Patent Application
20130318439
Glucose monitoring is a fact of everyday life for diabetic individuals. The accuracy of such monitoring can significantly affect the health and ultimately the quality of life of the person with diabetes. Generally, a diabetic patient measures blood glucose levels several times a day to monitor and control blood sugar levels. Failure to test blood glucose levels accurately and on a regular basis can result in serious diabetes-related complications, including cardiovascular disease, kidney disease, nerve damage and blindness. There are a number of electronic devices currently available which enable an individual to test the glucose level in a small sample of blood. One such glucose meter is the OneTouch® Profile™ glucose meter, a product which is manufactured by LifeScan.
In addition to glucose monitoring, diabetic individuals often have to maintain tight control over their lifestyle, so that they are not adversely affected by, for example, irregular food consumption or exercise. In addition, a physician dealing with a particular diabetic individual may require detailed information on the lifestyle of the individual to provide effective treatment or modification of treatment for controlling diabetes. Currently, one of the ways of monitoring the lifestyle of an individual with diabetes has been for the individual to keep a paper logbook of their lifestyle. Another way is for an individual to simply rely on remembering facts about their lifestyle and then relay these details to their physician on each visit.
The aforementioned methods of recording lifestyle information are inherently difficult, time consuming, and possibly inaccurate. Paper logbooks are not necessarily always carried by an individual and may not be accurately completed when required. Such paper logbooks are small and it is therefore difficult to enter detailed information requiring detailed descriptors of lifestyle events. Furthermore, an individual may often forget key facts about their lifestyle when questioned by a physician who has to manually review and interpret information from a hand-written notebook. There is no analysis provided by the paper logbook to distill or separate the component information. Also, there are no graphical reductions or summary of the information. Entry of data into a secondary data storage system, such as a database or other electronic system, requires a laborious transcription of information, including lifestyle data, into this secondary data storage. Difficulty of data recordation encourages retrospective entry of pertinent information that results in inaccurate and incomplete records.
There currently exist a number of portable electronic devices that can measure glucose levels in an individual and store the levels for recalling or uploading to another computer for analysis. One such device is the Accu-Check™ Complete™ System from Roche Diagnostics, which provides limited functionality for storing lifestyle data. However, the Accu-Check™ Complete™ System only permits a limited selection of lifestyle variables to be stored in a meter. There is a no intelligent feedback from values previously entered into the meter and the user interface is unintuitive for an infrequent user of the meter. Another device is the Agamatrix WaveSense. However, the WaveSense does not provide for detection of high trend or low trend.
In a first embodiment, a mobile computing device is provided that includes a touch sensitive screen display, memory, one or more microprocessor, and program instructions. The touch-sensitive display is responsive to commands by finger contact with the at least one microprocessor coupled to the display and memory and provided with program instructions stored in the memory. The program instructions are executable by the at least one microprocessor to: generate at least one informational screen on the touch-sensitive display indicative of a plurality of analyte measurements stored in the memory; display a segmented selection button on the at least one informational screen upon finger contact longer than a preset time; overlay a help screen on the at least one informational screen upon momentary finger contact on one segmented selection button in which the help screen allows for help information to be displayed over the at least one informational screen; overlay a sharing screen on the at least one informational screen upon momentary finger contact on another segmented selection button that allows for information related to the at least one informational screen to be sent to a different device including another mobile computing device.
In this first embodiment, the following features may be utilized with either singly in any combination with this embodiment: the informational screen may include a screen selected from one of a logbook screen, a logbook screen with high low trends indicia, a graphical screen, or summary screen for the touch-sensitive display; the different device may be at least one of a desktop computer, server, printer, and combinations thereof. For this first embodiment, the at least one microprocessor is further programmed to: store a plurality of analyte measurements; determine whether a most recent analyte measurement at a given time during a day is below a first threshold; evaluate whether at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X hours about the given time of the most recent analyte measurement over a period of N days, is lower than the first threshold; ascertain whether at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X hours about the given time of the most recent analyte measurement over a period of N days, are higher than the second threshold; and upon completion of the evaluate and ascertain, annunciate that in the same time frame of at least two days over the N number of days, the plurality of analyte measurements indicates a trend lower than the low threshold or a trend higher than a second threshold. It is noted that the annunciate may include a display of at least one trend and plurality of analyte measurements on the touch screen display of the mobile communication device in a table having multiple rows and multiple columns with respective row header and column header, the column header signifying different time periods during a day with subdivisions of each of the column header to signify a before meal or after meal analyte measurement within each time period of the day, and the row header signifying the date of each analyte measurement, and in which numerical values representing analyte values identified as part of one analyte trend are represented by a first indicia and as part of another analyte trend by a second indicia different from the first indicia.
In a second embodiment, a mobile computing device is provided that includes a touch sensitive screen display, memory, one or more microprocessor, and program instructions. The touch-sensitive display is responsive to commands by finger contact with the at least one microprocessor coupled to the display and memory and provided with program instructions stored in the memory. The program instructions are executable by the at least one microprocessor to: store a plurality of analyte measurements; determine whether a most recent analyte measurement at a given time during a day is below a first threshold; evaluate whether at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X hours about the given time of the most recent analyte measurement over a period of N days, is lower than the first threshold; ascertain whether at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X hours about the given time of the most recent analyte measurement over a period of N days, are higher than the second threshold; upon completion of the evaluate and ascertain, annunciate that in the same time frame of at least two days over the N number of days, the plurality of analyte measurements indicates a trend lower than the low threshold or a trend higher than a second threshold; generate at least one informational screen on the touch-sensitive display indicative of a plurality of analyte measurements stored in the memory; display a segmented selection button on the at least one informational screen upon finger contact longer than a preset time; overlay a help screen on the at least one informational screen upon momentary finger contact on one segmented selection button in which the help screen allows for help information to be displayed over the at least one informational screen; and overlay a sharing screen on the at least one informational screen upon momentary finger contact on another segmented selection button that allows for information related to the at least one informational screen to be sent to a different device including another mobile computing device.
In this second embodiment, the following features may be utilized with either singly in any combination with this embodiment: the informational screen may include a screen selected from one of a logbook screen, a logbook screen with high low trends indicia, a graphical screen, or summary screen for the touch-sensitive display, the different device may be at least one of a desktop computer, server, printer, and combinations thereof. It is noted that the microprocessor is programmed to display the plurality of analyte measurements on the display of the mobile communication device in a table having multiple rows and multiple columns with respective row header and column header, the column header signifying different time periods during a day with subdivisions of each of the column header to signify a before meal or after meal analyte measurement within each time period of the day, and the row header signifying the date of each analyte measurement, and in which numerical values representing analyte values identified as part of one analyte trend are represented by a first indicia and as part of another analyte trend by a second indicia different from the first indicia. Alternatively, the microprocessor is further programmed to confirm whether the most recent analyte measure was flagged as one of predetermined conditions including (a) a measurement made before a meal or (b) during a fasting period. The microprocessor is further programmed to confirm whether the most recent analyte measure is below a first threshold as the predetermined condition, and the N number of days may include any number from about 2 to about 14 and the X hours may include any number between about 0 and about 7 hours; the X hours may include any number from about 0 to about 3 hours; and the first threshold may include about 70 mg of glucose per deciliter of blood and the second threshold may include about 150 mg of glucose per deciliter of blood.
In a third embodiment, a method of notifying a user of high or low trends in blood glucose values is provided. The trend or trends may be obtained with an analyte measurement unit and used in conjunction with a mobile communication device, each having a microprocessor coupled to respective displays and memory storage devices. The method can be achieved by: transforming with the analyte measurement unit, an analyte in a physiological fluid into an enzymatic by-product and in the process provide a measurement of the analyte in the fluid; storing in the memory of the analyte measurement unit, one or more of the analyte measurements; determining with the mobile communication device, whether a most recent analyte measurement at a given time during a day is below a first threshold; evaluating with the mobile communication device, whether at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X hours about the given time of the most recent analyte measurement over a period of N days, is lower than the first threshold; annunciating that, in the same time frame over the N number of days, the plurality of analyte measurements including the at least one analyte measurement indicates an analyte trend lower than the low threshold, the annunciating further may include: displaying an informational screen on the touch-sensitive display indicative of the analyte trend; displaying a segmented selection button on the at least one informational screen upon finger contact longer than a preset time; overlaying a help screen on the at least one informational screen upon momentary finger contact on one segmented selection button in which the help screen allows for help information to be displayed over the at least one informational screen.
In the third embodiment, the following features may be utilized with either singly in any combination with this embodiment: overlaying a sharing screen on the at least one informational screen upon momentary finger contact on another segmented selection button that allows for information related to the at least one informational screen to be sent to a different device including another mobile computing device.
In a fourth embodiment, a method of notifying a user of high or low trends in blood glucose values is provided. The trend or trends may be obtained with an analyte measurement unit and used in conjunction with a mobile communication device, each having a microprocessor coupled to respective displays and memory storage devices. The method can be achieved by: initiating with the analyte measurement unit, a physical transformation of an analyte in a physiological fluid into an enzymatic by-product and in the process provide a measurement of the analyte in the fluid; storing in the memory of the analyte measurement unit, one or more of the analyte measurements; determining whether a most recent analyte measurement at a given time during a day is above a second threshold; confirming whether the most recent analyte measure was flagged as (a) a measurement made before a meal or (b) a measurement made during a fasting period; evaluating with the mobile communication device, whether at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X hours about the given time of the most recent analyte measurement over a period of N days, each is higher than the second threshold; annunciating that in the same time frame over the N number of days, the plurality of analyte measurements indicates an analyte trend higher than a second threshold, the annunciating further may include: displaying an informational screen on the touch-sensitive display indicative of the analyte trend; displaying a segmented selection button on the at least one informational screen upon finger contact longer than a preset time; overlaying a help screen on the at least one informational screen upon momentary finger contact on one segmented selection button in which the help screen allows for help information to be displayed over the at least one informational screen.
In this fourth embodiment, the following features may be utilized with either singly in any combination with this embodiment: overlaying a sharing screen on the at least one informational screen upon momentary finger contact on another segmented selection button that allows for information related to the at least one informational screen to be sent to a different device including another mobile computing device. It is noted that the annunciating may include: displaying a plurality of analyte measurements on the display of the mobile communication device in a table having multiple rows and multiple columns with respective row header and column header, the column header signifying different time periods during a day with subdivisions of each of the column header to signify a before meal or after meal analyte measurement within each time period of the day, and the row header signifying the date of each analyte measurement, and in which numerical values representing analyte values identified as part of one analyte trend are represented by a first indicia and as part of another analyte trend by a second indicia different from the first indicia. In this embodiment, the analyte may include glucose and the displaying may include showing a distribution of the first indicia of stored analyte for a trend of analyte measurements lower than the first threshold within a time frame of X hours about the given time of the most recent analyte measurement over a period of N days being connected to each other. Alternatively, the displaying may include showing a distribution of the second indicia of stored analyte for a trend of analyte measurements higher than the second threshold within a time frame of X hours about the given time of the most recent analyte measurement over a period of N days being connected to each other; the first indicia may include at least two circles with a connector in between, where the two circles comprise a first color; the second indicia may include at least two circles with a connector in between each of the circles, the circle comprising a second color; the recent N number of days may include any number from about 2 to about 14; the X hours may include any number between about 0 and about 7 hours; the X hours may include any number from about 0 to about 3 hours; the first threshold may include about 70 mg of glucose per deciliter of blood; the second threshold may include about 150 mg of glucose per deciliter of blood.
In a fifth embodiment, a diabetes management system is provided that includes at least one glucose test strip, measurement unit for the strip, and a mobile communication unit. The measurement unit may include a housing including a test strip port configured to receive the glucose test strip. The measurement microprocessor is coupled to the test strip port to provide data regarding an amount of glucose measured in a user's physiological fluid deposited on the test strip, the microprocessor further coupled to a memory. The mobile communication unit includes a mobile processor coupled to a display. One of the measurement microprocessor or the mobile microprocessor being programmed to: measure an analyte in a physiological fluid to provide an analyte measurement; store one or more of the analyte measurements; determine whether a most recent analyte measurement at a given time during a day is below a first threshold; evaluate whether at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X hours about the given time of the most recent analyte measurement over a period of N days, is lower than the first threshold; ascertain whether at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X hours about the given time of the most recent analyte measurement over a period of N days, are higher than the second threshold; and upon completion of one of the evaluate and ascertain, annunciate that in the same time frame of at least two days over the N number of days, the plurality of analyte measurements indicates a trend lower than the low threshold or a trend higher than a second threshold; generate at least one informational screen on the touch-sensitive display indicative of a plurality of analyte measurements stored in the memory; display a segmented selection button on the at least one informational screen upon finger contact longer than a preset time; overlay a help screen on the at least one informational screen upon momentary finger contact on one segmented selection button in which the help screen allows for help information to be displayed over the at least one informational screen; and overlay a sharing screen on the at least one informational screen upon momentary finger contact on another segmented selection button that allows for information related to the at least one informational screen to be sent to a different device including another mobile computing device.
In this fifth embodiment, the following features may be utilized with either singly in any combination with this embodiment: the processor is configured to display the plurality of analyte measurements on the display of the mobile communication device in a table having multiple rows and multiple columns with respective row header and column header, the column header signifying different time periods during a day with subdivisions of each of the column header to signify a before meal or after meal analyte measurement within each time period of the day, and the row header signifying the date of each analyte measurement, and in which numerical values representing analyte values identified as part of one analyte trend are represented by a first indicia and as part of another analyte trend by a second indicia different from the first indicia. Alternatively, the microprocessor is further programmed to confirm whether the most recent analyte measure was flagged as one of predetermined conditions including (a) a measurement made before a meal or (b) during a fasting period or the microprocessor is further programmed to confirm whether the most recent analyte measure is below a first threshold as the predetermined condition. It is noted that the recent N number of days may include any number from about 2 to about 14 and the X hours may include any number between about 0 and about 7 hours; the X hours may include any number from about 0 to about 3 hours; the first threshold may include about 70 mg of glucose per deciliter of blood and the second threshold may include about 150 mg of glucose per deciliter of blood.
In a sixth embodiment, a method of notifying a user of high or low trends in blood glucose values obtained with an analyte measurement unit and used in conjunction with a mobile communication device is provide. Each of the unit and device has a microprocessor coupled to memory storage devices. The mobile communication device includes a touch screen or touch-sensitive display. The method can be achieved by: initiating with the analyte measurement unit, a physical transformation of an analyte in a physiological fluid into an enzymatic by-product and in the process provide a measurement of the analyte in the fluid; storing in the memory of the analyte measurement unit, one or more of the analyte measurements; evaluating the one more of the analyte measurements to determine one or more of a high trend in which blood glucose values over a set time frame is increasing or a low trend in which blood glucose values over the set time frame is decreasing; displaying, on the touch screen, an informational screen indicative of the one or more analyte measurements including the high or low trend; upon contact of a finger on the informational screen for a duration longer than a timed threshold, displaying a segmented button that provides at least two finger selectable options; upon a finger tap on the informational screen of one of the at least two finger selectable options, annunciating information related to the informational screen indicative of the one or more analyte measurements including the high or low trend; or upon a finger tap on the informational screen of the other of the at least two finger selectable options, allowing data representing the informational screen to be sent to a different device including another mobile communication device, server, or printer.
In this sixth embodiment, the following features may be utilized with either singly in any combination with this embodiment: the at least two finger selectable options comprise a print option, a share option, or a help option; the informational screen may include a screen selected from one of a logbook screen, a logbook screen with high low trends indicia, a graphical screen, or summary screen.
These and other embodiments, features and advantages will become apparent to those skilled in the art when taken with reference to the following more detailed description of various exemplary embodiments of the invention in conjunction with the accompanying drawings that are first briefly described.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain features of the invention (wherein like numerals represent like elements).
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. The term “analyte” may be read to include one or more substances in fluids that are the subject of a test to determine its quantity or quality. In addition, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.
Operational amplifier circuit (not shown for brevity) can include two or more operational amplifiers configured to provide a portion of the potentiostat function and the current measurement function. The potentiostat function can refer to the application of a test voltage between at least two electrodes of a test strip. The current function can refer to the measurement of a test current resulting from the applied test voltage. The current measurement may be performed with a current-to-voltage converter. Microcontroller 24 can be in the form of a mixed signal microprocessor (MSP) such as, for example, the Texas Instrument MSP 430. The MSP 430 can be configured to also perform a portion of the potentiostat function and the current measurement function. In addition, the MSP 430 can also include volatile and non-volatile memory. In another embodiment, many of the electronic components can be integrated with the microcontroller in the form of an application specific integrated circuit (ASIC).
Strip port connector 16 can be configured to form an electrical connection to the test strip. Display 14 can be in the form of a liquid crystal display for reporting measured glucose levels, and for facilitating entry of lifestyle related information. Display 14 can optionally include a backlight. Alternatively, display 14 may include a touch-screen display to allow for entry of data and responses without requiring buttons and switches. Data port 18 can accept a suitable connector attached to a connecting lead, thereby allowing AMU 10 to be linked to an external device such as a personal computer or allow rechargeable battery of the meter 10 to be recharged. Data port 18 can be any port that allows for transmission of data such as, for example, a serial, USB, or a parallel port. Preferably, data port 18 is in the form of a USB 2.0 port. Clock (not shown for brevity) can be configured to keep current time related to the geographic region in which the user is located and also for measuring time. The AMU 10 can be configured to be electrically connected to a power supply such as, for example, a battery.
The AMU 10 is designed to work with a suitable analyte test strip (e.g., electrochemical or photochemical) that provides for one or more measurements of analytes in physiological fluid such as, for example, glucose, ketone, cholesterol and the like. In one exemplary embodiment, test strip 20 can be in the form of an electrochemical glucose test strip. Test strip 20 can include one or more working electrodes and a counter electrode. Test strip 20 can also include a plurality of electrical contact pads, where each electrode can be in electrical communication with at least one electrical contact pad. Strip port connector 16 can be configured to electrically interface to the electrical contact pads and form electrical communication with the electrodes. Test strip 20 can include a reagent layer that is disposed over at least one electrode. The reagent layer can include an enzyme and a mediator. Exemplary enzymes suitable for use in the reagent layer include glucose oxidase, glucose dehydrogenase (with pyrroloquinoline quinone co-factor, “PQQ”), and glucose dehydrogenase (with flavin adenine dinucleotide co-factor, “FAD”). An exemplary mediator suitable for use in the reagent layer includes ferricyanide, which in this case is in the oxidized form. The reagent layer can be configured to physically transform glucose into an enzymatic by-product and in the process generate an amount of reduced mediator (e.g., ferrocyanide) that is proportional to the glucose concentration. The working electrode can then measure a concentration of the reduced mediator in the form of a current. In turn, AMU 10 can convert the current magnitude into a glucose concentration. Details of the preferred test strip are provided in U.S. Pat. Nos. 6,179,979; 7,045,046; 7,291,256; 7,498,132, all of which are incorporated by reference in their entireties herein.
Referring again to
In operation, a patient may begin the use of system 100 by performing a blood test. Specifically, a suitable test strip 20 is inserted into the AMU 10 to turn on the device. Blood or a suitable physiological fluid is extracted by a suitable device (e.g., a lancet) and deposited on a distal end of the strip 20. Deposition of blood initiates a physical transformation of the analyte (e.g., glucose) into an enzymatic by-product such as, for example, gluconic acid, thereby allowing the AMU 10 to measure current flow from the enzymatic reaction in a test chamber of the test strip. After the enzymatic reaction has taken place and the current from the reaction measured, analyte result or in the exemplary embodiment, a blood glucose (“BG”) result at 202 is annunciated to the user. As used here, the term “annunciated” and variations on the root term indicate that an announcement may be provided via text, audio, visual or a combination of all modes of communication to a user.
The result from the electrochemical test is also transferred, if possible, immediately to the hand-held computing unit 40 for further processing in order to assist the user in management of the user's health or disease. The transfer of test result can be via a suitable wireless protocol such as, for example, WiFi, Zygbee, Bluetooth, CALM, and preferably via Bluetooth 2.0. Of course, the user could always enter the value manually using the touch screen or touch-sensitive display interface of the HCU 40 to write in the value using a finger tip and saving the data. Of note, whenever the meter 10 is connected to the nit 40 for transfer of data, a computer program containing software codes, identified here as an “App” checks the date and time stored in the meter. If the time difference is less than or equal to 15 minutes, the time of day in the meter is automatically updated to match the current time in the unit 40.
Various functionalities are provided by the App in the system 100, which functionalities are shown and described in Provisional U.S. Patent Application Ser. No. 61/308,217 filed 25 Feb. 2010 (Attorney Docket No. DDI-5194USPSP) and U.S. patent application Ser. No. 12/826,543(Attorney Docket No. DDI-5194USNP) filed 9 Jun. 2010, which are incorporated by reference in its entirety into this application. It should be noted that the functionalities described by the previously mentioned applications can be utilized in either the AMU 10 or the HCU 40, in part or in whole in either or both of these devices.
Once the blood glucose values have been transferred over to device 40 (manually or automatically), the user may immediately see the result and other related data, as shown in an informational screen which in this case is a summary screen of
The help-share functionality can be called up as follow. It is assumed that the device 40 in
As shown in
Rather than reviewing the details of each and every day within the 14 day reporting period, the user may elect to view the data at a different level of abstraction, shown here in
Another functionality is provided in the system 100 to allow for the device 40 to alert the user to a high trend (or a low trend) of the analyte measurements taken recently. Two variations on the logic for the low trend pattern detection is shown and described herein relation to
In
As an alternative to the logic of
Returning to process 414, if the process returns a false at 414, the flow proceeds to 432 to determine if there are updates to the results. Assuming that no new results were transferred while steps 412-424 were running, then the logic ends at 434.
A high trend detection logic 800 is also provided for the system, illustrated exemplarily here in
In this logic flow of
As an example of the logic 800, it will be assumed that a user conducted a series of measurements from Monday to Friday with a most recent BG result at 9 AM on Friday, as set forth in Table 1 below:
Referring to Table 1, the most recent BG has a logical true state for the logical queries 802 and 804 (i.e., exceeds the high threshold and flagged as fasting). At least one BG for each of the last four days has a logical true state for the logical queries 806 and 808. The logical query 810 must evaluate at least three BG's, which are the most recent BG (from queries 802 and 804) and the at least two BG's (from queries 806 and 808).
Based on the results collected in the previous 4 days, a warning message would be annunciated with the most recent BG on Friday at 9:00 AM. The 3 hour time bracket can include, in chronological order for time of day, 7:50 AM (Monday), 9:00 AM (Friday), and 10:49 AM (Tuesday), where the difference between the latest time and the earliest time is less than three hours (10:49 AM minus 7:50 AM=2 hours and 59 minutes). Thus, the Monday, Friday, and Tuesday BG's fall within the three hour time bracket. In addition to Monday, Friday, and Tuesday, the 3 hour time bracket can also include, in chronological order for time of day, 7:40 AM (Wednesday), 7:50 AM (Monday), and 9:00 AM (Friday), where the difference between the latest time and the earliest time is less than three hours (9:00 AM minus 7:40 AM=1 hour and 20 minutes).
Referring back to Table 1, there is no high trend alert for Wednesday. For Wednesday, 2 previous BG's and 1 most recent BG are evaluated in the logical query 810, which are 7:40 AM (Wednesday), 7:50 AM (Monday), and 10:49 AM (Tuesday), where the difference between the latest time and the earliest time is more than three hours (i.e., 10:49 AM minus 7:40 AM=3 hours and 9 minutes). Thus, the Wednesday, Monday, and Tuesday BG's do not fall within the three hour time bracket.
Referring back to Table 1, there is no high trend alert for Thursday. For Thursday, 2 previous BG's and 1 most recent BG are evaluated in the logical query 810. Note that there are three combinations of previous days that can be evaluated in the logical query 810, which are Monday/Tuesday; Monday/Wednesday; and Tuesday/Wednesday. Here, combining any one of the combinations of previous days with the most recent BG does not result in three BG's falling within the three hour time bracket.
Note that in the embodiment set forth in Table 1, only one glucose concentration per day was depicted that exceeds the high threshold and flagged as fasting. In other situations, there may be more than one glucose concentration per day that exceed the high threshold and are flagged as fasting. In such a case, the number of combinations of 3 BG's that need to be evaluated by the logic 800 will increase.
As a further demonstration of the applicability of logic routine 800, consider that the user further conducted a most recent BG measurement on the Saturday following the Friday (of Table 1), set forth herein Table 2.
In Table 2, the logic 800 would detect a high trend alert on Saturday (at 11:50 AM), which would be annunciated with the most recent BG. Note that there are six combinations of previous days that can be evaluated in the logical query 810, which are Monday/Tuesday; Monday/Wednesday; Monday/Thursday; Tuesday/Wednesday; Tuesday/Thursday; and Wednesday/Thursday. The 3 hour time bracket can include, in chronological order for time of day, 10:49 AM (Tuesday), 11:30 AM (Thursday), and 11:50 AM (Saturday), where the difference between the latest time and the earliest time is less than three hours (i.e., 11:50 AM minus 10:49 AM=1 hour and 1 minute). Thus, the Tuesday, Thursday, and Saturday BG's fall within the three hour time bracket. In summary based on Table 2, the user would be provided two messages: one on Friday and another message on Saturday. Alternatively, however, only one message may be generated on Saturday that reports the two high trends by prioritization of the trend data. Prioritization of the high trend or low trend reports can be based on the following: once a glucose value is used for a (high or low) trend, it will no longer be included in other (high/low) trends; if multiple trends are detected, the tightest clustering of results will be the one reported; or if there are multiple high and low BG measurements within an hour, only the first low or high BG measurements will be included in trend analysis (i.e., if there are either multiple high values with an hour or multiple low values within an hour, only the first will be included in trend analysis). Alternatively, the prioritization can be based on based on chronological closeness or based on the tightness of the clustering which can be determined by the closest 2 BG results in time to the most recent BG result, or the closest 3 BG results in time to the most recent BG result.
An alternate logic may also be utilized to detect high BG trend(s), illustrated exemplarily here in
Returning to process 500, if the process returns a false at 504, the flow proceeds to 526 to determine if there are updates to the results. Assuming that no new results were transferred while steps 508-518 were running, then the logic ends at 528. In the preferred embodiments, the window of X hours includes any numerical value from about 1 to about 6 hours (or in minutes) and the N number of days may range from about 2 to about 21 days. In another preferred embodiment, the window of X hours include about 3 hours and the N number of days may range from about 2 to about 30 days, and most preferably from about 2 to about 5 days. In a further preferred embodiment, the N number of days may range from about 2 days to about 90 days. It is noted that the word “days” denote any 24 hour period which may have its start time coinciding with the commonly understood starting point (e.g., 4 AM-8 AM) of a user.
The high patterns or low patterns are stored in the HCU 40 and annunciated to the user in a unique manner. Specifically, as shown in
Referring to
Where the user desires more details to the trends, the user may touch the relevant indicia in
As an alternative to displaying the high trend separately from the low trend (e.g.,
The resulting blood glucose values may be indexed against various indices such as, for example, time, date, flags, trends, meals and any other index suitable to the user to help manage and track diabetes. As shown in
The exemplary system also allows the log-book to be shared with a caretaker or a health care provider or for the user to seek help in interpreting the log-book. This feature is shown in
Selection of “Help” activates a suitable media such as, for example, a video (e.g., a Youtube or Facebook video) on the effects of glucose values trending lower over time or approved articles from health care providers, pop-up with explanatory text, or an acoustic tutorial. Alternatively, selection of “Help” opens a call to a pre-selected phone number or to a website (e.g., diabetes forum or a private Facebook website for diabetics). Selection of “Share” activates an overlay 709 with 3 choices: sending an email with a copy of the log-book data or a screen-captured image of the informational screen to another user; sending a text message that includes textual, video, or audio description of the log-book or image; or canceling this feature. Note that the help/share feature is not only applicable to the logbook, but can be categorically applied to all screens of the communication device. For example, the help/share feature may be applied to a Summary screen (see
Another feature that the system also provides is the ability to display analyte measurements in a graphical format. In this example, in screen 900 of
In a preferred embodiment, shown here in ”) rather than a solid icon (e.g., “”). For results 918 that have not been tagged as before or after meal, the icon is different from the before meal and after meal icon (e.g., “▴”). The color for icon 918 may also be different from the convention of the high and low results but preferably is the same to reduce confusion. The user may also view the high and low trends by finger tapping the “show patterns” button on screen 900. Once the pattern screen 920 is displayed, here in
Instead of displaying the measurements plotted against a numerical range and date as in
By virtue of the system and processes described herein, a method of notifying a user of high or low trends in blood glucose values obtained with an analyte measurement unit is provided. The method may include the steps of: performing with the microprocessor, a plurality of blood glucose measurements; storing in the memory, the plurality of blood glucose measurements; determining whether a most recent blood glucose measurement is below a first threshold or above a second threshold; evaluating with the microprocessor, whether at least one blood glucose measurement of the plurality of blood glucose measurements performed within a time frame as the most recent blood glucose measurement over a period of N days, is lower than the first low threshold or higher than the second threshold; and upon completion of the evaluating step, annunciating that in the same time frame of at least two days over the N number of days, the plurality of blood glucose measurements indicates a trend lower than the low threshold or a trend higher than a second threshold.
Furthermore, the various methods described herein can be used to generate software codes using off-the-shelf software development tools such as, for example, Visual Studio 6.0, C or C++ (and its variants), and suitable software-development-kit (“SDK”) from Apple, Blackberry, Google, and other less well-known software and hardware providers. The methods, however, may be converted or ported into other software languages depending on the requirements and the availability of new software languages for coding the methods. Additionally, the various methods described, once transformed into suitable software codes, may be embodied in any computer-readable storage medium that, when executed by a suitable microprocessor or computer, are operable to carry out the steps described in these methods along with any other necessary steps.
While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well.
This application claims the benefits under 35 USC §§119, 120, 365, and/or the Paris Convention for prior provisional patent application Ser. Nos. 61/415,598 (Attorney Docket No. LFS5217USPSP) filed on Nov. 19, 2010; 61/469,046 (Attorney Docket No. LFS2222USPSP) filed on Mar. 29, 2011; U.S. Design patent application Ser. No. 29/393,126 filed on May 31, 2011 (Attorney Docket No. LFS5223USDP) and non-provisional patent application Ser. No. 13/192,348 (Attorney Docket No. LFS5217USNP) on Jul. 27, 2011, which prior applications are hereby incorporated by reference into this application in their entirety.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US11/59416 | 11/4/2011 | WO | 00 | 8/12/2013 |
| Number | Date | Country | |
|---|---|---|---|
| 61415598 | Nov 2010 | US | |
| 61469046 | Mar 2011 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13192348 | Jul 2011 | US |
| Child | 13988306 | US | |
| Parent | 29393126 | May 2011 | US |
| Child | 13192348 | US |
