Non-invasive Glucose Monitoring Device Research Articles

Noninvasive Real-Time Glucose Monitoring Is in the Near Future.

Objective: Since the introduction of continuous glucose monitoring (CGM) technology, developers have rigorously researched the feasibility of creating a noninvasive glucose monitoring device. In a recent pilot study, investigators reported a strong correlation between glucose values obtained from novel noninvasive monitoring device (GWave) values to venous and capillary glucose measurements. Research Design and Methods: We investigated whether the level of accuracy observed in the pilot study could be reproduced in a larger cohort, using a smaller third-generation manufacturable device (Gen III GWave) containing a standardized sensor chip that can be mass produced for commercial use. The evaluation assessed concordance with capillary blood glucose, reproducibility between two Gen III devices, and accuracy during insulin-induced hypoglycemia. Results: Assessment of samples from 75 subjects (type 2 diabetes, n = 6; type 1 diabetes, n = 28; nondiabetic pregnant subjects, n = 10; and nondiabetic, n = 31) showed that 97% of values were in Zone A with 3% in Zone B of the Clarke Error Grid, with a mean absolute relative difference of 6.7% from reference blood glucose. Comparison between two independent Gen III GWave devices demonstrated reproducibility between the sensors (R2 = 0.95), with 100% of values within Zone A. In the hypoglycemia assessment, measurements from the Gen III sensor tightly followed the capillary glucose measurements down to 42 mg/dL (2.3 mmol/L), whereas the CGM measurements from two different CGM only converged with the GWave and capillary glucose readings after 90 min of decreasing glucose levels. Conclusion: Our results show promise as potentially the first noninvasive technology. Future studies will focus on larger number of people in all glucose ranges. Real-time noninvasive blood glucose monitoring is possible using GWave technology.

Development of sensor system and data analytic framework for non-invasive blood glucose prediction

Development of sensor system and data analytic framework for non-invasive blood glucose prediction

Analysis of Non-Invasive Devices and Techniques Involved in Continuous Monitoring of Interstitial Glucose of Patients with Type 1 Diabetes

Abstract: There are 422 million diabetes patients worldwide according to 2023 census of WHO, and around 100 million cases in India. 8.4 million type 1 diabetes cases were recorded as of 2021. By 2040, it is projected that the number of people living with Type 1 Diabetes will reach 13.5–17.4 million. The surge in diabetes cases has created the critical need for regular glucose monitoring to effectively manage this prevalent health issue. Currently, glucose levels are predominantly measured invasively by pricking the finger for a blood sample and involves invasive methods, such as fingertip pricks, which can be uncomfortable and inconvenient, particularly for paediatric patients. This method utilizes blood glucose monitoring devices, which measure sugar levels in a small blood sample placed on a disposable test strip and have a certain degree of inaccuracy. Patients do not test as often as they should because of the pain and hassle of finger pricks and many do not achieve optimal glycaemic control. However, the shift toward non-invasive continuous glucose monitoring is becoming increasingly imperative and a promising alternative. With current biotechnological advances, many techniques offer a non-invasive, continuous means of monitoring glucose levels and have garnered significant attention in recent years. The objective is to consolidate and summarize recent advancements in non-invasive continuous glucose monitoring, emphasizing integration into wearable platforms for seamless and real-time monitoring. Furthermore, paediatric patients with Type 1 Diabetes face elevated risks of severe hypoglycaemic and hyperglycaemic events due to challenges in glycaemic control. Frequently, monitoring blood glucose is crucial to mitigate these risks and achieve optimal glycaemic management. The objective of ongoing research is to validate AI-based algorithms utilizing ECG signals collected through non-invasive devices to detect glycaemic events. These advancements, once commercially available, have the potential to revolutionize glucose monitoring, offering a convenient, efficient, and less intrusive approach, particularly benefiting paediatric patients and improving overall healthcare management. Despite substantial research and development, challenges persist, including standardizing sweat collection methods, addressing sample degradation, accounting for variations in sweat composition among individuals, optimizing diverse detection methods, improving glucose detection sensitivity, and ensuring overall commercial viability. Overcoming these challenges is paramount to bridge the gap between research and market availability, paving the way for a technological revolution in glucose monitoring. In this study, we compared potential non-invasive glucose monitoring devices and techniques to evaluate the most accurate, pain-free, fast, and cost-friendly device. Upon examination and survey, we have theorized the drawbacks persisting in the existing devices and hypothesized techniques. Looking forward this study has a broader application in not only understanding the limitations and creating more accurate devices but also in continuous glucose monitoring for diabetic patient care.

Electro-Structured Cu Distorted Nanopyramids for Superior Sweat Glucose Sensing

There is a rising global demand for non-invasive glucose monitoring devices, due to an increase in diabetes and its associated health problems. Nanostructures, including needles, fibers, and rods, have drawn considerable attention due to their unique structural-based physical and chemical features in non-enzymatic electrochemical sensing. Copper is a potential candidate for applied research because of its higher electrical conductivity, low cost, and strong reactivity. To create 3-D nano copper structures, researchers have investigated chemical, electrochemical, and hydrothermal techniques. The electrochemical method can better control the formation reaction for these structures. The electrochemical process has better control over the formation reaction for these structures.Distinctive and self-supported copper nanopyramids were electrochemically created on a copper substrate within a few seconds by electrochemical deposition in a one pot synthesis. The SEM image of the constructed nano copper pyramids are shown in figure 1a. The built nano pyramids have a length of ~200 nm. The generated nanostructures display excellent catalytic activity for non-enzymatic glucose sensing. The created nonenzymatic sensor was tested for glucose detection in synthetic sweat and it displayed a linear response in the range of 20 µM- 2000 µM, making it appropriate for practical applications. The chrono amperometry for glucose sensing was performed at 0.5V for 60s. Figure 1b shows the calibration plot for glucose sensing. Linear response for the glucose was observed in the range from 20µM – 2000µM. The device showed a very low interference for uric acid and ascorbic acid. The device is stable upto 60 days, highly reproducible and can be reused upto 5 times. The correlation coefficient was 0.9857 for the linear equation I(μA) = (9.52*10-3) *C (in µM) + 5.065 and a sensitivity of 1.17 nA/(μM-cm2) was observed Figure 1

The effect of temperature on permittivity measurements of aqueous solutions of glucose for the development of non-invasive glucose sensors based on electromagnetic waves

This article presents for the first time an empirical study that shows the importance of considering temperature when analyzing the permittivity (dielectric constant) of aqueous glucose solutions of various concentrations. The permittivity is a parameter that is investigated by researchers as a biomarker for non-invasive measurement of glucose without drawing blood. The development of this technology will allow personalized healthcare diagnostics to monitor and prevent diabetes. Since human glucose levels in the blood vary in the range of a few milligrams per decilitre, estimating such small variations of glucose will require a highly accurate and repeatable sensing technology. Electromagnetic (EM) waves, specifically in the microwave and terahertz frequency ranges, have shown promise in detecting changes in the electrical properties of blood plasma as they relate to glucose concentration. However, it's important to note that while this technology shows promise, it is still in the research and development phase. It is shown here that the body temperature can affect the accuracy of the blood glucose measurements. Experiments were conducted with different glucose concentration solutions under various temperatures and the complex permittivity of the glucose was studied across a wide frequency range from 400 MHz to 11 GHz. The rise in thermal energy normally causes dipolar liquids like water to vibrate and rotate disrupting the alignment of the dipoles in response to an electric field thereby reducing its permittivity. Empirical results however show that for aqueous solution of glucose the permittivity increases with rise in temperature from 16 °C to 37 °C. This is attributed to the polar nature of the water and glucose molecules that becomes more pronounced with increased thermal energy. Based on the experimental results an accurate analytical expression is derived that considers the temperature of the aqueous glucose solution. The accuracy of the analytical expression is shown experimentally to be above 99%. The findings from the study should enable the design of accurate non-invasive glucose monitoring devices based on electromagnetic sensing techniques.

A Non-Invasive Glucose Monitoring Device using NIR (Near Infra Red)

In a developing country like India, systemic chronic diseases reach unsustainable heights as the population grows. According to WHO, diabetes affects an estimated 28.7 million people worldwide, or 28.5% of the population. Diabetes affects around 8.5 million people who have yet to be diagnosed (2022). Diabetes is one of these metabolic systemic chronic diseases that has captured the world's attention. The primary goal of our research is to develop non-invasive blood glucose monitoring technology that will benefit a large number of patients. We analyze the research progress and significant problems of non-invasive blood glucose detecting technologies in our project evaluation. In our study, we present an effective NIR-based optical detecting system. The existing non-invasive glucose monitoring device had a 60% accuracy level, however the proposed model will have an accuracy of 80% and will have a significant advantage over the existing system. Furthermore, the information is continuously delivered to the personal computer via serial communication via the UART protocol.

Noninvasive Blood Glucose Monitoring Systems Using Near-Infrared Technology-A Review.

The past few decades have seen ongoing development of continuous glucose monitoring (CGM) systems that are noninvasive and accurately measure blood glucose levels. The conventional finger-prick method, though accurate, is not feasible for use multiple times a day, as it is painful and test strips are expensive. Although minimally invasive and noninvasive CGM systems have been introduced into the market, they are expensive and require finger-prick calibrations. As the diabetes trend is high in low- and middle-income countries, a cost-effective and easy-to-use noninvasive glucose monitoring device is the need of the hour. This review paper briefly discusses the noninvasive glucose measuring technologies and their related research work. The technologies discussed are optical, transdermal, and enzymatic. The paper focuses on Near Infrared (NIR) technology and NIR Photoplethysmography (PPG) for blood glucose prediction. Feature extraction from PPG signals and glucose prediction with machine learning methods are discussed. The review concludes with key points and insights for future development of PPG NIR-based blood glucose monitoring systems.

Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes

Performance evaluation of egm1000™ non-invasive glucose monitoring device in patients with type 2 diabetes and subjects with prediabetes

Non-invasive glucose monitoring devices: A review

Diabetes is a growing chronic disease that affect millions of people in the world. Regular monitoring of blood glucose levels in patients is necessary to keep the disease under control. Current methods of blood glucose monitoring devices are typically invasive, causing discomfort to the patients. Non-invasive glucose monitoring devices are a possible game changer for diabetic patients as it reduces discomfort and provides continuous monitoring. This manuscript presents a review of non-invasive glucose biosensors with particular focus on leading technologies available in the market, such as microwave sensing, near-infrared spectroscopy, iontophoresis, and optical methods. This paper intends to describe non-invasive blood glucose monitoring methods using various biological fluids (sweat, saliva, interstitial fluid, urine), highlighting the advantages and drawbacks in latest device development. This review also discusses future trends of glucose detection devices and how it will improve patients’ quality of life.

Combination of surface plasmon resonance and differential Mueller matrix formalism for noninvasive glucose sensing

A novel technique is proposed for circular birefringence (CB) sensing using a surface plasmon resonance (SPR) prism coupler and differential Mueller matrix polarimetry. In the proposed system, the SPR prism coupler is placed in front of the sample in order to generate a weak-scattering medium model and enhance the sensitivity of the measurement process. The CB properties of the sample are then extracted using a dynamic Stokes-Mueller matrix polarimetry measurement system in the reflectance mode. The practical feasibility of the system is demonstrated by measuring the CB properties of aqueous glucose solutions and glucose phantom solutions containing 2% lipofundin. The oral glucose tolerance tests pilot study was performed on four healthy human volunteers aged between 20 and 25 years old. The experimental results show that the proposed method has a resolution of just 10 mg/dL. In general, the results confirm that the proposed polarimetry-SPR system provides a fastand reliable approach for CB detection and has significant potential for noninvasive glucose monitoring device (NIGMD) applications.

Технологии неинвазивных оптических методов определения уровня глюкозы в крови

The article studies the development of non-invasive optical methods for determining the concentration of glucose in the blood of patients with diabetes. Early diagnosis and day-to-day monitoring is essential to ensure a healthy life for patients with diabetes. Determining the concentration of glucose in the blood using conventional devices includes a chemical analysis of blood samples that are obtained by pricking a finger or extracting blood from the forearm. The pain, discomfort and inconvenience associated with modern invasive methods necessitated the study of non-invasive measurement methods. Non-invasive monitoring of blood glucose offers several advantages, including the absence of pain and biohazardous materials, the absence of sharp objects, an increase in the frequency of testing and, therefore, tighter control of glucose concentration. Given these potential benefits, the commercialization of non-invasive glucose monitoring devices has become a subject of increased interest. Some optical technologies may provide viable, non-invasive measuring devices. The purpose of this review study was to describe the main optical technologies for non-invasive monitoring of glucose and to compare their advantages and disadvantages.

Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions for Use

Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions for Use

Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device

Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device

Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

Non Invasive Technique for Measuring Blood Glucose based on IOT

Glucose monitoring devices acts as a good frontier in diabetes research. Many efforts have been taken in the way to develop various methods for non-invasive glucose monitoring devices, which can ease the life of people suffering from diabetes. The diabetes regulation method must be done in order to maintain proper glucose level in blood. As urine testing methods are outdated now, so to make the process easy, accurate, reliable and effective method is the use of IR technology. Due to lack of time people prefer self-monitoring system and it is also cost effective. Hence, a non-invasive method to get the value of glucose level. To provide a comfortable treatment a non-invasive device is made which measure the blood glucose level using the IR technology. Hence, by using non-invasive technique it is very easy and flexible to use and obtain the expected output without consuming much time, we can get the results within few seconds and the result is displayed in the LCD display.

Unsupervised calibration for noninvasive glucose-monitoring devices using mid-infrared spectroscopy

Noninvasive, glucose-monitoring technologies using infrared spectroscopy that have been studied typically require a calibration process that involves blood collection, which renders the methods somewhat invasive. We develop a truly noninvasive, glucose-monitoring technique using mid-infrared spectroscopy that does not require blood collection for calibration by applying domain adaptation (DA) using deep neural networks to train a model that associates blood glucose concentration with mid-infrared spectral data without requiring a training dataset labeled with invasive blood sample measurements. For realizing DA, the distribution of unlabeled spectral data for calibration is considered through adversarial update during training networks for regression to blood glucose concentration. This calibration improved the correlation coefficient between the true blood glucose concentrations and predicted blood glucose concentrations from 0.38 to 0.47. The result indicates that this calibration technique improves prediction accuracy for mid-infrared glucose measurements without any invasively acquired data.

Impact of a Noninvasive Blood Glucose Device on Glycemic Control and Daily Routine Measurement Aspects—Results of a Pilot Study

Regular blood glucose self-testing is considered to be the most painful procedure during daily treatment routine for patients with diabetes mellitus. This pilot study was undertaken to evaluate the performance of TensorTip CoG, a non-invasive glucose monitoring device (NI-CoG, CNOGA Medical, Israel) on glycemic control and daily measurement aspects in patients with type 1 and type 2 diabetes. The study was performed with 6 type 1 patients (T1D: 3 male/3 female, age: 43±16 years, HbA1c: 8.0±0.5%), and 15 type 2 patients (T2D: 8 male/7 female, 62±6 years, 7.2±1.3%). The participants used the NI-CoG device at home after an initial standardized meal experiment to evaluate device performance in comparison to a standard reference method (YSI Stat2300 plus). In addition, HbA1c was assessed and a treatment satisfaction questionnaire was completed after a period of three months of home use. During the meal experiment, NI-CoG showed good accuracy (mean bias: 15.3%; consensus error grid: 100% in zones A and B). A trend for HbA1c improvement was seen in both groups over 3 months (T1D: -0.22%, T2D: -0.1%, n.s.). Patients reported to measure more frequently, and to feel more comfortable with the non-invasive measurement procedure. Use of the device in the study initiated the general desire to switch to the new device also for daily routine use. The non-invasive TensorTip device was shown to increase the frequency of glucose testing and to have a positive impact on patients' perception of the measurement procedure. There was also an initial trend for improvements of glycemic control within the first three months of use in this pilot study. Disclosure A. Pfützner: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Lifecare. Speaker's Bureau; Self; Berlin-Chemie AG. Research Support; Self; Boehringer Ingelheim GmbH. A. Lier: None. S. Ramljak: None. F. Demircik: None.

Disruption in the diabetic device care market.

As diabetes mellitus (DM) has approached pandemic proportions, the pressure for effective glycemic management is mounting. The starting point for managing and living well with DM involves early diagnosis and monitoring blood glucose levels. Therefore, self-monitoring of blood glucose (SMBG) can help patients maintain their blood glucose levels within the appropriate range. The general principle behind the current SMBG method involves a finger prick test to obtain a blood drop, which is applied onto a reagent strip and read by an automated device. Novel techniques are currently under evaluation to create the next generation of painless and accurate glucose monitoring for DM. We began by outlining how the emerging technology of the noninvasive glucose monitoring devices (NIGMDs) provides both economic and clinical benefits for health systems and patients. We further explored the engineering and techniques behind these upcoming devices. Finally, we evaluated how the NIGMDs disrupt the diabetic device care market and drive health care consumerism. We postulated that the NIGMDs play a pivotal role in the implementation of next generation of diabetes prevention strategies.

The accuracy of a non-invasive glucose monitoring device does not depend on clinical characteristics of people with type 2 diabetes mellitus

Objective: GlucoTrack is a non-invasive device that indirectly measures glucose fluctuation in the earlobe tissue. Thus, its accuracy may be subjected to a time lag between glucose concentration in blood and tissue. This time lag was shown to depend on individual characteristics related to microvascular complications, such as diabetes duration, HbA1c level, and smoking history. Therefore, the current study investigated the effects of these factors on GlucoTrack performance.Research design and methods: Clinical trials were conducted on 114 people with type 2 diabetes. Device performance was clinically evaluated using Clarke error grid (CEG) analysis and numerically evaluated using the distribution of absolute relative difference (ARD) values.Results: CEG analysis revealed that 98.0% of glucose readings were within the clinically acceptable CEG A + B zones. Total mean ARD was 22.7%. Clinical and numerical accuracies were comparable between never smokers and former/current smokers, but slightly reduced in the HbA1c ≥ 7.5% group and in the diabetes duration ≥15 years group. Yet, likelihood ratio and parametric bootstrap tests statistically demonstrated that ARD values did not depend on diabetes duration, HbA1c level, or smoking history.Conclusions: GlucoTrack performance does not depend on diabetes duration, HbA1c level, and smoking history, indicating the device is suitable for various people with type 2 diabetes.

A Third Generation Glucose Biosensor Based on Cellobiose Dehydrogenase Immobilized on a Glassy Carbon Electrode Decorated with Electrodeposited Gold Nanoparticles: Characterization and Application in Human Saliva.

Efficient direct electron transfer (DET) between a cellobiose dehydrogenase mutant from Corynascus thermophilus (CtCDH C291Y) and a novel glassy carbon (GC)-modified electrode, obtained by direct electrodeposition of gold nanoparticles (AuNPs) was realized. The electrode was further modified with a mixed self-assembled monolayer of 4-aminothiophenol (4-APh) and 4-mercaptobenzoic acid (4-MBA), by using glutaraldehyde (GA) as cross-linking agent. The CtCDH C291Y/GA/4-APh,4-MBA/AuNPs/GC platform showed an apparent heterogeneous electron transfer rate constant (ks) of 19.4 ± 0.6 s−1, with an enhanced theoretical and real enzyme surface coverage (Γtheor and Γreal) of 5287 ± 152 pmol cm−2 and 27 ± 2 pmol cm−2, respectively. The modified electrode was successively used as glucose biosensor exhibiting a detection limit of 6.2 μM, an extended linear range from 0.02 to 30 mM, a sensitivity of 3.1 ± 0.1 μA mM−1 cm−2 (R2 = 0.995), excellent stability and good selectivity. These performances compared favourably with other glucose biosensors reported in the literature. Finally, the biosensor was tested to quantify the glucose content in human saliva samples with successful results in terms of both recovery and correlation with glucose blood levels, allowing further considerations on the development of non-invasive glucose monitoring devices.