Blood Glucose Tracking Apparatus and Methods
A measurement module for glucose testing includes a glucose testing measurement module housing, a test strip receptacle formed in the housing, and a connector portion formed in the housing and shaped to permit mechanical removable attachment of the housing to a hand-held computer. Electronics determine the amount of glucose present in a sample of body fluid, when the test strip is positioned in the receptacle and the body fluid is placed on a test strip, and communicate the glucose amount to the hand-held computer via the connector portion.
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The present application is a continuation of U.S. patent application Ser. No. 11/160,407 filed Jun. 22, 2005, entitled “Blood Glucose Tracking Apparatus and Methods”, which is a continuation of U.S. patent application Ser. No. 10/112,671 filed Mar. 29, 2002, issued as U.S. Pat. No. 7,041,468 on May 9, 2009, which claims the benefit of priority to U.S. Provisional Patent Application Nos. 60/300,011 filed Jun. 20, 2001 and 60/280,905 filed Apr. 2, 2001, which are assigned to the same assignee as the present application and are hereby incorporated by reference for all purposes.
BACKGROUND OF THE INVENTION1. Field of the Invention
The invention relates to blood glucose monitoring, and particularly to a blood glucose monitor and data management and display device integrated as a synchronous, handheld unit, as an effective and efficient diabetes management tool.
2. Discussion of the Related Art
Blood glucose self-measurements have been conventionally taken by diabetics. The diabetic uses a blood glucose measuring tool. The diabetic typically pricks his or her finger using a lancet. A droplet of exposed blood is applied to a sensor strip which is placed in the glucose measuring tool. A reading appears on a display of the measuring tool indicating the blood glucose level of the diabetic.
Diabetics sometimes use a computer having some form of software that permits the user to track the glucose measurements they have taken. The glucose measurements are typically loaded into the computer manually by the diabetic. Other transfer methods are possible that require steps by the diabetic in order that the information gets entered into the computer, e.g., transferring glucose readings that have been retained in memory of the measuring tool via a cable to the computer. The data may be sent to a health care professional who may also be keeping an eye on the diabetic's status. It is an object of this invention to provide a more efficient and reliable process of taking the measurement, determining the glucose level, entering the glucose level data into a diabetes management program, and managing the diabetes condition using diabetes management software.
In the past, the glucose measurement tool could be carried by the patient for use almost anywhere. However, access to data entry and management using the computer and software have been relegated to a PC setup at a fixed location such as the patient's home, and so these steps had to wait until the diabetic arrived back at his or her home. In the present invention, it is recognized that the development of hand-held devices such as PDAs and mobile phones and PDA/mobile phone combined units could permit diabetics to enter data and use the data management software away from their PCs. It is therefore an object of this invention to provide a system that permits data entry and management by the diabetic away from the diabetic's PC. In addition, it is desired to have a device that permits this mobile data entry and management, and yet permits the user to take off-finger measurements, or using so-called alternate site testing.
Conventional methods have utilized two very separate instruments, the glucose measurement tool and the PC. It is an object of this invention to provide a synchronous tool that performs the conventional functions of both the glucose measurement tool and PC, and perhaps additional features and advantages. It is a further object to synergistically provide this tool, such as by using a same power source and/or a same display for both purposes, i.e., glucose measurement and data management and/or analysis.
SUMMARY OF THE INVENTIONIn view of the above, and in particular accordance with the above objects, a measurement module for glucose testing is provided including a glucose testing measurement module housing, a test strip receptacle formed in the housing, and a connector portion formed in the housing and shaped to permit mechanical, removable attachment of the housing to a hand-held processing device, hand-held computer, PDA, mobile phone or wireless processing device. Electronics are provided either in the measurement module or in the hand-held processing device for determining the amount of glucose present in a sample of body fluid, when a test strip is positioned in the receptacle and the fluid is placed on the test strip, and for communicating the glucose amount to the processing device via the connector portion.
The test strip is typically inserted into the test strip receptacle so that the system may calibrate in preparation for application of the body fluid to the strip. Insertion of the strip may further initiate an activation of electrical components that participate in the testing of a body fluid sample. When the system is ready after connecting the measurement module with the hand-held processing device, and after insertion of the strip into the receptacle in the measurement module, and after any calibration or component activation, then the system display preferably indicates that the body fluid is to be now applied to the strip for testing. An alternative system may be or may become available to those skilled in the art wherein the body fluid is applied to the strip, and/or calibration/component activation occur, before strip insertion, and if such system would otherwise include one or more features of preferred embodiments herein, then such systems may also be within the scope of a preferred embodiment.
The housing of the glucose testing measurement module is configured so that a sample of body fluid may be easily applied to the strip when the module is connected to the hand-held processing device and the strip is inserted into the receptacle in the measurement module. The end of the housing from which the strip protrudes is substantially narrowed compared with the end that connects with the hand-held processing device. This narrowed end is preferably a tapered trapezoidal profile, is preferably rounded in two or three directions, protrudes from the connector end defining a shoulder or inset particularly for matching an alternate site body contour and is preferably made of low durometer material, so that the module can rest comfortably and securely on a body location near the test site for easy and precise application of the body fluid to the strip. This configuration of the housing is particularly advantageous when off-finger or alternate site testing is desired such as at an arm or a leg site.
The test strip may be side-filled and may also be tip-filled. Use of a side-filled strip is particularly advantageous for alternate site testing. For example, the module may be rested near the alternate test site (for example a forearm) with a user contacting a rounded shoulder of the housing on the user's skin. The device is then rocked comfortably into a test strip side-fill contact position with the body fluid, due to the ergonometric and/or arthopometric design of the module. For this purpose the module preferably has no square or sharp edges exposed when fitted with the handheld processing device. Even when using a tip-filled strip, exposed edges of the module are preferably rounded for rocking the strip into tip-filled contact with the body fluid, even though the depth of the module is small compared with its width particularly at the wider connection end, and contact with the user may be established perhaps only at a single point on the narrowed end when the body fluid in applied to the strip. The test strip advantageously uses only a relatively small amount of body fluid sample for performing reliable tests, such as less than 1 microliter. Measurements are conducted preferably using a coulometric technique, and alternatively an amperometric, reflectrometic or other technique understood by those skilled in the art, which is significant for alternate site testing wherein typically a lower volume of sample is made available by a same lancing operation at an alternate site than when testing is performed on the finger.
The removable connectability of the measurement module with the hand-held processing device is greatly facilitated by electronics that integrate the two components of this integrated system. An isolation barrier is provided for safe glucose monitoring and/or analysis, even though power is preferably supplied to the module from the hand-held processing device, while also data is transferred between the measurement module and hand-held processing device. The power is preferably transformer-coupled, or alternatively capacitatively-coupled, between the isolated and non-isolated sides of the barrier. Analog front-end signal acquisition circuitry of the measurement module allows signals including data indicative of a blood glucose level or other test of the body fluid to be acquired by the measurement module. Opto-isolators preferably isolate data I/O circuitry and provide a data signal transport route across the barrier to the hand-held processing device so that the data can be analyzed there and/or easily uploaded to a PC by HotSync. By “HotSync”, what is meant is any method of synchronizing data in the handheld with data in a PC, such as by cable, cradle, infrared or radio link. By “analyze”, it is meant that the hand-held processing device can do more than merely display a glucose measurement value. For example, charts, plots and graphs of compiled glucose data can be generated and additional factors such as diet, exercise, insulin regimen, etc., may be used to process and/or display various information relating to a diabetic condition or regimen. Serial to parallel conversion circuitry permits parallel access to a data/address bus of the hand-held processing device to the data transported across the barrier.
In a particular embodiment, a measurement module for glucose testing is further provided including a test strip receptacle in a glucose measurement module, a connector portion formed in the module shaped to permit connection of the module to a hand-held computer by inserting the connector portion of the glucose measurement module into a receptacle defined within the hand-held computer, and electronics for determining the amount of glucose present in a sample of body fluid, when the fluid is placed on a test strip and the test strip is positioned in the receptacle, and for communicating the glucose amount to the hand-held computer via the connector portion.
A glucose monitoring apparatus is further provided including a measurement module configured to couple with a test sensor and a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is coupled with the measurement module and body fluid is applied to the test sensor.
A further glucose monitoring apparatus is provided including a measurement module configured to couple with a test sensor and a hand-held processing device electrically and mechanically coupled with and separable from the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is coupled with the measurement module and body fluid is applied to the test sensor.
A glucose monitoring apparatus is also provided including a measurement module configured to couple with a test sensor and a hand-held processing device configured to receive data transmission from the measurement module. The measurement module and processing device form a synchronous unit for performing and analyzing a glucose measurement after the test sensor is coupled with the measurement module and body fluid is applied to the test sensor. The monitoring apparatus includes a single display at the processing device.
A glucose monitoring apparatus is further provided including a measurement module not having a display for displaying results of glucose measurements, the module being configured to couple with a test sensor, and a hand-held processing device configured to receive data transmission from the measurement module. The measurement module and the processing device form a synchronous unit for performing and analyzing a glucose measurement after the test sensor is coupled with the measurement module and body fluid is applied to the test sensor. The processing device includes a display for displaying the results of said glucose measurements.
A glucose monitoring apparatus is further provided including a measurement module configured to couple with a test sensor and a hand-held processing device configured to receive a data transmission from the measurement module. The measurement module and processing device form a synchronous unit for performing and analyzing a glucose measurement. The processing device is configured for automatically receiving the data transmission after the test sensor is coupled with the measurement module and body fluid is applied to the test sensor.
A method of performing a glucose measurement using a measurement module and a hand-held processing device is provided including coupling the processing device electrically and mechanically with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after a test sensor is inserted into the measurement module, coupling the test sensor with the measurement module, applying body fluid to the test sensor and reading a glucose level from a display on the integrated hand-held unit.
A method of performing a glucose measurement using a measurement module and a hand-held processing device is also provided including coupling the processing device with the measurement module to receive a data transmission from the measurement module such that the measurement module and the processing device form a synchronous unit including a single display on the processing device for performing and analyzing a glucose measurement after a test sensor is inserted into the measurement module, coupling the test sensor with the measurement module, applying body fluid to the test sensor and reading a body fluid glucose level from the display on the processing device.
A method of performing a glucose measurement using a measurement module and a hand-held processing device, is further provided including inserting the measurement module into a receptacle defined within the processing device for the processing device to receive a data transmission from the measurement module, such that the measurement module and the processing device form an integrated, hand-held unit for performing and analyzing a glucose measurement after a test sensor is inserted into the measurement module, coupling the test sensor with the measurement module, applying body fluid to the test sensor and reading a glucose level from a display on the processing device.
The invention further includes a method of performing a glucose measurement using a measurement module and a hand-held processing device including coupling the processing device with the measurement module to automatically receive a data transmission from the measurement module after a test sensor is inserted into the measurement module, such that the measurement module and the processing device form a synchronous unit for performing and analyzing a glucose measurement, coupling the test sensor with the measurement module, applying body fluid to the test sensor and reading a glucose level from a display.
A glucose monitoring apparatus is further provided including a measurement module configured to couple with a test sensor, and a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is inserted and body fluid is applied to the test sensor. The measurement module is further geometrically configured to enable off-finger or alternate site application of blood to the test strip.
A glucose monitoring apparatus is also provided including a measurement module configured to couple with a test sensor, and a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is inserted and body fluid is applied to the test sensor. The measurement module is rounded in three dimensions for providing smooth off-finger or alternate site points of contact with the skin of a person being tested.
A glucose monitoring apparatus is further provided including a measurement module configured to couple with a test sensor, and a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is inserted and body fluid is applied to the test sensor. The measurement module is rounded in at least two dimensions for providing smooth off-finger or alternate site points of contact with the skin of a person being tested.
A glucose monitoring apparatus is also provided including a measurement module configured to couple with a test sensor, and a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is inserted and body fluid is applied to the test sensor. The measurement module includes a telescoping trapezoidal profile for permitting placement of a test strip inserted within the module at an off-finger or alternate site location of a person being tested.
A glucose monitoring apparatus is also provided including a measurement module configured to couple with a test sensor, and a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is inserted and body fluid is applied to the test sensor. The measurement module includes an encapsulation port for the test sensor and a PC board including an opto-isolation component. The measurement module extends less than two inches in length and less than one half inch in thickness beyond dimensions of the wireless processing device.
A software program for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module configured to couple with a test sensor and a hand-held processing device is further provided. The measurement module and processing device form a synchronous unit for performing and analyzing a glucose measurement after the test sensor is inserted and body fluid is applied to the test sensor. The processing device is configured to HotSync with a PC. The software program includes instructions for a processor to perform the steps of creating a replica database on the PC of the glucose data stored in a device database on the processing device, and synchronizing the glucose data to a PC database program. The synchronizing step includes reading the glucose data stored in the device database on the processing device, matching the data to corresponding data in the replica database, format converting the data and writing the data to the replica database.
A software program for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module configured to couple with a test strip and a hand-held processing device is also provided. The measurement module and processing device form a synchronous unit for performing and analyzing a glucose measurement after the test strip is inserted and body fluid is applied to the test strip. The processing device is configured to HotSync with a PC. The software program includes instructions for a processor to perform the steps of measuring glucose data from the test strip having body fluid applied thereto, automatically downloading the glucose data from the measurement module to the processing device, and downloading the glucose data to a personal computer.
A method for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module configured to couple with a test sensor and a hand-held processing device. The measurement module and processing device form a synchronous unit for performing and analyzing a glucose measurement after the test sensor is inserted and body fluid is applied to the test sensor. The processing device is configured to HotSync with a PC. The method includes creating a replica database on the PC of the glucose data stored in a device database on the processing device, and synchronizing the glucose data to a PC database program. The synchronizing step includes reading the glucose data stored in the device database on the processing device, matching the data to corresponding data in the replica database, format converting the data, and writing the data to the replica database.
A method for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module configured to couple with a test strip and a hand-held processing device is also provided. The measurement module and processing device form a detachably integrated, hand-held unit for performing and analyzing a glucose measurement after the test strip is inserted and body fluid is applied to the test strip. The processing device configured to HotSync with a PC. The method includes measuring glucose data from the test strip having body fluid applied thereto, automatically downloading the glucose data from the measurement module to the processing device after measuring said glucose data, and downloading the glucose data to a personal computer.
A software program for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module configured to couple with a test sensor and a hand-held processing device is further provided. The measurement module and processing device form a synchronous unit for performing and analyzing a glucose measurement after the test sensor is inserted and body fluid is applied to the test sensor. The software program includes instructions for a processor to perform the steps of measuring glucose data, providing a sensory output of a glucose level corresponding to the data, and automatically entering the data into a database accessible by a diabetes management software program.
A method for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module configured to couple with a test sensor and a hand-held processing device. The measurement module and processing device form a detachably integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is inserted and body fluid is applied to the test sensor. The method includes measuring glucose data, providing a sensory output of a glucose level corresponding to the data, and automatically entering the data into a database accessible by a diabetes management software program.
What follows is a cite list of references each of which is, in addition to the background, the invention summary, the abstract and the claims, hereby incorporated by reference into the detailed description of the preferred embodiments below, as disclosing alternative embodiments of elements or features of the preferred embodiments not otherwise set forth in detail below. A single one or a combination of two or more of these references may be consulted to obtain a variation of the preferred embodiments described in the detailed description below. Further patent, patent application and non-patent references are cited in the written description and are also incorporated by reference into the preferred embodiment with the same effect as just described with respect to the following references:
U.S. patent application Ser. Nos. 09/413,565, 60/300,011 and 60/280,905, which are assigned to the same assignee as the present application;
U.S. published applications Nos. 2002029058, 2002025469, 2002008038, 2001054319, and 2001017269, which are also assigned to the same assignee as the present application;
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The module is shown having a slot 6 for insertion of an in vitro test strip 8. Some details may be found at U.S. patent application Ser. No. 09/413,565, which is assigned to the same assignee as the present application and is hereby incorporated by reference. When the test strip 8 is inserted into the slot 6, preferably blood such as whole blood, plasma and/or serum, and alternatively another body fluid such as interstitial fluid, sweat, urine, tears, saliva, dermal fluid, spinal fluid, etc., is applied to the strip 8 and the module 2 measures the glucose level of the body fluid applied to the strip 8. Hereinafter, whenever blood or body fluid is referred to for being applied to the strip 8, it is meant to include whatever body and/or biological fluid that may be applied to strip 8 for testing. The glucose level data automatically transfers to the PDA 4 (the data transfer mechanism is described in more detail below with reference to
The PDA 4 is configured to HotSync with a PC for transmitting data to a PC. The PDA 4 may also transmit data by wireless RF and/or IR connection to a remote or host client or server computer. The PDA 4 also preferably has internet connectability or is otherwise configured for logging into a network for transmitting and receiving data from the network.
An isolation barrier 16 is shown for isolating the power at the module from the power at the PDA 4. The isolation barrier 16 is provided to protect the user from having a high current pass through his or her body when the PDA 4 is in a HotSync cradle 18 and thus is connected to AC power. Since an electrically conductive part of the integrated measurement module 2/PDA 4 system (i.e., a strip) contacts the patient, the system may be considered to have a “patient applied part” and would be bound to comply with applicable standards (AAMI ES1, IEC60601-1-2, etc) for isolated patient connections. These standards contain requirements for a maximum amount of current that can flow in either direction between the patient and an AC power line or ground with either the module 2 or the patient in contact with 110% of line voltage.
When the glucose measurement module 2 is inserted into the PDA 4 and the PDA 4 is connected to it's HotSync cradle 18 as shown in
Referring to
In order to prevent this potentially dangerous situation, electrical connections which come into contact with the user 28 at the strip connector 30 are advantageously isolated from earth ground or AC in accord with a preferred embodiment.
This isolation barrier 16 is preferably created via a physical or otherwise insulating gap in the circuitry on the PC board or the module 20. A preferred dimension of this gap is around 4 mm and is generally dictated by electrical safety standards.
Referring back now to
A glucose value is calculated by circuitry 14 on the isolated side of the barrier 16. The glucose value, status, and errors are communicated across the isolation barrier 16 preferably via a bidirectional serial interface 38. Control commands may be preferably received from the PDA 4 via this same interface 38. Serial communication lines of the serial interface 38 bridge the isolation barrier 16 preferably via optoisolators (not shown, but see
As an alternative to providing an electrical isolation barrier between module 2 and PDA 4, features can be incorporated into module 2 that prevent it from being used at the same time that PDA 4 is connected to a HotSync cradle or cable, thereby eliminating the risk of passing high levels of electric current through the cradle or cable to or from the patient. This can be accomplished by providing an extended portion of the housing of module 2 that extends down along PDA 4 to interfere with the attachment of a cradle and/or cable to PDA 4 when module 2 is first attached thereto, or prevent the attachment of module 2 when a cradle or cable is already attached to PDA 4.
Data is transmitted serially from the glucose module 2 to the UART 66 (or converter 40 of the module 2 of
Power is transferred from the PDA 4 through the transformer (corresponding to the power transfer circuitry 32 of
The module 78 (corresponding to the module 2 of
The mounting portion 80 connects electrically and for data transfer to the PDA by preferably a 68 pin electrical connector 84 as shown in
The extension portion 82 is particularly ergonometrically and/or arthopometrically configured so that a patient may insert a strip into a strip insertion slot (corresponding to slot 6 of
A feature of the shape of the extension portion 82 is its protruding and/or telescoping trapezoidal profile. A utility design is provided at the extension portion 82 of the module 78 that promotes easy and efficient manipulation of the glucose strip on the blood drop whether if be on or off-finger or at an alternate site. The PDA module design incorporates a telescoping trapezoidal profile that allows ease of placement and inhibits the PDA body from encroaching or otherwise interfering with the placement, e.g., at a patient's arm. At the same time, the design is unobtrusive, streamlined and safe.
The telescopic and/or protruding trapezoidal profile of the module includes generous radii on each of the compound edges shown in
The extension 82 is preferably rounded in three dimensions or at least two dimensions, e.g., as illustrated by the various views of the preferred embodiment shown in
As shown in
The module 78 serves as a housing for the strip connector, PC board and the opto-isolation components, while not appearing bulky or obtrusive. As mentioned above, the module 78 does not include a display such as a LCD screen because the PDA display may be used as an advantageous PDA accessory for displaying blood glucose levels without delay due to the integrated design of the module 78 with the PDA (see
The module 78 shown and described with respect to
The module 78 advantageously mates with a PDA device and forms a single, hand-held unit for glucose measuring and data management. The mechanical design shown in
Alternative designs would provide for a more pointed profile to the module 78 to presumably provide easier access to the glucose strip or the module 78 may be alternatively connected through a strip connector and a flexible cable to allow flexibility of placement, independent of the PDA body. These alternative designs are not preferred, however, as the size of the pointed profile may be limited by the size of the strip connector and would likely not allow the user to effectively position the strip due to a lack of plastic real estate. Additionally, a flexible cable, although affording flexibility of placement, would be cumbersome and visibly obtrusive. The preferred design thus has the slightly wider tip such as shown in
The module 78 and particularly the extension portion 82 are made of a low durometer material or thermoplastic elastomer facepad detail on both sides of the enclosure, to act as a gripping surface for module insertion and extraction, as well as afford the module a measure of shock absorption. The material may preferably be a PC-ABS alloy or other non-filled plastic resin.
The PDA communicates with a PC when the PDA is preferably HotSynced to the PC. The PDA includes RAM as a temporary database for diabetes management application data and/or programs and non-volatile memory for permanent data and/or program storage. The measurement of the glucose level may however be advantageously performed when the PDA is not HotSynced to the PC, and the PDA includes many data processing features itself for managing data without support from the PC. For example, charts and/or graphs may be generated on the PDA display. The PC system includes standard peripheral devices such as a monitor 98, keyboard 100, CD-rom 102 and a printer 104.
The PDA 4 is shown having a PDA RAM and non-volatile storage 118, a PDA processor 120, a PDA display and touchscreen 122 and a PDA serial interface 124. The PDA is configured to HotSync to a PC system 96, such as that described above with respect to
The data may be entered on the PDA 4. This data may be HotSynced to the PC 96. The data may also be entered on the PC 96 and reverse HotSynced to the PDA 4. In the former case, e.g., the PC 96 would have an application stored in its memory for accepting this data. This PC application would display and print logbook data in various formats. The PC application would also export data to various data processing applications. The application may use a Microsoft Access Database or MDB format, while the data on the PDA may be stored using the Palm PDB format.
The user is preferably able to reverse HotSync data from the PC in order to restore the data to the state it was when it was last HotSynced. The user might want to do this in the event the database on the PDA becomes corrupted. The PC application and database may store a complete history of data that was entered on the PDA. The PDA user may choose to archive some of the PDA data on the PC.
A conduit program may be used. The program may perform the following steps: (1) create a replica of the data stored on the PDA, on the PC; and (2) synchronize data from the PDA to the database on the PC. The two steps may be performed in two separate conduit programs. Synchronizing the data may include reading data from a PDB file and writing it to the PC database. Microsoft Visual Studio may be used for opening, reading and writing data in the PC database. The data may be read from the PDA, matched to data on the PC, format converted, and written to the PC database. Similarly, data entered or modified on the PC may be matched to data on the PDA. The data on the PDA may be updated to reflect the changes made on the PC.
To match data from the PDA to the PC, unique ID numbers may be used in records on the two systems. These ID numbers may be created on the PDA as logbook records or on the PC as logbook entries there. The uniqueness of the ID numbers may be achieved by pre/post fixing the ID with an origin code identifying PC or PDA, or alternatively perhaps a GUID.
To read data from a PDA file and write it to the PC database, it is recognized herein that data in the PC database may be organized into tables, which may be organized into records, which may be broken down into predefined fields. Similarly, at some level data will be organized into records with a consistent field structure on the PDA.
The conduit program reads the data from the PDA file(s) and writes it out to PC tables. The conduit program also reads data from the PC tables and writes them out to PDA file(s). Various types of data conversion may be used. For example, data residing in fields in the PDA file may be converted from the format it exists in the PDA file to a format compatible with the PC and vice-versa. The logical structure of the records in the two systems may be different. Tables may be created (either in code or in an external file such as a database) which define the mapping of data in fields of one system to data in fields in the other. Data may be stored in temporary table(s) that may later be synchronized with main table(s) that contain a complete logbook history, or the conduit program may write to these tables directly.
The PDA 4 also receives firmware revision data, measurement state data and temperature data from the measurement module 2. The measurement state and temperature are preferably displayed on a display 10 of the PDA 4 or otherwise provided to a patient by sensory output such as audio or vibration output. The display 10 is preferably also configured to function with touchscreen software and electronics 135. The PDA 4 includes a timer and power module 136, information about which is also displayed. Data regarding the current time is also sent to the module 2 from the timer and power module 136 of the PDA 4.
The PDA advantageously also includes an event database 138 and a user preferences database 140. The event database 138 generally includes information relevant to diabetes management, such as glucose readings. Fields of an event may include time, data, event type. The glucose and error data are stored to the event database 138 after the PDA 4 receives the data from the module 2. The event database includes a logbook which collects glucose, insulin, carbohydrate and exercise data and time. The data in the event database 138 may be graphed in many ways according to helpful default or pre-programmed graphs or according to filtering and preferences inputs from a user. Some exemplary graphs that may be generated on the PDA display 10 from the event database and software loaded on the PDA without the PDA being HotSynced or otherwise connected to a PC or other processing device. In addition, the data including glucose data is automatically sent to the PDA 4 from the module 2 to be stored in the event database 138 where the data can be used to generate graphs that help a user such as a diabetes patient to track glucose and other information. The data measured by the module 2 does not need to be manually entered by the user into a computer before the data can be processed into graphs and the like, or so that the PDA's own software can process or analyze the data to provide useful data analysis to the patient regarding the glucose and other information relating to the condition of the patient. Software on the PDA also preferably includes insulin and carbohydrate tools, and software for communicating with a PC. The user preferences database 140 may store user input such as units of measure, date and time format, an audible or otherwise sensory alert level, the language to be used and other user preferences.
The PC 96 such as that schematically shown at
The logbook database 158 preferably includes time and date tagged events which are automatically or manually stored such as glucose measurements, manually entered glucose readings, exercise records, insulin injection records, meal time records, state of health records, note records, and medication among others. The user may input entries to the logbook database 158, e.g., that are derived from other glucose meters. Manually entered glucose readings may be flagged as user input rather than meter input. The user may enter other items such as insulin amount, type, and time period, meal times and carbohydrate values, exercise time, type, and degree of exertion (e.g., high, medium, low), state of health, comments and medications. These items may be available to the user from a predefined drop down list that can be edited and added to, or can be manually entered. Data associated with a past event may be entered or modified in the database 158 by the user. Events may be tagged with time periods.
Each application 150-156 is configured to process user inputs including glucose measurements. For example, the meter application is configured to process calibration code input, glucose readings and button presses. The glucose readings are advantageously automatically stored in the logbook database 158 on the PDA according to the programming of the meter application 150. The logbook application 152 is configured to process stored log data and manual entries, and to store and retrieve the log stored log data and manual entries into and from the logbook database 158, respectively. The diabetes management application 154 is configured to process a daily regimen and events such as exercise, meals, insulin dosages and times, etc. and to store and retrieve the daily regimen and events into and from the logbook database 158, respectively. The diabetes management application 154 is also configured to store and retrieve carbo data and manual carbo entries into and from the carbo database 160, respectively. The data management application 156 is configured to process structured data with user filters applied, and to store and retrieve automatic and manual entry information into and from the logbook database, respectively.
The data management application 156 may be configured to allow the user to view data summaries in graphical and text formats. The user may be able to select the length of time to be viewed. The user may also be able to set a default length of time to be viewed from within user preferences. The user may be able to view a complete data set or filter the screen display to show only a selected time period to view. The user may be able to select the event type to be displayed, more than one event type may be selected to be displayed simultaneously. Glucose summary statistics may be displayed by a selected date range and time period. Both selected date range and time period may appear on the display. The summary statistics may include the number of measurements, the highest measurement, the lowest measurement, the average measurement, the standard deviation of the measurements, the percentage of measurements within the target range, the percentage of measurements above the target range, the percentage of measurements below the target range, and insulin and carbohydrate statistics summary. Graphical summaries may also be provided such as line graphs and pie charts (see
The diabetes management application 154 may be configured with diabetes management tools such as carbohydrate tables, insulin tables, fast acting carbohydrate list, daily regimen (food and exercise patterns) and target glucose levels. The application 154 may process one or more carbohydrate tables and a food database. The user may be able to choose entries from a database listing carbohydrate values of foods per listed serving size. The user may be able to customize the food database by adding food items to the food database. The user may be able to tag entries as “quick picks”. The diabetes management application 154 may include a lookup table containing the dose of insulin required to lower glucose concentration by a known amount. The user may input insulin dosages based on a health care professional's recommendations.
One or more of the applications 150-156 may be configured to issue “alerts”. These alerts may be warnings directed to the user that are audible, or otherwise sensory such as by vibration, and displayed with graphics and/or text using the display screen on the PDA. Alerts may indicate that a planned activity is due to begin. Event markers may be used to indicate that the user makes an entry into the logbook 158 to designate a specific condition or incident that relates to a specific blood glucose measurement such as meals, time before or after exercise, medication taken, sickness, feeling hypoglycemic, etc. The applications 150-156, and particularly the diabetes management application 154, may be used for self-monitoring of glucose in whole blood, and may be used by people with diabetes and by healthcare professionals as an aid to monitor the effectiveness of diabetes management.
The applications 150-156, and particularly the meter application 150, may be used to provide direction to a user taking a glucose measurement and control data flow to the logbook 158. For example, when the user inserts a test strip into the module, the module is programmed to check the strip and perform a self test. The display then indicates to the user when to apply the blood. The user then applies the blood sample to the strip. The measurement module monitors for fill (the PDA may, e.g., beep on fill) and takes the measurement. The module is programmed to then determine the glucose level and the PDA displays the result. The glucose value is then automatically entered into the electronic logbook, i.e., without user intervention, and the meter waits for further user input. Once the glucose measurement is complete, the meter application 150 may be configured to relinquish control to one or more of the other applications 152-156.
As described above, the advantageous glucose measurement module 2, as schematically shown, e.g., at
“Coulometry” is the determination of charge passed or projected to pass during complete or nearly complete electrolysis of the analyte, either directly on the electrode or through one or more electron transfer agents. The charge is determined by measurement of charge passed during partial or nearly complete electrolysis of the analyte or, more often, by multiple measurements during the electrolysis of a decaying current and elapsed time. The decaying current results from the decline in the concentration of the electrolyzed species caused by the electrolysis. “Amperometry”, another method of electrochemically measuring glucose, includes steady-state amperometry, chronoamperometry, and Cottrell-type measurements.
While exemplary drawings and specific embodiments of the present invention have been described and illustrated, it is to be understood that that the scope of the present invention is not to be limited to the particular embodiments discussed. Thus, the embodiments shall be regarded as illustrative rather than restrictive, and it should be understood that variations may be made in those embodiments by workers skilled in the arts without departing from the scope of the present invention as set forth in the claims that follow, and equivalents thereof.
In addition, in the method claims that follow, the steps have been ordered in selected typographical sequences. However, the sequences have been selected and so ordered for typographical convenience and are not intended to imply any particular order for performing the steps, except for those claims wherein a particular ordering of steps is expressly set forth or understood by one of ordinary skill in the art as being necessary.
Claims
1. (canceled)
2. A system for managing healthcare data, comprising:
- a first set of at least one module providing primary healthcare functions;
- a first central engine controlling the first set of at least one module;
- a second set of at least one module providing secondary healthcare functions;
- a second central engine controlling the second set of at least one module; and
- a communication interface providing a connection between the first central engine and the second central engine.
3. The system of claim 2, wherein the first central engine is assembled with the first set of at least one module according to a first development process and the second central engine is assembled with the second set of at least one module according to a second development process.
4. The system of claim 2, wherein the communication interface is at least one of a USB interface, a radio frequency (RF) interface, a Wi Fi interface, and an Ethernet interface.
5. The system of claim 2, wherein the first central engine is implemented on a first mother board, the second central engine is implemented on a second mother board, the first set of at least one module is separately implemented on a first set of at least one daughter board, and the second set of at least one module is separately implemented on a second set of at least one daughter board.
6. The system of claim 2, further comprising a first housing including the first central engine and a second housing including the second central engine.
7. The system of claim 2, wherein the first set of at least one module provide a diabetes management system.
8. The system of claim 2, wherein the central engine is implemented on a mother board and the at least one module is separately implemented on a daughter board, the daughter board being standardized for connection with the mother board.
9. A method for managing healthcare data, comprising:
- developing, according to a first development process, a first assembly of a first central engine and a first set of at least one module providing primary healthcare functions, the first central engine controlling the first set of at least one module;
- developing, according to a second development process, a second assembly of a second central engine and a second set of at least one module secondary healthcare functions; and
- connecting the first assembly and the second assembly via a communication interface.
10. A device for managing health data, comprising:
- a first housing portion including a data storage system that stores health data; and
- a second housing portion including a data communications element that provides data communications between the data storage system and a processing device by connecting with the processing device, the processing device processing the health data according to a data management software,
- wherein the first housing portion and the second housing portion are connected by a cable that communicates signals between the data communications element and other components in the first housing portion.
11. The device of claim 10, wherein the data communications element is a USB connector that is received by a USB port in the processing device.
12. The device of claim 10, wherein a length of the cable between the first housing portion and the second housing portion is adjustable.
13. The device of claim 12, wherein the second housing portion includes a storage chamber for storing an excess length of the cable.
14. The device of claim 13, wherein the storage chamber includes a includes a spring device, the spring device drawing the excess length of the cable into the storage chamber.
15. The device of claim 10, wherein the first housing portion includes a storage cavity for receiving the second housing portion.
16. A device for managing health data, comprising:
- a first housing portion including a health data management system and a data communications element that provides data communications between the health data management system and an external processing device; and
- a second housing portion that is removably coupled to the first housing portion, the second housing portion including at least one component used by the health data management system.
17. The device of claim 16, wherein the second housing portion is a cap for the data communications element.
18. The device of claim 17, wherein the data communications element is a USB connector and the second housing portion is a cap for the USB connector.
19. The device of claim 17, wherein the at least one component is a power source that is provides power, via the data communications element, to the health data management system when the cap is coupled to the first housing portion.
20. The device of claim 19, wherein the power source is a rechargeable battery.
21. The device of claim 19, wherein the rechargeable battery exchanges power with another power source in the first housing portion via the data communications element.
22. The device of claim 19, wherein the power source is a backup for another power source in the first housing portion.
23. The device of claim 19, wherein the power source provides power to the health data management system when the cap is coupled to the first housing portion according to a first orientation, and does not provide power to the health data management system when the cap is coupled to the first housing according to a second orientation.
24. The device of claim 19, further comprising a third housing portion that is removably coupled to the first housing portion, the third housing portion storing test sensors for a health data measurement system included in the health data management system in the first housing portion.
25. The device of claim 16, wherein the health data management system includes a health data measurement system and a user interface that displays results from the health data measurement system.
26. The device of claim 25, wherein the at least one component includes one or more test sensors for the health data measurement system.
27. The device of claim 25, wherein the at least one component includes a temperature sensor that provides a measurement of ambient temperature to the health data management system, the health data management system using the measurement of ambient temperature to determine results from the health data measurement system.
28. The device of claim 27, wherein the temperature sensor measures the ambient temperature at a surface of the cap.
29. The device of claim 28, wherein the temperature sensor measures the ambient temperature of a thin membrane at the surface of the cap.
30. A system for managing healthcare data, comprising:
- at least one module providing a healthcare function;
- a central engine controlling the at least one module;
- one or more communication interfaces providing a connection to a remote server, the remote server storing one or more program components corresponding to the at least one module or the central engine; and
- a download engine configured to receive the one or more program components from the remote server via the one or more communication interfaces and to deliver the one or more program components for use with the at least one module or the central engine.
31. The system of claim 30, further comprising a version management component that determines whether the one or more program components is compatible with the at least one module or the central engine before the download engine receives the one or more program components.
32. The system of claim 30, wherein the one or more program components replaces an older version of a software running on the at least one module or the central engine with an updated version of the software.
33. The system of claim 32, further comprising a restore component that restores the older version of the software.
34. The system of claim 33, wherein the updated version of the software is downloaded to a memory area that is separate from the older version of the software, and the older version of the software remains available to be restored.
35. The system of claim 33, wherein the older version of the software is restored when a validation component determines that the updated version of the software operates incorrectly or has not been downloaded properly.
36. The system of claim 30, wherein the one or more program components provides a patch for software running on the at least one module or the central engine.
37. The system of claim 30, wherein the one or more program components provides a new function to be executed by the at least one module or the central engine.
38. The system of claim 30, wherein the one or more program components includes configuration information for software running on the at least one module or the central engine.
39. The system of claim 30, wherein the download engine is manually triggered by a user to receive and deliver the one or more program components.
40. The system of claim 30, wherein the download engine is automatically triggered to identify the one or more program components when communication to the remote server can be established.
41. The system of claim 30, wherein the one or more interfaces include at least one of a USB interface, a radio frequency (RF) interface, a Wi Fi interface, and an Ethernet interface.
42. The system of claim 30, wherein when communication to the remote server is established when the download engine is in range of a wireless network.
43. The system of claim 30, further comprising a data validation component configured to validate the one or more program components before the one or more program components is deployed.
44. The system of claim 43, wherein the data validation component determines whether the one or more program components are not corrupted.
45. The system of claim 43, wherein the data validation component determines, with a check sum routine, whether the one or more program components has been completely transferred from the remote server via the download engine.
46. The system of claim 43, wherein the one or more program components are removed if the data validation determines that the one or more program components is corrupted.
47. A system for managing health data, comprising:
- a data storage system storing health data, data management software, and an initialization program, the initialization program launching the data management software on a processing device and the data management software processing the health data on the processing device; and
- a data communications interface providing data communications between the data storage system and the processing device,
- wherein, upon establishment of the data communications between the data storage system and the processing device, the initialization program launches the data management software on the processing device without requiring prior installation, on the processing device, of an additional program component associated with the data management software.
48. The system of claim 47, wherein the data storage system includes at least one of a USB flash drive and a memory card.
49. The system of claim 47, wherein the data storage system is configured according to a memory map indicating security levels for areas of memory in the data storage system, the security levels determining access to data stored in the areas of memory.
50. The system of claim 47, wherein the data storage system includes a first memory device storing the data management software and the initialization program, and a second memory device storing the health data.
51. The system of claim 50, wherein the first memory device is an EEPROM and the second memory device is a flash memory.
52. The system of claim 47, further comprising a data check system validating data to be stored in the data storage system.
53. The system of claim 47, wherein the data management software processes the health data without permanently storing the data on the processing device.
54. The system of claim 47, wherein the data management software removes any data on the processing device associated with the data management software before ending execution.
55. The system according to claim 47, wherein the data management software closes when the data communications between the data portable device and the processing device is terminated.
56. The system of claim 47, wherein the processing device is compatible with an interface protocol configuration allowing data communication to be established between the data storage system and the processing device, and the initialization program reconfigures the data storage system to a software configuration specific to the data management software allowing the data management software to be launched on the processing device, the software configuration being different from the interface protocol configuration.
57. The system of claim 56, wherein the interface protocol configuration is a USB mass portable device (MSD) configuration.
58. The system of claim 47, wherein the data communications interface includes at least one of a universal serial bus (USB) interface, a secure digital (SD) interface, and a radio frequency (RF) link.
59. The system of claim 47, wherein the processing device is a personal computer, a personal digital assistant, or a smart cellular phone.
60. The system of claim 47, wherein the data communications interface further provides data communications between the data storage system and a blood glucose meter.
61. The system of claim 47, wherein, wherein the data communications interface further provides data communications between the data storage system and a printer, and wherein (i) the data storage system provides a ready to print file from the health data and sends the ready to print file to the printer, or (ii) the printer receives, formats, and prints the health data from the data storage system.
62. The system of claim 47, wherein the health data includes analyte data, temperature data, blood pressure data, heart rate data, breathing data or weight data.
63. The system of claim 47, wherein the health data includes blood glucose data.
64. The system of claim 47, wherein the processing device is one of a plurality of types of processing devices that are compatible with the data communications interface.
65. The system of claim 47, further comprising a measurement system determining health data from an individual for storage in the data storage system.
66. The system of claim 65, wherein the measurement system, the data storage device system, and the data communications interface are integrated with a housing.
67. The system of claim 66, further comprising a user interface integrated with the housing, the user interface operable to display the health data.
68. The system of claim 67, further comprising a local processor and local software integrated with the housing, the local processor processing the health data to be displayed via the user interface.
69. The system of claim 47, wherein one processing device is designated as a base station of the data storage system, wherein additional features of the data management software are enabled when the data storage system detects it is connected to the base station.
70. The system of claim 69, wherein the additional features include a download of all health data in the storage device to the base station or a launching of a master version of the data management software.
71. The system of claim 47, wherein a security component controls access by the processing device to the health data in the data storage system.
72. The system of claim 71, wherein the security component prompts a user for authentication information and validates the authentication information when the processing device attempts to access the health data.
73. The system of claim 71, wherein the security component establishes a trusted system by requiring the processing device to be registered with the data storage system.
74. The system of claim 73, wherein the processing device requires the data storage system to be registered and a two way authentication is established.
75. The system of claim 71, wherein the security component encrypts the health data on the data storage system during transmission to the processing device.
76. The system of claim 71, wherein the security component restricts access to the health data to the data management software.
77. The system of claim 71, wherein the security component restricts access to the health data in the data storage system according to data type.
78. The system of claim 71, wherein the health data is encrypted and the data management software is required to decrypt the data.
79. A system for managing health data, comprising:
- a portable device including data management software that processes health data, the portable device having a first software configuration corresponding to an interface protocol and a second software configuration specific to the data management software; and
- a processing device connected to the portable device, wherein upon connection between the portable device and the processing device, the processing device communicates with the portable device according to the interface protocol, and after the portable device is reconfigured from the first configuration to the second configuration, the processing device executes the data management software.
80. The system according to claim 79, wherein the portable device includes an initialization program, and upon connection between the storage device and the processing device, the initialization program is executed and reconfigures the portable device from the first configuration to the second configuration.
81. The system of claim 79, wherein the interface protocol corresponds to a universal serial bus (USB) and the first configuration is a USB mass portable device (MSD) configuration.
82. The system according to claim 79, wherein the portable device and the processing device are connected via a universal serial bus (USB) interface, a secure digital interface, or a radio frequency (RF) link.
83. The system of claim 79, wherein the processing device is a personal computer, a personal digital assistant, or a smart cellular phone.
84. The system of claim 79, wherein the data management software processes the health data without permanently storing the data on the processing device.
85. The system of claim 79, wherein the data management software removes any data on the processing device associated with the data management software before ending execution.
86. The system according to claim 79, wherein the data management software closes when the data communications between the data portable device and the processing device is terminated.
87. A method for managing health data, comprising:
- establishing, for a first time, data communications between a data storage system to a processing device via a data communications interface, the data storage system storing health data, data management software, and an initialization program;
- executing, on the processing device, the initialization program upon establishment of the data communications between the data storage system and the processing device, without requiring prior installation, on the processing device, of an additional program component associated with the data management software;
- launching, with the initialization program, the data management software on the processing device; and
- processing the health data on the processing device with the data management software.
88. The method of claim 87, wherein processing the health data on the processing device comprises processing the health data without permanently storing the data on the processing device.
89. The method of claim 87, further comprising removing any data on the processing device associated with the data management software before termination of the act of processing the health data.
90. The method according to claim 87, further comprising terminating the act of processing the health data when the data communications between the data portable device and the processing device is terminated.
91. The method of claim 87, wherein the processing device is compatible with an interface protocol configuration allowing data communication to be established between the data storage system and the processing device, and the act of executing the initialization program comprises reconfiguring the data storage system to a software configuration specific to the data management software, the software configuration being different from the interface protocol configuration.
92. The method of claim 91, wherein the interface protocol configuration is a USB mass portable device (MSD) configuration.
93. The method of claim 87, wherein the data communications interface includes at least one of a universal serial bus (USB) interface, a secure digital (SD) interface, and a radio frequency (RF) link.
94. The method of claim 87, wherein the processing device is a personal computer, a personal digital assistant, or a smart cellular phone.
95. The method of claim 87, further comprising controlling access by the processing device to the health data in the data storage system.
96. The method of claim 95, wherein controlling access comprises prompting a user for authentication information and validating the authentication information when the processing device attempts to access the health data.
97. The method of claim 95, wherein controlling access comprises establishing a trusted system by requiring the processing device to be registered with the data storage system.
98. The method of claim 95, wherein controlling access comprises requiring the data storage system to be registered and a two way authentication is established.
99. The method of claim 95, wherein controlling access comprises encrypting the health data on the data storage system during transmission to the processing device.
100. The method of claim 95, wherein controlling access comprises restricting access to the health data to the data management software.
101. The method of claim 95, wherein controlling access comprises restricting access to the health data in the data storage system according to data type.
102. The method of claim 95, further comprising encrypting the health data is encrypted and controlling access comprises requiring the data management software to decrypt the data.
103. A method for managing health data, comprising:
- detecting a connection between a portable device and a processing device, the portable device containing data management software processing health data and having a first software configuration corresponding to an interface protocol, wherein upon connection between the portable device and the processing device, the processing device communicates with the portable device according to the interface protocol;
- reconfiguring the portable device from the first configuration to a second configuration specific to the software; and
- launching the software from the reconfigured portable device.
104. The method of claim 88, further comprising launching an initialization program from the portable device upon detection of the connection, wherein the portable device is reconfigured by the initialization program.
105. The method of claim 88, further comprising receiving, by the portable device, the health data from a measurement system.
106. The method of claim 88, wherein the interface protocol corresponds to one of a universal serial bus (USB) interface, a secure digital interface, and a radio frequency (RF) link.
107. A system for managing health data, comprising:
- a first device that stores health data, data management software, and an initialization program;
- a second device that processes the health data with the data management software; and
- a data communications interface providing data communications between the first device and the second device,
- wherein upon establishment of the data communications between the data storage system and the processing device, the initialization program launches the data management software on the processing device without requiring prior installation, on the processing device, of an additional program component associated with the data management software.
Type: Application
Filed: Dec 3, 2009
Publication Date: May 13, 2010
Applicant: Abbott Diabetes Care Inc. (Alameda, CA)
Inventors: Steven Drucker (Oakland, CA), Charles T. Liamos (Pleasanton, CA), Fredric C. Colman (Oakland, CA), Mark Lortz (Pleasanton, CA), Kelley Lipman (Fremont, CA), Feng Jiang (Union City, CA), Henrik Bacho (San Francisco, CA)
Application Number: 12/630,722
International Classification: G06F 15/177 (20060101); H04L 9/32 (20060101); G06F 1/16 (20060101); G06F 19/00 (20060101); G06Q 10/00 (20060101); G06Q 50/00 (20060101); G06F 15/16 (20060101);