Glucose testing device and method

Abstract

The invention relates to a glucose test device for use in a handheld meter, comprising: a disposable test pad (16) responsive to glucose in a bodily fluid; and a support member (30) adapted to support the test pad (16) at an application site for applying bodily fluid from the skin of the user onto a receiving area (38) of the test pad (16) wherein the receiving area (38) faces away from the support member (30). In order to improve user assistance, it is proposed that one or more spacer elements (20) are arranged on the support element (30) adjacent to the test pad (16), the one or more spacer elements (20) having a skin contact end section (36) protruding above a receiving region (38).

Description

[0001] This application is a divisional application based on Chinese invention patent application No. 201880050488.5, filed on July 31, 2018, entitled "Glucose Testing Apparatus and Method". Technical Field

[0002] This invention relates to a glucose testing device for use in a handheld instrument, comprising: a disposable test pad responsive to glucose in bodily fluids; and a support member adapted to support the test pad at an application site for applying bodily fluids (especially bodily fluids as blood drops) from the user's skin and especially from the user's finger onto a receiving area of ​​the test pad, wherein the receiving area faces away from the support member, such that the sample fluid is applied from the top and the opposite sides are flattened and supported. The invention particularly relates to a test strip cartridge and also to a handheld instrument as a glucose concentration measuring device. Background Technology

[0003] In the field of blood glucose testing, it is known to use disposable test elements in handheld blood glucose meters for on-site measurements. Users provide a fresh blood sample by pricking their finger and transferring a drop of blood onto the test element. Specifically, multiple test elements can be provided for continuous use on a test strip, which can be loaded into the meter in the form of a replaceable strip cartridge. Therefore, users do not need to pay attention to the handling of each individual test element. However, this instrument is typically used by patients outside of a laboratory setting, and therefore measurements can be susceptible to unintended user manipulation. For example, contamination on the user's finger (e.g., from food) may result in an additional glucose content in the blood drop produced on the finger. Therefore, if the user does not properly wash their finger before performing the test, an erroneous high glucose reading may occur. Furthermore, some users may tend to press their fingers relatively firmly against the test field or test pad, or the user may rub their fingers on the test pad during measurement. In extreme cases of user manipulation, significant measurement bias may occur. Summary of the Invention

[0004] Based on this, the purpose of the present invention is to further improve known testing devices, equipment, and methods to ensure improved accuracy of blood glucose measurement results during the data acquisition or detection phase.

[0005] This objective is achieved through a combination of features stated in the independent claim. Advantageous embodiments and further developments of the invention are derived from the dependent claims.

[0006] This invention is based on the idea of ​​preventing measurement distortion by assisting the user in applying the sample to the test field. Therefore, a glucose testing device is proposed in which one or more spacer elements are arranged adjacent to the test pad on a support member, wherein the one or more spacer elements have skin-contacting end sections, particularly finger-contacting end sections, protruding above the receiving area of ​​the test pad. In this way, the user receives tactile feedback before contacting the test pad. Direct pressure of skin or fingers on the test pad is prevented, and / or even skin or finger contact with the test pad is prevented. Only blood droplets reach the receiving area of ​​the test pad. Furthermore, the spacer elements reduce the risk of the user wiping away contaminated blood from the surface of their fingers. Instead, the majority of the uncontaminated blood from the portion of the blood droplet further away from the skin or finger surface is applied to the test pad.

[0007] In order to provide a test pad at the application site, the test pad can be moved relative to the support member and relative to the spacer element thereon.

[0008] For large-area wetting with bodily fluids, it is advantageous that the bottom side of the test pad is flat and preferably fully adjacent to the support member, while the receiving area is arranged on the top side of the test pad opposite the bottom side of the test pad.

[0009] Furthermore, the spacer elements are arranged adjacent to the boundary of the receiving area, such that they are integrally separated from the test pad at the application site and do not have a strong connection with the test pad at the application site.

[0010] Advantageously, the spacer elements are selected from the group including ridges, strips, pins, nails, edges, rectangles, triangles and serrated structures.

[0011] To address specific sample application processes, spacer elements advantageously have beveled, chamfered, and / or rounded profiles.

[0012] To further enhance user assistance, the spacer element is made of a non-elastic material and is a rigidly shaped part.

[0013] According to a preferred embodiment, the spacer elements are arranged on opposite sides of the test pad, which preferably has a rectangular profile. This configuration is particularly advantageous for tape cassettes when the spacer elements are arranged on opposite sides of the test tape.

[0014] Advantageously, the spacer element is adapted to provide tactile feedback to the user during sample application.

[0015] For this purpose, the end sections of the spacer element have linear or pointed contact surfaces for contacting the user's skin.

[0016] As another advantageous measure, the spacer element is adapted to substantially prevent fingers from coming into direct contact with the test pad during sample application.

[0017] This device is particularly important when the test pad is at least partially compressible or becomes at least partially compressible after wetting.

[0018] For optimized functional values, the height of the spacer element should be in the range of 0.5 to 5 mm, especially in the range of 1 to 3 mm.

[0019] For direct measurement at the application site, it is advantageous that the support member includes a window on the bottom side opposite the receiving area for the optical scanning test pad. It is also advantageous that this window contains optical elements or defines an opening without optical elements.

[0020] Another improvement related to a cassette includes a support member formed to guide the tip of a conveyor belt that carries multiple test pads spaced apart from each other.

[0021] Alternatively, for the use of a single disposable item, the support structure is adapted to position the test strip that supports the test pad.

[0022] Another aspect of the invention relates to a cartridge for glucose testing, comprising a testing apparatus according to the invention, wherein a support member is formed as a deflection tip for a conveyor belt carrying a plurality of test pads spaced apart from each other, and wherein spacer elements are arranged on two longitudinal sides of the conveyor belt, preferably as injection-molded portions on the two longitudinal sides of the conveyor belt.

[0023] The present invention also relates to a handheld instrument for glucose testing, comprising the aforementioned cartridge or testing device and preferably a photometric detection unit operable to detect measurements on a test pad.

[0024] Another aspect of the present invention relates to a glucose testing method used in a handheld instrument, comprising the following steps: - Provides a disposable test pad that responds to glucose in bodily fluids. - The test pad is placed and positioned on a support member at the site of fluid application, wherein one or more spacer elements are arranged adjacent to the test pad on the support member. - Bodily fluids, particularly blood droplets, are applied from the user's skin to the receiving area of ​​the test pad, wherein the receiving area faces away from the supporting member. - By means of the skin contact end section of the one or more spacer elements, which protrudes above the receiving area, the test pad is made into contact with the user's skin, thereby preventing the finger from directly contacting the test pad during sample application, so as to improve the accuracy of glucose testing.

[0025] In this way, similar effects and advantages are achieved, as mentioned above. Attached Figure Description

[0026] The invention will now be further described based on the embodiments schematically illustrated in the accompanying drawings, wherein... Figure 1 A test strip cartridge for glucose testing is shown, having a deflecting tip and a finger contact spacer element protruding from the tip; the test system includes; Figure 2 This is a perspective view of a handheld blood glucose meter configured to use a test kit; Figure 3 yes Figure 1 Enlarged sectional view; and Figure 4 ad illustrates various forms of spacer elements on the tip. Detailed Implementation

[0027] like Figure 1 An exemplary embodiment of the disposable cassette 10 for blood glucose testing, as depicted herein, includes: a housing 12; a wound conveyor belt 14 carrying a plurality of test pads 16 spaced apart from each other; and a deflecting tip 18 for continuously providing the test pads 16 on the tip 18 for application of a sample in contact with a user's finger, wherein protruding spacer elements 20 on the tip 18 provide tactile feedback to the user during sample application and prevent direct contact between the skin or finger and the test pads. Transfer of the conveyor belt 14 is accomplished via two reels, as in conventional audio or video cassette tapes (not shown).

[0028] like Figure 2 As further shown, the portable blood glucose meter 12 is adapted to receive a disposable test strip cartridge 10 that can be inserted into a compartment of the meter housing 24. When the tip cap 26 is opened, the tip 18 of the inserted cartridge 10 can be accessed, and then the user applies a drop of blood by pricking their finger with a puncture aid and touching the top side of the test pad 16. During this manipulation step, the tip 18 acts as a support member 30 under the test pad 16.

[0029] The handheld instrument 22 is equipped with a photometric measurement unit 28 for determining the glucose concentration based on the measured value. For this purpose, a test pad 16 on the conveyor belt 14 is formed by a layered chemical field that responds to the analyte (i.e., glucose) through a color change. The measurement unit 22, provided as a reflectometer, then allows the analyte concentration to be measured by optically scanning the rear side of the test element 22 and the transparent conveyor belt 14 through an optical window in the support member 30. The measurement results and other information can be displayed to the user on the display 32.

[0030] As from Figure 3 Clearly, the spacer elements 20 are arranged laterally to the band 14 as a rigid, integral structure of the tip 18, preferably as an injection-molded portion. These spacer elements are formed as ribs or ridges protruding from the flat or curved support surface 34 of the support member 30. The linear skin-contact end section 36 of the spacer element 20 protrudes above the upper fluid (blood) receiving area 38 of the effective test pad 16 on the tip 18. Since the test pad 18 is at least partially compressible or becomes at least partially compressible after sample application, the spacer elements 20 should have sufficient height (e.g., in the range of 1 to 3 mm measured from the base) to avoid direct finger pressure. Such pressure after wetting can cause undesirable changes to the layered test structure (especially when the covering mesh provided for sample spreading is pressed into the chemical field), thereby impairing optical measurements.

[0031] Spacer elements 20 are arranged on opposite sides of the rectangular test pad 16. Therefore, the user receives tactile information before their fingers touch the test pad 16, thus avoiding the application of excessive pressure. Furthermore, spacer elements 20 reduce unwanted finger movements during sample application, such as due to tremors.

[0032] Figure 4 Various embodiments of the spacer element 20 on the tip 18 of the housing are schematically illustrated. Figure 4 In a, the spacer element 20 has a chamfered triangular shape terminating at a pointed contact surface 36. Also noticeable is the optical window 40 at the center of the support surface 34 used for reflectometer measurements. Figure 4 b shows the sawtooth structure of the spacer element 20, while Figure 4 c and Figure 4 Figure d illustrates the nail and rounded pin as spacer element 20. Example

[0033] The improvement of the design according to the invention was demonstrated in a comparative study, the results of which are given in Table 1 below. In this study, cartridges 10 with and without spacer elements 20 on the support member 30 were used. Results within the commonly used reference range of + / - 10 mg / dL (+ / - 0.56 mmol / L) from the reference value were approved in the glucose concentration range below 100 mg / dL, while results within a relative range of + / - 10% from the reference value were considered acceptable in the higher range of 100 mg / dL and above. Reference glucose values ​​for the samples were determined using the hexokinase method (hexokinase / glucose-6-phosphate-dehydrogenase) and a commercially available Cobas 6000 C501 analyzer system. The results obtained clearly demonstrate the improved accuracy of analyte measurements using the spacer element 20 on the cartridge tip.

[0034] Table 1: Comparative Study of Cassette Tape Design Boxes without spacer elements (conventional) A box with spacer elements (design of this invention) glucose concentration <100 mg / dL The result deviated from the control value by ±10 mg / dL. 98.7% （154 / 156） 99.5% （185 / 186） Glucose concentration ≥ 100 mg / dL The result deviated from the reference value by ±10%. 92.3% （410 / 444） 99.3% （411 / 414）

Claims

1. A glucose testing device for use in a handheld instrument, comprising: A disposable test pad (16) responsive to glucose in bodily fluids; and a support member (30) adapted to support the test pad (16) at an application site for applying bodily fluids, particularly as blood droplets, from a user's skin onto a receiving area (38) of the test pad (16), wherein the receiving area (38) faces away from the support member (30), characterized in that one or more spacer elements (20) are arranged adjacent to the test pad (16) on the support member (30), wherein the one or more spacer elements (20) have a skin-contact end segment (36) protruding above the receiving area (38). The test pad (16) is movable relative to the support member (30) and the spacer element (20) thereon. The support member (30) is formed as a tip (18) for guiding the conveyor belt (14), which carries a plurality of test pads (16) spaced apart from each other. The spacer element (20) is a discrete structure arranged laterally to the strip (14) as a rigid integral structure of the tip (18).

2. The apparatus according to claim 1, wherein, The bottom side of the test pad (16) located at the application site is flat and completely adjacent to the support member (30), and the receiving area (38) is arranged on the top side of the test pad (16) opposite to the bottom side of the test pad (16).

3. The apparatus according to claim 1, wherein, The spacer elements (20) are arranged adjacent to the boundary of the receiving area (38) such that they are integrally separated from the test pad (16) at the application site and do not have a strong connection with the test pad (16) at the application site.

4. The apparatus according to claim 1, wherein, The spacer element (20) is selected from the group consisting of ridges, strips, pins, nails, edges, rectangles, triangles and serrated structures.

5. The apparatus according to claim 1, wherein, The spacer element (20) has a beveled, chamfered and / or rounded profile.

6. The apparatus according to claim 1, wherein, The spacer element (20) is made of a non-elastic material and is a rigid shaped part.

7. The apparatus according to claim 1, wherein, The spacer element (20) is arranged on the opposite side of the preferably rectangular test pad (16).

8. The apparatus according to claim 1, wherein, The end section (36) of the spacer element (20) has a linear or pointed contact surface for contacting the user's skin.

9. The apparatus according to claim 1, wherein, The spacer element (20) is adapted to provide tactile feedback to the user and / or substantially prevent the finger from directly contacting the test pad (16) during sample application.

10. The apparatus according to claim 1, wherein, The test pad (16) is at least partially compressible, or becomes at least partially compressible after the sample is applied.

11. The apparatus according to claim 1, wherein, The height of the spacer element (20) is in the range of 0.5 mm to 5 mm, especially in the range of 1 mm to 3 mm.

12. The apparatus according to claim 1, wherein, The support member (30) includes a window (40) for optically scanning the bottom side of the test pad (16) opposite to the receiving area (38).

13. The apparatus according to claim 12, wherein, The window (40) contains optical elements or defines an opening without optical elements.

14. The apparatus according to any one of claims 1 to 13, wherein, The support member (30) is adapted to position the test strip that carries a single test pad (16).

15. A cartridge for glucose testing, comprising the device according to any one of claims 1 to 14, wherein, The support member (30) is formed as a deflection tip (18) for a conveyor belt (14) carrying a plurality of test pads (16) spaced apart from each other, wherein the spacer elements (20) are arranged on both sides of the conveyor belt (14), preferably as injection molded portions on both sides of the conveyor belt (14).

16. A handheld instrument for glucose testing, comprising: The cassette (10) or device according to any one of the preceding claims; And preferably a photometric detection unit (28), which is operable to detect measurements on the test pad (16).

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