|Publication number||US20060010098 A1|
|Application number||US 11/146,897|
|Publication date||Jan 12, 2006|
|Filing date||Jun 6, 2005|
|Priority date||Jun 4, 2004|
|Also published as||CA2572455A1, CA2572455C, CA2858901A1, EP1810185A2, EP1810185A4, US20100312577, US20110040489, US20110040570, US20110046973, US20110046977, US20110178717, WO2005119524A2, WO2005119524A3|
|Publication number||11146897, 146897, US 2006/0010098 A1, US 2006/010098 A1, US 20060010098 A1, US 20060010098A1, US 2006010098 A1, US 2006010098A1, US-A1-20060010098, US-A1-2006010098, US2006/0010098A1, US2006/010098A1, US20060010098 A1, US20060010098A1, US2006010098 A1, US2006010098A1|
|Inventors||Timothy Goodnow, Carolyn Anderson, Tom Love|
|Original Assignee||Goodnow Timothy T, Carolyn Anderson, Tom Love|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (99), Referenced by (60), Classifications (15), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims the benefit of priority under §35 USC 119(e) to U.S. provisional patent application Ser. No. 60/577,064, filed Jun. 4, 2004, which is hereby incorporated by reference.
The invention relates to diabetes care data management, and particularly to a host-client architecture for communicating, managing and analyzing the data and for generating versatile reports.
The invention provides a host-client data sharing system for managing diabetes care data. a host database, preferably web or internet based, is implemented for storing diabetes care data relating to multiple diabetics. A client or local database stores the diabetes care data relating to multiple diabetics on a personal appliance such as a PC, or a portable or handheld microprocessor-based computing device. The host database uses multiple servers for handling client interactions with the system. A host based data warehouse component is used for storing, searching and/or analyzing, customer information and health data stored on the host database for the population of multiple diabetics using the Host. The host-based data warehouse component applies security mechanisms to protect access to the data stored on the host server. The data mining terminal runs an analytical data processing application and has access to the data warehouse.
A browser-accessible or client-resident graphics rendering component provides a graphical user interface (GUI) that includes a patient selection component permitting uploading data to or calling data from, the database, or both, relating to a particular diabetic of the multiple diabetics. The GUI further includes diabetes care device and health care professional (HCP) selection components, and report configuration components for generating customized reports of selected diabetics, HCPs, data ranges, data types or categories and other criteria.
Population analysis reporting or generation of reports on a population of multiple diabetics is permitted with the report generation component. These reports are allowed to base the data analysis on multiple selection criteria. These data elements may be applied in a selected combination and may use a selected number of selection criteria, such as patient profile information, demographic information, selected data event types, a range of values for a given selection criteria, dates, or other data filters or elements. The report may then be ordered using a selected column or field in the resulting report. Multiple Filter/search criteria may be stored together or individually, and then selectively applied and turned off in the resulting display. A pattern recognition component for the resulting display uses the GUI (color or other highlighting) to draw the user's attention to determining whether patterns of interest exist within the data and for indicating any recognized patterns.
Diabetes related health information may be overlayed in a particular form of report. In a weekly Pump Report, a combination of insulin data (which may be derived from an insulin pump) is provided in a weekly format summarizing each day in a one week period where the GUI is divided left to right by day with vertical demarcation, and containing data analysis statistics that include insulin information, glucose information and/or carbohydrate information, among other data types described herein, summarized in each day's column. In a daily combination report, a combination of Glucose, insulin and/or carbohydrate data, or other data type, may be provided in an hourly format summarizing one full day, where the GUI is divided left to right by hour with vertical demarcation, and containing data analysis statistics that include insulin information, glucose information and carbohydrate information summarized into each hour's column. For each report, whether it be monthly, weekly, daily or another selected temporal duration, the report may include graphical charts or pictures or text-based analytical information, or a combination of these. The statistics and analytical information shown can be adjusted for pump users and non pump users depending on the insulin data type.
The system provides an ability to tracking a large number of health and demographic elements on a same report. These may include glucose, insulin, meals, exercise, state of health, medication, medical exam, lab result, ketones, or combinations thereof. These elements may be displayed in a graphical or text based (charts) or in a tabular form. Reports may be filtered, grouped or sorted by any of the fields associated with these events. Multiple criteria may be applied to a single patient's data or multiple patients' data.
The system provides a data sharing feature including a synchronization architecture by which a diabetic client may share data useful in management of the diabetic condition with selected health care professionals. This architecture may be implemented through an Internet-based synchronizing server. The system can handle incrementally added or modified data that is synchronized to the internet-based server. This features saves having to copy a full database each time a synchronization operation is requested. A security process assures that data is shared only as authorized by the original user and is accepted by the sharing health care professional.
The system provides for storing packets of new or modified data on the Internet-based synchronizing server. The system of stored packets of new or modified data can be organized into a database for meaningful viewing and analysis of the contained data. A diabetic client may maintain data useful in management of the diabetic condition in two or more physically separate locations and/or computers and by which this data may be synchronized to be identical on the multiple locations and/or computers.
Data protection is provided by which a diabetic client may store back-up copies of data useful in management of the diabetic condition in a remote, protected internet server location.
Local area networking provides a mechanism by which multiple client computers may store and retrieve data useful in management of diabetes from a single server database in a local area networking environment.
Synchronizing internet computer scalability is provided for distributing stored synchronizing diabetes management data across multiple server computers in order to scale the capacity of the system. A client database is also synchronized within the system. Traffic to the multiple servers is managed for storing synchronizing diabetes management data that balances the load more or less equally among the various multiple available servers.
A host email system permits the host to send email messages notifying host users of upgrades, or other health or product information or upgrades. A user may also upload from a compatible device and immediately or subsequently print out any or all of the available reports (or specific multiple reports) in a desired date range (date ranges apply specifically to each report) with any personal printing preferences specified. In one embodiment, a user profile may be created first, while selection of report generation and printing preferences may be manually applied or automatically selected based on past history or other default criteria.
A system in accordance with a preferred embodiment is referred to as the FreeStyle CoPilot™ Health Management System (also referred to as the FreeStyle CoPilot System or the System), and is a personal computer (PC or portable or handheld appliance)-based software application that permits people with diabetes, their healthcare team, and caregivers to upload data preferably from FreeStyle™ and Precision Xtra™ blood glucose monitoring systems (and generally to several other commercially available blood glucose meters and insulin pumps) into the FreeStyle CoPilot application.
The FreeStyle CoPilot System provides graphs and other software tools for people with diabetes and their healthcare professionals (HCPs) to help evaluate and analyze glucose readings, carbohydrate intake, insulin dosage, and other diabetes-related factors uploaded from devices or manually entered into the System. The System can help identify trends that can be used to educate persons with diabetes to improve their glucose control.
Common terms that have additional special meanings within the FreeStyle CoPilot System are capitalized to distinguish their special usage (for example, Diary as opposed to a written diary). System-specific screen, control, commands, and function names (for example, Home page, the Apply button) are also capitalized throughout. The specific usages of these terms within the system of the preferred embodiment is intended to be added to their ordinary meanings and usages to enlarge the scopes of these terms in the context of the invention, and not to limit them.
The FreeStyle CoPilot Health Management System provides an accessory to a blood glucose monitoring system such as the FreeStyle and Precision Xtra blood glucose monitoring systems and other commercially available blood glucose meters and insulin pumps. The FreeStyle CoPilot Health Management System may be used in home and clinical settings to upload data from these devices to a patient's or healthcare professional's computer where the data may be saved, displayed in a number of formats, printed, or exported to an authorized user. The FreeStyle CoPilot System is an aid to people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results, insulin dosages, and carbohydrate intake data to support an effective diabetes management program. The System may be used in home and healthcare professional settings to manage diabetes factors, such as insulin dosage, carbohydrate intake, and exercise.
There are two primary users contemplated for the System: home users (people with diabetes or their caregivers), and HCP users (healthcare professionals). A home version of the software for a person with diabetes or the caregiver of a person with diabetes may permit recording information for them such as glucose, insulin, meals, exercise and/or other data types described herein. A HCP version of the software is for managing health data provided to a HCP by one or more patients with diabetes. HCP can mean an individual healthcare professional (such as physician, nurse educator, or other diabetes healthcare team member), a group or entity (such as a clinic), or even case managers, medical directors, and other managed care professionals, if authorized by the person with diabetes. The System may be used to monitor the health status of the patients they manage.
The System is a personal computer (PC) or personal computing appliance software application that enables users to upload, store, and/or analyze glucose readings and other important information for diabetes management. This information can be used by people with diabetes, their healthcare professionals (HCPs), and caregivers.
After installing the System on a PC or PC appliance, glucose data can be uploaded or copied from a compatible glucose meter, or data can typed in from a keyboard, or imported from a file. One can maintain a record of his or her glucose, carbohydrates, insulin, exercise, state of health, doctor visits, medications, blood ketones, and/or laboratory results. One may enter as much or as little information as desired.
The System analyzes the data and displays it in simple, clear reports (graphs and tables). The reports can be viewed on the computer screen or on the display of the computing appliance or they can be printed out (black-and-white or color). One can also automatically print one or more reports that are selected to be printed or displayed each data is uploaded from a particular device.
The System further allows permits data sharing securely over the Internet with selected HCPs. The System further promotes teamwork for effective diabetes health management. The System encourages people with diabetes to stick to lifestyle recommendations and medication plans. It can help them and their HCPs to identify trends in health or care.
The System preferably utilizes a personal computing desktop, portable or handheld appliance with 400 megahertz (MHz) or higher processor clock speed recommended. The system preferably includes either an internet connection or a compact disc (CD-ROM) drive or other digital storage device interface. Random access memory (RAM) of 64 megabytes (MB) or more is recommended, while available hard disk space of 30 MB is used for running the program. Microsoft® Windows 98 SE, 2000, NT, ME, or XP operating systems are preferred. A monitor with 1024×768 or higher resolution is preferred. A standard keyboard and mouse are also preferred, or other input device that may be utilized with a particular personal computing appliance.
A few optional accessories that can be useful in combination with the System include a serial port, available 9-pin EIA-232 (also known as RS-232 or V.24) or appropriate adapter for a universal serial bus (USB) for glucose meter connection, a Windows-compatible printer for printing copies of reports, a Windows-compatible fax software and drivers for faxing reports, an email application for e-mailing reports, data cables for uploading from compatible devices, and a HotSync® cradle for uploading data from a PDA-type diabetes management system.
The System is preferably available as a download from a web site such as the FreeStyle CoPilot website (www.freestylecopilot.com), and/or on a CD purchased through a website or customer care center.
Using the System, a diabetic or HCP can read (upload) or export data from devices such as glucose meters and insulin pumps. These devices can be connected to the System by serial port or USB.
Display screens of the System preferably have a consistently similar look and structure. Common screen icons are preferably organized on a Home page, such as that illustrated in
Tabs on the main menu bar 2 enable access to program activities. The small icons 4 and large buttons 6 represent a subset of the program activities including commonly used activities. Clicking on a tab of the main menu bar 2, a small icon 4, or a large button 6 opens a corresponding screen. The Home page is described in more detail below with reference to
The System can as a stand-alone product operated by itself on a user's PC and can serve as a self-management tool for the collection and analysis of diabetes-related data. The System can also be used by HCPs in an office or clinic. The System can also operate in a LAN environment. In this case, a central database is preferably installed on the LAN server, wherein each computer in the network can access and review this central database.
For users who want to communicate and share data remotely, the System has a Host server on the internet that acts as a processing, storage, and routing center for the files of users who choose to use these communication and data access capabilities. A user may choose to synchronize with the Host via internet access from a PC or other capable desktop, portable or handheld appliance (hereinafter simply referred to as PC). The communication can occur between people with diabetes and their HCPs or among HCPs.
Users (Home and HCP) can share data by synchronizing. Synchronization allows each user to update and match the data they track. The process includes sending data from a PC to a Host server. The Host server acts as the central database for the System. When a user synchronizes the client System with the Host server, diabetes data, notes, comments, new entries, and edits entered into the client System are mirrored on the Host server and client PC. Each party sharing data preferably synchronizes regularly with the Host server to stay current.
The System software can be installed by downloading the program from the Internet, or installing the program from a CD or other digital storage device.
A User Profile can now be set up, as described in more detail below. Setting up a User Profile allows a diabetic to take full advantage of advantageous features of the System. The process begins with an initial user set up screen, such as that illustrated at
From the Home page, a diabetic or HCP can access multiple advantageous features of the System, either by clicking a small icon 4 or a large button 6, or by selecting a tab on the main menu bar 2.
A select user field 24 is illustrated in
The small icons 4 provide access to program functions. From left to right in
The Large Buttons 6 provide quick access to main program functions. From left to right in
When the client is synchronized with the Host computer via the Internet, messages are preferably sent from the Host that may include information about data sharing, healthcare management, and updates to the System.
A Resource Links section provides options to take a user directly to resources available as the System website. These may include Ask the Diabetes Educator, Diabetes News, Check for Software Updates and Contact Tech Support. Contact tech support is preferably an email support option that, upon clicking, will result in a pop-up window either informing the user that a “local mail client” is not available or will supply the user with the e-mail address for Customer Service/Tech Support.
A Turning On Password Protection option is for users desiring to protect their data (and their privacy) by requiring the entry of a User ID and Password each time they start the System or each time they select a different user in the Select User field (Home version) or the Select HCP field (HCP version). To turn on password protection, on the Home page, a user may select System Settings from the File drop-down box (see
For a home user to take advantage of many features of the program, a user should set up a Home User Profile. This allows the user and HCP, if selected, to enter data and create reports to monitor trends in the health or care of the diabetic user.
A Profile For screen is illustrated in
A screen shot such as that illustrated at
A user may select a Glucose Targets tab to enter target glucose ranges. If these are not known, the HCP can be contacted to help manage glucose levels. The target ranges that are set are displayed on a graph on the screen illustrated at
A graph can be viewed preferably in at least three modes. A desired mode may be selected from a Mode drop-down box 40, such as that illustrated at
Glucose targets may be set in all three modes to take advantage of different reports the System can create. A table of the reports that use glucose targets and the modes they use is provided further below. The glucose targets mode selected here will become the default and will display in the reports that use glucose targets. To change the mode, a different Mode can be selected by returning to the Glucose Targets screen illustrated at
Clicking on up/down arrows for High and Low sets glucose targets. To automatically restore Glucose Target Ranges to the ranges shown in
To customize Time Periods to a normal daily schedule, a user can click on up/down arrows next to a time period (for example, Pre-Bkfst, Post-Bkfst, Sleep, etc.) to change the time. To automatically restore all Time Periods to the times shown here as defaults, a user can click Restore Default Time Periods in the box illustrated at
An option tab may be selected, and an options screen will appear such as that illustrated at
By selecting Rights 52 at the lower left of the Options screen illustrated at
A user profile may be changed or updated. A user selects the tab he or she wants (e.g., User Information, Health Profile, etc.) and changes or adds information.
A User Profile may also be added by selecting Add User from a File drop-down box on the Home Page.
A user may also remove a User Profile at a User List screen such as that illustrated at
User rights may also be assigned. From the UserProfile drop-down box on the main menu bar 2 of the Home Page, User List may be selected as illustrated at
A HCP Profile may also be added. A user can create as many HCP profiles as is desired. This is often a good way to store names, addresses, and other information about doctors, clinics, etc. The HCPs added here will not have access to the user's System data unless the user invites them to share your data (described below).
A HCP Profile may be edited. From the UserProfile drop-down box illustrated at
A HCP Profile can be removed. From the UserProfile drop-down box on the main menu bar (see
With a User ID and password, a user can use the System. But to take greater advantage of the System, a user may also set up a HCP Profile. This will allow a HCP user to view (and sometimes edit) data and reports to monitor trends in the patient's health or care.
The Glucose Targets tab 66 can be selected from the HCP profile for screen illustrated at
A user may set an Authorization Level (, e.g., None, Read Only, Full, Owner) for the HCP by checking the desired level as illustrated at
There are three ways to enter events (data) into the System in accordance with a preferred embodiment: upload from a device, manually enter data (e.g., from a keyboard, and import an existing file or database. The System can upload data from supported glucose monitoring devices (meters), such as FreeStyle Meter, Precision Xtra Meter, FreeStyle Flash Meter, FreeStyle Tracker System, and glucose meters of companies other than Abbott Diabetes Care™, as well as insulin pumps. At least the following data (event types) may be automatically uploaded to the System when uploading from a device: glucose readings, state of health, insulin doses, lab results, carbohydrates, medical exams, exercise, ketones (blood), medications and notes. Data previously uploaded from a device will not be overwritten when uploading again from that same device. Only the new data will be uploaded to your file. Meter functions, displays, and printed output assume a single glucose calibration type, either plasma or whole blood. When uploading glucose data from a device, the System does not differentiate between devices that are whole-blood or plasma calibrated. The System merely uploads the data with no calculations made. Because there are slight differences between the two calibrations, a user should not mix data from devices that use different calibration references. Uploading data into a user's account occurs if the device contains only that person's data. The System is preferably designed not to upload a specific portion of data from a device if data is intermixed with data from another person.
Before uploading, the device is connected to an available COM port on a PC or other computing appliance using an approved data cable for that device. A exemplary cable connection is illustrated at
A Device Setup screen appears as illustrated at
Once the device is connected to the computer and the device is set up, data may be uploaded to the System. On the home page the user whose data is being uploaded from the device is selected. As illustrated at
A device upload may be undone. That is, the data from the most recent device upload may be undone as long as no data has been manually since the device upload and another user has not been selected. DataEntry is selected on the main menu bar of the Home page; then Undo Last Upload 88 is chosen from the drop-down menu illustrated at
Uploading from a PDA-based system such as the FreeStyle Tracker System may be handled somewhat differently than uploads from other devices as follows. The PDA-based system is connected to the PC. DataEntry is selected from the main menu bar, and Read Tracker 90 or other PDA-based product is selected from the drop-down list as illustrated at
When HotSync completes, options may be selected for upload from the FreeStyle Tracker of other PDA-based device such as Event Data, Glucose Targets, Time Periods and Preferences, as illustrated at
As data from the FreeStyle Tracker System is uploaded, the System displays the Profile Updated message illustrated at
The System allows data to be added, edited, deleted, and recovered manually, e.g., from a keyboard. When manually recorded events are deleted, they are omitted from views and reports but are preferably not removed from your database. A complete list of a user's events (whether entered manually, uploaded, or imported) may be viewed by clicking on Reports 94 and selecting Diary List 96 as illustrated at
Manually recordable events include the following categories: glucose readings, glucose control readings, insulin doses, meals (carbohydrates in grams, e.g.), exercise sessions, state of health/health conditions, medication doses, medical exams, lab results, ketone readings, or ketone control readings, or combinations thereof.
The insulin data screen illustrated at
A meal may be recorded by selecting the Meal icon from the Data Entry screen to reveal a Meal data entry screen as illustrated at
One meal may include more than one item (beverage, entree, fruit, etc.). To select several items to describe one meal, a food is selected in the Food Item list as well as the number of servings eaten. The Carbs and Total Carbs automatically display. The cursor is placed in the Total Carbs field to the right of the carbs displayed there. Then, another item is selected and so on. As items are added, the total carbs for the meal are shown as illustrated at
To make manual data entry faster and easier, a user can modify several of the drop-down lists by adding new entries or by hiding entries he or she does not use. The following lists may be modified.
A list may be customized by selecting Customize Data Entry Lists 114 from the DataEntry drop-down box as illustrated at
Some databases can be imported directly into the System. Databases from certain programs may be automatically detected by the System as long as the software for the programs that created them is installed on the user's PC. These programs are referred to as supported databases. To import a database, DataEntry 118 is selected on the main menu bar 2 of the Home page; and then Import 120 is selected from the drop-down box. From the Import drop-down box 122, the name of the device to upload the database from is selected as illustrated at
Exporting data is similar to archiving data (see below), except that exported data is not removed from the System's database. To export data, a user selects Reports 126 on the main menu bar; then chooses Diary List 128 from the drop-down box, as illustrated at
With the FreeStyle CoPilot System, data entered manually or uploaded from a device can be displayed on the screen in a variety of ways. Statistical and other calculations are automatically performed on the data, and the results are put into tables and graphs. A report is one or a set of these tables and/or graphs designed to present information helpful for health management. A reports window is illustrated at
A report can be customized to a user's preferences. Many variables can be adjusted in real time as the report is studied. Data preferably cannot be changed in reports except the Diary List. Corrections or additions can be made by accessing the Data Entry screen for the event. The changes display immediately on any affected report.
Once opened, a report remains open until it is closed by the user. Any number of reports can be open at the same time; while preferably only one is visible. Each open report shows as a tab at the top of the screen. Open reports apply an active date range, data filter options, and display features. In a preferred embodiment, changing these settings in one report changes them for one or more other open reports.
To call up a default report from the Home page, the View Reports large button is clicked. The user may select a default report and date range interval. To open another report, a name may be selected from a drop-down box under Reports on the main menu bar as illustrated at
The reports screens offer numerous tools for navigation, including tools for setting the date range, interactive data elements, and signal colors that help users interpret reports at a glance. Displaying the legend will help a user understand the report.
The data range may be adjusted to include any date and any date interval (see
To move back in time in increments equal to the currently displayed date interval, the user clicks the Previous arrow (For example, if a 2-week date range is currently displayed, the user clicks the Previous arrow to display additional 2-week intervals). To move forward in time, the user may click the Next arrow. To select a specific date range (with beginning and ending dates specified), the user clicks or otherwise chooses the respective dates from the drop-down calendars.
The reports preferably have interactive data elements that link to related or more complete information. These elements can include data points on a graph, regions on a chart, and/or cells in a table. A pointer becomes the hand icon when it is hovering over an interactive data element. For example, by hovering the pointer over a triangle (glucose reading data element), a user can display the value, date, and time of the reading in a pop-up bubble. To go to the Glucose Reading event in the Diary List, the user can double-click the triangle. For example, carbohydrate events are represented by peach-colored circles; the size of each circle is proportional to the carbohydrate value. Insulin data is represented by dark green and dark red bars. Glucose readings are represented by circles (manual entries) or triangles (uploaded entries), which can be linked by a solid or dotted line.
Glucose readings are separated into target ranges, which are represented on graphs and tables either in signal colors or in distinctive patterns for black-and-white printing. A user can choose to display data in three ranges (High, Within, and Low) or five ranges (Very High, High, Within, Low, and Very Low). These choices can be changed at any time on the Miscellaneous tab of the Report Configuration form (see
Reports may be printed (using a Print drop down box such as that illustrated at
Reports can be personalized to a user's preferences by making choices for Report Options on the Profile for screen and by activating data filters and display features on the Report Configuration screen.
Data filters are tools for selecting the types of data a user wants to include in a report. A user selects the data filters desired by clicking a Report Configuration icon on the Reports toolbar and choosing items from the Event Types, Time Periods, and Week Days sections on the Data Filter tab (see
Some display features are configured on the Miscellaneous tab of the Report Configuration screen, as illustrated at
The following is a table of reports that use glucose targets and the modes they use.
Glucose Target Mode
Glucose Target Mode
Glucose Modal Day
Lab & Exam Record
Daily Combination View
Weekly Pump View
HCP Group Analysis
Depending on the report, a day (24 hours) is calculated from midnight to midnight or pre-breakfast to pre-breakfast. The various reports define a day as follows:
Definition of a Day
Midnight to Midnight
Glucose Modal Day
Pre-breakfast to Pre-breakfast
Midnight to Midnight
Pre-breakfast to Pre-breakfast
Midnight to Midnight
Glucose Pie - Total Pie
Pre-breakfast to Pre-breakfast
Pre-breakfast to Pre-breakfast
Lab & Exam Record
Midnight to Midnight
Pre-breakfast to Pre-breakfast
Daily Combination View
Midnight to Midnight
Weekly Pump View
Midnight to Midnight
HCP Group Analysis
Midnight to Midnight
The Diary List is a table of data entries made over the specified date range. Each row corresponds to one event.
To Hide an event, a user can click any cell in the row, then right-click, and then Click Hide Data on the pop-up menu (see
A user can customize columns in the Diary List by changing the order of events in a column, adding and removing columns, and resizing columns. To change the order of the events in the Diary List, the user can click any of the following column heads:
To remove a column from the report, the user can drag-and-drop the column head cell off the table. To add a column to the report, right-click anywhere on the table to call up the pop-up window (see
The Glucose Modal Day Report shows the daily pattern of glucose levels over the specified date range. A dotted line linking the readings for a specific date can be displayed or hidden.
To zoom in on (magnify) an area of the graph, a user can place the mouse in the upper left of the graph, press and hold the left mouse button, and drag to the lower right corner of the graph. The user can repeat this action to further magnify the area of interest. To return the graph to its original state, the user can place the mouse in the lower right of the graph, press and hold the left mouse button, and drag to the upper left corner. To go to the Glucose Reading entry in the Diary List, the user can double-click the data element.
The Glucose Line Report is useful for seeing trends in glucose levels. It plots each glucose reading over the specified date range.
The Glucose Average Report may help identify times of the day that may need more testing or improved control. The report separates glucose readings over the specified date range into pre-meal (cream-colored bars) and post-meal (blue bars) groupings and averages the values for each group. For convenience, there are two graphs. One shows pre-meal and post-meal glucose averages over the date range by meal. The other shows overall pre-meal and post-meal averages by day over the date range.
The Glucose Histogram Report separates glucose readings over the specified date range into the default target ranges and displays the data as a histogram (bar chart) with its bar height proportional to the number of readings in each glucose target range.
The Glucose Pie Chart separates glucose readings over the date range into the default glucose target ranges and averages the values within each range. These averages are displayed in a series of pie charts. Each segment (wedge) displays in the signal color of its glucose target range.
The Logbook Report is a table of glucose, carbohydrate, and insulin values associated with each time period over the specified date range.
The Lab and Exam Record Report is a table of data from all Medical Exam and Lab Test Result data entry screens over the specified date range.
The Statistics Report provides an overview of glucose, carbohydrate, and insulin data (including insulin pump data) over the date range and displays it in a series of tables. A user can attach the Statistics Report to any other report by default.
The Glucose Statistics table (see
The Insulin Statistics table (see
These entries are calculated using all types of insulin recorded.
If the insulin is administered by pump, the table (
The Carbs Statistics table (see
The Daily Combination View Report summarizes glucose, carbohydrate, and insulin data (including pump data) for a single day and displays it in both graphic and table formats. To select the day for the data you want to see, a user can use the date field on the right (see
This graph (see
This graph (see
This table (see
The Weekly Pump View Report shows the components of insulin doses for each day in a seven-day period in bar graph (
The HCP Group Analysis Report is available to HCP users only. This report is a user-configurable view of all FreeStyle CoPilot System data for all patients of the HCP. The HCP can display data for any patient he/she manages. This includes all device data uploaded at the clinic during a patient visit, all data entered manually at the clinic, and all data imported into the HCP's database through information sharing (see Chapter 7, Host). This report facilitates viewing and comparing of data for all patients of the HCP or clinic.
A user can customize the columns in the HCP Group Analysis Report by changing the order of events in a column, adding and removing columns, and resizing columns. To save the custom changes, the user can click Customize (bottom right of screen). The Filter Builder screen displays (see
To reverse the order of items in any column, the user can click on the column heading, then click on the little arrow that appears to the right of the heading. The user can do the same to change the order back to its original sequence. To remove a column from the report, the user can drag-and-drop the column head cell off the table. To add a column to the report, the user can right-click anywhere on the table to call up a pop-up window (see
For any column-head in the table, a user can configure a data filter using the selection list. To display the selection list for any column, the user can click the down-arrow at the right. To display data for all patients, with any or no entry in the corresponding data field, the user can click All. To customize the data filter, the user can click Customize, and complete the dialog box.
The System of the preferred embodiment incorporates insulin management tools to make health management easier for Home and HCP users. The System provides additional insulin management tools to support the Home User's healthcare. An Insulin Adjustment Table is used to determine insulin dose adjustment based on a user's current blood glucose level. All values entered in this table should be determined by the HCP. A Prescribed Plan table is used to store and review healthcare guidelines established by the HCP.
The HCP first sets up the values in this table (see
On the Home page, a user can select References on the main menu bar (see
The Prescribed Plan is a table Home users can use to store and review guidelines from their HCP for Insulin type, dosage, and time of day, insulin sensitivity, medication type, dosage, and time of day, carbohydrates for each individual meal time, and/or ratio of amount of insulin per grams of carbohydrate.
On the Home page, a user can select References on the main menu bar (see
Individuals with low insulin sensitivity usually need a higher insulin dose to lower their glucose levels to acceptable levels than people with higher insulin sensitivity. The user's insulin sensitivity is determined by his or her HCP. The insulin-to-carbohydrate ratio is used to determine how much insulin to administer per grams of carbohydrates eaten. A user's insulin-to-carbohydrate ratio is determined by his or her HCP.
The Host System of the preferred embodiment resides on an Internet server. The Host database stores data that has been synchronized with the System data on a user's PC. Data stored on the Host can be shared with other users. A Home user can choose to share your data with his or her HCP or several HCPs. HCP users can share data with other HCPs. In either case, the user “invites” the other party to share data. The user sets up a Host Account if he or she wishes to use the Host's capabilities. A Host Account defines access, privileges, and functions associated with a particular user.
Synchronization is the process whereby the System application on a user's PC connects to the Internet and transmits data and other information between the user's program and the Host server. Synchronization matches and updates the data between the System application installed on the user's computer and the Host System. Following synchronization, new and modified data is reflected in both the local System database and the database on the Host server.
The first time a user synchronizes with the Host, the Synchronize window opens. The user can follow the steps on the screen, a Host account will be created and a confirmation e-mail will be sent to the user. The user can verify his or her Host account number by looking on the User Profile screen. If a user selects an item from the Host drop-down menu, the System will try to open an Internet connection automatically. If the Internet connection cannot be opened this way, it can be opened manually before selecting items on the Host menu.
The user can click the Synchronize icon or select Host on the main menu bar and choose Synchronize from the drop-down box (Home version) or Synchronize Current HCP (HCP version).
If the user has previously logged in and set up an account, he or she can synchronize with the Host as follows. The user can click the icon or select Host on the main menu bar and choose Synchronize from the drop-down box (Home version) or Synchronize Current HCP (HCP version) (see
In a single household, there may be more than one person with diabetes that manages their diabetes using the System. For convenience, a Home user may synchronize the data for all the Home users using the System in the household with a single click of the mouse. The user can select Host on the main menu bar and choose Synchronize All from the Home user Host drop-down box (see
In a clinic, for example, there may be several HCPs using the same System. For convenience, a HCP may synchronize the patient data for all the HCPs using the System with a single click of the mouse. The user can select Host on the main menu bar and choose Synchronize All HCPs from the drop-down box (see
Once the user (Home or HCP) sets up a Host Account, he or she can authorize one or more HCPs to have access to the data. To do this, the user can initiate an “invitation” to the HCP to share data via the Host. This notifies the Host that the user will allow the selected HCP to view (and in some cases, edit) their data.
There are several ways to invite an HCP to share data. The HCP may have a Host Account: Once a user is logged in to the Host, he or she can search for the HCP using the HCP's State/Province or Host Account number. The HCP may not have a Host Account: In this case, the HCP's e-mail address is discovered and used. If the HCP fails to accept or decline the invitation within 30 days, the invitation to share data expires. A user then can send another invitation to the same HCP after 30 days.
From the Host menu on the main menu bar, the user can choose Invite to Share Data.
If a patient user issues an invitation to share their data with a user, the user will see a message in the Messages From CoPilot Host window as illustrated at
If the HCP does not have a Host Account, a user can send an e-mail invitation to the HCP to share data if the HCP's Internet address (example: email@example.com) is known. From the Host menu on the main menu bar, the user can choose Invite to Share Data. An Internet connection to the Host server will open and the screen illustrated at
When a user receives an e-mail invitation to share data, the message will instruct the user to download the Health Management System from the Internet (e.g., by just clicking on the hyperlink in blue), install the software and set up a user profile, and synchronize with the Host and set up a Host Account. The user then makes note of the Invitation Code included near the end of the e-mail (see
After the user has downloaded and installed the software, he or she can set up a user profile and register with the Host. From the Host drop-down box on the main menu bar, the user can choose Accept E-Mail Invitation.
A user can limit, expand, or deny an HCP access to his or her data on the Host using a Manage Shared Data function.
From the Host drop-down box (see
A HCP user can view a list of the patients with whom he or she shares data. The HCP user can also unsubscribe patients, which means the HCP user will no longer have access to their data. From the Host drop-down box (see
To ensure that information remains accurate, the System provides the user with the capability to perform database maintenance. The Database Maintenance feature includes the ability to, archive data, backup data and restore data from the last backup. More than one database can be created and maintained by the System application. The last database selected will be opened by each successive execution of the software until another database is selected by the user.
When a user chooses to archive data, the data being archived will be removed from the System database. The user can restore the data by importing it. On the Home page, the user can select Database Maintenance from the File drop-down box (see
The user can close or minimize the system application. The user opens the file browser and browses to the folder where he or she saved the archived *.xml file.
Archived data can be reloaded into the System as follows. On the Home page, a user can select Import from the DataEntry drop-down box (see
A backup of the database is performed automatically each time the user exits (closes) the application. The user can also create a backup of his or her database at any time and save it in any directory. The user can Backup the database as follows. On the Home page, the user can select Database Maintenance from the File drop-down box (see
The System database is automatically restored if a system integrity check fails. A user can also restore a database whenever desired, as follows. On the Home page, the user can select Database Maintenance from the File drop-down box (see
The user can view the Restore Log at any time, as follows. The user can close or minimize the System application. The user can open the file browser and find the Health Management System folder. This is the folder where the application was installed.
For answers to questions about how to do something within the System, a user can consult the User's Guide or take advantage of the System's built-in onscreen Help. The user can access Help from any screen in the System that displays the main menu bar. The user can get context-sensitive Help on most screens. For example, if the user is viewing the Diary List and has a question, he or she can click WY. The Help screen will automatically open to the Help text that describes the Diary List.
On the Home page, a user can click an icon, or select Help on the main menu bar and then select Contents from the drop-down list (see
Help text is displayed in the large window on the Help screen. The Contents, Index, and Search tabs at the left offer three ways to find the Help topic the user is looking for. When the user selects a topic, the Help text appears in the large window on the right. Some text may contain links to more detailed information about a topic. These links appear as blue text followed by three dots (for example, Local Home User Account . . . ). If it is a link, the cursor will change from an arrow to a hand when passed over the link. The user can click the link to see the additional text. Green text may be underlined and in italics. If it is a link, the cursor will change from an arrow to a hand when passed over the link. The user can click the link to see the additional text.
The user can click to hide the column with the Contents, Index, and Search tabs from displaying on screen. The user can click to show the column with the Contents, Index, and Search tabs. The user can click to see the previous page in the Help text. The user can click to see the next page in the Help text, and can click to print the Help page being viewed.
Contents is the first tab displayed when the user opens the Help screen (see
The user can click on the Index tab to display an alphabetical list of all topics covered in the Help file. The user can select a topic from the list and double-click. The text displays in the big window (see
The user can click on the Search tab if he or she wants to use keywords to find Help text.
The present invention is not limited to the embodiments described above herein, which may be amended or modified without departing from the scope of the present invention as set forth in the appended claims, and structural and functional equivalents thereof.
In methods that may be performed according to preferred embodiments herein and that may have been described above and/or claimed below, the operations have been described 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 operations.
In addition, the following references, in addition to the summary of the invention section, are hereby incorporated by reference into the detailed description of the preferred embodiments as disclosing alternative embodiments:
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|U.S. Classification||1/1, 707/999.001|
|International Classification||G06F19/00, G06Q50/22, G06F17/30|
|Cooperative Classification||G06Q50/22, G06F19/322, G06F19/3487, G06F19/3481, G06F19/324|
|European Classification||G06F19/32C, G06F19/32E, G06F19/34P, G06F19/34N, G06Q50/22|
|Oct 28, 2005||AS||Assignment|
Owner name: THERASENSE, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:GOODNOW, TIMOTHY T;ANDERSON, CAROLYN;LOVE, TOM;REEL/FRAME:016702/0289;SIGNING DATES FROM 20050707 TO 20050712
|Feb 27, 2015||AS||Assignment|
Owner name: ABBOTT DIABETES CARE INC., CALIFORNIA
Free format text: CHANGE OF NAME;ASSIGNOR:THERASENSE, INC.;REEL/FRAME:035110/0938
Effective date: 20050725