Handheld Diabetes Manager With A Personal Data Module
A handheld diabetes manager communicates with an external insulin pump and includes a port for blood glucose measurement, a blood glucose measurement module, a communications module that selectively communicates wirelessly with the insulin pump, and a user interface module. The user interface module communicates with the blood glucose measurement module and the communications module and operates to provide a graphical user interface on a display of the diabetes manager. The graphical user interface includes a personal data menu screen from which a logbook option can be selected to display a logbook screen, and a trend graph option that can be selected to display a trend graph screen. The logbook screen displays a plurality of time data records. Each time data record includes blood glucose data, bolus insulin data, and carbohydrate data for a corresponding time, and a plurality of data icons indicating corresponding events.
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This application claims the benefit of U.S. provisional application 61/581,149 filed on Dec. 29, 2011. The disclosure of the above application is incorporated herein by reference in its entirety.
FIELDThe present disclosure relates to a handheld diabetes manager that has a module for the personal data of the diabetes patient.
BACKGROUNDDiabetes mellitus, often referred to as diabetes, is a chronic condition in which a person has elevated blood glucose levels that result from defects in the body's ability to produce and/or use insulin. According to the American Diabetes Association, diabetes mellitus, or simply, diabetes, is a group of diseases characterized by high blood glucose levels that result from defects in the body's ability to produce and/or use insulin. Type 1 diabetes is usually diagnosed in children and young adults, and was previously known as juvenile diabetes. In type 1 diabetes, the body does not produce insulin. Type 2 diabetes is the most common form of diabetes. In type 2 diabetes, either the body does not produce enough insulin or the cells ignore the insulin. During pregnancy—usually around the 24th week—many women develop gestational diabetes. A diagnosis of gestational diabetes doesn't mean that you had diabetes before you conceived, or that you will have diabetes after giving birth.
Diabetes is managed primarily by controlling the level of glucose in the bloodstream. This level is dynamic and complex, and is affected by multiple factors including the amount and type of food consumed, and the amount of insulin (which mediates transport of glucose across cell membranes) in the blood. Blood glucose levels are also sensitive to exercise, sleep, stress, smoking, travel, illness, menses, and other psychological and lifestyle factors unique to individual patients. The dynamic nature of blood glucose and insulin, and all other factors affecting blood glucose, often require a person with diabetes to forecast blood glucose levels. Therefore, therapy in the form of insulin or oral medications, or both, can be timed to maintain blood glucose levels in an appropriate range.
Management of diabetes is time-consuming for patients because of the need to consistently obtain reliable diagnostic information, follow prescribed therapy, and manage lifestyle on a daily basis. Diagnostic information, such as blood glucose, is typically obtained from a capillary blood sample with a lancing device and is then measured with a handheld blood glucose meter. Interstitial glucose levels may be obtained from a continuous glucose sensor worn on the body. Prescribed therapies may include insulin, oral medications, or both. Insulin can be delivered with a syringe, an ambulatory infusion pump, or a combination of both. With insulin therapy, determining the amount of insulin to be injected can require forecasting meal composition of fat, carbohydrates and proteins along with effects of exercise or other physiologic states. The management of lifestyle factors such as body weight, diet, and exercise can significantly influence the type and effectiveness of a therapy.
Management of diabetes involves large amounts of diagnostic data and prescriptive data acquired in a variety of ways: from medical devices, from personal healthcare devices, from patient-recorded logs, from laboratory tests, and from healthcare professional recommendations. Medical devices include patient-owned bG meters, continuous glucose monitors, ambulatory insulin infusion pumps, diabetes analysis software, and diabetes device configuration software. Each of these systems generates and/or manages large amounts of diagnostic and prescriptive data. Personal healthcare devices include weight scales, blood pressure cuffs, exercise machines, thermometers, and weight management software. Patient recorded logs include information relating to bG levels, meals, exercise and lifestyle. Lab test results include HbA1C, cholesterol, triglycerides, and glucose tolerance. Healthcare professional recommendations include prescriptions, diets, test plans, therapy changes and other information relating to the patient's treatment.
The present teachings are directed to a handheld diabetes manager that includes a user interface communicating with an external insulin pump and including a module for the personal data of the diabetes patient.
SUMMARYThis section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
The present teachings provide a handheld diabetes manager that communicates with an external insulin pump and includes a port for blood glucose measurement, a blood glucose measurement module, a communications module that selectively communicates wirelessly with the insulin pump, and a user interface module. The user interface module communicates with the blood glucose measurement module and the communications module and operates to provide a graphical user interface on a display of the diabetes manager. The graphical user interface includes a personal data menu screen from which a logbook option can be selected to display a logbook screen. The logbook screen displays a plurality of time data records. Each time data record may include blood glucose data, bolus insulin data, basal insulin data, carbohydrate data, meal time data, health event data and free entry notes for a corresponding time and a plurality of data icons indicating corresponding events.
A trend graph option can be selected from the personal menu screen to display a trend graph screen. The trend graph screen displays within a graph area a blood glucose line graph, a carb bar graph, a basal rate line graph and a bolus bar graph representing corresponding data during a selected time interval.
Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.
Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
DETAILED DESCRIPTIONThe following description is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. For purposes of clarity, the same reference numbers will be used in the drawings to identify similar elements. As used herein, the phrase at least one of A, B, and C should be construed to mean a logical (A or B or C), using a non-exclusive logical “or”. It should be understood that steps within a method may be executed in different order without altering the principles of the present disclosure.
Referring now to
During a healthcare consultation, the patient 100 typically shares with the clinician a variety of patient data including blood glucose measurements, continuous glucose monitor data, amounts of insulin infused, amounts of food and beverages consumed, exercise schedules, and other lifestyle information. The clinician may obtain additional patient data that includes measurements of HbA1C, cholesterol levels, triglycerides, blood pressure, and weight of the patient 100. The patient data can be recorded manually or electronically on a handheld diabetes management device (“diabetes manager”) 104 having a display 103, a diabetes analysis software executed on a personal computer (PC not shown), and/or a web-based diabetes analysis site (not shown). The clinician can analyze the patient data manually or electronically using the diabetes manager 104, diabetes analysis software and/or the web-based diabetes analysis site. After analyzing the patient data and reviewing adherence of the patient 100 to previously prescribed therapy, the clinician can decide whether to modify the therapy for the patient 100.
Referring now to
The diabetes manager 104 can perform various tasks including measuring and recording blood glucose levels, determining an amount of insulin to be administered to the patient 100 via the insulin pump 202 or 204, receiving patient data via a user interface, archiving the patient data, etc. The diabetes manager 104 periodically receives glucose levels of the patient 100 from the CGM patch 200, or data from which glucose levels of the patient 100 may be computed. The diabetes manager 104 transmits instructions to the insulin pump 202 or 204, which delivers insulin to the patient 100. Insulin can be delivered in a scheduled manner in the form of a basal dose, which maintains a predetermined insulin dose to the patient 100. Additionally, insulin can be delivered in the form of a bolus dose, which raises the amount of insulin delivered to the patient 100 by a determined amount.
Generally, and referring now to
The diabetes manager 104 can receive glucose readings from one or more sources (e.g., from the CGM patch 200). The CGM patch 200 regularly monitors the interstitial glucose level of the patient 100. The CGM patch 200 periodically communicates glucose levels to the diabetes manager 104. The diabetes manager 104 and the CGM patch 200 communicate wirelessly using generally a proprietary wireless protocol, such as, for example, the standard Bluetooth Low Energy protocol. Any other suitable wireless protocol can be used instead.
Additionally, the diabetes manager 104 includes a blood glucose meter (BGM) and a port that communicates with the BGM (not shown). The port can receive a blood glucose measurement strip 306. The patient 100 deposits a sample of blood on the blood glucose measurement strip 306. The BGM analyzes the sample and measures the blood glucose level in the sample. The blood glucose level measured from the sample is used to determine the amount of insulin to be administered to the patient 100 using, for example, the insulin pump 202, 204.
The diabetes manager 104 also communicates with the insulin pump 202 or 204. The insulin pump 202 or 204 can be configured to receive instructions from the diabetes manager 104 to deliver a predetermined amount of insulin to the patient 100 in the form of basal dose or bolus dose. In some embodiments, the insulin pump 202 or 204 can receive other information including meal and/or exercise schedules of the patient 100. The insulin pump 202 or 204 can determine the amount of insulin to administer based on the additional information as a basal dose or bolus dose. In other embodiments the bolus calculation is on the diabetes manager 104.
The insulin pump 202 or 204 can also communicate data to the diabetes manager 104 via wireless communication module including, for example, a pump transceiver or a communications radio. The data can include amounts of insulin delivered to the patient 100, corresponding times of delivery, and pump status. The diabetes manager 104 and the insulin pump 202 or 204 can communicate using a wireless communication protocol such as Bluetooth. Other wireless communication protocols can also be used.
In addition, the diabetes manager 104 can communicate with the other healthcare devices 304. For example, the other healthcare devices 304 can include a blood pressure meter, a weight scale, a pedometer, a fingertip pulse oximeter, a thermometer, etc. The other healthcare devices 304 obtain and communicate personal health information of the patient 100 to the diabetes manager 104 through wireless, USB, or other interfaces. The other healthcare devices 304 may use communication protocols compliant with ISO/IEEE 11073 extended using guidelines from Continua® Health Alliance. The diabetes manager 104 can communicate with the other healthcare devices 304 using interfaces including Bluetooth, USB, etc. Further, the devices of the diabetes management system 300 can communicate with each other via the diabetes manager 104.
The diabetes manager 104 can communicate with the PC 106 using Bluetooth, USB, or other wireless interfaces. A diabetes management software running on the PC 106 includes configuration software (configurator) that stores configuration information of the devices of the diabetes management system 300. The configurator has a database to store configuration information of the diabetes manager 104 and the other devices. The configurator can communicate with users through standard web or computer screens in non-web applications. The configurator transmits user-approved configurations to the devices of the diabetes management system 300. The analyzer retrieves data from the diabetes manager 104, stores the data in a database, and outputs analysis results through standard web pages or computer screens in non-web based applications.
The diabetes manager 104 can communicate with the mobile device 302 using Bluetooth or another suitable wireless communication protocol. The mobile device 302 may include a cellular phone, a pager, or a personal digital assistant (PDA). The diabetes manager 104 can send messages to an external network through the mobile device 302. The mobile device 302 can transmit messages to the external network upon receiving requests from the diabetes manager 104. In some embodiments, a cellphone chip can be built into the diabetes manager 104 for direct communication to the external network.
Referring now to
The processing module 408 processes data received from the BGM module 400, the communication module 402, and the user interface module 404. The processing module 408 uses memory 410 for processing and storing data. The memory 410 can include volatile and nonvolatile memory. The processing module 408 outputs data to and receives data from the user interface elements 406 via the user interface module 404. The processing module 408 outputs data to and receives data from the devices of the diabetes management system 300 via the communication module 402. The power module 412 supplies power to the components of the diabetes manager 104. The power module 412 can include a rechargeable battery. The battery can be charged via the USB port of the diabetes manager 104 using an adapter that plugs into a wall outlet or using a cable that plugs into a PC.
Referring to
As briefly outlined in reference to
In the context of the user interface for the handheld diabetes manager 104, a use case is an observable result based upon an action by a user. A use case describes the behavior and navigation along a primary or alternate path including any standard business rules for diabetes management and is graphically represented in an activity or behavior diagram, as shown, for example, in
Referring to
Referring to
With continued reference to
Referring to
Pressing the logbook button 702 from the “my data” screen 700, displays a logbook screen 730, as seen in
With continued reference to
The third column 738 of the logbook screen 730 can provide bolus insulin data in insulin units U, an icon representing the type of bolus and an icon indicating whether a bolus advice recommendation was accepted or not. In the illustrative logbook screen 730 of
With continued reference to
The logbook screen 730 can also include a back button 770 for returning to the previous screen and an “add data” button 772 for displaying an “add data” menu screen for editing and/or adding various parameters, including time, date, meal time related conditions, health events, carb values, bolus insulin values and basal insulin values.
Referring to
Additionally, if the pump paused during bolus delivery associated with a bG record, the pump-paused icon 752 is shown superimposed on the corresponding standard bolus icon 756, extended bolus icon 758 and/or multiwave bolus icon 760. An example is shown as icon 757 in
With continued reference to
Referring to FIGS. 6 and 9-14, pressing the trend button 704 from the “my data” menu screen 700 displays the trend graph screen 830 illustrated in
Each of the four graphs displayed in the trend graph screen 830 of
The carb scale 862 for the carb bar graph 834 is shown at the right bottom vertical axis. The selected carb units, chosen as g (grams) in this example, are shown at the bottom left of the graph area at 874 next to the carb data icon 768 (illustrated as an apple). The carb bar graph 834 is illustrated in
The basal rate scale 866 for the basal rate line graph 836 is shown at the left top vertical axis. The basal data icon 750 is indicated at the upper left of the graph area along with the insulin units symbol “U”. Similarly, the bolus scale 864 for the bolus bar graph 838 is shown at the right top vertical axis. The bolus data icon 756 is indicated at the upper right of the graph area along with insulin units symbol U. The bolus data 756 is displayed for standard bolus, 758 for extended bolus and 760 for multiwave bolus. Additionally, a mealtime icon is displayed in the report information area (field) 876 of the trend graph screen 830 between the scroll buttons 842, 844. The mealtime icon corresponds to a filter selected for the trend graph and is one of the icons shown in an icon help screen 970 displayed by pressing the icon help button 850. The mealtime options include: all bG measurements, before meal bG measurements, after meal bG measurements, bedtime bG measurements and fasting bG measurements with corresponding icons: all bG measurements icon 878 (showing circled items), before meal bG measurements icon 880 (showing an entire apple with a leaf and color-coded red), an after meal icon bG measurements 882 (apple core), a bedtime bG measurements icon 884 (bed with letter Z), a fasting bG measurements icon 886 (crossed out fork and spoon) and an “other” icon 888 (star-shaped) for other times that do not fall within the above categories. Additional icons in the trend icon help screen 970 include the basal data icon 750, the carb data icon 768, the bolus data icon 756, the health event icon 742, and a “pump stopped” icon 890 (color coded red, for example) and a “pump paused” icon 752 (square color coded blue, for example). Pressing the help icon button 850 displays the trend icon help screen 970 showing a description of all the icons discussed above. Additionally, the graphs and corresponding scales can be color-coded with the matching colors.
With continued reference to
Referring to
Pressing the meal time button 906 displays a meal time screen 950 from which various options for mealtime data can be selected, only one at a time, in radio marks 951 by pressing a corresponding radio button to set the selection, such as “all” radio button 952, before mealtime radio button 954, after mealtime radio button 956, bedtime radio button 958, fasting radio button 960 and an “other” radio button 962. The selections can be saved by pressing the save button 964 or the changes can be canceled by pressing the cancel button 966.
Summarizing the above discussion, an exemplary activity diagram for the trend graph is illustrated in
As used herein, the term module may refer to, be part of, or include an Application Specific Integrated Circuit (ASIC); an electronic circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor (shared, dedicated, or group) that executes code; other suitable components that provide the described functionality; or a combination of some or all of the above, such as in a system-on-chip. The term module may include memory (shared, dedicated, or group) that stores code executed by the processor.
The term code, as used above, may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, and/or objects. The term shared, as used above, means that some or all code from multiple modules may be executed using a single (shared) processor. In addition, some or all code from multiple modules may be stored by a single (shared) memory. The term group, as used above, means that some or all code from a single module may be executed using a group of processors. In addition, some or all code from a single module may be stored using a group of memories.
The apparatuses and methods described herein may be implemented by one or more computer programs executed by one or more processors. The computer programs include processor-executable instructions that are stored on a non-transitory tangible computer-readable medium. The computer programs may also include stored data. Non-limiting examples of the non-transitory tangible computer readable medium are nonvolatile memory, magnetic storage, and optical storage.
The broad teachings of the disclosure can be implemented in a variety of forms. Therefore, while this disclosure includes particular examples, the scope of the disclosure should not be so limited since other modifications will become apparent to the skilled practitioner upon a study of the drawings, the specification, and the following claims.
Claims
1. A handheld diabetes manager communicating with an external insulin pump and having a personal data module comprising:
- a port configured to receive a test strip for blood glucose measurement;
- a blood glucose measurement module cooperatively operable with a test strip inserted in the port for blood glucose measurement;
- a communications module that selectively communicates via a wireless data link with an external insulin pump; and
- a user interface module in data communication with the blood glucose measurement module and the communications module and operable to provide a graphical user interface on a display of the diabetes manager, wherein the graphical user interface includes a personal data menu screen from which a logbook option can be selected to display a logbook screen, the logbook screen displaying a plurality of time data records, each time data record including blood glucose data, bolus insulin data and carbohydrate data for a corresponding time, and a bolus icon and a first icon in association with the bolus icon when a bolus advice recommendation is accepted, and a second icon, different from the first icon, when a bolus advice recommendation is not accepted.
2. The handheld diabetes manager of claim 1, wherein the logbook screen displays a health event icon when a health event was entered during the corresponding time data record.
3. The handheld diabetes manager of claim 1, wherein the logbook screen displays a “pump paused” icon when the insulin pump was paused in the corresponding time data record.
4. The handheld diabetes manager of claim 1, wherein the logbook screen displays a blood glucose indicator icon associated with the blood glucose value of the corresponding time data record.
5. The handheld diabetes manager of claim 1, wherein the logbook screen displays a carb icon and the first icon in association with the carb icon when a carb advice recommendation is accepted, and the second icon when a carb advice recommendation is not accepted.
6. The handheld diabetes manager of claim 1, wherein the logbook screen displays different icons for each of standard, extended and multiwave bolus associated with each time data record.
7. The handheld diabetes manager of claim 1, wherein a detailed blood glucose screen reached for a time data record associated with an accepted bolus advice recommendation displays a lock icon indicating that the corresponding data cannot be changed.
8. A handheld diabetes manager communicating with an external insulin pump and having a personal data module comprising:
- a port configured to receive a test strip for blood glucose measurement;
- a blood glucose measurement module cooperatively operable with a test strip inserted in the port for blood glucose measurement;
- a communications module that selectively communicates via a wireless data link with an external insulin pump; and
- a user interface module in data communication with the blood glucose measurement module and the communications module and operable to provide a graphical user interface on a display of the diabetes manager, wherein the graphical user interface includes a personal data menu screen from which a trend graph option can be selected to display a trend graph screen, the trend graph screen displaying within a graph area a blood glucose line graph, a carb bar graph, a basal rate line graph and a bolus bar graph representing corresponding data during a selected time interval.
9. The handheld diabetes manager of claim 8, wherein the blood glucose line graph is a piecewise linear graph connecting data points corresponding to blood glucose data.
10. The handheld diabetes manager of claim 8, wherein the carb bar graph is a bar graph corresponding to carb data.
11. The handheld diabetes manager of claim 8, wherein the trend graph screen displays a color-coded area indicating a normal blood glucose range.
12. The handheld diabetes manager of claim 8, wherein the trend graph screen displays a color-coded line indicating a hypoglycemia limit.
13. The handheld diabetes manager of claim 8, wherein the trend graph screen displays along an upper portion of the graph area from left to right icons representing events that occurred in the trend graph's time interval, including icons indicating health events, icons indicating “pump stopped” events and icons indicating “pump paused” events.
14. The handheld diabetes manager of claim 8, wherein the trend graph screen includes an “icon help” button for displaying a screen including a plurality of icons and their corresponding descriptions as used in the trend graph screen.
15. The handheld diabetes manager of claim 8, wherein the trend graph screen includes a left scroll arrow, a right scroll arrow and a report information field in between.
16. The handheld diabetes manager of claim 15, wherein the left and right scroll arrows operate to update the graph data with respective older or newer data at respective decrements and increments of time corresponding to a time scale for the selected time interval.
17. The handheld diabetes manager of claim 15, wherein a mealtime icon is displayed in the report information field, the mealtime icon representing a type of mealtime event selected for the graph, including before meal, after meal, bedtime, fasting, or all mealtime events.
18. The handheld diabetes manager of claim 8, wherein the trend graph screen includes a configure button for selecting time scale options, data option and mealtime options for graphical representation.
19. A handheld diabetes manager communicating with an external insulin pump and having a personal data module comprising:
- a port configured to receive a test strip for blood glucose measurement;
- a blood glucose measurement module cooperatively operable with a test strip inserted in the port for blood glucose measurement;
- a communications module that selectively communicates via a wireless data link with an external insulin pump; and
- a user interface module in data communication with the blood glucose measurement module and the communications module and operable to provide a graphical user interface on a display of the diabetes manager, wherein the graphical user interface includes a personal data menu screen from which a logbook option can be selected to display a logbook screen, and a trend graph option can be selected to display a trend graph screen, wherein:
- the logbook screen displays a plurality of time data records, each time data record including blood glucose data, bolus insulin data and carbohydrate data for a corresponding time, a bolus icon and a first icon in association with the bolus icon when a bolus advice recommendation is accepted, and a second icon, different from the first icon, when a bolus advice recommendation is not accepted; and
- the trend graph screen displays within a graph area a blood glucose line graph, a carb bar graph, a basal rate line graph and a bolus bar graph representing corresponding data during a selected time interval.
20. The handheld diabetes manager of claim 19, wherein a detailed blood glucose screen reached for a time data record associated with an accepted bolus advice recommendation displays a lock icon indicating that the corresponding data cannot be changed.
21. The handheld diabetes manager of claim 20, wherein the detailed blood glucose screen includes a bolus button and an icon displaying the type of bolus associated with the time data record.
22. The handheld diabetes manager of claim 21, wherein the detailed blood glucose screen displays a pump-paused icon combined with the bolus icon if the pump was paused during bolus delivery.
Type: Application
Filed: Oct 26, 2012
Publication Date: Jul 4, 2013
Applicant: ROCHE DIAGNOSTICS OPERATIONS, INC. (Indianapolis, IN)
Inventor: Roche Diagnostics Operations, Inc. (Indianapolis, IN)
Application Number: 13/661,539
International Classification: A61B 5/145 (20060101);