Abstract: A method of making a sensor includes depositing a layer of hydrogel over a substrate, the hydrogel configured to change thickness or volume in response to a selected condition and including a plurality of magnetic particles disposed in the hydrogel so that a magnetic property of the hydrogel changes with changes of thickness or volume of the hydrogel. The hydrogel is sacrificed in selected region(s) of the layer so that the hydrogel outside the selected region(s) forms a plurality of spaced-apart islands of the hydrogel. The islands of the hydrogel are enclosed in an enclosure at least partly permeable to a selected fluid. A sensor for detecting a condition includes the substrate, islands, and a device coil arranged with respect to the hydrogel so that changes in the magnetic property modulate an electrical property of the sensor. A system includes the substrate, islands, and a magnetic-field detector.

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.

Abstract: Method and apparatus for receiving a first signal from a first working electrode of a glucose sensor positioned at a first predetermined position under the skin layer, receiving a second signal from a second working electrode of the glucose sensor positioned at a second predetermined position under the skin layer, the second signal received substantially contemporaneous to receiving the first signal, detecting a dropout in the signal level associated with one of the first or second signals, comparing the first signal and the second signal to determine a variation between the first and second signals, and confirming one of the first or second signals as a valid glucose sensor signal output when the determined variation between the first and the second signals is less than a predetermined threshold level are provided.

Abstract: Generally, embodiments of the invention relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have improved uniformity of distribution of one or more components of the sensor by inclusion of a low surface tension polymer leveling agent, where the components are disposed proximate to a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

Abstract: Methods and system to provide glycemic control and therapy management based on monitored glucose data, and current and/or target Hb1AC levels are provided.

Abstract: Disclosed are a system and method for determining a metric and/or indicator of a reliability of a blood glucose sensor in providing glucose measurements. In one aspect, the metric and/or indicator may be computed based, at least in part, on an observed trend associated with signals generated by the blood glucose sensor.

Abstract: The present disclosure provides systems and methods for calibrating medical devices and processing physiological measurements using a medical device management system. As an example, the medical device can be a handheld glucometer configured for invasive testing and non-invasive testing of physiological parameters of a patient.

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: Various embodiments are described and illustrated to calculate an insulin bolus, recommend such bolus, and provide reminder messages for performing an additional glucose test.

Abstract: The medical testing instrument integrates the multiclix insulin pen with lancet and with testing meter which show the result on the touch screen. The device also, can connect to smart phone application through Bluetooth or other wireless connections.

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: Tools and techniques for estimating and/or predicting a patient's current and/or future blood pressure. In some cases, the tools will analyze physiological data captured from the patient against a model of blood pressure values to estimate/predict the patient's blood pressure value. In particular cases, derived parameters, such as a patient's compensatory reserve index (“CRI”) can be analyzed against such models, while in other cases, data captured from sensors can be directly analyzed against such models.

Abstract: Cartridge for a testing device and method of testing using the testing device with the cartridge is disclosed. The cartridge includes a plurality of lancet needles and a mechanism allowing the cartridge to be mounted to the testing device. The method provides for puncturing a surface of skin using the testing device by arranging the testing device adjacent or against a user's skin, triggering the testing device so that one of the plurality of lancet needles is caused to penetrate the user's skin, and rotating the cartridge to another position. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

Abstract: Disclosed is an assembly for use with a portable therapeutic device. The assembly includes a mounting housing securable to skin of a patient, and a cannula subcutaneously insertable through a passageway provided within the housing. The cannula is configured to be inserted subsequent to securing of the housing to the skin of the patient.

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: An analyte test device is constructed as an integrated, single-use, disposable cartridge which can be releasably installed into a compatible analyte test monitor. In use, the device can be used in conjunction with the monitor to lance the skin of a patient to create a blood sample and, in turn, calculate the concentration of a particular analyte in the expressed blood sample. In one embodiment, the device includes a base and a cover which are affixed together to create a test cartridge which has a substantially flat and low profile design. A lancet carrier is disposed between the base and the cover and includes a anchor fixedly mounted on the base and a lancet support member which is slidably mounted on the base, the anchor and the lancet support member being connected by a spring. A lancet is removably mounted on the lancet support member is disposed directly beneath an analyte test strip which secured to the underside of the cover.

Abstract: An implantable infusion pump possesses operational functionality that is, at least in part, controlled by software operating in two processor ICs which are configured to perform some different and some duplicate functions. The pump exchanges messages with an external device via telemetry. Each processor controls a different part of the drug infusion mechanism such that both processors must agree on the appropriateness of drug delivery for infusion to occur. Delivery accumulators are incremented and decremented with delivery requests and with deliveries made. When accumulated amounts reach or exceed, quantized deliverable amounts, infusion is made to occur. The accumulators are capable of being incremented by two or more independent types of delivery requests. Operational modes of the infusion device are changed automatically in view of various system errors that are trapped, various system alarm conditions that are detected, and when excess periods of time lapse between pump and external device interactions.

Abstract: Method and system for determining real time analyte concentration including an analyte sensor having a portion in fluid contact with an interstitial fluid under a skin layer, an on-body electronics including a housing coupled to the analyte sensor and configured for positioning on the skin layer, the on-body electronics housing including a plurality of electrical contacts, on the housing; and a data analysis unit having a data analysis unit housing and a plurality of probes, on the housing. Each of the probes configured to electrically couple to a respective electrical contact when the data analysis unit is positioned in physical contact with the on-body electronics. The one or more signals on the probes correspond to one or more of a substantially real time monitored analyte concentration level (MACL), MACL over a predetermined time period, or a rate of change of the MACL, or combinations thereof, are provided.

Abstract: Apparatuses and methods for medical monitoring physiological characteristic values such as blood glucose levels for the treatment of diabetes, are presented. The apparatuses and methods provide advanced alarm and reminder functions, as well as advanced data presentation tools to further facilitate convenient and efficient management of various physiological conditions. For example, an alarm repeat delay can be used to prevent redundant alarms for a specified period and an alarm snooze function can be used to prevent alarms generally for a specified period.

Abstract: An eye-mountable device includes an electrochemical sensor embedded in a polymeric material configured for mounting to a surface of an eye. The electrochemical sensor includes a working electrode, a reference electrode, and a reagent that selectively reacts with an analyte to generate a sensor measurement related to a concentration of the analyte in a fluid to which the eye-mountable device is exposed. The working electrode can have at least one dimension less than 25 micrometers. The reference electrode can have an area at least five times greater than an area of the working electrode. A portion of the polymeric material can surround the working electrode and the reference electrode such that an electrical current conveyed between the working electrode and the reference electrode is passed through the at least partially surrounding portion of the transparent polymeric material.

Abstract: The present invention acquires self-tracking information obtained by integrating habit information and biological signal information. Based on personal genome information and the acquired self-tracking information, characteristic information about characteristics of a user is acquired, and the acquired characteristic information is output.

Abstract: A system and method for providing balanced, automated regulation of a patient's physiological condition by monitoring at least one physiological parameter and, optionally, monitoring and controlling additional physiological parameters, is disclosed. The system includes a physiological parameter monitor, an intelligent control device and a multi-channel delivery device for providing controlled intravenous delivery of at least two medications that affect the physiological condition being controlled. Control logic in the intelligent control device is derived by an algorithm based on model predictive control. The control logic includes mathematically modeled systems, empirical data systems or a combination thereof. The system of the present invention is optionally included in a networked system to provide centralized data storage and archival of system information as well as data export and query capabilities that can be used for patient file management, health care facility management and medical research.

Abstract: Systems for rapid and accurate analyte measurement are described. For example, periodic glucose measurements can be achieved with high accuracy in a critical care environment by drawing blood into a device more than once per hour, analyzing blood (for example using infrared radiation through plasma). Safety and accuracy can be achieved by improved fluid control and avoidance of clotting. Data can be conveyed (e.g., displayed) to a user. A user can be allowed to annotate the data. For example, a touchscreen or other interface can allow addition of notes on a running graph of data, indicating events or other items of interest that may correspond to data readings or to particular times.

Abstract: Monitoring systems are provided for monitoring physiologic parameters of at least one subject. The systems generally include a monitoring device or a plurality of monitoring devices, and a transmission device associated with the one or the plurality of the monitoring devices. The monitoring device(s) includes at least one physiologic sensor for measuring at least one physiologic parameter of a subject and a wireless communication unit. The transmission device includes at least one communication unit for communicating with the monitoring device wirelessly and for communicating with a remote computer. The monitoring device(s) communicate data measured with the monitoring device to the transmission device wirelessly and the transmission device communicates the measured data to the remote computer.

Abstract: Embodiments of the invention pertain to kiosks and home kits capable of providing authenticated health information for purposes of privacy, rewards, or incentives. In an embodiment of the invention, biometric measurement devices coupled with a communications infrastructure implement a system of secure information exchange and enhanced data security. In an embodiment of the invention, a user's communications device such as a cell phone is wirelessly connected through or by the machine to a call center or other responder to allow for consultation when appropriate. In an embodiment of the invention, a security/verification system is built into the kiosk, so as to be able to verify a user's identity.

Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the device has a sensing mechanism and a sensing membrane that includes at least one surface-active group-containing polymer and that is located over the sensing mechanism. The sensing membrane may have a bioprotective layer configured to substantially block the effect and/or influence of non-constant noise-causing species.

Abstract: A cartridge (700) for insertion into a meter comprises: a plurality of cartridge brackets (704) disposed on an inner wall (703) of the cartridge; a spindle (702) mounted so as to be rotatable within the cartridge and movable longitudinally in first and second directions within the cartridge; and a plurality of testing members (708) each arranged to be supported temporarily by at least one of the plurality of cartridge brackets, each of the testing members including) a hole (306) through which the spindle is located, the spindle having a plurality of spindle brackets (706) disposed on an outer surface thereof, each spindle bracket being movable between first and second positions.

Abstract: A control unit obtains, from a memory unit, data of a plurality of pre-meal blood sugar levels that are blood sugar levels measured before meals and data of a plurality of post-meal blood sugar levels that are blood sugar levels measured after meals, calculates a pre-meal average value that is an average value of the plurality of pre-meal blood sugar levels, calculates a post-meal average value that is an average value of the plurality of post-meal blood sugar levels, calculates an average blood sugar level that is an average of the pre-meal average value and the post-meal average value, calculates an estimated HbA1c value using the average blood sugar level, and displays the calculated estimated HbA1c value in a display unit.

Abstract: Methods, devices, systems, and kits are provided that buffer the time spaced glucose signals in a memory, and when a request for real time glucose level information is detected, transmit the buffered glucose signals and real time monitored glucose level information to a remotely located device, process a subset of the received glucose signals to identify a predetermined number of consecutive glucose data points indicating an adverse condition such as an impending hypoglycemic condition, confirm the adverse condition based on comparison of the predetermined number of consecutive glucose data points to a stored glucose data profile associated with the adverse condition, where confirming the adverse condition includes generating a notification signal when the impending hypoglycemic condition is confirmed, and activate a radio frequency (RF) communication module to wirelessly transmit the generated notification signal to the remotely located device only when the notification signal is generated.

Abstract: An apparatus for sensing multiple parameters includes an implantable housing and a plurality of implantable sensors disposed within the implantable housing. The plurality of implantable sensors sense parameters in a patient, such as biological or physiological parameters, for example, and each responds to an analyte in the patient. The plurality of implantable sensors may include, but is not limited to, electrochemical, potentiometric, current and optical sensors.

Abstract: Subject matter disclosed herein relates to monitoring and/or controlling levels of an analyte in bodily fluid. In particular, estimation of a concentration of the analyte in a first physiological compartment based upon observations of a concentration of the analyte in a second physiological compartment may account for a latency in transporting the analyte between the first and second physiological compartments.

Abstract: The present application relates to an apparatus for eliciting a blood sample. The apparatus has a housing having an aperture. A shaft extends in the housing and a testing member is mounted on the shaft which rotates with the shaft. A lancing member is pivotably mounted to the testing member and a lancet protrudes from the lancing member. The lancing member is arranged to pivot relative to the testing member from a retracted position to a skin penetrating position in which the lancet extends into or through the aperture when the testing member is rotated so that the lancing member is coincident with the aperture.

Abstract: The present disclosure provides a method and system for stimulating and monitoring intensity of pain experienced by one or more users. The method includes measuring the intensity of pain experienced by the one or more users on a pre-determined scale and augmented chart or physician's personal assessment using a plurality of one or more bio-markers, determining co-relation between the plurality of one or more bio-markers and the intensity of pain experienced by the one or more users, refining the co-relation between the plurality of one or more bio-markers and the intensity of pain experienced by the one or more users by learning from responses of one or more similar users, generating a pain profile for each of the one or more users and utilizing the learned information and the generated profile for monitoring, evaluating and treating the one or more users.

Abstract: A patient care surveillance system comprises a data store operable to receive and store clinical and non-clinical data associated with at least one patient, a user interface configured to receive user input of current information related to at least one patient, a monitor configured to sense at least one parameter associated with at least one patient, and further configured to generate real-time patient monitor data, a data analysis module configured to access the data store and analyze the clinical and non-clinical data, receive and analyze the current information and real-time patient monitor data, and identify at least one adverse event associated with the care of at least one patient, and a data presentation module operable to present information associated with at least one adverse event to a healthcare professional, the information including contextual information associated with the adverse event.

Abstract: A flexible system capable of utilizing data from different monitoring techniques and capable of providing assistance to patients with diabetes at several scalable levels, ranging from advice about long-term trends and prognosis to real-time automated closed-loop control (artificial pancreas). These scalable monitoring and treatment strategies are delivered by a unified system called the Diabetes Assistant (DiAs) platform. The system provides a foundation for implementation of various monitoring, advisory, and automated diabetes treatment algorithms or methods. The DiAs recommendations are tailored to the specifics of an individual patient, and to the patient risk assessment at any given moment.

Abstract: The present invention provides techniques for non-invasive measurement of blood related parameters based on NMR (nuclei) relaxation techniques carried out using a relatively low constant magnetic field in the range of 0.15 to 0.5 Tesla. A plurality of electromagnetic excitation pulse sequences having relatively low radiofrequencies are applied over a living tissue placed in the magnetic field and blood related parameters of the examined subject are determined using a plurality of nuclear spin echo signals received from the tissue in response to the applied excitation sequences, thereby allowing to improve the accuracy of the obtained signals and substantially reducing the time duration of the process.

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: A cartridge for a testing device and method of testing using the testing device with the cartridge is disclosed. The cartridge includes a plurality of lancet needles, a plurality of test strips, and a mechanism allowing the cartridge to be mounted to the testing device. The method provides for puncturing a surface of skin using the testing device by arranging the testing device against a user's skin, triggering the testing device so that one of the plurality of lancet needles is caused to penetrate the user's skin, placing an amount of blood on one of the plurality of test strips, and rotating the cartridge to another position.

Abstract: Methods and devices for the diagnosis and treatment of diabetes are disclosed in which an analyte concentration within a peritoneal fluid of a human subject may be determined by implanting an analyte sensor apparatus in the subject where the apparatus may comprise a housing and a flexible sensing catheter which has a lumen with a plurality of apertures and an exterior surface with an analyte sensor affixed thereto. The catheter may comprise a proximal end attached to the housing and the remaining end may be positioned freely within the peritoneal space to contact peritoneal fluid where an analyte concentration in the peritoneal fluid may be sensed. The housing may be anchored at a subcutaneous site proximate the peritoneal space. The sensed analyte concentration may then be transduced into a transmittable electrical signal.

Abstract: A processor module includes memory having instructions for executing functions of a handheld diabetes management device and a processor that selectively executes the instructions. Battery terminals electrically connect the processor module with a re-chargeable battery. A receptacle is configured in accordance with a universal serial bus (USB) standard. A component is included for communicating information from the handheld diabetes management device to a user or another device. A multiplexer module relays power from the receptacle to a bus voltage node. A first switching device is connected between the bus voltage node and a second voltage node. The component receives power from the second voltage node. A second switching device is connected between the bus voltage node and a third voltage node. The processor module is directly connected to the bus voltage node and to the third voltage node.

Abstract: A reader for communicating with both an eye-mountable device and a display device is provided. The reader can transmit radio frequency power to a tag that is part of the eye-mountable device. The reader can communicates with the tag using a first protocol. Communicating with the tag can include having the reader request data from the tag and receive the requested data from the tag. The reader can process the received data. The reader can store the processed data. The reader can communicates with the display device using a second protocol, where the first and second protocols can differ. Communicating with the display device can include having the reader transmit the stored data to the display device. The display device can receive the transmitted data, process the transmitted data, and generate one or more displays including the transmitted and/or processed data.

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 describes improved systems and methods for attaching external medical devices to the body of a patient using a multilayer attachment apparatus. Medical devices that require attachment to the body, including monitoring devices, drug-infusing devices and the like, can utilize embodiments of the attachment apparatus and method described herein. Embodiments of the invention include new adhesive and hook and loop attachment mechanisms and methods for using embodiments of the multilayer attachment apparatus to attach medical device and/or medical device components to the body.

Abstract: A system comprising processor means configured to collect and store data, display means controlled by the processor means, and switch means allowing the system to be set in a display mode or a data transfer mode. When the system is in the display mode the processor means is configured to control the display means to display stored data using user-readable numeric values, and when in data transfer mode the processor means is configured to generate a machine-readable-only visual representation of the stored data, and control the display means to display the machine-readable-only visual representation.

Abstract: Apparatus for eliciting a blood sample, the apparatus comprising; a testing member rotatably mounted on a shaft; and an aperture for positioning a body part of the user relative to the edge of the testing member, wherein an edge of the testing member is shaped such as repeatedly to exert pressure on the skin of a user when the testing member is rotated.

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: 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: Body-mountable devices and methods for embedding a structure in a body-mountable device are described. A body-mountable device includes a transparent polymer and a structure embedded in the transparent polymer. The transparent polymer defines a posterior side and an anterior side of the body-mountable device. The structure has an outer diameter and an inner diameter and includes a sensor configured to detect an analyte and an antenna. The antenna includes a plurality of conductive loops spaced apart from each other between the outer diameter and the inner diameter.

Abstract: The specification describes a cartridge for insertion into a meter, the interior of the meter comprising a boss having a main body and a protrusion extending from the main body. The cartridge comprises an orientation member provided at one end of the cartridge, the orientation member comprising a recess having a cross-sectional shape corresponding to that of the boss and configured to receive the boss therein, the orientation member further comprising a ramp surrounding at least part of the portion of the recess corresponding to the main body, the portion of the recess which corresponds to the protrusion adjoining the lower end of the ramp via a step.