Glucose tolerance test device

• US 8,420,401 B2
• Filed: 08/22/2008
• Issued: 04/16/2013
• Est. Priority Date: 08/23/2007
• Status: Active Grant

• Current Assignee: Diagnostics Limited
• Original Assignee: Smartsensor Telemed Limited
• Inventors: Jackson, James
• Primary Examiner(s): Alexander, Lyle
• Application Number:
  US12/733,290
• Publication Number:
  US 20100240079A1
• Time in Patent Office: 1,698 Days
• Field of Search: 422/403, 422/430, 422/68.1, 436/50, 436/63, 436/95
• US Class Current: 436/95
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 plurality of test zones, each having a means to receive a blood test sample 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 each 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 according to claim 1, wherein said device consists of two test zones.

3. A device according to claim 1, wherein said test zones are integral to the device.

4. A device according to claim 1, wherein raw test data are stored in said data register for calibration externally in a separate instrument.

5. A device according to claim 4, further comprising means to measure and store the temperature of the device or its environment when measurements are made.

6. A device according to claim 4, further comprising a unique identification code that may be used to identify a particular individual using the device.

7. A device according to claim 1, wherein said data storage part is detachable.

10. 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;

adds a first blood spot sample to a test zone on the test device to obtain a first result;

ingests a standardized glycaemic load;

optionally following ingestion of a standardized 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 adding at least one further blood sample to a test zone on the test device to obtain a further result.

11. The method of claim 10, 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.

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

a plurality of test zones, each having a means to receive a blood test sample spaced apart by a predetermined time interval, each of said test zones fabricated integral with said device and adapted to be torn away from the device after use;

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 each 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.

9. A device as claimed in claim 8, whereas each of said test zones comprise a test strip containing a reagent for performing a glucose test, each said test strip affixed to, and extending from, said device for manually gripping and tearing away from the device after use.