Abstract: A handheld diabetes management device having a database management system is disclosed. The device comprises a plurality of input modules, including a blood glucose reader, a user interface, a communications interface, and a continuous blood glucose input module. The input modules output data used to generate data records of different record types. The device further comprises N databases, each database having a different frequency range associated thereto, wherein the new record is stored in a particular database of the N databases based on the frequency range of the particular database and the frequency of the particular record type, and N is an integer greater than 1. The device further includes a database operation module that performs database operations on the N databases. The database management system provides increased reliability in the keeping of records on which medically important decisions are made.

Abstract: Methods, devices, and kits are provided for determining a recommended insulin dose to be administered to user based upon analyte data determined by an analyte sensor.

Abstract: This biological sample measuring device has the display screen of a display section (2) divided into a first display area (2a) that displays measurement values, and a second display area (2b) that displays the operating status. When the scheduled maintenance is near, a controller (9) displays an scheduled maintenance warning in the first and second display areas (2a and 2b) upon the first start-up that day, and displays an scheduled maintenance warning only in the second display area (2b) upon the second and subsequent start-ups that day.

Abstract: Methods of determining a corrected analyte concentration in view of some error source are provided herein. The methods can be utilized for the determination of various analytes and/or various sources of error. In one example, the method can be configured to determine a corrected glucose concentration in view of an extreme level of hematocrit found within the sample. In other embodiments, methods are provided for identifying various system errors and/or defects. For example, such errors can include partial-fill or double-fill situations, high track resistance, and/or sample leakage. Systems are also provided for determining a corrected analyte concentration and/or detecting some system error.

Abstract: In particular embodiments, methods, devices and systems including calibrating analyte data associated with a monitored analyte level received from an analyte sensor based on a reference measurement, determining a lag time constant associated with the calibrated analyte data, and performing lag correction of the calibrated analyte data based on the determined time lag constant are disclosed.

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 transcutaneous measurement of glucose in a host.

Abstract: Disclosed herein are systems and methods for a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes first and second working electrodes to measure analyte or non-analyte related signal, both of which electrode include an interference domain.

Abstract: A method is provided for contextualizing manual entries of blood glucose measures for a patient into a patient log of a portable computing device. The method includes: administering a structured collection procedure, where the structured collection procedure specifies two or more collection actions for obtaining blood glucose measures from a patient; generating a reminder notification for a given collection action of the structured collection procedure, where the given collection action is associated with a given event of patient; and displaying a data entry interface upon receipt of an acceptance input from a user in response to the reminder notification, where the data entry interface includes a first input for a blood glucose measure and a second input for an event associated with the blood glucose measure, such that value for the second input is defaulted to the given event from the reminder notification.

Abstract: A handheld diabetes manager is presented with an improved graphical user interface for a bolus calculator. The bolus calculator is configured to receive blood glucose measurements from a blood glucose measurement module and operates, in response to an input, to compute an insulin recommendation for a patient based in part on the blood glucose measurements. The graphical user interface for the bolus calculator includes a health adjustment screen that enables a user to input a value for health events associated with the insulin recommendation, where the input value represents a cumulative effect of the health events on insulin of the patient and the health adjustment screen presents a different icon for each of the health events associated with the insulin recommendation.

Abstract: A handheld diabetes manager communicates with an external insulin pump and includes a port for blood glucose measurement, a blood glucose measurement module, a communications module that selectively communicates wirelessly with the insulin pump, and a user interface module. The user interface module communicates with the blood glucose measurement module and the communications module and operates to provide a graphical user interface on a display of the diabetes manager. The graphical user interface includes a personal data menu screen from which a logbook option can be selected to display a logbook screen, and a trend graph option that can be selected to display a trend graph screen. The logbook screen displays a plurality of time data records. Each time data record includes blood glucose data, bolus insulin data, and carbohydrate data for a corresponding time, and a plurality of data icons indicating corresponding events.

Abstract: A handheld diabetes manager has a graphical user interface for displaying status of an external medical device and includes a port configured to receive a test strip and a blood glucose measurement module. The diabetes manager includes a communications module that selectively communicates via a wireless data link with an external medical device to receive status data pertaining to the operation of the external medical device, and a user interface module in data communication with the blood glucose measurement module and the communications module. The graphical user interface includes a status screen that presents data pertaining to a glucose measure determined by the blood glucose measurement module concurrently with the status data received from the external medical device, such that the status data of the external medical device is presented on the status screen only when the communication module is in data communication with the external medical device.

Abstract: A handheld diabetes manager has a flight mode that cooperatively interacts with an external medical device and includes a port configured to receive a test strip for blood glucose measurement, a blood glucose measurement module operable with the test strip, a communications module and a user interface module. The communications module selectively communicates wirelessly with an external medical device. The user interface module communicates with the blood glucose measurement module and the communications module and operates to provide a graphical user interface on a display of the diabetes manager. The graphical user interface includes a screen with a flight mode option. When the flight mode option is enabled and the external medical device is paired and currently communicating with the diabetes manager, the user interface module interacts with the communication module to send a command to the external medical device to turn off wireless communication of the external medical device.

Abstract: A mobile device for managing diabetes care of a patent is disclosed. The device has a data entry interface configured to receive glucose measures for the patient and store the glucose measures in a patient log residing on the device. The device has a selection module that operates to selectively analyze the glucose measure in the patient log and select a given structural collection procedure from a plurality of standardized collection procedures.

Abstract: A medical device is presented for reduced-pain blood sampling and testing. The device comprises a housing defining a finger site for supporting a user's finger or a portion thereof within said finger site during the device operation; piercing, sampling and testing assemblies sequentially actuatable to successively initiate piercing, sampling and testing operational modes of the device; a carriage at least partially accommodated within said housing and being adapted for movement with respect to said finger site between its first position corresponding to the piercing mode of the device and a second position corresponding to the sampling and testing modes of the device, the device being thereby capable of operating in the piercing, sampling and testing modes while at a static position of the user's finger.

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: Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.

Abstract: Methods, system and devices for providing improved calibration accuracy of continuous glucose monitoring system based on insulin delivery information are provided.

Abstract: An ambulatory medical device is presented. The ambulatory medical device comprises a function module to provide the intended functionality of the device, a controller module to control the device, a sound generation module with an acoustic transducer to produce an acoustic signal and a signal generator to drive the acoustic transducer with a certain frequency. The signal generation module is arranged within a housing of the device. A tuning module varies the frequency used by the signal generator to drive the acoustic transducer and determines one or more frequencies that correspond to an optimum sound level of the acoustic signal outside of the housing of the device. The optimum sound level of the acoustic signal is a maximum sound level outside of the housing of the device, and/or a maximum perceivable sound level as determined by a user.

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: 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: Disclosed are a universal adapter for the personal health device (PHD) standardization of a non-standardized healthcare device and an operating method thereof. The universal adapter includes: an adapter interface device communicating with a non-standardized healthcare device, which does not follow PHD standardization, to collect measurement data measured by the non-standardized healthcare device; and a universal adapter device receiving the measurement data from the adapter interface device, generating a PHD standard message including the received measurement data, and transmitting the PHD standard message to a PHD gateway according to a PHD standard communication scheme.

Abstract: Embodiments of the invention are directed to an optical sensor for detecting blood glucose. The sensor comprises a chemical indicator system disposed within a gap between the distal end of an optical fiber and an atraumatic tip portion, wherein the optical fiber and atraumatic tip portion are coupled by a coupling member, such as a rod or hypotube or cage that traverses the gap. The sensor further comprises a means for generating and detecting an optical reference signal unrelated to the blood glucose, such that ratiometric correction of blood glucose measurements for artifacts in the optical system is enabled.

Abstract: In aspects of the present disclosure, an auto turn on blood glucose monitoring unit including a calibration unit integrated with one or more components of an analyte monitoring system is provided. Also disclosed are methods, systems, devices and kits for providing the same.

Abstract: Disclosed is a process and composition of matter to support safe, assisted, independent living. The process is to create ubiquitous monitoring of the invention user's activities, physiology, and environment; analyze information from monitoring and sensing devices; and act on the information in a prioritized manner to address emergent events, and potentially undesirable conditions. The invention uses a software architecture and schema called Adaptive Scalable Plug&play Infrastructure for Responsive Engineering (ASPIRE).

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 electrochemical analyte sensor formed using conductive traces on a substrate can be used for determining and/or monitoring a level of analyte in in vitro or in vivo analyte-containing fluids. For example, an implantable sensor may be used for the continuous or automatic monitoring of a level of an analyte, such as glucose, lactate, or oxygen, in a patient. The electrochemical analyte sensor includes a substrate and conductive material disposed on the substrate, the conductive material forming a working electrode. In some sensors, the conductive material is disposed in recessed channels formed in a surface of the sensor. An electron transfer agent and/or catalyst may be provided to facilitate the electrolysis of the analyte or of a second compound whose level depends on the level of the analyte. A potential is formed between the working electrode and a reference electrode or counter/reference electrode and the resulting current is a function of the concentration of the analyte in the body fluid.

Abstract: Systems, devices, and methods for monitoring an analyte in a subject.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: A system and a method for determining an assessed carbohydrate to insulin ratio of a patient is described. The system and the method can comprise a memory component adapted for storing an initial set of values comprising at least one of a blood glucose level, a target blood glucose level, an insulin sensitivity, and, an estimated carbohydrate to insulin ratio. The system and the method can also comprise a bolus selection component adapted for selecting a test bolus corresponding to the determined initial set of values and a planned meal. In one implementation, the bolus selection component can receive bolus dose input from a user. In another implementation, the bolus selection component can estimate the bolus dose using a set of available inputs (e.g. the amount of carbohydrates in the planned meal). The system and the method can further comprise a user interface component adapted for receiving a confirmation that the test bolus has been administered to the patient.

Abstract: The present disclosure provides methods of processing data provided by a transcutaneous or subcutaneous analyte sensor utilizing different algorithms to strike a balance between signal responsiveness accompanied by signal noise and the introduction of error associated with that noise. The methods utilize the strengths of a lag correction algorithm and a smoothing algorithm to optimize the quality and value of the resulting data (glucose concentrations and the rates of change in glucose concentrations) to a continuous glucose monitoring system. Also provided are systems and kits.

Abstract: Devices, systems, kits and methods for increasing the skin's permeability controlled by measured skin electrical parameter are described herein. They may be used for transdermal drug delivery and/or analyte extraction or measurement. The controlled abrasion device contains (i) a hand piece, (ii) an abrasive tip, (iii) a feedback control mechanism, (iv) two or more electrodes, and (v) an electrical motor. Preferably the feedback control mechanism is an internal feedback control mechanism. In this embodiment, the abrasive tip contains two electrodes, i.e. both the source electrode and the return electrode. In another embodiment, the feedback control mechanism is an external feedback control. In the preferred embodiment for external feedback control, the device contains a co-axial or concentric arrangement of the two electrodes. In this embodiment, the abrasive tip contains the source electrode and the return electrode is located at the proximal end of the hand piece.

Abstract: Described and illustrated herein are an exemplary methods and system to display analyte sensor data. Such method may be achieved by the medical device receiving data from the analyte sensor for a period of time and displaying a target zone and a graphical representation of the data in which one or more portions of the graphical representation comprises a specific indicia of clinical risk.

Abstract: A system for testing a blood glucose measurement engine includes a host device emulator having a measurement engine port communicatively coupled to a communications port and electrically coupled to a power supply. A diagnostic computer may be communicatively coupled to the communications port of the host device emulator. The diagnostic computer may include a processor and a memory having computer readable and executable instructions. When the blood glucose measurement engine is communicatively coupled to the measurement engine port, the host device emulator simulates connection to a host device by facilitating the communication of signals between the diagnostic computer and the blood glucose measurement engine.

Abstract: Described herein are systems and methods for distinguishing between a control solution and a blood sample. In one aspect, the methods include using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or a control solution based on at least two characteristics. Further described herein are methods for calculating a discrimination criteria based upon at least two characteristics. Still further described herein are system for distinguishing between blood samples and control solutions.

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: Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.

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

Abstract: Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.

Abstract: The invention relates to an inserter for a transcutaneous sensor comprising a sensor part e.g. for registration of the bloods content of glucose. The inserter comprises a needle unit comprising a needle hub and a carrier body, and a sensor housing. The sensor housing and the needle hub are releasably connected and when they are connected, the insertion needle is placed along the sensor e.g. surrounding the sensor wholly or partly. The carrier body guides the movement relative to the housing between a retracted and an advanced position. When released the needle unit and the sensor housing are forced by a spring unit to an advanced position where the needle and sensor are placed subcutaneously. The object of the invention is to provide a disposable inserter for a transcutaneous sensor which inserter is easy and safe for the user to handle during use and to dispose of after use.

Abstract: A system and method is described for rapid charging and power management of a battery for a meter. A charger component is operably associated with the meter and is capable of executing a rapid charge algorithm for a rechargeable battery. The algorithm includes monitoring for a connection to an external power source and implementing a charging routine of a battery at a first charge rate and then at a second charge rate. The second charge rate is lower than the first charge rate. A temperature rise in the rechargeable battery due to the first charge rate has a negligible heat transfer effect on the fluid sample. The meter can also include a power switch for controlling current flow to a battery fuel gauge. The power switch is open when the meter enters into a sleep mode. The state of battery charge is determined after the meter exits the sleep mode.

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: The present invention is directed to a method of reducing false readings in a hypoglycemic detector that includes establishing a predetermined hypoglycemic threshold, a predetermined critical threshold, a predetermined rate of change in glucose concentration where the predetermined critical threshold is below the predetermined hypoglycemic threshold. A first sampling rate is then calculated based upon said predetermined hypoglycemic threshold, said predetermined critical threshold, and said predetermined rate of change in glucose concentration.

Abstract: A patient monitoring network pertaining to blood glucose and other analyte measurements includes wireless blood glucose or other analyte measuring devices and a networked computer or server. Each monitoring device is associated with a patient and is configured to measure the glucose level or other analyte from a given blood sample via inserted test strips, transmit the measurements to the networked computer, and display received messages. The messages may relate to the current or past measurements, or may include an alert prompting the user of the monitoring device to order more supplies, such as test strips. The measurements received by the networked computer may be stored in a record of a database, which may be accessed by a remote computer. The remote computer may also access a script editor to edit certain scripts which produce certain messages sent to the monitoring device.

Abstract: Methods and devices to detect analyte in body fluid are provided. Embodiments include positioning an analyte sensor in fluid contact with an analyte, detecting an attenuation in a signal from an analyte sensor after positioning during a predetermined time period, categorizing the detected attenuation in the analyte sensor signal based, at least in part, on one or more characteristics of the signal, performing signal processing to generate a reportable data associated with the detected analyte sensor signal during the predetermined time period, managing if and when to request additional reference signal measurements, and managing if and when to temporarily not display results.

Abstract: The technology relates to spray dried plasma and methods of making the same. The method includes providing plasma to a spray drying apparatus, spray drying the plasma, at the spray drying apparatus, to form physiologically active plasma powder, the spray drying apparatus configured utilizing one or more parameters, and storing the physiologically active plasma powder.

Abstract: Novel membranes comprising various polymers containing heterocyclic nitrogen groups are described. These membranes are usefully employed in electrochemical sensors, such as amperometric biosensors. More particularly, these membranes effectively regulate a flux of analyte to a measurement electrode in an electrochemical sensor, thereby improving the functioning of the electrochemical sensor over a significant range of analyte concentrations. Electrochemical sensors equipped with such membranes are also described.

Abstract: A non-invasive body information measurement apparatus, in which a blood glucose level is corrected using a blood glucose level measured with an invasive blood glucose measurement apparatus, wherein in a calibration period, measurement of body information is performed at a plurality of luminous energy levels, a plurality of estimated blood glucose levels are calculated from a plurality of characteristic quantities calculated at the various luminous energy levels and from blood glucose levels measured with an invasive blood glucose measurement apparatus, and at the end of the calibration period, the blood glucose levels measured with the invasive blood glucose measurement apparatus are compared with a plurality of estimated blood glucose levels, and in a normal measurement period a light source is controlled so that measurement is performed at a luminous energy level corresponding to the estimated blood glucose level that satisfies the targeted accuracy.

Abstract: Systems and methods for minimizing or eliminating transient non-glucose related signal noise due to non-glucose rate limiting phenomenon such as ischemia, pH changes, temperatures changes, and the like. The system monitors a data stream from a glucose sensor and detects signal artifacts that have higher amplitude than electronic or diffusion-related system noise. The system replaces some or the entire data stream continually or intermittently including signal estimation methods that particularly address transient signal artifacts. The system is also capable of detecting the severity of the signal artifacts and selectively applying one or more signal estimation algorithm factors responsive to the severity of the signal artifacts, which includes selectively applying distinct sets of parameters to a signal estimation algorithm or selectively applying distinct signal estimation algorithms.