Abstract: An ambulatory medical device for detecting acceleration, temperature, and/or humidity conditions in or around the medical device is provided. The medical device includes one or more acceleration, thermal, and/or humidity sensors which detect acceleration, temperature, and/or humidity conditions in or around the medical device. In response to detected conditions, the medical device may, among other things, alter the operation of the device, provide an alarm or warning to the user, or transmit data about the detected conditions to another device.

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 methods, apparatuses, etc. for glucose sensor signal reliability analysis.

Abstract: The present invention relates generally to systems, apparatuses, and methods for obtaining a fluid sample from a patient. In particular, the present invention relates to a various types of fluid access interfaces for enabling contact between a patient blood sample and blood parameter sensors for the measurement of physiological parameters and blood constituents.

Abstract: A system is provided including a continuous analyte sensor that produces a data stream indicative of a host's analyte concentration and a device that receives and records data from the data stream from the continuous analyte sensor. The data received from the continuous analyte sensor may be used to provide alarms to the user when the analyte concentration and/or the rate of change of analyte concentration, as measured by the continuous analyte sensor, is above or below a predetermined range. Data received from the continuous analyte sensor may also be used to prompt the diabetic or caregiver to take certain actions, such as to perform another single point blood glucose measurement. The device may provide for toggling between modes that allow or prevent the display of glucose concentration values associated with the continuous glucose sensor.

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: The subject matter disclosed herein relates to systems, methods and/or devices for calibrating sensor data to be used in estimating a blood glucose concentration. A relationship between sensor signal values and reference readings may be used to estimate a relationship between sensor signal values and measurements of blood glucose concentration.

Abstract: A transmission device includes a transmitter for transmitting various signals to a reception device, a receiver for receiving a response signal emitted from the reception device in response to the transmission of the various signals from the transmitter to the reception device, a transmission/reception controller for performing control of the receiver and the transmitter, and a reception specifier for specifying the reception timing of the intermittent reception of the reception device when a response signal from the reception device has been received. The transmission/reception controller decides the timing at which the transmission of the various signals will begin, and how long the transmission will last, on the basis of the reception timing specified by the reception specifier.

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.

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 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: An analyte sensor for use in connection with a biofluid is described. The analyte sensor may comprise any suitable interface between the biofluid and a derivative of the biofluid and any suitable transducer of information concerning an analyte. At least one catalytic agent is provided in a locale or vicinity of the interface. The catalytic agent, such as a proteinaceous agent or a non-proteinaceous, organic-metal agent, is sufficient to catalyze the degradation of reactive oxygen and/or nitrogen species that may be present in the vicinity of the interface. An analyte-sensing kit and a method of sensing an analyte are also described.

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 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: A method for monitoring blood glucose (bG) levels of a diabetic user. The method may be implemented on a non-transitory computer readable medium adapted to run on a processing subsystem, the processing subsystem forming a portion of a handheld diabetes management device for monitoring the bG levels of a diabetic user and determining a correction bolus to be provided to the user. The method may comprise using a memory to store information in a plurality of different time blocks. The information may include a plurality of differing user defined health events that each include a predetermined associated percentage value set by the user by which a correction bolus calculation will be modified to account for one of an increase or a decrease in insulin associated with each one of the defined health events. The processing subsystem may be used to communicate with the memory and to obtain the information and to calculate therefrom the correction bolus.

Abstract: A system for managing power consumption of a handheld diabetes management device and limiting effects of temperature on operations performed by the handheld diabetes management device comprises a blood glucose measuring module, a temperature sensing module, and a power management module. The blood glucose measuring module selectively measures blood glucose in a blood sample and generates a status signal indicating a status of operation of the blood glucose measuring module. The temperature sensing module senses an internal temperature of the handheld diabetes management device and estimates an ambient temperature external to the handheld diabetes management device. The power management module deactivates one or more components of the handheld diabetes management device based on the status of operation of the blood glucose measuring module when the internal temperature of the handheld diabetes management device exceeds a threshold temperature.

Abstract: A handheld diabetes management device for providing enhanced illumination includes a housing with an access port and a light aperture. The housing further includes a coupling member on an inner surface thereof. Furthermore, the device includes a measurement engine housed within the housing and communicating with the access port for analyzing body fluid disposed on a dosing area of a diabetes test element. Also, the device includes a circuit board communicating with the measurement engine. The device further includes a light source mounted to the circuit board and a light pipe coupled to the housing via the coupling member. The light pipe is disposed adjacent the light source to receive light from the light source travelling in a first direction. The light pipe redirects the light along a second direction to be emitted out of the housing through the light aperture toward the dosing area of the diabetes test element.

Abstract: A method of improving updatability of entry, adherence, and exit criteria stored in memory of a handheld diabetes management device, the method includes: providing the handheld diabetes management device with a blood glucose (bG) measurement engine that measures a bG level in a sample of blood of a user and that generates sample data indicative of the bG level; providing the handheld diabetes management device with the memory and a touchscreen display; providing the handheld diabetes management device with a processor module that is in communication with the bG measurement engine, the touchscreen display, and the memory; storing firmware that is executable by the processor module for performing operations to carry out a structured bG test in a non-modifiable portion of the memory; and storing the entry, adherence, and exit criteria in a modifiable portion of the memory.

Abstract: A handheld diabetes management device having a plurality of communication modules for communicating with a plurality of medical devices via a shared antenna or multiple antennas, where the handheld diabetes management device includes a first communication module, a second communication module, and an arbitration module. The first communication module selectively communicates in a first frequency band with an insulin infusion pump external to the handheld diabetes management device via a first antenna using a first wireless communication protocol. The second communication module selectively communicates in the first frequency band with a continuous glucose monitor external to the handheld diabetes management device via a second antenna or the first antenna using a second wireless communication protocol.

Abstract: A handheld diabetes management device includes a blood glucose measurement engine that measures a blood glucose level of a patient. The device includes a physical port that is exposed at an exterior of the device. The device includes a processing module that includes first, second, and third physical interfaces that are internal to the device. The device includes a multiplexing module that alternatively connects the physical port to one of the first, second, and third physical interfaces of the processing module. The processing module selectively operates the first physical interface using first and second modes. When an external host is connected to the physical port, the processing module selectively transfers information based on the blood glucose level to the external host using the first mode. When the external host is connected to the physical port, the processing module selectively provides file access to the external host using the second mode.

Abstract: A medical device or medical software is provided that supports system extensibility for diabetes care. The medical device or software is comprised of an application and particular data structures that support diabetes care. The data structures include: a patient class that has attributes and methods associated with a person receiving medical treatment for diabetes; a patient log class that has a composition relationship with the patient class and attributes and methods that log actions taken by the patient; a treatment plan class that has a composition relationship with the patient class and attributes and methods that define a series of planned actions related to medical treatment of the patient; and an adherence class that has a composition relationship with the patient log class and attributes and methods define relationships between actions planned for the patient and actions taken by the patient.

Abstract: The present teachings provide a system for modifying insulin therapy support parameters such as warning limit data and time block data on a hand-held diabetes management device. The system can include a graphical user interface module that creates a graphical user interface having a plurality of bar structures positionable on or between a first line that indicates an upper limit and a second line that illustrates a lower limit. Each of the bar structures can have a first side that indicates a start time of a time window opposite a second side that indicates an end time of the time window and a third side that indicates a lower target value for a blood glucose level opposite a fourth side that indicates an upper target value for the blood glucose level. The bar structures, the first line and the second line can be adjustable by a user input.

Abstract: A method for noninvasive blood glucose monitoring involves metabolic heat measurement and algorithm to correct interferences from environmental factors, and physiological or pathological conditions of subjects.

Abstract: A computer-implemented diabetes management system is provided for configuring a structured collection procedure implemented on a collection device having a meter that measures the concentration of glucose in blood. The system includes: a collection application that executes a structured collection procedure for obtaining measurement data from the meter and provides access to the measurement data via a communication protocol defined in accordance with IEEE standard 11073-20601; a configuration application that accesses and manipulates the parameters of the structured collection procedure using a set of action commands, where the set of action commands are defined in compliance with the communication protocol; and a collection interface that receives an action command from the configuration application, executes the received action command and issues a response command in response thereto, where the response command is defined in compliance with the communication protocol.

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 calibrating a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes one or more electrodes to measure an additional analyte. Such measurements may provide a baseline or sensitivity measurement for use in calibrating the sensor. Furthermore, baseline and/or sensitivity measurements may be used to trigger events such as digital filtering of data or suspending display of data.

Abstract: An analyte sensor including an antiglycolytic agent or a precursor thereof and a chelating agent that stabilizes the antiglycolytic agent positioned proximate to the working electrode of the sensor. Also provided are systems and methods of using the electrochemical analyte sensors in analyte monitoring.

Abstract: Access to key diagnostic medical devices requires pre-approval by a screening physician. A computer-implemented system and method for mediating patient-initiated physiological monitoring and ensuring appropriate follow up, bypassing the need for a screening physician, are provided. A request for a medical monitoring device from a patient at a point of prescriptive medicine dispensing is entered. The patient is enrolled in a medical service network that includes healthcare providers and medical services, and one or more on-call prescribing physicians. The patient is interfaced in real time with one of the prescribing physicians. Upon physician approval, the monitoring device is dispensed to the patient at the point of dispensing. Following monitoring, data from the monitoring device is retrieved for the medical service network. The retrieved data is evaluated for medical concerns.

Abstract: A biocompatible biosensor and transmitter device for temporary implantation prior to, during and following trauma-induced hemorrhaging detects the presence and level of at least one analyte and transmits detected data to a second, external device. Thus, a method for managing post-trauma patient outcomes includes providing such a biosensor and transmitter device, temporarily implanting the biocompatible biosensor and transmitter device intramuscularly in a trauma victim; and monitoring the presence and level of the at least one analyte detected by the biocompatible biosensor and transmitter device and transmitted to the external data receiving means.

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 include unique architectural arrangement in the sensor region that allows accurate data to be obtained over long periods of time.

Abstract: The invention is directed to an integrated device for sampling and testing an analyte. The device generally comprises a housing, a lancing device for sampling an analyte, a test strip for substantially capturing at least a portion of the analyte, and a display unit for displaying a result corresponding to the captured portion of the analyte. The invention is further directed to methods for sampling and testing. For example, one method comprises performing a single operation to sample an analyte, to capture the sampled analyte, to perform testing on the sampled analyte, and to display a result corresponding to the performed test. A method such as this can be carried out using an integrated sampling and testing device of the invention, for example, by placing the device the device on a test site of a subject, such as a patient, and performing the single operation to obtain a test result.

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.

Abstract: The present invention provides a method of determining disease state in an individual. A portion of the tissue of the individual is illuminated with excitation light, then light emitted by the tissue due to fluorescence of a chemical in the tissue responsive to the excitation light is detected. The HbA1c or FPG measurement of the individual (or other secondary indication of disease state) can also be determined. A model combining the tissue fluorescence and one or more of the secondary indications can be used to determine the disease state of the individual. In some embodiments, the tissue fluorescence can be used as an initial screen, and the combination with secondary indications only made for those individuals for whom the fluorescence screen indicates an increased likelihood of disease.

Abstract: A structure, method, and computer program product for a diabetes control system provides, but is not limited thereto, the following: open-loop or closed-loop control of diabetes that adapts to individual physiologic characteristics and to the behavioral profile of each person. An exemplary aspect to this adaptation is biosystem (patient or subject) observation and modular control. Consequently, established is the fundamental architecture and the principal components for a modular system, which may include algorithmic observers of patients' behavior and metabolic state, as well as interacting control modules responsible for basal rate, insulin boluses, and hypoglycemia prevention.

Abstract: A blood glucose monitoring kit includes a case constructed in the form of a bi-fold wallet which comprises an upper flap and a lower flap that are connected together through a fold. The case includes an outer layer constructed out of a water resistant and soft fabric and an inner layer constructed out of a water resistant material, the outer and inner layers being sewn together about their peripheries. A layer of cushioned material is preferably disposed between the inner and outer layers to provide the case with a soft feel. Blood glucose monitoring electronics are preferably integrated directly into the upper flap of the case, the electronics including a printed circuit board (PCB), a test port mounted on the PCB and a display mounted on the PCB. Preferably, the upper flap is provided with an opening through which the test port is externally accessible. Additionally, the upper flap is provided with a window through which the display is externally visible.

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

Abstract: 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: New methods and systems for noninvasive glucose monitoring and sensing with electromagnetic waves or ultrasound are disclosed. The methods are based on absolute or relative measurement of tissue dimensions (or changes in the dimensions) including, but not limited to: thickness, length, width, diameter, curvature, roughness as well as time of flight of ultrasound and optical pulses and optical thickness, which change with changing blood glucose concentrations. By measuring noninvasively absolute or relative changes in at least one dimension of at least one tissue or tissue layer or absolute or relative changes in time of flight of ultrasound or optical pulses, one can monitor blood glucose concentration noninvasively.

Abstract: An implantable device for constant collection and dosage of glycemia with real-time monitoring, with no need of external collection by punctioning which is constituted by a metal compartment, hermetically sealed with the cap, containing at least a micro-computerized mini-center fed by the battery or similar, which is externally rechargeable. The device contains a sensor which collects a portion of the circulating blood and reads glycemia levels in real time, sending reading information through the transmission component. The device is connected to an inlet catheter with its collecting edge duly implanted by means of punctioning at the subclavian vein, to deviate a small flow of blood to pass through within said dosage and monitoring device, thus allowing the sensor to verify the glycemic dosage and following its natural course by exiting the exit catheter through the outlet edge, thus returning to the blood current within said subclavian vein.

Abstract: A system and method is described for non-invasive monitoring of blood glucose levels. The system includes a pulse-sensor unit configured to detect a pulse wave travelling through a blood vessel and a processor unit configured to determine pulse wave velocity, to calculate the blood density and so to determine blood glucose level. Various embodiments include pulse-sensor arrays and wearable units configured to communicate with insulin pumps worn about the person of the subject.

Abstract: An approach to instrumentation and telemetry of physiological and physical parameters of an animal and its environment has particular application to horses. This approach improves the effectiveness of one or more of evaluation, diagnosis, care conditioning or monitoring of animals because it does not require use of restrictive equipment such as force plates or treadmills, and it can provide objective and quantitative data that is complete, accurate, precise and reproducible, and this data can be obtained under real-world conditions, for either or both of more or less real-time or continuous processing of data to perform the monitoring or diagnosis. That is, in such an approach objective and quantitative data can be collected under real-world conditions and this data can be processed and the information can be displayed in a form that is familiar to experts in real-time locally, or can be stored for subsequent retrieval or transmitted for remote review.

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.

Abstract: A product and method for implementing and maintaining a “medical food” program for a patient having special nutrient needs in which a medical food is prescribed for said patient and for facilitating the required ongoing supervision of said patient and evaluation of the effectiveness of the prescription, the product comprising software permitting input of basic patient data, said method to include the input of basic patient information, the prescription and repeated input of physiological factors permitting review, supervision and evaluation of the effectiveness of the prescribed medical food.

Abstract: A limited-use blood glucose meter includes a printed circuit board assembly that includes a power source, a strip port, a strip reading device, a controller device, a bi-stable display, and a display controller. The strip reading measures a reaction between a blood sample present on the blood glucose test strip and the blood glucose reagent, generates a blood glucose signal, and calculates a blood glucose level. The controller device receives the blood glucose level from the strip reading device. The controller device provides display instructions to the display controller and the display controller provides drive voltages to the bi-stable segments such that the bi-stable segments persistently display the most-recent blood glucose level. The strip reading device performs a predetermined number of blood glucose tests and calculates a blood glucose level only for blood glucose strips associated with the disposable blood glucose meter.

Abstract: Methods and devices to detect analyte in body fluid are provided. Embodiments include enhanced analyte monitoring devices and systems.

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

Abstract: A medical system is proposed comprising at least one medical device for carrying out at least one medical function, and at least one medical consumable item interacting with the medical device in order to carry out the medical function. The medical device has at least one code reader for reading out at least one information component of an optical code on the medical consumable item. The code reader has at least one image sensor having a plurality of sensors. Furthermore, the code reader comprises at least one light-optical fiber plate, which is arranged in order to guide an image of the optical code to the image sensor.

Abstract: The present invention includes a method and device for warning of hypoglycaemic attacks, which is a big problem for especially diabetics, who are in insulin treatment. It is estimated that about 1 million people have a decreased quality of life as a result of hypoglycaemic attacks. The invention collects EEG signals from people, who must be supervised and analyses these in order to detect characteristic changes in the EEG signals, which occurs in advance of a hypoglycaemic attack. In a preferred embodiment the EEG signals are collected with subcutaneously placed electrodes and the signals are lead via wires drawn under the person's skin to a similar subcutaneously placed signal processing unit. The signal processing analyses the EEG signals and when the pre-seizure characteristics signal changes are detected, a warning signal is given to the person from an alarm giver build into the signal processing unit, e.g. in form of a vibrator.

Abstract: A diabetes management system for predicting a future blood glucose value of a patient and for recommending a corrective action to the patient when the future blood glucose value lies outside of a target range. The system includes a patient-operated apparatus for measuring blood glucose values and for storing data relating to insulin doses administered to the patient. The apparatus predicts the patient's future blood glucose value based upon the patient's current blood glucose value, the fraction of insulin action remaining from the insulin doses, and the patient's insulin sensitivity. The apparatus also determines the corrective action for the patient when the predicted blood glucose value lies outside of a target range. The system also includes a physician computer in communication with the apparatus for receiving the blood glucose values and insulin dose data and for calculating an adjusted insulin sensitivity for use in subsequent predictions.