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

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

Abstract: A device for detection of substances transmitted into the body surrounding environment through body boundaries including a first sensor arranged to face a body boundary surface and structured to locally detect a substance indicative of at least one targeted substance of interest transmitted through the body boundary surface in proximity of the body boundary surface of a monitored subject. The device also includes a second sensor arranged to face in an opposite direction from the body boundary surface and structured to detect in a surrounding environment at least one substance indicative of the targeted substance of interest transmitted through the body boundary surface of the monitored subject. In addition the device further include an electronic circuit structured to receive and process the signals generated by the first and second sensors, and to determine presence of the at least one targeted substance of interest.

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

Abstract: In a process for producing a microneedle (12) that can be inserted into body tissue in which a needle tip (20) and a preferably capillary collecting channel (14) having a distal inlet for body fluid formed at the needle tip (20) are formed, it is provided that at least part of a preform (38) prefabricated from a flat material is shaped into a tubular structure (22) so that the collecting channel (14) is at least substantially annularly closed in the cross-section in the area of the tubular structure (22).

Abstract: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

Abstract: 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: 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 processing sensor data, including calculating a rate of change of sensor data and/or determining an acceptability of sensor or reference data.

Abstract: A portable apparatus for measuring a glucose level of a user having: a card-like member; a processor within the card-like member; at least one glucose sensor comprising a reagent, the glucose sensor generating a signal indicative of a measured glucose level upon application of a blood sample to the glucose sensor, wherein the glucose sensor is fixed to the card-like member and operably coupled to the processor; and at least one cover alterable between a first position in which the glucose sensor is covered and a second position in which the glucose sensor is exposed for use.

Abstract: The invention relates to a method and a device for predicting a glycaemic profile of a subject. A multistage algorithm is employed comprising a prediction setting stage specifying a functional space for the prediction and a prediction execution stage specifying a predicted future glycaemic state of the subject in the functional space as a continuous function of time.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: A handheld diabetes management device for managing blood glucose test data and continuous glucose monitoring data includes a port configured to receive a test strip, a wireless transceiver, a communications processor, and a user interface processor. The communications processor communicates with the wireless transceiver to periodically collect glucose measurement data from a continuous glucose monitoring device and to store the glucose measurement data in a first data storage module. The communications processor is operable to consume electrical power at a first rate. The user interface processor communicates with the communication processor to receive the glucose measurement data and operable to display the glucose measurement data on the device. The communications processor operates asynchronously from operation of the user interface processor to collect the glucose measurement data and the user interface processor operates to consume electrical power at a second rate that is higher than the first rate.

Abstract: Methods, devices, and systems for calibrating an analyte sensor are provided. Embodiments include determining a sensitivity value associated with an analyte sensor, retrieving a prior sensitivity value associated with the analyte sensor, determining whether a variance between the determined sensitivity value and the retrieved prior sensitivity value is within a predetermined sensitivity range, determining a composite sensitivity value based on the determined sensitivity value and the retrieved prior sensitivity value, and assigning a successful calibration sensitivity value based on the retrieved prior sensitivity value when the variance is within the predetermined sensitivity range.

Abstract: This embodiment relates to portable handheld medical devices and in particular to handheld devices functioning without batteries. The medical devices connect to an external system and receive power. The external system may refer to any of everyday devices like a laptop or a mobile phone and so on. The medical devices operate once the power source i.e. the external device is connected. The medical devices can be shut down after use and connection between the external system and handheld medical devices is removed.

Abstract: An infusion system that includes a controller device and a communication system to provide for two-way communication between the controller device and an infusion device that controls delivery of fluids to a user's body. Either the controller device or the infusion device may be integrated with a characteristic determining device in a single housing. The housing, in turn, may include a test-strip receptacle and an illuminator disposed so as to illuminate an area covering the receptacle and a test-strip inserted therein. The illuminator may be configured to be activated automatically when a test strip is inserted into the receptacle, selectively by the user via a button, key, or similar mechanism, and/or when the ambient light level, measured, e.g., with a light sensor, falls below a predetermined intensity. The illuminator may be a LED emitting white light, and may provide illumination at various levels of intensity.

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: It is provided with a medical inquiry processing unit for acquiring the response to a medical inquiry presenting medical inquiry items to a person to be examined, a nutrient requirement amount calculating unit for calculating the nutrient requirement amount of the person to be examined from the response to the medical inquiry, a nutritional supplement suggesting unit for suggesting the blend of a nutritional supplement based on the nutrient requirement amount of the person to be examined and a nutritional supplement blending unit for blending nutrients to prepare the nutritional supplement based on the blend of the nutritional supplement.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: An apparatus for detecting a physiological condition in a person, comprising input means for receiving at least two physiological parameters, processing means for determining, from the received physiological parameters, a result signal indicative of the presence or onset of said physiological condition, and output means for generating an output indicative of the result signal. The apparatus further comprises storage means for storing a look-up table comprising a plurality of entries, each entry corresponding to a pre-calculated probability of the presence or onset of said physiological condition, the pre-calculated probabilities being determined by means of a mathematical process from previously monitored physiological parameters; and the processing means is adapted to process the received at least two physiological parameters to identify one of the plurality of entries of the look-up table, and to determine said result signal from the identified entry of the look-up table.

Abstract: According to some embodiments of the present disclosure, a device and method for determining an allowable amount of blood glucose (bG) of a patient is disclosed. The method further includes receiving a current bG measurement, determining a target bG value, and determining a correction delta bG value based on one or more advice history records. The method includes determining a correction meal rise value and determining a maximum allowed bG value based on the target bG value, the correction delta bG value, and the correction meal rise value. The method includes setting the allowable amount of bG value equal to the maximum allowed bG value when the current bG measurement is greater than the target bG value and determining the allowable amount of bG value using the target bG value and the correction delta bG value when the current bG measurement is less than the target bG value.

Abstract: Systems and methods for dynamically and intelligently estimating analyte data from a continuous analyte sensor, including receiving a data stream, selecting one of a plurality of algorithms, and employing the selected algorithm to estimate analyte values. Additional data processing includes evaluating the selected estimative algorithms, analyzing a variation of the estimated analyte values based on statistical, clinical, or physiological parameters, comparing the estimated analyte values with corresponding measure analyte values, and providing output to a user. Estimation can be used to compensate for time lag, match sensor data with corresponding reference data, warn of upcoming clinical risk, replace erroneous sensor data signals, and provide more timely analyte information encourage proactive behavior and preempt clinical risk.

Abstract: 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 processing sensor data, including calculating a rate of change of sensor data and/or determining an acceptability of sensor or reference data.

Abstract: Disclosed are methods, apparatuses, etc. for glucose sensor signal purity analysis. In certain example embodiments, a series of samples of at least one sensor signal that is responsive to a blood glucose level of a patient may be obtained. Based at least partly on the series of samples, at least one metric may be determined to characterize one or more non-physiological anomalies of a representation of the blood glucose level of the patient by the at least one sensor signal. A reliability of the at least one sensor signal to represent the blood glucose level of the patient may be assessed based at least partly on the at least one metric. Other example embodiments are disclosed herein.

Abstract: Embodiments of the invention provide analyte sensors having elements designed to modulate their chemical reactions as well as methods for making and using such sensors. In certain embodiments of the invention, the sensor includes an analyte modulating membrane that comprises a blended mixture of a linear polyurethane/polyurea polymer, and a branched acrylate polymer.

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: Presented herein is a modular analyte measurement system. The analyte measurement system includes an analyte meter and at least one modular attachment. In one embodiment, a modular attachment is provided to communicate with, and transmit/receive data to, one or more external devices. Embodiments of the present invention relate to modular components of the analyte measurement system.

Abstract: Method and system for providing a fault tolerant data receiver unit configured with a partitioned or separate processing units, each configured to perform a predetermined and/or specific processing associated with the one or more substantially non-overlapping functions of the data monitoring and management system is provided.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: A solute concentration measurement device is disclosed. The device may comprise a filter membrane, an exchange chamber, a sensing chamber, a separator, and a sensor. The device may be configured to be placed in fluid communication with a sample solution containing a solute and a solvent. The filter membrane may provide selective fluid communication between the solution and the exchange chamber. The separator may separate the exchange chamber from the sensing chamber and cause a change in a condition of the sensing chamber corresponding to a change of a condition of the exchange chamber. The sensor may sense the condition pertaining to the sensing chamber and calculate the concentration of the sample solution corresponding to this change.

Abstract: An aspect of an embodiment or partial embodiment of the present invention (or combinations of various embodiments in whole or in part of the present invention) comprises, but not limited thereto, a method and system (and related computer program product) for continually assessing the risk of hypoglycemia for a patient and then determining what action to take based on that risk assessment. A further embodiment results in two outputs: (1) an attenuation factor to be applied to the insulin rate command sent to the pump (either via conventional therapy or via open or closed loop control) and/or (2) a red/yellow/green light hypoglycemia alarm providing to the patient an indication of the risk of hypoglycemia. The two outputs of the CPHS can be used in combination or individually.

Abstract: Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

Abstract: A measurement device includes a housing that has an attached biosensor that includes a reagent selectively responding to a specific analyte in a biological fluid, and is configured so as to be carried by a user, an analyte measurer that measures a concentration of the specific analyte with a biosensor, and a motion measurer that measures a motion level of the housing. A living activity level calculator calculates a living activity level of the user based on the motion level measured by the motion measurer, a recorder records the living activity level calculated by the living activity level calculator, and a controller associates the concentration of the specific analyte measured by the analyte measurer with an event of living activity of the user, estimated based on the living activity level recorded in the recorder, and records them in the recorder.

Abstract: Systems and methods for weight and performance management are described. More particularly, an embodiment relates to a system and method of employing a non-invasive, real-time, continuous blood glucose monitoring device to measure glucose levels in a subject. The determined levels are subsequently used to manage the subject's caloric intake and utilization multiple times during the course of a day.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: Systems and methods for non-invasively scanning and analyzing one or more characteristics of a sample utilizing electromagnetic radiation are described. More particularly, the systems and methods utilize an electromagnetic radiation source connected to a transmitter and an analyzer connected to a receiver. A sample to be analyzed is placed between the transmitter and receiver in a variety of different manners and a frequency sweep of electromagnetic radiation is transmitted through the sample to create a series of spectral data sets that are used to create one or more composite spectrograms, which are then analyzed to determine one or more characteristics of the sample. A magnetic field can alternatively be applied around the transmitter, receiver and sample to enhance some characteristic analysis applications. Samples include inert and living items, and the characteristics include a wide variety of different applications.

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

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: A 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 system and method for modeling a blood glucose (BG) level of an individual is presented. A continuous glucose monitor (CGM) device is configured to monitor a blood glucose level of the individual. A processor is configured to receive CGM data of the individual from the CGM device, smooth the CGM data into a plurality of continuous curves, and generate an individual-level model of a BG profile of the individual using the plurality of continuous curves. The processor is configured to estimate the average blood glucose curve and inter-day variance-covariance of BG within the individual using the individual-level model, and generate a report based on the average blood glucose curve and inter-day variance-covariance of BG within the individual.

Abstract: A health and wellness social network can collect digital health and wellness information about network users and incentivize the users to engage in a more healthy and active lifestyle. In one example, a method includes receiving, at a server device, data related to a health of a user, the data being generated by a health measurement device configured to transmit the data over a network to the server device. The techniques also includes, responsive to receiving the data related to the health of the user, determining, by the server device, a wellness reward for the user, where different wellness rewards are associated with different data received from the user. The technique also includes modifying, by the server device, a user profile associated with the user to reflect the wellness reward.

Abstract: Method and apparatus for communicating with a sealed electronic device via the electronic device's existing data ports for programming, testing configuration or diagnosis of the electronic device such as a transmitter unit for use in a data monitoring and management system such as analyte monitoring and management system is provided.

Abstract: An embeddable module for measuring a blood glucose level may be embedded in an external host and may comprise a host interface, a microcontroller, an ASIC, a temperature measuring element, and a measurement strip port. The host interface may permit electrical communication between the host and the microcontroller. The microcontroller and ASIC may communicate with each other and may work together to measure the blood glucose level of a blood sample. The measurement strip port may receive a removable measurement strip having the blood sample. The ASIC may communicate with the measurement strip port such that the ASIC may receive signals from the measurement strip port related to the blood glucose level of the blood sample. The temperature measuring element may be in electrical communication with the microcontroller and may measure the temperature of the module and transmit signals to the microcontroller related to the temperature of the module.

Abstract: A body fluid component measuring system which is capable of continuous measurement and reduces downtime includes a sensor unit which is positionable indwelling in the skin of a subject and which measures a predetermined body fluid component included in the body fluid of the subject; and a transmission unit which is detachably attached to the sensor unit and which calculates blood glucose level based on measurement data measured by the sensor unit, and transmits the calculated blood glucose level to a display unit. Identification information for establishing communication between the transmission unit and the display unit is stored in the sensor unit, and the transmission unit, upon activation, uses the identification information read out by the sensor unit to establish communication with the display unit.

Abstract: Apparatus, method, system and kit for receiving a plurality of continuous analyte sensor values for corresponding reference analyte values, calculating a rate of change value for the continuous analyte sensor values, defining a plurality of data range windows of the reference analyte values, evaluating the corresponding continuous analyte sensor values, the rate of change values, the reference analyte values, and/or a plurality of corresponding difference values for the plurality of data range windows, and determining a best fit based on the evaluation of the plurality of data range windows are provided.

Abstract: In one aspect, a diagnostic test system includes a receptacle, optical detectors, and a logic circuit. Each of the optical detectors has a corresponding view in the receptacle and produces an electrical signal at a respective detector output in response to light from the corresponding view. The logic circuit includes logic inputs that are respectively coupled to the detector outputs and that produce an output logic signal corresponding to a logical combination of signals received at the logic inputs. In another aspect, respective detection signals are produced in response to light received from respective ones of multiple views of the test strip, and at least one output logic signal corresponding to a respective logical combination of the detection signals is generated.

Abstract: Various system embodiments include a glucose control input, a low physical activity input, and a diabetic therapy delivery system adapted to respond to the glucose control input and the low physical activity input to deliver diabetic therapy. According to various embodiments, the diabetic therapy includes an anti-arrhythmia therapy, a hypertension therapy, a neural stimulation therapy adapted to reduce a risk of myocardial infarction, a neural stimulation therapy adapted to be applied after a myocardial infarction to reduce an infarct area, a neural stimulation therapy adapted to reduce a risk of sudden cardiac death, a therapy adapted to secrete insulin, or a therapy to reduce a workload of a diabetic heart. Other aspects and embodiments are provided herein.

Abstract: A blood glucose meter integrated with a computing or communication device that includes a test strip receiving device that is coupled to and powered by the communication port or jack of the computing or communication device and utilizes a blood glucose meter application that resides in the memory and is operated by the microprocessor of the computing or communication device. Advantageously, blood glucose meter data can be transmitted by the computing or communication device to a memory storage “cloud” for later review and/or manipulation by a user, a doctor, and/or the like.