Abstract: Methods and systems for managing patient compliance with a treatment are disclosed. An example method can comprise receiving data indicative of a time on active therapy. The method can comprise receiving data indicative of a pressure associated with the time on active therapy. The method can further comprise determining a patient compliance factor based on the data indicative of the time on active therapy and the data indicative of the pressure associated with the time on active therapy. The method can comprise determining a graphical object modifier based on the patient compliance factor and displaying a graphical object based on the graphical object modifier.

Abstract: The present disclosure relates to a communication connection method for a continuous glucose monitoring system. A communication connection method for a continuous glucose monitoring system according to an embodiment of the present disclosure may comprise: a step in which, in order to connect communication between a communication terminal and a sensor transmitter attached to a human body so as to continuously monitor biometric information of the human body, the communication terminal receives information of the sensor transmitter from the sensor transmitter; a step of determining, on the basis of the received information, whether the sensor transmitter is a new sensor transmitter or an already used sensor transmitter; and a step in which, when the sensor transmitter is an already used transmitter, communication connection is controlled on the basis of use information of the already used sensor transmitter.

Abstract: Methods, systems, and devices for continuous glucose monitoring. More particularly, the methods, systems, and devices describe a working electrode with a GOx sensor and a background electrode in which the background electrode has no GOx sensor. The system may then compare the first signal and the second signal to detect ingestion of a medication by the user. The system may generate a sensor glucose value based on the comparison.

Abstract: Systems and methods for applying time-dependent algorithmic compensation functions to data output from a continuous analyte sensor. Some embodiments determine a time since sensor implantation and/or whether a newly initialized sensor has been used previously.

Abstract: Systems and methods disclosed here provide ways to discriminate fault types encountered in analyte sensors and systems and further provide ways to process such discriminated faults responsively based on sensor data, clinical context information, and other data about the patient or patient's environment. The systems and methods thus employ clinical context in detecting and/or responding to errors or faults associated with an analyte sensor system, and discriminating the type of fault, and its root cause, particularly as fault dynamics can appear similar to the dynamics of physiological systems, emphasizing the importance of discriminating the fault and providing appropriate responsive processing. Thus, the disclosed systems and methods consider the context of the patient's health condition or state in determining how to respond to the fault.

Abstract: Embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have a sensing surface that includes an array two or more discontiguous sensing elements deposited on a substrate surface, where the sensing elements comprise one or more droplets of a sensing element formulation.

Abstract: A sensor device for detecting at least one analyte in a body fluid of a user. The sensor device includes an evaluation device for evaluating a data stream of time-dependent concentrations c of the analyte. The evaluation device includes a comparator device for comparing a current value c(t) of the concentration c with a first threshold value L and a second threshold value H, wherein H>L. The evaluation device defines a tolerance time interval. Further, the evaluation device, by using the comparator device, is configured to detect if the concentration c rises and exceeds the first threshold value L during the tolerance time interval and to prepare a warning signal W accordingly. The evaluation device is configured to suppress an output of the warning signal W at least until the tolerance time interval expires, under the precondition that c(t)<H during the tolerance time interval.

Abstract: An electrochemical sensor array for detecting analytes in water, including a frame; a plurality of sensor electrodes each mounted to the frame, including a free chlorine working electrode including a gold thin film and having a free chlorine sensing surface to be exposed to the water; and a reference electrode including a silver thin film and a silver and silver chloride layer and having a reference sensing surface to be exposed to the water. A method of manufacturing an electrochemical sensor array for detecting analytes in water, including forming a free chlorine electrode, including forming a gold thin film on a first base layer; forming a reference electrode, including forming a silver thin film on a second base layer and applying a silver and silver chloride paste to a portion of the silver thin film; and arranging the free chlorine electrode and the reference electrode on a common frame.

Abstract: A connector device includes a connector. An electrical lead wire is positioned in the connector. The electrical lead wire is configured to provide communication between the connector device and an external device. In certain embodiments, the electrical lead wire includes a contact point on a surface of the connector for electrically coupling the connector device to the external device. In addition to or as an alternative to the electrical lead wire, the connector device may include an optical coupling or channel in the connector configured for optical light transmission between the connector device and the external device.

Abstract: Certain aspects of the present disclosure relate to methods and systems for technical support of continuous analyte monitoring and sensor systems. In certain aspects, a method includes sensing, by an analyte sensor, analyte levels of a patient to generate one or more sensed signals. The method further includes generating, by a transmitter, a plurality of event indications based on the one or more sensed signals. The method further includes transmitting, by the transmitter, the plurality of event indications to a processor. The method also includes receiving the plurality of event indications indicating one or more errors associated with the analyte sensor. The method further includes determining one or more root causes associated with the plurality of event indications based on a pattern associated with the plurality of event indications. The method also includes taking one or more actions to resolve the one or more root causes.

Abstract: A medical device for delivering a drug compound through a stratum corneum includes a support having an aperture, an array of microneedles extending outwardly from the support, a plurality of nanostructures associated with each microneedle, and a reservoir wherein the drug compound is retained. At least one microneedle contains a shaft extending from the support. The shaft includes a tip configured to penetrate the stratum corneum. The shaft defines a channel extending from the support to the tip. The channel is in at least partial alignment with the aperture. At least some of the microneedles of the array of microneedles each have a cross-sectional dimension of from about 1 micrometer to about 1 millimeter. At least some of the nanostructures have a cross-sectional dimension less than about 500 nanometers and greater than about 5 nanometers and an aspect ratio of from about 0.2 to about 5.

Abstract: In some examples, a sensor holder device is described. The sensor holder device may include a rigid body, a set legs attached to the rigid body, a sensor guiding structure, a sensor retaining structure, and an electrical trace. The sensor retaining structure may be sized to accommodate a sensor wire. The electrical trace may extend proximate the sensor retaining structure and along one of the legs.

Abstract: Methods and analyte sensors including at least a first working electrode having a first active area thereon, and performing a dip coating operation to deposit a bilayer membrane upon the first working electrode and the first active area. The bilayer may include an inner layer having a first membrane polymer and an outer layer having a second membrane polymer, the first membrane polymer and the second membrane polymer differing from one another. The dip coating operation may comprise one or more first dips in a first membrane formulation to form the inner layer of the bilayer membrane and one or more second dips in a second membrane formulation to form the outer layer of the bilayer membrane upon the inner layer.

Abstract: The disclosure relates to a method and system for controlling glucose levels comprising receiving behavioral sensor measurements and analyte sensor measurements, determining a plurality of analyte profiles from continuous analyte sensor measurements; grouping the plurality of analyte profiles into clusters; assigning a selected behavioral parameter or a selected pattern of behavioral parameters to each analyte profile in a first cluster, and providing a treatment recommendation.

Abstract: A method of depositing a nanoscale-thin film onto a substrate is disclosed. The method generally comprises depositing a layer of a solid or gaseous state functionalizing molecule onto or adjacent to the first surface of the substrate and exposing the first surface to a source of ionizing radiation, thereby functionalizing the first surface of the substrate. Once the layer of functionalizing molecule is removed, a nanoscale-thin film is then deposited onto the functionalized first surface of the substrate.

Abstract: The present invention relates to a personal health monitoring system including an implantable sensor and a monitoring device. The present invention further relates to a multiple user health monitoring system including a plurality of such personal health monitoring systems. The present invention further relates to a method of monitoring the biological parameters of at least one user.

Abstract: Described herein is a system and method for optimizing patient-specific intervention strategies using point of care diagnostics. In accordance with an embodiment, the system allows for biological sampling in a portable or point of care device, and generation of healthcare data wherein instantaneous results have value at a particular location for emergency care, improvement of overall healthcare, fitness and/or disease management, or to provide an economic value. In accordance with an embodiment, the system can be used to evaluate a biological sample, and optionally guide a user, such as a medical professional or carer through inputting or retrieving additional objective and/or subjective observations and/or retrieving historical medical information for the patient. The system can use various inputs to generate status and performance indications, such as whether a patient seems in good or poor health, or is particularly likely to perform well, or not.

Abstract: A method for detecting cancer involved lymph nodes. The method includes placing a pH-sensing paper inside a needle of an injection syringe, filling the injection syringe with a buffer solution, putting the pH-sensing paper in contact with lymphatic fluid of a lymph node by inserting the needle of the injection syringe inside the lymph node, putting the lymphatic fluid in interaction with the buffer solution by injecting the buffer solution into the lymph node utilizing the injection syringe, and detecting that the lymph node as a cancer involved lymph node if color of the pH-sensing paper is changed to an acidic-range pH color.

Abstract: Described here are patches and methods for measuring glucose in sweat (and tears and the like). In general, the patches comprise an adhesive layer adapted to bond to skin of an individual, a substrate layer disposed over the adhesive layer and comprising a glucose sensing complex including a chromogen that changes color in the presence of certain concentrations of glucose, and a cover. In typical embodiments, the substrate layer has elements formed to direct and accumulate sweat that migrates from the skin of the individual to the glucose sensing complex. Methods of using the invention can comprise cleaning the skin surface, collecting sweat in a patch comprising this microfluidic constellation of elements, and observing concentrations of glucose collected in the sweat, for example either visually, or by using a smartphone or other computer processing device.

Abstract: Tracer kinetic models are utilized as temporal constraints for highly under-sampled reconstruction of DCE-MRI data. In one embodiment, a method for improving dynamic contrast enhanced imaging. The method includes steps of administering a magnetic resonance contrast agent to a subject and then collecting magnetic resonance contrast agent from the subject. A tracer kinetic model (i.e. eTofts or Patlak) is selected to be applied to the magnetic resonance imaging data. The tracer kinetic model is applied to the magnetic resonance imaging data. Tracer kinetic maps and dynamic images are simultaneously reconstructed and a consistency constraint is applied. The proposed method allows for easy use of different tracer kinetic models in the formulation and estimation of patient-specific arterial input functions jointly with tracer kinetic maps.

Abstract: Method and system for providing diabetes management and insulin therapy based on substantially real time glucose monitoring system is provided.

Abstract: Introduced here is an attachable unit that connects to a base unit through a snap-fitting mechanism. The attachable unit can include a top housing structure and a bottom housing structure that are ultrasonically welded together. The top housing structure can include the toe portion that is integral with remaining portions of the top housing structure, where the toe portion is configured to provide the snap-fit with the base unit.

Abstract: A method of calibrating a device for measuring the concentration of creatinine using one or more calibration solutions, the method comprising: receiving concentrations at an initial time of creatine, Cr, and/or creatinine, Crn, of the one or more calibration solutions; receiving outputs of the measuring device at the end time; calculating the concentration of Cr and/or Crn in the calibration solutions at an end time using a temperature model, wherein the temperature model indicates changes in temperature of the calibration solutions from the initial time to the end time; and determining a relationship between the outputs of the measuring device and the calculated concentrations of Cr and/or Crn.

Abstract: A continuous glucose monitoring system may include a hand-held monitor, a transmitter, an insulin pump, and an orthogonally redundant glucose sensor, which may comprise an optical glucose sensor and a non-optical glucose sensor. The former may be a fiber optical sensor, including a competitive glucose binding affinity assay with a glucose analog and a fluorophore-labeled glucose receptor, which is interrogated by an optical interrogating system, e.g., a stacked planar integrated optical system. The non-optical sensor may be an electrochemical sensor having a plurality of electrodes distributed along the length thereof. Proximal portions of the optical and electrochemical sensors may be housed inside the transmitter and operationally coupled with instrumentation for, e.g., receiving signals from the sensors, converting to respective glucose values, and communicating the glucose values.

Abstract: Devices and methods are described herein for directly and accurately measuring sweat flow rates using miniaturized thermal flow rate sensors. The devices (100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500) include the flow rate sensors (220, 320, 420, 520, 620, 720, 820, 920, 1020, 1120, 1220, 1320, 1420) in or adjacent to a microfluidic component (230, 330, 430, 530, 630, 730, 830, 930, 1030, 1130, 1230, 1330, 1430, 1530) of a wearable sweat sensing device. The devices and methods optimize the sensitivity of the flow rate sensors, while minimizing the presence of noise, in order to accurately and directly measure sweat flow rates.

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: Some embodiments an infusion pump system can be configured to modify alarm limit parameters as the user's insulin load increases or decreases. Moreover, in particular embodiments, the infusion pump system can be configured to provide a “missed bolus” or “missed meal” alarm in response to the user's blood glucose characteristics, the user's insulin load information, or the like.

Abstract: A transcutaneous sensor configured to measure one or more physiological conditions of a patient. The transcutaneous sensor includes a substrate and first and second working electrodes on the substrate. The first working electrode includes a first active sensing area and the second working electrode includes a second active sensing area. The first active sensing area of the first working electrode is longitudinally offset along the substrate from the second active sensing area of the second working electrode.

Abstract: A sensor implanted in tissues and including a sensing enzyme takes an electrical measurement and compares it to reference curves for the voltage current relationship. The sensor determines whether molecular compounds are present which interfere with the detection of the molecule of interest. If interfering species are found, the measurement voltage is set in a low range to reduce errors, while if the interfering species are not found, the measurement voltage is set in a high range to increase the detected signal.

Abstract: A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

Abstract: A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

Abstract: A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

Abstract: The present invention is directed to a cuff-like medical device that may analyze and report the concentrations of various biomarkers in a subject's bodily fluids, samples of which may be extracted by the device in the field and analyzed on the spot using the cuff-like medical device. For example, extracellular fluid (commonly known as “tissue fluid”) of a patient may be analyzed by the present invention, and in particular, the constituent interstitial fluid—the known main component of extracellular fluid—may be analyzed for concentrations of one or more specific types of proteins. A sensor component within the device may include one or more aptamers that permit chemical binding of at least one biomarker of interest. When the aptamer-protein binding complex is complete, an electronic component of the device may employ nanoscale weighing using frequency differential analysis through quartz crystal microbalances to determine the presence and concentration of biomarkers.

Abstract: A portable complex sensor device for measuring multiple items of biometric information, according to the present invention, comprises: a plurality of electrodes for receiving the biometric information; a plurality of biometric information measuring circuits for measuring the biometric information received from the plurality of electrodes; a plurality of current sensors which are always supplied with power so as to sense electric current when an object to be measured contacts the electrodes; a wireless communication means for transmitting and receiving data to and from a smart phone; and a microcontroller for controlling the power supply of a battery by being operated in a sleep mode or an active mode on the basis of whether the current sensors have sensed the electric current.

Abstract: Systems and methods for compensating for effects of temperature on implantable sensors are provided. In some embodiments, systems and methods are provided for measuring a temperature to determine a change in temperature in a sensor environment. In certain embodiments, a temperature compensation factor is determined based on a change in temperature of the sensor environment. The temperature compensation factor can be used in processing raw data of an analyte signal to report a more accurate analyte concentration.

Abstract: A method for estimating glucose values of a user and an insulin infusion and management system are provided. The insulin infusion and management system can include an insulin infusion device configured to deliver insulin to a user; a blood glucose meter; a source of user activity data; and a processor-based computing device that supports data communication with the insulin infusion device. A processor device of the computing device can perform a method for estimating glucose values of a user. In accordance with the method, a first set of inputs can be received and processed via an estimation model for a user to generate a set of estimated glucose values that track actual glucose values.

Abstract: Described is a system comprising an input module receiving a first data set indicative of at least one patient condition for each of a plurality of patients obtained during a predetermined time period, a comparison module comparing each of the at least one patient condition to at least one filter criteria, a filter module selecting a patient to include in a second data set if the at least one patient condition of the patient satisfies the at least one filter criteria, a report module generating a report based on the second data set, wherein the report includes at least one patient identifier for each patient in the second data set and at least one descriptor of the at least one patient condition for each patient in the second data set, and a classification module storing at least one classification value for the at least one patient condition.

Abstract: Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor.

Abstract: Methods and apparatus, including computer program products, are provided for remote monitoring. In some example implementations, there is provided a method. The method may include receiving, at a remote monitor, a notification message representative of an event detected, by a server, from analyte sensor data obtained from a receiver monitoring an analyte state of a host; presenting, at the remote monitor, the notification message to activate the remote monitor, wherein the remote monitor is configured by the server to receive the notification message to augment the receiver monitoring of the analyte state of the host; accessing, by the remote monitor, the server, in response to the presenting of the notification message; and receiving, in response to the accessing, information including at least the analyte sensor data. Related systems, methods, and articles of manufacture are also disclosed.

Abstract: A method of manufacturing a microneedle includes selecting and providing a microneedle material whose viscosity/elastic modulus measured for each shear rate using a viscoelasticity measuring equipment falls in a range between a predetermined upper limit and a predetermined lower limit, and manufacturing the microneedle using the microneedle material by an extension process.

Abstract: Electrochemical Impedance Spectroscopy (EIS) is used in conjunction with continuous glucose monitors and continuous glucose monitoring (CGM) to enable in-vivo sensor calibration, gross (sensor) failure analysis, and intelligent sensor diagnostics and fault detection. An equivalent circuit model is defined, and circuit elements are used to characterize sensor behavior.

Abstract: A device and method for compressing a renal artery prior to delivery of radiofrequency ablative energy to the renal nerves. The device includes a stent structure with a focal region that expands outwards to place the RF electrodes located on the stent structure in close proximity to the renal nerves. A covering is applied to the stent structure to prevent intimal hyperplasia.

Abstract: Sensing and infusion devices are described. In one embodiment, a sensing and infusion device may include an implantable segment having a sensor. The sensing and infusion device may also include a catheter, and a sensor channel may be formed in the catheter. The sensor channel may be configured to retain at least a portion of the implantable segment.

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 method comprising executing a prescription digital therapeutic configured to treat symptoms associated with migraines experienced by a patient.

Abstract: Contained herein is a system and method for using non-contact diffuse optical skin reflectance method to obtain remote sensing of in-vivo glucose levels in biological tissue or fluids. One embodiment uses an optical, non-contact method capable of measuring glucose levels at a stand-off distance of 0.5 to 2 meters. In this method, the tissue is illuminated with a collimated beam of near-infrared (optical) band of light having a specific band of wavelengths. The diffuse reflectance measured from the tissue/fluid is collected while varying the optical circuit. Using the collected data, an algorithm to unravel the mixed effects of tissue/fluid scattering and absorption is applied to determine the absorption level of the light, which is then associated with a quantitative glucose level.

Abstract: An input data creation device for powder additive manufacturing that can design and provide an appropriate support that avoids manufacturing failure. The device creates input data of a model in which a support is provided to a manufacturing designed object in powder additive manufacturing. The device includes a mechanical quantity calculation unit including a mechanism configured to calculate a mechanical quantity generated on a surface to which the support is provided in the manufacturing designed object; and a support shape determination unit including a mechanism configured to determine, based on information on a plurality of types of support shapes, information on an allowable mechanical quantity defined for each support shape, and a mechanical quantity calculated by the mechanical quantity calculation unit, an optimized support shape having an allowable mechanical quantity equal to or greater than the calculated mechanical quantity from among the plurality of types of support shapes.

Abstract: A sensor includes: a tubular needle member that includes a side wall and defines a hollow portion; and a linear detection member located in the hollow portion. The side wall of the needle member includes a thick portion that is thicker than another portion of the side wall in a cross-section of the needle member, and wherein the thick portion protrudes toward the hollow portion.

Abstract: A diversified glucose sensor system comprises an introducer needle and two or more independent sensor bodies, each sensor body having one or more sensing elements that can be subcutaneously positioned in a patient's body by insertion of the introducer needle for glucose measurement. The system further includes a progressive insertion device comprising an insertion shaft that pushes the sensor bodies out the end opening of the introducer needle to a desired depth in the patient prior to removal of the insertion shaft and the introducer needle. The sensor bodies are bent or folded and held under stress within the introducer needle for insertion, and released and biased outwardly when pushed out of the introducer needle. The sensing elements are anchored and disposed within the patient at positions providing X/Y/Z-axis diversity for measurement.

Abstract: Embodiments of the invention provide multilayer analyte sensors having elements and/or architectures that function to improve oxygen delivery to sensor enzymes in manner that enhances sensor function, as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.