GLUCOSE TEST ARRANGEMENT AND METHOD

Abstract

A glucose test arrangement is provided for use in a handheld meter. The arrangement comprises a disposable test pad responsive to glucose in a body fluid, and a supporting member adapted to support the test pad at an application site for applying body fluid from a user's skin onto a receiving area of the test pad. The receiving area faces away from the supporting member. One or more spacer elements are arranged on the supporting member adjacent to the test pad, wherein the one or more spacer elements have a skin-contacting end section which protrudes above the receiving area.

Claims

1. A glucose test arrangement for use in a handheld meter, comprising a disposable test pad which is responsive to glucose in a body fluid, and a supporting member adapted to support the test pad at an application site for applying a drop of blood from a user's skin onto a receiving area of the test pad, wherein the receiving area faces away from the supporting member, and further comprising one or more spacer elements arranged on the supporting member adjacent to the test pad, wherein the one or more spacer elements have a skin-contacting end section which protrudes above the receiving area.

2. The arrangement of claim 1, wherein the test pad is moveable relative to the supporting member and to the spacer elements thereon.

3. The arrangement of claim 1, wherein a bottom side of the test pad provided at the application site flatly and fully abuts against the supporting member, and the receiving area is arranged on a top side of the test pad opposite to the bottom side of the test pad.

4. The arrangement according to claim 1, wherein the spacer elements are arranged adjacent to a boundary of the receiving area such that they are bodily separate from the test pad at the application site and without solid connection to the test pad at the application site.

5. The arrangement according to claim 1, wherein the spacer elements are adapted to provide a haptic feedback to the user and/or to essentially prevent direct finger contact with the test pad during sample application.

6. The arrangement according to claim 5, wherein the spacer elements are selected from the group comprising ridges, bars, pins, spikes, edges, rectangles, triangles, and saw-tooth structures.

7. The arrangement according to claim 5, wherein the spacer elements have a beveled, chamfered and/or rounded contour.

8. The arrangement according to claim 5, wherein the end section of the spacer elements has a linear or pointed contact surface for contacting the user's skin.

9. The arrangement according to claim 1, wherein the spacer elements are made of a non-elastic material as a rigid formed part.

10. The arrangement according to claim 1, wherein the spacer elements are arranged on opposite sides of the test pad.

11. The arrangement according to claim 1, wherein the test pad is at least partly compressible or becomes at least partly compressible after sample application.

12. The arrangement according to claim 1, wherein the spacer elements have a height in the range from about 0.5 mm to about 5 mm.

13. The arrangement according to claim 12, wherein the height is in the range from about 1 mm to about 3 mm.

14. The arrangement according to claim 1, wherein the supporting member comprises a window for optically scanning a bottom side of the test pad opposite to the receiving area.

15. The arrangement according to claim 14, further comprising a photometric detection unit operable for detecting measuring values on the test pad.

16. The arrangement of claim 14, wherein the window contains an optical element or delimits an opening free from an optical element.

17. The arrangement according to claim 1, wherein the supporting member is formed as a tip for guiding a transport tape which carries a plurality of test pads spaced apart from each other.

18. The arrangement according to claim 17, wherein the supporting member is further adapted to position a test strip carrying a single test pad.

19. A tape cassette for glucose tests, comprising the arrangement of claim 1, wherein the supporting member is formed as a deflection tip for a transport tape which carries a plurality of test pads spaced apart from each other, and wherein the spacer elements are arranged on both sides of the transport tape and comprise injection-molded parts.

20. A glucose test method for use in a handheld meter, comprising: providing a disposable test pad which is responsive to glucose in a body fluid, positioning the test pad on a supporting member at an application site for body fluid, where one or more spacer elements are arranged on the supporting member adjacent to the test pad, applying a drop of blood from a user's skin onto a receiving area of the test pad, where the receiving area faces away from the supporting member, contacting the user's skin by means of a skin-contacting end section of the one or more spacer elements which protrudes above the receiving area, thereby preventing direct finger contact with the test pad during sample application for enhanced accuracy of the glucose test.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In the following, the invention is further elucidated on the basis of an embodiment example shown schematically in the drawings, where:

[0029] FIG. 1 shows a test tape cassette for glucose tests having a deflection tip and finger-contacting spacer elements projecting from the tip; testing system including;

[0030] FIG. 2 is a perspective view of a handheld glucose meter configured for using the test tape cassette;

[0031] FIG. 3 is an expanded cut-out from FIG. 1; and

[0032] FIG. 4 illustrates various alternative forms of spacer elements on the tip, denoted as a.), b.), c.) and d.).

DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION

[0033] As depicted in FIG. 1, an exemplary embodiment of a disposable tape cassette 10 for blood glucose tests comprises a housing 12, a spoolable transport tape 14 which carries a plurality of test pads 16 spaced apart from each other and a deflection tip 18 for successive provision of the test pads 16 on the tip 18 for sample application in contact with a user's finger, wherein protruding spacer elements 20 on the tip 18 provide a haptic feedback to the user during sample application and prevent direct skin or finger contact with the test pad. Forwarding of the transport tape 14 is accomplished by two spools as in a conventional audio or video cassette (not shown).

[0034] As further shown in FIG. 2, a portable glucose meter 22 is adapted to receive the disposable test tape cassette 10 which can be inserted into a compartment of the meter housing 24. The tip 18 of the inserted tape cassette 10 is accessible upon opening a tip cover 26. Then, the user applies a drop of blood by pricking a finger with a lancing aid and contacting the top side of the test pad 16. During this handling step, the tip 18 serves as a supporting member 30 underneath the test pad 16.

[0035] The handheld meter 22 may be provided with a photometric-type measuring unit 28 for determining a glucose concentration from the measured values. For this purpose, the test pads 16 on the transport tape 14 are formed by a layered chemistry field which is responsive to the analyte, such as glucose, by a color change. Then, the measuring unit 28 allows a measurement of the analyte concentration by optical scanning of the rear side of transport tape 14 at the location of a dosed test pad 16, through an optical window in the support member 30 and the transparent transport tape 14. The measuring result and other information can be displayed to the user on a display 32.

[0036] As apparent from FIG. 3, the spacer elements 20 are arranged laterally to the tape 14 as a rigid unitary structure of the tip 18, made, for example, as injection-molded parts. These are formed as ribs or ridges protruding from the flat or curved supporting surface 34 of the supporting member 30. The linear skin-contacting end section 36 of the spacer elements 20 protrudes above the upper fluid (blood) receiving area 38 of the active test pad 16 on the tip 18. As the test pad 16 may be at least partly compressible or may become at least partly compressible after sample application, the spacer elements 20 should have a sufficient height in the range of about 0.5 mm to about 5.0 mm, such as from about 1 mm to about 3 mm, measured from the surface of the supporting member 30, in order to avoid direct finger pressure. Pressure from a finger after wetting may lead to an unwanted modification of the layered test structure, for example if a covering net or mesh is provided for sample spreading it may become impressed into the chemistry field, thus impairing or impacting an optical measurement.

[0037] The spacer elements 20 may be arranged on opposite sides of the test pad 16. As shown, the test pad 16 has a rectangular contour. Thereby, the user receives tactile feedback information before his finger reaches the test pad 16. In this way, excessive exertion of pressure can be avoided. Furthermore, the spacer elements 20 may provide a certain stability for the applying finger, for example by reducing unwanted finger movement during sample application, such as due to tremor.

[0038] FIG. 4 schematically shows various alternative embodiments of spacer elements 20 on a cassette tip 18. In FIG. 4a, the spacer elements 20 have a chamfered, triangular shape ending in a pointed contact surface 36. Also apparent is an optical window 40 in the center of the supporting surface 34 for reflectometric measurement. FIG. 4b shows saw-toothed structures of spacer elements 20, whereas FIG. 4c and FIG. 4d illustrate spikes and rounded pins as spacer elements 20.

EXAMPLE

[0039] The improvement with the design according to an embodiment of the present invention was demonstrated in a comparative study, the results of which are given in Table 1 below. In the study, tape cassettes 10 with and without spacer elements 20 on the supporting member 30 have been used. In the glucose concentration range below 100 mg/dL, results in a commonly used benchmark interval of +/10 mg/dL (+/0.56 mmol/L) from reference values have been approved, whereas in the higher range of 100 mg/dL and above results in a relative interval of +/10% from reference values have been counted as acceptable. The reference glucose values for the samples were determined using a hexokinase methodology (hexokinase/glucose-6-phosphate-dehyrogenase) and a commercially available Cobas 6000 c501 analyzer system. The obtained results clearly demonstrate the enhanced precision of the analyte measurements employing the spacer elements 20 on the tape cassette tip.

TABLE-US-00001 TABLE 1 Comparative study of tape cassette design Cassette without Cassette with spacer elements spacer elements (conventional) (inventive design) Glucose Result within 98.7% 99.5% concentration +/10 mg/dL (154/156) (185/186) <100 mg/dL from reference value Glucose Result within 92.3% 99.3% concentration +/10% from (410/444) (411/414) 100 mg/dL reference value