fluid is then determined. It is found that the stimulation of the skin provides results that are generally closer to the results of measurements from the fingertips, the traditional site for obtaining body fluid for analyte testing.

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

Abstract: 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: 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: An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

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 mountable device includes a bio-compatible structure embedded in a polymer that defines at least one mounting surface. The bio-compatible structure includes an electronic component having electrical contacts, sensor electrodes, and electrical interconnects between the sensor electrodes and the electrical contacts. The bio-compatible structure is fabricated such that it is fully encapsulated by a bio-compatible material, except for the sensor electrodes. In the fabrication, the electronic component is positioned on a first layer of bio-compatible material and a second layer of bio-compatible material is formed over the first layer of bio-compatible material and the electronic component. The electrical contacts are exposed by removing a portion of the second layer, a conductive pattern is formed to define the sensor electrodes and electrical interconnects, and a third layer of bio-compatible material is formed over the conductive pattern.

Abstract: Wireless molecular sensor methods and systems integrate radio frequency (RF) technology to interrogate, power, operate and/or readout signals corresponding to levels of molecules of interest from microelectromechanical systems (MEMS) implanted within the body. Various alternative embodiments are disclosed.

Abstract: The present invention relates to a blood glucose monitoring system, a strip accommodation device, a strip storage device, and an automated blood collection device, wherein the blood glucose monitoring system has the strip accommodation device formed integrally therewith, the strip accommodation device being configured to convert a rotary motion of a cover of an operating member into an upward linear motion and to eject one of a plurality of strips through an ejection hole, thereby easily storing the strips therein, preventing the contamination of the strips from the foreign matters like outside moisture, and accurately and easily measuring the concentration of the glucose in the blood.

Abstract: This document provides methods and materials related to the non-invasive measurement of analytes in blood.

Abstract: The present disclosure relates to an electrode strip, a sensor strip, a system thereof and a manufacturing method thereof. The sensor strip includes a first reactive film, a second reactive film and a vent hole. The first reactive film includes a substrate, a first electrode layer and a first insulation layer. The first end of the first insulation layer is concaved to a first depth to form a first reactive area. The second reactive film includes a second electrode layer and a second insulation layer. The first end of the second insulation layer is concaved to a second depth to form a second reactive area. The vent hole penetrates the second insulation layer, the second electrode layer and the first insulation layer so as to connect the first reactive area and the second reactive area.

Abstract: A calibration system is disclosed for calibrating a first physiological monitoring device using a second physiological monitoring device. The first physiological monitor measures a first indication of a physiological parameter. The second physiological monitor measures a second indication of the physiological parameter. The first and second indications are used to calibrate the first physiological monitoring device.

Abstract: In aspects of the present disclosure, a no coding 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 do not require a calibration code is provided. Also disclosed are methods, systems, devices and kits for providing the same.

Abstract: Methods and apparatus for providing a power supply to a device, including an inductive rechargeable power supply for a data monitoring and management system in which a high frequency magnetic field is generated to provide power supply to a rechargeable power source such as a battery of a transmitter unit in the data monitoring and management system are provided.

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: 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: Devices and methods for determining analyte levels are described. The devices and methods allow for the implantation of analyte-monitoring devices, such as glucose monitoring devices that result in the delivery of a dependable flow of blood to deliver sample to the implanted device. The devices include unique architectural arrangement in the sensor region that allows accurate data to be obtained over long periods of time.

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 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.