US20110015502A1 - Analyte Monitoring and Management System and Methods Therefor - Google Patents

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 a limited functions to provide application specific convenience to the user or patient is disclosed.

Description

RELATED APPLICATIONS
• The present application is a continuation of pending U.S. patent application Ser. No. 12/606,890 filed Oct. 27, 2009, which is a continuation of U.S. patent application Ser. No. 11/396,181 filed Mar. 31, 2006, now U.S. Pat. No. 7,801,582, the disclosures of each of which are incorporated herein by reference for all purposes.
BACKGROUND
• Analyte, e.g., glucose monitoring systems including continuous and discrete monitoring systems generally include a small, lightweight battery powered and microprocessor controlled system which is configured to detect signals proportional to the corresponding measured glucose levels using an electrometer, and RF signals to transmit the collected data. One aspect of certain analyte monitoring systems include a transcutaneous or subcutaneous analyte sensor configuration which is, for example, partially mounted on the skin of a subject whose analyte level is to be monitored. The sensor cell may use a two or three-electrode (work, reference and counter electrodes) configuration driven by a controlled potential (potentiostat) analog circuit connected through a contact system.
• The analyte sensor may be configured so that a portion thereof is placed under the skin of the patient so as to detect the analyte levels of the patient, and another portion of segment of the analyte sensor that is in communication with the transmitter unit. The transmitter unit is configured to transmit the analyte levels detected by the sensor over a wireless communication link such as an RF (radio frequency) communication link to a receiver/monitor unit. The receiver/monitor unit performs data analysis, among others on the received analyte levels to generate information pertaining to the monitored analyte levels.
• The receiver/monitor units generally include sophisticated functionalities and features, while providing robust data management system, also provide a steep learning curve and challenge to the initial users of such devices. In addition, due to its sophistication and robust functionality, the reduction in the size of the receiver/monitor unit can be limited. For diabetic children that use the analyte monitoring system, for example, having a complex device such as the receiver/monitor unit may pose a health risk in addition to its intended benefit. Indeed, the receiver/monitor unit may be misprogrammed, or otherwise, its settings and/or features modified by the user and thus not operate properly.
• In addition, due to its size, it is cumbersome to engage in physical activities such as exercise while carrying the receiver/monitor unit so as to be in signal range with the on-body transmitter unit.
• In view of the foregoing, it would be desirable to have a system which includes a receiver/monitor unit for use with the data monitoring and management system which is compact in size and that has limited set of primary features that is less cumbersome to transport and which is easy to manipulate and use by children, for example.
SUMMARY OF THE INVENTION
• In view of the foregoing, in accordance with the various embodiments of the present invention, there is provided a method and system for providing a secondary receiver/monitor unit in a data monitoring and management system which is configured for data communication with the primary receiver/monitor unit, and further, where the secondary receiver/monitor unit can replace the functionalities of the primary receiver/monitor unit during a predetermined time periods such as exercise periods, sleeping periods, travel periods, or any other periods during which access to the full functionality of the primary receiver/monitor unit is not needed.
• These and other objects, features and advantages of the present invention will become more fully apparent from the following detailed description of the embodiments, the appended claims and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates a block diagram of a data monitoring and management system for practicing one embodiment of the present invention;
• FIG. 2 is a block diagram of the transmitter unit of the data monitoring and management system shown inFIG. 1 in accordance with one embodiment of the present invention;
• FIG. 3 is a block diagram of the receiver/monitor unit of the data monitoring and management system shown inFIG. 1 in accordance with one embodiment of the present invention;
• FIG. 4 is a flowchart illustrating data synchronization procedure between the primary receiver unit and the secondary receiver unit of the analyte monitoring system in accordance with one embodiment of the present invention; and
• FIG. 5 is a flowchart illustrating data synchronization procedure between the primary receiver unit and the secondary receiver unit of the analyte monitoring system in accordance with another embodiment of the present invention.
DETAILED DESCRIPTION
• FIG. 1 illustrates a data monitoring and management system such as, for example, analyte (e.g., glucose)monitoring system100 in accordance with one embodiment of the present invention. The subject invention is further described primarily with respect to a glucose monitoring system for convenience and such description is in no way intended to limit the scope of the invention. It is to be understood that the analyte monitoring system may be configured to monitor a variety of analytes, e.g., lactate, and the like.
• Analytes that may be monitored include, for example, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormones, hormones, ketones, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be monitored.
• Theanalyte monitoring system100 includes asensor101, atransmitter unit102 coupled to thesensor101, and aprimary receiver unit104 which is configured to communicate with thetransmitter unit102 via acommunication link103. Theprimary receiver unit104 may be further configured to transmit data to adata processing terminal105 for evaluating the data received by theprimary receiver unit104. Moreover, the data processing terminal in one embodiment may be configured to receive data directly from thetransmitter unit102 via acommunication link103 which may optionally be configured for bi-directional communication.
• Also shown inFIG. 1 is a secondary receiver unit106 which is operatively coupled to the communication link and configured to receive data transmitted from thetransmitter unit102. Moreover, as shown in the Figure, the secondary receiver unit106 is configured to communicate with theprimary receiver unit104 as well as thedata processing terminal105. Indeed, the secondary receiver unit106 may be configured for bi-directional wireless communication with each of theprimary receiver unit104 and thedata processing terminal105. As discussed in further detail below, in one embodiment of the present invention, the secondary receiver unit106 may be configured to include a limited number of functions and features as compared with theprimary receiver unit104. As such, the secondary receiver unit106 may be configured substantially in a smaller compact housing or embodied in a device such as a wrist watch, for example. Alternatively, the secondary receiver unit106 may be configured with the same or substantially similar functionality as theprimary receiver unit104, and may be configured to be used in conjunction with a docking cradle unit for placement by bedside, for night time monitoring, and/or bi-directional communication device.
• Only onesensor101,transmitter unit102,communication link103, anddata processing terminal105 are shown in the embodiment of theanalyte monitoring system100 illustrated inFIG. 1. However, it will be appreciated by one of ordinary skill in the art that theanalyte monitoring system100 may include one ormore sensor101,transmitter unit102,communication link103, anddata processing terminal105. Moreover, within the scope of the present invention, theanalyte monitoring system100 may be a continuous monitoring system, or semi-continuous, or a discrete monitoring system. In a multi-component environment, each device is configured to be uniquely identified by each of the other devices in the system so that communication conflict is readily resolved between the various components within theanalyte monitoring system100.
• In one embodiment of the present invention, thesensor101 is physically positioned in or on the body of a user whose analyte level is being monitored. Thesensor101 may be configured to continuously sample the analyte level of the user and convert the sampled analyte level into a corresponding data signal for transmission by thetransmitter unit102. In one embodiment, thetransmitter unit102 is mounted on thesensor101 so that both devices are positioned on the user's body. Thetransmitter unit102 performs data processing such as filtering and encoding on data signals, each of which corresponds to a sampled analyte level of the user, for transmission to theprimary receiver unit104 via thecommunication link103.
• In one embodiment, theanalyte monitoring system100 is configured as a one-way RF communication path from thetransmitter unit102 to theprimary receiver unit104. In such embodiment, thetransmitter unit102 transmits the sampled data signals received from thesensor101 without acknowledgement from theprimary receiver unit104 that the transmitted sampled data signals have been received. For example, thetransmitter unit102 may be configured to transmit the encoded sampled data signals at a fixed rate (e.g., at one minute intervals) after the completion of the initial power on procedure. Likewise, theprimary receiver unit104 may be configured to detect such transmitted encoded sampled data signals at predetermined time intervals. Alternatively, theanalyte monitoring system100 may be configured with a bi-directional RF (or otherwise) communication between thetransmitter unit102 and theprimary receiver unit104.
• Additionally, in one aspect, theprimary receiver unit104 may include two sections. The first section is an analog interface section that is configured to communicate with thetransmitter unit102 via thecommunication link103. In one embodiment, the analog interface section may include an RF receiver and an antenna for receiving and amplifying the data signals from thetransmitter unit102, which are thereafter, demodulated with a local oscillator and filtered through a band-pass filter. The second section of theprimary receiver unit104 is a data processing section which is configured to process the data signals received from thetransmitter unit102 such as by performing data decoding, error detection and correction, data clock generation, and data bit recovery.
• In operation, upon completing the power-on procedure, theprimary receiver unit104 is configured to detect the presence of thetransmitter unit102 within its range based on, for example, the strength of the detected data signals received from thetransmitter unit102 or a predetermined transmitter identification information. Upon successful synchronization with thecorresponding transmitter unit102, theprimary receiver unit104 is configured to begin receiving from thetransmitter unit102 data signals corresponding to the user's detected analyte level. More specifically, theprimary receiver unit104 in one embodiment is configured to perform synchronized time hopping with the corresponding synchronizedtransmitter unit102 via thecommunication link103 to obtain the user's detected analyte level.
• Referring again toFIG. 1, thedata processing terminal105 may include a personal computer, a portable computer such as a laptop or a handheld device (e.g., personal digital assistants (PDAs)), and the like, each of which may be configured for data communication with the receiver via a wired or a wireless connection. Additionally, thedata processing terminal105 may further be connected to a data network (not shown) for storing, retrieving and updating data corresponding to the detected analyte level of the user.
• Within the scope of the present invention, thedata processing terminal105 may include an infusion device such as an insulin infusion pump or the like, which may be configured to administer insulin to patients, and which may be configured to communicate with thereceiver unit104 for receiving, among others, the measured analyte level. Alternatively, thereceiver unit104 may be configured to integrate an infusion device therein so that thereceiver unit104 is configured to administer insulin therapy to patients, for example, for administering and modifying basal profiles, as well as for determining appropriate boluses for administration based on, among others, the detected analyte levels received from thetransmitter unit102.
• Additionally, thetransmitter unit102, theprimary receiver unit104 and thedata processing terminal105 may each be configured for bi-directional wireless communication such that each of thetransmitter unit102, theprimary receiver unit104 and thedata processing terminal105 may be configured to communicate (that is, transmit data to and receive data from) with each other via thewireless communication link103. More specifically, thedata processing terminal105 may in one embodiment be configured to receive data directly from thetransmitter unit102 via thecommunication link103, where thecommunication link103, as described above, may be configured for bi-directional communication.
• In this embodiment, thedata processing terminal105 which may include an insulin pump, may be configured to receive the analyte signals from thetransmitter unit102, and thus, incorporate the functions of thereceiver103 including data processing for managing the patient's insulin therapy and analyte monitoring. In one embodiment, thecommunication link103 may include one or more of an RF communication protocol, an infrared communication protocol, a Bluetooth enabled communication protocol, an 802.11x wireless communication protocol, or an equivalent wireless communication protocol which would allow secure, wireless communication of several units (for example, per HIPPA requirements) while avoiding potential data collision and interference.
• FIG. 2 is a block diagram of the transmitter of the data monitoring and detection system shown inFIG. 1 in accordance with one embodiment of the present invention. Referring to the Figure, thetransmitter unit102 in one embodiment includes ananalog interface201 configured to communicate with the sensor101 (FIG. 1), auser input202, and atemperature detection section203, each of which is operatively coupled to atransmitter processor204 such as a central processing unit (CPU). As can be seen fromFIG. 2, there are provided four contacts, three of which are electrodes—work electrode (W)210, guard contact (G)211, reference electrode (R)212, and counter electrode (C)213, each operatively coupled to theanalog interface201 of thetransmitter unit102 for connection to the sensor unit201 (FIG. 1). In one embodiment, each of the work electrode (W)210, guard contact (G)211, reference electrode (R)212, and counter electrode (C)213 may be made using a conductive material that is either printed or etched, for example, such as carbon which may be printed, or metal foil (e.g., gold) which may be etched.
• Further shown inFIG. 2 are a transmitterserial communication section205 and an RF transmitter206, each of which is also operatively coupled to thetransmitter processor204. Moreover, apower supply207 such as a battery is also provided in thetransmitter unit102 to provide the necessary power for thetransmitter unit102. Additionally, as can be seen from the Figure,clock208 is provided to, among others, supply real time information to thetransmitter processor204.
• In one embodiment, a unidirectional input path is established from the sensor101 (FIG. 1) and/or manufacturing and testing equipment to theanalog interface201 of thetransmitter unit102, while a unidirectional output is established from the output of the RF transmitter206 of thetransmitter unit102 for transmission to theprimary receiver unit104. In this manner, a data path is shown inFIG. 2 between the aforementioned unidirectional input and output via a dedicated link209 from theanalog interface201 toserial communication section205, thereafter to theprocessor204, and then to the RF transmitter206. As such, in one embodiment, via the data path described above, thetransmitter unit102 is configured to transmit to the primary receiver unit104 (FIG. 1), via the communication link103 (FIG. 1), processed and encoded data signals received from the sensor101 (FIG. 1). Additionally, the unidirectional communication data path between theanalog interface201 and the RF transmitter206 discussed above allows for the configuration of thetransmitter unit102 for operation upon completion of the manufacturing process as well as for direct communication for diagnostic and testing purposes.
• As discussed above, thetransmitter processor204 is configured to transmit control signals to the various sections of thetransmitter unit102 during the operation of thetransmitter unit102. In one embodiment, thetransmitter processor204 also includes a memory (not shown) for storing data such as the identification information for thetransmitter unit102, as well as the data signals received from thesensor101. The stored information may be retrieved and processed for transmission to theprimary receiver unit104 under the control of thetransmitter processor204. Furthermore, thepower supply207 may include a commercially available battery.
• Thetransmitter unit102 is also configured such that thepower supply section207 is capable of providing power to the transmitter for a minimum of about three months of continuous operation after having been stored for about eighteen months in a low-power (non-operating) mode. In one embodiment, this may be achieved by thetransmitter processor204 operating in low power modes in the non-operating state, for example, drawing no more than approximately 1 μA of current. Indeed, in one embodiment, the final step during the manufacturing process of thetransmitter unit102 may place thetransmitter unit102 in the lower power, non-operating state (i.e., post-manufacture sleep mode). In this manner, the shelf life of thetransmitter unit102 may be significantly improved. Moreover, as shown inFIG. 2, while thepower supply unit207 is shown as coupled to theprocessor204, and as such, theprocessor204 is configured to provide control of thepower supply unit207, it should be noted that within the scope of the present invention, thepower supply unit207 is configured to provide the necessary power to each of the components of thetransmitter unit102 shown inFIG. 2.
• Referring back toFIG. 2, thepower supply section207 of thetransmitter unit102 in one embodiment may include a rechargeable battery unit that may be recharged by a separate power supply recharging unit (for example, provided in the receiver unit104) so that thetransmitter unit102 may be powered for a longer period of usage time. Moreover, in one embodiment, thetransmitter unit102 may be configured without a battery in thepower supply section207, in which case thetransmitter unit102 may be configured to receive power from an external power supply source (for example, a battery) as discussed in further detail below.
• Referring yet again toFIG. 2, thetemperature detection section203 of thetransmitter unit102 is configured to monitor the temperature of the skin near the sensor insertion site. The temperature reading is used to adjust the analyte readings obtained from theanalog interface201. The RF transmitter206 of thetransmitter unit102 may be configured for operation in the frequency band of 315 MHz to 322 MHz, for example, in the United States. Further, in one embodiment, the RF transmitter206 is configured to modulate the carrier frequency by performing Frequency Shift Keying and Manchester encoding. In one embodiment, the data transmission rate is 19,200 symbols per second, with a minimum transmission range for communication with theprimary receiver unit104.
• Referring yet again toFIG. 2, also shown is a leak detection circuit214 coupled to the guard electrode (G)211 and theprocessor204 in thetransmitter unit102 of the data monitoring andmanagement system100. The leak detection circuit214 in accordance with one embodiment of the present invention may be configured to detect leakage current in thesensor101 to determine whether the measured sensor data are corrupt or whether the measured data from thesensor101 is accurate.
• Additional detailed description of the continuous analyte monitoring system, its various components including the functional descriptions of the transmitter are provided in U.S. Pat. No. 6,175,752 issued Jan. 16, 2001 entitled “Analyte Monitoring Device and Methods of Use”, and in application Ser. No. 10/745,878 filed Dec. 26, 2003 entitled “Continuous Glucose Monitoring System and Methods of Use”, each assigned to the Assignee of the present application, and the disclosures of each of which are incorporated herein by reference for all purposes.
• FIG. 3 is a block diagram of the receiver/monitor unit of the data monitoring and management system shown inFIG. 1 in accordance with one embodiment of the present invention. Referring toFIG. 3, theprimary receiver unit104 includes a blood glucosetest strip interface301, anRF receiver302, aninput303, atemperature detection section304, and aclock305, each of which is operatively coupled to areceiver processor307. As can be further seen from the Figure, theprimary receiver unit104 also includes apower supply306 operatively coupled to a power conversion andmonitoring section308. Further, the power conversion andmonitoring section308 is also coupled to thereceiver processor307. Moreover, also shown are a receiverserial communication section309, and anoutput310, each operatively coupled to thereceiver processor307.
• In one embodiment, thetest strip interface301 includes a glucose level testing portion to receive a manual insertion of a glucose test strip, and thereby determine and display the glucose level of the test strip on theoutput310 of theprimary receiver unit104. This manual testing of glucose can be used to calibratesensor101. TheRF receiver302 is configured to communicate, via the communication link103 (FIG. 1) with the RF transmitter206 of thetransmitter unit102, to receive encoded data signals from thetransmitter unit102 for, among others, signal mixing, demodulation, and other data processing. Theinput303 of theprimary receiver unit104 is configured to allow the user to enter information into theprimary receiver unit104 as needed. In one aspect, theinput303 may include one or more keys of a keypad, a touch-sensitive screen, or a voice-activated input command unit. Thetemperature detection section304 is configured to provide temperature information of theprimary receiver unit104 to thereceiver processor307, while theclock305 provides, among others, real time information to thereceiver processor307.
• Each of the various components of theprimary receiver unit104 shown inFIG. 3 is powered by thepower supply306 which, in one embodiment, includes a battery. Furthermore, the power conversion andmonitoring section308 is configured to monitor the power usage by the various components in theprimary receiver unit104 for effective power management and to alert the user, for example, in the event of power usage which renders theprimary receiver unit104 in sub-optimal operating conditions. An example of such sub-optimal operating condition may include, for example, operating the vibration output mode (as discussed below) for a period of time thus substantially draining thepower supply306 while the processor307 (thus, the primary receiver unit104) is turned on. Moreover, the power conversion andmonitoring section308 may additionally be configured to include a reverse polarity protection circuit such as a field effect transistor (FET) configured as a battery activated switch.
• Theserial communication section309 in theprimary receiver unit104 is configured to provide a bi-directional communication path from the testing and/or manufacturing equipment for, among others, initialization, testing, and configuration of theprimary receiver unit104.Serial communication section104 can also be used to upload data to a computer, such as time-stamped blood glucose data. The communication link with an external device (not shown) can be made, for example, by cable, infrared (IR) or RF link. Theoutput310 of theprimary receiver unit104 is configured to provide, among others, a graphical user interface (GUI) such as a liquid crystal display (LCD) for displaying information. Additionally, theoutput310 may also include an integrated speaker for outputting audible signals as well as to provide vibration output as commonly found in handheld electronic devices, such as mobile telephones presently available. In a further embodiment, theprimary receiver unit104 also includes an electro-luminescent lamp configured to provide backlighting to theoutput310 for output visual display in dark ambient surroundings.
• Referring back toFIG. 3, theprimary receiver unit104 in one embodiment may also include a storage section such as a programmable, non-volatile memory device as part of theprocessor307, or provided separately in theprimary receiver unit104, operatively coupled to theprocessor307. Theprocessor307 is further configured to perform Manchester decoding as well as error detection and correction upon the encoded data signals received from thetransmitter unit102 via thecommunication link103.
• Referring back toFIGS. 1 and 3, in one embodiment of the present invention, the secondary receiver unit106 may be configured substantially in the manner described in conjunction withFIG. 3. Alternatively, in another embodiment of the present invention, the secondary receiver unit106 may be configured to include a limited number of functionalities as compared with theprimary receiver unit104 described in detail in conjunction withFIG. 3.
• For example, in one embodiment of the present invention, the secondary receiver unit106 maybe substantially incorporated into a wrist watch worn by the user of the analyte monitoring system. Accordingly, in addition to keeping accurate time, the secondary receiver unit106 is configured to receive the transmitted signals from thetransmitter unit102 worn by the user. In one embodiment, the wrist watch/secondary receiver unit106 configuration includes a display section that, in addition to displaying the time and date information, displays the monitored analyte levels substantially in real time received from thetransmitter unit102. This configuration is also programmable to store the received analyte data from thetransmitter unit102 which can later be transferred to theprimary receiver unit102. Other features of the receiver unit display such as trend information or graphical representation of the trend data, may not be displayed in this configuration given the limited display area size on the wrist watch.
• In one embodiment, the communication link between theprimary receiver unit104 and the secondary receiver unit106 may be established using Bluetooth communication protocol, and each device is configured to periodically transmit data such that the information stored in theprimary receiver unit104 and the secondary receiver unit106 are maintained substantially up to date and in synchronization with each other. In addition, each of theprimary receiver unit104 and the secondary receiver unit106 maybe configured to uniquely identify thetransmitter unit102 such that bothprimary receiver unit104 and the secondary receiver unit106 are configured to receive data transmission from thetransmitter unit102 without interruption, and to store the same in the respective storage sections of the receiver units.
• In this manner, in one embodiment of the present invention, the user or patient may conveniently interchange the use between theprimary receiver unit104 and the secondary receiver unit106 without any interruption in theanalyte monitoring system100, and importantly, without losing data transmitted from thetransmitter unit102. For example, a diabetic child using theanalyte monitoring system100 may carry theprimary receiver unit104 in her backpack during the course of the day, and wear the secondary receiver unit106 which is configured as a wrist watch. During the time period when the backpack containing theprimary receiver unit104 is in close proximity to thetransmitter unit102 attached to the body of the diabetic child, theprimary receiver unit104 is configured to receive the transmitted data from thetransmitter unit102 corresponding to the monitored analyte levels of the diabetic child. During recess at school or any other time period during which the backpack containing theprimary receiver unit104 is not in signal range of thetransmitter unit102, the secondary receiver unit106 is configured to receive the signals from thetransmitter unit104. Periodically during the day or at a preprogrammed time during a 24 hour period, theprimary receiver unit104 may be configured to synchronize with the secondary receiver unit106 such that all of the transmitted signals from thetransmitter unit102 is stored in theprimary receiver unit104.
• Such multiple receiver unit implementation of the analyte monitoring system may be additionally beneficial in other circumstances. For example, the secondary receiver unit106 may be used during the time period that the user or patient is engaged in physical activities such as sports or other types of activities where carrying an electronic device such as theprimary receiver unit104 may be cumbersome.
• In addition, the secondary receiver unit106 may be configured to operate in a low power transmission state such as that complying with Class B transmission regulated by the Federal Aviation Authority (FAA) which mandate electronic transmission devices to be turned off during airplane take off and landing procedures. In such cases, theprimary receiver unit104 may be powered down completely while the Class-B compliant secondary receiver unit106 maybe configured to continue receiving the signals from thetransmitter unit102. Thereafter, at a later time period when theprimary receiver unit104 may be turned on, theprimary receiver unit104 is configured to synchronize data with the secondary receiver unit106 so that the transmitted signals from thetransmitter unit102 during the time that theprimary receiver unit104 was turned off can be captured and stored in theprimary receiver unit104.
• FIG. 4 is a flowchart illustrating data synchronization procedure between the primary receiver unit and the secondary receiver unit of the analyte monitoring system in accordance with one embodiment of the present invention. Referring toFIG. 4, atstep410 in one embodiment of the present invention, the secondary receiver unit106 (FIG. 1) is configured to receive and store the signals received from thetransmitter unit102 that are associated with the monitored analyte levels. Thereafter atstep420, the secondary receiver unit106 determined whether theprimary receiver unit104 is back in the power on state. In one embodiment, theprimary receiver unit104 may be configured to broadcast a power on state signal as soon as it is powered on. Alternatively, in another embodiment, the secondary receiver unit106 is configured to periodically transmit a signal to theprimary receiver unit104, and when a return acknowledgement signal is received by the secondary receiver unit106 as originating from theprimary receiver unit104, it is determined that theprimary receiver unit104 is in the powered on state.
• Referring back toFIG. 4, if it is determined atstep420 that theprimary receiver unit104 is not in the power on state, then the secondary receiver unit106 returns to step410 where thetransmitter unit102 signals are continuously received and stored. If however it is determined atstep420 that theprimary receiver unit104 is in the power on state, then at step430, the secondary receiver unit106 is configured to retrieve the stored data received from thetransmitter unit102, and atstep440, the secondary receiver unit106 is configured to transmit the retrieved data corresponding to data received from thetransmitter unit102 to theprimary receiver unit104. Thereafter, optionally, the secondary receiver unit106 may be configured to enter a powered down or hibernate mode to conserve its power supply. In the hibernate mode, the secondary receiver unit106 may be configured to not accept data transmitted from thetransmitter unit102.
• In an alternate embodiment, the secondary receiver unit106 may be configured to continue to receive the transmitted data from thetransmitter unit102 even when theprimary receiver unit104 is in the power on state and receiving data from thetransmitter unit102. In this manner,transmitter unit102 data redundancy may be achieved.
• FIG. 5 is a flowchart illustrating data synchronization procedure between the primary receiver unit and the secondary receiver unit of the analyte monitoring system in accordance with another embodiment of the present invention. Referring toFIG. 5, atstep510, the primary receiver unit104 (FIG. 1) entered the power on state by, for example, the user or patient powering on theprimary receiver unit104. Thereafter at step520, the primary receiver unit520 is configured to retrieve the time information associated with the power off state duration. For example, in one embodiment, theprimary receiver unit104 is configured to retrieve the time stamp information (as maybe provided by its internal clock305 (FIG. 3) of the beginning of the power off state, and the time stamp information of the beginning of the power on state.
• Referring toFIG. 5, the retrieved time information associated with the power off duration is transmitted to the secondary receiver unit106 atstep530. Thereafter, at step540, theprimary receiver unit104 is configured to receivetransmitter unit102 data from thesecondary receiver unit104 that correspond to the time information associated with the power off duration. That is, since during the power off state theprimary receiver unit104 did not receive any data from thetransmitter unit102 which are associated with the monitored analyte level, theprimary receiver unit104 may be configured in one embodiment to receive this data from the secondary receiver unit106.
• In addition, within the scope of the present invention, theprimary receiver unit104 and the secondary receiver unit106 may be configured as a bedside monitor system where, the secondary receiver unit106 (or interchangeably the primary receiver unit104) may be placed at or near the bedside of the child or patient wearing thetransmitter unit102. The primary receiver unit104 (or interchangeably the secondary receiver unit106) may be placed at another location within the house (or hospital or any other location within communication range with the secondary receiver unit106. In this manner, even though the RF communication link103 between thetransmitter unit102 and the remotely locatedprimary receiver unit104 may not be enabled due to distance, the secondary receiver unit106 which is in signal communication with thetransmitter unit102 may be configured as a relay device to retransmit the receivedtransmitter unit102 signals to theprimary receiver unit104. In this manner, parents of diabetic children wearing atransmitter unit102 to monitor the children's glucose levels, or patients in hospitals may conveniently and remotely monitor the analyte levels substantially in real time.
• Accordingly, a system for providing analyte monitoring in one embodiment of the present invention includes a sensor configured for subcutaneous placement for detecting a plurality of analyte levels, a transmitter unit configured for electrical communication with the sensor; the transmitter unit configured to transmit a plurality of signals each associated with a respective one or more of the detected plurality of analyte levels, a first receiver unit configured to receive a first portion of the transmitted plurality of signals from the transmitter unit, a second receiver unit configured to receive a second portion of the transmitted signals from the transmitter unit.
• In one embodiment, each of the plurality of signals transmitted by the transmitter unit maybe associated with a corresponding detection time information, where each detection time information may substantially correspond to the detection time of the corresponding associated analyte level by the sensor.
• The second receiver unit maybe configured to transmit the received second portion of the signals to the first receiver unit, where the first portion of the plurality of signals and the second portion of the plurality of signals may be substantially non-overlapping.
• Further, the first receiver unit may include a storage unit for storing the first and second portions of the plurality of the signals.
• In addition, the first receiver unit may include an output unit for outputting one or more of a visual indication, an audible indication or a vibratory indication associated with the received one or more of the plurality of signals.
• In a further aspect, the second receiver unit may include a housing substantially configured as one of a wrist watch, a bed side monitor unit, a two way radio communication unit, a mobile telephone, a pager, or a personal digital assistant.
• The first receiver unit and the second receiver unit in yet another aspect may be configured to communicate over a communication link which may include one or more of an infrared communication link, an RF communication link, a Bluetooth communication link, or a cable connection.
• In yet another aspect, each of the first and second receiver units may be configured for bi-directional communication.
• A method of analyte monitoring in accordance with another embodiment of the present invention includes transmitting a plurality of signals associated with detected analyte levels, receiving a first portion of the plurality of signals at a first remote location, receiving a second portion of the plurality of signals at a second remote location, wherein the first and second portions of the plurality of signals are substantially non-overlapping.
• The method may further include the step of transmitting the second portion of the plurality of signals from the second remote location to the first remote location.
• In another aspect, the method may also include one or more steps of storing the plurality of signals, or displaying at least a portion of the plurality of signals.
• A method of analyte monitoring in accordance with still another embodiment of the present invention includes receiving one or more signals associated with a respective one or more analyte levels being monitored, storing the received one or more signals, detecting an active state of a receiver unit, and transmitting the stored one or more signals to the receiver unit.
• In another aspect, the method may also include the steps of detecting the one or more analyte levels, and transmitting the one or more signals each corresponding to the detected one or more analyte levels substantially in real time.
• A method of analyte monitoring in still yet another embodiment of the present invention includes retrieving a time information associated with an inactive state, transmitting the retrieved time information, and receiving one or more signals each associated with a monitored analyte level corresponding to the time information.
• The time information may include a beginning time and an end time of the inactive state.
• In a further aspect, the method may also include the step of storing the received one or more signals.
• Various other modifications and alterations in the structure and method of operation of this invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. It is intended that the following claims define the scope of the present invention and that structures and methods within the scope of these claims and their equivalents be covered thereby.

Claims (28)

1. (canceled)

2. A method for processing sensor data from a continuous analyte sensor, the method comprising:

receiving at a sensor electronics module sensor data from each of one or more sensors coupled to a host, wherein the sensor electronics module comprises a data structure storing delivery options each indicative of at least sensor data content respectively associated with display device attributes, alert condition attributes, and/or status attributes;

determining at the sensor electronics module that at least some of the sensor data matches at least a first alert condition, wherein the first alert condition indicates at least one threshold level of an attribute of the sensor data;

determining a first display device associated with the at least the first alert condition;

selecting at least one delivery option in the data structure associated with one or more of a type of the first display device, one or more attributes of the first alert condition, and/or a status of the host;

selecting data associated with the sensor data for transmission to the first display device, wherein the data selected comprises at least the sensor data content indicated in the selected delivery options;

generating at the sensor electronics module a data package for transmission to the first display device, wherein the data package includes the selected data; and

initiating transmission of the data package to the first display device.

3. The method ofclaim 2, wherein the at least the first alert condition comprises a second alert condition that indicates at least one threshold level of an attribute of second sensor data from a second sensor.

4. The method ofclaim 2, wherein the second sensor comprises one or more of a temperature sensor.

5. The method ofclaim 2, wherein the status of the host is selected from the group comprising one or more of: resting, exercise, illness, mealtime, day, night, hyperglycemia, hypoglycemia, clinical risk, and noise.

6. The method ofclaim 2, wherein the data associated with the sensor data comprises one or more of filtered sensor data, calibrated sensor data, transformed sensor data, status data, event data, trend data, rate of change data, rate of acceleration data, sensor diagnostic data, alert condition data, graphical data, textual data, audible data, and/or tactile data.

7. The method ofclaim 2, wherein the sensor data content indicates portions of one or more of filtered sensor data, calibrated sensor data, transformed sensor data, trend data, status data, event data, rate of change data, rate of acceleration data, sensor diagnostic data, alert condition data, graphical data, textual data, audible data, and/or tactile data.

8. The method ofclaim 2, further comprising:

determining a second display device associated with the at least the first alert condition;

selecting at least one second delivery option in the data structure associated with one or more of a type of the second display device, one or more attributes of the first alert condition, and/or the status of the host;

selecting second data associated with the sensor data for transmission to the second display device, wherein the second data comprises at least the sensor data content indicated in the selected second delivery options;

generating at the sensor electronics module a second data package for transmission to the second display device, wherein the second data package includes the selected second data; and

initiating transmission of the second data package to the second display device.

9. A method of monitoring the glucose level of a person using a glucose sensor, wherein the glucose sensor is coupled to a sensor electronics module that is configured to transmit customized data packages to each of a plurality of display devices respectively associated with a triggered alert, the method comprising:

determining that an alert associated with sensor data from the glucose sensor has triggered;

identifying each of a plurality of display devices associated with the alert;

generating a customized data package for at least some of the display devices, wherein content of the customized data packages is determined based on at least one or more characteristics of the sensor data, the sensor electronics module, the triggered alert, the display device, or the person; and

initiating transmission of the customized data packages to respective display devices.

10. The method ofclaim 9, wherein content of a first customized data package configured for transmission to a first display device is selected based on a type of the first display device.

11. The method ofclaim 9, wherein content of a first customized data package configured for transmission to a first display device is selected based on a status of the first display device.

12. The method ofclaim 11, wherein the status of the first display device is selected from the group comprising one or more of resting and exercise.

13. The method ofclaim 9, wherein the characteristics of the triggered alert indicates whether the person is in a hypoglycemic state or is near the hypoglycemic state and the content of a first customized data package configured for transmission to a first display device and/or a type and/or identity of the first display device is selected based on the characteristics of the alert.

14. The method ofclaim 9, wherein content of a first customized data package configured for transmission to a first display device is selected based on one or more attributes of the triggered alert, wherein at least one of the attributes indicates a severity of a hypoglycemic condition associated with the triggered alert.

15. The method ofclaim 9, wherein a first alert triggers in response to determining that sensor data indicates the person is in or near a hypoglycemic state.

16. The method ofclaim 15, wherein a second alert triggers in response to determining that the first alert has previously triggered and the person has not performed a response action addressing the first alert.

17. The method ofclaim 9, wherein the alert associated with sensor data triggers in response to one or more attributes of the sensor data matching one or more requirements associated with the alert.

18. The method ofclaim 17, wherein the one or more requirements associated with the alert are modified in response to a current status of the person.

19. The method ofclaim 9, wherein at least some of the customized data packages include different sensor data.

20. The method ofclaim 9, further comprising transforming at least some of the sensor data into transformed sensor data indicating at least one trend in the sensor data over a time period.

21. The method ofclaim 20, wherein at least some of the customized data packages include some of the transformed sensor data.

22. The method ofclaim 20, wherein the data packages each comprise one or more of sensor data and transformed sensor data that is configured for display on the respective display device without further analysis of the sensor data or transformed sensor data.

23. The method ofclaim 9, further comprising transforming at least some of the sensor data into calibrated analyte concentration values.

24. The method ofclaim 9, wherein at least one of the display devices comprises a drug delivery device and the customized data package transmitted to the drug delivery device includes instructions for automatic delivery of a drug to the person.

25. A computer readable medium storing software code thereon, the software code configured for execution by one or more processors of a sensor electronics module configured for coupling to a biological sensor that is attached to a host, wherein the software code, if executed by the one or more processors, causes the sensor electronics module to perform a method of transmitting sensor data to each of a plurality of display devices, wherein the method comprises:

intermittently receiving sensor data from the biological sensor attached to the host, wherein the sensor data indicates a characteristic of the host;

storing the sensor data on a storage device of the sensor electronics module;

transforming at least some of the sensor data into transformed data indicative of characteristics of the host;

based on at least some of the transformed data, determining that a first alert has been triggered;

for each of the plurality of display devices associated with the first alert:

determining a type of the display device;

based on the determined type of the display device, determining a portion of the sensor data and the transformed sensor data for delivery to the display device;

generating displayable sensor information including the determined portion of the sensor data and the transformed sensor data, wherein the displayable sensor information is configured for display on the respective display device; and

initiating transmission of the displayable sensor information to the display device.

26. The computer readable medium ofclaim 25, wherein the sensor data comprises calibrated and/or filtered raw sensor data.

27. The computer readable medium ofclaim 25, wherein the portion of the sensor data and the transformed sensor data are determined based on delivery options associated with respective display device types.

28. The computer readable medium ofclaim 25, wherein the displayable sensor information is transmitted to respective display devices via one or more of a data network, a cellular telephone network, a Bluetooth communication, and a radio frequency communication.

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