A wearable continuous analyte monitoring (CAM) device includes a disposable sensor unit and a long-life reusable transmitter unit. The transmitter unit has no power source and has an enclosure that seals wireless transmitter circuitry within. The disposable sensor unit is configured to receive and provide power to the transmitter unit therein. Upon expiration of the disposable sensor unit, the transmitter unit can be removed from the disposable sensor unit and reused in another disposable sensor unit with a fresh power source. The CAM device has a cover constructed of a fabric material to improve aesthetics and feel of the CAM device. Methods of preparing and applying the CAM device to a user' s skin are also provided, as are other aspects.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
2.
BASE UNITS, TRANSMITTER UNITS, WEARABLE DEVICES, AND METHODS OF CONTINUOUS ANALYTE MONITORING
A base unit of a wearable device for continuous analyte monitoring includes a cup configured to receive a power source. A first power source contact is at least partially located in the cup and configured to electrically contact a first terminal of the power source in response to the power source being received in the cup. At least one base contact is electrically coupled to the first power source contact, the at least one base contact configured to electrically contact at least one transmitter contact of a transmitter unit in response to the transmitter unit and the base unit being coupled together. Numerous other embodiments are provided.
A biosensor inserter is configured to insert a biosensor. The biosensor inserter includes a push member including a receiver, a contact member translatable relative to the push member, and a trocar holder having a sheath configured to receive a trocar assembly including a trocar therein. The trocar holder is configured to be insertable into, and removable from, the receiver. Thus, an amount of medical waste can be minimized by discarding only the removable trocar holder and trocar assembly after use. System and method embodiments are provided.
A continuous analyte monitor wearable device. The wearable device includes a primary portion comprising at least a sensor assembly comprising a biosensor, and a secondary portion comprising a pocket configured to receive a transmitter unit and a sealable opening to the pocket, the sealable opening containing an adhesive on edges thereof; and a backing member provided over the adhesive wherein removing the backing member exposes the adhesive to seal the sealable opening and encapsulate the transmitter unit. Biosensor inserters and method of using the biosensor inserter are also provided.
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
5.
ANALYTE METERS, TEST STRIP EJECTORS, AND METHODS OF USING SAME
An analyte meter having a test strip ejector. The analyte meter includes a housing body including a front side, a back side, a first side, a second side, an end, and a test strip port at the end configured to receive a test strip; and a strip ejector configured to eject the test strip from the test strip port. The test strip ejector includes a slide member slidable relative to the housing body, an engagement member coupled to the slide member and configured to be contacted by a user, the engagement member located on the back side of the housing body opposite then display screen, and a push member coupled to the slide member and positioned to be engageable with the end of the test strip. Test strip ejectors and methods of ejecting test strips are provided, as are numerous other aspects.
A flexible circuit board for a continuous analyte monitoring (CAM) device includes a plurality of physically separate circuit board cells each having circuitry thereon. The flexible circuit board also includes a plurality of flexible interconnections each connecting one of the physically separate circuit board cells to another of the physically separate circuit board cells. Each one of the flexible interconnections is operable to couple power, electrical signals, or both to the physically separate circuit board cells connected thereto. The flexible circuit board is bendable in multiple directions in three dimensions. Methods of constructing flexible circuit boards for CAM devices are also provided, as are other aspects.
A system for determining analyte information of a fluid sample includes an electrochemical test sensor, an NFC-enabled dongle and an NFC-enabled reader. The test sensor includes a base, an enzyme adapted to react with the analyte, electrodes and test-sensor contacts. The NFC-enabled dongle includes a near field communication (NFC) tag chip, an analog front end (AFE), and a microcontroller. The dongle includes an exterior covering that forms an opening for receiving the test sensor. The NFC-enabled reader wirelessly receives data from the dongle to assist in determining the analyte information of the fluid sample. Another system for determining analyte information of a fluid sample includes an electrochemical test sensor, a Bluetooth-enabled dongle and a Bluetooth-enabled reader.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
An electrochemical test sensor is adapted to receive a fluid sample including an analyte. The electrochemical test sensor includes a base. The base includes an enzyme adapted to react with the analyte. The electrochemical test sensor further includes a plurality of electrodes, a near field communication (NFC) tag chip, an analog front end (AFE) and a microcontroller.
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
H04W 12/47 - Security arrangements using identity modules using near field communication [NFC] or radio frequency identification [RFID] modules
9.
METHODS AND APPARATUS FOR CALCULATING SLOPE IN A GRAPH OF ANALYTE CONCENTRATIONS
0PP00; and calculating a slope of the analyte concentration at time t0 based at least in part on the first data set. Other methods and apparatus are disclosed.
G16H 20/60 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
10.
METHODS AND APPARATUS FOR DISPLAYING A PROJECTED RANGE OF FUTURE ANALYTE CONCENTRATIONS
G16H 20/60 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
11.
METHODS AND APPARATUS FOR PREDICTING WHETHER AND WHEN A HYPO/HYPER ANALYTE CONCENTRATION EVENT WILL OCCUR
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G16H 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indicesICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
12.
METHODS AND APPARATUS ENABLING COUPLING OF AN ELECTRONICS UNIT TO A BASE UNIT OF A CONTINUOUS ANALYTE MONITORING DEVICE
A coupling tool (400) for coupling together an electronics unit and a base unit of a wearable device for continuous analyte monitoring, such as continuous glucose monitoring, includes a carrier (404) comprising a receiving feature and a carrier retention device (632), the carrier retention device configured to retain an electronics unit adjacent the receiving feature. The coupling tool also includes an activator (402) including: a first member at least partially receivable in the receiving feature and a contact member (514) configured to release the electronics unit from the carrier retention device in response to movement of the activator relative to the carrier. The coupling tool is in a locked configuration when the carrier retention device (632) is configured to retain the electronics unit, and the coupling tool is in an unlocked configuration when the carrier retention device (632) is configured to release the electronics unit from the carrier retention device (632). Other embodiments and methods are also disclosed. Since a wearable device and an associated electronics unit may be very small so as not to interfere with movement of the user or irritate the user, the coupling tool (400) may facilitate manually coupling an electronics unit and a base unit together.
A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function value and the primary current signal; determining a connection function based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection function value. Other aspects are provided.
A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function and a measured probing potential modulation current signal; determining a connection function value based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection function value. Other aspects are disclosed.
A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function and a ratio of measured probing potential modulation current signals; determining a connection function value based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection function value. Other aspects are disclosed.
A biosensor system is configured to establish a steady-state condition and alternate between the steady-state condition and a non-steady-state condition to determine an analyte concentration. The biosensor system includes an electrode system having at least one working electrode and one counter electrode. The working electrode is covered with an analyte catalyzing layer for converting an analyte into measurable species. A membrane system encompasses the electrode system and comprises an analyte permeable membrane. The membrane has an analyte permeability with lower analyte solubility than an analyte solubility outside the membrane. The membrane is configured to trap a measureable species within the membrane such that a steady-state of the measurable species resulting from the analyte is established near the electrode surface. A bias circuit is configured to apply a potential modulation sequence to the working electrode to cause alternating of steady-state and non-steady-state conditions within the electrode system for analyte concentration determination.
In response to insertion of a continuous glucose monitoring (CGM) sensor into the skin of user, a CGM system compares an identifier of the sensor to any previously-stored identifiers of previously-inserted sensors, If the identifier does not match a previously-stored identifier, indicating a newly-inserted sensor, the identifier and a time stamp are stored and CGM may begin, Upon removal of the sensor, a removal time stamp is stored, If the identifier of an inserted sensor matches a previously-stored identifier, indicating a reinserted sensor, a reinsertion time is obtained and an elapsed removal time is checked to determine whether it exceeds a maximum removal time limit. If it does, CGM is halted. If it does not, CGM may continue with the reinserted sensor. Methods of tracking insertion and removal times of a CGM sensor are also provided, as are other aspects.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
18.
DETECTING REINSERTION OF A CONTINUOUS GLUCOSE MONITORING SENSOR
A continuous glucose monitoring (CGM) system is configured to detect a reinserted CGM sensor. The system reads a CGM sensor identifier stored in a CGM sensor unit memory in response to insertion of a CGM sensor into the skin of user. The system compares the identifier to any previously-stored identifiers of previously-inserted CGM sensors. If the identifier does not match a previously-stored identifier, indicating a newly-inserted sensor, the identifier is stored and CGM may begin. If the identifier matches a previously- stored identifier, indicating a reinserted sensor, a usage limit corresponding to the stored identifier of the reinserted sensor is then checked to determine whether it has been met. If it has, CGM is halted. If it has not, CGM may continue with the reinserted CGM sensor. Methods of detecting reinsertion and usage limits of a CGM sensor are also provided, as are other aspects.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
19.
METHODS AND APPARATUS FOR TIME-VARYING FILTERING OF SIGNALS OF CONTINUOUS ANALYTE MONITORING SYSTEMS
A method of filtering a signal in a continuous analyte monitoring (CAM) system includes applying time-varying filtering to the signal using a time-varying filter to generate a filtered continuous analyte' monitoring signal during an analyte monitoring period. Other methods, apparatus, continuous analyte monitoring devices, and continuous glucose monitoring devices are also disclosed.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
20.
METHOD AND APPARATUS FOR ADAPTIVE FILTERING OF SIGNALS OF CONTINUOUS ANALYTE MONITORING SYSTEMS
A method of filtering a signal in a continuous analyte monitoring system (CAM) includes applying adaptive filtering to the signal using an adaptive filter to generate a filtered continuous analyte monitoring signal during an analyte monitoring period, and increasing the adaptive filtering applied to the signal as a function of increasing noise on the signal. Other methods, apparatus, continuous analyte monitoring devices, and continuous glucose monitoring devices are also disclosed.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
21.
METHODS AND APPARATUS CONFIGURED TO TRANSMIT DATA IN CONTINUOUS ANALYTE MONITORS
In one or more embodiments, a base unit of a wearable device for continuous analyte monitoring may include sensor memory circuitry and a sensor assembly. The sensor memory circuitry stores information (data) of at least one parameter of at least one component of the base unit, such as, e.g., the sensor assembly. The base unit is configured to couple to a transmitter unit of the wearable device and to transfer the information to the transmitter unit. Analyte determinations are made based at least in part on the information. Numerous other embodiments are provided.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
22.
FLEXIBLE PRINTED CIRCUIT BOARD HAVING A BATTERY MOUNTED THERETO
A flexible printed circuit board (PCB) may have one or more coin cell batteries mounted thereto such that the flexibility of the flexible PCB is maintained. The flexible PCB has one or more battery contact pads fabricated thereon. Each battery contact pad includes a pattern of metalized vias each extending from a top surface to a bottom surface of the flexible PCB. A coin cell battery may be positioned over or under the battery contact pad. Conductive light curable epoxy is applied to and in each metalized via to contact and adhere to the coin cell battery to form a conductive path from the battery through the battery contact pad to printed conductors on the flexible PCB. Methods of mounting one or more coin cell batteries to a flexible PCB are also provided, as are other aspects.
H05K 3/32 - Assembling printed circuits with electric components, e.g. with resistor electrically connecting electric components or wires to printed circuits
H05K 1/18 - Printed circuits structurally associated with non-printed electric components
H05K 3/40 - Forming printed elements for providing electric connections to or between printed circuits
H05K 1/11 - Printed elements for providing electric connections to or between printed circuits
H05K 1/09 - Use of materials for the metallic pattern
H05K 3/12 - Apparatus or processes for manufacturing printed circuits in which conductive material is applied to the insulating support in such a manner as to form the desired conductive pattern using printing techniques to apply the conductive material
23.
STERILIZED REUSABLE WEARABLE DEVICES AND WEARABLE DEVICE FORMING METHODS IN CONTINUOUS ANALYTE MONITORING
In one or more embodiments, a continuous analyte monitoring wearable device includes a disposable base unit having a power source and an analyte sensor, and a reusable transmitter unit that includes electronic circuitry configured to bias the analyte sensor, measure current through the analyte sensor, and may even compute analyte values based on measured current through the analyte sensor. The disposable base unit is configured to couple to the reusable transmitter unit and supply electrical power to the electronic circuitry of the reusable transmitter unit for continuous analyte monitoring. Numerous other embodiments are provided.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
24.
WEARABLE DEVICES, WEARABLE DEVICE FORMING METHODS, AND METHODS OF REUSE OF TRANSMITTER UNITS OF WEARABLE DEVICES IN CONTINUOUS ANALYTE MONITORING SYSTEMS
In one or more embodiments, a continuous analyte monitoring wearable device includes a disposable base unit having a power source and an analyte sensor, and a reusable transmitter unit that includes electronic circuitry configured to bias the analyte sensor, measure current through the analyte sensor, and, in some embodiments, even compute analyte values based on measured current through the analyte sensor. The disposable base unit is configured to couple to the reusable transmitter unit and supply electrical power to the electronic circuitry of the reusable transmitter unit for continuous analyte monitoring. Numerous other embodiments are provided.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
25.
DEVICES, SYSTEMS, AND METHODS FOR MEASURING ANALYTES IN INTERSTITIAL FLUID
An analyte monitor includes a controller including a processor coupled to a memory. The memory has instructions stored therein that, when executed by the processor, cause the controller to: provide a working electrode voltage to a working electrode of an analyte sensor; selectively provide a first counter electrode voltage and a second counter electrode voltage to a counter electrode of the analyte sensor; and provide a guard ring voltage to a guard ring associated with the working electrode. The analyte monitor further includes a current measurement circuit coupled to the controller and configured to measure current flow to the working electrode and a reference resistor electrically coupled between the working electrode and the guard ring associated with the working electrode. Other monitors, systems, sensors, and methods are disclosed.
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
26.
AUTOMATIC ACTIVATION OF CONTINUOUS GLUCOSE MONITORING (CGM) TRANSMITTER
A battery-operated electronic device, such as, e.g., a continuous glucose monitoring (CGM) transmitter, has a switch disconnect circuit that reduces battery discharge while the device is stored and/or in "shelf mode." The device has two externally-accessible activation pads each configured to contact a same electrical conductor positioned in packaging for the device that causes the switch disconnect circuit to disconnect the battery from device electronics while the device is in the packaging. Upon removal of the device from the packaging, the two activation pads no longer contact the electrical conductor, causing the switch disconnect circuit to automatically connect the battery to the device electronics. Methods of reducing battery discharge in a battery-operated electronic device and other aspects are also described.
A continuous glucose monitoring (CGM) device may include a wearable portion having a sensor configured to produce glucose signals from interstitial fluid, a processor, a memory and transmitter circuitry. The memory may include a pre-determined gain function based on a point-of-interest glucose signal and glucose signals measured prior to the point-of-interest glucose signal. The memory may also include computer program code stored therein that, when executed by the processor, causes the CGM device to (a) measure and store a plurality of glucose signals using the sensor and memory; (b) for a presently-measured glucose signal, employ the plurality of previously-measured glucose signals stored in the memory and the pre-determined gain function to compute a compensated glucose value; and (c) communicate the compensated glucose value to a user of the CGM device. Numerous other embodiments are provided.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1495 - Calibrating or testing in vivo probes
28.
CONTINUOUS ANALYTE MONITOR INSERTER APPARATUS AND METHODS
An inserter apparatus (e.g., a continuous analyte monitoring inserter apparatus) includes an outer member; an inner member; a transmitter carrier configured to support a transmitter and biosensor assembly during insertion of a biosensor, the transmitter carrier including a bias member; and a pivot member configured to pivot at times relative to the transmitter carrier and support an insertion device during biosensor insertion. The outer member is configured to press the bias member against the pivot member during insertion of the biosensor. During a first stroke portion of the insertion apparatus, the pivot member is prevented from pivoting, In a second stroke portion, pivoting is allowed, and the bias member causes, pivoting of the pivot member and retraction of the insertion device. Other systems and methods embodiments are provided.
A biosensor inserter includes a push member with a push element, a contact member including a latch, a transmitter carrier supporting a transmitter and sensor assembly, and a pivot member having a latch end, the pivot member supporting an insertion device during biosensor insertion. In operation, the push member is telescoped axially by the user relative to the contact member, which is provided in contact with a user's skin. This pushes the push element against the pivot member and translates the transmitter carrier during insertion of the biosensor. During a first portion of a stroke of the insertion device, insertion of the biosensor is accomplished, and the pivot member is prevented from pivoting. In a second portion of the stroke, after latch end moves past the latch, the pivot member is allowed to pivot and the insertion device is retracted. Other system and method embodiments are provided.
An analyte concentration sensor system is disclosed that selects a temperature for input to an analyte concentration estimation algorithm. The analyte concentration estimation algorithm is executed by an analyte meter that analyzes a sample in a test sensor. A thermistor based temperature sensor is configured to measure temperature. An estimated temperature is obtained via a temperature estimation algorithm. The difference between the estimated temperature and the measured temperature is determined. One of the estimated temperature or the measured temperature is selected based on the estimated temperature, the measured temperature and the absolute difference between the estimated temperature and the measured temperature. In addition, a malfunction in the test sensor may be determined based on the estimated temperature, the measured temperature and the absolute difference between the estimated temperature and the measured temperature.
Continuous glucose monitoring (CGM) may include applying a periodic excitation signal via an electrode of a CGM sensor to human interstitial fluid to drive an oxidation/reduction reaction, and measuring the current through the electrode. In some embodiments, the measured current is sampled and digitized, and various harmonics of the excitation signal's fundamental frequency are extracted. A set of relationships of at least two harmonics each is generated from the spectral amplitudes of a set of pairs, triplets, etc.,of the harmonics, and the set of relationships is mapped to a glucose concentration such as based on the contents of a harmonic relationship database having a pre-existing set of harmonic relationships and glucose concentrations to which those sets of harmonic relationships correspond, for example. Numerous other embodiments are provided.
Apparatus and methods are operative to probe the condition of a sensor either initially, at any point thereafter or continuously during a continuous sensor operation for measuring an analyte in a bodily fluid (such as performed by, e.g., a continuous glucose monitoring (CGM) sensor). Results of the probe may include calibration indices determined from electrical signals obtained during the probe. The calibration indices may indicate whether in-situ adjustment of the sensor-s calibration should be performed either initially and/or at random check points. Probing potential modulation parameters also may be used during analyte calculations to reduce the effects of lot-to-lot sensitivity variations, sensitivity drift during monitoring, temperature, interferents, and/or the like. Other aspects are disclosed.
A flexible monitoring system for continuous monitoring of a fluid in a user is disclosed. The flexible monitoring system includes a transmitter support assembly and a sensor assembly. The transmitter support assembly includes a base substrate layer having a first surface for contact with the skin of the user. A circuit board layer is located on an opposite second surface of the base substrate layer. A cover layer is placed over the circuit board and the base substrate layer. The sensor assembly is supported by the transmitter support assembly and includes a sensor extending through the base substrate layer. The sensor is insertable in the skin when the first surface of the base is placed in contacts with the skin.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
34.
SENSOR ASSEMBLY APPARATUS AND METHODS FOR CONTINUOUS GLUCOSE MONITORS
A sensor apparatus for a continuous glucose monitoring system has a sensor housing that includes a first end having a sealing surface configured to seal against an introducer having an insertion shaft, a second end having a sealing surface configured to seal against an insertion shaft cover, and an insertion shaft opening having a width that allows the insertion shaft to travel there through and that extends between the first and second ends. The sensor housing may further include a sensor wire channel that extends between the insertion shaft opening and a sensor wire contact location in an outer surface of the sensor housing. The sensor wire channel and sensor wire contact location may be configured to receive a sensor that extends between the insertion shaft opening and the sensor wire contact location to allow the sensor to make electrical contact to system circuitry. Numerous other aspects are provided.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
35.
SENSOR ASSEMBLY APPARATUS AND METHODS FOR CONTINUOUS GLUCOSE MONITORS
In some embodiments, a sensor assembly for a continuous glucose monitoring system is provided that includes (1) a sensor carrier having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate; (2) a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer; and (3) electronics for the continuous glucose monitoring system. The sensor unit is positioned within the sensor unit receiving area of the sensor carrier and the electronics are positioned on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit. Numerous other aspects are provided.
Systems, methods, and apparatus for diabetes management include a portable diabetes management system (DMS) device. The DMS device includes a processor, a data storage device, a touchscreen display, and wireless communications facilities. An interactive display screen configured to be displayed on the touchscreen display lists a selectable subset of a plurality of different detected patterns related to blood glucose measurement data received by the DMS device. The patterns are detected based on a plurality of algorithms executable on the processor. A subset of detected patterns is determined based upon a frequency with which the patterns are detected and a priority is assigned to the detected patterns. Numerous other aspects are provided.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
Methods, devices, and systems are disclosed for the determination and logging of risk factor parameters associated with a sample, in association with the measurement of a concentration of an analyte in the sample. The methods, devices, and systems provide for applying an input signal to a sample via an electrode. The input signal has at least one excitation. The methods, devices, and systems further provide for measuring an output signal responsive to the input signal. The methods, devices, and systems further provide for determining a concentration of an analyte within the sample based on the output signal, and determining at least one risk factor parameter associated with at least one species in the sample other than the analyte.
Embodiments provide systems, methods and apparatus for illuminating a portion of the face of a display lens proximate to and along one or more edges of the display lens. The display lens includes a transparent lens having four edges and a face surface. At least one edge includes an angle relative to the face surface configured to reflect light in the lens out of the face surface. Numerous other aspects are provided.
Embodiments provide systems, methods, and apparatus for a medication delivery device. The device includes a dose selector for selecting an amount of medication to deliver; a first capacitive sensor adjacent the dose selector and operative to detect linear displacement of the dose selector during medication delivery; a screw coupled to the dose selector; a second capacitive sensor adjacent the screw and operative to detect linear displacement of the screw during medication delivery; and a processor coupled to the first and second capacitive sensors and operative to determine an amount of medication actually delivered by the medication delivery device. Numerous other aspects are provided.
Devices and methods for determining one or more analyte concentrations in a sample, determining a sample type, and/or accounting for interference species in a sample are disclosed that include intertwining a first input signal, via a first electrode having a reagent, with a second input signal, via a second electrode lacking a reagent, by applying to the sample the first input signal having at least two excitations and a relaxation, and applying to the sample the second input signal having at least two excitations and a relaxation, such that the excitations of the first input signal are nonconcurrent with the excitations of the second input signal. The method further includes measuring a first output signal responsive to the first input signal and a second output signal responsive to the second input signal.
Embodiments of the present invention provide systems, apparatus, and methods for powering electronic devices with low voltage batteries. Embodiments include a circuit including a transistor having a base, an emitter, and a collector; a microcontroller having an output port, a system power terminal, and an input port; a first signal generated from the output port of the microcontroller and coupled to an enable pin of a DC-DC booster; and a second signal generated from the output port of the microcontroller and coupled to the base of the transistor, wherein the second signal is an inverted version of the first signal. The emitter of the transistor is coupled to ground and the collector of the transistor is coupled to the enable pin of the DC-DC booster. Numerous additional aspects are disclosed.
A method and system for determining an analyte concentration in a fluid sample. A mobile device such as a smart phone includes a processor, a camera, and a memory. A carrying case is provided to hold the mobile device. The carrying case has a sensor housing to hold a test sensor having a reaction area for holding the fluid sample. When the carrying case is mated with the mobile device, the reaction area of the test sensor is aligned with the camera. A metering application is loaded on the mobile device. The application is executed by the processor to capture image data of the fluid sample from the camera and analyze the content of the fluid sample based on the image data.
Embodiments provide systems, methods, and apparatus for reducing the impact of user-entered data errors in a data management system (DMS) such as for diabetes. Embodiments include storing user-entered data received from a user into a primary DMS database; storing secondary data received from a source other than the user into a secondary tracking database; associating the secondary data with one or more events described by the user-entered data; cross-checking the user-entered data against the associated secondary data; evaluating user-entered data based on the cross-checking results; presenting for review evaluated user-entered data; treating user-entered data in the primary DMS database based on review results; and determining a diabetes management plan based on the treated user-entered data. Numerous other aspects are provided.
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
44.
SYSTEMS, METHODS AND APPARATUS FOR GENERATING MEAL MARKERS BASED ON SENSOR DATA
Embodiments provide systems, methods and apparatus for automatically generating meal markers. Embodiments include providing a neck-worn sensor for detecting consumption of food; receiving a signal from the neck-worn sensor indicating food consumption; storing a record of the food consumption; and asking a user to confirm if the record corresponds to a meal. Numerous other aspects are provided.
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
Methods and biosensor systems for compensating an analyte measurement are provided. The methods and systems determine a secondary output signal based on the measured primary output signal in order to better approximate the effects of an extraneous stimulus on the primary output signal under actual measurement conditions. The methods and systems according to the present disclosure may provide a more accurate analyte measurement, and may be particularly useful in detecting and compensating an analyte measurement during an off-condition.
A method of operating a glucose management device. The glucose management device includes one or more processing components, a housing, a user interface including a display and a user-input mechanism, and a memory. The method includes displaying on the display a prompt for initiating a carbohydrate factor determination sequence via the user- input mechanism and displaying on the display at least one query, the at least one query including a query associated with a user's type of diabetes. The method further includes receiving the user's response to the at least one query via the user-input mechanism and determining, via the at least one processing component, the carbohydrate factor using the user's response to the at least one query and information stored in the memory.
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
47.
LOCATION-BASED WIRELESS DIABETES MANAGEMENT SYSTEMS, METHODS AND APPARATUS
Embodiments provide systems, methods and apparatus for diabetes management using location-based reminders. Embodiments include requesting a user select a diabetes management related task to be reminded to perform; requesting the user select a location at which the user is to be reminded to perform the selected diabetes management related task; monitoring the user's location; detecting the user has entered the selected location; triggering the reminder in response to detecting the user has entered the selected location; and presenting the reminder to the user. Numerous other aspects are provided like helping a user locate a blood glucose meter (BGM) by identifying a most recent data transfer from the BGM based on a stored date and time associated with the most recent data transfer from the BGM, and identifying patterns of diabetes management events corresponding to particular location types.
Embodiments of the present invention include a mechanical user interface for an electrical device such as a blood glucose meter. The interface includes a center button; a rocker ring disposed around the center button and adapted to pivot about a pivot axis when either one of two user contact portions are pressed; a gasket seal disposed below the center button and the rocker ring, the gasket seal including a peripheral ridge having a generally circular shape with two flattened sides and two curved sides, the flattened sides disposed below the rocker ring adjacent the pivot axis and the curved sides surrounding an area below the user contact portions of the rocker ring; and a hinge plate assembly disposed below the gasket seal and adapted to provide support for the center button and the rocker ring. Numerous other aspects are provided.
H01H 13/86 - Switches having rectilinearly-movable operating part or parts adapted for pushing or pulling in one direction only, e.g. push-button switch having a plurality of operating members associated with different sets of contacts, e.g. keyboard characterised by the casing, e.g. sealed casings or casings reducible in size
H01H 25/04 - Operating part movable angularly in more than one plane, e.g. joystick
A portable data-management system based on an analyte testing device which communicates wirelessly with a mobile device. The mobile device runs an application to manage and analyze data obtained by the analyte testing device. The mobile device may assist the user in displaying testing data, identifying patterns to assist healthy behavior or issue warnings based on the collected data. The mobile device may be connected to a network to store user health data for use by other parties.
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
50.
SMART LOGGING FOR MANAGEMENT OF HEALTH-RELATED ISSUES
A system managing health-related issues (e.g., diabetes) includes a measurement device to measure a health characteristic and a processing device communicatively coupled to the measurement device. The processing device receives the measurement from the measurement device. The processing device includes at least one memory device, a processor, and a user interface. The at least one memory device stores the one or more measurements and computer-readable instructions for a healthcare application. The processor executes the healthcare application. The health care application displays and receives, via the user interface, supplemental health data in association with the one or more measurements. The healthcare application allows a user to input the supplemental data according to adherence burst prompting, measurement and logging prescription, retroactive logging, and/or data display with an electronic calendar. The healthcare application may prompt the user to take a measurement and to input the supplemental data according to these features.
G06Q 10/06 - Resources, workflows, human or project managementEnterprise or organisation planningEnterprise or organisation modelling
G06Q 50/22 - Social work or social welfare, e.g. community support activities or counselling services
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
Systems and methods employ a test sensor that includes an identification feature, such as a resistive element or other detectable circuit element, which allows a measurement device to interrogate the test sensor and to determine whether the correct test sensor type is being used to collect a fluid sample. For example, some embodiments employ test sensors that a measurement device can identify according to a response received from the test sensors when the measurement device applies an electrical signal to the test sensors. By facilitating identification of a test sensor, embodiments help ensure that the desired test type, calibration codes, and/or assay sequence are applied to the fluid sample collected by the test sensor.
A system for measuring health data includes a measurement device. The measurement device includes at least one measurement interface to receive a first fluid sample, a processor to measure one or more first characteristics of the first fluid sample, and at least one memory device to store first data. The processor reads the first data and measures the one or more first characteristics of the first fluid sample according to the first data. The at least one memory device also stores second data. The processor reads the second data instead of the first data to reconfigure the measurement device and measures one or more second characteristics of a second fluid sample according to the second data. An external processing device may be communicatively coupled to the measurement device and may execute a healthcare application that communicates with the measurement device and may be employed to reconfigure the measurement device.
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G01N 33/487 - Physical analysis of biological material of liquid biological material
53.
LIGHT SWITCHING INDICATORS BY WAVELENGTH FILTRATION
A testing system configured to determine an analyte concentration has a user interface that includes a number of visual indicators on its exterior housing. The visual indicators convey different types of information to a user of the testing system when illuminated. Additionally, the indicators are independent of one another in that they can each be illuminated in different colors from one other and turn on and/or off independently of one another. Further, the visual indicators are illuminated using a common lighting element (e.g., a single light emitting diode ("LED")) in combination with one or more waveguides and one or more filters located inside the testing system.
A low-power USB (Universal Serial Bus) host device can be configured to establish communication with a high-power USB peripheral device. The low-power USB host device can be configured to continue an enumeration process with the high-power USB peripheral device regardless of whether the USB host device can meet a maximum power parameter of the high power USB peripheral device. In response to completing the enumeration process, the low-power USB host device can be configured to provide a lower than specified voltage to the high-power USB peripheral device, wherein the reduced voltage is sufficient to power communication between the low-power USB host device and the high-power USB peripheral device. Methods of establishing communication with a USB peripheral device are also provided, as are other aspects.
Some embodiments of the present invention include placing a smart device and a peripheral device in pairing mode; detecting at least one pairing motion event with a dual use piezo circuit within the peripheral device; transmitting an indication of the occurrence of the at least one pairing motion event to the smart device; receiving in the smart device the indication of the occurrence of the at least one pairing motion event in satisfaction of at least one pairing condition; and pairing the smart device with the peripheral device in response to satisfaction of the at least one pairing condition. Numerous other aspects are provided.
Embodiments include determining a reference value on a first device; broadcasting the reference value from the first device; connecting the first device to a second device if the second device requests data from the first device; transmitting any new data if the second device requests data from the first device; generating and broadcasting a new reference value if the first device has new data; broadcasting the reference value from the first device again if the first device does not have new data; receiving a reference value in the second device from the first device; and if the received reference value does not match the stored reference value then transmitting a request from the second device for new data from the first device, receiving new data from the first device into the second device, and storing the received reference value as a new stored reference value. Numerous other aspects are provided.
H04W 4/00 - Services specially adapted for wireless communication networksFacilities therefor
H04W 4/20 - Services signallingAuxiliary data signalling, i.e. transmitting data via a non-traffic channel
H04L 29/08 - Transmission control procedure, e.g. data link level control procedure
H04W 4/06 - Selective distribution of broadcast services, e.g. multimedia broadcast multicast service [MBMS]Services to user groupsOne-way selective calling services
57.
IMPROVED DEVICE PAIRING TAKING INTO ACCOUNT AT LEAST ONE CONDITION
Some embodiments of the present invention include pairing two wireless devices by placing at least one of two devices in a pairing mode; performing at least one pairing motion event with at least one of the wireless devices to satisfy at least one pairing condition; detecting satisfaction of the at least one pairing condition; and pairing the two wireless devices in response to detecting satisfaction of the at least one pairing condition. Numerous other aspects are provided.
Sensor clip assemblies, sensor clips, analyte testing systems, and methods for making and using the same are disclosed. A sensor clip assembly is disclosed for storing and dispensing analyte testing sensors. The sensor clip assembly includes numerous test sensors arranged in a stack. Each test sensor is configured to assist in testing an analyte in a fluid sample. The sensor clip assembly also includes a skeletal frame with a top, a bottom, and numerous sides. The top, bottom and sides are interconnected to define an internal chamber within which is stored the stack of test sensors. At least one of the sides includes one or more elongated rails with structural gaps on opposing sides thereof. For some configurations, multiple sides of the skeletal frame comprise at least one or multiple elongated rails, each of which has structural gaps on opposing sides thereof and may be columnar in nature.
A power source switching circuit for a dual-powered electronic device can provide improved battery utilization by allowing a lower range of battery voltages to be used without causing the electronic device to reset when the device is switched from an external power source to a non-rechargeable battery power source. The power source switching circuit can prevent a transient voltage drop that can occur during such power source transitions. A comparator can control the operation of a switch that connects and disconnects the non-rechargeable battery power source to the load of the electronic device such that the system voltage provided to the load remains above a reset voltage threshold during transitions from the external power source to the non-rechargeable battery power source. Methods of providing a power source switching circuit for dual-powered electronic devices are also provided, as are other aspects.
A wireless transmitter adapter (206) can provide wireless data transmission capability to a battery-operated biosensor meter (100), such as a blood glucose meter, originally configured for hardwired data downloads. In some embodiments, the wireless transmitter adapter (206) can be configured to replace a biosensor meter's battery cover (106). The wireless transmitter adapter (206) can include wireless transmitter circuitry (700), a connector (218) configured to be received in a biosensor meter's communications port (112) to electrically couple to the meter's processor circuitry (107), and one or more electrical contacts (625a, 625b) configured to electrically couple to the biosensor meter's one or more batteries (102a, 102b) to power the wireless transmitter circuitry (700). In other embodiments, the wireless transmitter adapter (206) can be configured to surround at least a portion of a biosensor meter (100) and to include its own battery compartment (804) to separately provide power to the wireless transmitter circuitry (700). Methods of providing a wireless transmitter adapter (206) for battery-operated biosensor meters (100) are also provided, as are numerous other aspects.
According to one aspect of the present invention, a sensor for diagnosing a physiological or physical state includes a measurement system configured to determine clinical data for one or more parameters related to the physiological or physical state, a first memory configured to store the clinical data, a transmitter configured to transmit the clinical data according to a first communications protocol, a receiver configured to receive enhanced data according to a second communications protocol, and a second memory configured to store the enhanced data. The enhanced data is based on the clinical data.
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
62.
METHODS AND APPARATUS FOR ENHANCING A MEDICATION DELIVERY DEVICE
Embodiments of the invention provide systems, methods, and apparatus for attaching an automated dose setting apparatus to a medication delivery device, receiving a first signal from an analyte monitoring system, the first signal indicating a dose of medication to be administered, and driving a dose knob of the medication delivery device with the automated dose setting apparatus to set a dose corresponding with the dose of medication to be administered. Numerous other aspects are disclosed
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
A test sensor (100) for determining an analyte concentration in a biological fluid comprises a strip including a fluid receiving area (128) and a port-insertion region (126). A first row of optically transparent (132) and non-transparent positions forms a calibration code pattern (130) disposed within a first area of the port-insertion region (126). A second row of optically transparent (142) and non-transparent positions forms a synchronization code pattern (140) disposed within a second area of the port-insertion region (126). The second area is different from the first area. The synchronization code pattern (140) corresponds to the calibration code pattern (130) such that the synchronization code pattern (140) provides synchronization of the serial calibration code pattern (130) during insertion of the port- insertion region (126) into the receiving port of the analyte meter.
Embodiments of the invention provide systems, methods, and apparatus for arbitrating a multi-master computer bus. The embodiments include a multi-master serial computer bus; a first master coupled to the bus; a second master coupled to the bus; a slave device coupled to the bus; a first I/O line from the first master going to the second master and the slave device; and a second I/O line from the second master going to the first master and the slave device. A bus arbitration protocol for arbitrating use of the bus restricts the masters to a single transaction each time either master becomes a bus master, and the masters are each adapted to use the I/O lines to signal to each other not to become a bus master. Numerous other aspects are disclosed.
G06F 13/376 - Handling requests for interconnection or transfer for access to common bus or bus system with decentralised access control using a contention resolving method, e.g. collision detection, collision avoidance
G06F 13/42 - Bus transfer protocol, e.g. handshakeSynchronisation
65.
SETUP SYNCHRONIZATION APPARATUS AND METHODS FOR END USER MEDICAL DEVICES
Embodiments of the present application enable setup synchronization of an end user medical device (110) such as a blood glucose meter. The invention includes a controller (302) including a memory (304); a transceiver (306) operatively coupled to the controller; and a host computer (104) interface (208) operative to couple the controller to a host computer, wherein the memory is operative to store instructions executable on the controller. The instructions are adapted to cause the controller to scan for an advertising medical device using the transceiver, establish a communications connection with a medical device advertising for synchronization, and transmit synchronization data to a medical device once a communication connection has been established. Numerous other aspects are disclosed.
Graphical representation of glycemic variation and average blood glucose values. The invention comprises storing in a memory a series of blood glucose values measured over a period of time; determining, using a processor, a variation value for the series of blood glucose values during the time period based on a standard deviation of the series of blood glucose values; plotting points using the processor for each of the blood glucose values around a center point where the radial distance from the center point to each point to be plotted is determined based on the variation value and a blood glucose value of the point to be plotted, and outputting to a display operative coupled to the processor, a graphical representation of the plotted series of blood glucose values and an indicia representative of the variation value.
An analyte meter to detect an analyte concentration level in a bio-fluid sample may be cleaned and disinfected with a cleaning liquid without harming electrical and internal meter components. In some embodiments, the analyte meter is washable and immersable and may include a sealed sensor connector, sealed battery connector, and possibly a sealed USB connector that may be subjected to a cleaning liquid without the liquid entering an internal chamber of the analyte meter and contacting internal electronic components. In some embodiments, a sealed display screen and sealed keypad are provided such that liquids are prevented from entering the internal chamber. Manufacturing methods and systems utilizing the analyte sensors are provided, as are numerous other aspects.
patents
