Abstract: Systems and methods for determining an in vivo concentration of a small molecule substance of interest is provided that takes advantage of the semi-permeable nature of skin, which allows small molecules to passively diffuse through the skin and onto the skin surface. The systems and methods of the present invention allow for the collection of these small molecules that have passively diffused through the skin without skin disruption or breaking of the skin. The systems and methods of the present invention are noninvasive, painless and safe even for delicate newborns, and are particularly suited for the determination of blood glucose in newborns and infants in a noninvasive manner.

Abstract: Provided herein is a stabilized oxygen transport matrix that includes a reversible oxygen binding protein, such as hemoglobin, immobilized throughout the stabilized oxygen transport matrix. The stabilized oxygen transport matrix is used to transport oxygen and can be used as an oxygen transport region and a reaction region of an analyte sensor, such as an implantable glucose sensor. The reversible binding protein can also function as an oxygen probe within the analyte sensor.

Abstract: Membrane systems incorporating silicone polymers are described for use in implantable analyte sensors. Some layers of the membrane system may comprise a blend of a silicone polymer with a hydrophilic polymer, for example, a triblock poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) polymer. Such polymeric blends provide for both high oxygen solubility and aqueous analyte solubility.

Abstract: Disclosed are methods, apparatuses, etc. for glucose sensor signal stability 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 assess an underlying trend of a change in responsiveness of the at least one sensor signal to the blood glucose level of the patient over time. A reliability of the at least one sensor signal to respond to the blood glucose level of the patient may be assessed based at least partly on the at least one metric assessing an underlying trend. Other example embodiments are disclosed herein.

Abstract: An apparatus and method for measuring augmented osmotic pressure in a reference cavity is provided, in which the device comprise a substrate frame (4) attached to a support structure (1) in which a plurality of transducer devices (2) are buried. An array of osmotic membranes (3) is integrated by the support structure and which acts to facilitate a trans-membrane pressure gradient as a function of the osmotic pressure change in a sealed cavity (7). The sealed cavity is formed by rigid substrate materials (5,6) in which the membranes, support structure and transducer devices only will be subject to induced stress in response to augmented osmotic pressure and thereby generate a pressure induced signal change observed from the transducer devices. The transducer devices may be arranged as piezoresistive elements, as micromechanical switches, as variable capacitive elements or as an optical light source and detector.

Abstract: Method and apparatus for providing multiple data receiver units in a data monitoring and management system such as analyte monitoring system where a first data receiver includes all of the functionalities for the data monitoring and management system receiver unit, and a second data receiver unit is configured with limited functions to provide application specific convenience to the user or patient is disclosed.

Abstract: Systems, devices, techniques and methods are disclosed for implementing an actuator mechanism of an analyte testing device. In one aspect, a method to test an analyte includes advancing an analyte sensor from a first position within a sensor cartridge of an analyte testing device to a second position that exposes at least a portion of the analyte sensor outside of the device, advancing a lancet projecting component from an initial position to a cocked position for a subsequent projection of a lancet, in which the advancing the analyte sensor and the advancing the lancet projecting component are initiated by a single operation, projecting the lancet to expose at least a portion of the lancet outside of the device, receiving a testing sample including an analyte at the exposed portion of the analyte sensor, processing the testing sample to determine a parameter of the analyte, and ejecting the analyte sensor from the device.

Abstract: A method, system, and computer program product related to the maintenance of optimal control of diabetes, and is directed to predicting the long-term exposure to hyperglycemia, and the long-term and short-term risks of severe or moderate hypoglycemia in diabetics, based on blood blucose readings collected by a self-monitoring blood glucose device. The method, system, and computer program product pertain directly to the enhancement of existing home blood glucose monitoring devices, by introducing an intelligent data interpretation component capable of predicting both HbA1c and periods of increased risk of hypoglycemia, and to the enhancement of emerging continuous monitoring devices by the same features. With these predictions the diabetic can take steps to prevent the adverse consequences associated with hyperglycemia and hypoglycemia.

Abstract: Methods and apparatus for providing multi-stage signal amplification in a medical telemetry system are provided.

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: A sensor system includes a sensor and a sensor electronics device. The sensor includes a plurality of electrodes. The sensor electronics device includes a connection detection device, a power source, and a delay circuit. The connection detection device determines if the sensor electronics device is connected to the sensor and transmits a connection signal. The delay circuit receives the connection signal, waits a preset hydration time, and couples the regulated voltage from the power source to an electrode in the sensor after the preset hydration time has elapsed. Alternatively, the sensor electronics device may include an electrical detection circuit and a microcontroller. The electrical detection circuit determines if the plurality of electrodes are hydrated and generates an interrupt if the electrodes are hydrated. A microcontroller receives the interrupt and transmits a signal representative of a voltage to an electrode of the plurality of electrodes.

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 a host's peripheral vein or artery.

Abstract: A device for monitoring a diabetic patient includes continuous glucose monitoring system that is configured to generate glucose data indicative of the patient's actual glucose level. An continuous subcutaneous insulin infusion pump is configured to inject insulin into the patient and that is configured to generate insulin data regarding when and how much insulin has been injected into the patient. A processor, programmed with a discrete-time reiterative filter, calculates a predicted glucose level corresponding to a predicted glucose level currently expected to be sensed by the continuous glucose monitoring system, based on the insulin data and the glucose data over time and is also programed to generate an alert when the actual glucose level is different from the predicted glucose level by a predetermined amount. An alert generating device is coupled to the processor and is configured to generate an aesthetically-sensible event corresponding to the generation of the alert.

Abstract: Methods and systems for providing data communication in medical systems are disclosed including a data communication unit to transmit one or more signals related to the monitored analyte level received from the analyte sensor to a remote device.

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: A long term analyte sensor for measuring at least one analyte in the body of a user and which includes a housing, a plurality of analyte contacting sensor elements and at least one structure for relaying information away from the sensor. This plurality of analyte contacting sensor elements are typically disposed in an array. The analyte sensor further includes at least one sensor protection membrane that is controllable in a manner such that sensor elements may be activated (e.g. exposed to the external environment) at different times so as to extend the useful life of the sensor. In illustrative analyte sensors, the analyte is glucose.

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: Methods, devices and systems for receiving an instruction to determine a glycemic variation level, retrieving a stored metric for determining the glycemic variation level, retrieving one or more parameters associated with the retrieved metric analysis, determining the glycemic variation level based on the retrieved one or more parameters for the retrieved metric analysis, and outputting the determined glycemic variation level when it is determined that the retrieved one or more parameters associated with the retrieved metric analysis meets a predetermined condition are disclosed.

Abstract: A blood glucose monitor for non-invasive, in-vivo characterisation of a blood glucose level in a living body, the monitor comprising: a microwave resonator having a resonant response to input microwaves and designed such that said response will experience a perturbation by a living body in proximity or contact with the resonator; and detection means for detecting changes in said resonant response from which said level can be characterised.

Abstract: A sensor assembly includes: an electrically insulating and flexible body (13), in the form of a plate having a first face (13a) and a second face (13b); and a first sensor (15; 315) and a second sensor (17), which are incorporated in the body (13). The first sensor (15) is set between the first face (13a) and the second sensor (17), and the second sensor (17) is set between the first sensor (15) and the second face (13b).

Abstract: Provided is a non-invasive method of determining glycogen stores including: receiving an ultrasound scan of at least a portion of a target muscle; and evaluating at least a portion of the ultrasound scan to determine glycogen store within the target muscle.

Abstract: An implantable medical device, implantable cardiac stimulation device, implantable defibrillator or pacemaker provides continuous monitoring of blood-glucose concentration in the blood of a patient. Blood-glucose concentration and blood-glucose concentration trends are calculated by measuring changes in the hematocrit of the patient. An external blood-glucose monitor may be used to provide blood-glucose calibration values to the implantable device to enhance accuracy of blood-glucose concentration values. The implantable device compares the blood-glucose concentration and/or concentration trends with acceptable limits and generates appropriate warning signals. The implantable device may optionally control one or more therapeutic devices to maintain blood-glucose concentration within an acceptable range. The enhanced control of blood-glucose concentration reduces the risk of arrhythmia and enhances the effectiveness of cardiac pacing and/or defibrillation.

Abstract: When diabetics undergo a hyperglycemic or hypoglycemic event, their cognitive-motor function can be severely impaired. This has contributed to a positive correlation between diabetes and traffic incidences. Thus, there are ongoing efforts to improve blood glucose monitoring to improve safety of diabetic drivers.

Abstract: Devices and methods for determining the concentration of an analyte are provided. Embodiments of the subject devices include analyte monitoring systems that include an analyte sensor capable of providing clinically accurate analyte data without a substantial time delay after operably positioning the sensor in a patient. Embodiments of the subject methods include operably positioning an analyte sensor in a patient and obtaining clinically accurate analyte data without a substantial time delay after the positioning. Also provided are systems and kits for use in analyte monitoring.

Abstract: Method and system for providing an integrated analyte monitoring system and on-body patch pump with multiple cannulas and a sensor combination is provided.

Abstract: Methods and apparatuses including determining a calibration parameter associated with a detected analyte value, calibrating the analyte value based on the calibration parameter, and dynamically updating the calibration parameter are disclosed. Also provided are systems, kits, and computer program products.

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

Abstract: Method and apparatus for inserting at least a portion of a sensor into a patient is provided.

Abstract: Method and apparatus for providing a peak detection circuit comprising a diode including an input terminal and an output terminal the input terminal of the diode configured to receive an input signal, a capacitor operatively coupled to the output terminal of the diode, an output terminal operatively coupled to the capacitor and the output terminal of the diode for outputting an output signal is provided. Other equivalent switching configuration is further provided to effectively detect and compensate for a voltage droop from a power supply signal, as well as to electrically isolate the voltage droop from the system circuitry.

Abstract: Provided is a system for non-invasive determination of glycogen stores including: a glycogen evaluator structured and arranged to evaluate at least one selected portion of a scan of a selected target muscle to determine a glycogen store within the target muscle.

Abstract: The present invention relates to a sensor for percutaneous insertion and intravascular residence without an indwelling cannula. In preferred embodiments, a glucose sensor is inserted into a blood vessel using a removable cannula. After the cannula is removed, the glucose sensor remains within the blood vessel by itself and forms a seal with the patient's tissue.

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: In a method of determining insulin sensitivity in a patient, glucose level is sensed continuously. A first area under the curve representing the glucose level over time is calculated. An amount of insulin that has been administered to the patient is sensed. An estimation of insulin on board the patient is calculated based on the glucose level and the amount of insulin administered to the patient. A second area under the curve representing the insulin on board over time is calculated. Patient data indicative of at least one patient physical parameter is received. Information indicative of amount of glucose ingested by the patient during a meal is received. An insulin sensitivity output indicative of ability of insulin to stimulate glucose utilization and inhibit glucose production in the patient based on the first and second area under the curve, the patient data and the meal information is generated.

Abstract: The present invention provides a sensor head for use in an implantable device that measures the concentration of an analyte in a biological fluid which includes: a non-conductive body; a working electrode, a reference electrode and a counter electrode, wherein the electrodes pass through the non-conductive body forming an electrochemically reactive surface at one location on the body and forming an electronic connection at another location on the body, further wherein the electrochemically reactive surface of the counter electrode is greater than the surface area of the working electrode; and a multi-region membrane affixed to the nonconductive body and covering the working electrode, reference electrode and counter electrode. In addition, the present invention provides an implantable device including at least one of the sensor heads of the invention and methods of monitoring glucose levels in a host utilizing the implantable device of the invention.

Abstract: Method and system for providing continuous calibration of analyte sensors includes calibrating a first sensor, receiving data associated with detected analyte levels from the first sensor, and calibrating a second sensor based on a predetermined scaling factor and data associated with detected analyte levels from the first sensor, is disclosed.

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

Abstract: This invention provides devices, compositions and methods for determining the concentration of one or more metabolites or analytes in a biological sample, including cells, tissues, organs, organisms, and biological fluids. In particular, this invention provides materials, apparatuses, and methods for several non-invasive techniques for the determination of in vivo blood glucose concentration levels based upon the in vivo measurement of one or more biologically active molecules found in skin.

Abstract: The invention provides a medical device system comprising at least two technologies wherein at least one technology is based on bio-impedance measuring and/or at least one technology is based on spectrophotometry measurements wherein software cross analyses the results to assess the homeostasis of an individual. The technologies measure a variety of parameters. In one embodiment the bioimpedance measuring equipment measures in bipolar mode and in tetrapolar mode and the spectophotmeter measuring equipment comprises a pulse oximeter. The system and homeostasis score can be used to determine and monitor therapy for a patient.

Abstract: A system including a plurality of wireless sensors for monitoring one or more parameters of a subject is provided. The wireless sensors can be attachable to or implantable in the subject and form a network. The sensors can include a sensing component configured to detect a signal corresponding to at least one condition of the subject. The sensors further can include a communication component configured to wirelessly transmit the detected signal to at least another of the plurality of wireless sensors, and wirelessly receive a signal transmitted from at least one of the remaining sensors in the network.

Abstract: The invention relates to a viscosimetric sensor for monitoring an analyte level in a patient or in body fluids ex vivo. In particular, the invention relates to a sensor for monitoring analytes, such as glucose levels in a patient. The sensor comprises at least two hermetically closed chambers (2a, 2b), including an activation chamber and a measuring chamber, containing a sensitive fluid (3), the chambers communicating with each other through at least one microchannel (5), and a semi-permeable barrier (4) allowing the analyte to enter or leave the chambers. Each said chamber comprises at least one flexible membrane (6, 7) configured for antagonistic variations of the volume of the chambers.

Abstract: A transdermal test sensor assembly adapted to determine an analyte concentration of a fluid sample is disclosed. The assembly comprises a sensor support including at least one reservoir adapted to hold a liquid. The assembly further comprises a test sensor being coupled to the sensor support. The test sensor forms at least one aperture therein. At least a portion of the at least one aperture is adjacent to the at least one reservoir. The assembly further comprises a hydrogel composition positioned on the test sensor. The hydrogel composition is linked to the at least one reservoir via the at least one aperture.

Abstract: A tissue-implantable sensor for measurement of solutes in fluids and gases, such as oxygen and glucose, is provided. The sensor includes: i) a detector array including at least one detector; ii) a telemetry transmission portal; iii) an electrical power source; and iv) circuitry electrically connected to the detector array including signal processing means for determining an analyte level, such as glucose level, in a body fluid contacting the detectors. The sensor components are disposed in a hermetically sealed housing having a size and shape suitable for comfortable, safe, and unobtrusive subcutaneous implantation allowing for in vivo detection and long term monitoring of tissue glucose concentrations by wireless telemetry.

Abstract: Medical sensing devices and systems that transmit digital data from a first device via an ultrasonic digital modem to a receiver such as a smartphone. Methods of transmitting digital biological data by ultrasound are also described.

Abstract: A device and a method are disclosed for positioning a body part (16) on an analytical device (14) for body fluids includes a flexible compression element (24) for pressing against the body part (16) while increasing the pressure and a rigid support part (26) to hold the compression element (24) on a housing (12) of the analytical device (14). The compression element (24) has an engaging member (34) for the body part (16) which can be pressed into the housing (12) such that a withdrawal region (56) of the body part (16) is exposed in the interior (18) of the housing (12) in order to remove liquid.

Abstract: Subject matter disclosed herein relates to a method and/or system for tailoring insulin therapies to physiological characteristics of a patient. In particular, observations of a blood glucose concentration of a patient responsive to a meal profile and an insulin profile may be used for estimating one or more physiological parameters.

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: Disclosed is a method of configuring a medical device through utilization of a computing device that includes a user interface, a processor and memory. The method includes the steps of determining whether a configuration file contains a focal modified parameter, displaying the focal modified parameter, prompting a manual re-entry of the displayed focal modified parameter, receiving through the user interface the manual re-entry of the displayed focal modified parameter, and utilizing the processor to automatically determine whether the manual re-entry of the displayed focal modified parameter matches the displayed focal modified parameter.

Abstract: A fluid handling module that is removably engageable with a bodily fluid analyzer is provided. The module may comprise a fluid handling element, and a fluid component separator that is accessible via the fluid handling element and configured to separate at least one component of a bodily fluid transported to the fluid component separator. The fluid handling element may have at least one control element interface.

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.