Patent Application
20130085682
Home monitoring of various health conditions, such as diabetes, has become very popular in recent years because it gives a patient greater control and understanding of their treatment regimen. However, along with this increase in the popularity of home diagnostic testing, there are a number of issues that have slowed the adoption of home diagnostic testing both in developing and industrialized countries. For example, in developing countries, there are too few meters available for diabetic patients to use for monitoring. As a result, multiple patients at a health clinic may share the same meter. This sharing of meters makes tracking individual patient data quite difficult. In contrast, in developed or industrialized countries, the relative cost of a meter is inexpensive, and a diabetic patient will commonly have more than one meter which can make data collection across the multiple meters quite difficult. This inability in either case to accurately track patient data makes diagnosing sources of glucose control problems quite difficult.
Thus, there is a need for improvement in this field.
To help better control diabetes, various testing regimens or structured tests have been developed in order to determine factors that affect an individual's blood glucose level. An example of one such structured test is an ACCU-CHEK® 360 View tool. While these structured tests as well as other tests have proven to be effective, a number of issues have been found that make compliance problematic. As one example, notably in developing countries in which multiple users utilize the same meter, data segregation is an issue. As noted before, diabetics in developing countries typically share one or more glucose meters, which in turn makes separating out the readings for the numerous users difficult, especially where some of the patients are participating in a structured testing regimen. On the other hand, in developed countries it is common that the meter cost is relatively inexpensive such that an individual may own multiple meters. While this can make it easier for the patient to monitor blood glucose levels because they may have a meter at home and a second at work, it makes aggregating the readings from the multiple meter for structured testing difficult. For instance, while physicians typically request that their patients bring in all of the meters they use so the physicians can collect all of the data, it was found that most often patients do not comply with this requirement due to the simple hassle factor of trying to collect all of their meters. In both of these instances, data integrity as well as ensuring all data has been properly collected such that are no “holes” in the data are always a concern.
As will be explained below, the technique and system developed by the inventor addresses these issues as well as others by utilizing a portable memory card in which the individual's data is stored and identified based on a personal identification number or key. With this system, the meter and the health care provider are able to track testing data across multiple meters as well as between various individuals. Moreover, it gives the capability of using retrospective analysis in which, while a structured test may have been intended but the specific questions or data input were not available at the time, the individual is allowed to update the data later on when it becomes available. By having the individual's data stored on a memory card or key fob, the individual is able to keep the data in their possession and also helps with patient confidentiality. Moreover, it was found that the use of the memory card/key fob made the system much simpler because, among other things, it avoided the cost and patient privacy concerns associated with meters transmitting information over cellular communication systems.
Another issue that this technique and system addresses is what is termed the “nagging” factor for structured testing. Structured testing is typically intended to be performed for a predetermined period time or short number of days, such as 3 to 7 days. However, the meter typically reminds the user to perform a certain task, such as to eat a meal, conduct a blood glucose test and collect other data. Once the testing period has ended, the meter may continue to alert the user, which can tend to be quite frustrating. These constant and repetitive alerts make compliance difficult in the long term because the individual starts to ignore the reminders. The memory card or key fob helps to eliminate this issue by only performing structured testing when the memory card is inserted and programmed to perform a structured test. Once the memory card is removed or otherwise disassociated from the meter, the meter acts in a normal manner and does not have annoying alarms or alerts that can bother a patient.
Further forms, objects, features, aspects, benefits, advantages, and embodiments of the present invention will become apparent from a detailed description and drawings provided herewith.
For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates. One embodiment of the invention is shown in great detail, although it will be apparent to those skilled in the relevant art that some features that are not relevant to the present invention may not be shown for the sake of clarity. While the examples below will be described with reference to blood glucose monitoring, it should be appreciated that various aspects of this system and technique can be incorporated to monitor other health issues.
For the convenience of the reader, it should be initially noted that a drawing in which an element is first introduced is typically indicated by the left-most digit(s) in the corresponding reference number. For example, a component identified with a one-hundred series reference number (e.g., 100, 101, 102, 103, etc.) will usually be first discussed with reference to
As mentioned before, the cost of blood glucose meters in industrialized or developed countries is relatively inexpensive such that a diabetic patient may own more than one. For example, a patient may have a meter they use at home, a meter they use at work, and another that is packed for travel.
A health care provider (HCP) computer 104 is used to not only program the portable memory card 102 but also to receive data from the portable memory card 102. An example of the health care provider computer 104 can include a personal computer, laptop, tablet, cell phone, and/or other type of computing device to name just a few examples. In the illustrated example, the individual uses the portable memory card 102 in conjunction with three meters: a first blood glucose (BG) meter 106, a second BG meter 108, and a third BG meter 110. As noted before, the user may have, for example, the first meter 106 for use at work, the second meter 108 for use at home, and the third meter 110 for use at a vacation home or for travel. The meters can include various types and/or brands of glucose meters, such as continuous glucose monitoring device and/or discrete testing type meters. In a typical testing regimen, the physician asks the individual to bring in all meters so that information may be downloaded from the individual meters, but as a practical matter, this never occurs due to the number of meters involved. With the portable memory card 102, the user is able to aggregate readings from each of the meters to provide to the health care provider. By having the portable memory card 102 in the individual's possession, such as on their key chain, the meter can be personalized for the patient. The portable memory card 102 has a personal identification number or other designation that identifies the individual to the meter, such that when inserted, the meter can be configured specifically for that user. For example, the age, weight, and units of measure (e.g., mmol/l or mg/dl) can be specified for the particular user. In addition, the portable memory card 102 has the ability to store the user's information so the data collected on the various meters 106, 108, 110 can all reside in the portable memory card 102 and data can be aggregated for use by the health care provider computer 104. In other examples, the personal identification number (or other identifier) is not necessarily patient specific, but it is instead used for authorizing specific features, tests, and/or other functionality for glucose meters.
In one particular example, the physician or other health care provider, using the health care provider computer 104, programs a specific structured test that needs to be conducted, and the structured test is downloaded onto the portable memory card 102. In another example, the meters 106, 108 can be used to program the card as well. It should be recognized that the HCP computer 104 and/or the meters 106, 108 can be used to initialize the portable memory card 102 (e.g., link the portable memory card 102 to a particular user), but only the HCP (through any conduit) should configure a tailored function. When the individual inserts the portable memory card 102 into a particular meter, such as the first meter 106, the meter identifies the user and is aware that a structured test needs to be conducted based on information stored on the memory card 102. The first meter 106 in this example then provides the appropriate alerts and collects the data using the portable memory card 102. To avoid any of the nagging factors by providing alerts when they are not needed, once the portable memory card 102 is removed from the first meter 106, the first meter 106 returns to its normal operation mode in which it simply provides blood glucose readings without any structured testing alerts. Returning to the previous example, when the user travels to work and does the blood glucose measurements using the second meter 108, the individual simply inserts the portable memory card 102 into the second meter 108 which then operates to continue the structured testing procedure. Once the portable memory card 102 is removed from the second meter 108, the second meter 108 returns to its normal operational mode in which no alerts are provided for structured testing. The individual can then loan the second meter 108 to another so that they can check their blood glucose levels without affecting the structured test. When the same individual is on a business trip, they can continue the structured test on the third meter 110, which is kept in their travel case, by inserting the portable memory card 102 into the third meter 110. Upon returning from the trip, the individual only needs to take the portable memory card with them to the health care provider's office. At the office, the physician downloads the structured testing results onto the health care provider computer 104 for analysis. With this particular ability of the portable memory card 102, structured testing can be conducted across multiple meters without any data loss. Moreover, the user is not annoyed by having the constant reminders programmed into the glucose meter when structured testing is not required.
As noted before, in developing countries individuals may need to share the same or a group of the same glucose meters or other health monitoring devices. For example, an individual health clinic may only have one glucose meter that is shared among its patients. As should be appreciated, this can create all types of issues for using a structured testing approach because the individual meter is not associated with a particular individual. As a result, structured testing can be extremely difficult due to the difficulty in tracking the various structured tests that need to be performed as well as the ability to associate data with an individual. In addition, performing structured tests is difficult when sharing meters because one individual may not require the structured test alerts that would be used for other individuals also using the meter, but the alerts would still occur on the meter regardless of who was using the meter. Previous health monitoring system designs rely on the internet to transmit patient data. However, it should be recognized that not everyone, especially the elderly, has internet access. This is especially true for those in developing countries. It should be appreciated that the health care monitoring systems described herein do not rely on the internet. This in turn promotes adoption by those without internet access.
A health care monitoring system 200 illustrated in
As one example, the health care provider may prescribe a structured test for the first user 202. The first user 202 can insert their portable memory card 102 into the first meter 106, which in turn would then configure the first meter 106 for a structured test having the alerts and other data input requirements as usually occurs for structured testing. In this example, the second user 204 may not require a structured test at this time and may still want to use the first meter 106 when it is not being used by the first user 202. When the second user 204 utilizes the first meter 106, the meter is then configured to not have the alerts normally associated with structured testing, and the second user 204 can perform normal glucose testing as would usually occur. It should be appreciated that this eliminates unnecessary alerts and issues associated with structured testing which in turn is beneficial to both the first 202 and second 204 users. Continuing with this example, if the first meter 106 is not available, the second user can use their portable memory card 102 and insert it into the second meter 108 such that they are able to continue their structured test without any data loss. Once the structured test is complete and/or the first user 202 visits the health care provider, the health care provider via the health care provider computer 104 can download the structured testing data from the portable memory card 102 of the first user 202 and perform the appropriate analysis.
The sensor port 410 allows a disposable biosensor 412 to be coupled to the meter 106. For example, when the meter 106 is a blood glucose meter, the sensor port 410 provides an electrical connection between the meter 106 and the biosensor 412. In one example, the biosensor 412 is a disposable test strip, but it is contemplated that in other variations all or part of the biosensor 412 can be integrated into the meter 106 so as to not be disposable. It should be recognized that the illustrated example is merely a simplified diagrammatic view of the meter system 400, and it is contemplated that the system 400 can include other components normally found in meters. Moreover, the communication paths illustrated by the arrows can be configured differently in other embodiments. Although components such as the processor 402 and internal memory 404 are illustrated as distinct components, it should be appreciated that one or more of the components in the meter system 400 can be integrated together to form a single unit. Likewise, the individual components can be divided into various subcomponents to form and be made of multiple units. For example, the internal memory 404 may include multiple internal memory units.
The processor 402 along with the internal memory 404 and other components of the meter system 400 are designed to perform the techniques described herein. In the following description of the flow charts, it should be recognized that the methods or techniques are performed using the processor 402, internal memory 404, I/O device 406, card port 408, and sensor port 410 as well as other components of the meter system 400. These techniques can be programmed as software, firmware, and/or hard coded in the hardware of the meter system 400.
A technique for performing a structured test using for example the aggregation-type monitoring system 100 (e.g.,
As noted before, each portable memory card 102 has a unique personal identification (PID) number that identifies the individual patient. The portable memory card 102 can also include additional information for customizing the meter 106 based on data contained within the portable memory card 102. In stage 506, based on the PID number and/or other information such as specific flags, the meter 106 can be configured and customized to fit the personal needs of the individual (e.g., units of measure). For instance, the units measured as well as alerts and alarms can be updated for a specific user. In another example, simply based on the PID number the processor 402 retrieves from internal memory 404 the specific customized configuration stored in the internal memory of the meter 106. It should be recognized that the meter 106 can be customized or programmed in other manners.
The health care provider via the health card provider computer 104 can program the portable memory card 102 for a specific structured testing regimen. For example, a physician may want the diabetic patient over a number of days to measure blood glucose levels before eating each meal and two hours after each meal as well as to record the size of the meal to determine whether a change in insulin dosage or some other change needs to occur. The health care provider computer 104 can be used to program the portable memory card 102 to indicate whether a structured testing regimen needs to occur, and if so, what type. The specific details of the structured testing regimen can reside on the portable memory card 102, can be stored within the internal memory 404 of the meter 106, can be remotely located on some other device, and/or can include some combination of these storage configurations. For example, the portable memory card 102 can include data for programming the meter 106 to perform all of the alerts and data collection requirements for a specific structured testing regimen. In another example, the portable memory card 102 may include an identification number that activates a specific structured testing regimen pre-programmed in the internal memory 404 of the meter 106. In still yet another alternative, the portable memory card 102 may include a path or universal resource locator (URL) that triggers the processor 402 to download a specific testing regimen from the internet. It should be appreciated that a combination of all of these techniques or other techniques may be used to program the meter 106 for a structured testing regimen.
In stage 508, the processor 402 of the meter 106 determines whether a structured test is warranted. For instance, based on the PID number stored on the portable memory card 102, the processor 402 can determine based on information stored in the internal memory 404 whether the individual matching the PID number is required to perform structured testing. In another example, the portable memory card 102 can contain a flag as well as other information indicating that structured testing is required. If the portable memory card 102 indicates that no structured testing is required, then the meter 106 operates in a normal fashion and collects traditional blood glucose data. On the other hand, if the meter 106 determines in stage 508 that structured testing is required, the processor 402 of the meter 106 determines whether or not the particular meter is compatible with the required structured testing regimen. Alternatively or additionally, the portable memory card 102 can make such a determination as to compatibility and alert the processor 402 of any incompatibility issues. The meter 106 may be incompatible for a particular structured test or even all structured testing for a whole host of reasons. For example, the meter 106 may not have enough precision for a specific structured test and/or may not have the proper I/O device 406 for entering data into the meter 106. In other examples, the internal memory 404 of the meter 106 may not be large enough and/or configured properly to record additional data required for the structured test. The meter 106 may also be needed to collect data but be limited in functionality for a structured test. For example, a structured test may require a graphical display to provide custom prompts (e.g., “have you been fasting for the last 8 hours?”). However, if the meter 106 only has an icon-based display, the structured test can still be performed by collecting data (e.g., blood glucose readings) at the appropriate times. When the portable memory card 102 is later placed in a device that has a graphical display, the device can prompt the user to enter the appropriate additional information. The structured test for instance may require the user to enter information about meals consumed, exercise activities, medication information, energy levels, and other possible factors for diabetic control problems which some generic, low featured meters are unable to store and/or process.
On the other hand, if the meter 106 is compatible with the structured test, the processor 402 of the meter 106 creates any required alerts for the structured test in stage 512 and, if needed, programs or structures the internal memory 404 so as to be able to store the additional data. For example, if the I/O device 406 includes a speaker, the meter 106 can be programmed to generate an alarm for the user to perform a particular test, and a portion of the internal memory 404 can be assigned to store the additional data. In a similar fashion, when the I/O device 406 includes a display, the display may also alert the user to perform a test and/or provide additional instructions about the test. Returning to the previous example in which the testing occurs in a window around each meal, the I/O device 406 in stage 512 instructs the user to take a blood glucose reading before the meal as well as characterize the size and type of meal. Alternatively or additionally, the alert in stage 512 may also inform the user that the meter 106 is compatible with the prescribed structured test.
In stage 514, the user enters into the meter 106 one or more pieces of data related to the structured test, and the meter 106 receives this data input that is used to provide context to the blood glucose readings. As should be appreciated, structured testing analysis is not based purely on blood glucose levels; rather, other contextual data is collected along side the blood glucose readings such that the contextual data is able to identify one or more sources for the blood glucose control problem. This contextual data can for example include information about exercise habits, mental state, sleep habits, diet (e.g., meal size, nutritional content, carbohydrates, calories, time of day, etc.), general activity levels, medication (e.g., insulin dosages) as well as other information that may directly or indirectly affect glucose control. By identifying a potential source for the problem through the structured test, the physician or other health care provider can prescribe a treatment therapy to combat the identified glucose control problem. It should be recognized that different treatment therapies might be required depending on the relationships between the contextual data. As a case in point, a diabetic with a fasting blood glucose that is too high and a post lunch blood glucose level that is too low may require a different treatment therapy from a diabetic who has a fasting blood glucose that is too high as well as a post lunch blood glucose level that is too high. It should be recognized that this structured testing data in stage 514 can be collected at other times than is shown in
In stage 516, the meter 106 can collect the blood glucose data related to the structured test, or alternatively if no structured test is required, simply collect the traditional blood glucose readings. As should be appreciated, the blood glucose data can be collected by the user applying a blood sample to the test strip 412 which is in turn drawn and analyzed electrochemically, photometrically, and/or in other manners as would occur to those skilled in the art. It should also be recognized that blood glucose readings can be collected at other times than is shown in
As is shown by the flow chart 500 in
As discussed before, the portable memory card 102 also addresses the “nagging” factor in which the meter 106 alerts the user to perform specific acts of a structured test after the test has been completed (or is not required). Generally speaking, the memory card 102 acts like a key such that the structured test alerts only occur within the specific window for a particular user needing to perform a structured test. When the portable memory card 102 is not present in stage 504, the processor 402 of the meter 106 in stage 520 determines based on information from the previously inserted key whether the prior user was in the midst of a structured test. If not, the meter 106 operates in a normal fashion without any alerts for performing a structured test. That is, the meter 106 proceeds to stage 516 in
Another feature of this technique is the ability to infer when structured testing needs to be performed even if the portable memory card 102 is not in communication with or otherwise secured to the meter 106. When the processor 402 of the meter 106 determines that no portable memory card 102 is attached to the card port 408 and the current time is still within the window of the structured test, the processor 402 assumes that the previous structured test was interrupted and should still be occurring. For example, a user is instructed to perform a three day structured test and only one day of data collection has occurred before removal of the portable memory card 102, the processor 402 can, if desired, infer that the structured test should still be occurring. To ensure the same individual is using the meter 106, the meter 106 for instance may request via the I/O device 406 the user to identify themselves. Based on information stored in the internal memory 404, the processor 402 in stage 520 determines whether the particular individual is required to still perform a structured test based on information downloaded from the portable memory card 102 when previously inserted in the meter 106. For example, when the internal memory 404 has a flag indicating structured testing is still required, the processor 402 of the meter 106 in stage 522 operates as if the structured testing is required and performs a typical structured test. The structured testing flag in internal memory 404 can have an expiration time such that after the expiration period, the flag is changed to indicate that structured testing is no longer required. Alternatively or additionally, the meter 106 via the I/O device 406 may request that the user confirm that a structured test is required. If the information contained in the internal memory 404 and/or elsewhere indicates that a structured test should not be inferred, the meter 106 performs normal blood glucose data collection in stage 516.
As noted above, the meter 106 in stage 510 determines whether the meter 106 is capable of performing a structured test. For example, the I/O device 406 may not have the capability for entering and/or displaying the information required for the particular structured test. If the meter hardware and/or software is not compatible with the particular structured test for the user or structured testing in general, the processor 402 of the meter 106 then determines in stage 524 whether the hardware and/or software is capable of providing and/or collecting at least some of the information required for structured testing. In an alternative embodiment, the determination in stage 524 can be performed by the portable memory card 102 and/or some other external device. If the meter 106 is incapable of even partially performing the structured test, such as for example the meter 106 does not have the required precision, the meter 106 then alerts the user in stage 526 that the meter 106 is incapable of performing any structured testing via the I/O device 406. The meter 106 proceeds to stage 516 so as to collect blood glucose readings in its normal operational mode. On the other hand, if the meter 106 is capable of performing at least some of the functions required of structured testing, the processor 402 of the meter 106 flags the data and proceeds with the blood glucose measurement collection without the full capabilities in stage 528. In stage 528, the meter 106 can also alert the user that the meter is only able to partially perform the structured test. If appropriate, the meter 106 in stage 528 also can instruct the user to record the required structured testing data in a paper logbook (or in some other manner). To illustrate this point, the meter 106 can for example instruct the user via the I/O device 406 to record meal size, type, and time information along with insulin dosages and blood glucose readings in a patient logbook when the meter 106 is not able to record the information. This technique allows at least part of the structured testing procedure to be performed. If needed, some retrospective input of data required for structured testing may occur using the technique such as will be described with reference to
When there is an indication in stage 604 that a structured test was attempted and/or the information required to at least partially fill in the structured testing data is available on the portable memory card 102, the computer obtains other information to complete the structured test in stage 606. For instance, the computer can display and request answers to a series of questions relating to the structured test, such as what meals they ate during the test, activities/exercises performed, medication dosages, blood glucose readings, and the like. The information entered in stage 606 can be based on the user's memory or on information contemporaneously record at the time, such as in the logbook that was discussed previously. When the information is entered based on memory alone, the computer can be configured to ask variations of the same question or take other precautions to ensure that the user's memory is accurate about events that took place during the structured test. With the now complete data set for structured testing, the data in stage 608 can be downloaded either to the portable memory card 102 and/or directly into the health care provider computer 104. It should be recognized that the data can be downloaded to other systems as well. In stage 610, any data is analyzed using normal structured testing analysis. Utilizing this retrospective structured testing technique helps improve compliance which in turn helps to avoid frustration of the user because data that was normally collected by a structured test is not lost.
As should be appreciated, the techniques described above allow the meter system 400 to perform structured testing in both segregation-type and aggregation-type collection environments. By having the data collected on the portable memory card 102, information from multiple meters is able to be aggregated, such as in an aggregation example illustrated in
It should be recognized that numerous other variations to the systems and methods described above are possible. Depending on the desired functionality, various stages of the above-described techniques can be eliminated, duplicated, and/or reordered, depending on the requirements. For example, the data input occurring in stages 514 and 516 can occur in a different order than is shown in
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes, equivalents, and modifications that come within the spirit of the inventions defined by following claims are desired to be protected. All publications, patents, and patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.
