WO2006070196A1

WO2006070196A1 - Analyte measurement module and a meter and system incorporating such a module

Info

Publication number: WO2006070196A1
Application number: PCT/GB2005/005098
Authority: WO
Inventors: Alan Coulson; William David Taylor
Original assignee: Lifescan Scotland Limited
Priority date: 2004-12-29
Filing date: 2005-12-29
Publication date: 2006-07-06

Abstract

A method of manufacturing a meter or system for measuring an analyte in a body fluid including the steps of defining a first hardware specification for an analyte measurement module. The step of defining a first software specification for an analyte measurement module. The step of manufacturing one or more analyte measurement modules according to said first hardware and software specifications. The step of defining a second hardware specification for said system module. And the step of defining a second software specification for said system module. The method further including the step of manufacturing one or more of said analyte measurement modules according to said first hardware and software specifications. The step of manufacturing one or more of said system modules according to said second hardware and software specifications. The step of testing said analyte measurement module to verify that said analyte measurement module meets said first hardware and software specifications. The step of testing said system module to verify that said system module meets said second hardware and software specifications. And the step of combining said analyte measurement module with said system module.

Description

ANALYTE MEASUREMENT MODULE AND A METER AND SYSTEM INCORPORATING SUCH A MODULE

BACKGROUND OF INVENTION

1. Field of the Invention

[0001] The invention relates to an analyte measurement module, a meter and/or system incorporating such a module, a method of manufacturing such a module, meter or system, and a method of using such a module, meter or system, for use for example in measuring an analyte or indicator in a fluid sample for glucose concentration in body fluid, such as blood, urine, plasma or interstitial fluid.

2. Background to the Invention

[0002] Meters or devices for measuring an analyte or indicator, e.g. glucose, HbAIc, lactate, cholesterol, in a fluid such as a body fluid, e.g. blood, plasma, interstitial fluid (ISF), urine, typically make use of disposable test sensors. A test sensor that is specific for the analyte or indicator of interest may be inserted within a connector in the meter or system, or be delivered to a test location from within the meter or system. The test sensor becomes physically and electrically connected with a measuring circuit. A sample, for example blood, plasma, interstitial fluid (ISF) or urine, will typically contain numerous soluble or solubilized components, one of which will be the analyte or indicator of interest. An example user group that might benefit from the use of such a meter or system are those affected with diabetes and their health care providers.

3. Summary of the Invention

[0003] A method of manufacturing a meter or system for measuring an analyte in a body fluid including the steps of defining a first hardware specification for an analyte measurement module. The step of defining a first software specification for an analyte measurement module. The step of manufacturing one or more analyte measurement modules according to said first hardware and software specifications. The step of defining a second hardware specification for said system module. And the step of defining a second software specification for said system module. The method further including the step of manufacturing one or more of said analyte measurement modules according to said first hardware and software specifications. The step of manufacturing one or more of said system modules according to said second hardware and software specifications. The step of testing said analyte measurement module to verify that said analyte measurement module meets said first hardware and software specifications. The step of testing said system module to verify that said system module meets said second hardware and software specifications. And the step of combining said analyte measurement module with said system module.

4. Brief Description of the Drawings [0004] A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments by way of example only, in which the principles of the invention are utilized, and in the accompanying drawings of which:

[0005] Figure 1 shows a block diagram of a prior art meter;

[0006] Figure 2 shows a schematic view of a system incorporating for example a meter and strip according to an embodiment of the invention; [0007] Figure 3 shows a block diagram of a meter according to an embodiment of the invention; [0008] Figure 4 shows a block diagram of a meter or system incorporating an analyte testing module (e.g. a blood glucose module) and a separate application module for connecting to the analyte testing module and comprising additional components or functions, according to an embodiment of the invention;

[0009] Figure 5 shows a more detailed block diagram of a meter or system incorporating an analyte measurement module (e.g. a blood glucose module) and a separate application module according to an embodiment of the invention;

[00010] Figure 6 shows a detailed block diagram of an analyte testing meter or system incorporating an analyte measurement module (e.g. a blood glucose module) and an integral application module according to an embodiment of the invention;

[00011] Figure 7 shows a circuit block diagram of the blood glucose meter or system of Figure 6, incorporating a blood glucose module and integral application module according to an embodiment of the invention;

[00012] Figure 8 shows a process flow for a method of using an analyte measurement module within a meter;

[00013] Figure 9 shows a process flow diagram for a method of manufacturing an analyte measurement module e.g. a blood glucose module and optionally manufacturing an analyte measurement meter or system;

[00014] Figure 10 shows a process flow diagram for an alternative method of manufacturing a meter or system incorporating analyte measurement module components;

[00015] Figure 11 shows a schematic view of an example analyte testing module e.g. a blood glucose module in combination with one or more other electronic devices; [00016] Figure 12 shows a schematic view of an example networked system incorporating a number of analyte measurement modules e.g. blood glucose modules. 5. Detailed Description of the Drawings

[00017] Figure 1 shows a prior art meter 10 including a printed circuit board (PCB) 11, a microcontroller 12, an application specific integrated circuit (ASIC) 14, a thermistor 16, a strip port 18, button(s) 20, a display 22, and a serial port (data jack) 24. Strip port 18 is designed to receive a test sensor such as a test strip. ASIC 14 converts analogue signals from the strip, via the strip port 18 and thermistor 16 into digital signals. Thermistor 16 is an off-the-shelf electronic component the resistance of which changes with ambient temperature. Display 22 is a customised segmented display. Microcontroller 12 contains software designed to convert the digital signals from the ASIC 14 into an analyte measurement result, and to apply a temperature correction to that result based upon the signal from thermistor 16.

[00018] Figure 2 shows an example embodiment of a meter 100, including a housing 102, buttons 104, a serial port 106, a display 108, a test sensor e.g. a strip 110, a strip reaction zone 112, a sample droplet e.g. interstitial fluid, plasma, blood or control solution 114, and a personal or network computer 116.

[00019] Meter 100 plus strips 110 are used for the quantitative determination of an analyte e.g. glucose in a body fluid e.g. capillary blood by health care professionals or lay persons in the home e.g. for the self monitoring of blood glucose. Results are expressed in mg/dl or mmol/1 on display 108. Here, the system comprises at least one disposable reagent strip 110 and the hand-held meter 100, 102, optionally including a computer 116. The user inserts one end of a strip 110 into meter 100, 102 and places a small (circa, lμl) blood sample on the other end. By applying a small voltage across the blood sample and measuring the resulting electric current versus time, the meter is able to determine the glucose concentration. The result is displayed on the meter's liquid crystal display 108. The meter logs each glucose measurement typically along with a date and time stamp in a memory (not shown). The user is able to recall these measurements and using suitable internal or external software, the user may view glucose measurements on the display 108 or download glucose measurements to a PC or networked computer 116 for further analysis.

[00020] Figure 3 shows an example embodiment of a meter 200 including a printed circuit board (PCB) 201, a microcontroller 202, buttons 204, a serial port (data jack) 206, a strip port 208 and a display 210. The microcontroller 202 has advanced digital signal processing capabilities to enable it to do the work previously done by the ASIC and optionally that of the thermistor (items 14 and 16 in Figure 1) as will be explained later.

[00021] Figure 4 shows an analyte measurement module 300, a unitary housing 301, a separate application module 302, an analyte measurement circuit 304, an optional measurement input/output line 305, a microcontroller 306, pre-loaded software 307 (e.g. firmware), a clock 308, first analyte measurement algorithm 309, a bi-directional communication link 310, additional hardware 312, a user interface 314, additional software 316 and additional communication links 318.

[00022] Analyte measurement module 300 is connected to separate external application module 302 via bi-directional communication link 310 that may include a wire and/or a wireless connection. Analyte measurement module 300 may comprise components (software and hardware) designed to measure the concentration of glucose in blood or, for example, to measure a parameter associated with or any other analyte such as HbAlC, cholesterol, etc in, for example, any body fluid, e.g. urine, blood, plasma, interstitial fluid. Analyte measurement module 300 comprises a basic analyte measurement circuit 304 arranged to conduct, for example, a test for an analyte or indicator in a sample fluid via an input/output measurement line 305 as will be explained hereinafter. For example, the test may be conducted using a test strip for testing the concentration of glucose in blood such as the One Touch Ultra test strip available from LifeScan Inc., Milpitas, California, USA.

[00023] Basic analyte measurement circuit 304 is connected to and controlled by software 307 in microcontroller 306. Micro-controller 306 includes software 307 already embedded in it for testing for a particular analyte or indicator in a particular body fluid. For example, microcontroller 306 may include a blood glucose concentration algorithm 309 for determining the concentration of glucose in blood. An example of such an algorithm is already utilized in the One Touch blood glucose monitoring system (the One Touch system is available from LifeScan Inc., Milpitas, California, USA).

[00024] A clock 308 e.g. a crystal oscillator is also provided within the analyte measurement module as an input for the microcontroller 306 to facilitate running of the software. Optionally clock 308 or an additional real time clock (not shown) functions as an input to microcontroller 306 to facilitate operation of, or interaction with the basic analyte measurement circuit (e.g. a countdown during measurement). Optionally, microcontroller 306 has an onboard clock 308.

[00025] Analyte measurement module 300 typically comprises the three basic elements of a basic analyte measurement circuit 304, a microcontroller 306 and a clock 308. In one example embodiment analyte measurement module 300 may be constructed and verified as a separate unit as will be described hereinafter. Blood glucose module 300 may be used to form the basis of a meter or system as described hereinafter. Alternatively the components of the analyte measurement module are combined with additional application module components and constructed and verified as a single unit as will be described in relation to Figures 4 to 6.

[00026] Additional software 316 may include a second or further analyte measurement algorithm, data manipulation capability e.g. data averaging over 7, 14, 21 days, trend analysis and so on. Additional hardware 312 may include one or more PCBs, housing 301, battery capability, database, additional memory and display. Additional communication link(s) 318 may be or include wire and/or wireless capability.

[00027] Figure 5 shows in more detail analyte measurement module

300 and separate application module 302, here shown within a unitary housing 301. In particular, Figure 5 shows an analyte measurement module 300 including a basic analyte measurement circuit 304, a measurement line (optionally, a measurement input and output line) 305, a microcontroller 306 and a clock 308, for example a crystal oscillator. Furthermore, Figure 5 shows a first bi-directional communicational line (optionally wireless) 310, a separate application module 302, comprising optionally additional hardware 312, a user interface 314, additional software 316 and/or additional communication links 318. Figure 5 also shows a voltage reference circuit 320, a measurement circuit 324 e.g. a current to voltage converter, a measurement control/result line(s) 330, an optional strip port connector 332, an optional non-volatile memory 334 e.g. EEPROM, an optional second bi-directional communication line 336, an optional electro-static discharge protection circuit 338, an optional serial port 340 (data jack), an optional third communication line 342, an optional clock communication line 346. [00028] Optionally, housing 301 may form part of the analyte measurement module 300 and may therefore be constructed, verified and/or validated along with that module. Optionally, housing 301 may form part of the application module 302. Optionally, housing 301 will contain both analyte measurement module 300 and application module 302. Housing 301 may be in nature (size, shape and/or colour) to suit the desired application supported by application module 302.

[00029] An example strip port connector 332 is that found in the One

Touch Ultra meter available from LifeScan Inc., Milpitas, California. The strip port connector 332 may be replaced by an alternative measurement device connector, for example, a continuous measurement device connector such as that described in co-pending patent application WO02/49507 (DDI-12.1 "Analyte Measurement") the contents of which are hereby incorporated by reference.

[00030] One skilled in the art would understand that one or both of optional measurement input/output line(s) 305, bi-directional communication link 310 and/or additional communication link(s) 318 may be or include wire and/or wireless connections e.g. a serial or parallel cable, fire wire cable (high speed serial cable), USB, infrared, RF, RFID, Bluetooth, WIFI (e.g. 802.1 IX), ZIGBEE or other communication media, protocols or data links or any combination thereof. Measurement line(s) 305 connects strip port connector 332 to measurement circuit 324. Measurement circuit 324 may be in the form of a current to voltage converter. Measurement circuit 324 may require a voltage reference input. This can be provided by voltage reference circuit 320 from which a constant reference voltage is available. Voltage reference circuit 320 may also provide a constant reference voltage to microcontroller 306 to be used by an analogue to digital converter within microcontroller 306. Measurement circuit 324 is connected to microcontroller 306 via measurement control/result line(s) 330.

[00031] Non-volatile memory 334 communicates with microcontroller

306 via bi-directional communication line 336. Thus, information such as the last result, the last n results (e.g. where n equals e.g. 50, 100, 200, 300, 400, 500), or calibration code information for a particular batch of test sensors and so on can be stored. Thus, when microcontroller 306 is powered down, such information can be retained within non-volatile memory 334. It will be appreciated by those skilled in the art that whereas it is possible to have non- volatile memory 334 provided within the analyte measurement module, it is not necessary to do so. This is because the information stored within the non- volatile memory may be uploaded via bi-directional communication line 310 from other memory devices within application module 302. Indeed memory within microcontroller 306 may be used as an alternative as in the blood glucose module of Figure 4. This latter option is less suitable if the memory is needed to operate the meter effectively even at low battery voltage, in which case a separate nonvolatile memory is preferred as in Figure 5. Storing one or more analyte measurement results within the application module is also an option, particularly if a date/time stamp is stored along with each result since optionally a real time clock is provided within additional hardware 312 within application module 302.

[00032] Electro-static discharge protection is provided by optional ESD protection circuit 338 to any components or lines that are thought to be vulnerable to ESD. An analogue input/output is provided by serial port 340 to and from microcontroller 306 via optional third bidirectional communication line 342. Clock 308 is connected to microcontroller 306 by clock communication line 346. [00033] Application module 302 may contain one or more additional components in hardware and/or software to compliment the analyte measurement module 300 and in turn form a meter or system suitable for use by a patient or health care professional. Application module 302 typically comprises other hardware, for example, a housing 301, 102, a display 354, a button module 352, a backlight circuit 356 and so on. Other hardware that may optionally be included is additional memory (not shown) or even a second or third microcontroller to provide either additional memory and/or additional processing power (not shown). Application module 302 may contain further software such as a second analyte measurement algorithm (e.g. a second blood glucose concentration algorithm) or further display or analysis features for the results. Application module 302 may also contain a real time clock as previously described.

[00034] Application module 302 optionally may also include additional software either on microcontroller 306 or in a second microcontroller or second non- volatile memory or indeed in a separate processing device such as a personal computer, personal digital assistant, mobile phone or separate analyte measurement meter as shown in Figures 11 and 12. Alternatively, or in addition, a user interface 314 may be provided on microcontroller 306 as part of the software verified within the analyte measurement module. Alternatively or in addition all or part of the user interface may be provided separately within application module 302. Similarly, additional communication links or options 318 may be provided on microcontroller 306 and/or within analyte measurement module 300 and/or may be provided within application module 302.

[00035] Figure 6 shows a combined analyte measurement module 300 and application module 302 within an analyte measurement meter or system 350. In this particular embodiment the analyte measurement module within meter 350 has been supplemented with some additional hardware and some additional software. Meter 350 includes an analyte testing measurement having a basic measurement circuit 304, a microcontroller 306, a clock 308 e.g. a crystal oscillator and a first bidirectional communication line(s) 310. User interface 314 and additional software 316 are preloaded onto microcontroller 306 in this embodiment and verified along with the basic analyte measurement module 300. The analyte measurement module further includes a voltage reference circuit 320, a measurement circuit 324, a measurement control/result line(s) 330, a strip port connector 332, a non-volatile memory 334, an ESD protection circuit 338, a serial port 340 e.g. a data jack, second bi-directional communication link 336, third bi-directional communication link 342 and clock communication line 346. The application module includes additional hardware 312 including a button module 352, display 354, a back light circuit 356, additional software components including user interface 314, averaging software modules and data manipulation modules 316.

[00036] Optionally, drivers for additional hardware and/or a user interface or further user interface and/or other additional software may be built into microcontroller 306 as shown in box 311.

[00037] Figure7 shows a block diagram of meter 350, for testing, for example, the concentration of glucose in blood using disposable test sensors in the form of test strips. Meter 350 includes a microcontroller 306, a clock 308, first bi-directional communication link 310, a voltage reference circuit 320, a battery circuit 321, a measurement circuit 324 e.g. current to voltage converter, a first voltage reference line 326, a second voltage reference line 328, a measurement control/result line(s) 330, a strip port connector 332, a non-volatile memory 334, a second bi-directional communication link 336, an electro-static discharge circuit 338, an input/output port or data jack 340, ESD protection lines 344, a button module 352, an LCD display circuit 354 and a backlight circuit 356.

[00038] It can be seen from Figure 7 that strip port connector 332 is connected to measurement circuit 324. A voltage reference circuit 320 provides voltage references such as a 40OmV reference voltage in the case of a One Touch Ultra strip to measurement circuit 324. Voltage reference circuit uses a voltage reference integrated circuit e.g. LM41201M5-1.8 available from National Semiconductors. This is a very accurate voltage reference integrated circuit and it has a very good temperature coefficient (50 ppm/°C). Measurement circuit 324 supplies a voltage reference of 40OmV, for example, on two separate lines to pins 1 and 2 on the strip port connector 332. Strip port connector 332 may be the same used as in the One Touch Ultra meter available from LifeScan Inc, Milpitas, California, USA. Typically, the strip to be inserted in strip port connector 332 can form two electrochemical circuits by means of a first working electrode and a second working electrode each with reference to a single reference electrode on the test strip. A typical test strip is the One Touch Ultra test strip available from LifeScan Inc., Milpitas, California, USA.

[00039] For example, non- volatile memory 334 is a 24256 available from ATMEL Semi-conductors Display circuit 354 and non- volatile memory 334 use an I²C interface allowing these both to be connected to the same ports or microprocessor 306 but addressed separately by microcontroller 306. Microcontroller 306 may be from the family of MSP 430xl3x, MSP 430xl4x, MSP 430x14x1 microprocessors, such as the MSP 430F133, MSP 430F135, MSP 430F147, MSP 430F1471, MSP 430F148, MSP 430F1481, MSP 430F149, MSP 430F1491 available from Texas Instruments, Dallas, Texas. These microcontrollers have a range of memory from 8KB + 256 B Flash and 256B RAM to 60KB + 256 B Flash and 2KB RAM. [00040] Measurement circuit 324 applies a voltage of 40OmV to each of the first and second working electrodes on the test strip and measures the current drawn between these working electrodes and a reference electrode on the strip (connected to pin 4 of the strip port connector 332). The current drawn from one or two working electrodes on the test strip is fed into the microcontroller as one or two analogue voltages by measurement control/result line(s) 330. An analogue to digital converter within microcontroller 306 converts these into digital signals. Microcontroller 306 is optionally a 16 bit or greater microcontroller optionally a mixed signal microprocessor capable of receiving and processing both analogue and digital signals.

[00041] Pre-loaded software within microcontroller 306 optionally includes a blood glucose algorithm and a temperature correction algorithm. The blood glucose algorithm is used to convert the current measured at one working electrode, or an average current at two working electrodes together with elapsed time, into a glucose concentration. Next, the temperature diode inbuilt on the microcontroller 306 gives a temperature measurement and allows the temperature compensation algorithm to be applied to the result.

[00042] Typically, measurement circuit 324 delivers a voltage representative of the current drawn from the measurement circuit to the microcontroller 306 rather than a current. The microcontroller 306 then converts this voltage to a value akin to a current to provide a current transient response with respect to time. The current developed after 5 seconds is converted into a glucose concentration using a known formula and calibration code information, the formula is of the form Y = MX+C where X is time, Y is current at 5 seconds and M and C are calibration constants typically retrieved from the non- volatile memory. Button module 352 controls the operation of the user interface 314. LCD display 354 displays the results from the microcontroller 306. Backlight circuit 356 can be operated via button module 352 and microcontroller 306 to enhance the view on the LCD display 354 by switching on the backlight, as described in co-pending application "Scheme for providing backlight on a meter" (DDI5068). Button Module 352 is used to manipulate the user interface on as described in co-pending application " Blood Glucose Monitor User Interface" (DDI5061 by the same applicant filed herewith) the entire contents of which are hereby incorporated by reference. In one embodiment button module 352 includes 3 buttons ("OK", "UP" and "DOWN"). Optionally, the OK button can be used to switch the meter on by depressing it for a few seconds, and/or select an item highlighted by a cursor on the display 354 and/or toggle ON/OFF the backlight by depressing it for a few seconds as well as being used to discharge the capacitors in the VSO circuit during battery changing as described below. Similarly, optionally the "UP" and "DOWN" buttons also can be used in more than one way.

[00043] Figure 8 shows a process flow for a method of using an analyte measurement module within a meter. Firstly (Step 410) a test sensor such as a test sensor strip 110 is inserted in an analyte measurement module 300 such as that in the blood glucose meter 350 of Figures 4 to 7. Next (Step 420) body fluid is applied to the strip. Next (Step 430) the analyte measurement module conducts the test e.g. the measurement circuit 324 conducts the test under the control of the microcontroller 306. Next (Step 440) the analyte measurement algorithm within microcontroller 306 is applied to the measurement to give the result. Next (not shown) optionally, a temperature compensation algorithm is applied to the result. Next (Step 450) the result is sent to the application module 302, optionally (Step 460) via wireless or other form of data communication. Next (Step 470) the result is optionally displayed on the display. Next, (Step 480) optionally further analysis takes place, e.g. averaging, trending as would be understood by someone skilled in the art.

[00044] Figure 9 shows a process flow diagram for a method of manufacturing an analyte measurement module e.g. a blood glucose module and optionally manufacturing an analyte measurement meter or system. First (Step 510) an analyte measurement module is designed, first hardware and first software specifications developed, (as discussed in relation to Figures 4 to 7) and a module is constructed substantially to meet those hardware and software specifications. Optionally (Step 520) the microprocessor is calibrated for its voltage reference and/or for its internal temperature sensor as would be understood by someone skilled in the art. Next (Step 530) optionally the analyte measurement module is verified to ensure that it substantially meets the first software and first hardware specifications. Optionally next (not shown) a second software and second hardware specification is written for a meter or system. Next (Step 540) optionally, a combined meter or system including the analyte measurement module is constructed. Next, optionally the meter or system is verified to ensure it substantially meets the second hardware and second software specifications. Next (Step 550) optionally the meter or system is validated to ensure it meets the users' needs.

[00045] Verification of a module including hardware and software is necessary to ensure that the hardware and software operate safely and effectively within expected operating parameters. Typically verification involves the writing of a hardware requirement specification and a software requirement specification then constructing the hardware and software (e.g. a number of modules to a pre-specified design) to meet these specifications. Next, verification involves ensuring these perform to specification by conducting tests e.g. experimental or clinical tests to ensure the design has been built to the pre-specified hardware and software requirements. Thus, once verified analyte measurement module 300 may be combined with a variety of further applications including software 316, hardware 312, user interface(s) 314 or communication links 318 to produce any number of different analyte measurement meters or analyte measurement systems according to the invention. For example, analyte measurement module 300 may be combined with application module 302 within a unitary housing 301 to form a first meter or system. Later, analyte measurement module may be combined with a different application module 302 having the same or different unitary housing 301 to form a second different meter or system. Pre-constructing and verifying the analyte measurement module and its basic components facilitates the construction and/or the verification and/or validation methodology of several different kinds of meter or system of which it forms part since the basic components may not have to be re-constructed or re-verified each time.

[00046] Thus in one example embodiment of the invention analyte testing module 300 is first built and tested as shown in Figure 6. Once analyte testing module 300 has been built and tested, identical components and/or components of the same specification are used along with the components of application module 302 to build a meter 350 within a housing 301. This means that verification testing of fully built meters 350 may be simplified since the components within the analyte measurement module 300 had been independently verified in an earlier prototype.

[00047] Figure 10 shows a process flow diagram for a method of manufacturing an analyte measurement meter or system. First (Step 560) a meter or system including components of an analyte testing module is constructed to substantially meet defined first and second hardware and first and second software specifications. Next (Step 570) the meter or system is verified. Optionally, next (Step 580) the meter or system is validated to assess if it meets a users' needs.

[00048] Figure 11 shows a schematic view 600 of a blood glucose module 610 in combination with one or more other electronic devices. A verified analyte measurement module 610 may be constructed and used in combination with a number of other devices for example modular meter 620 and/or a blood glucose meter 630 such as that shown in any of Figures 2 to 7 and/or a personal digital assistant 640 and/or a mobile telephone 650 and/or other communication devices and/or computing devices whether portable or not as would be understood by someone skilled in the art.

[00049] Figure 12 shows a schematic view of a networked system 700 incorporating a number of analyte measurement modules 710 e.g. blood glucose modules, a personal or networked computer 720 and optionally a database 730 for storing results, calibration or other information. Thus in one embodiment a number of analyte measurement modules 710 such as blood glucose modules may be used in parallel for automatic laboratory testing during construction of meters, or design or manufacture of test strips or during laboratory testing of samples or testing of patients within a clinic setting, for example if the analyte testing module is a continuous analyte measurement module such as that described in co-pending patent application WO02/49507 (DDI 12.1 'Analyte measurement'). A number of patients could each be continuously monitored and the information connected and fed to a central computer and database, thus ongoing glycemic control of several patients could be monitored.

[00050] Each blood glucose module, for example, may be attached to one or more personal or networked computers 720 by wires, wirelessly or via the web. Optionally a database 730 or other data storage means is provided. Such a system would allow several discrete or several continuous analyte measurement tests to be carried out for a whole variety of purposes and yet not require the building, verification and validation of an entire analyte test meter or system, thus saving time and costs. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. A method of manufacturing a meter or system for measuring an analyte in a body fluid comprising the steps of: defining a first hardware specification for an analyte measurement module; defining a first software specification for said analyte measurement module; manufacturing one or more of said analyte measurement modules according to said first hardware and software specifications; defining a second hardware specification for a system module; defining a second software specification for said system module; manufacturing one or more of said system modules according to said second hardware and software specifications; testing said analyte measurement module to verify that said measurement module meets said first hardware and software specifications; testing said system module to verify that said system module meets said second hardware and software specifications; combining said analyte measurement module with said system module.

2. A method of manufacturing a meter or system according to Claim 1 wherein the application module comprises additional hardware and/or drivers for additional hardware including a display, a button module, a backlight circuit, one or more additional microcontrollers, one or more additional memory circuits, a PCB, a housing.

3. A method of manufacturing a meter or system according to Claim 1 wherein said system module includes a user interface.

4. A method of manufacturing a meter or system according to Claim 1 wherein said system module comprises additional software including averaging software, data manipulation software, or a second analyte testing algorithms.