U.S. patent application number 12/842824 was filed with the patent office on 2011-07-21 for diabetes care host-client architecture and data management system.
This patent application is currently assigned to Abbott Diabetes Care Inc.. Invention is credited to Carolyn Anderson, Timothy T. Goodnow, Thomas W. Love.
Application Number | 20110178717 12/842824 |
Document ID | / |
Family ID | 35463572 |
Filed Date | 2011-07-21 |
United States Patent
Application |
20110178717 |
Kind Code |
A1 |
Goodnow; Timothy T. ; et
al. |
July 21, 2011 |
Diabetes Care Host-Client Architecture and Data Management
System
Abstract
A host-client data sharing system manages 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.
Inventors: |
Goodnow; Timothy T.;
(Pleasanton, CA) ; Anderson; Carolyn; (Dublin,
CA) ; Love; Thomas W.; (Monticello, FL) |
Assignee: |
Abbott Diabetes Care Inc.
|
Family ID: |
35463572 |
Appl. No.: |
12/842824 |
Filed: |
July 23, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11146897 |
Jun 6, 2005 |
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12842824 |
|
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60577064 |
Jun 4, 2004 |
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Current U.S.
Class: |
702/19 ;
705/2 |
Current CPC
Class: |
G06F 13/4282 20130101;
G06F 13/102 20130101; G16H 10/60 20180101; G16H 70/60 20180101;
G06F 13/20 20130101; G16H 15/00 20180101; G06F 13/4068
20130101 |
Class at
Publication: |
702/19 ;
705/2 |
International
Class: |
G06F 19/00 20110101
G06F019/00; G06Q 50/00 20060101 G06Q050/00 |
Claims
1-49. (canceled)
50. A method of operating an analyte measurement device having a
display, user interface, processor, memory and user interface
buttons, the method comprising: measuring an analyte in a
biological fluid of a user with the analyte measurement device;
displaying a value representative of the analyte; prompting or
querying a user to select a flag to associate the flag with the
value of the analyte; and pressing only one of the user interface
buttons once to store the flag with the value in the memory of the
device.
51. The method of claim 50, in which the user interface buttons
comprise an up button, a down button and an enter button.
52. The method of claim 50, in which the user selectable flag
comprises a flag selected from a group consisting of a before meal
flag or an after meal flag.
53. The method of claim 52, in which the user selectable flag
comprises an after meal flag.
54. The method of claim 50, in which the prompting comprises
prompting a user whenever a measuring step indicates that an
analyte value is outside a predetermined range.
55. The method of claim 50, in which the analyte measurement device
comprises a glucose meter.
56. The method of claim 50, in which the user selectable flag is
selected from a group consisting essentially of at least one of a
comment title, a plurality of comments, comment page number, no
comment, not enough food, too much food, mild exercise, strenuous
exercise, medication, stress, illness, hypoglycemic state, menses,
vacation, and combinations thereof.
57. The method of claim 50, further comprising selecting a
plurality of menus to be displayed.
58. The method of claim 57, in which one of the plurality of menus
comprises a prompt for last result, all results, result average,
and set up.
59. The method of claim 58, in which another of the plurality of
menus comprises a display of a prompt for all results average,
before meal average, and after meal average.
60. A method of operating an analyte measurement device having a
display, user interface, processor, memory and user interface
buttons, the method comprising: measuring an analyte in a
biological fluid of the user with the analyte measurement device;
displaying a value representative of the analyte; prompting a user
to select a flag to associate the flag with the value of the
analyte whenever the measuring is completed; ignoring activation of
any of the user interface buttons except for a selected button; and
associating the value with the flag upon activation of the selected
button in the memory of the device.
61-77. (canceled)
78. A testing system comprising: a user interface including a
display for displaying information relating to measurements of
health data and an input device for receiving information from a
user relating to the health data; and an autologging feature
adapted to provide the user with user-selectable options on the
display and to prompt the user, during a time period corresponding
to the amount of time needed to perform the measurements, to input
information relating to the health data that corresponds to the
appropriate user-selectable option.
79. The testing system of claim 78, wherein the user-selectable
options are before-food and after-food meal markers.
80. The testing system of claim 78, wherein the health data is
related to an analyte in a body fluid sample.
81. The testing system of claim 78, wherein the health data is
related to a heart rate, a blood pressure, a body temperature, a
breathing rate for COPD analysis, or a weight measurement for
analyzing Lasix use.
82. The testing system of claim 78, wherein the user-selectable
options are displayed in connection with a set of soft keys.
83. The testing system of claim 78, wherein the user-selection
option selected by the user is displayed in connection with a
measurement value of the health data.
84. The testing system of claim 78, wherein the time period is
about five seconds.
85. A method of providing a testing system, the method comprising
the acts of: providing the testing system having a user interface
including a display; receiving health data of the user via a
measurement system; prompting the user to input user information
that corresponds to the health data, the prompting occurring within
a time period corresponding to the amount of time needed to perform
measurements relating to the health data; performing the
measurements relating to the health data; during the performing of
the measurements, receiving the user information that corresponds
to the health data via an input device; and displaying the
measurements of the health data on the display.
86. The method of claim 85, wherein the prompting of the user to
input user information that corresponds to the health data includes
displaying a plurality of user-selectable options.
87. The method of claim 86, wherein the user-selectable options
include before-food and after-food meal markers.
88. The method of claim 86, wherein the user-selectable options are
displayed in connection with a set of soft keys.
89. The method of claim 85, wherein the time period is about five
seconds.
90. The method of claim 85, wherein the health data is related to
an analyte in a body fluid sample.
91. The method of claim 90, wherein the analyte in the body fluid
sample is glucose.
92. The method of claim 85, wherein the health data is related to a
heart rate, a blood pressure, a body temperature, a breathing rate
for COPD analysis, or a weight measurement for analyzing Lasix use.
Description
PRIORITY
[0001] This application claims the benefit of priority under
.sctn.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.
FIELD OF THE INVENTION
[0002] 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.
SUMMARY OF THE INVENTION
[0003] 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.
[0004] 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.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1. Home Page
[0015] FIG. 2. Application Installation Screen
[0016] FIG. 3. Installation Destination Screen
[0017] FIG. 4. Select Program Manager Group Screen
[0018] FIG. 5. Start Installation Screen
[0019] FIG. 6. Finish Screen
[0020] FIG. 7. Location of Start Button (PC Desktop) and Programs
List
[0021] FIG. 8. Initial User Setup Screen
[0022] FIG. 9. Home Page
[0023] FIG. 10. HCP Version: Select HCP and Select Patient
Fields
[0024] FIG. 11. File Drop-Down Box: System Settings
[0025] FIG. 12. System Settings Screen
[0026] FIG. 13. Logon to System Screen
[0027] FIG. 14. Home Page: UserProfile Drop-Down Box
[0028] FIG. 15. User Information Screen
[0029] FIG. 16. Health Profile Screen
[0030] FIG. 17. Condition Drop-Down Box
[0031] FIG. 18. Date Diagnosed Drop-Down Calendar
[0032] FIG. 19. Data Entry Preferences Screen
[0033] FIG. 20. Glucose Target Ranges Screen: Standard Mode
[0034] FIG. 21. Glucose Targets Mode Drop-Down Box
[0035] FIG. 22. Pre/Post Meal Mode with Hypo/Hyper Checked (left);
All Time Periods Mode (right)
[0036] FIG. 23. Hypo/Hyper Values Check Box
[0037] FIG. 24. Time Periods
[0038] FIG. 25. Time Period Error Message
[0039] FIG. 26. Glucose Unit of Measure Drop-Down Box
[0040] FIG. 27. Options Screen
[0041] FIG. 28. User Rights Screen
[0042] FIG. 29. File Drop-Down Box: Add User
[0043] FIG. 30. User List Screen
[0044] FIG. 31. Error Message
[0045] FIG. 32. Home: UserProfile Drop-Down Box
[0046] FIG. 33. User Rights Screen
[0047] FIG. 34. File Menu Drop-Down Box: Add HCP
[0048] FIG. 35. HCP Profile Screen
[0049] FIG. 36. HCP Type Drop-Down Box
[0050] FIG. 37. UserProfile Drop-Down Box: HCP List
[0051] FIG. 38. HCP List Screen
[0052] FIG. 39. HCP Home Page
[0053] FIG. 40. HCP: UserProfile Drop-Down Box
[0054] FIG. 41. HCP User Information Screen
[0055] FIG. 42. Glucose Target Ranges Screen: Standard Mode
[0056] FIG. 43. Glucose Targets Mode Drop-Down Box
[0057] FIG. 44. Pre/Post Meal Mode with Hypo/Hyper Checked (left);
All Time Periods Mode (right)
[0058] FIG. 45. Hypo/Hyper Values Check Box
[0059] FIG. 46. Glucose Unit of Measure Drop-Down Box
[0060] FIG. 47. HCP Profile Options Screen
[0061] FIG. 48. User Rights Screen
[0062] FIG. 49. HCP: UserProfile Drop-Down Box
[0063] FIG. 50. Patient List Screen
[0064] FIG. 51. Patient Profile Screen
[0065] FIG. 52. Patient List Screen
[0066] FIG. 53. Patient List Screen
[0067] FIG. 54. Assign Patients Drop-Down Box
[0068] FIG. 55. Authorization Levels
[0069] FIG. 56. HCP: File Drop-Down Box
[0070] FIG. 57. HCP List Screen
[0071] FIG. 58. Reassign Local Patients Message
[0072] FIG. 59. User Rights Screen
[0073] FIG. 60. Cable Connection Example
[0074] FIG. 61. Home Page with Select User Drop-Down List
[0075] FIG. 62. DataEntry Drop-Down List: Device Setup
[0076] FIG. 63. Device Setup Screen
[0077] FIG. 64. Device Setup Screen with Details
[0078] FIG. 65. DataEntry Drop-Down List: Read Device
[0079] FIG. 66. Assign Device Screen
[0080] FIG. 67. Summary Window
[0081] FIG. 68. DataEntry Drop-Down List: Undo Last Upload
[0082] FIG. 69. DataEntry Drop-Down List: Read Tracker
[0083] FIG. 70. Read Tracker Screen: HotSync Prompt
[0084] FIG. 71. HotSync Progress Screen
[0085] FIG. 72. Assign Device Screen
[0086] FIG. 73. Profile Updated Screen
[0087] FIG. 74. Upload Summary Screen
[0088] FIG. 75. Reports Drop-Down List: Diary List
[0089] FIG. 76. Glucose Reading Data Entry Screen
[0090] FIG. 77. Insulin Data Entry Screen
[0091] FIG. 78. Meal Data Entry Screen
[0092] FIG. 79. Multi-Item Meal with Total Carbs Shown
[0093] FIG. 80. Exercise Data Entry Screen
[0094] FIG. 81. State of Health Data Entry Screen
[0095] FIG. 82. Medication Data Entry Screen
[0096] FIG. 83. Medical Exam Data Entry Screen
[0097] FIG. 84. Lab Test Result Data Entry Screen
[0098] FIG. 85. Ketones (Blood) Data Entry Screen
[0099] FIG. 86. Sample Site Drop-Down Box
[0100] FIG. 87. Notes Data Entry Screen
[0101] FIG. 88. DataEntry Drop-Down Box: Customize Data Entry
Lists
[0102] FIG. 89. Select List to Customize Drop-Down List
[0103] FIG. 90. Exercise Types
[0104] FIG. 91. Food List
[0105] FIG. 92. Insulin Names List
[0106] FIG. 93. Test Types List
[0107] FIG. 94. Medications List
[0108] FIG. 95. Exam Types List
[0109] FIG. 96. DataEntry Drop-Down Box and Import Drop-Down
Box
[0110] FIG. 97. File Browser Window: Select Database to Import
[0111] FIG. 98. Import Drop-Down Box: Activate FreeStyle CoPilot I
Data
[0112] FIG. 99. Import Drop-Down List: Import Events From File
[0113] FIG. 100. File Browser Window
[0114] FIG. 101. Reports Drop-Down Box
[0115] FIG. 102. Diary List: Date Adjustment
[0116] FIG. 103. File Browser Window
[0117] FIG. 104. Reports Window: Glucose Modal Day Report (Default
Report)
[0118] FIG. 105. Reports Drop-Down Box
[0119] FIG. 106. Glucose Line Report Active with Several Other Open
Reports
[0120] FIG. 107. Reports Toolbar (Date Range)
[0121] FIG. 108. Print Drop-Down Box
[0122] FIG. 109. User Profile Screen with Options Tab Active
[0123] FIG. 110. Report Configuration Screen: Data Filter Tab
[0124] FIG. 111. Report Configuration Screen: Miscellaneous Tab
[0125] FIG. 112. Black-and-White Display: Distinctive Patterns
(Screen Detail)
[0126] FIG. 113. Diary List
[0127] FIG. 114. Reports: Right-Click Pop-Up Menu
[0128] FIG. 115. Customization List
[0129] FIG. 116. Glucose Modal Day Report (Dotted Line Linking
Readings for Apr. 3, 2004)
[0130] FIG. 117. Glucose Line Report (Show Line Is Activated)
[0131] FIG. 118. Pop-up Menu: Glucose Line Report
[0132] FIG. 119. Glucose Average Report: By Meal
[0133] FIG. 120. Glucose Average Report: By Day
[0134] FIG. 121. Glucose Histogram Report
[0135] FIG. 122. Glucose Pie Chart Report: Total Readings Pie
Chart
[0136] FIG. 123. Glucose Pie Chart Report: Ten Summary Pie
Charts
[0137] FIG. 124. Logbook Report
[0138] FIG. 125. Lab & Exam Record Report: Lab Record
[0139] FIG. 126. Lab & Exam Record Report: Exam Record
[0140] FIG. 127. Lab & Exam Record Report: A1C History
[0141] FIG. 128. Statistics Report: Glucose Statistics
[0142] FIG. 129. Statistics Report: Insulin and Carbs Statistics
Tables
[0143] FIG. 130. Date Field for Selecting Date
[0144] FIG. 131. Daily Combination View Report: Glucose Line and
Carbohydrates Graphs
[0145] FIG. 132. Daily Combination View Report: Insulin Summary and
Data Table
[0146] FIG. 133. Date Field for Selecting Date
[0147] FIG. 134. Weekly Pump View Report: Bar Graph
[0148] FIG. 135. Weekly Pump View Report: Pie Charts and Glucose
Statistics Table
[0149] FIG. 136. HCP Group Analysis Report
[0150] FIG. 137. Pop-Up Window
[0151] FIG. 138. Customization List
[0152] FIG. 139. Filter Builder Screen
[0153] FIG. 140. References Drop-Down Box
[0154] FIG. 141. Insulin Adjustment Table
[0155] FIG. 142. Prescribed Plan
[0156] FIG. 143. Home User: Host Drop-Down Box (left); HCP User:
Host Drop-Down Box (right)
[0157] FIG. 144. First Time Synchronization Screen
[0158] FIG. 145. Host Account Number
[0159] FIG. 146. Synchronization Summary Screen
[0160] FIG. 147. Confirmation Message From the Host
[0161] FIG. 148. Invite to Share Data (Home User Screen, left; HCP
User Screen, right)
[0162] FIG. 149. Invite HCP to Share Data Screen
[0163] FIG. 150. Find HCP from Existing Accounts Screen
[0164] FIG. 151. Assign Access Level Screen
[0165] FIG. 152. Process Complete Screen
[0166] FIG. 153. Invite HCP to Share Data Screen
[0167] FIG. 154. Enter Host HCP Account Number Screen
[0168] FIG. 155. Assign Access Level Screen
[0169] FIG. 156. Process Complete Screen
[0170] FIG. 157. Messages from CoPilot Host Window
[0171] FIG. 158. Invitation to Share Data (from Host)
[0172] FIG. 159. Invite HCP to Share Data Screen
[0173] FIG. 160. E-mail Invitation to HCP with No Host Account
[0174] FIG. 161. Assign Access Level
[0175] FIG. 162. Process Complete Screen
[0176] FIG. 163. E-mail Invitation to Register and Share Data
[0177] FIG. 164. Invitation Code Example
[0178] FIG. 165. HCP: Host Drop-Down List
[0179] FIG. 166. Accept Invitation Screen
[0180] FIG. 167. Synchronization Screen
[0181] FIG. 168. Home User: Host Drop-Down Box
[0182] FIG. 169. Manage My Shared Data Screen
[0183] FIG. 170. HCP User: Host Drop-Down Box
[0184] FIG. 171. Manage Data Being Shared With Me Screen
[0185] FIG. 172. Changed Access Level Message
[0186] FIG. 173. File Drop-Down Box: Database Maintenance
Submenu
[0187] FIG. 174. Archive Event Data Screen
[0188] FIG. 175. File Browser Window: Save Archive Data
[0189] FIG. 176. File Browser: Location of Archived Data File
(*.xml)
[0190] FIG. 177. DataEntry Drop-Down Box: Import Submenu
[0191] FIG. 178. Importing Screen
[0192] FIG. 179. File Browser: Select Backup Location
[0193] FIG. 180. Restore Log
[0194] FIG. 181. File Browser: Restore Log
[0195] FIG. 182. Help Drop-Down List
[0196] FIG. 183. Help Screen
[0197] FIG. 184. Help: Index Tab
[0198] FIG. 185. Help: Search Tab
[0199] FIG. 186. Help Drop-Down Box
[0200] FIG. 187. Customer Service Contact Information Screen
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0201] A system in accordance with a preferred embodiment is
referred to as the FreeStyle CoPilot.TM. 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.TM. and Precision Xtra.TM. blood glucose
monitoring systems (and generally to several other commercially
available blood glucose meters and insulin pumps) into the
FreeStyle CoPilot application.
[0202] 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.
[0203] 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.
[0204] 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.
[0205] 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.
[0206] 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.
[0207] 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.
[0208] 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.
[0209] 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.
[0210] 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.RTM.
Windows 98 SE, 2000, NT, ME, or XP operating systems are preferred.
A monitor with 1024.times.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.
[0211] 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.RTM. cradle for uploading
data from a PDA-type diabetes management system.
[0212] 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.
[0213] 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.
Graphical User Interface
[0214] 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 FIG. 1, with
the main user activities highlighted. The screen shot illustrated
at FIG. 1 includes a main menu bar 2, a small icons bar 4, large
buttons 6, and name of open database 8.
[0215] 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 FIG. 9.
[0216] 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.
[0217] 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.
[0218] 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.
[0219] 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. FIG. 2 illustrates a screen shot of
an application installation screen.
[0220] FIG. 3 illustrates an installation destination screen. A
user may install the System on a selected device. If installing the
program on a local area network (LAN), synchronizing with a network
administrator is preferred. At a select program manager group
screen, such as that illustrated at FIG. 4, a suggested program
manager group 10 or another selected from a scroll-down list 12,
may be selected. A start installation screen such as that
illustrated at FIG. 5 permits the software to be installed. If the
installation is successful in fully installing the System, a final
setup screen then displays, such as that illustrated at FIG. 6. A
System icon will now appear on the PC desktop, and System program
and user guides are added to the PC's Programs list.
[0221] FIG. 7 illustrates location of Start Button 14 (PC Desktop)
and Programs List 16 within Windows.TM.. The system program files
and guides menu options 18 can be accessed this way.
[0222] 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 FIG. 8, if this is the first time a user is running the program.
The user may select Home User 20 if he or she is a person with
diabetes, or Health Care Professional 22 if he or she is a HCP.
Personal identification information including a password is then
input in a user identification section 24. After filling in the
Initial User Setup information, this screen is not utilized again,
and instead a home page, such as that illustrated at FIG. 9, will
display when the System program is run.
Home Page
[0223] 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.
[0224] A select user field 24 is illustrated in FIG. 9. The name of
the active user is displayed in the Select User field 24. The
select user filed 24 includes a drop-down list of multiple persons
each having a User Profile in the System. Referring to FIG. 10, in
a HCP version, there is a Select HCP field 26 and a Select Patient
field 28.
[0225] The small icons 4 provide access to program functions. From
left to right in FIG. 9, preferred small icons 4 include: a go to
home page icon, a read data from a meter icon, a manually enter
data icon, a view reports icon, a synchronize with host icon, and
edit current user's profile or edit current patient's profile icon,
and a show context help icon.
[0226] The Large Buttons 6 provide quick access to main program
functions. From left to right in FIG. 9, preferred large icons 6
include: a User List or patient list icon a Read Device icon, a
Manual Entry icon, a View Reports icon, and a User Profile or
Patient Profile icon.
[0227] 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.
[0228] 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.
[0229] 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 FIG. 11). If System
Settings is grayed out, then a user does not have the User Rights
to turn on password protection. If a user does have User Rights,
then the System Settings screen displays (see FIG. 12). When the
box to Require User Logon is checked, then password protection is
turned on and the first screen will be a Logon to System screen
(see FIG. 13). This screen will also display when changing users in
the Select User field (Home version) or in the Select HCP field
(HCP version). The home page will appear upon typing in or
otherwise inserting a User ID and Password.
[0230] 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.
[0231] FIG. 14 illustrates a home page having a UserProfile tab on
the main menu bar 2 selected and expanded. The User Profile button
of the large icon bar 6 may also be clicked. Either way, User
Profile may be now selected from the drop-down box 30 or other menu
expansion architecture.
[0232] A Profile For screen is illustrated in FIG. 15. In the
screen display of FIG. 15, the User Information tab 32 is selected.
A user may provide whatever information that he or she wishes to,
except that fields marked with an asterisk (*) or double-asterisk
(**) will be required fields. Information can be added by selecting
items from drop-down boxes or by typing in words and numbers. A
Health Profile tab is illustrated at FIG. 16. When a Condition
column arrow is clicked, a drop-down box is displayed such as that
illustrated at FIG. 17. The user can select any of the conditions
listed that apply to him or her, or type in a new condition that
will be added to the list.
[0233] A screen shot such as that illustrated at FIG. 18 will
appear when the arrow on a Date Diagnosed column is clicked. The
screen shot of FIG. 18 is preferably a basic calendar. The arrows
may be used to select the date this condition was diagnosed.
[0234] FIG. 19 illustrates a Data Entry Preferences screen that can
be used to save time in manually entering data by setting up Data
Entry Preferences. For example, if a user regularly takes a certain
type of insulin at a particular dose, the user can enter it here.
The same is true for regular exercise routines and other
medications the user may take. Information entered here will then
be automatically listed when manual entries are made. To enter your
preferences, the user selects a Data Entry Preferences tab and
fills in Exercise Preferences (type, duration, intensity); Insulin
Preferences (insulin name, dosage, type); and/or Medication
Preferences (medication name, dosage, number of pills). Each column
heading preferably has a drop-down box. A user can select one of
the listed entries or type in a new entry that will be added to the
list.
[0235] 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 FIG. 20, as well
as in many other reports that can be generated by the System. The
ranges may be displayed in signal colors for easy viewing.
[0236] 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 FIG. 21. Standard, Pre/Post Meal and All Time
Periods modes may be selected. In Standard mode, glucose target
ranges set apply to all glucose readings, regardless of when the
glucose reading is taken. For example, target ranges will be the
same for pre-meal readings as for post-meal readings or bedtime
readings. In Pre/Post Meal mode, glucose target ranges set for
pre-meal readings can be different from the target ranges for
post-meal readings. In All Time Periods mode, glucose target ranges
set can be different for each time period listed, for example,
Pre-Bkfst, Post-Bkfst, Pre-Lunch, Post-Lunch, Pre-Dinner,
Post-Dinner, Bed, and Sleep. FIG. 22 illustrates Ore/Post Meal Mode
with Hypo/Hyper checked (left) and All Time Periods Mode
(right).
[0237] 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 FIG. 21.
[0238] Clicking on up/down arrows for High and Low sets glucose
targets. To automatically restore Glucose Target Ranges to the
ranges shown in FIG. 20 (the defaults), a Restore Default Glucose
Target Ranges button 42 can be clicked. Clicking Restore Default
Glucose Target Ranges 42 preferably automatically also restores the
mode to Standard Mode and unchecks a Use Hypo/Hyper Values box 44
illustrated at FIG. 23. Checking the Use Hypo/Hyper Values box 44
activates Very Low and Very High data fields 46 and 48. Clicking on
up/down arrows for Very Low 46 and Very High 48 changes these
values.
[0239] 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 FIG. 24. The System will generally not allow a user
to enter a normal daily schedule that exceeds 24 hours. If a user
tries, he or she will receive an error message illustrated at FIG.
25, and the time periods will be readjusted to equal 24 hours. As
user can select a Glucose Unit of Measure from the drop-down box
illustrated at FIG. 26. The default is mg/dL; and another choice is
mmol/L.
[0240] An option tab may be selected, and an options screen will
appear such as that illustrated at FIG. 27. Under Program Options,
boxes may be checked for the options a user wishes to use. A user
may also select Data Entry and Report Options, and can select the
options that apply to his or her diabetes management. This
simplifies use, entry, and viewing of data/events.
[0241] By selecting Rights 52 at the lower left of the Options
screen illustrated at FIG. 27, a User Rights screen displays as
illustrated at FIG. 28. A user may choose to control access for
additional profiles that he or she may create. By checking the Edit
Data box 54 allows the user to edit data/events and delete user
accounts. For example, many households might have only one person
using the System, but some households may have more than one.
Home User: Managing a User Profile
[0242] 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.
[0243] A User Profile may also be added by selecting Add User from
a File drop-down box on the Home Page. FIG. 29 illustrates a File
Drop-Down Box for Adding a User.
[0244] A user may also remove a User Profile at a User List screen
such as that illustrated at FIG. 30. If a user tries to delete his
or her own user profile, the System will display an error message
such as that illustrated at FIG. 31.
[0245] 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 FIG. 32. The User List screen
displays (see FIG. 30). User rights may be changed by first
highlighting the name of the user whose rights are to be changed.
The User Rights screen will appear such as illustrated at FIG. 33,
and rights can be selected or de-selected by checking or unchecking
appropriate boxes. The Edit Data box 54 allows the user to edit
data/events and/or delete user accounts.
[0246] 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). FIG. 34 illustrates a drop down box for adding a HCP. The
Profile for screen displays as illustrated at FIG. 35. A user may
select a description of the HCP from the HCP Type drop-down box
illustrated at FIG. 36. If there is no selection for the one
desired, then a user may type in a description.
[0247] A HCP Profile may be edited. From the UserProfile drop-down
box illustrated at FIG. 37, which is accessible from the main menu
bar 2 of the Home Page, HCP List is selected and the HCP list
screen appears (see FIG. 38). The name of the HCP User is then
highlighted. By selecting Edit HCP Profile from the File menu on
the HCP List screen, or clicking a representative icon, the Profile
for screen for the HCP user displays, and edits can be made on the
screen.
[0248] A HCP Profile can be removed. From the UserProfile drop-down
box on the main menu bar (see FIG. 37), a user can choose HCP List.
By highlighting the name of the HCP User on the HCP List screen,
and selecting Remove HCP from the File menu on the HCP List screen,
the HCP can be removed. The System will ask the user to
confirm.
HCP User: Setting Up a User Profile
[0249] 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. FIG. 39 illustrates a HCP Home Page. On the Home page, a user
may select HCP Profile from the UserProfile drop-down box 64 on the
main menu bar 62. The HCP Profile for screen displays with the User
Information tab selected as illustrated at FIG. 41. Information is
filled in here. Information may be added by selecting items from
drop-down boxes or by keying in words and numbers. If a desired HCP
type is not found in the HCP Type drop-down box, a description can
be entered at the keyboard.
Glucose Targets
[0250] The Glucose Targets tab 66 can be selected from the HCP
profile for screen illustrated at FIG. 42 to customize glucose
target ranges. The glucose targets set here will apply to the
reports viewed for the persons with diabetes the HCP user manages
via the System. A HCP user may view the graph in three modes as
illustrated in FIG. 43 by selecting the desired mode from the Mode
drop-down box. The standard, Pre/Post Meal and All Time Periods
modes were described above and not repeated here. In addition,
setting target glucose ranges were described above and the
descriptions of FIGS. 44, 45 and 46 are similar to those described
above and thus not repeated here. FIGS. 47-48 illustrate an Options
tab and User Rights screen also similar to described above for
diabetic users and not repeated here. In addition, managing a HCP
profile is similar to managing a diabetic user profile, and that
description is not repeated here with reference to FIGS. 49-54.
[0251] 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 FIG. 55. Adding, Editing and Removing HCP profiles
are similar to those described above and not repeated here with
reference to FIGS. 55-57. However, if a HCP is to be removed, and
if local patients are assigned to this HCP, the System then will
prompt the user to reassign the patients to another HCP on the
local computer as illustrated at FIG. 58. User rights may be
assigned similar to above at a User Rights screen as illustrated at
FIG. 59.
Data Entry
[0252] 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.TM., 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.
Connecting a Device to a Computer
[0253] 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 FIG. 60. To set up the device to the computing
device, on the Home page, the user whose data is being uploaded
from the device is selected, from the select user menu illustrated
at the Home page of FIG. 61. Next, Data Entry 72 is selected on the
main menu bar 2, as illustrated at FIG. 62; and then Device Setup
74 is chosen from the drop-down list.
[0254] A Device Setup screen appears as illustrated at FIG. 63.
Under Select Options 76, the device is selected from the Meter Type
drop-down list 78. The communications port (COM1, COM2, etc.) is
selected from the Available Ports drop-down list 80. The System
stores Meter Type and Available Ports settings during Device Setup.
The user will not have to select them the next time he or she
uploads data from this meter as long as he or she connects the
device to the same communications port. By clicking Test at the
bottom of the Device Setup screen illustrated at FIG. 63, the
device details are displayed in the Details box 84, and the System
is ready to upload data from the meter. An illustration of the
meter and details are preferably displayed as illustrated at FIG.
64.
Uploading Data from a Device
[0255] 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 FIG. 65, from DataEntry on the main menu bar; Read
Device 86 is selected from the drop-down list. When a device has
been detected but cannot be identified as belonging to a specific
user, the System will prompt the user to assign the device to an
existing user or to add a new user as illustrated at FIG. 66. The
data from the device is then automatically uploaded to the PC. A
progress bar indicates when the upload is complete. A summary of
the upload then displays in a pop-up window as illustrated at FIG.
67.
[0256] 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 FIG. 68. The System will then automatically undo the
last upload.
[0257] 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 FIG. 69. If the device is
detected, the System prompts to HotSync 92 as illustrated at FIG.
70. As HotSync takes place, the HotSync Progress screen displays as
illustrated at FIG. 71.
[0258] 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 FIG. 70. Event Data will be generally automatically uploaded
from the FreeStyle Tracker System. Glucose Targets may be selected
to upload and overwrite the Glucose Targets data with data from the
FreeStyle Tracker System. Time Periods may be selected to reset
Time Periods data according to data from the FreeStyle Tracker
System. Preferences may be selected to overwrite Preference
Settings with settings from the FreeStyle Tracker System. Set as
Default may be selected if a user wants to save these options as
the defaults. If prompted to assign the device to a current user or
to a new user, as illustrated at FIG. 72, then OK should be clicked
after making a choice, keeping in mind that more than one device
may be associated with a same user.
[0259] As data from the FreeStyle Tracker System is uploaded, the
System displays the Profile Updated message illustrated at FIG. 73
if Preferences were checked on the Read Tracker screen of FIG. 70.
When the upload is done, an Upload Summary screen displays (see
FIG. 74). It shows a list of the type and number of events
uploaded.
Manual Data Entry
[0260] 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 FIG. 75.
[0261] 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.
[0262] FIG. 76 illustrates a glucose reading data entry screen. If
the date and time of the glucose reading are different from the
current date and time, the Date, Time, and Time Period fields 98 at
the top of the Glucose Reading screen should be adjusted using
drop-down boxes and up/down arrows. The value of the manual glucose
reading should be entered in the Glucose Value field 100. In the
Sample Site field 102, the site may be selected from which the
reading was taken (finger, forearm, etc.). In the Hours Since Last
Meal field 104, the time of the last meal should be entered. A
calibration code may be entered from the glucose monitor into the
Calibration Code field 106. The control reading box 108 should be
checked if this is a Control Solution reading from your glucose
monitor. To add another event, the icon at the top of the Data
Entry screen should be selected that applies, e.g., Insulin, Meal,
Exercise, Health, Meds, Exam, Lab, Ketones, or Note.
Recording an Insulin Dose
[0263] The insulin data screen illustrated at FIG. 77 will display
when the insulin icon 110 is clicked on the Data Entry screen. An
icon may be clicked at the Home page to get to the data entry
screen as already described. The Date, Time, and Time Period fields
can be set using the up/down arrows for the time of the injection
that is being recorded. The field 112 directly under the Insulin
Name header is for selecting the brand of insulin from the
drop-down box. If the name of the insulin is not listed, it can be
typed in. Dosage (Units) and injection type also are entered.
Injection types generally include bolus, injection, meal,
correction, combination, dual wave, and square wave.
Recording a Meal
[0264] 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 FIG. 78. Date, Time, and Meal fields may be adjusted for the
meal being entered. Drop-down boxes may be used to describe the
meal. The drop-down box displays a very extensive list of foods to
choose from. If what was eaten is not listed, it may be typed in.
Serving size and carbohydrates per serving should be entered with
it. The number of servings should be selected, after which the
grams of carbohydrates per serving and total carbs are
automatically displayed.
[0265] 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
FIG. 79. Other activities may be recorded including Exercise
Activity (FIG. 80), State of Health (FIG. 81), a Medication event
(FIG. 82), a Medical Exam (FIG. 83, a Lab Test Result (FIG. 84), a
Ketone Reading (FIGS. 85 and 86) and notes (FIG. 87).
[0266] 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.
TABLE-US-00001 Exercise Types Test Types Food Items Medications
Insulin Names Exam Types
[0267] A list may be customized by selecting Customize Data Entry
Lists 114 from the DataEntry drop-down box as illustrated at FIG.
88. The desired list is selected from the Select List to Customize
drop-down list 116 illustrated at FIG. 89. FIGS. 90-95 illustrate
different lists from the above table that may be customized.
Importing a Database
[0268] 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 FIG. 96. If the database is detected,
the System will simply ask the user to confirm the import
operation. If the database is not detected, the file browser opens
as illustrated at FIG. 97. The user then browses to the directory
where the file is located, selects the file type in the Files of
Type window 124, and ff the file is located in that directory, it
will be displayed and can be opened. FIG. 98 illustrates an Import
Drop-Down Box for Activating FreeStyle CoPilot I Data, and FIG. 99
illustrates an Import Drop-Down List for Importing Events From a
File. FIG. 100 illustrates a File Browser Window for selecting a
file type for automatic import according to file type.
Exporting Data
[0269] 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 FIG. 101. The Diary List displays, which is a log of
the events that have been entered. The date may be adjusted to
include the data desired to be exported, as illustrated at FIG.
102. A user selects Export from the File menu on the Home page.
When file browser opens, a user'can browse to the directory where
the file is to be saved as illustrated at FIG. 103.
Reports
[0270] 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 FIG. 104 as a Glucose Modal Day
Report (Default Report).
[0271] 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.
[0272] 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.
Opening a Report
[0273] 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 FIG. 105. The first report remains open but
hidden, except for its tab (see FIG. 106). The new report displays
with the same date range, active data filters, and display
features. To redisplay a report, the user clicks its tab. To close
an active report, the user clicks the Close Report icon on the
Reports toolbar.
Navigating a Report
[0274] 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.
[0275] The data range may be adjusted to include any date and any
date interval (see FIG. 107). To view entries over a date range
ending on the current date (up to and including today's data), a
user may select an interval of interest (for example, Last 2 Weeks,
Current Month, etc.) from an Interval drop-down box on the Reports
toolbar.
[0276] 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.
Data Elements
[0277] 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.
[0278] 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 FIG. 111) by checking or unchecking
the Show Hypo/Hyper box. Each target range is associated with a
distinctive signal color: Very High (turquoise), High (purple),
Within (green), Low (peachy-gold), and Very Low (pink). If a user
selects to display glucose data in three ranges (the Show
Hypo/Hyper box is not checked), Very High readings display as High
readings (purple) and Very Low readings display as Low readings
(peachy-gold).
[0279] Reports may be printed (using a Print drop down box such as
that illustrated at FIG. 108) and sent using standardized printing
and email or fax architectures. A user may print one copy of each
of his or her favorite reports on a default printer by clicking
Print Favorite Reports. To save the open report in the Adobe
Acrobat (PDF) file format, a user can click Save as PDF file. A
user can select this option if the E-Mail Report to option (below)
does not automatically create a *.pdf file. A user can select this
option if there is a printing problem and then the report may be
printed from Adobe Acrobat. To email a report as an attachment, a
user can click E-Mail Report to, and the report will be attached to
the e-mail message as a *.pdf file. (The user does not have to Save
as PDF file before selecting E-Mail Report to). The E-Mail Report
option is designed to automatically access a user's e-mail account
and open a new e-mail message screen. The report is automatically
attached to the message as a *.pdf file. If the e-mail account is
not detected automatically, the user may e-mail the report
manually.
[0280] 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. FIG. 109 illustrates a User Profile Screen
with Options Tab Active. Report options include default report
type, default report data range, include statistics summary with
each report printout, Print Favorite Reports After Device Upload,
and Favorite Reports.
[0281] 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 FIG. 110). Data
filters and display features (see below) preferably apply to all
reports except the HCP Group Analysis Report. Changing data filter
or display settings in a report changes them for other open
reports. Not all filters are configurable in all reports. Several
data filters can be applied together. For example, a user could
uncheck Exercise events in the Event Types filter and check only
Tuesday and Friday in the Week Days filter.
[0282] Some display features are configured on the Miscellaneous
tab of the Report Configuration screen, as illustrated at FIG. 111.
These include options to display time periods, show hypo/hyper,
show glucose targets, show hidden data, show text on graphs in
daily combination report, show legend and color. FIG. 112
illustrates a black-and-white display having distinctive patterns
(screen detail).
Glucose Target Modes
[0283] The following is a table of reports that use glucose targets
and the modes they use.
Reports: Glucose Target Modes Used
TABLE-US-00002 [0284] Home Version HCP Version Report Glucose
Target Mode Glucose Target Mode Diary List User's choice HCP's
choice Glucose Modal Day User's choice HCP's choice Glucose Line
Standard Mode Standard Mode Glucose Average Standard Mode Standard
Mode Glucose Histogram Standard Mode Standard Mode Glucose Pie
User's choice HCP's choice Logbook User's choice HCP's choice Lab
& Exam Record Not applicable Not applicable Statistics User's
choice HCP's choice Daily Combination View User's choice HCP's
choice Weekly Pump View Standard Mode Standard Mode HCP Group
Analysis Not applicable Standard Mode
Definition of a Day
[0285] 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:
Reports: Definition of a Day
TABLE-US-00003 [0286] Report Definition of a Day Diary List
Midnight to Midnight Glucose Modal Day Pre-breakfast to
Pre-breakfast Glucose Line Midnight to Midnight Glucose Average
Pre-breakfast to Pre-breakfast Glucose Histogram Midnight to
Midnight Glucose Pie - Total Pie Pre-breakfast to Pre-breakfast
Logbook Pre-breakfast to Pre-breakfast Lab & Exam Record
Midnight to Midnight Statistics Pre-breakfast to Pre-breakfast
Daily Combination View Midnight to Midnight Weekly Pump View
Midnight to Midnight HCP Group Analysis Midnight to Midnight
Descriptions of Reports
[0287] The Diary List is a table of data entries made over the
specified date range. Each row corresponds to one event. FIG. 113
illustrates a Diary List. A day (24 hours) is defined as midnight
to midnight. The glucose target mode is user's choice. Columns are
for data categories. The Value column displays the value in units
appropriate to the event type. For Glucose Reading events, the
Value cell is shaded with the signal color for the glucose target
range. To call up the original Data Entry screen for a specific
event, the user can double-click any cell in the row. Data that was
entered manually can be edited. Uploads from devices cannot be
edited.
[0288] 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 FIG.
114). To Un-Hide the event, the user can click on the Reports
toolbar. On the Miscellaneous tab screen, the user can check the
box to Show Hidden Data. The Diary List now displays with a Hidden
column (far left). Hidden entries display in this column. The user
can Right-click the hidden entry and select Un-Hide Data. The event
is no longer hidden.
[0289] 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: [0290]
Hidden Hidden entries display at the top. Click to display hidden
entries at the bottom. [0291] Type Events are grouped by Event
Type. Click to reverse the order. [0292] Date Events display in
ascending order (earliest date at the top) or descending order
(latest date at the top). Click to reverse the order. [0293] Time
The events display in chronological order. Click to group entries
by time of day. [0294] Time Period Time periods are arranged in
chronological order. Click to list the time periods in alphabetical
order. [0295] Value Click to change the order. [0296] Description
Events are displayed in ascending alphabetical order. Click to
reverse the order. [0297] Other Info Click to reverse the order.
[0298] Comment Events with Comments display in ascending
alphabetical order. Events with no comments display first. Click to
reverse the order.
[0299] 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 FIG. 114). Select Customize Columns. The
Customization list displays (see FIG. 115). From the list, select
the column head you want to add. Then drag-and-drop it to the
preferred position in the column-head row. Two green arrows display
to help you position the column. To move columns left or right in
the table, the user can drag-and-drop the column-head cell to the
preferred position in the column head row. To adjust the width of
any column, the user can use the sizing tool that becomes active
when hovering the pointer over the right margin of the column-head
cell.
Glucose Modal Day Report
[0300] 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. FIG.
116 illustrates a Glucose Modal Day Report (Dotted Line Linking
Readings for Apr. 3, 2004). The horizontal axis is a 24-hour
timeline. All readings for all dates display on the same timeline.
The vertical axis plots the glucose level. A day (24 hours) is
defined as pre-breakfast to pre-breakfast. The glucose target mode
is user's choice. Each data element represents one glucose reading.
For the date, time, and value of the reading, the pointer can be
hovered over the triangle. HI/LO indicates a reading outside the
working range of the meter. A list of all days in the date range
displays to the right of the graph. To link all the readings for a
single day with a dotted line, the user can click the date of
interest in the list of all days in the date range (FIG. 116). All
the data elements for that date change color and enlarge, and a
dotted line is drawn linking them. By clicking on it, a triangle
data element in the line can be cancelled.
[0301] 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.
Glucose Line Report
[0302] The Glucose Line Report is useful for seeing trends in
glucose levels. It plots each glucose reading over the specified
date range. FIG. 117 illustrates a Glucose Line Report (Show Line
Is Activated). The horizontal axis is a timeline of the entire date
range. The vertical axis plots the glucose level. A day (24 hours)
is defined as midnight to midnight. The glucose target mode is
Standard. Each data element represents one reading; a solid line
connecting them can be displayed or hidden. To hide the line, point
to any data element, then right-click. A user can click Show/Hide
Line on the pop-up menu (see FIG. 118). For the date, time, and
value of the glucose reading, the pointer can be hovered over the
data element. To zoom in on (magnify) an area of the graph, the
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 event data in the Diary List, the user can double-click
the data element.
Glucose Average Report
[0303] 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. FIGS. 119-120
illustrate Glucose Average Reports by meal and by day,
respectively. The horizontal axis is a timeline showing the time
periods (pre-meal and post-meal) and the average for all meals. The
vertical axis plots the glucose level. Each bar shows the average
value of all glucose readings over the date range for the specific
time period (for example, the average value of all pre-breakfast
readings). A day (24 hours) is defined as pre-breakfast to
pre-breakfast. A user can Double-click any bar to call up the Diary
List entries for these events.
Glucose Histogram Report
[0304] 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. FIG. 121 illustrates a Glucose Histogram Report. The
horizontal axis shows the default glucose target ranges (not the
user-defined glucose target ranges). The vertical axis plots the
glucose level. A day (24 hours) is defined as midnight to midnight.
The color of the bar corresponds to the signal color for the
glucose target range. The height of the bar is proportional to the
number of readings in that range; that is, the bar for a range in
which there are 20 readings is twice as high as the bar for a range
with 10 readings. The percentage of readings in the range is shown
at the top of the bar. The user can double-click the bar to call up
the Diary List entries that make up that bar.
Glucose Pie Chart
[0305] 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. FIG. 122 illustrates a Glucose Pie Chart
Report: Total Readings Pie Chart, and FIG. 123 illustrates a
Glucose Pie Chart Report: Ten Summary Pie Charts. A maximum of 10
individual pie charts (2 rows of 5) and 1 total pie chart
summarizing the glucose readings for all configured time periods
over the date range are displayed. A day (24 hours) is defined as
pre-breakfast to pre-breakfast on Total Readings pie chart (see
FIG. 122). The glucose target mode is user's choice. A user can
double-click a wedge on any of the pie charts to call up the Diary
List entries that make up that wedge.
Logbook Report
[0306] The Logbook Report is a table of glucose, carbohydrate, and
insulin values associated with each time period over the specified
date range. FIG. 124 illustrates a Logbook Report. Insulin,
carbohydrate, and pre-meal, post-meal, bedtime, and sleep glucose
reading values are displayed in columns under each time period
(Breakfast, Lunch, Dinner, Bed and Sleep) for each day over the
date range. A day (24 hours) is defined as pre-breakfast to
pre-breakfast. The glucose target mode is user's choice. To call up
the entry in the Diary List, a user can double-click any cell in
the row.
Lab and Exam Record Report
[0307] 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. FIGS. 125-127 illustrate Lab & Exam
Record Reports: Lab Record, Exam Record, and A1C History,
respectively. The screen shows a table of lab test data on the top
(FIG. 125) and the exam data below (FIG. 126). Each event is shown
in one row. Below the table is a graph showing A1C test results for
the current year and the previous year (FIG. 127). A day (24 hours)
is defined as midnight to midnight. A user can double-click any
cell in a row to go to the Diary List entry for the event. The user
can double-click any bar on the graph to go to the Diary List entry
for the A1C test event.
Statistics Report
[0308] 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. FIG.
128 illustrates a Statistics Report: Glucose Statistics. A day (24
hours) is defined as pre-breakfast to pre-breakfast. The glucose
target mode is user's choice. A user can double-click any cell to
see the entries from the Diary List that are included in the data
set for a particular statistical calculation.
Glucose Statistics
[0309] The Glucose Statistics table (see FIG. 128) shows data
regarding the number of readings per day, the values of the highest
and lowest readings in each time period, and the results of some
automatic calculations (averages and standard deviation) within and
across time periods.
TABLE-US-00004 # Readings By Time Period: Reports the number of
readings recorded during the Time Period specified for each day of
the selected Date Range. Total/Summary: Reports the number of
readings recorded during the selected Date Range. # Days w/ By Time
Period: Reports the number of days within the selected Readings
Date Range where one or more readings are recorded during the
specified Time Period. Total/Summary: Reports the number of days
within the selected Date Range where one or more readings are
recorded. Avg Readings/ By Time Period: Reports the number of
readings recorded during Day the Time Period specified for each day
of the selected Date Range divided by the number of days in the
selected Date Range regardless of whether a glucose reading was
recorded or not. Total/Summary: Reports the number of readings
recorded during the selected Date Range divided by the number of
days in the selected Date Range regardless of whether a glucose
reading was recorded or not. Highest By Time Period: Reports the
highest reading recorded during the Time Period specified within
the selected Date Range. Total/Summary: Reports the highest reading
recorded during the selected Date Range. Lowest By Time Period:
Reports the lowest reading recorded during the Time Period
specified within the selected Date Range. Total/Summary: Reports
the lowest reading recorded during the selected Date Range. Average
By Time Period: Reports the sum of the readings recorded during the
selected Date Range that fall within the specified Time Period
divided by the number of readings recorded during the selected Date
Range that fall within the specified Time Period. Total/Summary:
Reports the sum of the readings recorded during the selected Date
Range divided by the number of readings recorded during the
selected Date Range. Standard By Time Period: Reports the mean* of
the readings recorded during Deviation the Time Period specified
within the selected Date Range. Total/Summary: Reports the mean* of
the readings recorded during the selected Date Range. Note: N/A is
displayed where fewer than three readings are recorded. Above % By
Time Period: Reports the number of readings recorded above the
patient's defined normal glucose limits during the Time Period
specified within the selected Date Range divided by the total
number of readings recorded during the Time Period specified within
the selected Date Range.** Total/Summary: Reports the total number
of readings recorded above the patient's defined normal glucose
limits during the selected Date Range divided by the total number
of readings recorded during the selected Date Range.** Within % By
Time Period: Reports the number of readings recorded within the
patient's defined normal glucose limits during the Time Period
specified within the selected Date Range divided by the total
number of readings recorded during the Time Period specified within
the selected Date Range. Total/Summary: Reports the total number of
readings recorded within the patient's defined normal glucose
limits during the selected Date Range divided by the total number
of readings recorded during the selected Date Range. Below % By
Time Period: Reports the number of readings recorded below the
patient's defined normal glucose limits during the Time Period
specified within the selected Date Range divided by the total
number of readings recorded during the Time Period specified within
the selected Date Range.** Total/Summary: Reports the total number
of readings recorded below the patient's defined normal glucose
limits during the selected Date Range divided by the total number
of readings recorded during the selected Date Range.** Very High %
By Time Period: Reports the number of readings recorded as hyper
events during the Time Period specified within the selected Date
Range divided by the total number of readings recorded during the
Time Period specified within the selected Date Range.***
Total/Summary: Reports the total number of readings recorded as
hyper events during the selected Date Range divided by the total
number of readings recorded during the selected Date Range.*** High
% By Time Period: Reports the number of readings recorded above the
patient's defined normal glucose limits and below the limits of a
hyper event during the Time Period specified within the selected
Date Range divided by the total number of readings recorded during
the Time Period specified within the selected Date Range.***
Total/Summary: Reports the total number of readings recorded above
the patient's defined normal glucose limits and below the limits of
a hyper event during the selected Date Range divided by the total
number of readings recorded during the selected Date Range.*** Low
% By Time Period: Reports the number of readings recorded below the
patient's defined normal glucose limits and above the limits of a
hypo event during the Time Period specified within the selected
Date Range divided by the total number of readings recorded during
the Time Period specified within the selected Date Range.***
Total/Summary: Reports the total number of readings recorded below
the patient's defined normal glucose limits and above the limits of
a hypo event during the selected Date Range divided by the total
number of readings recorded during the selected Date Range.*** Very
Low % By Time Period: Reports the number of readings recorded as
hypo events during the Time Period specified within the selected
Date Range divided by the total number of readings recorded during
the Time Period specified within the selected Date Range.***
Total/Summary: Reports the total number of readings recorded as
hypo events during the selected Date Range divided by the total
number of readings recorded during the selected Date Range.*** *The
mean of the recorded readings is related to the patient's average
glucose level. For example, a small number (less than half the
average) indicates that most of the glucose readings during the day
are close to the average value and that the patient is maintaining
glucose levels near that value. A large number (more than half the
average) indicates that many glucose levels during the day vary
considerably from the average and that the patient is not
maintaining glucose levels near the average value. **Available when
three target zones are being reported: Show Hypo/Hyper not selected
***Available when five target zones are being reported: Show
Hypo/Hyper selected.
Insulin Statistics
[0310] The Insulin Statistics table (see FIG. 129) shows average
insulin dosages over the date range (calculated from insulin data).
FIG. 129 illustrates a Statistics Report: Insulin and Carbs
Statistics Tables.
TABLE-US-00005 Avg per Day By Time Period: Reports the sum of the
units of Insulin delivered (insulin name) during the Time Period
specified for the selected Date Range divided by the number of days
in the selected Date Range where that particular type of Insulin
was recorded during that Time Period. Total/Summary: Reports the
sum of the units of Insulin delivered during the selected Date
Range divided by the number of days in the selected Date Range
where that particular type of Insulin was recorded. Note: Separate
entries exist for each type of Insulin recorded. Avg Total Insulin
By Time Period: Reports the sum of the units of all Insulin
delivered per Day during the Time Period specified for the selected
Date Range divided by the number of days in the selected Date Range
where any type of Insulin was recorded during that Time Period.
Total/Summary: Reports the sum of the units of all Insulin
delivered during the selected Date Range divided by the number of
days in the selected Date Range where any type of Insulin was
recorded.
[0311] These entries are calculated using all types of insulin
recorded.
Pump Statistics
[0312] If the insulin is administered by pump, the table (FIG. 129)
will say Pump Statistics (instead of Insulin Statistics) and
display the following information:
TABLE-US-00006 Avg General By Time Period: Reports the sum of all
Meal Bolus* Insulin Bolus per Day recorded during the specified
Time Period for the selected Date Range divided by the number of
days in the selected Date Range where Meal Bolus* Insulin entries
were recorded during that Time Period. Total/Summary: Reports the
sum of all Meal Bolus* Insulin recorded during the selected Date
Range divided by the number of days in the selected Date Range
where Meal Bolus* Insulin entries were recorded. Avg Correction By
Time Period: Reports the sum of all Correction Bolus Insulin Bolus
per Day recorded during the specified Time Period for the selected
Date Range divided by the number of days in the selected Date Range
where Correction Bolus Insulin entries were recorded during that
Time Period. Total/Summary: Reports the sum of all Correction Bolus
Insulin recorded during the selected Date Range divided by the
number of days in the selected Date Range where Correction Bolus
Insulin entries were recorded. Total Avg Bolus By Time Period:
Reports the sum of all Meal and Correction Bolus per Day Insulin
entries recorded during the specified Time Period for the selected
Date Range divided by the number of days in the selected Date Range
where Meal and Correction Bolus Insulin entries were recorded
during that Time Period. Total/Summary: Reports the sum of all Meal
and Correction Bolus Insulin entries recorded during the selected
Date Range divided by the number of days in the selected Date Range
where Meal and Correction Bolus Insulin entries were recorded. Avg
Basal per By Time Period: Reports the sum of the Basal Insulin
delivered Day during the Time Period specified for the selected
Date Range divided by the number of days in the selected Date Range
where Basal Insulin was recorded for that Time Period.
Total/Summary: Reports the sum of the Basal Insulin delivered
during the selected Date Range divided by the number of days in the
selected Date Range where Basal Insulin was recorded. Avg Total
Insulin By Time Period: Reports the sum of the Total Bolus and
Basal per Day Insulin doses delivered during the Time Period
specified for the selected Date Range divided by the number of days
in the selected Date Range where Insulin entries were recorded for
that Time Period. Total/Summary: Reports the sum of the Total Bolus
and Basal Insulin doses delivered during the selected Date Range
divided by the number of days in the selected Date Range where
Insulin entries were recorded. *Meal Bolus is defined as the sum of
all insulin entries (from pump uploads and manual entries) of the
following injection types: Injection, Bolus, Meal Bolus,
Combination Bolus, Dual Wave Bolus, and Square Wave Bolus.
Carbohydrate Statistics
[0313] The Carbs Statistics table (see FIG. 129) shows average
carbohydrates over the date range (calculated from carbohydrates
data).
TABLE-US-00007 Average per Day By Time Period: Reports the sum of
the meal Carbohydrate intake Carbs for the Time Period specified
during the selected Date Range divided by the number of days within
the selected Date Range where meal Carbohydrate entries were
recorded during the Time Period specified. Total/Summary: Reports
the sum of the meal Carbohydrate intake during the selected Date
Range divided by the number of days within the selected Date Range
where meal Carbohydrate entries were recorded.
Daily Combination View Report
[0314] 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 FIG. 130). Also, the user can set the date field
on the left to the same date. FIG. 130 illustrates a Date Field for
Selecting Date. FIG. 131 illustrates a Daily Combination View
Report: Glucose Line and Carbohydrates Graphs.
Glucose Line Graph
[0315] This graph (see FIG. 131) plots glucose readings by hour of
day. The horizontal axis is a 24-hour timeline. The vertical axis
plots the glucose level. Each data element represents one reading.
The user can Hover the cursor over the data element to see the
glucose value, date, and time of that reading. The user
candouble-click a data element to view this entry in the Diary
List. To display or hide the solid line connecting the data
elements, the user can right-click a data element, then select
Toggle Glucose Line from the pop-up list.
Carbohydrates Graph
[0316] This graph (see FIG. 131) plots carbohydrate events by hour
of day. The carbohydrate data element represents one carbohydrate
event. The size of the circle is proportional to the carbohydrate
value. Its position along the horizontal axis corresponds to the
time (hour) of the meal. The user can double-click an icon to view
this entry in the Diary List.
Insulin Summary
[0317] FIG. 132 illustrates a Daily Combination View Report:
Insulin Summary and Data Table. This graph (FIG. 132) plots insulin
events by hour of day. The horizontal axis is a 24-hour timeline.
The vertical axis is units of insulin. Basal insulin data (light
green shaded area) can be uploaded to the System. Each dark green
bar represents one meal bolus insulin event. Its position along the
horizontal axis corresponds to the time (hour) of the insulin
event. Its height correlates with dosage. A user can double-click
to view this entry in the Diary List. Each red bar represents one
correction bolus insulin event. Its position along the horizontal
axis corresponds to the time (hour) of the insulin event. Its
height correlates with dosage. A user can double-click to view this
entry in the Diary List. A meal bolus may be an extended, square
wave, or combination bolus. The scale is indicated on the left.
Data Table
[0318] This table (see FIG. 132) tracks glucose, carbohydrates, and
insulin values hourly. Each column represents 1 hour. Each event
type is one row. Each event is one cell. The value associated with
the event displays in the cell. A user can double-click the cell to
view this event in the Diary List.
Weekly Pump View Report
[0319] The Weekly Pump View Report shows the components of insulin
doses for each day in a seven-day period in bar graph (FIG. 134)
and pie chart (FIG. 135) formats. To select the week (7 days) for
the data a user wants to view, using the date field on the right
(see FIG. 133), the user can select the last date in the week the
user wants to see (Aug. 3, 2004, for example). The user can set the
date field on the left to the first day of that week (Jul. 28,
2004, for example). FIG. 133 illustrates a Date Field for Selecting
a Date. FIGS. 134-135 illustrates Weekly Pump View Reports: Bar
Graph and Pie Charts and Glucose Statistics Table, respectively. A
Glucose Statistics table (see FIG. 135) summarizes the glucose
readings for the week displayed.
HCP Group Analysis Report
[0320] 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. FIG. 136 illustrates a HCP Group
Analysis Report. By default, the report displays with column heads
for Patient ID, Last Name, First Name, and for a number of
event-related data fields. Data for each patient displays in one
row. Each glucose value displays in a cell shaded the signal color
of its target range. The glucose target mode is Standard. A day (24
hours) is defined as midnight to midnight.
[0321] 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 FIG. 139). The user can then select
Save As, enter a filename, and click Save.
[0322] 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
FIG. 137), and select Customize Columns. The Customization list
displays (see FIG. 138). From the list, the user can select the
column head you want to add. Then the user can drag-and-drop it to
the preferred position in the column-head row. Two green arrows
display to help the user position the column. FIG. 138 illustrates
a Customization List. To move columns left or right in the table,
the user can drag-and-drop the column-head cell to the preferred
position in the column head row. To adjust the width of any column,
the user can use the sizing tool that becomes active when he or she
hovers the pointer over the right margin of the column-head
cell.
Data Filter
[0323] 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. FIG. 139 illustrates a Filter Builder Screen. To display data
for any patient with a particular value in the corresponding data
field, the user can click the value of interest. To save the data
filter changes, the user can click Customize (bottom right of
screen). The Filter Builder screen displays (see FIG. 139). The
user can select Save As, enter a filename, and click Save.
Insulin Management Tools
[0324] 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. FIG. 140
illustrates a References Drop-Down Box.
Insulin Adjustment Table
[0325] The HCP first sets up the values in this table (see FIG.
141). Insulin adjustment may not be necessary for every Home user.
The Glucose Start Value (mg/dL) in the table is the blood glucose
level at which the insulin dose should be increased. Beginning with
this value, consecutive blood glucose ranges are provided for each
increase in insulin. These ranges are determined by the value
entered as the patient's Insulin Sensitivity. The Insulin Dosage
Amount is the amount of insulin above the patient's normal dose
that should be taken when the patient's blood glucose level falls
within the range specified The Insulin Adjustment Table is provided
as a convenient reference, and entries made in this table are
generally not used by other application features.
Defining Insulin Adjustment
[0326] On the Home page, a user can select References on the main
menu bar (see FIG. 140). A user can select Insulin Adjustment Table
from the drop-down list, and the Insulin Adjustment Table displays.
FIG. 141 illustrates an Insulin Adjustment Table. The user can set
the Glucose Start Value (mg/dL) to the value determined by his or
her HCP. The Glucose Start Value is used to set the lowest glucose
value on the Insulin Adjustment Table and indicates when to start
adjusting the insulin dose. The user can set the value of Insulin
Sensitivity to the value determined by your HCP. The Insulin
Sensitivity value is used to set the increase in value between each
of the consecutive blood glucose ranges displayed.
Prescribed Plan
[0327] 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. FIG. 142
illustrates a Prescribed Plan. Data for each of these items can be
individually entered for breakfast, lunch, dinner, bedtime, and a
snack. Comments can also be added. Once the Prescribed Plan is
entered, a user can view the plan by returning to this screen. A
user can also print it out by clicking Print at the bottom of the
screen.
Defining a Prescribed Plan
[0328] On the Home page, a user can select References on the main
menu bar (see FIG. 140). The user can select Prescribed Plan from
the drop-down list. The Prescribed Plan screen (see FIG. 142) then
displays. The user can select an entry type from the Type drop-down
list: Insulin or Medication. The user can select Insulin to record
an insulin type and dose for each meal field. The user can select
Medication to record a medication type and dose for each meal field
where it is taken. The user can enter the name of the Insulin or
the Medication and the dosage in the Item field. The user can
select Ratio to record the optimum meal-based
insulin-to-carbohydrate ratio. The user can select Carbohydrates to
record the optimum carbohydrate intake. The user can enter the
desired number of grams of carbohydrate for each meal field. The
user can select Sensitivity and enter the Insulin Sensitivity
factor his or her HCP calculated for the user. The user can enter
any comments in the Comments field (optional). By clicking OK, the
plan is saved and the Prescribed Plan window closes. (Or, to clear
all data entered into the plan, the user can click Reset.)
Insulin Sensitivity
[0329] 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.
Host
[0330] 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
[0331] 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.
Host Account Setup
[0332] 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.
[0333] 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).
[0334] FIG. 143 illustrates a Home User: Host Drop-Down Box (left),
and HCP User: Host Drop-Down Box (right). The End-User Agreement
Screen will display. The user can review the End-User Agreement
(see FIG. 144), and click Next to continue.
[0335] FIG. 144 illustrates a First Time Synchronization Screen.
The user proceeds through the setup process on the screen. A
password is established and a Host Account number is assigned to
the user (which now appears on his or her user Profile screen).
[0336] FIG. 145 illustrates a Host Account Number. The System then
synchronizes the user's account, and a summary of the synchronized
data automatically displays.
[0337] FIG. 146 illustrates a Synchronization Summary Screen. A
confirmation message is sent to the user from the Host and to the
user's e-mail address. FIG. 147 illustrates a Confirmation Message
From the Host
Synchronizing with the Host
[0338] 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 FIG. 143). The System then
automatically synchronizes the user's local and Host accounts
(including all event and profile data). A summary of the
synchronized data automatically displays (see FIG. 146).
Synchronize all (Home Version)
[0339] 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 FIG.
143). The System displays a list of all the Home users on your PC.
Synchronization starts automatically. A blue progress bar indicates
when synchronization is complete for each Home user's data.
Synchronize all HCP Users (HCP Version)
[0340] 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 FIG. 143). The
System displays a list of all the HCPs on your local system and the
patients they manage. Synchronization starts automatically. A blue
progress bar indicates when synchronization is complete for each
HCP's and patient's data.
Invitation to Share Data
[0341] 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.
[0342] 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.
Invitation to Share Data: HCP has a Host Account
[0343] From the Host menu on the main menu bar, the user can choose
Invite to Share Data. FIG. 148 illustrates an Invite to Share Data
(Home User Screen, left; HCP User Screen, right). An Internet
connection to the Host server will be opened and the screen
illustrated at FIG. 149 will display. The user can select the
appropriate option. If the user does not know the HCP's Host
Account number, he or she can select Search Host HCP database to
find an HCP from the list of existing accounts, and then click
next. On the next screen, the user can select the state/province
where the HCP is located.
[0344] FIG. 150 illustrates a Find HCP from Existing Accounts
Screen. The user can then click Search. HCPs from the selected
state with a Host Account will be displayed. The user can then
highlight the HCP he or she wants and click Next. The screen for
selecting Access Level displays.
[0345] FIG. 151 illustrates an Assign Access Level Screen. The user
can select Read-Only Access or Full Access (Read and Enter Data),
and then click Submit. The Host then displays the Process Complete
screen and sends an invitation to share data to the HCP.
[0346] FIG. 152 illustrates a Process Complete Screen. If you know
the HCP's Host Account Number, he or she can select enter the Host
HCP Account Number provided by the HCP.
[0347] FIG. 153 illustrates an Invite HCP to Share Data Screen. The
user can click Next. On the next screen, the user enters the Host
HCP Account Number.
[0348] FIG. 154 illustrates an Enter Host HCP Account Number
Screen. The user can click Search. The HCP is displayed as the
search result. If this is the HCP the user is looking for, the user
can click Next. The screen for selecting Access Level displays. The
user can select Read-Only Access or Full Access (Read and Enter
Data), and click Submit.
[0349] FIG. 155 illustrates an Assign Access Level Screen. The Host
then displays the Process Complete screen and sends an invitation
to share data to the HCP. FIG. 156 illustrates a Process Complete
Screen
Accepting an Invitation from the Host to Share Data: HCPS Only
[0350] 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 FIG. 157. If the user fails
to accept or decline the invitation within 30 days, the invitation
to share data expires. The user can double-click the message header
to display the invitation to share data. FIG. 158 illustrates an
Invitation to Share Data (from Host). To accept the invitation, a
user can click Accept Invitation (bottom of screen). The Host will
then synchronize with the user's system, and the patient's data
will be uploaded to Host computer. A summary of the synchronized
data then automatically displays. The user can then click Close to
exit. At this point, the user has successfully accepted the
invitation and received the patient's data.
Invitation to Share Data: HCP does not have a Host Account
[0351] 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: jsloane@aol.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 FIG. 159 will display. The user can select send an
e-mail invitation to an HCP who does not have an existing account,
and click next. When the next screen opens, the user can enter the
Name and E-mail Address of the HCP he or she wishes to invite.
[0352] FIG. 160 illustrates an E-mail Invitation to HCP with No
Host Account. The screen for selecting Access Level displays. The
user can select Read-Only Access or Full Access (Read and Enter
Data), and click Submit.
[0353] FIG. 161 illustrates an Assign Access Level screen. When the
user clicks next, the Host then displays the Process Complete
screen. FIG. 162 illustrates a process Complete Screen. The Host
will send the HCP an e-mail inviting him/her to have access to the
data. The message instructs the HCP to download the Management
System, 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. The Host will notify the user when the HCP has accepted the
invitation to share data. If the user does not receive this message
within a reasonable period of time, the HCP should be contacted
directly.
Accepting an E-Mail Invitation to Share Data (HCPS Only)
[0354] 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 FIG. 164). FIG. 163 illustrates an E-mail Invitation to
Register and Share Data. An invitation code may look like that
illustrated in FIG. 164.
[0355] 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. FIG. 165 illustrates a HCP: Host
Drop-Down List. The System connects to the Host server and the
screen illustrated at FIG. 166 displays. The user can enter the
Invitation Code in the box provided and click Next. The Host then
synchronizes with the user's System, and the patient's data is
downloaded. A summary of the synchronized data then automatically
displays. A synchronization screen is illustrated at FIG. 167.
Managing Shared Data: Home User
[0356] A user can limit, expand, or deny an HCP access to his or
her data on the Host using a Manage Shared Data function.
Defining or Changing HCP Access to Data
[0357] From the Host drop-down box (see FIG. 168) on the main menu
bar, the user can choose Manage my shared data. The next screen
shows a list of each authorized HCP along with the level of access
granted to them. FIG. 169 illustrates a Manage My Shared Data
Screen. The user can highlight the HCP whose access he or she
wishes to change and choose to Grant NO Access which removes all
access to your data by the listed HCP, Grant Read-Only Access,
which restricts the HCP to viewing your data, or Grant Full Access,
which allows the HCP to view and edit the data, including event
data, glucose targets, the user's prescribed plan, etc. The user
can click Close to exit, and the Host the sends a message to the
HCP about the changed access level.
Managing Shared Data: HCP User
[0358] 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 FIG. 170) on the main menu bar, the HCP
user can choose Manage data being shared with me (see FIG. 171).
The next screen shows a list of the patients who share data with
the HCP user. The HCP user can then highlight the patient that he
or she wants to unsubscribe. Then, the HCP user can click the
Unsubscribe button (lower left of screen). The Access Level for
this patient will change to NONE. The Host will send a message
confirming the changed Access Level. The next time the patient or
the HCP who assigned the patient to synchronize with the Host, the
Access Level on their Manage My Shared Data screen will be NONE.
FIG. 172 illustrates a Changed Access Level Message.
Database Management
[0359] 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.
Archiving Data
[0360] 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 FIG. 173).
The user can select the Archive option from the menu. A window will
open, allowing the user to specify a date. The user can select the
last date of the data to be included in the archive, and click OK.
FIG. 174 illustrates an Archive Event Data Screen. A file browser
will open. The user can browse to the directory where the file is
to be saved. The user should make sure XML file (*.xml) is
displayed in the Save as Type window. FIG. 175 illustrates a File
Browser Window: Save Archive Data. The user can enter the name of
the file in the File Name window and click Save. The file is saved
as an .xml file in the directory specified.
Viewing Archived Data
[0361] 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. FIG. 176 illustrates a File
Browser: Location of Archived Data File (*.xml). To open an *.xml
file, a Web browser (for example, Internet Explorer, Netscape,
etc.) is used that is installed on your PC. The user can highlight
the archive file and click Open.
Restoring Archived Data
[0362] 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 FIG. 177). The user can choose Import Events
from File from the Import submenu. A file browser opens. The user
can browse to the directory where the file is located. The user can
select the file type (*.xml or *.tab) in the Files of Type window.
The user can Highlight the file and click Open. Importing will
automatically begin. The Importing progress screen (see FIG. 178)
displays the progress of the import procedure. The Importing screen
closes when data import is finished.
Backing Up the Database
[0363] 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 FIG. 173). The user can choose Backup from the
Database Maintenance submenu. A file browser opens. The user can
browse to the directory where he or she wants the file to be
located. FIG. 179 illustrates a File Browser: Select Backup
Location. The user makes sure that the words System (or other
designated name such as FreeStyle CoPilot) Backup File are
displayed in the Save as Type window. The user can then enter the
name of the file in the File Name window and click Save.
Restoring a Backed Up Database
[0364] 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 FIG. 173). The user
can choose Restore from the Database Maintenance submenu. A file
browser opens. The user can browse to the directory where the
database was saved. The checks to make sure the words System or
FreeStyle CoPilot Backup are displayed in the File of Type window.
The user enters the name of the file in the File Name window and
clicks Open. The Restore Log then displays as illustrated at FIG.
180, showing the restored transactions.
Viewing the Restore Log
[0365] 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. FIG. 181
illustrates a File Browser: Restore Log. The user can highlight the
file named Restore log and click Open to view the log.
Help
[0366] 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.
Accessing on-Screen Help
[0367] 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 FIG. 182). FIG. 183 illustrates a Help Screen that would
then display.
Help Screen
[0368] 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.
Help Screen Icons
[0369] 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 Tab
[0370] Contents is the first tab displayed when the user opens the
Help screen (see FIG. 183). This is the table of contents for the
Help file. The Help information is arranged by topic here. The user
can double-click on a topic listed (for example, Getting Started)
and subsections will display. Some of the subsections have further
subsections.
Index Tab
[0371] 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 FIG. 183). FIG. 184 illustrates a
Help: Index Tab. Alternatively, a user can type a keyword into the
Type in the keyword to find: field. Then click the icon at the
bottom of the screen. A list of Help topics matching the keyword
displays. The user can select a topic and double-click. The text
displays in the big window.
Search Tab
[0372] The user can click on the Search tab if he or she wants to
use keywords to find Help text. FIG. 185 illustrates a Help: Search
Tab. To search, The user can type a keyword into the Type in the
keyword to find: field. Then click the icon. A list of topics
related to your keyword displays in the Select Topic to Display
window. The user can select a topic and double-click (or select a
topic and click the icon. The text displays in the large window.
The user can also contact Technical Support and Service (see FIG.
186 which illustrates a Help Drop-Down Box). A Customer Service
Contact Information screen displays (see FIG. 187). The screen
shows the ways a user can get help if he or she has questions about
using the System, such as On-Line Help, E-Mail Customer Service,
and Customer Service Hotline. FIG. 187 illustrates a Customer
Service Contact Information Screen.
[0373] 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.
[0374] 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.
[0375] 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:
[0376] U.S. Pat. Nos. 5,307,263, 5,899,855, 6,186,145, 5,918,603,
5,913,310, 5,678,571, 5,822,715, 5,956,501, 6,167,362, 6,233,301,
6,379,301, 5,997,476, 6,101,478, 6,168,563, 6,248,065, 6,368,273,
6,381,577, 5,897,493, 5,933,136, 6,151,586, 5,960,403, 6,330,426,
5,951,300, 6,375,469, 6,240,393, 6,270,455, and 6,161,095;
[0377] United States published applications no. 2001/0011224,
2003/0163351, and 2003/0069753;
[0378] U.S. patent applications Nos. 60/577,064 and 10/112,671;
and
[0379] Internet web sites: www.freestylecopilot.com,
www.abbottdiabetescare.com, www.lifescan.com/care,
www.bddiabetes.com, www.roche-diagnostics.com, www.healthhero.com,
and www.minimed.com.
* * * * *
References