WO2022201009A1 - Non-invasive glucose level monitoring device using absorption spectroscopy with affordability - Google Patents

Non-invasive glucose level monitoring device using absorption spectroscopy with affordability Download PDF

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Publication number
WO2022201009A1
WO2022201009A1 PCT/IB2022/052581 IB2022052581W WO2022201009A1 WO 2022201009 A1 WO2022201009 A1 WO 2022201009A1 IB 2022052581 W IB2022052581 W IB 2022052581W WO 2022201009 A1 WO2022201009 A1 WO 2022201009A1
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Prior art keywords
glucose level
monitoring
absorption spectroscopy
affordability
invasive
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PCT/IB2022/052581
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French (fr)
Inventor
Duvvuru Varshitha
Vimal KUMAR RN
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Duvvuru Varshitha
Kumar Rn Vimal
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Application filed by Duvvuru Varshitha, Kumar Rn Vimal filed Critical Duvvuru Varshitha
Publication of WO2022201009A1 publication Critical patent/WO2022201009A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters

Definitions

  • the present invention generally relates to the field of non-invasive glucose level monitoring device, particularly relates to non-invasive monitoring using absorption spectroscopy. More particularly, the present invention relates to a device for non-invasive glucose level monitoring device using absorption spectroscopy with affordable cost in terms of buying accessories and maintenance.
  • Diabetes is one among the major health issues which has been reached to alarming levels. Nearly half billion are living with diabetes worldwide. Diabetes is one among the fastest growing health disorders of the 21st century.
  • Insulin is the essential hormone which will be produced in the pancreas which allows glucose from the bloodstream to enter into body cells, and also helps in initiating protein and fat metabolism. Poor production of insulin or inability of cells to respond to it, typically leads to high levels of glucose. Diabetes is a serious long-term condition that occurs when the body cannot produce any or enough insulin or stops effectively using the insulin it produces. Diabetes is associated along with many other metabolic diseases and disorders. The long term persistence of diabetes results in many metabolic complications related to organs such as eyes (retina), Renal, liver etc. There are four main categories of diabetes: Type-1, Type-2, Gestational and pre- diabetes.
  • Type-1 Diabetes Most common chronic diseases in childhood caused by autoimmune reactions where the immune system attacks insulin producing beta cells and can also occur at any stage. As a result, the body will produce little or no insulin hormone. The individuals with type -1 need to intake insulin daily to maintain their blood glucose levels regularly. Frequent glucose monitoring and proper education are needed to lead the healthy lifestyle. Symptoms like excessive thirst, blurred vision, and frequent urination, lack of energy & fatigue and constant hunger can be observed. Type - 1 can be diagnosed in the presence of polyuria, polydipsia and frequent weight loss.
  • Type-2 Diabetes Around 90% of the world suffers from diabetes mellitus, Getting hyperglycemia is the result initially, of the inability of body cells to respond fully to the insulin hormone, which is known as insulin resistance. During the condition of Type -2 the insulin hormone is ineffective, which can develop as a result of failure of pancreatic cells (beta cells).Type -2 is symptomless when compared to type-1 and the time of onset is critically impossible to determine. l/3rd of the population with type-2 left undiagnosed. Unrecognition for a long time leads to complications such as retinopathy or a lower -limb ulcer. Type-2 especially varies in genetic susceptibility. Females are most commonly affected by type-2 in all groups.
  • IGT and IFT are the conditions of hyperglycemic levels and hypoglycemic levels. IGT and IFT can also be called Non diabetic hyperglycemia or intermediate hyper hyperglycemia. Pre- diabetes signifies the risk of future development of type- 2 and it denotes already heightened risk of Cardiovascular Diseases. WHO use of HBA1C > 6.5% for the diagnostics of diabetes as a part of diagnostic criteria. Gestational phase: Diabetes during the stage of pregnancy or childbirth is known as diabetic mellitus. According to the International Federation of Gynaecology and obstetrics (HIP) can be classified into gestational phase diabetes mellitus or diabetes in pregnancy.
  • Diabetes is hereditary condition and the on-set of diabetes is expected among non-diabetic population with a history of diabetes from ancestors.
  • 1 in 2 people with diabetes are more than 65 years old, 1 in 6 live births that is the average of 20 Million population is affected by hyperglycemia (High Sugar), 84% of which have gestational phase diabetes.
  • hyperglycemia High Sugar
  • 84% of which have gestational phase diabetes Over 1.1 million children and adolescents below 20 years have type-1 diabetes.
  • 1 in 2 adults are left undiagnosed (232 Million) people due to the uncomfortable and infeasible diagnosing measures.
  • Blood sugar monitoring is a procedure that measures the amount of sugar which is your body’s main source of energy, glucose levels in your blood. Monitoring blood glucose levels is an important tool in managing your diabetes because it is the main form of keeping your diabetes under control. Keeping one’s blood sugar within the normal range is important to avoid the complications caused by diabetes. For individuals with diabetes blood glucose monitoring provides the instant results of your hyper and hypoglycemia levels which can lead to major health problems including Cardiac arrest and Brain damage if not treated. So there is a high necessity level to monitor blood glucose levels among every individual suffering from diabetes.
  • US20070123761 titled - “Extended focal region measuring apparatus and method” describes that the “A method and apparatus for measuring an apparent depth of a section of an animal body are disclosed.
  • Light is focused concurrently to an extended focal region comprising a plurality or continuum of measurement locations.
  • Light reflected by a refractive index interface coincident with one of the plurality of measurement locations is detected.
  • Detected light signals are generated from light reflected from first and second interfaces respectively defining the section under investigation, so that the apparent positions of the interfaces may be derived.
  • a confocal arrangement and an axicon element may be employed.
  • the section is the aqueous humor of an eye.
  • Lrom changes in its refractive index corresponding changes in glucose concentration in the aqueous humor and, in turn, in the blood stream of a patient may be derived, offering a non-invasive monitoring means for diabetic patients.
  • Other compounds and structures of the body may alternatively be investigated”.
  • EP3466320 tiled - “Method and multi-sensor device for noninvasive monitoring of blood glucose levels” describes that the “The present invention allows for non-invasive monitoring of the blood sugar levels in diabetic patients.
  • At least one heat and waterproof applicator is applied to the skin surface by a dosage pressure.
  • Temporal dynamics of physiological parameters of the local tissue region are measured under the applicator.
  • Temporal dynamics of climatic parameters of the environment are measured simultaneously or before the beginning of measurement of physiological parameters in the monitoring mode.
  • enthalpy of tissue is calculated with account for the influence of climatic parameters.
  • Magnitude of thermal effect of metabolism of the local area of living tissue is calculated on the basic thermodynamics equation, connecting enthalpy of tissue with variables of thermodynamic state. Relative changes in the level of glucose are calculated in blood, proportional to the value of the thermal metabolism of the local area of living tissue”.
  • WO20 10030609 titled - “sweat collection devices for glucose measurement” describes that the “Devices, methods, and kits for collecting sweat that has come to the surface of the skin are provided.
  • the sweat may be collected for measuring sweat glucose levels. Because sweat glucose levels correlate to blood glucose levels, the provided devices, methods, and kits may be used by diabetic patients to non - invasively monitor blood glucose levels.
  • Sweat collection devices may be attachable to the surface of the skin and may collect about one microliter or less of sweat. Because only a small, fixed volume of sweat may be collected, the sweat glucose level may be measured in a matter of minutes. Further, as a fixed volume of sweat is tested, inaccuracies due to estimates of the sweat volume being tested are less likely to cause an inaccurate glucose measurement”.
  • W02020102573 titled - “Non-invasive monitoring system” describes that the “A wearable device for non-invasive monitoring of the presence, amount, and/or concentration of an analyte in a sample from a user of the device is described.
  • the analyte is selected to be indicative of or related to a physiological status of a user.
  • Relevant physiological status include hypoglycemia, infection, respiratory infection, urinary infection, gastrointestinal infection, obesity, diabetes, type I diabetes and type II diabetes”. None of the above-mentioned prior arts neither teaches nor discloses about accurate measurement of glucose levels for more than 95% using absorption spectroscopy technique. Accordingly, there exists a need for a system which is non-invasive accurate measurement of glucose levels.
  • It is another object of the present invention is to have the plug use technique that is just insert or Place your finger into the device monitoring takes place with Near IR radiation.
  • the device is more comfortable and convenient with the aid “companion app” which displays the glycemic levels with High, medium or low notification alerts and weekly data analytics with no limitation in monitoring can be done as often as needed, along with it is affordable due to onetime investment thereby no repeated expenses on lancets and test strips are incurred.
  • the device supports and improves your diabetes management by understanding how your diet and lifestyle affects your diabetic life with the aid of data analytics is being embedded with this device as well as thereby not comprising the test result accuracy instantly with proven performance in clinical studies and approaches.
  • the basic aspect of the present invention is to provide non-invasive glucose level monitoring device using absorption spectroscopy with affordability, said device comprising of: a mobile application (1); a monitoring unit (2); and a measuring object (3), wherein, the mobile application (1) is assessing the data through the input from the monitoring unit (3) and displays the glucose level in the user mobile display, thereby the measuring object (3) as the provision to place inside the monitoring unit (2), wherein, the mobile application ( 1 ), which is capable of read and display the information receives from the monitoring unit (2), wherein, the user mobile display, is capable of display the data receives from the mobile application (1), wherein, the monitoring unit (2), further comprises of Near InfraRed spectroscopy unit in the measuring range of 940 -1 lOOnm.
  • the other aspect of the device is non-invasive method for measuring the glucose level and the plug-in-based technique that is just insert your finger into the device monitoring takes place with Near IR radiation a kind of absorption spectroscopy.
  • the other aspect of the device is more comfortable and convenient with the aid “companion app” which displays the glycemic levels with High, medium or low notification alerts and weekly data analytics with no limitation in monitoring can be done as often as needed, along with it is affordable due to onetime investment thereby no repeated expenses on lancets and test strips are incurred.
  • Another aspect of the device is supports and improves your diabetes management by understanding how your diet and lifestyle affects your diabetic life with the aid of data analytics is being embedded with this device as well as thereby not comprising the test result accuracy instantly with proven performance in clinical studies and approaches.
  • Yet another aspect of the device is having the accuracy in measurement of 95.5%.
  • Figure 1 illustrates a non-invasive glucose level monitoring device using absorption spectroscopy with affordability.
  • the present invention as herein described relates to an affordable, non-invasive device for glucose level monitoring using absorption spectroscopy.
  • Glucose is a carbohydrate which is an example of a simple sugar molecule which is commonly known as blood sugar.
  • Glucose is an optically chiral molecule (Optically active) which reacts and excites based on short wave Near InfraRed Radiation at the wavelength range of 750-2500 Nm.
  • Blood glucose concentration or Blood sugar level is the concentration of glucose levels present in the blood.
  • Regular blood glucose monitoring is the most important thing you can do to manage type-1 or type-2 diabetes. You will be able to see what makes your numbers go up or down, such as eating food, exercise, taking your medicine or being physically active.
  • glucometers are mainly based on electro enzymatic reactions, which require a finger - prick device to obtain a drop of blood and apply onto a disposable testing strip.
  • Glucometers Although the accuracy of these types of invasive, Glucometers has been proved and is accepted, physical pain, numbness and infection can be easily caused by pricking your finger.
  • These finger pricking methods are a little bit painful when they are supposed to measure glucose level every day. When it comes to young patients or infants tolerating this pain is very difficult, due to this pain caused by finger pricking technique the patients of young age might develop psychological conditions which keep them away from monitoring their blood glucose levels.
  • semi-invasive or minimally invasive devices have been developed, with the aim in order to replace those existing finger pricking devices and achieve continuous blood glucose monitoring. They usually measure the glucose concentration in interstitial fluid by implanting a tiny and relatively painless subcutaneous sensor.
  • the advanced devices allow the diabetic individuals to test the blood glucose levels from various regions such as the upper arm, the base of the thumb, lower arm, ear lobe, palm and thigh.
  • the results vary in contrast to the measurement results provided by the fingertip region or distribution of blood capillaries.
  • the results are also not as accurate as measured from the finger bed samples while there is a fluctuation level, especially in patients with long - term diabetic condition.
  • the present invention relates to a non-invasive glucometer to monitor glucose levels in the blood. More specifically, this relates to a glucose measurement of the person without pricking the epidermis or collecting the blood sample.
  • the proposed invention - the non- invasive glucometer for monitoring blood glucose levels works based on the principle of Attenuated Total Reflection by Near Infrared (NIR) Spectroscopy. NIR spectroscopy is a spectroscopic method that uses the Near Infra- Red region of the electromagnetic spectrum from the range of (780-2500 nm).
  • NIR neurodegenerative medicine
  • Typical applications of NIR include research including blood sugar , pulse oximetry, functional neuroimaging and medical and physiological diagnostics, elite sports training, sports medicine , ergonomics , neonatal research , rehabilitation, Brain computer interface, bladder contraction and neurology.
  • applications in other areas such as food and agrochemical quality control, pharmaceuticals, combustion research and atmospheric research.
  • Absorption spectroscopy basically refers to the spectroscopic techniques which measure the absorption of radiation, as a function of the wavelength or frequency due to its interaction with the given sample.
  • the presented device is connected through the USB port of a smartphone, introducing a concept of the both smartphone and device performing master and slave roles.
  • the device operates on drawing power from the smartphone and uses the latter's display as the output screen through its dedicated application.
  • the radiation of wavelength between 940 -l lOOnm of Near InfraRed is incident to the pollex (thumb) finger bed region, since the thumb finger bed region consists of a large amount of blood capillaries.
  • CeH ⁇ Oe is optically active (a compound which is capable of optical rotation), interacts with the incident Near InfraRed radiation and undergo vibrational excitations.
  • This optical interaction between the Near InfraRed radiation and the glucose molecule is recorded as the absorption spectrum by the spectrometric sensor in the device.
  • the spectrometric sensor consists of 6- Near InfraRed channels which is realized by gaussian filters via nano optic deposited interference filter technology (An optical filter that reflects one or more filter bands or, lines and transmits others, while maintaining a nearly zero coefficient of absorption for all wavelengths of interest).
  • the values of the absorption spectrum obtained from the dedicated spectroscopic sensor is fed through a linear regression (used to predict values within continuous range) based on the dedicatedly built Machine Learning algorithm.
  • the intervened linear regression algorithm predicts the accurate concentration of blood glucose molecules present in the blood, as a result of pre-trained datasets.
  • the predicted blood glucose concentration is displayed on the screen of an individual's mobile application.
  • the embodiment comprises of a mobile application (1), a, a monitoring unit (2), and a measuring object (3).
  • the mobile application (1) is assessing the data through the input from the monitoring unit (2) and displays the glucose level in the user mobile display, thereby the measuring object (3) as the provision to place inside the monitoring unit (2).
  • the mobile application (1) which is capable of read and display the information receives from the monitoring unit (2).
  • the user mobile display is capable of display the data receives from the mobile application (1).
  • the monitoring unit (2) further comprises of Near InfraRed spectroscopy unit in the measuring range of 940 -1 lOOnm.

Abstract

The non-invasive glucose level monitoring device using absorption spectroscopy with affordability is connected through the USB port of a smartphone, introducing a concept of the both smartphone and device performing master and slave roles. The device operates on drawing power from the smartphone and uses the latter's display as the output screen through its dedicated application. In the present intervention, the radiation of wavelength between 940 -1100nm of Near InfraRed is incident to the pollex (thumb) finger bed region, since the thumb finger bed region consists of a large amount of blood capillaries. As the glucose molecule C6H12O6 is optically active, thereby interaction between the Near InfraRed radiation and the glucose molecule is recorded as the absorption spectrum by the spectrometric sensor in the device.

Description

NON-INVASIVE GLUCOSE LEVEL MONITORING DEVICE USING ABSORPTION SPECTROSCOPY WITH AFFORDABILITY
FIELD OF INVENTION
The present invention generally relates to the field of non-invasive glucose level monitoring device, particularly relates to non-invasive monitoring using absorption spectroscopy. More particularly, the present invention relates to a device for non-invasive glucose level monitoring device using absorption spectroscopy with affordable cost in terms of buying accessories and maintenance.
BACKGROUND OF INVENTION
Diabetes is one among the major health issues which has been reached to alarming levels. Nearly half billion are living with diabetes worldwide. Diabetes is one among the fastest growing health disorders of the 21st century.
Insulin is the essential hormone which will be produced in the pancreas which allows glucose from the bloodstream to enter into body cells, and also helps in initiating protein and fat metabolism. Poor production of insulin or inability of cells to respond to it, typically leads to high levels of glucose. Diabetes is a serious long-term condition that occurs when the body cannot produce any or enough insulin or stops effectively using the insulin it produces. Diabetes is associated along with many other metabolic diseases and disorders. The long term persistence of diabetes results in many metabolic complications related to organs such as eyes (retina), Renal, liver etc. There are four main categories of diabetes: Type-1, Type-2, Gestational and pre- diabetes.
Type-1 Diabetes: Most common chronic diseases in childhood caused by autoimmune reactions where the immune system attacks insulin producing beta cells and can also occur at any stage. As a result, the body will produce little or no insulin hormone. The individuals with type -1 need to intake insulin daily to maintain their blood glucose levels regularly. Frequent glucose monitoring and proper education are needed to lead the healthy lifestyle. Symptoms like excessive thirst, blurred vision, and frequent urination, lack of energy & fatigue and constant hunger can be observed. Type - 1 can be diagnosed in the presence of polyuria, polydipsia and frequent weight loss.
Type-2 Diabetes: Around 90% of the world suffers from diabetes mellitus, Getting hyperglycemia is the result initially, of the inability of body cells to respond fully to the insulin hormone, which is known as insulin resistance. During the condition of Type -2 the insulin hormone is ineffective, which can develop as a result of failure of pancreatic cells (beta cells).Type -2 is symptomless when compared to type-1 and the time of onset is critically impossible to determine. l/3rd of the population with type-2 left undiagnosed. Unrecognition for a long time leads to complications such as retinopathy or a lower -limb ulcer. Type-2 especially varies in genetic susceptibility. Females are most commonly affected by type-2 in all groups. Pre-Diabetes: IGT and IFT are the conditions of hyperglycemic levels and hypoglycemic levels. IGT and IFT can also be called Non diabetic hyperglycemia or intermediate hyper hyperglycemia. Pre- diabetes signifies the risk of future development of type- 2 and it denotes already heightened risk of Cardiovascular Diseases. WHO use of HBA1C > 6.5% for the diagnostics of diabetes as a part of diagnostic criteria. Gestational phase: Diabetes during the stage of pregnancy or childbirth is known as diabetic mellitus. According to the International Federation of Gynaecology and obstetrics (HIP) can be classified into gestational phase diabetes mellitus or diabetes in pregnancy. It is highly recommended for screening of gestational phase diabetes between the 24th and 28th week of pregnancy. It has been estimated that most (75- 90%) cases of HIP are GDM. It is difficult to distinguish GDM from normal symptoms. In the year of 2000, the global estimate of diabetic prevalence in the 20-79 year old age group was noted to be 151M. Projections for the future have clearly indicated that the global impact of diabetes is likely to continue increasing considerably. The count of diabetic individuals was 151M in the year of 2000, 194M in 2003, 246M in 2006, 285M in 2009, 366M in 2011, 382M in 2013, 415M in 2015, 425M in 2017, 460M in 2019 and projected to reach 578M by 2030 & 745 by 2045. Diabetes is hereditary condition and the on-set of diabetes is expected among non-diabetic population with a history of diabetes from ancestors. 1 in 2 people with diabetes are more than 65 years old, 1 in 6 live births that is the average of 20 Million population is affected by hyperglycemia (High Sugar), 84% of which have gestational phase diabetes. Over 1.1 million children and adolescents below 20 years have type-1 diabetes. 3 in 4 79% of people with diabetes live in low and middle income countries and 2 in 3 people with diabetes live in urban areas (310.3M). 1 in 2 adults are left undiagnosed (232 Million) people due to the uncomfortable and infeasible diagnosing measures.
Having diabetes develops several risks among individuals so in order to maintain a healthy lifestyle it is advised to monitor blood glucose levels. Blood sugar monitoring is a procedure that measures the amount of sugar which is your body’s main source of energy, glucose levels in your blood. Monitoring blood glucose levels is an important tool in managing your diabetes because it is the main form of keeping your diabetes under control. Keeping one’s blood sugar within the normal range is important to avoid the complications caused by diabetes. For individuals with diabetes blood glucose monitoring provides the instant results of your hyper and hypoglycemia levels which can lead to major health problems including Cardiac arrest and Brain damage if not treated. So there is a high necessity level to monitor blood glucose levels among every individual suffering from diabetes. Monitoring of blood glucose level and diagnosis of diabetes became uneconomical due to the iterative expenses of test strips and lancets. The individuals suffering from Type-1 diabetes have to monitor their blood glucose levels 4- 5 times a day and Type -2 have to monitor 3-4 times a day. The existing glucometers which are widely available in the market are very expensive, where a type-1 diabetic individual has to spend INR 100 a day and type -2 have to spend INR 60 a day on the strips which are of single time use for glucose measurement. Moreover, the annual cost of testing strips is estimated to be 1, 80,000 INR per patient .These strips and lancets need to be replaced once it is finished.
US20070123761 titled - “Extended focal region measuring apparatus and method” describes that the “A method and apparatus for measuring an apparent depth of a section of an animal body are disclosed. Light is focused concurrently to an extended focal region comprising a plurality or continuum of measurement locations. Light reflected by a refractive index interface coincident with one of the plurality of measurement locations is detected. Detected light signals are generated from light reflected from first and second interfaces respectively defining the section under investigation, so that the apparent positions of the interfaces may be derived. A confocal arrangement and an axicon element may be employed. Preferably, the section is the aqueous humor of an eye. Lrom changes in its refractive index corresponding changes in glucose concentration in the aqueous humor and, in turn, in the blood stream of a patient may be derived, offering a non-invasive monitoring means for diabetic patients. Other compounds and structures of the body may alternatively be investigated”.
EP3466320 tiled - “Method and multi-sensor device for noninvasive monitoring of blood glucose levels” describes that the “The present invention allows for non-invasive monitoring of the blood sugar levels in diabetic patients. At least one heat and waterproof applicator is applied to the skin surface by a dosage pressure. Temporal dynamics of physiological parameters of the local tissue region are measured under the applicator. Temporal dynamics of climatic parameters of the environment are measured simultaneously or before the beginning of measurement of physiological parameters in the monitoring mode. Further, enthalpy of tissue is calculated with account for the influence of climatic parameters. Magnitude of thermal effect of metabolism of the local area of living tissue is calculated on the basic thermodynamics equation, connecting enthalpy of tissue with variables of thermodynamic state. Relative changes in the level of glucose are calculated in blood, proportional to the value of the thermal metabolism of the local area of living tissue”.
WO20 10030609 titled - “sweat collection devices for glucose measurement” describes that the “Devices, methods, and kits for collecting sweat that has come to the surface of the skin are provided. The sweat may be collected for measuring sweat glucose levels. Because sweat glucose levels correlate to blood glucose levels, the provided devices, methods, and kits may be used by diabetic patients to non - invasively monitor blood glucose levels. Sweat collection devices may be attachable to the surface of the skin and may collect about one microliter or less of sweat. Because only a small, fixed volume of sweat may be collected, the sweat glucose level may be measured in a matter of minutes. Further, as a fixed volume of sweat is tested, inaccuracies due to estimates of the sweat volume being tested are less likely to cause an inaccurate glucose measurement”.
W02020102573 titled - “Non-invasive monitoring system” describes that the “A wearable device for non-invasive monitoring of the presence, amount, and/or concentration of an analyte in a sample from a user of the device is described. The analyte is selected to be indicative of or related to a physiological status of a user. Relevant physiological status include hypoglycemia, infection, respiratory infection, urinary infection, gastrointestinal infection, obesity, diabetes, type I diabetes and type II diabetes”. None of the above-mentioned prior arts neither teaches nor discloses about accurate measurement of glucose levels for more than 95% using absorption spectroscopy technique. Accordingly, there exists a need for a system which is non-invasive accurate measurement of glucose levels.
OBJECTS OF INVENTION
One or more of the problems of the conventional prior art may be overcome by various embodiments of the system of present invention.
It is the primary object of the present invention to provide non-invasive method for measuring the glucose level, it means that, pain free measurement without any blood loss and pricking.
It is another object of the present invention is to have the plug use technique that is just insert or Place your finger into the device monitoring takes place with Near IR radiation.
It is another object of the present invention, wherein the device is more comfortable and convenient with the aid “companion app” which displays the glycemic levels with High, medium or low notification alerts and weekly data analytics with no limitation in monitoring can be done as often as needed, along with it is affordable due to onetime investment thereby no repeated expenses on lancets and test strips are incurred.
It is another object of the present invention, wherein the device supports and improves your diabetes management by understanding how your diet and lifestyle affects your diabetic life with the aid of data analytics is being embedded with this device as well as thereby not comprising the test result accuracy instantly with proven performance in clinical studies and approaches.
It is another object of the present invention, wherein the device has the accuracy in measurement of 95.5%.
SUMMARY OF INVENTION
Thus, the basic aspect of the present invention is to provide non-invasive glucose level monitoring device using absorption spectroscopy with affordability, said device comprising of: a mobile application (1); a monitoring unit (2); and a measuring object (3), wherein, the mobile application (1) is assessing the data through the input from the monitoring unit (3) and displays the glucose level in the user mobile display, thereby the measuring object (3) as the provision to place inside the monitoring unit (2), wherein, the mobile application ( 1 ), which is capable of read and display the information receives from the monitoring unit (2), wherein, the user mobile display, is capable of display the data receives from the mobile application (1), wherein, the monitoring unit (2), further comprises of Near InfraRed spectroscopy unit in the measuring range of 940 -1 lOOnm.
The other aspect of the device is non-invasive method for measuring the glucose level and the plug-in-based technique that is just insert your finger into the device monitoring takes place with Near IR radiation a kind of absorption spectroscopy. The other aspect of the device is more comfortable and convenient with the aid “companion app” which displays the glycemic levels with High, medium or low notification alerts and weekly data analytics with no limitation in monitoring can be done as often as needed, along with it is affordable due to onetime investment thereby no repeated expenses on lancets and test strips are incurred.
Another aspect of the device is supports and improves your diabetes management by understanding how your diet and lifestyle affects your diabetic life with the aid of data analytics is being embedded with this device as well as thereby not comprising the test result accuracy instantly with proven performance in clinical studies and approaches.
Yet another aspect of the device is having the accuracy in measurement of 95.5%.
BRIEF DESCRIPTION OF DRAWING
Figure 1: illustrates a non-invasive glucose level monitoring device using absorption spectroscopy with affordability.
DETAILED DESCRIPTION OF THE INVENTION WITH REFERENCE TO THE ACCOMPANYING FIGURES
The present invention as herein described relates to an affordable, non-invasive device for glucose level monitoring using absorption spectroscopy.
Glucose is a carbohydrate which is an example of a simple sugar molecule which is commonly known as blood sugar. Glucose is an optically chiral molecule (Optically active) which reacts and excites based on short wave Near InfraRed Radiation at the wavelength range of 750-2500 Nm. Blood glucose concentration or Blood sugar level is the concentration of glucose levels present in the blood. Regular blood glucose monitoring is the most important thing you can do to manage type-1 or type-2 diabetes. You will be able to see what makes your numbers go up or down, such as eating food, exercise, taking your medicine or being physically active. The well-established glucometers are mainly based on electro enzymatic reactions, which require a finger - prick device to obtain a drop of blood and apply onto a disposable testing strip. Although the accuracy of these types of invasive, Glucometers has been proved and is accepted, physical pain, numbness and infection can be easily caused by pricking your finger. These finger pricking methods are a little bit painful when they are supposed to measure glucose level every day. When it comes to young patients or infants tolerating this pain is very difficult, due to this pain caused by finger pricking technique the patients of young age might develop psychological conditions which keep them away from monitoring their blood glucose levels.
Therefore, semi-invasive or minimally invasive devices have been developed, with the aim in order to replace those existing finger pricking devices and achieve continuous blood glucose monitoring. They usually measure the glucose concentration in interstitial fluid by implanting a tiny and relatively painless subcutaneous sensor. Alternatively the advanced devices allow the diabetic individuals to test the blood glucose levels from various regions such as the upper arm, the base of the thumb, lower arm, ear lobe, palm and thigh. However, the results vary in contrast to the measurement results provided by the fingertip region or distribution of blood capillaries. Moreover, the results are also not as accurate as measured from the finger bed samples while there is a fluctuation level, especially in patients with long - term diabetic condition. Additionally, the use of semi-invasive sensors by placing them skin to monitor blood glucose levels for continuous glucose monitoring, which transmits the readings to the recording device worn by the diabetic individuals, which even sounds an alarm when the blood glucose levels increase. However, these sensors are not affordable. They are too expensive and need to be replaced very frequently. Hence, in order to overcome the disadvantages that are existing state of the art devices available in the market, there is a critical need of a non-invasive glucose monitoring device which reads glucose levels along with proper data analysis in order to make individuals live their diabetic life better and happier.
The present invention relates to a non-invasive glucometer to monitor glucose levels in the blood. More specifically, this relates to a glucose measurement of the person without pricking the epidermis or collecting the blood sample. The proposed invention - the non- invasive glucometer for monitoring blood glucose levels works based on the principle of Attenuated Total Reflection by Near Infrared (NIR) Spectroscopy. NIR spectroscopy is a spectroscopic method that uses the Near Infra- Red region of the electromagnetic spectrum from the range of (780-2500 nm). Typical applications of NIR include research including blood sugar , pulse oximetry, functional neuroimaging and medical and physiological diagnostics, elite sports training, sports medicine , ergonomics , neonatal research , rehabilitation, Brain computer interface, bladder contraction and neurology. There are also applications in other areas such as food and agrochemical quality control, pharmaceuticals, combustion research and atmospheric research.
The embodiment works on the principle is the intervention is “Absorption Spectroscopy”. Absorption spectroscopy basically refers to the spectroscopic techniques which measure the absorption of radiation, as a function of the wavelength or frequency due to its interaction with the given sample. The presented device is connected through the USB port of a smartphone, introducing a concept of the both smartphone and device performing master and slave roles. The device operates on drawing power from the smartphone and uses the latter's display as the output screen through its dedicated application. In the present intervention, the radiation of wavelength between 940 -l lOOnm of Near InfraRed is incident to the pollex (thumb) finger bed region, since the thumb finger bed region consists of a large amount of blood capillaries. As the glucose molecule CeH^Oe is optically active (a compound which is capable of optical rotation), interacts with the incident Near InfraRed radiation and undergo vibrational excitations. This optical interaction between the Near InfraRed radiation and the glucose molecule is recorded as the absorption spectrum by the spectrometric sensor in the device. The spectrometric sensor consists of 6- Near InfraRed channels which is realized by gaussian filters via nano optic deposited interference filter technology (An optical filter that reflects one or more filter bands or, lines and transmits others, while maintaining a nearly zero coefficient of absorption for all wavelengths of interest). The values of the absorption spectrum obtained from the dedicated spectroscopic sensor is fed through a linear regression (used to predict values within continuous range) based on the dedicatedly built Machine Learning algorithm.
The intervened linear regression algorithm predicts the accurate concentration of blood glucose molecules present in the blood, as a result of pre-trained datasets. The predicted blood glucose concentration is displayed on the screen of an individual's mobile application.
The embodiment comprises of a mobile application (1), a, a monitoring unit (2), and a measuring object (3). The mobile application (1) is assessing the data through the input from the monitoring unit (2) and displays the glucose level in the user mobile display, thereby the measuring object (3) as the provision to place inside the monitoring unit (2). The mobile application (1), which is capable of read and display the information receives from the monitoring unit (2). The user mobile display is capable of display the data receives from the mobile application (1). The monitoring unit (2), further comprises of Near InfraRed spectroscopy unit in the measuring range of 940 -1 lOOnm.

Claims

WE CLAIM:
1. A non-invasive glucose level monitoring device using absorption spectroscopy with affordability, said device comprising of: a mobile application (1); a monitoring unit (2); a measuring object (3); an user mobile display (4); and an USB connector (5), wherein the mobile application (1) is assessing the data through the input from the monitoring unit (2) and displays the glucose level in the user mobile display , thereby the measuring object (3) as the provision to place inside the monitoring unit (2), wherein the mobile application (1), which is capable of read and display the information receives from the monitoring unit (2), wherein the user mobile display (4) is capable of display the data receives from the mobile application (1), wherein the monitoring unit (2) further comprises of Near InfraRed spectroscopy unit in the measuring range of 940 -1 lOOnm. wherein the USB connector (5) is establishing the connectivity between the monitoring unit (2) and a mobile application ( 1 ).
2. The non-invasive glucose level monitoring device using absorption spectroscopy with affordability as claimed in claim 1, wherein said device is non-invasive method for measuring the glucose level and the plug-in-based technique that is just insert or place your finger into the device monitoring takes place with Near IR radiation a kind of absorption spectroscopy.
3. The non-invasive glucose level monitoring device using absorption spectroscopy with affordability as claimed in claim 1 , wherein said device is more comfortable and convenient with the aid “companion app” which displays the glycemic levels with High, medium or low notification alerts and weekly data analytics with no limitation in monitoring can be done as often as needed, along with it is affordable due to onetime investment thereby no repeated expenses on lancets and test strips are incurred.
4. The non-invasive glucose level monitoring device using absorption spectroscopy with affordability as claimed in claim 1, wherein said device supports and improves your diabetes management by understanding how your diet and lifestyle affects your diabetic life with the aid of data analytics is being embedded with this device as well as thereby not comprising the test result accuracy instantly with proven performance in clinical studies and approaches.
5. The non-invasive glucose level monitoring device using absorption spectroscopy with affordability as claimed in claim 1 , wherein said device has the accuracy in measurement of 95.5%.
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Citations (1)

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Publication number Priority date Publication date Assignee Title
US20190216319A1 (en) * 2009-10-06 2019-07-18 Cercacor Laboratories, Inc. Personal digital assistant or organizer for monitoring glucose levels

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190216319A1 (en) * 2009-10-06 2019-07-18 Cercacor Laboratories, Inc. Personal digital assistant or organizer for monitoring glucose levels

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