Non-invasive Glucometer Research Articles

NIR-Based Electronic Platform for Glucose Monitoring for the Prevention and Control of Diabetes Mellitus.

The glucose level in the blood is measured through invasive methods, causing discomfort in the patient, loss of sensitivity in the area where the sample is obtained, and healing problems. This article deals with the design, implementation, and evaluation of a device with an ESP-WROOM-32D microcontroller with the application of near-infrared photospectroscopy technology that uses a diode array that transmits between 830 nm and 940 nm to measure glucose levels in the blood. In addition, the system provides a webpage for the monitoring and control of diabetes mellitus for each patient; the webpage is hosted on a local Linux server with a MySQL database. The tests are conducted on 120 people with an age range of 35 to 85 years; each person undergoes two sample collections with the traditional method and two with the non-invasive method. The developed device complies with the ranges established by the American Diabetes Association: presenting a measurement error margin of close to 3% in relation to traditional blood glucose measurement devices. The purpose of the study is to design and evaluate a device that uses non-invasive technology to measure blood glucose levels. This involves constructing a non-invasive glucometer prototype that is then evaluated in a group of participants with diabetes.

Non-invasive glucometer monitoring system through optical based near-infrared sensor method

ABSTRACT Diabetes is a fast-developing medical issue that causes most renal and cardiac illnesses. Thus, diabetes management requires regular glucose monitoring. One potential technology is non-invasive glucometer monitoring. This work aims to develop a user-friendly near-infrared sensor-based non-invasive glucose monitoring system, correlating sensor output voltage variations with glucose levels, to provide accurate and convenient glucose monitoring for diabetes management. The objective is to validate the system’s accuracy against existing fingerpick methods and analyze its performance across different age groups and food intake conditions through experimental testing and Clarke grid analysis. In our research, we propose a near-infrared sensor-based non-invasive-type glucose monitoring technique which is a user-friendly system. The experimental setup and prototype system are designed and implemented for measuring the variation of glucose level with respect to a sensor output voltage. Using Beer Lambert’s law, the established results correlated the absorbance property of light with the sample concentration level. Demonstration of testing for different aged people was done under various food intake conditions. The obtained results are tabulated and validated with the existing fingerpick method and achieved an accuracy of 97.8%. Also, Clarke grid analysis has been done and depicted the pattern obtained.

Design and Development of IoT Based Optical Glucometer

This research presents the development of an IoT based non-invasive glucometer using optical methods for diabetes monitoring. Diabetes needs to be identified as soon as possible and its development is closely monitored. One of the measures to control this disease is the daily monitoring of blood sugar levels by using glucometer. Glucometers on the market are invasive that require blood sampling or sensors implantation. To get a blood sample, it is necessary to prick a fingertip with a needle to obtain a blood sample. This procedure is uncomfortable, and repeated punctures increase the risk of transmission of infectious diseases. Alternatively, a non-invasive method using optical technique was proposed in this paper. The prototype device is mainly consisting of an NIR LED (940nm) acting as a light transmitter delivered through a finger and reflect to photodetector (BPW34) that acting as a light receiver. The prototype was integrated with the IoT platform using Arduino Cloud for monitoring purpose. The next step involved the development of calibration model. Ten healthy individuals were recruited to take part in glucose readings measurement that conducted by National Kidney Foundation Batu Pahat. A calibration model ( y=82.19x+12.91) was successfully obtained from this experiment. The accuracy of the developed device was between 93.2 and 96.9 % where the error percentage was found to be less than 7 %. In conclusion, a painless non-invasive glucometer based near-infrared LED and photodiode was successfully developed. For future development, the accuracy of the system can possibly be improved by using a longer wavelength of light emitter such as 1500 nm.

Design of a portable noninvasive Glucometer with clinical accuracy

Design of a portable noninvasive Glucometer with clinical accuracy

Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study.

The aim of this study was to evaluate the stability and accuracy of glucose measurements determined using the metabolic heat conformation (MHC)-based non-invasive glucometer in a multicentre, self-controlled clinical trial. This device is the first to obtain a medical device registration certificate awarded by the National Medical Products Administration of China (NMPA). The multicentre clinical study was conducted at three sites and enrolled 200 subjects whose glucose was measured with a non-invasive glucometer (the Contour Plus blood glucose monitoring system) and by venous plasma glucose (VPG) measurements, in a fasted state and at 2 and 4h after meals. Based on both the non-invasive and VPG measurements, 93.9% (95% confidence interval 91.7-95.6%) of the blood glucose (BG) values fell within consensus error grid (CEG) zones A + B. The measurements obtained in a fasted state and at 2h after meals were more accurate, with 99.0% and 97.0% of the BG values, respectively, falling within zones A + B. Compared to those subjects who received insulin, the proportion of values in zones A + B and the correlation coefficients were 3.1% and 0.0596 higher, respectively. The accuracy of the non-invasive glucometer was influenced by the level of insulin resistance calculated by the homeostatic model assessment method, which had a correlation coefficient with the mean absolute relative difference of - 0.1588 (P = 0.0001). The MHC-based non-invasive glucometer assessed in the present study demonstrates generally high stability and accuracy in the glucose monitoring of people with diabetes. The calculation model needs to be further explored and optimised for patients with different diabetes subtypes, levels of insulin resistance and insulin secretion capacity. ChiCTR1900020523.

The peroxidase-like activity of papain colorimetrically detects H2O2 and glucose with high sensitivity

To date, several glucometer methods are available for patient-guided glycemic control, which diminishes the onset and severity of diabetic complications. In a dipstick urine glucose test, horseradish peroxidase (HRP) oxidizes tetramethylbenzidine (TMB) in the presence of hydrogen peroxide (H2O2) to quantitatively produce a colorimetric signal and predict glucose concentration. Papain, a sulfhydryl protease secreted by the latex of Carica papaya, displays HRP-like activity with high selectivity. However, the current papain-based glucometer method lacks sensitivity. We hypothesized that catalyzing the oxidation of papain under varying buffer conditions (e.g., papain, TMB, and acetic acid concentrations) would improve glucose detection sensitivity. To test this, we performed glucose oxidase (GOx)-mediated glucose oxidation and papain-mediated TMB oxidation under varying sample conditions in vitro and spontaneously coupled them. The aims of this study were to validate the coupling of GOx-mediated glucose oxidation and papain-mediated TMB oxidation and identify the optimized conditions that maximize catalytic activity. We confirmed that glucose oxidase quantitatively produces H2O2 (in a glucose concentration-dependent manner), the presence of which catalyzes papain-mediated production of a colorimetric signal. When two oxidation reactions were coupled, we identified that the sensitivity of papain’s glucose detection increased by ten-fold compared to previous studies with a markedly high correlation (R2 = 0.99). In particular, substituting sodium acetate-acetic acid (HAc-NaAc) buffer with acetic acid and increasing the sample incubation time and papain concentration markedly increased the sensitivity of colorimetric signals. The optimized protocols can be integrated into emerging hydrogel technology to develop a non-invasive glucometer patch predicting blood glucose from the patient’s produced sweat.

Non-invasive Glucometer using Acetone Gas Sensor for Low Income Earners’ Diabetes Monitoring

A glucometer is an important device used to monitor blood glucose level of diabetes patients to prevent degenerated health conditions. The conventional glucometers are characterized by piercing of the sample site for patients’ testing. The invasive nature of these glucometers is painful to the patients and some patients are also scared at the sight of blood. To promote glucometer acceptance among patients, it is important to develop a non-invasive glucometer using acetone gas sensor with “exhaled breath” collected non-invasively as the sample for the glucometer. After the device development, exhaled breath sample of twenty subjects with age range of 20 to 55 years from a University were taken using the developed acetone sensor device. Prior to the exhaled breath sample collection, the blood glucose levels of the volunteered subjects were also determined using the conventional and proprietary invasive clinical method. To infer whether there is significant different between the mean of the results obtained from the conventional and the exhaled breath method, a t-test was carried out on the results and P values of 0.9860 and 0.9306 were obtained for fasting blood sugar and random blood sugar respectively, indicating no significant differences in the results obtained from the developed device when compared with the proprietary device. Hence, non-invasive glucometer using acetone gas sensor can be used to promote inexpensive personalized diabetes monitoring without inflicting pain on the patients. Promotion of this device could also reduce the expenses incurred on lancet and test strips, thus, making it suitable for low income earners.

IGLU 3.0: A Secure Noninvasive Glucometer and Automatic Insulin Delivery System in IoMT

Consumer technologies have changed human life through various products for smart healthcare management. The evaluation of Internet-of-Medical-Things (IoMT) has provided the closed loop control system for point of care mechanism. The hardware security of medical devices has drawn the attention where any security breach could have catastrophic impact. The paper discusses iGLU 3.0 which includes security model of glucose measurement device along with insulin pump of IoMT framework. The novel glucose-insulin model has been proposed for glucose control of diabetes patient. The physical unclonable function (PUF) based security solution is developed for non-invasive glucometer iGLU and insulin pump for safe insulin secretion. PUF based Hardware-Assisted Security (HAS) is helpful to mitigate challenges which are present in automatic insulin delivery with iGLU.

Design and Development of a Non-invasive Glucometer System

The outbreak of Covid-19 disease has caused issues in public health, and its impact has grown in population with non-communicable diseases like diabetes, a life-threatening condition, worldwide. Individuals in low-income countries with limited diagnosis and monitoring systems require continuous and regular blood glucose monitoring. Invasive or minimally invasive blood glucose monitoring has been utilised with good accuracy but a high risk of infections and complications. Non-invasive monitoring technology is critical and recommended worldwide, with the potential of improving safety and reducing workload in blood glucose control. The design, development, and evaluation analysis of a non-invasive GSM (Glucose Screening Measurement) module glucometer using near-infrared sensors at 1550nm wavelength as an emitter, transmitting through the fingertip and the ATMega38 microcontroller as the controller to determine the glucose level in human blood are presented in this study. A total of forty individuals were recruited in the investigation. Repeatability, validity, and reliability were evaluated using the Bland and Altman Analysis, the concurrent validity, and the reliability analysis. Passing and Boblok Regression Analysis was used to assess the statistical significance further. Repeatability showed no significant difference with a 95% confidence interval and 0.6895 bias. The linear relationship showed 99.72% agreement and 99.9% reliability using regression analysis. This study revealed that using a non-invasive GSM module glucometer to measure blood glucose effectively enhances patient surveillance in diabetes insulin treatment.

A Pilot Trial to Evaluate the Accuracy of a Novel Non-Invasive Glucose Meter.

The non-invasive self-monitoring of blood glucose (SMBG) has been the subject of intense investigation over recent decades. We conducted a pilot study designed to examine a novel non-invasive glucometer, the HGR GWave, utilizing radiofrequency (RF) sensing. Blood glucose levels assessed by this HGR prototype were compared to measurements performed by a hexokinase core laboratory assay during an oral glucose tolerance test (oGTT) for 5 subjects with type 2 diabetes. The HGR glucose meter readings were also compared to two Abbot Freestyle® glucose meters, which were also used for calibration. The accuracy of the results was evaluated through the calculation of relative absolute difference (RAD), specified percentage differences between 43 reference glucose measurements, and using comparator measurements. The median RAD was −4.787. We detected 79.04%, 92.99% and 97.64% of HGR readings within ±10%, ±15% and ±20% of the reference glucose measurements. The HGR readings had a high correlation with reference lab glucose measurements with R2 = 0.924 (95% CI 0.929–0.979; p < 0.0001). When compared to the Freestyle® glucose meters 94.3% and 100% of the readings were within ±5% and ±10%, with R2 = 0.975 (0.975–0.994; p < 0.0001). The HGR prototype glucose meter was found to be accurate in detecting real-time blood glucose during an oGTT in this small pilot study. A study with a broader range of blood glucose levels is needed to further assess its accuracy and its suitability for clinical use.

IGLU 2.0: A New Wearable for Accurate Non-Invasive Continuous Serum Glucose Measurement in IoMT Framework

To best of the authors knowledge, this article presents the first-ever non-invasive glucometer that takes into account serum glucose for high accuracy. In case of blood glucose measurement, serum glucose value has always been considered precise blood glucose value during prandial modes. Serum glucose can be measured in laboratory and more stable glucose level compare to capillary glucose. However, this invasive approach is not convenient for frequent measurement. Sometimes, Conventional invasive blood glucose measurement may be responsible for cause of trauma and chance of blood related infections. To overcome this issue, in the current paper, we propose a novel Internet-of-Medical (IoMT) enabled glucometer for non-invasive precise serum glucose measurement. In this work, a near-infrared (NIR) spectroscopic technique has been used for glucose measurement. The novel device called iGLU 2.0 is based on optical detection and precise machine learning (ML) regression models. The optimal multiple polynomial regression and deep neural network models have been presented to analyze the precise measurement. The glucose values of serum are saved on cloud through open IoT platform for endocrinologist at remote location. To validate iGLU 2.0, Mean Absolute Relative Difference (mARD) and Average Error (AvgE) are obtained 6.07% and 6.09%, respectively from predicted blood glucose values for capillary glucose. For serum glucose, mARD and AvgE are found 4.86% and 4.88%, respectively. These results represent that the proposed non-invasive glucose measurement device is more precise for serum glucose compared to capillary glucose.

Evaluation of a Novel Noninvasive Blood Glucose Monitor Based on Mid-Infrared Quantum Cascade Laser Technology and Photothermal Detection.

Background:A prototype of a noninvasive glucometer combining skin excitation by a mid-infrared quantum cascade laser with photothermal detection was evaluated in glucose correlation tests including 100 volunteers (41 people with diabetes and 59 healthy people).Methods:Invasive reference measurements using a clinical glucometer and noninvasive measurements at a finger of the volunteer were simultaneously recorded in five-minute intervals starting from fasting glucose values for healthy subjects (low glucose values for diabetes patients) over a two-hour period. A glucose range from >50 to <350 mg/dL was covered. Machine learning algorithms were used to predict glucose values from the photothermal spectra. Data were analyzed for the average percent disagreement of the noninvasive measurements with the clinical reference measurement and visualized in consensus error grids.Results:98.8% (full data set) and 99.1% (improved algorithm) of glucose results were within Zones A and B of the grid, indicating the highest accuracy level. Less than 1% of the data were in Zone C, and none in Zone D or E. The mean and median percent differences between the invasive as a reference and the noninvasive method were 12.1% and 6.5%, respectively, for the full data set, and 11.3% and 6.4% with the improved algorithm.Conclusions:Our results demonstrate that noninvasive blood glucose analysis combining mid-infrared spectroscopy and photothermal detection is feasible and comparable in accuracy with minimally invasive glucometers and finger pricking devices which use test strips. As a next step, a handheld version of the present device for diabetes patients is being developed.

Non Invasive Glucometer of Automatic Measurement of the Glucose Level in Blood

This article aims to create a non-invasive method for determining glucose levels in diabetes to prevent diabetes. A non-invasive glucometer is aimed at creating a detection concept based on the biophysical parameters of biologically active points. When developing non-invasive fluorescence, experiments were carried out on healthy people and patients with two types of diabetes, confirmed by mathematical and statistical methods that correlate the amount of glucose in the blood and biophysical parameters at biologically active points.

Diabetes Care in Motion: Blood Glucose Estimation Using Wearable Devices

Diabetics should monitor their blood glucose daily to prevent severe acute complications. However, the pain sensation due to finger pricking is not only an inconvenience to patients, but can also reduce compliance with diabetes management. A reliable, mobile, easy-to-use, and noninvasive glucometer can address this problem. Noninvasive optical signals, such as those used to obtain a photoplethysmogram (PPG), have recently been used to measure human physiological and vascular conditions and have been adopted to estimate glucose. In this study, we conducted a clinical trial to acquire the PPG signals using wearable devices from nine type 2 diabetic patients. The global and personalized models were built using random forest and adaboost regression models. The accuracy of the models was determined by the tenfold cross validation and leave-one-out validation approaches. The results show that it is feasible to attain 90% accurate glucose predictions. Therefore, diabetic patients can use a wearable noninvasive glucometer utilizing the PPG signals.

REAL-TIME SENSING THE GLUCOSE CONCENTRATION BY QUADRATIC-SHAPED MICROWAVE SENSOR

In this study we present a microwave sensor based on the quadratic-shape and designed for detecting glucose concentration in aqueous solutions by using a microwave near-field electromagnetic interaction technique. We found a linear relationship between the microwave $ S_{11} $ reflection coefficient of the suggested system and the concentration of glucose in solution. Due to this linear relationship we were able to determine the glucose concentration in the range of 0–250 mg/dL at an operating frequency near 3.6 GHz. The measured minimum detectable signal was 0.0044 dB/(mg/dL) and the measured minimum detectable concentration was 6.8 mg/dL. These results suggest that the system we offer has a high enough accuracy for non-contact glucose monitoring and provides a promising basis for developing a non-invasive glucometer.

970-P: The Clinical Accuracy Evaluation of Noninvasive Glucometer Based on Metabolic Heat Conformation Method: A Multicenter Study

Objective: To evaluate the accuracy of noninvasive glucometer based on metabolic heat conformation (MHC) method by multicenter clinical trial. Methods: This study was a multi-center, open, self-controlled trial. Venous plasma glucose measured by the hexokinase method was taken as reference level. The screening period was 1 to 7 days before the test, and a fasting blood glucose of the subjects who enrolled to this study was recorded as a calibration value. Subjects were tested at 3 time points successively on experimental day: fasting, 2-hour and 4-hour postprandial. On each time point, the noninvasive glucose measurement was performed at first, and followed by venous blood sample collection within 5 minutes. The subjects ate the 80 g standard noodle meal after the fasting test. The meal should be finished within 15 minutes. Results: 3 centers participated with 210 subjects (M/F=98/112, average age is 61.2 year-old, 200 with T2DM, 7 with T1DM, 3 with prediabetes) were enrolled. The correlation coefficient of noninvasive glucose value and the serum glucose value in fasting, 2h and 4h postprandial status was 0.79, 0.61, 0.63 respectively. Conclusion: The noninvasive glucometer based on MHC method showed a good correlation with the venous plasma glucose, especially in fasting state. Disclosure A. Li: None. Z. Geng: None. S. Li: None. X. Guo: None. J. Zhang: None. F. Tang: None.

Estimation of blood glucose by non-invasive method using photoplethysmography

This paper presents a system which estimates blood glucose level (BGL) by non-invasive method using Photoplethysmography (PPG). Previous studies have shown better estimation of blood glucose level using an optical sensor. An optical sensor based data acquisition system is built and the PPG signal of the subjects is recorded. The main contribution of this paper is exploring various features of a PPG signal using Single Pulse Analysis technique for effective estimation of BGL values. A PPG data of 611 individuals is recorded over duration of 3 minutes each. BGL value estimation is performed using two types of feature sets, (i) Time and frequency domain features and (ii) Single Pulse Analysis (SPA). Neural network is trained using above mentioned proposed feature sets and BGL value estimation is performed. First we validate our methodology using the same features used by Monte Moreno in his earlier work. The experimentation is performed on our own dataset. We obtained comparable results of BGL value estimation as compared with Monte Moreno, with maximum R2 = 0.81. Further, BGL estimation using (i) Time and frequency domain features and (ii) Single Pulse Analysis (SPA) is performed and the resulting coefficient of determination (i.e., R2) obtained for reference vs. prediction are 0.84 and 0.91, respectively. Clarke Error Grid analysis for BGL estimation is clinically accepted, so we performed similar analysis. Using Time and frequency domain feature set, the distributions of data samples is obtained as 80.6% in class A and 17.4% in class B. 1% samples in zone C and Zone D. For Single Pulse Analysis technique (SPA) the distribution of data samples are 83% in class A and 17% in class B. The proposed features in SPA have shown significant improvement in R2 and Clarke Error grid analysis. SPA technique with the proposed feature set is a good choice for the implementation of system for measurement of non-invasive glucometer.

NIBG: an efficient near-infrared spectroscopy-based device for tele-monitoring blood glucose level of diabetes outpatients in an e-health system

Major conventional blood glucose measuring systems pose a lot of inconveniences to diabetes patients, such as recurring pains incurred from finger-prick, infections from biosensor implant into the subcutaneous tissue, recurring costs incurred from the purchase of strips and biosensors, and inability to perform real-time monitoring of blood glucose with such devices, making them unsuitable for e-health systems. This paper proposes a pain-free, non-infectious and non-invasive blood glucometer (NIBG) for blood glucose measurement and monitoring. The device is based on near infrared (NIR) transmittance spectroscopy which does not involve pricking into the blood capillary during measurement thereby reducing the risk of micro-vascular complication associated with invasive methods. Also the approach may reduce blood glucose measurement apathy thereby preventing long-term complications of diabetes. Both the validation and clinical trial tests results indicated that the device is clinically accurate.

Noninvasive, continuous, real-time glucose measurements compared to reference laboratory venous plasma glucose values

Purpose: Current modalities for glucose monitoring are invasive and inconvenient. The search for a noninvasive technique is still ongoing, without a clinically viable product. The aim of our study was to evaluate the safety and accuracy of a novel non-invasive continuous glucometer – the Wizmi™ device.Methods: Prospective, observational, controlled clinical trial. We included healthy pregnant women designated to undergo a 3-hour oral glucose tolerance test. Each participant underwent synchronous and simultaneous glucose measurement by venous sampling of plasma glucose and non-invasive glucose by Wizmi device. Primary outcome was the accuracy of the Wizmi device as assessed by comparing between paired measurements, i.e. non-invasive glucose measurements by Wizmi versus standard plasma glucose levels, which were taken at the exact same time.Results: Thirty-two women underwent oral glucose tolerance test (OGTT), contributing 224 paired glucose measurements. Of the 224 paired measurements, all were within the clinically appropriate zones of the Clarke error grid analysis zones −208 (93%) in Zone A and 16 (7%) in zone B. Mean absolute relative difference of the Wizmi non-invasive glucose versus plasma glucose laboratory reference was 7.23% or 9.66 mg/dl. Overall, for all 224 paired measurements, across all Wizmi glucose ranges, the agreement was 86.6, 92.0, 97.8 and 99.5% for deviations within ±15, 20, 30, 40% (if glucose >80 mg/dl) or mg/dl (if glucose ≤80 mg/dl).Conclusions: Wizmi device is novel non-invasive continuous glucose monitor, safe to use, with overall high accuracy compared to a gold standard reference of plasma glucose.

NOVEL APPROACHES TO NON-INVASIVE BLOOD GLUCOSE MEASUREMENT

Aim. Development of a novel method for non-invasive blood glucose measurement based on the hemodynamics parameters, and implementation of non-invasive glucometer. Material and methods. Totally, 170 persons studied, of the age 20-75 y.o.: with arterial hypertension (n=70), diabetes type 2 (n=70), healthy (n=30). Blood pressure (BP) was measured on both arms of patient, fasting and after a meal. The mean values of systolic BP, diastolic BP, pulse BP were calculated, and BP coefficient as their relation. At the same time chemistry was done for glucose levels. Results. The case was being resolved by the method of mathematical modelling using Statistica software. Correlational and functional multifactorial tests were done, in all groups. The highest correlational coefficients in all dimensions represent the relations of glucose level with BP response (0,75-0,85), which was selected for regression equations for BP and glucose relation. Optimal regression equations were used for the device measuring glycemia non-invasively. Conclusion. A novel method for non-invasive glycemia diagnostics is developed, based on the modelling of correlation of systemic hemodynamics and blood glucose concentration. The relations obtained, are used for invention of automatic non-invasive glucometer by the pulse wave parameters. Novelty has been proved by RF patents: “Method for non-invasive glucose concentration measurement in blood”; “Equipment for non-invasive assessment of blood glucose concentration”. Non-invasive glucometer can be used in healthcare institutions and for individual use.