KR-20260065863-A - Method for measuring the level of an analyte in a subject

KR20260065863AKR 20260065863 AKR20260065863 AKR 20260065863AKR-20260065863-A

Abstract

A method for measuring an analyte level of a subject is disclosed. The method comprises the following steps: ㆍ a) non-invasively detecting a first amount of at least one first volatile organic marker originating from a first source of the subject; ㆍ b) non-invasively detecting a second amount of at least one first volatile organic marker originating from a second source of the subject, wherein the second source is different from the first source; and ㆍ c) measuring an analyte level of the subject based on the first amount and the second amount.

Inventors

벤더 제프리 엠
치타잘루 시바
피셔 제니퍼
미야카와 토마스
핑크 헤르베르트

Assignees

로셰 다이어비티즈 케어 게엠베하
로셰 다이어비티즈 케어 인코포레이티드

Dates

Publication Date: 20260511
Application Date: 20240910
Priority Date: 20231002

Claims (15)

A method for measuring the level of an analyte of a subject, comprising the following steps: a) a step of non-invasively detecting a first amount of at least one first volatile organic marker originating from a first source of the object; b) a step of non-invasively detecting a second amount of at least the first volatile organic marker originating from a second source of the subject, wherein the second source is different from the first source; and c) A step of measuring the level of the analyte of the subject based on the first and second amounts.
A method according to paragraph 1, wherein the first source is exhaled breath and the second source is another source of gas emission different from exhaled breath, or vice versa.
A method according to paragraph 1 or 2, wherein the analyte is glucose.
A method according to any one of claims 1 to 3, wherein the first volatile organic marker is selected from a group of markers in which the amount of the volatile organic marker has a negative correlation with the glucose level.
A method according to any one of claims 1 to 4, wherein the first volatile organic marker is one of indole (C8H7N), a partially saturated derivative of indole, a fully saturated derivative of indole, and a true fraction of indole.
A method according to any one of claims 1 to 3, wherein the first volatile organic marker is selected from the group consisting of formaldehyde and methanol.
In any one of paragraphs 1 through 6, d) a step of non-invasively detecting a third amount of at least a second volatile organic marker originating from the first source of the subject; and e) additionally includes the step of non-invasively detecting a fourth amount of at least one second volatile organic marker originating from a second source of the subject; A method in which, in step c), the levels of the analyte of the target are detected based on the first amount, second amount, third amount, and fourth amount.
In any one of paragraphs 1 through 3, d) a step of non-invasively detecting a third amount of at least a second volatile organic marker originating from the first source of the subject; and e) additionally includes the step of non-invasively detecting a fourth amount of at least one second volatile organic marker originating from a second source of the subject; A method in which, in step c), the levels of the analyte of the subject are detected based on the first, second, third, and fourth amounts, and the first volatile organic marker is indole and the second volatile organic marker is formaldehyde or methanol.
In Article 7 or Article 8, f) a step of non-invasively detecting a fifth amount of at least a third volatile organic marker originating from the first source of the object; and g) additionally includes the step of non-invasively detecting a sixth amount of at least one third volatile organic marker originating from a second source of the subject; A method in which, in step c), the levels of the analyte of the target are detected based on the first, second, third, fourth, fifth, and sixth amounts.
In paragraph 8, f) a step of non-invasively detecting a fifth amount of at least a third volatile organic marker originating from the first source of the object; and g) additionally includes the step of non-invasively detecting a sixth amount of at least one third volatile organic marker originating from a second source of the subject; In step c), the levels of the analytes of the subject are detected based on the first, second, third, fourth, fifth, and sixth amounts, and the first volatile organic marker, the second volatile organic marker, and the third volatile organic marker are formaldehyde, methanol, and indole, respectively.
A method according to any one of claims 1 to 10, wherein in step a) a first amount of at least one first volatile organic marker originating from the first source of the object is detected continuously, and in step b) a second amount of at least one first volatile organic marker originating from the second source of the object is detected discontinuously.
A system for measuring the level of an analyte of a subject, configured to execute a method according to any one of claims 1 to 6, and comprising the following: ㆍ A first volatile organic marker detection unit configured to non-invasively detect a first amount of at least one first volatile organic marker originating from a first source of the object; ㆍ A second volatile organic marker detection unit configured to non-invasively detect a second amount of at least one first volatile organic marker originating from a second source of the object; and At least one evaluation device configured to measure the level of an analyte of a subject based on a first amount and a second amount.
A system according to claim 12, wherein the first volatile organic marker detection unit and the second volatile organic marker detection unit can be placed at different locations on the body of the subject.
A system according to claim 12 or 13, wherein the first volatile organic marker detection unit and the second volatile organic marker detection unit may be connected to each other, particularly through wireless communication, preferably through wireless remote communication, and at least one of the first volatile organic marker detection unit and the second volatile organic marker detection unit is configured to transmit data to at least one external device.
A system according to any one of claims 12 to 14, wherein one of the first volatile organic marker detection unit and the second volatile organic marker detection unit is configured to make skin contact with the skin of a subject, and the other of the first volatile organic marker detection unit and the second volatile organic marker detection unit is configured to be positioned below the nostrils of a subject or below the mouth of a subject.

Description

Method for measuring the level of an analyte in a subject Technology field The present invention relates to a non-invasive method for measuring a subject's blood glucose level based on detecting volatile organic markers in exhaled breath or other gas emissions from the subject. Background Technology Monitoring blood glucose levels is crucial for diabetes management. Typical glucose measurement methods involve puncturing the skin (typically a finger) to collect blood and applying the collected blood to a chemically active disposable medium. To avoid the inconvenience of repeatedly puncturing the skin, various non-invasive blood glucose monitoring technologies have also been proposed. Existing technology describes the measurement of volatile organic compounds (VOCs) originating from various sources, such as breath samples, in various environments, and utilizes various detection methods, for example, electrochemical detection. Additionally, the combination of the detection of multiple VOCs is known, such as the simultaneous measurement of multiple VOCs using one or more detection devices. US10526633B2 describes an electrochemical sensor for plant/plant pathogen volatile compounds, a system for detecting plant/plant pathogen volatile compounds, and a method for detecting stress-induced plant volatile compounds and/or plant pathogen-released volatile compounds. US9551712B2 describes a set of VOCs for breath analysis. A method for using this for the diagnosis, monitoring, or prognosis prediction of breast cancer, head and neck cancer, prostate cancer, or colorectal cancer is disclosed. US20210341461A1 describes a method for detecting respiratory biomarkers to detect cancer early and monitor its progression. The method includes the step of evaluating the activity of aldoketo reductase by measuring the concentration of an exogenous substrate for aldoketo reductase in the exhaled breath of a subject and/or measuring the concentration of metabolites of said substrate. Preferably, the cancer is lung cancer. EP2270496A1 describes the identification of markers for disease states associated with cystic fibrosis (CF). The diagnostic uses of these markers and a novel method for marker identification are described. Patients with cystic fibrosis were distinguished from normal subjects by checking whether markers selected from the set were present in exhaled breath. These markers were found to be useful for the early diagnosis of cystic fibrosis. WO2022101598A1 describes an apparatus for detecting the presence of a subject or subjects infected with a viral, bacterial, and/or parasitic disease or diseases in a closed environment, wherein the apparatus comprises: (a) an air sampling unit capable of collecting an air sample from the atmosphere of a closed environment and converting said sample for detection; (b) a selected set of definite sensors comprising at least two sensors that respond to a specific odor or volatile organic compound (VOC) present in the air sample collected from the environment; (c) a processing unit comprising a pattern recognition analyzer, wherein the pattern recognition analyzer receives an output signal from the sensor set and compares it with a disease-specific pattern derived from a database of response patterns of the sensor set exposed to all bodily fluid discharges of a subject having a known disease or diseases (each said disease-specific pattern represents a specific disease selected from bacterial, viral, and parasitic diseases), and selects the closest match between the output signal of said sensor set and the disease-specific pattern; and (d) a control unit that triggers air space sampling of the environment at a predetermined time or interval to fully automate the apparatus and allow it to operate autonomously. WO2012040318A2 describes compositions, methods, and kits for melanoma detection and melanoma boundary determination. This relates to a panel of volatile metabolic biomarkers that can be used for the diagnosis of melanoma skin cancer. The approach for detecting melanoma is based on volatile byproducts of modified cancer metabolism. Furthermore, a method for identifying molecules useful for melanoma detection is provided, which lays the foundation for the development of biosensors, a non-invasive detection technology for melanoma diagnosis. CN115297768A describes a method for determining whether a subject has mild cognitive impairment (MCI) or Alzheimer's disease, and the method includes the step of measuring one or more VOC concentrations in a sample of the subject's breath and comparing the said concentrations to a reference concentration. EP4085832A1 describes a method for non-invasively measuring a subject's blood glucose level by analyzing exhaled breath or other gas emissions from a subject, and the method comprises the steps of non-invasively detecting the amount of at least one volatile organic marker in the subject's exhaled breath or other gas emissions as marker data, and mea