# Patent

## Title
Glucose measuring device for use in personal area network

## Abstract

A glucose measuring system includes a glucose meter that incorporates wireless communication capabilities. The meter can advantageously be a low cost meter by eliminating expensive components, such as the display. The user nevertheless is able to retrieve and view his or her glucose values by referring to displays within the glucose measuring local area network. Feedback via these displays can advantageously be used by the diabetic to create a higher level of confidence and safety.

## Background
RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 10/861,625 filed on Jun. 4, 2004, entitled “Glucose Measuring Device For Use In Personal Area Network”, which claims priority to U.S. Provisional Patent Application No. 60/477,730 filed on Jun. 10, 2003, entitled “Glucose Measuring Device For Use In Personal Area Network”, the disclosures of each of which are incorporated herein by reference for all purposes.


FIELD OF THE INVENTION
This invention relates to a device and method for determining and reporting glucose readings in wireless personal area networks for diabetics.
BACKGROUND
The number of diagnosed cases of diabetes continues to increase in the U.S. and throughout the world, creating enormous economic and public health consequences. Devices and therapies that improve the quality of life for the diabetic patient thus are important not only for the patient, but for society at large. One area in which recently developed technologies have been able to improve the standard of care has been in the maintenance of tight control over the blood glucose levels. It is well known that if a diabetic patient's blood glucose values can be maintained in a relatively narrow and normal range of from about 80 milligrams per deciliter (mg/dL) to about 120 mg/dL, the physiologically damaging consequences of unchecked diabetes can be minimized. With better blood glucose information, diabetic patients can better exercise tight control of their blood glucose level through a variety of means, including diet, exercise, and medication. For this reason a large industry has developed to provide the diabetic population with ever more convenient and accurate ways to measure blood glucose. There are many forms of these measuring devices; one common type is represented by hand-held electronic meters which receive blood samples via enzyme-based “test strips”. In using these systems, the patient lances a finger or alternate body site to obtain a blood sample, the strip is inserted into a test strip opening in the meter housing, the sample is applied to the test strip and the electronics in the meter convert a current generated by the enzymatic reaction in the test strip to a blood glucose value. The result is displayed on the (typically) liquid crystal display of the meter. Usually, this display must be large so that diabetics who often have deteriorating vision, can more easily see the result.
It is known that such hand-held meters can advantageously be manufactured to include wireless communication capability. Such capability can assist the user in downloading data to a home computer or to a handheld computing device, for example. This minimizes the need for the user to write down data and transfer it later to an electronic record.
It is also known that hand-held meters are often given to users, so that suppliers of the strips used with the meters can generate greater strip sales. This makes the cost of the hand-held meters critical to profitability of the manufacturers. If the cost of a meter is relatively high, profits from the sale of strips will be small or worse yet, non-existent. If the cost of the meter can be reduced, profitability is improved.
Lastly, it is well known that if a strip and meter system is convenient to use, patients will test more often and compliance with treatment programs will improve. Including wireless communication in the meter adds convenience, but at a cost. For these reasons, there is a continuing need for a low cost meter and strip glucose monitoring system that nevertheless has highly convenient features, including wireless communication capabilities.
SUMMARY OF THE INVENTION
The present invention is a glucose monitoring system which includes a glucose meter system of the meter and strip type that includes wireless communication capabilities. The system can be a reduced cost system however, by eliminating components from the meter, such as the relatively large LCD display, and instead relying on such components in other electronic devices that now typically surround a patient almost every day and can form part of the monitoring system. By eliminating high cost components from the meter but retaining the wireless communication functionality, the meter portion of the system can be relatively low cost, yet the system overall provides highly convenient features to the user.
Accordingly, in one embodiment of the present invention, there is provided a data communication system including a data network, a client unit operatively coupled to the data network, and a server unit operatively coupled to the data network for communicating with the client unit, said server unit further configured to receive blood glucose related data from the client unit over the data network.
The client unit may be configured to encrypt the blood glucose related data for wireless transmission over the data network to the server unit. Moreover, the client unit may include a blood glucose meter.
In an alternate embodiment, the data communication over the data network may include one of an 802.11 protocol, a Bluetooth® protocol, a radio frequency (RF) protocol, and an Infrared Data Association (IrDA) protocol.
Furthermore, the server unit may in one embodiment include a display.
The system in accordance with yet another embodiment may include a base unit configured to communicate with the server unit over the data network, the base unit configured to store data received from the server unit, and further, the base unit configured to provide an insulin pump protocol to said server unit.
The data network may include a personal area network, where the personal area network is configured for short range wireless communication.
In a further embodiment, the client unit may be configured with password protection.
Additionally, the client unit may include one or more of a compact handheld device, a personal digital assistant, and a mobile telephone.
In accordance with another embodiment of the present invention, there is provided a method of providing a data communication system including the steps of establishing a data network, operatively coupling a client unit to the data network, and operatively coupling a server unit to the data network to communicate with the client unit, the server unit further configured to receive blood glucose related data from the client unit over the data network.
The method may further include the step of encrypting the blood glucose related data for wireless transmission over the data network.
Moreover, the step of establishing the data network may include the step of implementing one of an 802.11 protocol, a Bluetooth® protocol, an RF protocol, and an IrDA protocol.
Also, the method in a further embodiment may include the step of displaying the data received from the client unit.
Moreover, in another embodiment, the method may include the step of configuring a base unit to communicate with the server unit over the data network, the step further including storing data received from the server unit. Also, the step of configuring the base unit further may include the step of providing an insulin pump protocol to said server unit. Moreover, the method may also include configuring the personal area network for short range wireless communication.
Additionally, the method may include the step of password protecting access to the client unit.
In accordance with yet another embodiment of the present invention, there is provided a personal area network, a blood glucose meter operatively coupled to the personal area network, and a server unit operatively coupled to the personal area network for wirelessly communicating with the meter, said server unit further configured to receive blood glucose data from the meter over the personal area network.
The invention will now be described by reference to the figures, wherein like reference numerals and names indicate corresponding structure throughout the several views.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view showing typical data signal flow between devices of a wireless system constructed according to one embodiment of the present invention.
FIG. 2 is a schematic view showing the client device of FIG. 1.
FIG. 3 is a schematic view showing the server device of FIG. 1.
FIG. 4 is a pictorial view showing a typical client device and typical server devices.
FIG. 5 is a perspective view showing an integrated device of an alternative embodiment.



DETAILED DESCRIPTION
Referring to FIG. 1, a wireless system constructed according to a preferred embodiment of the present invention will be described. Test strip 101 electrically communicates with client device 102, which wirelessly communicates with server device 104, such as by two-way radio frequency (RF) contact, infrared (IR) contact, Bluetooth® contact or other known wireless means 103. Optionally, server device 104 can also communicate with other devices such as data processing terminal 105 by direct electronic contact, via RF, IR, Bluetooth® or other wireless means.
Test strip 101 is a commonly known electrochemical analyte test strip, such as a blood glucose test strip as described in U.S. patent application Ser. No. 09/434,026 filed Nov. 4, 1999 entitled “Small Volume In Vitro Analyte Sensor and Methods”, incorporated herein by reference. It is mechanically received in a test strip port of a client device 102, similar to a commonly known hand-held blood glucose meter as described in the aforementioned patent application. In the preferred embodiment, client device 102 is constructed without a user interface or display to keep the size and cost of device 102 to a minimum. Client device 102 can take the form of a highlighter or easel-sized pen, as shown in FIG. 4, and can be powered by a single AA or AAA size battery.
Client device 102 wirelessly communicates with server device 104, preferably using a common standard such as 802.11, Bluetooth®, wireless protocol, or an IrDA infrared protocol. Server device 104 can be another portable device, such as a Personal Digital Assistant (PDA) or notebook computer, or a larger device such as a desktop computer, appliance, etc. as shown by the examples in FIG. 4. Preferably, server device 104 does have a display, such as a liquid crystal display (LCD), as well as an input device, such as buttons, a keyboard, mouse or touch-screen. With this arrangement, the user can control client device 102 indirectly by interacting with the user interface(s) of server device 104, which in turn interacts with client device 102 across wireless link 103.
Server device 104 can also communicate with another device 105, such as for sending glucose data from devices 102 and 104 to data storage in device 105, and/or receiving instructions or an insulin pump protocol from a health care provider computer 105. Examples of such communication include a PDA 104 synching data with a personal computer (PC) 105, a mobile phone 104 communicating over a cellular network with a computer 105 at the other end, or a household appliance 104 communicating with a computer system 105 at a physician's office.
Referring to FIG. 2, internal components of the client device 102 such as a blood glucose meter of the preferred embodiment are shown. As shown, the client device 102 includes an analog interface 201 configured to communicate with the test strip 101 (FIG. 1), a user input 202, and a temperature detection section 203, each of which is operatively coupled to a processor 204 such as a central processing unit (CPU). Further shown in FIG. 2 are a serial communication section 205 and an RF transmitter 206, each of which is also operatively coupled to the client device processor 204. Moreover, a power supply 207 is also provided in the client device 102 to provide the necessary power for the client device 102. Additionally, as can be seen from the Figure, a clock 208 is provided to, among others, supply real time information to the client device processor 204.
Alternatively, user input 202, such as push button(s), and other sections can be eliminated to reduce size and cost of client device 102. The glucose meter housing may contain any glucose sensing system of the type well known in the art that can be configured to fit into a small profile. Such a system can include, for example, the electrochemical glucose strip and meter sensing system sold by Abbott Diabetes Care Inc. of Alameda, Calif. under the FreeStyle® brand, or other strip and meter glucose measuring systems. The housing may thus encompass the sensor electronics and a strip connector, which connector is accessed via a test strip port opening in the housing. The housing will typically also include a battery or batteries.
Referring to FIG. 3, internal components of a server device 104 of the preferred embodiment are shown. Referring to FIG. 3, the server device 104 includes a blood glucose test strip interface 301, an RF receiver 302, an input unit 303, a temperature detection section 304, and a clock 305, each of which is operatively coupled to a server device processor 307. As can be further seen from the Figure, the server device 104 also includes a power supply 306 operatively coupled to a power conversion and monitoring section 308. Further, the power conversion and monitoring section 308 is also coupled to the server device processor 307. Moreover, also shown are a receiver serial communication section 309, and an output 310, each operatively coupled to the server device processor 307.
Note that a redundant test strip interface 301 can be provided if desired for receiving test strips 101 (FIG. 1). Device 104 can be a proprietary unit designed specifically for use with blood glucose meters, or can be a generic, multipurpose device such as a standard PDA. An example of a similar device designed for blood glucose testing is disclosed in U.S. Pat. No. 6,560,471 issued May 6, 2003 entitled “Analyte Monitoring Device and Methods of Use”, incorporated herein by reference.
FIG. 4 shows examples of the devices to and from which the meter of the invention can communicate. Such devices will become part of an individual's personal area network and each becomes enabled with short range wireless communication capabilities. Desktop, laptop and handheld computers, as well as printers can be so enabled and will provide displays and printouts valuable as records for the diabetic. Telephones will also be enabled in this fashion and can be used for displaying glucose data as well as further transmitting the data over larger networks. Many of these devices can assist the diabetic by responding to glucose levels by providing alarms, or suggesting that action be taken to correct a hypo or hyperglycemic condition, or to call necessary medical assistance. Diabetics are aware of the risks involved in driving when glucose levels are out of range and particularly when they are too low. Thus, the navigation computer in the diabetic's car may become part of the local area network and will download glucose data from the meter when the diabetic enters the car. For safety sake, the car computer system may be programmed to require that the diabetic perform a glucose test before driving, and more specifically the car may be disabled unless the diabetic takes the test and the result is in an appropriate range.
The pen shaped client device 102 shown in FIG. 4 preferably has a test strip port 201 (not shown in FIG. 4) located on its distal end. Because the sensitive analog “front end” circuitry associated with measuring the very small electrochemistry currents from test strips 101 is located adjacent to strip port 201, it is advisable to not design a wireless link antenna too close to this distal end as it may interfere with the proper operation of the glucose sensing circuitry. On the other hand, if the wireless link antenna is located at the proximal end of the client device 102, it will likely be covered by the hand of the user holding it, which may limit the range of the low transmission power device to an unacceptable distance. Accordingly, it is preferable to design the layout of client device 102 such that an internal antenna is located in a middle section of the device away from the distal and proximal ends.
Referring to FIG. 5, an alternative embodiment of the present invention is shown. Due to the reduced size of a blood glucose meter 102 when it does not include a display or push buttons, it can be combined with a lancing device to form an integrated unit 102′. Test strip port 201 can be located in the side of integrated device 102′ or wherever there is room available. A test strip storage compartment can also be located within integrated device 102′ and accessed through a flip-lid 220 or other suitable closure means. If room permits, a second test strip storage compartment (not shown) can be included so that fresh strips and used strips can be separately stored. Preferably, a desiccant is provided in one of the storage compartments to preserve the fresh strips. The design and use of lancing devices is described in U.S. Pat. No. 6,283,982 issued on Sep. 4, 2001 entitled “Lancing Device and Method of Sample Collection”, incorporated herein by reference. By integrating these features together in a single device without a user interface, the typical test kit that is carried around by people with diabetes can be made much smaller, easier to handle, and less costly.
Thus, one of the important features of the invention is reliance of the “displayless” glucose meter unit on a separate display device in order to minimize the complexity and cost of the meter unit. This permits the user to use the larger display units within his or her personal area network, all of which can be synchronized as they interact and communicate with the wireless enabled meter. When the meter is used, the sequences through which the user must “step” to complete the test are readily viewed on the larger display units (e.g. entering the calibration code, prompting application of the sample). At the same time the meter unit is simplified, smaller and less expensive to manufacture. Additionally, control buttons that are found on typical glucose meters can be eliminated, saving additional size and cost, since the user can rely on the user in out features of the server device instead. It is expected that the simplified, wireless enabled meters of the invention may ultimately become inexpensive enough to make them disposable after a specified number of uses, permitting the producer to routinely upgrade as appropriate.
Additionally, the system permits the user to include security coding at any time the meter unit accesses a display device, so that the user's data is secure. That is, it is considered an important feature of the invention that when the “client” meter of the invention is used, that the system will require the user to enter an identity code in order to verify that the person handling the meter is indeed an authorized user. Of course, it is possible for the system to permit more than one user if the meter owner so desires. Moreover, the user's data may optionally be encrypted prior to wireless transmission and thereafter respectively decrypted upon wireless reception.
While the module need not include a large or expensive display, it may nevertheless be advantageous to include some ability to advise the user of a glucose level which is determined when the module is used as a “stand-alone” unit. For example, the module could include a very low cost, small three digit LCD display. Alternatively, the module could include LED indicator lights (e.g. red for out of desired range, green for within desired range). Other possibilities include a red LED for below range, a green LED for within range, and a yellow LED for above range, or a column of LEDs or an electroluminescent strip (similar to those used on common batteries to indicate battery life) to indicate approximate or relative glucose levels.
Various other modifications and alterations in the structure and method of operation of this invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. It is intended that the following claims define the scope of the present invention and that structures and methods within the scope of these claims and their equivalents be covered thereby.

## Claims

1. A data communication system, comprising:
a data network configured to facilitate transmission of data between at least two devices;
a client unit operatively coupled to the data network to communicate data over the data network, the client unit comprising a glucose monitoring unit; and
a household appliance operatively coupled to the data network and configured to communicate with the client unit over the data network to receive glucose data from the client unit;
wherein the glucose monitoring unit comprises a grip portion and a wireless antenna located away from the grip portion; and
wherein the glucose monitoring unit comprises a test strip port located away from both the grip portion and the wireless antenna, the grip portion located distally from the test strip port along a longitudinal axis of the glucose monitoring unit, and configured to be held in the hand of a user.

2. The system of claim 1, wherein the client unit is configured to encrypt the glucose data.

3. The system of claim 2, wherein the household appliance is configured to decrypt the glucose data.

4. The system of claim 1, wherein the data network comprises a wireless network.

5. The system of claim 1, wherein the data network is configured to support communication based on an 802.11 protocol, a wireless protocol, an RF protocol, an IrDA protocol, or one or more combinations thereof.

6. The system of claim 1, wherein the household appliance is configured to generate one or more health management related signals based on the glucose data received from the client unit.

7. The system of claim 1, wherein the household appliance includes an alarm that is configured to activate based upon received glucose data.

8. The system of claim 7, wherein the alarm comprises one or more of an audible alert, a vibratory alert and a graphical display.

9. The system of claim 1, wherein the household appliance is configured to provide a suggested action to be taken based on the received glucose data.

10. The system of claim 1, wherein the household appliance is configured to request for assistance based on the received glucose data.

11. The system of claim 1, wherein the household appliance comprises a display to display information related to the glucose data received from the client device.

12. The system of claim 11, wherein the household appliance display comprises an input device to control, at least in part, one or more operations or functions of the client device.

13. The system of claim 12, wherein the input device comprises a touch screen.

14. The system of claim 1, wherein the appliance comprises a processor programmed to request glucose data.

15. The system of claim 14, wherein the processor is programmed to include acceptable glucose level ranges.

16. The system of claim 1, wherein the glucose monitoring unit comprises an interface to receive one or more blood glucose test strips.

17. The system of claim 1, wherein the system comprises a processor programmed with security coding.

18. The system of claim 17, wherein the security coding comprises one or more user authorization codes.

19. The system of claim 1, wherein the client unit includes a processor programmed with password protection.

20. The system of claim 1, wherein the household appliance is a refrigerator.

21. The system of claim 1, wherein the household appliance is a television.

22. The system of claim 1, wherein the glucose monitoring unit comprises an integrated lancing unit.

23. The system of claim 16, wherein the glucose monitoring unit comprises an integrated test strip storage compartment.

24. The system of claim 1, wherein the antenna is located midway between the grip portion and the test strip port along the longitudinal axis of the glucose monitoring unit.

25. The system of claim 1 wherein the antenna is positioned between a distal end and a proximal end of the glucose monitoring unit along the longitudinal axis, and away from the distal and proximal ends of the glucose monitoring unit.