WO2009076245A2

WO2009076245A2 - Method and system for automatic time adjustment for an analyte-testing device

Info

Publication number: WO2009076245A2
Application number: PCT/US2008/085770
Authority: WO
Inventors: Jun Chen; Qiang Fu; Harris Lieber; Mitchel Stein
Original assignee: Bayer Healthcare Llc
Priority date: 2007-12-10
Filing date: 2008-12-06
Publication date: 2009-06-18
Also published as: WO2009076245A3

Abstract

A system and method for monitoring an analyte concentration of a fluid or tissue sample comprises the act of detecting a connection between a analyte-testing device and a processing device. The system and method further include synchronizing time information from the processing device to the analyte-testing device.

Description

METHOD AND SYSTEM FOR AUTOMATIC TIME ADJUSTMENT FOR AN ANALYTE-TESTING DEVICE

FIELD OF THE INVENTION

[001] The present invention generally relates to a method and system for automatic time adjustment for an analyte-testing device. More particularly, the method and system of the embodiments of the present invention may be used for adjusting the time on an analyte- testing device to account for travel among different time zones, the beginning and end of Daylight Savings Time, and the like.

BACKGROUND OF THE INVENTION

[002] The quantitative determination of analytes in body fluids is of great importance in the diagnoses and maintenance of certain physiological conditions. For example, lactate, cholesterol, and bilirubin should be monitored in certain individuals. In particular, it is important that individuals who have diabetes frequently check the glucose level in their body fluids to regulate the glucose intake in their diets. While the remainder of the disclosure herein will be directed toward use in glucose meters, it is to be understood that the embodiments described herein may be implemented in meters used for gathering information related to other analytes.

[003] In one type of blood-glucose testing system, test sensors are used to test a blood sample. The results of such tests can be used to determine what, if any, insulin or other medication needs to be administered. If the results of the test show that the glucose level is too low or too high, the user may need to ingest diabetes pills or insulin doses or use an insulin pump.

[004] Some existing glucose meters allow users to store past glucose readings and other information associated with the reading, including, for example, the date and time. Often, it is important for the user to store these readings for future reference. Physicians may review this stored information to assist in diagnosing and monitoring the health of their patients.

[005] Some existing meters also allow users to store event information that may be relevant to glucose measurements. Such events may include meals, exercise, illness, stress, symptoms, tracking ketones in urine, or other events that may alter blood-glucose levels. Typically, a user may enter the type of event that occurred and a time at which that event occurred into the blood-glucose meter. Other information about the event may also be input into the meter. This information may be used for studying patterns of patient daily glucose levels and how daily glucose levels are affected by daily activities. Additionally, glucose measurements may be better understood in view of recent events stored in the meter. For example, if a particular glucose measurement is abnormal (i.e., too high or too low), a user may review the event history to determine the amount of time that passed since the user had eaten, exercised, taken a medication, or the like.

[006] Often, the variations in glucose measurements may be accounted for by the occurrence (or lack of occurrence) of one or more events. For example, a user's blood- glucose level is expected to be higher shortly after ingesting a meal than just prior to ingesting a meal. Thus, when a user eats a meal, he or she may input the time of the meal into the meter. The user may also input other information including, but not limited to, the type of meal, the calorie content, or the like. If a user tests his or her glucose level shortly after the meal, the glucose measurement will likely be elevated by the ingestion of the recent meal. Likewise, if the user tests his or her glucose level several hours after ingesting a meal, the glucose measurement will likely be somewhat low due to the user not ingesting any sugar for an extended period of time. Likewise, a user's blood-glucose level is likely to be lower shortly after exercising.

[007] Existing glucose meters that include event markers present difficulties for users experiencing a time change. Specifically, existing meters are generally set to a time zone associated with a user's residence and do not adjust for, for example, cross-time zone travel or the beginning or end of Daylight Savings Time, which may cause inconsistencies and confusion. For example, if a user in New York enters a meal time in Eastern Standard Time (e.g., at 7:00 AM (EST)), then travels to California, tests his or her blood-glucose level, and enters a time of the glucose testing in Pacific Standard Time (e.g., at 11 :00 AM (PST)), the stored data will incorrectly reflect that only four hours - not the actual seven hours - had past since mealtime. Thus, the timestamps associated with the stored events and glucose measurements would be inaccurate. Inaccurate testing information may result in dangerous analyte levels (e.g., hyperglycemic or hypoglycemic conditions) being undetected or falsely detected, which may be dangerous for a user and may have serious health-related consequences.

[008] Erroneous timestamps generated by existing meters also have other disadvantages. For example, erroneous timestamps may cause confusion when a user downloads glucose testing information from multiple meters into a single database.

Additionally, information is often uploaded to a personal computer or web server that does not synchronize its local time with the meter, thereby causing confusion and/or erroneous timestamps.

[009] Therefore, it would be desirable to overcome such disadvantages in existing glucose meters.

SUMMARY OF THE INVENTION

[010] According to one process of the present invention, a method of monitoring an analyte concentration of a fluid or tissue sample comprises the act of detecting a connection between a analyte-testing device and a processing device. The method further comprises synchronizing time information from the processing device to the analyte- testing device.

[011] According to one embodiment of the present invention, a system for processing time information related to an analyte in a fluid or tissue sample comprises a processing device having time zone information associated therewith. The system further comprises an analyte-testing device configured to receive the time zone information from the processing device upon connection between the processing device and the analyte- testing device..

[012] The above summary of the present invention is not intended to represent each embodiment, or every aspect, of the present invention. Additional features and benefits of the present invention are apparent from the detailed description and figures set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

[013] FIG. Ia is a test sensor including a lid according to one embodiment. [014] FIG. Ib is the test sensor of FIG. Ia without the lid. [015] FIG. 2 is a front view of a meter according to one embodiment. [016] FIG. 3 shows the meter of FIG. 2 including a data port.

[017] While the invention is susceptible to various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and are described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the invention. DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[018] The present invention is directed to a method and system for automatic time zone adjustment for an analyte-testing device. The device may be used with electrochemical test sensors or other types of test sensors that are used to determine a concentration of at least one analyte in a fluid or tissue sample. The device may also be used with sensors that may be implanted subcutaneous Iy into a patient. The device of the embodiments described herein may also be used with continuous analyte monitoring systems and/or insulin delivery devices.

[019] Analytes that may be determined using the analyte-testing device include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL, and HDL), microalbumin, hemoglobin AiC, fructose, lactate, or bilirubin. The present invention is not limited, however, to devices for determining these specific analytes, and it is contemplated that other analyte concentrations may be determined. The analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, other body fluids like ISF (interstitial fluid) and urine, or a tissue sample.

[020] According to one embodiment, the test sensors to be used in the devices are typically provided with a capillary channel that extends from the front or testing end of the sensors to biosensing or reagent material disposed in the sensor. When the testing end of the sensor is placed into fluid (e.g., blood that is accumulated on a person's finger after the finger has been pricked), a portion of the fluid is drawn into the capillary channel by capillary action. The fluid then chemically reacts with the reagent material in the sensor so that an electrical signal indicative of the analyte (e.g., glucose) level in the fluid being tested is supplied and subsequently transmitted to an electrical assembly.

[021] Various reagent materials may be used to assist in determining glucose concentrations. Some examples of suitable reagent materials include glucose oxidase or glucose dehydrogenase. It is further contemplated that other reagent material may be used to assist in determining glucose such as, for example, reagents including enzymes such as pyrrolo-quinoline quinone glucose dehydrogenase and potassium ferricyanide. The selected reagent may influence items such as the amount of fluid needed and the length of time needed to perform the testing to determine the analyte concentration. If an analyte other than glucose is being tested, different reagent material will likely be used.

[022] One non-limiting example of a test sensor is shown in FIGs. Ia, Ib. FIGs. Ia, Ib depict a test sensor 70 that includes a capillary channel 72, a lid 74, and electrodes 76 and 80. The electrodes include a counter electrode 76 and a working electrode 80. As shown in

FIG. Ib, the test sensor 70 includes a fluid-receiving area 82 that contains reagent. The operation of a fluid-receiving area with reagent and the electrodes on the test sensors is known to those skilled in the art and will therefore not be described in further detail. Examples of electrochemical test sensors, including their operation, may be found at, for example, U.S. Patent No. 6,531,040 assigned to Bayer Corporation. It is contemplated that other electrochemical test sensors may also be employed.

[023] The test sensors that may be used with the meters of the embodiments of the present invention are not limited to electrochemical test sensors. For example, it is contemplated that optical test sensors may be used in the present invention.

[024] Referring to FIG. 2, a glucose meter 100 is shown according to one embodiment. As shown in FIG. 2, the meter 100 includes a display 102, a test sensor dispensing port 104, and a plurality of buttons 106a, 106b.

[025] After a user places a fluid (e.g., blood) on a test sensor, the test sensor contacts the meter, and the glucose level is determined by the meter 100, which displays the glucose reading on the display 102. The user may then press buttons 106a, 106b or the like to, for example, locate and/or scroll through a menu listing possible event markers for indicating events such as meals, exercise, illness, stress, symptoms, tracking ketones in urine, or other events. The user may also press buttons 106a, 106b to assign a time associated with when the event occurred or will occur. In other embodiments, the time that the event was entered into the meter may be used as the default time associated with the event.

[026] It is contemplated that the event(s) and/or time(s) associated therewith may be input into the meter using mechanisms other than the previously described buttons 106a, 106b. Such other mechanisms include, but are not limited to, a touch screen, a single button, a dial, a scrolling mechanism, a toggle switch, preset event times in the meter, auto mark, wireless commands via a wireless-enabled device such as a cell phone, personal digital assistant, combinations thereof, or the like.

[027] According to the embodiments of the present invention, analyte-testing meters are configured to adjust for certain time changes such as travel through various time zones and/or the beginning and end of Daylight Savings Time. The meters described herein detect a connection between the analyte-testing device and a processing device, and time information associated with the processing device is then synchronized to the analyte-testing device.

[028] In one embodiment of the present invention, a meter includes a Global Positioning System (GPS) receiver. The GPS receiver receives signals from one or more GPS satellites. The signals transmit location and/or time information to the meter. The transmitted information may be used to synchronize the time of the meter to local time. The synchronization may include changing the time displayed on and stored in the meter, marking stored information (e.g., events and glucose measurements) with the local time of the appropriate time zone, or the like. In embodiments where location information is transmitted, the meters include software for determining the time zone of the transmitted location, thereby deriving and synchronizing with the local time. In another embodiment, a meter marks the information with the appropriate time zone such that the time differences among the various time zones may be accounted for when a user reviews his or her testing information. Thus, accurate locations and/or timestamps may be associated with glucose measurements and/or event information input into the meter.

[029] The GPS receiver may be positioned within the meter or may be detachable with the meter. The GPS receiver may be programmed to turn on and receive signals once a day, once an hour, every 30 seconds, upon user input (e.g., pressing a button to alert the meter that the user has traveled to another time zone), or the like. In other embodiments, the time on a meter may be automatically adjusted in a similar manner using signals from other satellites, cellular phone towers, radio clock, atomic clock, or the like.

[030] In the embodiment of FIG. 2, a meter 300 may include a data port 309, which may be connected to a host 310 via an interface element (e.g., Universal Serial Bus (USB) connector, cord, or cable) 311. Although in the illustrated embodiment, the host is a personal computer, the host may be selected from a variety of processing devices such as desktop or laptop computers (PCs), handheld or pocket personal computers (HPCs), compatible personal digital assistants (PDAs), and smart cellular phones. The data port 309 allows the meter 300 to communicate with the host 310 so that the meter 300 automatically synchronizes to the local time associated with the host 310. The time information synchronization may be automatically launched when the host 310 detects the meter 300. As described above, the synchronization may include changing the time displayed on the meter, marking stored information with the appropriate time zone, or the like. The time information of the meter

300 may also be updated via an Internet connection available through the host 310.

[031] In other embodiments, a physical connection between the meter 300 and the host 310 is not required. Instead, the meter 300 and the host 310 may communicate via a radio-frequency (RF) link (e.g., a short-range RF telemetry), such as Bluetooth® or a lower- power version such as Wibra, wireless technologies, Zigbee, Z-Sense™ technology, FitSense, BodyLAN™ system, or other RF technologies. It is also contemplated that other wireless technologies, such as Wi-Fi or infrared (IR) links, may be used.

[032] According to one embodiment, a meter is based on the IEEE 802.11 standards such that the meter is Wi-Fi enabled. Using Wi-Fi technology, the date and time of the meter may be automatically synchronized using less meter power. The date and time information may be synchronized worldwide. According to this embodiment, when a user, for example, travels across time zones, the meter may wirelessly connect to the Internet via a hotspot when the meter is within range of a wireless network connected to the Internet. The meter may then be assigned an IP address associated with the hotspot. The IP address includes information associated with the location and, thus, the date and time information may be determined.

[033] The meter may perform data sensing or acquisition that may be stored in a network database. The data or information may be processed either in a distributed or centralized manner and may be communicated to other parts of the network. Thus, a "smart environment" may be created, which may considerably enhance the ability to efficiently manage glycemia of patients.

[034] In another embodiment, when the user downloads the stored glucose testing information onto, for example, his or her personal computer, the time information received from a processing device (e.g., GPS satellite, other satellite, cellular phone tower, PC, HPC, PDA) is automatically converted into a corresponding time in a single time zone (e.g., the time zone of the user's residence). Thus, when a user compares the time of glucose measurement to a time of a preceding event(s), the user may easily see how a glucose measurement may have been affected by a particular event or by the time of the event relative to the time of the glucose testing. [035] By accounting for time changes such as cross-time zone travel and Daylight

Savings Time, the meters of the present invention assist in eliminating confusion and inaccurate glucose testing information that may be associated with such time changes.

ALTERNATIVE PROCESS A

[036] A method of monitoring an analyte concentration of a fluid or tissue sample, the method comprising the acts of: detecting a connection between a analyte-testing device and a processing device; and synchronizing time information from the processing device to the analyte-testing device.

ALTERNATIVE PROCESS B

[037] The method of Alternative Process A, wherein the processing device is a Global Positioning System satellite.

ALTERNATIVE PROCESS C

[038] The method of Alternative Process B, wherein the time information is a location, the method further comprising determining a time zone associated with the location.

ALTERNATIVE PROCESS D

[039] The method of Alternative Process A, wherein the processing device is a computer.

ALTERNATIVE PROCESS E

[040] The method of Alternative Process D, further comprising the act of connecting the analyte-testing device to the computer using a cable.

ALTERNATIVE PROCESS F

[041] The method of Alternative Process D, wherein the connection is a wireless connection.

ALTERNATIVE PROCESS G

[042] The method of Alternative Process A, wherein the processing device is a cellular phone tower.

ALTERNATIVE PROCESS H

[043] The method of Alternative Process A, where in the time information is associated with Daylight Savings Time.

ALTERNATIVE EMBODIMENT I [044] A system for processing time information related to an analyte in a fluid or tissue sample, the system comprising: a processing device having time zone information associated therewith; and an analyte-testing device configured to receive the time zone information from the processing device upon connection between the processing device and the analyte-testing device.

ALTERNATIVE EMBODIMENT J

[045] The system of Alternative Embodiment I, wherein the processing device is a Global Positioning System satellite.

ALTERNATIVE EMBODIMENT K

[046] The system of Alternative Embodiment J, wherein the time zone information is a location having a time zone associated with the location.

ALTERNATIVE EMBODIMENT L

[047] The system of Alternative Embodiment I, wherein the processing device is a computer.

ALTERNATIVE EMBODIMENT M

[048] The system of Alternative Embodiment I, wherein the analyte-testing device is further configured to store event information and at least one time associated with the event information.

ALTERNATIVE EMBODIMENT N

[049] The system of Alternative Embodiment I, wherein the time information is associated with Daylight Savings Time.

ALTERNATIVE EMBODIMENT O

[050] A method of monitoring an analyte concentration of a fluid or tissue sample, the method comprising the acts of: detecting a connection between a analyte-testing device and a wireless network; and synchronizing time information from the processing device to the analyte-testing device.

ALTERNATIVE PROCESS O

[051] The method of Alternative Process P, wherein the network is Wi-Fi. [052] While the invention is susceptible to various modifications and alternative forms, specific embodiments and methods thereof have been shown by way of example in the drawings and are described in detail herein. It should be understood, however, that it is not intended to limit the invention to the particular forms or methods disclosed, but, to the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Claims

WHAT IS CLAIMED IS:

1. A method of monitoring an analyte concentration of a fluid or tissue sample, the method comprising the acts of: detecting a connection between a analyte-testing device and a processing device; and synchronizing time information from the processing device to the analyte-testing device.

2. The method of claim 1, wherein the processing device is a Global Positioning System satellite.

3. The method of claim 2, wherein the time information is a location, the method further comprising determining a time zone associated with the location.

4. The method of claim 1, wherein the processing device is a computer.

5. The method of claim 4, further comprising the act of connecting the analyte- testing device to the computer using a cable.

6. The method of claim 4, wherein the connection is a wireless connection.

7. The method of claim 1, wherein the processing device is a cellular phone tower.

8. The method of claim 1 , where in the time information is associated with Daylight Savings Time.

9. A system for processing time information related to an analyte in a fluid or tissue sample, the system comprising: a processing device having time zone information associated therewith; and an analyte-testing device configured to receive the time zone information from the processing device upon connection between the processing device and the analyte-testing device.

10. The system of claim 9, wherein the processing device is a Global Positioning System satellite.

11. The system of claim 10, wherein the time zone information is a location having a time zone associated therewith.

12. The system of claim 9, wherein the processing device is a computer.

13. The system of claim 9, wherein the analyte-testing device is further configured to store event information and at least one time associated with the event information.

14. The system of claim 9, wherein the time information is associated with

Daylight Savings Time.

15. A method of monitoring an analyte concentration of a fluid or tissue sample, the method comprising the acts of: detecting a connection between an analyte-testing device and a wireless network; and synchronizing time information from the processing device to the analyte-testing device.

16. The method of claim 15 wherein the network is Wi-Fi.