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: Some embodiments include fabricating a narrow border of a projected capacitive (PCAP) touchscreen. Some embodiments include a vertical electrode on a cover glass coupled to a first set of traces within the narrow border, and printing a first insulating black mask (BM) layer on the cover glass, that includes a first opening above an electrode terminus of the vertical electrode. Some embodiments further include printing a portion of a conductive black via (BV) in the first opening, coupling the conductive BV to the electrode terminus and a first silver trace of the first set of silver traces. Some embodiments include combining the cover glass with a sensor glass, where the first set of silver traces substantially overlaps a second set of silver traces of the sensor glass within the narrow border, where the overlapped sets of silver traces are separated by a shield layer.

Abstract: Example sensor apparatus for microfluidic devices and related methods are disclosed. In examples disclosed herein, a method of fabricating a sensor apparatus for a microfluidic device includes etching a portion of an intermediate layer to form a sensor chamber in a substrate assembly, where the substrate assembly has a base layer and the intermediate layer, and where the base layer comprises a first material and the intermediate layer comprises a second material different than the first material. The method includes forming a first electrode and a second electrode in the sensor chamber. The method also includes forming a fluidic transport channel in fluid communication with the sensor chamber, where the fluidic transport channel comprises a third material different than the first material and the second material.

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, methods, and apparatus are provided for analyte level estimation to improve accuracy thereof. Systems include sensor electronics operatively coupled to an analyte sensor configured for contact with a user's biofluid. A user interface device is configured for communication with the sensor electronics and configured to determine a predicted state estimate using exogenous measurement data and a past state estimate and, thereafter, determine a corrected state estimate, including an estimated analyte level, using the predicted state estimate and current analyte sensor measurement data.

Abstract: Systems and methods for processing sensor data and self-calibration are provided. In some embodiments, systems and methods are provided which are capable of calibrating a continuous analyte sensor based on an initial sensitivity, and then continuously performing self-calibration without using, or with reduced use of, reference measurements. In certain embodiments, a sensitivity of the analyte sensor is determined by applying an estimative algorithm that is a function of certain parameters. Also described herein are systems and methods for determining a property of an analyte sensor using a stimulus signal. The sensor property can be used to compensate sensor data for sensitivity drift, or determine another property associated with the sensor, such as temperature, sensor membrane damage, moisture ingress in sensor electronics, and scaling factors.

Abstract: The application relates to a device (100) for non-invasively sampling interstitial fluid comprising one or more analytes from dermis (101 a) to skin surface (101 b) by using the magneto-hydrodynamic effect. The device comprises a first electrode (102a) and a second electrode (102b) adapted to be positioned adjacent to the skin surface, the first electrode separated from the second electrode by a distance (103), a power source (104) adapted to induce an electric current through the first electrode, the interstitial fluid and the second electrode, and also a magnet (105) adapted to produce a magnetic field to the interstitial fluid. Direction of the magnetic field and direction of the electric current produced by the magnet and the power source, respectively, is such that Lorentz force drives the fluid from the dermis towards the skin surface.

Abstract: The present invention generally relates to devices and techniques associated with diagnostics, therapies, and other applications, including skin-associated applications, for example, devices for delivering and/or withdrawing fluid from subjects, e.g., through the skin. In some embodiments, the device includes a system for accessing an extractable medium from and/or through the skin of the subject at an access site, and a pressure regulator supported by a support structure, able to create a pressure differential across the skin at at least a portion of the access site. The device may also include, in some cases, a sensor supported by the support structure for determining at least one condition of the extractable medium from the subject, and optionally a signal generator supported by the support structure for generating a signal relating to the condition of the medium determined by the sensor.

Abstract: The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.

Abstract: Devices that sense sweat and are capable of providing chronological assurance are described. The device uses at least one sensor to measure sweat or its components and to determine a sweat sampling rate. The chronological assurance is determined, at least in part, using the sweat sampling rate. The sweat sampling rate may be determined, at least in part, using a sweat volume and/or a sweat generation rate, both of which may be measured or predetermined.

Abstract: The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.

Abstract: An on-body insertion system is described. The on-body system includes a sensor in a first position being substantially parallel to an insertion surface. Activation of an actuator transitions the sensor to a second position. Wherein the transition imparts movement to the sensor that is substantially parallel to the insertion surface and the second position results in the sensing area being beneath the insertion surface.

Abstract: A kit for determining a concentration of an analyte in a body fluid is disclosed, the kit comprising: a) a sensor module comprising i. a sensor adapted to determine the concentration; ii. a control device connected to the sensor comprising a data collection device to collect measurement data acquired by the sensor, the control device further comprising a wireless near-field communication device adapted to transmit measurement data, the sensor module comprising a sensor module mechanical interface; b) a data reader module adapted to receive measurement data transmitted by the sensor module via wireless near-field communication, the data reader module comprising at least one data storage device; c) a data transmission module to receive measurement data transmitted by the sensor module via wireless near-field communication, the data transmission module comprising a wireless far-field communication device to transmit the measurement data to an external device.

Abstract: The present disclosure proposes a method for supporting a user. The method contains providing an acceleration measurement of the user and measuring at least one vital parameter of the user if the acceleration measurement is above a predefined acceleration threshold. A need of assistance for the user is signaled if the measured vital parameter of the user deviates from a standard vital parameter of the user by more than a predefined threshold.

Abstract: The present disclosure relates to a method for operating a measurement site for determining at least one measurand of a medium, wherein the measurement site has at least one sensor unit, in contact with the medium, for detecting measured values, and an operating unit with a display element, wherein the sensor unit is connected wirelessly or by wire to the operating unit for communication, wherein the method includes the steps of determining a first value that represents a remaining time span up to a specified time point for a maintenance measure to be performed on the sensor unit; determining a second value that represents a current state of the sensor unit; determining a third value, based at least upon the first and second values, that represents a recommended action with regard to the sensor unit; and displaying the third value or a symbol derived therefrom, or a signal derived from the third value, by means of the display element.

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: A simple, disposable sensing device for sensing an analyte is housed in a single case. The sensing device can transmit sensor data to monitoring device(s). The sensing device includes: a case having a lower major wall adapted to be mounted against a patient's skin, and an upper opposing major wall; a sensor extending from the case and having a distal end sensitive to the analyte to produce an electrical signal, and a proximal end within the case having electrical contacts; a printed circuit board assembly within the case supported by one of the major walls to receive the electrical signal via the electrical contacts; and an elastomeric pad disposed in the case and biased by the other major wall to urge the proximal end of the sensor into contact with the printed circuit board assembly and maintain an electrical connection between the electrical contacts and the printed circuit board assembly.

Abstract: Techniques and systems are disclosed for implementing textile-based screen-printed amperometric or potentiometric sensors. The chemical sensor can include carbon based electrodes to detect at least one of NADH, hydrogen peroxide, potassium ferrocyanide, TNT or DNT, in liquid or vapor phase. In one application, underwater presence of chemicals such as heavy metals and explosives is detected using the textile-based sensors.

Abstract: Systems and methods for processing sensor data and self-calibration are provided. In some embodiments, systems and methods are provided which are capable of calibrating a continuous analyte sensor based on an initial sensitivity, and then continuously performing self-calibration without using, or with reduced use of, reference measurements. In certain embodiments, a sensitivity of the analyte sensor is determined by applying an estimative algorithm that is a function of certain parameters. Also described herein are systems and methods for determining a property of an analyte sensor using a stimulus signal. The sensor property can be used to compensate sensor data for sensitivity drift, or determine another property associated with the sensor, such as temperature, sensor membrane damage, moisture ingress in sensor electronics, and scaling factors.

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: Systems, methods and/or devices for treating diabetes mellitus by alleviating glucotoxicity and restoring pancreatic beta-cell function, comprising at least a first memory for storing data inputs corresponding at least to one or more components in a patient's present insulin dosage regimen, and data inputs corresponding at least to the patient's blood-glucose-level measurements determined at a plurality of times, and a processor operatively connected to the at least first memory. The processor is programmed at least to determine from the data inputs corresponding to the patient's blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the components of the patient's present insulin dosage regimen.

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: An apparatus for estimating a substance in blood in a noninvasive manner is provided. The apparatus includes a light source configured to emit light to skin of a user; a plurality of detectors which are disposed at different distances from the light source and configured to detect light signals from the light returning from the skin; and a processor configured to determine a similarity between at least two light signals among the detected light signals and estimate the substance in blood based on the similarity.

Abstract: Embodiments described herein relate to an analyte monitoring device having a user interface with a display and a plurality of actuators. The display is configured to render a plurality of display screens, including a home screen and an alert screen. The home screen is divided into a plurality of simultaneously displayed panels, with a first panel displays a rate of change of continuously monitored analyte levels in interstitial fluid, a second panel simultaneously displays a current analyte level and an analyte trend indicator, and a third panel displays status information of a plurality of components of the device. When an alarm condition is detected, the display renders the alert screen in place of the home screen, the alert screen displaying information corresponding to the detected alarm condition. Furthermore, the actuators are configured to affect further output of the analyte monitoring device corresponding to the detected condition.

Abstract: Embodiments of the invention provide analyte sensors having optimized elements and/or configurations of elements as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: A system for drug delivery by infusion is disclosed where the concentration of the drug solution withdrawn from a drug container (1, 2) to be delivered to the patient (8) according to a predetermined dose rate protocol for the drug is repeatedly analyzed during the infusion, and the concentration data obtained are used to continuously control the infusion rate to at least substantially maintain the predetermined dose rate. A method for drug delivery by infusion is also disclosed.

Abstract: Provided are systems and methods using which users may learn and become familiar with the effects of various aspects of their lifestyle on their health, e.g., users may learn about how food and/or exercise affects their glucose level and other physiological parameters, as well as overall health. In some cases the user selects a program to try; in other cases, a computing environment embodying the system suggests programs to try, including on the basis of pattern recognition, i.e., by the computing environment determining how a user could improve a detected pattern in some way. In this way, users such as type II diabetics or even users who are only prediabetic or non-diabetic may learn healthy habits to benefit their health.

Abstract: Devices are presented for measurement of an analyte concentration. The devices comprise: a sensor configured to generate a signal indicative of a concentration of an analyte; and a sensing membrane located over the sensor. The sensing membrane comprises an enzyme domain comprising an enzyme, a base polymer, and a hydrophilic polymer which makes up from about 5 wt. % to about 30 wt. % of the enzyme domain.

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 a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes first and second working electrodes to measure additional analyte or non-analyte related signal. Such measurements may provide a background and/or sensitivity measurement(s) for use in processing sensor data and may be used to trigger events such as digital filtering of data or suspending display of data.

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

Abstract: A diabetes management system including a pump for dispensing a medicant and a control device for controlling the pump includes a user interface for controlling functions of the pump and providing information related to operation of the pump and other information. The user interface can display blood glucose information and insulin dosing data such that a user can appropriately act on the information and/or gain confidence that the diabetes management system is operating appropriately to manage the disease. User interfaces provided herein can include displays of current and projected glucose values, bolus calculators, charts displaying glucose levels and/or insulin delivery data, system maintenance reminders, system status information, patient configuration input screens, and log-in screens. Diabetes management systems can include insulin pumps, continuous glucose monitors, blood glucose monitors, mobile computing devices, servers, and/or other insulin delivery devices (e.g., insulin pens).

Abstract: A system for sensing glucose concentration is provided and includes following components. A light source generates a light beam. The system may include a polarization state generator (PSG) for changing the polarization of the light beam, and then the light beam is emitted to a biological tissue. A polarization state analyzer (PSA) receives the light beam reflected from the biological tissue, and the received light beam is used to calculate Stokes vectors. A Mueller matrix is calculated according to the Stokes vectors. In some embodiments, the system includes an optical coherence tomography (OCT) in which the light beam is sensed by a detector for calculating the Mueller matrix. An optical rotation angle and a depolarization index are calculated in accordance with the differential Mueller matrix formalism. The glucose concentration is calculated in accordance with the optical rotation angle and the depolarization index.

Abstract: New wearable systems for noninvasive glucose sensing include an ultrasound generator, an ultrasound detector and a feedback unit. Methods for noninvasive glucose sensing using a wearable device include measuring a thickness (geometrical and/or optical) of a target tissue or a time of flight of ultrasound or optical pulses in the target tissue and determining a glucose value from the thickness of the target tissue or the time of flight in the target tissue in accordance with a target tissue thickness (geometrical and/or optical) or time of flight versus glucose calibration curve.

Abstract: Methods and apparatuses for blood glucose measurement are provided. A first glucose concentration in a body fluid of a user is detected based on a first measurement interval. A first blood glucose level of the user is determined based on the first glucose concentration. A glucose concentration measurement interval is changed from the first measurement interval to a second measurement interval according to an occurrence of an event. A second glucose concentration in the body fluid is detected based on the second measurement interval. A second blood glucose level of the user is determined based on the second glucose concentration.

Abstract: The various embodiments disclosed herein are devices that deliver electrical stimulation and/or vibration stimulation to the surface of skin in proximity to insulin injections and/or glucose testing in order to decrease or eliminate the pain of these procedures.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves determining one or more signal characteristics associated with a subset of the measurements corresponding to a monitoring period, determining a reliability metric for the monitoring period based on the one or more signal characteristics, and providing indication of a maintenance condition when the reliability metric violates a threshold.

Abstract: An automatic sensor excitation voltage adjustment feature, a multi-range concentration feature, a single calibration feature and a barrier circuit feature. The automatic sensor excitation voltage adjustment feature includes a transmitter having a transmitter microprocessor that provides an initial voltage to a sensor having a sensor microprocessor. As the voltage changes a correction signal is relayed from the sensor microprocessor to the transmitter microprocessor. The correction signal is used to adjust the voltage applied to the sensor. The multi-range concentration sensor feature includes an amplifier associated with the sensor/microprocessor to create gain settings used to optimize sensor resolution by changing a gain value for the sensor. This enables use of a single sensor for a variety of different concentration ranges.

Abstract: Methods, devices, and systems are provided that determine analyte trends according to different methods depending on whether a change-resistant state is active or not active. The method used when the change-resistant state is activated provides for different requirements for a resulting analyte trend to transition between states (e.g., level to non-level). Furthermore, in some aspects, methods, devices, and systems of selecting or modifying a response rate of an analyte monitoring device for an individual user are provided. User instructions for selecting or modifying a response rate of the device or system is received externally via a user interface or communication channel. The response rate of the analyte monitoring device or system is then selected or modified to the first response rate, and the device or system operated with the first response rate.

Abstract: A method of calibrating an analyte measurement system is provided.

Abstract: Methods and devices to detect analyte in body fluid are provided. Embodiments include processing sampled data from analyte sensor, determining a single, fixed, normal sensitivity value associated with the analyte sensor, estimating a windowed offset value associated with the analyte sensor for each available sampled data cluster, computing a time varying offset based on the estimated windowed offset value, and applying the time varying offset and the determined normal sensitivity value to the processed sampled data to estimate an analyte level for the sensor.

Abstract: A control unit for an electronically controlled pump unit controls the pump unit to infuse insulin into a diabetic's body in a substantially continuous way according to a preset infusion schedule as a function of time. The control unit includes an intervention unit that continuously evaluates a blood-glucose indicative input for detecting an actual or expected hypoglycaemia and executes, in response to an actual or expected hypoglycaemia, a temporary hypoglycaemia intervention. The intervention includes, for an intervention time interval, overriding the preset infusion schedule by temporarily suspending insulin infusion or temporarily reducing insulin infusion below the preset infusion schedule. The intervention unit adapts its way of operation with respect to executing the hypoglycaemia intervention in accordance with a control signal that is separate from the blood-glucose indicative input. The control unit automatically generates the control signal as a function of time and/or based on sensor input.

Abstract: A biosensor includes a microfluidics layer, a transduction layer and a transceiver layer. The transduction layer further includes a functionalized layer that reacts with a biomarker, and a plurality of carbon nanotubes adjacent the functionalized layer. The conductivity of the carbon nanotubes changes in response to a biomarker reacting with at least a portion of the functionalized layer. The functionalized layer can include dendrimers, such as a tadpole dendrimer scaffolding that includes a plurality of sites for receiving receptors for biomarkers.

Abstract: A system for drug delivery by infusion is disclosed where the concentration of the drug solution withdrawn from a drug container (1, 2) to be delivered to the patient (8) according to a predetermined dose rate protocol for the drug is repeatedly analyzed during the infusion, and the concentration data obtained are used to continuously control the infusion rate to at least substantially maintain the predetermined dose rate. A method for drug delivery by infusion is also disclosed.

Abstract: Technologies are generally described to monitor a sweat rate of an area of a skin. A hydration status of a human or non-human entity is monitored based on the sweat rate. The sweat rate is monitored when the sweat rate monitor is detected as sealed against the surface of the skin. The sweat rate monitor is attached to the surface of the skin with an adhesive, or a tape among other schemes to hold the sweat rate monitor in place during a measurement. The sweat rate monitor includes a container to capture an initial amount of sweat that comes out of the surface of the skin. When, the container is detected as filled with the initial amount of sweat, a pump of the sweat rate monitor is actuated to compress the container. The container is compressed to force a volume of the initial amount of sweat in the container out of an ejection port of the sweat rate monitor.

Abstract: The double layer capacitance of a working electrode of a sensor may be measured with minimal disruption to the sensor equilibrium by open circuiting the working electrode and measuring the voltage drift on a periodic, or as-needed, basis. The values of the double layer capacitance may be monitored over time to determine, e.g., sensor age and condition.

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

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: Methods and apparatus for encrypting and decrypting data for wearable devices that are not based on authentication techniques, such as login/password or handshaking, are provided. A computing device receives a message. The message includes encrypted data and a cryptographic reference. The encrypted data includes physiological data of a wearer of the wearable device. The cryptographic reference includes a reference to a first cryptographic technique. The computing device determines the first cryptographic technique based on the reference to the first cryptographic technique. The computing device determines a cryptographic key. The computing device decrypts the encrypted data using the first cryptographic technique and the cryptographic key to obtain decrypted data. The computing device stores the decrypted data.

Abstract: Embodiments described herein relate to an analyte monitoring device having a user interface with a display and a plurality of actuators. The display is configured to render a plurality of display screens, including a home screen and an alert screen. The home screen is divided into a plurality of simultaneously displayed panels, with a first panel displays a rate of change of continuously monitored analyte levels in interstitial fluid, a second panel simultaneously displays a current analyte level and an analyte trend indicator, and a third panel displays status information of a plurality of components of the device. When an alarm condition is detected, the display renders the alert screen in place of the home screen, the alert screen displaying information corresponding to the detected alarm condition. Furthermore, the actuators are configured to affect further output of the analyte monitoring device corresponding to the detected condition.