GLUCOSE TOLERACE TEST DEVICE

• US 20100240079A1
• Filed: 08/22/2008
• Published: 09/23/2010
• Est. Priority Date: 08/23/2007
• Status: Active Grant

• Current Assignee: Diagnostics Limited
• Original Assignee: Smartsensor Telemed Limited
• Inventors: Jackson, James
• Granted Patent: US 8,420,401 B2
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150847 Communication to or from blood sampling device transmitting measured data A61B5/0002
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: Y10T 436/115831 Condition or time responsive
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A glucose tolerance test device comprising: a test zone having a means to receive at least first and second blood test samples spaced apart by a predetermined time interval; a timer to measure such a time interval, and for example to measure elapsed time after collection of a said first sample; an indicator to indicate at least that a second test is due, operatively Jinked to the timer so as to make such indication after lapse of a predetermined time interval; a data collector to collect data from the lest zone in relation to each test sample; a data register to store data in relation to each test sample, in data communication with said data collector. A method of use is also described.

Claims

1. A test data collection device for testing glucose tolerance comprising:

a test zone having a means to receive at least first and second blood test samples spaced apart by a predetermined time interval;

a timer to measure such a time interval, and for example to measure elapsed time after collection of a said first sample;

an indicator to indicate at least that a second test is due, operatively linked to the timer so as to make such indication after lapse of a predetermined time interval;

a data collector to collect data from the test zone in relation to each test sample;

a data register to store data in relation to each test sample, in data communication with the said data collector.

2. A device in accordance with claim 1 wherein the timer is adapted at least to measure a specified first time interval in order to work in conjunction with the indicator to indicate when a second test is due.

3. A device in accordance with claim 1 wherein the timer additionally measures at least a first elapsed time between performance of the a test, when a first sample is placed in a sample collection area, and/or when a time interval start control is actuated;

and performance of a second test, when a second sample is placed in a sample collection area.

4. A device in accordance with claim 1 including a user-actuatable time interval start control to commence measurement of an elapsed time

5. A device in accordance with claim 1 wherein a test zone includes a means to detect the presence of a sample in a sample collection area, and thus to enable indication and/or recorded of when a test is performed.

6. A device in accordance with claim 1 provided with, or adapted to be placed in data communication with, a suitable input means to input data associated with a test.

7. A device in accordance with claim 1 wherein a test zone is adapted by provision of one or more sample collection areas for the collection of at least two blood samples over at least one predetermined specified time interval, and optionally of a larger plurality of successive samples spaced apart by a plurality of predetermined intervals.

8. A device in accordance with claim 7 wherein a sample collection area comprises a sample collection well to retain such a blood sample in situ during performance of the test in fluid communication with a suitable means to provide for data collection.

9. A device in accordance with claim 8 wherein a sample collection well comprises an apertured or structured portion in a device body defining a receptacle structure into which a sample can be received and retained for testing.

10. A device in accordance with claim 1 wherein in order to collect plural samples a plurality of test zones and/or a plurality of sample collection areas are defined.

11. A device in accordance with claim 10 wherein plural sample collection areas are provided, in the form of plural attachable and/or detachable sample collection modules, each defining at least a sample collection area and an attachment portion to attach the module in data communicating manner to a receiving portion in the test device so as to form when so received or attached a said test zone.

12. A device in accordance with claim 11 wherein each sample collection module constitutes a separate attachable test strip which is attachable to the test device to provide a sample collection area in data communication with the rest of the device in use, but is detachable after performance of the test.

13. A device in a accordance with claim 11, wherein a plurality of detachable sample collection modules are provided, one for each sample to be collected, initially as an integral part of the device of the invention but adapted to be detached and discarded once a sample has been processed on the sample collection area and data therefrom collected by the data collector.

14. A device in accordance with claim 1 wherein the indicator is an audio and/or visual indicator for indicating the progress of the predetermined time interval, wherein said indicator includes means for providing an audio and/or visual alarm on expiry of the predetermined time interval.

15. A device in accordance with claim 1 including a processor for receiving downloaded data from a remote register, wherein the processor is adapted to process raw test data into a test result and store said test result for subsequent retrieval.

16. A device in accordance with claim 1 which is adapted both to collect data in a simple domestic environment under non-expert use and to allow the data to be readily passed to a clinical supervisor for processing.

17. A device in accordance with claim 16 provided in two parts, comprising a data collecting part including at least the test zone and for example also the data collector, and a recording part including at least the data register, the two parts being in data communication in use, but the data recording part being detachable from the data collecting part after use.

18. A device in accordance with claim 16 wherein the device, or the data recording part as the case may be, is adapted to allow for electronic upload of collected data to a remote site in that it includes a data connection means to enable connection to a data network site such as an ethernet port, a serial or parallel port for connection to a computer, a port for connection to a wired or wireless telecommunications network for direct download, or any other suitable data connection link.

19. A device in accordance with claim 18 wherein the data connection means enables test protocol parameters, for example the time interval, to be downloaded to the device.

20. A device in accordance with claim 1 fabricated to have a generally planar body, being fabricated from planar sheet-like material.

21. A device in accordance with claim 20 wherein, the sheet material is cardboard or plastics material.

22. A device in accordance with claim 20 wherein the sheet material, or at least an external surface thereof, comprises fluid proof or fluid resistant material.

23. A device in accordance with claim 20 provided with accompanying instructions printed upon a surface of the sheet in order to guide a user as to correct performance of a test protocol.

24. A glucose tolerance test kit, comprising a device in accordance with claim 1 provided in combination with one or more of the following:

a standardised glycaemic load;

one or more test strips selectively attachable to the device to provide at least a sample collection area of a test zone;

one or more lancets to obtain a finger prick sample from a user, for example in the form of a lancing pen;

additional instructions for performance of successive tests in accordance with the predetermined protocol.

25. A method of collecting data for performance of a glucose tolerance test comprising the use of a device or kit in accordance with claim 1.

26. A method of collecting data for performance of a glucose tolerance test in which a user carries out the following steps:

fasts for a specified time period;

obtains a test device in accordance with claim 1;

obtains a first blood spot sample, and adds this sample to a test zone on the test device to obtain a first result;

ingests a standardised glycaemic load;

optionally following ingestion of a standardised glycaemic load operates a user operable control to indicate the start of a predetermined time interval;

waits a predetermined time interval before performing at least one further blood test by obtaining at least one further blood sample and adding this sample to a test zone on the test device to obtain a further result.

27. The method of claim 26 including the further step of supplying data collected for final analysis in that the device comprises detachable collecting part and recording part, and the method comprises detaching the recording part and forwarding the same for analysis of the data.

28. The method of claim 26 wherein in an additional step, the data is analysed, by comparing test data from the at least two tests, and data concerning the predetermined time interval and/or a measured time interval between the carrying out of at least those two tests.

29. The method of claims 25 wherein test protocol parameters are downloaded to the device via a data connection means.

30. A method of collecting data for performance of a glucose tolerance test in which a user carries out the following steps:

obtain a test device in accordance with claim 1;

obtain a first blood spot sample, and adds this sample to a test zone on the test device to obtain a first result which automatically triggers a test device timer to commence timing of a predetermined time interval;

ingest a standardised glycaemic load;

wait until the predetermined time interval has elapsed before performing at least one further blood test by obtaining at least one further blood sample and adding this sample to a test zone on the test device to obtain a further result.