This disclosure relates to handheld in vitro blood glucose meters that store and display blood glucose measurements and related data.
Diabetes mellitus, often referred to as diabetes, is a chronic condition in which a person has elevated blood glucose levels that result from the body's inability to produce insulin, use insulin, or both. There are three main types of diabetes. Type 1 diabetes usually strikes children and young adults and is linked to conditions such as autoimmune, genetic, environmental, or a combination. Type 2 diabetes accounts for 90-95% of diabetes cases and is linked to obesity and physical inactivity. Gestational diabetes is a form of glucose intolerance diagnosed during pregnancy that usually resolves soon after delivery.
In 2013, some 382 million people worldwide are estimated to have diabetes, and an estimated 5.1 million people between the ages of 20 and 79 die from diabetes annually, according to the International Diabetes Foundation Diabetes Atlas. In the United States, nearly 24 million Americans have diabetes with an estimated 25 percent of seniors age 60 and older being affected, according to The Centers for Disease Control and Prevention. Diabetes costs are estimated to be $174 billion in the United States alone every year, according to the National Diabetes Information Clearinghouse. Without treatment, diabetes can lead to severe complications such as heart disease, stroke, blindness, kidney failure, amputations, and death related to pneumonia and flu.
Handheld blood glucose meters are used by persons with diabetes in a self-monitoring environment, such as at home and work, to periodically measure their blood glucose to obtain diagnostic information for therapy decisions. Blood glucose measurements are typically associated with a date and time but limited other information. For persons who test frequently, it is easy to get lost in the data because it can be difficult to select and view this data in a meaningful way. An example of a self-monitoring blood glucose meter is described in Roche, Accu-Chek® Nano Owner's Booklet for Self-Testing Only (2013). Other manufacturers of self-testing blood glucose meters include LifeScan, Inc. and Abbott Diabetes Care.
Some blood glucose meters provide pattern recognition that typically notify a user immediately when a current blood glucose measurement matches a pattern such as higher than the target range or lower than the target range and whether a collection of blood glucose measurement are trending toward higher than target range or trending toward lower than target range. Typically, blood glucose meter pattern recognition, once enabled, operates in the background on the meter without the need for user interaction other than to perhaps acknowledge when a pattern was recognized. An example of a handheld blood glucose meter with pattern recognition is described in the Life Scan, Inc., OneTouch Verio IQ Blood Glucose Monitoring System, Owner's Booklet (2011), and U.S. Patent Pub. No. 2013/0318439, Analyte Testing Method and System with High and Low Analyte Trends Notification, published Nov. 28, 2013, assigned to Life Scan, Inc.
There is a need for a handheld blood glucose meter that selectively filters blood glucose measurements for interpretation by the user for improved health care decisions.
A handheld blood glucose meter with contextual data filtering has a display and is operated by a user to obtain blood glucose measurements. The meter associates a date and time with each blood glucose measurement. The meter displays a plurality of event indicators on the meter display, and each of the event indicators are associated with a set of sub-event indicators, which are also known as contextual data. The user selects an event indicator from the plurality of event indicators, and the meter associates the blood glucose measurement with an event that corresponds to the event indicator. The meter displays a plurality of sub-event indicators associated with the selected event indicator. The user selects a sub-event indicator from the plurality of sub-event indicators, and the meter associates the blood glucose measurement with a sub-event that corresponds to the sub-event indicator. The user repeats the preceding steps to obtain a plurality of blood glucose measurements with associated events and sub-events.
To perform contextual filtering of the plurality of blood glucose measurements with associated events and sub-events, the user first selects data filtering on the meter display. Next, the user selects a predetermined range of blood glucose measurements, e.g. low blood glucose measurement or high blood glucose measurements. The user then selects an event indicator on the meter display and selects a sub-event indicator on the meter display that is associated with the event indicator. The meter displays a plurality of blood glucose measurements within the predetermined range that have both event indicator and sub-event indicator to aid the user in making healthcare decisions.
In other embodiments, the meter can have a plurality of blood glucose measurements stored that have an associated date and time along with an associated event and sub-event. The meter can then perform contextual filtering of blood glucose measurements without the need to obtain new blood glucose measurements as described above. In yet another embodiment, the meter can have a plurality of blood glucose measurements stored that have an associated date and time along with an associated event and sub-event. The meter transmits these blood glucose measurements to a computing device, such as a mobile phone, that performs contextual filtering of blood glucose measurements as described above.
The computing device 18 generally has components that correspond to the handheld blood glucose meter 12 however without a strip port 28 and the capability to perform blood glucose measurements 56 (
Blood glucose measurements 56 are stored in memory 50 such as a circular buffer that can hold blood glucose records indefinitely provided there is storage space before beginning to write over the oldest blood glucose measurements 56 that exceed the storage limit. For example, storage space hold a maximum of 500 blood glucose measurements 56 before beginning to write over the oldest blood glucose measurements 56. Blood glucose measurements 56 include a sequence number, date and time, and can also include additional contextual information such as related to a target range 68, events 62 and sub-events 64. If the target range function is enabled, the blood glucose measurements 56 can also include a bit fill or flag representing whether the blood glucose measurement 56 was within the target range, higher than the target range, lower than the target range, hyperglycemic, or hypoglycemic. The blood glucose measurement 56 contextual information for an event 62 or sub-event 64 can also be represented with a bit fill or flag.
Creating Blood Glucose Measurement with Contextual Data
The user 10 obtains a blood glucose measurement 56 with a blood glucose meter 12 having a meter display 24. The user 10 inserts a test strip 15 in the strip port 28 of the blood glucose meter 12, lances typically a finger, and places a small drop of blood on the test strip 30. The test strip 30 reacts chemically with the blood, and the measurement module 46 performs an electro-chemical or photometric analysis of the strip 15 to determine the blood glucose measurement 56. The blood glucose measurement 56 is generated by the measurement module 46 and the date and time along with the sequence number are added.
After performing the blood glucose measurement 56, the meter processor 48 reads the blood glucose measurement from the measurement module 46, writes the blood glucose measurement 56 to memory 50 and writes a glucose measurement for display 13 to the meter display 24 that includes a comments field. The user operates the up-scroll button 32 or down-scroll button 34 to highlight the comment field. The user then operates the selection button 36 to request the meter processor 48 to read from memory 50 a plurality of event indicators 58 that are then written to the meter display 24. Each of the event indicators 58 is associated with set of sub-event indicators 60 in memory 50 that are not yet displayed. The event indicator 58 appears on the meter display and represents events 62 that are relevant for better understanding of conditions when blood glucose was measured. Examples of event indicators 58 are before meal, after meal, fasting, bedtime, felt hypoglycemic, exercise, alcohol, and the like. The user 10 operates the up-scroll button 32 or down-scroll button 34 to highlight the desired event indicator 58. The user 10 then operates the selection button 36 to request the meter processor 48 write the event 62 to memory 50 that is associated with the event indicator 58. The meter processor 48 associates the blood glucose measurement 56 with an event 62 that corresponds to the event indicator 58, and stores the event 62 and the event's association with the blood glucose measurement 56 in the meter's memory 50.
The meter processor 48 then reads from memory 50 and writes to the meter display 24 a plurality of sub-event indicators 60 associated with the selected event indicator 60 that provide further relevant information for a better understanding of the conditions or context of the blood glucose measurement 56. The user 10 operates the up-scroll button 32 or down-scroll button 34 to highlight the desired sub-event indicator 60. The previously selected event indicators 58 of before meal and after meal each have the associated sub-event indicator 60 selected from one of breakfast, lunch, dinner, and snack. The selected event indicator 58 of exercise has the associated sub-event indicators 60 selected from one of walking, running, cycling, and swimming. The user 10 then operates the selection button 36 to request the meter processor 48 to write the sub-event 64 to memory 50 that is associated with the sub-event indicator 60. The processor 48 associates the blood glucose measurement 56 with a sub-event 64 that corresponds to the sub-event indicator 60, and stores the sub-event 64 association with the blood glucose measurement 56 in the meter's memory 50. Table 1 below summarizes the previously described events 62 and associated with sub-events 64 provides additional events 62 and sub-events 64 along with their association.
The user 10 repeats the steps of obtaining a blood glucose measurement 96, displaying a plurality of event indicators 98, selecting an event indicator 100, associating the blood glucose measurement 56 with an event 102, displaying a plurality of sub-event indicators 104, selecting a sub-event indicator 106, and associating the blood glucose measurement 56 with a sub-event 108. By repeating these steps 110, the user creates a plurality of blood glucose measurements 110 with associated events 62 and 64 sub-events.
Filtering Blood Glucose Measurements with Contextual Data
The user 10 begins the process of filtering blood glucose measurements 56 from the meter 12 main menu by highlighting and selecting My Data that displays data filtering 112 with a display indicator such as “Low/High Data.” The meter 12 then displays predetermined ranges 116 of blood glucose measurements 56 such as high data, low data, hypoglycemic and hyperglycemic. In one embodiment, the predetermined range 116 is selected from one of a low data range that is below a target range and a high data range that is above a target range. The low data range selected from within a first range from about 50 mg/dL to about 100 mg/dL, and the high data range selected from within a second range from about 101 mg/dl to about 200 mg/dl. Table 2 below summarizes the previously described predetermined range for blood glucose measurements 56 and provides additional predetermined ranges.
The user 10 operates the up-scroll button 32 or down-scroll button 34 to highlight the desired predetermined range of blood glucose measurements 56. The user then operates the selection button 36 to request the meter processor 48 to write the highlighted predetermined range to memory 50 for operation by the processor 48.
The meter processor 48 then writes to the display 24 event indicators 58 available for selection. The user 10 operates the up-scroll button 32 or down-scroll button 34 to highlight the desired event indicator 58. The user then operates the selection button 36 to request the meter processor 48 to write the event 62 associated with the event indicator 58 to memory 50 for operation by the processor 48. The meter processor 48 then writes to the display 24 sub-event indicators 60 available for selection. The user 10 operates the up-scroll button 32 or down-scroll button 34 to highlight the desired sub-event indicator 60. The user 10 then operates the selection button 36 to request the meter processor 48 to write the sub-event 64 associated with the sub-event indicator 60 to memory 50 for operation by the processor 48.
The meter 12 displays a plurality of blood glucose measurements 118 within the predetermined range that have both the selected event 62 and the selected sub-event 64 in a tabular format. This plurality of blood glucose measurements 118 with contextual data is not typically stored in memory to ensure that the measurements 118 are current. In addition to the event 62, sub-event 64, and predetermined range 116, the meter 12 can be configured to show blood glucose measurements over a time period such as 90 days. The plurality of blood glucose measurements 56 displayed would typically be ordered with the most recent blood glucose measurement 56 meeting the selection criteria displayed first, and the user would scroll through the older blood glucose measurements 56.
In another embodiment, the blood glucose meter 12 does not need to create a plurality of blood glucose measurements 110 with associated events 62 and sub-events 64 because they are already stored in meter memory 50. In this embodiment, the user 10 would begin the process of filtering blood glucose measurements 56 from the meter main menu by highlighting and selecting My Data and follow the process discussed above.
Thus, embodiments of the handheld blood glucose meter with contextual data filtering are disclosed. One skilled in the art will appreciate that the teachings can be practiced with embodiments other than those disclosed. The disclosed embodiments are presented for purposes of illustration and not limitation, and the invention is only limited by the claims that follow.