WO2007030457A1

WO2007030457A1 - Test meter having time and date correction and method for correcting the same

Info

Publication number: WO2007030457A1
Application number: PCT/US2006/034571
Authority: WO
Inventors: Brian C. Thompson
Original assignee: Bayer Healthcare LLC
Current assignee: Bayer Healthcare LLC
Priority date: 2005-09-07
Filing date: 2006-09-06
Publication date: 2007-03-15
Anticipated expiration: 2008-03-07
Also published as: TW200718393A; AR058034A1

Abstract

A meter with a time and date adjustment log adapted to determine an analyte concentration reading and a method of using the same is provided. The meter comprises a display, at least one user input mechanism, a memory device, and a time and date buffer log. The display is adapted to display information to a user of the meter. The display includes information regarding an analyte concentration reading and a time and date indicator. The user input mechanism allows the user to operate the meter. The memory device stores the analyte concentration reading and a time and date associated with the concentration reading. The time and date buffer log operatively connects to the memory device. The time and date buffer log stores information regarding adjustments made to a time and date setting of the meter.

Description

TEST METER HAVING TIME AND DATE CORRECTION AND METHOD FOR CORRECTING THE SAME

FIELD OF THE INVENTION

[0001] The present invention relates generally to meters and methods of using the same, and more particularly, to a meter having time and date correction feature to store a log in a memory of the meter that tracks updates made to a date and time record of the meter.

BACKGROUND OF THE INVENTION

[0002] The quantitative determination of analytes in body fluids is of great importance in the diagnoses and maintenance of certain physiological abnormalities. For example, lactate, cholesterol, bilirubin and glucose should be monitored in certain individuals. In particular, determining glucose in body fluids is important to diabetic individuals who must frequently check the glucose concentration in their body fluids to regulate the glucose intake in their diets. [0003] Diabetic individuals often test their blood glucose levels via a blood glucose meter. Instances exist where an individual needs to be able to review results from several tests to better manage their treatment, hi order to assist an individual in this endeavor, many blood glucose meters contain a memory that is capable of saving the results of a plurality of blood glucose tests. For instance, it is important to know how an individuals blood glucose level fluctuates throughout the day, to allow a health care professional to modify the individuals treatment plan based on these results. It is also important to know the time of the test of an individual's blood glucose level after a meal, when blood glucose levels most typically spike and can cause the most harm. Therefore, if the date and time recorded with a test result is not accurate, the context of the test result is not known and the readings lose some of their clinical value, as trends can not be established, effects of certain events can not be determined, and full evaluations of disease control can not be made. Thus, it would be desirable to have a meter that provides a feature to update the time and date stamp associated with a test result when time and date settings on the meter are adjusted, so that an accurate time and date stamp is associated with each test result. SUMMARY OF THE INVENTION

[0004] According to one embodiment of the present invention, a meter adapted to determine an analyte concentration reading is provided. The meter comprises a display, at least one user input mechanism, a memory device, and a time and date buffer log. The display is adapted to display information to a user of the meter. The display includes information regarding an analyte concentration reading and a time and date indicator. The at least one user input mechanism allows the user to operate the meter. The memory device stores the analyte concentration reading and a time and date associated with the concentration reading. The time and date buffer log operatively connects to the memory device. The time and date buffer log stores information regarding adjustments made to a time and date setting of the meter.

[0005] According to one process of the present invention, a method for adjusting a time and date setting of a meter adapted to determine an analyte concentration reading of a sample is provided. The method receives a time and date setting adjustment instruction from an input mechanism. The method adjusts a time date setting of the meter based on the time and date setting adjustment instruction. The method stores data in a time and date buffer log based on the adjusting of the time and date setting.

[0006] 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 DRAWING

[0007] FIG. 1 is a front view of a meter having a time and date correction feature according to one embodiment of the present invention.

DESCRIPTION OF ILLUSTRATED EMBODIMENTS

[0008] The present invention is directed to a meter that is adapted to determine an analyte concentration in a body fluid sample which is collected with a lancing device. Examples of the types of analytes which may be collected include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin Aic, fructose, lactate, or bilirubin. It is contemplated that other analyte concentrations may also 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, and non-body fluids. As used within this application, the term "concentration" refers to an analyte concentration, activity (e.g., enzymes and electrolytes), titers (e.g., antibodies), or any other measure concentration used to measure the desired analyte.

[0009] One embodiment of the present invention is a meter 10 as shown in FIG. 1. The meter 10 has a display 12 that is adapted to display information to a user of the meter 10. Some of the information that may be displayed to a user includes concentration readings, time and date indicators, markers and alarms. The meter 10 also has at least one user input mechanism 15 that is adapted to allow the user to make selections relating to one or more user features. The user input mechanism 15 may include, for example, buttons, scroll bars, touch screens, or any combination of such items. The meter 10 also has a memory device 17 that is adapted to store concentration readings, etc.

[00010] According to one embodiment of the present invention, the meter 10 includes a time and date buffer log 18 operatively connected to the memory device 17. This time and date buffer log is adapted to record any modification of the date and time settings of the meter 10. While the remainder of the disclosure herein will be directed towards time and date buffer logs associated with glucose meters, it is to be understood that the time and date buffer log may be implemented in meters used for determining other analytes.

[00011] Turning in more detail to FIG. 1, the display 12 shows an analyte concentration reading 16. The reading 16 includes the numerical value and the appropriate units, i.e., 180 mg/dL. The display 12 further contains a time and date indicator 20. Other markers and/or features may be displayed on the display 12 in addition to the items described above. [00012] To illustrate the use of the meter 10 and the time and date buffer log 18 according to one embodiment, once a blood glucose concentration reading 16 is obtained, the meter 10 displays certain markers and/or user features. These features may be pre-programmed into the meter 10 before it is used by a user or the meter 10 may be customized for a particular user's needs after use begins. One of the items displayed is the time and date indicator 20. In the example in FIG. I₅ the time and date indicator 20 show that the date is October 30, and the time of the test is 12:08 p.m. If the user notes that the time and date stamp 20 is not accurate, the user may adjust the time and date by using the user input mechanism 15. [00013] Using the input mechanism 15 the user is able to adjust the time and date setting of the meter 10 that was shown on the display 12 until the time and date setting matches the actual time and date. When the user adjusts the time and date setting, data is stored within the time and date buffer log 18 corresponding to the amount of adjustment the user made to the time and date setting. For example, if the user adjusted the time and date setting by adjusting the time three (3) hours forward, e.g., a change from 1:00 p.m. on September 29, 2010 to 4:00 p.m. on September 29, 2010, the time and date buffer log 18 stores this three hour forward adjustment. [00014] When the user transfers the data contained on the memory device 17 to a processing and storage device, such as a personal computer, the time and date stamp 20 recorded for each concentration reading 16 within the memory device 17 is also transferred. This way, the user, or a health care professional, may track trends in blood glucose levels to verify that a proper treatment plan is being implemented. However, if the user has adjusted the time and date setting of the meter 10 since the last time data was transferred from the memory device 17, not all of the concentration readings will correspond to the time and date on which they were actually taken. Thus, readings 16 recorded before the user adjusted the time and date setting of the meter 10, likely have an inaccurate time and date stamp 20. The processing and storage device also reads the data stored within the time and date buffer log 18. The processing and storage device utilizes the data stored within the time and date buffer log to adjust the time and date stamp 20 for the readings 16 recorded before the time and date setting of the meter 10 was adjusted. Thus, using the previous three (3) hour forward adjustment example previously described, if that adjustment took place on September 29, 2010, any time and date stamps 20 for readings 16 recorded prior to 3:00 p.m. on September 29, 2010 would also be adjusted forward by three hours. This way, the adjustment to the meter 10 time and date setting is applied to all affected concentration readings 16.

[00015] It is further contemplated that more than one adjustment may be made to the time and date setting of the meter 10. When additional time and date settings are made, additional data is stored in the time and date buffer log 18. Thus, continuing with the prior example, if the user adjusts the time and date setting forward by an additional two (2) hours, the time and date buffer log 18 stores this two hour forward adjustment. The total adjustment indicated by the data within the time and date buffer log 18 in this example would therefore by five (5) hours forward adjustment. [00016] Once the time and date stamp 20 for each concentration reading 16 has been adjusted, the user, or health care professional, may accurately analyze the data shown by the concentration reading 16, to obtain trends in blood glucose levels or access the need to modify a treatment plan for the user.

[00017] According to another embodiment of the present invention, the processing and storage device may detect that the time and date setting of the meter 10 does not match the time and date setting of the processing and storage device. In this case, the processing and storage device is adapted to store data within the time and date buffer log 18 to indicate that the time and date setting in the meter 10 is incorrect. The next time the user transfers data from the memory device 17 to the processing and storage device, the data stored in the time and date buffer log 18 by the processing and storage device is utilized to adjust the time and date stamp 20 for each concentration reading.

[00018] According to a further embodiment of the present invention, the processing and storage device may detect that the time and date setting of the meter 10 does not match the time and date setting of the processing and storage device. According to this further embodiment, the processing and storage device is adapted to adjust the time and date setting of the meter 10 to match the time and date setting of the meter by placing data in within the time and date buffer log 18 that the meter uses to adjust the meter 10 time and date setting.

[00019] Some commercially available meters, such as those that are manufactured and/or sold by Bayer Healthcare LLC of Tarrytown, New York, may be redesigned to incorporate the present invention, such as the Ascensia® CONTOURcg) Blood Glucose Monitoring System and the Ascensia® BREEZE® Blood Glucose Monitoring System. It is contemplated that other meters, in addition to the ones listed above, may incorporate the present invention as described herein.

[00020] ALTERNATIVE EMBODIMENT A

A meter adapted to determine an analyte concentration reading, the meter comprising: a display adapted to display information to a user of the meter, the display including information regarding an analyte concentration reading and a time and date indicator; at least one user input mechanism adapted to allow the user to operate the meter; a memory device adapted to store the analyte concentration reading and a time and date associated with the concentration reading; and a time and date buffer log operatively connected to the memory device, the time and date buffer log adapted to store information regarding adjustments made to a time and date setting of the meter.

[00021] ALTERNATIVE EMBODIMENT B

The meter according to Alternative Embodiment A, wherein the analyte is glucose. [00022] ALTERNATIVE EMBODIMENT C

The meter according to Alternative Embodiment A, wherein the time and date buffer log is located within the memory device.

[00023] ALTERNATIVE EMBODIMENT D

The meter according to Alternative Embodiment A, wherein the user input mechanism is accessed to allow the user to adjust a time and date setting of the meter. [00024] ALTERNATIVE EMBODIMENT E

The meter according to Alternative Embodiment A, wherein the time and date buffer is adapted to be read by a processing and storage device. [00025] ALTERNATIVE EMBODIMENT F

The meter according to Alternative Embodiment E, wherein the processing and storage device adjusts time and date associated with the analyte concentration readings based on the time and date buffer.

[00026] ALTERNATIVE PROCESS G

A method for adjusting a time and date setting of a meter adapted to determine an analyte concentration reading of a sample, the method comprising the acts of: receiving a time and date setting adjustment instruction from an input mechanism; adjusting a time and date setting of the meter based on the act of receiving a time and date setting adjustment instruction; and storing data in a time and date buffer log based on the act of adjusting the time and date setting.

[00027] ALTERNATIVE PROCESS H

The method according to Alternative Process G, further comprising the acts of: sending stored analyte concentration readings from a memory to a processing device, the analyte concentration readings including a time and date indicator; reading stored data from the time and date buffer; and adjusting the time and date indicator of the analyte concentration readings with the processing device based upon the act of reading stored data from the time and date buffer. [00028] ALTERNATIVE PROCESS I

The method according to Alternative Process H, wherein the analyte is glucose. [00029] ALTERNATIVE PROCESS J

The method according to Alternative Process H, wherein the act of adjusting the time and date indicator of the analyte concentration readings only applies to analyte concentration readings taken prior to the act of adjusting a time and date setting. [00030] ALTERNATIVE PROCESS K

The method according to Alternative Process H, wherein the act of adjusting the time and date indicator of the analyte concentration readings occurs for each act of adjusting a time and date setting.

[00031] 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 drawing and are described in detail herein. It should be understood, however, that the description herein 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 as defined by the appended claims.

Claims

CLAIMS:

1. A meter adapted to determine an analyte concentration reading, the meter comprising: a display adapted to display information to a user of the meter, the display including information regarding an analyte concentration reading and a time and date indicator; at least one user input mechanism adapted to allow the user to operate the meter; a memory device adapted to store the analyte concentration reading and a time and date associated with the concentration reading; and a time and date buffer log operatively connected to the memory device, the time and date buffer log adapted to store information regarding adjustments made to a time and date setting of the meter.

2. The meter according to claim 1, wherein the analyte is glucose.

3. The meter according to claim 1, wherein the time and date buffer log is located within the memory device.

4. The meter according to claim 1, wherein the user input mechanism is accessed to allow the user to adjust a time and date setting of the meter.

5. The meter according to claim 1, wherein the time and date buffer is adapted to be read by a processing and storage device.

6. The meter according to claim 5, wherein the processing and storage device adjusts time and date associated with the analyte concentration readings based on the time and date buffer.

7. A method for adjusting a time and date setting of a meter adapted to determine an analyte concentration reading of a sample, the method comprising the acts of: receiving a time and date setting adjustment instruction from an input mechanism; adjusting a time and date setting of the meter based on the act of receiving a time and date setting adjustment instruction; and storing data in a time and date buffer log based on the act of adjusting the time and date setting.

8. The method according to claim 7, further comprising the acts of: sending stored analyte concentration readings from a memory to a processing device, the analyte concentration readings including a time and date indicator; reading stored data from the time and date buffer; and adjusting the time and date indicator of the analyte concentration readings with the processing device based upon the act of reading stored data from the time and date buffer.

9. The method according to claim 8, wherein the analyte is glucose.

10. The method according to claim 8, wherein the act of adjusting the time and date indicator of the analyte concentration readings only applies to analyte concentration readings taken prior to the act of adjusting a time and date setting.

11. The method according to claim 8, wherein the act of adjusting the time and date indicator of the analyte concentration readings occurs for each act of adjusting a time and date setting.