WO2017168432A1

WO2017168432A1 - A non invasive hba1c meter for measuring blood glucose levels in diabetic patients without physical blood sample using nir (near infra red light)

Info

Publication number: WO2017168432A1
Application number: PCT/IN2016/000158
Authority: WO
Inventors: Aneel Joseph ANTONY
Original assignee: Antony Aneel Joseph
Priority date: 2016-04-01
Filing date: 2016-06-21
Publication date: 2017-10-05

Abstract

A Non-invasive Hba1c meter comprising of 980nm Near Infra Red LED emitter and a Ingas photo detector with wave length of 1 100 nm, integrated with 970-10 nm Bandpass filter, 980nm IngasLED emitter, a Poly IR Window 900-1000 to integrate to a sensor. This sensor is integrated with 16 bit microprocessor board and LCD display and power supply through a battery and key pad after which it is assembled in an Enclosure to form an instrument which emits NIR light photons to penetrate body tissue and collect the reflected photons through the sensor to predict the Hba1c and glucose values. Once Hba1c is determined by the ADC range standard blood glucose values are calibrated for the fixed ADC values of Hba1c range. The ADC values vary based on the Hba1c and Glucose present at the time of collecting the NIR reflectance through the sensor. The Hba1c and the glucose levels are calculated using a proprietary algorithm and predicted and displayed on the screen.

Description

levels in diabetic patients without physical blood sample

using NIR (Near Infra red light).

DESCRIPTION OF THE INVENTION:

FIELD OF THE INVENTION

The invention relates to a device for measuring Glycated haemoglobin (Hbalc) and blood glucose in diabetic patients without the help of real blood sample. More particularly this invention relates to Non Invasive Hbalc meter used to measure the blood glucose levels and Glycated Haemoglobin in human body.

BACKGROUND AND PRIOR ART

The Incidence of diabetes shows an increasing trend and has become a serious threat to human health. Improving the method of diagnostics has become the need of the day.

Invasive diagnostic kits generate biological waste which can prove to be dangerous if not disposed accordingly. This biological waste will lead to contamination and spread of deadly diseases like hepatitis B, AIDS etc. The method of diagnostics in the strip based glucometer involves piercing the finger tip and drawing blood on a chemical strip and calculating the chemical reaction with glucose. This kind of instruments are likely to give false results if consistency in manufacture of chemical strips are ill maintained.

The measurement of blood glucose through Near infrared spectrum (NIR) reduces the risk of contamination and cost of test.

The measurement of Hbalc and Glucose through NIR eliminates the need to draw Intravenous blood.

The measurement of Hbalc and Glucose through NIR eliminates the high cost of test for Hbalc which ranges between rupees 300 to 400.

The measurement of Hbalc and Glucose through NIR helps in understanding the level of Hbalc (Glycated haemoglobin) in the blood and helps in treatment and control of diabetes.

Presently Diabetes is spreading at an alarming rate and by 2020 one third of the world population will be suffering from diabetes. In order to prevent and facilitate early detection this instrument has been designed. DETAILED DESCRIPTION OF THE INVENTION

Brief description of drawings:

Fig 1; Is the layout diagram for the Non Invasive Hbalc glucometer showing Bottom Cover (1), PCB (2), LCD Display (3), Battery (4), Battery Lid (5), Sensor Block (6), Key Pad (7), Top cover (8)

The NIR Hbalc meter consists of the following parts 1) Bottom cover which houses the Microcontroller board 2) PCB and 3) LCD Display is mounted on the Microcontroller board. 4) Battery is connected to the microcontroller board and 5) Battery lid to hold the battery in place in the Bottom cover (1) 6. The Sensor consist of NIR emitter 980nm, photodiode 1100nm and bandpass filter 970-1 Onm assembled in the sensor block and poly IR glass 900 to 1000nm CW to form the sensor block (6) . The key pad is assembled on the top cover and connected to the microcontroller board (2) to operate the instrument. Finally the display is assembled with the top cover and closed to form NIR Hbalc glucometer.

Fig 2: is the Hbalc Glucometer design consisting of usb, display, and NIR window and memory card slot.

This drawing consist the details of the PCB (2) the microcontroller board and the features are described in the block diagram.

Non invasive measurement of Hbalc blood glucose in diabetic patients by using (Near Infra Red-NIR) NIR- emitter and Ingas photo detector with wave length of 1100 nm. The emitter is an 980nmlngas IR LED. The emitter and the detector are assembled along with a Bandpass filter 970-10 to a sensor to provide accurate wave length of 980nm, This sensor is integrated with a microprocessor and display and power supply, to make an instrument which has a poly IR Window through which the NIR is emitted where the finger or any body part like palm, earlobe, cheek, finger, wrist can be placed to measure the blood glucose levels. The instrument measures the returning photons from the body and collects the signals and converts them from Analog to Digital using ADC, which is processed to get Hbalc and blood glucose levels in Mg/dl, and displayed on the instrument or computer screen using proprietary software application. The incidence of diabetes shows an increasing trend, and has become a serious threat to human health. Thereby, improving the accuracy in the diagnosis of diabetes and strengthening prevention measures are significant. In traditional diagnosis and therapeutic monitoring of diabetes various parameters, such as fasting blood glucose, post prandial blood glucose and oral glucose tolerance, are determined however, the measured values of this parameters > only correspond to the instantaneous blood glucose levels. Glycated haemoglobin, which is an effective index of long term blood glucose level, has been widely used in the diagnosis of diabetes mellitus. As well as an evaluating the effects of therapy on Diabetes.

Glycated Hb comprises Hba1 and other Hb glucose adduct. Hba1 is made up of Hbal a, Hbal b and Hbalc. Hbalc which is a major component of Hba1 , is formed by a non enzymatic irreversible process of combination of the aldehyde group of glucose with the amino-terminal valine of the three chain of Hb this process comprises a sequence of non enzymatic reactions known as Maillard reactions.

Hbalc is a major biochemical indicator of glycated Hb.The clinical value of Hbalc is expressed as a unit of relative percentage, which is equivalent to the ratio of the absolute content of Hbalc and the amount of Hb.ln the clinical practice, Hbalc is referenced to a non-diabetic range 4.0%-5%and 6%-14% as diabatic. This is calculated through correlation of Lab Hbalc value of blood with the quantity of reflectance photons generated by an LED emitter 980nm and collected through a band pass filter of 970-1 Onm norrow band width and a photo detector of 1100nm wave length. This gives us a range of value falling within A to B for a given percentage of Hbalc. The quantum of reflectance is proportional to the number of emitter used in the sensor. We have used four emitters to obtain a standard quantity of reflectance for a given value of Hbalc.

Hbalc 8 NIR ADC reflectance 1200 1300

Hbalc 9 NIR ADC reflectance 1 100 1200

Hbalc 10 NIR ADC reflectance 1000 1100

Hbalc 1 1 NIR ADC reflectance 900 1000

Hbalc 12 NIR ADC reflectance 800 900

Once Hbalc is determined by the ADC range standard blood glucose values are calibrated for the fixed ADC values of Hbalc range.

The ADC values vary based on the Hbalc and Glucose present at the time of collecting the NIR reflectance through the sensor. The Hbalc and the glucose levels are calculated using a proprietary algorithm and predicted and displayed on the screen. The following equation has been derived to find the Hbalc and prediction of glucose values. The glucose values can be measured as fasting blood glucose, Post prandial blood glucose, and random blood glucose.

Total time of reflectance in mili sec Difference = XADC (New D)

ADC obtained for Reference (25mili secX .16) =YADC (Delta D)

The Blood glucose values are calculated with reference ADC and the difference ADC with the proprietary software and displayed on the screen with the Hbalc.

Claims

I Claim:

1. A Non-invasive Hbalc meter comprising of 980nm Near Infra Red LED emitter and a Ingas photo detector with wave length of 1100 nm, integrated with 970-10 nm Bandpass filter, 980nm IngasLED emitter, a Poly IR Window 900-1000 to integrate to a sensor and 16 bit microprocessor, display and power supply and an Enclosure to form an instrument which emits NIR light photons to penetrate body tissue and collect the reflected photons through the sensor to predict the Hbalc and glucose values.

2. A Non-invasive Hbalc meter as claimed in claim 1 , wherein the Near Infra Red - emitter is an 980nm IR LED

3. A Non-invasive Hbalc meter as claimed in claim 1 , wherein the Ingas photo detector is a photodiode chip with 1100nm wave length

4. A Non-invasive Hbalc meter as claimed in claim 1 , wherein the Band pass filter is a 970-10 Narrow bandpass filter with 970-10 nm CW wave length

5. A Non-invasive Hbalc meter as claimed in claim 1 , wherein the Poly IR window is a 900-1000nm window glass to pass NIR 970-1 Onm wave length

6. A method of measuring glucose levels of body tissue, wherein body tissue is penetrated with Near infrared (NIR) light photons and quantity of returning photons is detected usinga Band pass filter which sends only specific wavelength of photons to the detector which is placed adjacent to the NIR emitter to measure the absorption of NIR levels to calculate Hbalc and blood glucose present at the time of measurement.

Dated this the 31^st day of March 2016