Accuracy of FreeStyle Libre flash glucose monitoring in patients with type 2 diabetes who migrated from highlands to plains

BACKGROUND The FreeStyle Libre flash glucose monitoring(FGM)system entered the Chinese market in 2017 to complement the self-monitoring of blood glucose.Due to its increased usage in clinics,the number of studies investigating its accuracy has increased.However,its accuracy has not been investigated in highland populations in China.AIM To evaluate measurements recorded using the FreeStyle Libre FGM system compared with capillary blood glucose measured using the enzyme electrode method in patients with type 2 diabetes(T2D)who had migrated within 3 mo from highlands to plains.METHODS Overall,68 patients with T2D,selected from those who had recently migrated from highlands to plains(within 3 mo),were hospitalized at the Department of Endocrinology from August to October 2017 and underwent continuous glucose monitoring(CGM)with the FreeStyle Libre FGM system for 14 d.Throughout the study period,fingertip capillary blood glucose was measured daily using the enzyme electrode method(Super GL,China),and blood glucose levels were read from the scanning probe during fasting and 2 h after all three meals.Moreover,the time interval between reading the data from the scanning probe and collecting fingertip capillary blood was controlled to<5 min.The accuracy of the FGM system was evaluated according to the CGM guidelines.Subsequently,the factors influencing the mean absolute relative difference(MARD)of this system were analyzed by a multiple linear regression method.RESULTS Pearson’s correlation analysis showed that the fingertip and scanned glucose levels were positively correlated(R=0.86,P=0.00).The aggregated MARD of scanned glucose was 14.28±13.40%.Parker's error analysis showed that 99.30%of the data pairs were located in areas A and B.According to the probe wear time of the FreeStyle Libre FGM system,MARD_(1 d) and MARD_(2-14 d) were 16.55%and 14.35%,respectively(t=1.23,P=0.22).Multiple stepwise regression analysis showed that MARD did not correlate with blood glucose when the largest amplitude of glycemic excursion(LAGE)was<5.80 mmol/L but negatively correlated with blood glucose when the LAGE was≥5.80 mmol/L.CONCLUSION The FreeStyle Libre FGM system has good accuracy in patients with T2D who had recently migrated from highlands to plains.This system might be ideal for avoiding the effects of high hematocrit on blood glucose monitoring in populations that recently migrated to plains.MARD is mainly influenced by glucose levels and fluctuations,and the accuracy of the system is higher when the blood glucose fluctuation is small.In case of higher blood glucose level fluctuations,deviation in the scanned glucose levels is the highest at extremely low blood glucose levels.

Application and management of continuous glucose monitoring in diabetic kidney disease

Diabetic kidney disease(DKD)is a common complication of diabetes mellitus that contributes to the risk of end-stage kidney disease(ESKD).Wide glycemic var-iations,such as hypoglycemia and hyperglycemia,are broadly found in diabetic patients with DKD and especially ESKD,as a result of impaired renal metabolism.It is essential to monitor glycemia for effective management of DKD.Hemoglobin A1c(HbA1c)has long been considered as the gold standard for monitoring glycemia for>3 months.However,assessment of HbA1c has some bias as it is susceptible to factors such as anemia and liver or kidney dysfunction.Continuous glucose monitoring(CGM)has provided new insights on glycemic assessment and management.CGM directly measures glucose level in interstitial fluid,reports real-time or retrospective glucose concentration,and provides multiple glycemic metrics.It avoids the pitfalls of HbA1c in some contexts,and may serve as a precise alternative to estimation of mean glucose and glycemic variability.Emerging studies have demonstrated the merits of CGM for precise monitoring,which allows fine-tuning of glycemic management in diabetic patients.Therefore,CGM technology has the potential for better glycemic monitoring in DKD patients.More research is needed to explore its application and management in different stages of DKD,including hemodialysis,peritoneal dialysis and kidney transplantation.

Recent developments in non-invasive blood glucose monitoring technology

Diabetes mellitus is a huge and significantly grow ing problem. Continuous and real-time monitoring of blood glucose plays a key role for the people with diabetes,which can help them to control glucose concentration more effectively. However,current blood glucose monitoring methods require blood by needle-pricking,which limit the detection frequency. It is necessary to develop non-invasive blood glucose monitoring methods to achieve the ideal therapeutic and management of diabetes. In this paper,the developments and challenges of non-invasive blood glucose monitoring technologies in recent years are reviewed. And the bottleneck and the developing trends are also analyzed.

Nanomaterial-assisted wearable glucose biosensors for noninvasive real-time monitoring:Pioneering point-of-care and beyond

This review explores glucose monitoring and management strategies,emphasizing the need for reliable and userfriendly wearable sensors that are the next generation of sensors for continuous glucose detection.In addition,examines key strategies for designing glucose sensors that are multi-functional,reliable,and cost-effective in a variety of contexts.The unique features of effective diabetes management technology are highlighted,with a focus on using nano/biosensor devices that can quickly and accurately detect glucose levels in the blood,improving patient treatment and control of potential diabetes-related infections.The potential of next-generation wearable and touch-sensitive nano biomedical sensor engineering designs for providing full control in assessing implantable,continuous glucose monitoring is also explored.The challenges of standardizing drug or insulin delivery doses,low-cost,real-time detection of increased blood sugar levels in diabetics,and early digital health awareness controls for the adverse effects of injectable medication are identified as unmet needs.Also,the market for biosensors is expected to expand significantly due to the rising need for portable diagnostic equipment and an ever-increasing diabetic population.The paper concludes by emphasizing the need for further research and development of glucose biosensors to meet the stringent requirements for sensitivity and specificity imposed by clinical diagnostics while being cost-effective,stable,and durable.

A Review: Biosensor Progression in Glucose Monitoring for Patients with Diabetes

Diabetes is a condition that can come to the surface at any point throughout a person’s life. Although Type 1 and Type 2 Diabetes have different triggers that cause them to arise, a person can experience similar complications from either if not monitored and treated accordingly. Through the Diabetes Control and Complications Trial, it was found that a significant way to monitor diabetes is through glucose levels in a person’s body. The research surrounding glucose monitoring dates to the mid-1800s, with the first successful reagent for glucose testing being developed in 1908. Since then, glucose sensing has become one of the most rapidly growing areas of research and development in biosensor technology, creating a competitive market for more advanced, accurate, and convenient glucose monitoring. This article reviews the history of biosensors used for glucose monitoring, and major advancements in biosensor technology to enhance performance and improve quality of life for patients with diabetes.

Microarrow sensor array with enhanced skin adhesion for transdermal continuous monitoring of glucose and reactive oxygen species

Conventional blood sampling for glucose detection is prone to cause pain and fails to continuously record glucose fluctuations in vivo.Continuous glucose monitoring based on implantable electrodes could induce pain and potential tissue inflammation,and the presence of reactive oxygen species(ROS)due to inflammationmay affect glucose detection.Microneedle technology is less invasive,yet microneedle adhesion with skin tissue is limited.In this work,we developed a microarrow sensor array(MASA),which provided enhanced skin surface adhesion and enabled simultaneous detection of glucose and H_(2)O_(2)(representative of ROS)in interstitial fluid in vivo.The microarrows fabricated via laser micromachining were modified with functional coating and integrated into a patch of a three-dimensional(3D)microneedle array.Due to the arrow tip mechanically interlocking with the tissue,the microarrow array could better adhere to the skin surface after penetration into skin.The MASA was demonstrated to provide continuous in vivo monitoring of glucose and H_(2)O_(2) concentrations,with the detection of H_(2)O_(2) providing a valuable reference for assessing the inflammation state.Finally,the MASA was integrated into a monitoring system using custom circuitry.This work provides a promising tool for the stable and reliable monitoring of blood glucose in diabetic patients.

Utilising continuous glucose monitoring for glycemic control in diabetic kidney disease

In this editorial,we comment on the article by Zhang et al.Chronic kidney disease(CKD)presents a significant challenge in managing glycemic control,especially in diabetic patients with diabetic kidney disease undergoing dialysis or kidney transplantation.Conventional markers like glycated haemoglobin(HbA1c)may not accurately reflect glycemic fluctuations in these populations due to factors such as anaemia and kidney dysfunction.This comprehensive review discusses the limitations of HbA1c and explores alternative methods,such as continuous glucose monitoring(CGM)in CKD patients.CGM emerges as a promising technology offering real-time or retrospective glucose concentration measure-ments and overcoming the limitations of HbA1c.Key studies demonstrate the utility of CGM in different CKD settings,including hemodialysis and peritoneal dialysis patients,as well as kidney transplant recipients.Despite challenges like sensor accuracy fluctuation,CGM proves valuable in monitoring glycemic trends and mitigating the risk of hypo-and hyperglycemia,to which CKD patients are prone.The review also addresses the limitations of CGM in CKD patients,emphasizing the need for further research to optimize its utilization in clinical practice.Altogether,this review advocates for integrating CGM into managing glycemia in CKD patients,highlighting its superiority over traditional markers and urging clinicians to consider CGM a valuable tool in their armamentarium.

Continuous glucose monitoring metrics in pregnancy with type 1 diabetes mellitus

Managing diabetes during pregnancy is challenging,given the significant risk it poses for both maternal and foetal health outcomes.While traditional methods involve capillary self-monitoring of blood glucose level monitoring and periodic HbA1c tests,the advent of continuous glucose monitoring(CGM)systems has revolutionized the approach.These devices offer a safe and reliable means of tracking glucose levels in real-time,benefiting both women with diabetes during pregnancy and the healthcare providers.Moreover,CGM systems have shown a low rate of side effects and high feasibility when used in pregnancies complicated by diabetes,especially when paired with continuous subcutaneous insulin infusion pump as hybrid closed loop device.Such a combined approach has been demonstrated to improve overall blood sugar control,lessen the occurrence of preeclampsia and neonatal hypoglycaemia,and minimize the duration of neonatal intensive care unit stays.This paper aims to offer a comprehensive evaluation of CGM metrics specifically tailored for pregnancies impacted by type 1 diabetes mellitus.

A Study on Near-Infrared Non-Invasive Blood Glucose Concentration Regression Prediction Based on PSO-MKL-SVR

To improve the accuracy of predicting non-invasive blood glucose concentration in the near-infrared spectrum, we utilized the Particle Swarm Optimization (PSO) algorithm to optimize hyperparameters for the Multi-Kernel Learning Support Vector Machine (MKL-SVR). With these optimized hyperparameters, we established a non-invasive blood glucose regression model, referred to as the PSO-MKL-SVR model. Subsequently, we conducted a comparative analysis between the PSO-MKL-SVR model and the PSO-SVR model. In a dataset comprising ten volunteers, the PSO-MKL-SVR model exhibited significant precision improvements, including a 16.03% reduction in Mean Square Error and a 0.29% increase in the Squared Correlation Coefficient. Moreover, there was a 0.14% higher probability of the Clark’s Error Grid Analysis falling within Zone A. Additionally, the PSO-MKL-SVR model demonstrated a faster operational speed compared to the PSO-SVR model.

Non-invasive biomarkers for monitoring the fibrogenic process in liver:A short survey

The clinical course ofchronic liver diseases is significantly dependent on the progression rate and the extent offibrosis, i.e. the non-structured replacement of necrotic parenchyma by extracellular matrix. Fibrogenesis, i.e. the development offibrosis can be regarded as an unlimited wound healing process, which is based on matrix (connective tissue) synthesis in activated hepatic stellate cells, fibroblasts (fibrocytes), hepatocytes and biliary epithelial cells, which are converted to matrix-producing (myo-)fibroblasts by a process defined as epithelial-mesenchymal transition. Blood (noninvasive) biomarkers offibrogenesis and fibrosis can be divided into class and class analytes. Class biomarkers are those single tests, which are based on the pathophysiology offibrosis, whereas class biomarkers aremostly multiparametric algorithms, which have been statistically evaluated with regard to the detection and activity ofongoing fibrosis. Currently available markers fulfil the criteria ofideal clinical-chemical tests only partially, but increased understanding ofthe complex pathogenesis offibrosis offers additional ways for pathophysiologically well based serum (plasma) biomarkers. They include TGF-β-driven marker proteins, bone marrow-derived cells (fibrocytes), and cytokines, which govern proand anti-fibrotic activities. Proteomic and glycomic approaches ofserum are under investigation to set up specific protein or carbohydrate profiles in patients with liver fibrosis. These and other novel parameters will supplement or eventually replaceliver biopsy/histology, high resolution imaging analysis, and elastography for the detection and monitoring of patients at risk ofdeveloping liver fibrosis.

Pros and cons of continuous glucose monitoring in the intensive care unit

Diabetes mellitus affects people worldwide,and management of its acute complications or treatment-related adverse events is particularly important in critically ill patients.Previous reports have confirmed that hyperglycemia can increase the risk of mortality in patients cared in the intensive care unit(ICU).In addition,severe and multiple hypoglycemia increases the risk of mortality when using insulin or intensive antidiabetic therapy.The innovation of continuous glucose monitoring(CGM)may help to alert medical caregivers with regard to the development of hyperglycemia and hypoglycemia,which may decrease the potential complications in patients in the ICU.The major limitation of CGM is the measurement of interstitial glucose levels rather than real-time blood glucose levels;thus,there will be a delay in the treatment of hyperglycemia and hypoglycemia in patients.Recently,the European Union approved a state-of-art artificial intelligence directed loop system coordinated by CGM and a continuous insulin pump for diabetes control,which may provide a practical way to prevent acute adverse glycemic events related to antidiabetic therapy in critically ill patients.In this mini-review paper,we describe the application of CGM to patients in the ICU and summarize the pros and cons of CGM.

Continuous glucose monitoring defined time-in-range is associated with sudomotor dysfunction in type 2 diabetes

BACKGROUND Time in range(TIR),as a novel metric for glycemic control,has robust relevance with diabetic complications.Diabetic peripheral neuropathy(DPN)is characterized by sudomotor dysfunction.AIM To explore the relationship between TIR obtained from continuous glucose monitoring(CGM)and sudomotor function detected by SUDOSCAN in subjects with type 2 diabetes.METHODS The research enrolled 466 inpatients with type 2 diabetes.All subjects underwent 3-d CGM and SUDOSCAN.SUDOSCAN was assessed with electrochemical skin conductance in hands(HESC)and feet(FESC).Average feet ESC<60μS was defined as sudomotor dysfunction(+),otherwise it was sudomotor dysfunction(-).TIR refers to the percentage of time when blood glucose is between 3.9-10 mmol/L during 1 d period.RESULTS Among the enrolled subjects,135(28.97%)presented with sudomotor dysfunction.Patients with sudomotor dysfunction(+)showed a decreased level of TIR(P<0.001).Compared to the lowest tertile of TIR,the middle and the highest tertiles of TIR was associated with an obviously lower prevalence of sudomotor dysfunction(20.51%and 21.94%vs 44.52%)(P<0.001).In addition,with the increase of TIR,HESC and FESC increased(P<0.001).Regression analysis demonstrated that TIR was inversely and independently linked with the prevalence of sudomotor dysfunction after adjusting for confounding values(odds ratio=0.979,95%CI:0.971-0.987,P<0.001).CONCLUSION The tight glycemic control assessed by TIR is of vitally protective value for sudomotor dysfunction in type 2 diabetes mellitus.

Comparing a non-invasive hemodynamic monitor with minimally invasive monitoring during major open abdominal surgery

As part of the enhanced recovery after surgery （ERAS） protocol, the goal-directed fluid management with hemodynamic monitoring can effectively guide perioperative fluid use and significantly improve the outcomes in highrisk patients undergoing major surgeries. Several minimally invasive and non-invasive monitoring devices are commercially available for clinical use. As part of an internal evaluation, we reported the results from three different hemodynamic monitoring devices used in a patient undergoing a major abdominal surgery.

Accuracy of pipeline blood glucose monitoring in patients with severe liver injury undergoing artificial liver support system treatment

Severe deterioration of liver function in patients can be characterized by coagulation disorders, jaundice, hepatic encephalopathy, ascites, and other symptoms. Severe liver injury can develop as acute liver failure, subacute liver failure, acute-on-chronic liver failure, or further worsening of end-stage liver disease [1].

Intrapartum application of the continuous glucose monitoring system in pregnancies complicated with diabetes: A review and feasibility study

Intrapartum maternal normoglycemia seems to play an important role in the prevention of adverse perinatal, maternal and neonatal outcomes. Several glucose monitoring protocols have been developed, aiming to achieve a tight glucose monitoring and control. Depending on the type of diabetes and the optimal or suboptimal glycemic control, the treatment options include fasting status of the parturient, frequent monitoring of capillary blood glucose, intravenous dextrose infusion and subcutaneous or intravenous use of insulin. Continuous glucose monitoring system(CGMS) is a relatively new technology that measures interstitial glucose at very short time intervals over a specifi c period of time. The resulting profi le provides a more comprehensive measure of glycemic excursions than intermittent home blood glucose monitoring. Results of studies applying the CGMS technology in patients with or without diabetes mellitus(DM) have revealed new insights in glucose metabolism. Moreover, CGMS have a potential role in the improvement of glycemic control during pregnancy and labor, which may lead to a decrease in perinatal morbidity and mortality. In conclusion, the use of CGMS, with its important technical advantages compared to the conventional way of monitoring, may lead into a more etiological intrapartum management of both the mother and her fetus/infant in pregnancies complicated with DM.

Non-invasive glucose measuring apparatus based on conservation of energy method

A new non-invasive blood glucose measuring apparatus (NBGMA) made up of MSP430F149 SCM (single chip micyoco) was developed,which can measure blood glucose level (BGL) frequently,conveniently and painlessly. The hardware and software of this apparatus were designed,and detecting algorithms based on conservation of energy method (COEM) were presented. According to the law of conservation of energy that the energy derived by human body equals energy consumed by metabolism,and the relationship between convection,evaporation,radiation and the BGL was established. The sensor module was designed. 20 healthy volunteers were involved in the clinical experiment. The BGL measured by an automatic biochemical analyzer (ABA) was set as the reference. Regression analysis was performed to compare the conservation of energy method with the biochemical method,using the 20 data points with blood glucose concentrations ranging from 680 to 1 100 mg/L. Reproducibility was measured for healthy fasting volunteers. The results show that the means of BGL detected by NBGMA and ANA are very close to each other,and the difference of standard deviation (SD) is 24.7 mg/L. The correlative coefficient is 0.807. The coefficient of variation (CV) is 4% at 921.6 mg/L. The resultant regression is evaluated by the Clarke error grid analysis (EGA) and all data points are included in the clinically acceptable regions (region A:100%,region B:0%). Accordingly,it is feasible to measure BGL with COEM.

Parsimonious Model for Blood Glucose Level Monitoring in Type 2 Diabetes patients

To establish the parsimonious model for blood glucose monitoring in patients with type 2 diabetes receiving oral hypoglycemic agent treatment. One hundred and fifty-nine adult Chinese type 2 diabetes patients were randomized to receive rapid-acting or sustained-release gliclazide therapy for 12 weeks.

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 midinfrared 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 coeffcient 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.

Noninvasive Blood Glucose Monitoring System Based on Distributed Multi-Sensors Information Fusion of Multi-Wavelength NIR

In this research, a near infrared multi-wavelength noninvasive blood glucose monitoring system with distributed laser multi-sensors is applied to monitor human blood glucose concentration. In order to improve the monitoring accuracy, a multi-sensors information fusion model based on Back Propagation Artificial Neural Network is proposed. The Root- Mean-Square Error of Prediction for noninvasive blood glucose measurement is 0.088mmol/L, and the correlation coefficient is 0.94. The noninvasive blood glucose monitoring system based on distributed multi-sensors information fusion of multi-wavelength NIR is proved to be of great efficient. And the new proposed idea of measurement based on distri- buted multi-sensors, shows better prediction accuracy.

Review of minimally invasive continuous glucose monitoring technology & instruments

Continuous blood glucose monitoring is important for the diagnosis,treatment,and study of diabetes. many organizations have been working on this subject in recent two decades. Glucose concentration in interstitial fluid is closely related to the blood glucose levels. Minimally invasive continuous blood glucose monitoring technology based on the glucose detection in interstitial fluid develops rapidly and gets more and more attentions from the patients and the doctors,due to its instantaneous real-time display of glucose level,"24/7"coverage,and the ability to characterize glycemic variability. According to the different detection methods,most of the continuous glucose monitoring technology could be divided into two kinds: subcutaneous implantation method and transdermal extraction method. This paper review s the recent development of minimally invasive blood glucose monitoring technology and instruments. The mainly remained challenges and related research directions are presented as well.