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 analyte levels in an individual and store the levels for recalling or uploading to another computer for analysis. However, the known 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 an embodiment, a method of notifying a user of high or low trends in analyte values obtained with an analyte measurement unit and used in conjunction with a mobile communication device. Each of the analyte measurement unit and the communication device includes 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 a first threshold; and annunciating in the mobile communication unit that, in the same time frame over the N number of days, the plurality of analyte measurements indicates a analyte trend lower than the first threshold.
In yet another embodiment, a method of notifying a user of high or low trends in analyte values obtained with an analyte measurement unit and used in conjunction with a mobile communication device. Each of the analyte measurement unit and the communication device includes a microprocessor coupled to respective displays and memory storage devices. The method can be achieved by: initiating with the analyte measurement unit, a 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 either one or both of (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 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 higher than the second threshold; and annunciating that in the same time frame over the N number of days, the plurality of analyte measurements indicates a analyte trend higher than a second threshold.
In yet a further embodiment, a method of notifying a user of high or low trends in analyte values obtained with an analyte measurement unit and used in conjunction with a mobile communication device. Each of the analyte measurement unit and the communication device includes a microprocessor coupled to respective displays and memory storage devices. The method can be achieved by: initiating with the analyte measurement unit, a 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 either one or both of 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 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 higher than the second threshold; and annunciating that in the same time frame over the N number of days, the plurality of analyte measurements indicates a analyte trend higher than a second threshold; and 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 another embodiment, a chronic disease management system is provided that includes an analyte measurement unit and mobile communication unit. The analyte measurement unit includes a housing and a test strip port configured to receive an analyte test strip with a test strip port to provide data regarding an amount of an analyte from a user's physiological fluid deposited on one or more test strips, and an analyte microprocessor coupled to a memory. The memory is configured to store data representing a plurality of analyte measurements. The mobile communication unit includes a mobile processor coupled to a display. One of the analyte microprocessor or the mobile microprocessor is configured to determine 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 a most recent analyte measurement over a period of N days, is lower than a first threshold, and display in a time frame over the N number of days, an analyte trend lower than the first threshold with a first indicia.
In yet another aspect, a chronic disease management system is provided that includes an analyte measurement unit and mobile communication unit. The analyte measurement unit includes a housing and a test strip port configured to receive an analyte test strip with a test strip port to provide data regarding an amount of an analyte from a user's physiological fluid deposited on one or more test strips, and an analyte microprocessor coupled to a memory. The memory is configured to store data representing a plurality of analyte measurements. The mobile communication unit includes a mobile processor coupled to a display. One of the analyte microprocessor or the mobile microprocessor is configured to determine 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 a most recent analyte measurement over a period of N days, is higher than the second threshold, and display in a time frame over the N number of days, an analyte trend higher than the second threshold.
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. 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. Also, the term “analyte” indicates any component (e.g., glucose, ketone, urea, cholesterol, hematocrit and so on) of any fluid extractable from a user (hereafter “physiological fluid”) including but not limited to blood, urine, saliva, or sweat.
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 analyte 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 an analyte (e.g. glucose) into an enzymatic by-product and in the process generate an amount of reduced mediator (e.g., ferrocyanide) that is proportional to the analyte 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 an analyte 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 fluid 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 test (e.g., electrochemical or electro-optical) 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. Various functionalities are provided in the system 100, which 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 application can be utilized in either the AMU 10 or the HCU 40, in part or in whole in either or both of the devices.
One 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 less 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 with an hour, only the first 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 hours expressed 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
The exemplary system also allows the log-book to be shared with 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 on the effects of glucose values trending lower over time or approved articles from health care providers. Alternatively, selection of “Help” opens a call to a pre-selected phone number or to a website. Selection of “Share” activates an overlay 709 with 3 choices: sending an email with a copy of the log-book to another user; sending a text message that includes textual description of the log-book; or canceling this feature.
Another feature that the system also provides is the ability to display analyte measurements in a graphical format. In this example, in screen 800 of
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 analyte values obtained with an analyte measurement unit is provided. The method may include the steps of: performing with the microprocessor, a plurality of analyte measurements; storing in the memory, the plurality of analyte measurements; determining whether a most recent analyte measurement is below a first threshold or above a second threshold; evaluating with the microprocessor, whether at least one analyte measurement of the plurality of analyte measurements performed within a time frame as the most recent analyte measurement over a period of N days, is lower than the first low threshold or higher than the second threshold; and annunciating 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.
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 transformed 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 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 or 120 of prior provisional application Ser. Nos. 61/415,598 (Attorney Docket No. LFS5217USPSP) filed on Nov. 19, 2010 and 61/469,046 (Attorney Docket No. LFS2222USPSP) filed on Mar. 29, 2011, which is hereby incorporated by reference into this application in its entirety.
Number | Date | Country | |
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61415598 | Nov 2010 | US | |
61469046 | Mar 2011 | US |