Electrochemical Glucose Sensors: Classification, Catalyst Innovation, and Sampling Mode Evolution.

Glucose sensors are essential tools for monitoring blood glucose concentration in diabetic patients. In recent years, with the increasing number of individuals suffering from diabetes, blood glucose monitoring has become extremely necessary, which expedites the iteration and upgrade of glucose sensors greatly. Currently, two main types of glucose sensors are available for blood glucose testing: enzyme-based glucose sensor (EBGS) and enzyme-free glucose sensor (EFGS). For EBGS, several progresses have been made to comprehensively improve detection performance, ranging from enhancing enzyme activity, thermostability, and electron transfer properties, to introducing new materials with superior properties. For EFGS, more and more new metallic materials and their oxides are being applied to further optimize its blood glucose monitoring. Here the latest progress of electrochemical glucose sensors, their manufacturing methods, electrode materials, electrochemical parameters, and applications were summarized, the development glucose sensors with various noninvasive sampling modes were also compared.

Multilayer patch functionalized microfibrillated cellulosic paper sensor for sweat glucose monitoring.

Electrochemical analysis of glucose monitoring without painful blood collection provides a new noninvasive route for monitoring glucose levels. Thus, in this study, biobased cellulosic papers (methylated and phosphorylated one) based glucose monitoring sensor is developed. To achieve high hydrophilicity, microfibrillated cellulose (MFC) were functionalized using hexokinase mediated phosphorylation (-OH to -[Formula: see text]). The instinctive increased surface charge density from 36.2 ± 3.4 to 118.4 ± 1.2 µmol/g and decrease contact angle (45°-22°) confirms the increased hydrophilicity of paper. Furthermore, functionalized phos-MFC paper increase the capillary flow of sweat, required low quantity (1 µl) of sweat for accurate analysis of glucose level. Additionally, chemically induced methyl groups (-CH3) make the sensor more barrier to other chemicals. In addition, a multilayer patch design combined with sensor miniaturization was used to lead to an increase in the efficiency of the sweat collection and sensing processes. Besides, this paper sensor integrated with artificial transdermal drug delivery unit (agarose gel as skin) for monitoring glucose levels in sweat. The patch monitoring system increase the accuracy of sensing with fluctuation in sweat vol. (1-4 µl), temperature (20-70 °C), and pH (4.0-7.0). In addition, temperature dependency artificial transdermal delivery (within agarose gel) of drug metformin agrees the measurement accuracy of sensor, called "switch system" without any error. As a result, the reported MFC paper based multi-patch disposable sensing system provides a novel closed-loop solution for the noninvasive sweat-based management of diabetes mellitus.

Availability, price and affordability of insulin, delivery devices and self-monitoring blood glucose devices in Indonesia.

Insulin is essential for the survival of people with type 1 diabetes and for better management of people with type 2 diabetes. People with diabetes using insulin also require self-monitoring blood glucose (SMBG) devices (e.g., meters, strips, continuous monitoring systems) for day-to-day management. It is essential to ensure that insulin and these devices are available and affordable. This study aimed to evaluate the availability, price, and affordability of insulin and SMBG devices in Indonesia using an adaptation of the World Health Organization/Health Action International (WHO/HAI) price survey. A total of 34 public health facilities (hospitals, primary healthcare centres/Puskesmas) and 37 private pharmacies were sampled. Information from three major online marketplaces was also collected. Prices were expressed as median patient prices (US$). Affordability was defined as the number of days' wages needed by the lowest paid unskilled government worker (LPGW) to purchase 30 days' supply of insulin, delivery devices and SMBGs. Availability of analogue insulin was slightly higher in public facilities (63.6%) than in the private sector (43.2%), with no human insulin available in both sectors. Conversely, better availability was observed in private facilities for SMBG devices as public sector facilities did not supply devices for self-testing. Median prices for 1000IU analogues varied between the public sector (US$ 5.26) and the private sector (US$11.24). The highest median price of analogues was seen in online marketplaces (US$ 28.65). The least costly median price of SMBG devices were observed in online platforms (meter: US$ 18.37, test strip: US$ 0.27, lancet: US$ 0.02). A low-income person had to work 2-3 days to buy 1000IU of analogues. It required 5-7 days' and 4-5 day's wages to purchase a meter and a month's supply of test strips, respectively. The availability and affordability of insulin and SMBG devices remain important issues in Indonesia requiring holistic approaches for further improvement.

Hydrogel Capacitors Based on MoS2 Nanosheets and Applications in Glucose Monitoring.

Non-invasive/minimally invasive continuous monitoring of blood glucose and blood glucose administration have a high impact on chronic disease management in diabetic patients, but the existing technology is yet to achieve the above two purposes at the same time. Therefore, this study proposes a microfluidic microneedle patch based on 3D printing technology and an integrated control system design for blood glucose measurement, and a drug delivery control circuit based on a 555 chip. The proposed method provides an improved preparation of a PVA-PEG-MoS2 nanosheet hydrogel, making use of its dielectric properties to fabricate a microcapacitor and then embedding it in a microfluidic chip. When MoS2 nanosheets react with interstitial liquid glucose (and during the calibration process), the permittivity of the hydrogel is changed, resulting in changes in the capacitance of the capacitor. By converting the capacitance change into the square-wave period change in the output of the 555 chip with the control circuit design accordingly, the minimally invasive continuous measurement of blood glucose and the controlled release of hypoglycemic drugs are realized. In this study, the cross-linking structure of MoS2 nanosheets in hydrogel was examined using infrared spectroscopy and scanning electron microscopy (SEM) methods. Moreover, the critical doping mass fraction of MoS2 nanosheets was determined to be 2% via the measurement of the dielectric constant. Meanwhile, the circuit design and the relationship between the pulse cycle and glucose concentration is validated. The results show that, compared with capacitors in series, the microcapacitors embedded in microfluidic channels can be connected in parallel to obtain better linearized blood glucose measurement results.

[Continuous glucose monitoring for better glucose control in type 2 diabetes?] / Diabète de type 2 : vers un contrôle opti­mal grâce au ­suivi continu du glucose ?

This article reviews the use of continuous glucose monitoring (CGM) devices in the management of type 2 diabetes (T2D). Study results show that continuous CGM use improves glycemic control, lowers glycated hemoglobin (HbA1c) levels, and reduces hypoglycemic episodes compared with traditional monitoring methods. -Observational studies also suggest a reduction in diabetes-related emergencies and hospitalizations. In addition, sporadic use of CGM appears to be beneficial for certain groups of people with T2D. However, more research is needed to fully understand the long-term effects and limitations of this technology. This article discusses -innovative perspectives on T2D management.

Cet article explore l'impact des dispositifs de mesure continue du glucose (MCG) dans la gestion du diabète de type 2 (DT2). Les ­résultats des études démontrent que l'utilisation régulière de la MCG améliore le contrôle de la glycémie, réduit les taux d'hémoglobine glyquée (HbA1c) et diminue les épisodes hypoglycémiques par rapport à la surveillance traditionnelle. Les données issues d'études observationnelles mettent également en évidence une réduction des événements aigus liée au diabète et des hospitalisations. De plus, l'emploi occasionnel de la MCG semble davantage bénéfique pour certains groupes de patients DT2. Toutefois, des recherches supplémentaires sont nécessaires pour clarifier les effets à long terme et les limites de cette technologie. Cet article discute les perspectives innovantes pour la gestion du DT2.

A hybrid Transformer-LSTM model apply to glucose prediction.

The global prevalence of diabetes is escalating, with estimates indicating that over 536.6 million individuals were afflicted by 2021, accounting for approximately 10.5% of the world's population. Effective management of diabetes, particularly monitoring and prediction of blood glucose levels, remains a significant challenge due to the severe health risks associated with inaccuracies, such as hypoglycemia and hyperglycemia. This study addresses this critical issue by employing a hybrid Transformer-LSTM (Long Short-Term Memory) model designed to enhance the accuracy of future glucose level predictions based on data from Continuous Glucose Monitoring (CGM) systems. This innovative approach aims to reduce the risk of diabetic complications and improve patient outcomes. We utilized a dataset which contain more than 32000 data points comprising CGM data from eight patients collected by Suzhou Municipal Hospital in Jiangsu Province, China. This dataset includes historical glucose readings and equipment calibration values, making it highly suitable for developing predictive models due to its richness and real-time applicability. Our findings demonstrate that the hybrid Transformer-LSTM model significantly outperforms the standard LSTM model, achieving Mean Square Error (MSE) values of 1.18, 1.70, and 2.00 at forecasting intervals of 15, 30, and 45 minutes, respectively. This research underscores the potential of advanced machine learning techniques in the proactive management of diabetes, a critical step toward mitigating its impact.

Analytical Performance of the FreeStyle Libre 2 Glucose Sensor in Healthy Male Adults.

Continuous Glucose Monitoring (CGM) not only can be used for glycemic control in chronic diseases (e.g., diabetes), but is increasingly being utilized by individuals and athletes to monitor fluctuations in training and everyday life. However, it is not clear how accurately CGM reflects plasma glucose concentration in a healthy population in the absence of chronic diseases. In an oral glucose tolerance test (OGTT) with forty-four healthy male subjects (25.5 ± 4.5 years), the interstitial fluid glucose (ISFG) concentration obtained by a CGM sensor was compared against finger-prick capillary plasma glucose (CPG) concentration at fasting baseline (T0) and 30 (T30), 60 (T60), 90 (T90), and 120 (T120) min post OGTT to investigate differences in measurement accuracy. The overall mean absolute relative difference (MARD) was 12.9% (95%-CI: 11.8-14.0%). Approximately 100% of the ISFG values were within zones A and B in the Consensus Error Grid, indicating clinical accuracy. A paired t-test revealed statistically significant differences between CPG and ISFG at all time points (T0: 97.3 mg/dL vs. 89.7 mg/dL, T30: 159.9 mg/dL vs. 144.3 mg/dL, T60: 134.8 mg/dL vs. 126.2 mg/dL, T90: 113.7 mg/dL vs. 99.3 mg/dL, and T120: 91.8 mg/dL vs. 82.6 mg/dL; p < 0.001) with medium to large effect sizes (d = 0.57-1.02) and with ISFG systematically under-reporting the reference system CPG. CGM sensors provide a convenient and reliable method for monitoring blood glucose in the everyday lives of healthy adults. Nonetheless, their use in clinical settings wherein implications are drawn from CGM readings should be handled carefully.

Evaluation of New Blood Glucose Monitoring System According to ISO 15197 and the Food and Drug Administration Standard.

OBJECTIVE: Self-monitoring blood glucose levels using a blood glucose monitoring system (BGMS) helps minimize mortality and morbidity in patients with diabetes. We evaluated the accuracy of a new BGMS (CareSens S Fit [CaseSens; i-SENS Inc., Seoul, Korea]). METHODS: Patients who visited the Endocrinology Department at Kangbuk Samsung Hospital between July 13, 2021, and August 18, 2021 were included. CareSens was evaluated in accordance with the International Organization for Standardization 2013 (ISO 15197:2013) and the Food and Drug Administration (FDA) standard 2020. RESULTS: The study included 350 patients. The accuracy evaluation for CareSens, according to ISO 15197:2013 and FDA standard 2020, revealed that >99% of test results are within the allowed range. CONCLUSIONS: The CareSens performed excellently, meeting ISO 15197:2013 and FDA Standard 2020.

Advances in diabetes technology within the digital diabetes ecosystem.

Ongoing innovations in glucose monitoring, insulin delivery, and telehealth technologies have created a digital diabetes ecosystem populated by connected tools and technologies that have been shown to improve clinical outcomes, lower costs, and reduce the burden of diabetes. Advances in connected continuous glucose monitoring devices, insulin pumps, and insulin pens have led to the development of automated insulin delivery systems that modulate insulin infusion based on sensor glucose data. Similar integrations of continuous glucose monitoring and connected blood glucose meter data into "smart" pens have lessened the guesswork of intensive insulin management for individuals who prefer traditional injection therapy. A growing number of health apps that can be accessed through smartphones and wearable devices provide information and advice that support individuals in adopting healthier lifestyles. The differences in features and functionality give users the ability to select the devices that best meet their unique requirements and preferences. This article reviews the most current digital diabetes technologies and discusses how the connectivity of these tools can create an overarching architecture of feedback mechanisms that monitor an individual's health status, motivate and enhance adherence to self-management, and provide advice and decision-support tools to clinicians as well as other members of the health care team to make living with diabetes more manageable.

Use of glucose sensors for post-discharge care triaging of insulin-treated patients with type 2 diabetes: a feasibility study.

The use of glucose sensors to triage post-discharge follow-up was investigated among hospital inpatients with type 2 diabetes. Feasibility, utility and patient satisfaction with this model of care were studied. Feasibility was 36.5%, with 90/198 (45.5%) inpatients discharged with glucose sensors but 9.0% unable to use glucose sensors effectively. Follow-up plans were altered in 76.3% of the patients able to use the sensor technology. Patient satisfaction was high and was improved on follow-up after 6 months.

Recent Developments in Personal Glucose Meters as Point-of-Care Testing Devices (2020-2024).

Point-of-care testing (POCT) is a contemporary diagnostic approach characterized by its user-friendly nature, cost efficiency, environmental compatibility, and lack of reliance on professional experts. Therefore, it is widely used in clinical diagnosis and other analytical testing fields to meet the demand for rapid and convenient testing. The application of POCT technology not only improves testing efficiency, but also brings convenience and benefits to the healthcare industry. The personal glucose meter (PGM) is a highly successful commercial POCT tool that has been widely used not only for glucose analysis, but also for non-glucose target detection. In this review, the recent advances from 2020 to 2024 in non-glucose target analysis for PGMs as POCT devices are summarized. The signal transduction strategies for non-glucose target analysis based on PGMs, including enzymatic transduction, nanocarrier transduction (enzyme or glucose), and glucose consumption transduction are briefly introduced. Meanwhile, the applications of PGMs in non-glucose target analysis are outlined, encompassing biomedical, environmental, and food analysis, along with other diverse applications. Finally, the prospects of and obstacles to employing PGMs as POCT tools for non-glucose target analysis are discussed.

Validating the Use of Continuous Glucose Monitors With Nondiabetic Recreational Runners.

PURPOSE: Continuous glucose monitors (CGMs) are becoming increasingly popular among endurance athletes despite unconfirmed accuracy. We assessed the concurrent validity of the FreeStyle Libre 2 worn on 2 different sites at rest, during steady-state running, and postprandial. METHODS: Thirteen nondiabetic, well-trained recreational runners (age = 40 [8] y, maximal aerobic oxygen consumption = 46.1 [6.4] mL·kg-1·min-1) wore a CGM on the upper arm and chest while treadmill running for 30, 60, and 90 minutes at intensities corresponding to 50%, 60%, and 70% of maximal aerobic oxygen consumption, respectively. Glucose was measured by manually scanning CGMs and obtaining a finger-prick capillary blood glucose sample. Mean absolute relative difference, time in range, and continuous glucose Clarke error grid analysis were used to compare paired CGM and blood glucose readings. RESULTS: Across all intensities of steady-state running, we found a mean absolute relative difference of 13.8 (10.9) for the arm and 11.4 (9.0) for the chest. The coefficient of variation exceeded 70%. Approximately 47% of arm and 50% of chest paired glucose measurements had an absolute difference ≤10%. Continuous glucose Clarke error grid analysis indicated 99.8% (arm) and 99.6% (chest) CGM data fell in clinically acceptable zones A and B. Time-in-range analysis showed reduced accuracy at lower glucose levels. However, CGMs accurately detected trends in mean glucose readings over time. CONCLUSIONS: CGMs are not valid for point glucose monitoring but appear to be valid for monitoring glucose trends during steady-state exercise. Accuracy is similar for arm and chest. Further research is needed to determine whether CGMs can detect important events such as hypoglycemia during exercise.

Microvolumetric determination of thrombomodulin based on competitive immunoreaction using a portable glucometer.

A new method of reducing the amount of reagent and sample for determination of thrombomodulin (TM) was developed based on competitive immunoreaction using a portable glucometer (PGM). Two types of nanocomposites, TM protein-modified magnetic nanoparticles (MNPs-TM) and TM antibody-/glucose oxidase-modified gold nanoparticles (Ab-GNPs-GOx), were prepared. Their binding product, MNPs-TM-Ab-GNPs-GOx, in the microvolumetric solution was used to catalyze the oxidation of glucose, leading to a decline of the glucose content. The TM-involved competitive immunoreaction had a negative effect on the generation of MNPs-/GNPs-based nanocomposites and inhibited the catalytic oxidation of glucose. The glucose content difference in the microvolumetric solution, which was revealed by a PGM, was in proportion to the logarithm of the TM concentration from 25 ng mL-1 to 2.5 µg mL-1. The limit of detection was 5.7 ng mL-1. Microvolumetric solution and a PGM were used in the measurement, which overcame some deficiencies of classical methods in chemo/biosensing, for example, special instrument, complicated measurement procedure, and high cost.

Optical blood glucose non-invasive detection and its research progress.

Blood glucose concentration is an important index for the diagnosis of diabetes, its self-monitoring technology is the method for scientific diabetes management. Currently, the typical household blood glucose meters have achieved great success in diabetes management, but they are discrete detection methods, and involve invasive blood sampling procedures. Optical detection technologies, which use the physical properties of light to detect the glucose concentration in body fluids non-invasively, have shown great potential in non-invasive blood glucose detection. This article summarized and analyzed the basic principles, research status, existing problems, and application prospects of different optical glucose detection technologies. In addition, this article also discusses the problems of optical detection technology in wearable sensors and perspectives on the future of non-invasive blood glucose detection technology to improve blood glucose monitoring in diabetic patients.

Paper-based analytical device for point-of-care nucleic acid quantification combining CRISPR/Cas12a and a personal glucose meter.

Although CRISPR-based nucleic acid detection has great potential in point-of-care testing due to its simplicity, it has been rarely integrated into paper-based analytical devices (PADs), which are attractive platforms to simplify assays. This work introduces a CRISPR-assisted nucleic acid quantification approach integrated into a PAD with signal readout by a personal glucose meter (PGM). Retention of magnetic beads by filter paper and pre-deposition of all required reagents by freeze-drying stabilized with trehalose enabled the indirect quantification of human papilloma virus (HPV) DNA through a PGM readout without complicated user intervention and complex reagent handling. The calculated limit of detection was 57 pM, which is comparable with other amplification-free CRISPR-based assays detecting nucleic acids. The fully integrated device exhibited good storage stability for up to 4 weeks, suggesting its applicability toward practical point-of-care nucleic acid quantification.

Two-week continuous glucose monitoring-derived metrics and degree of hepatic steatosis: a cross-sectional study among Chinese middle-aged and elderly participants.

BACKGROUND: Continuous glucose monitoring (CGM) devices provide detailed information on daily glucose control and glycemic variability. Yet limited population-based studies have explored the association between CGM metrics and fatty liver. We aimed to investigate the associations of CGM metrics with the degree of hepatic steatosis. METHODS: This cross-sectional study included 1180 participants from the Guangzhou Nutrition and Health Study. CGM metrics, covering mean glucose level, glycemic variability, and in-range measures, were separately processed for all-day, nighttime, and daytime periods. Hepatic steatosis degree (healthy: n = 698; mild steatosis: n = 242; moderate/severe steatosis: n = 240) was determined by magnetic resonance imaging proton density fat fraction. Multivariate ordinal logistic regression models were conducted to estimate the associations between CGM metrics and steatosis degree. Machine learning models were employed to evaluate the predictive performance of CGM metrics for steatosis degree. RESULTS: Mean blood glucose, coefficient of variation (CV) of glucose, mean amplitude of glucose excursions (MAGE), and mean of daily differences (MODD) were positively associated with steatosis degree, with corresponding odds ratios (ORs) and 95% confidence intervals (CIs) of 1.35 (1.17, 1.56), 1.21 (1.06, 1.39), 1.37 (1.19, 1.57), and 1.35 (1.17, 1.56) during all-day period. Notably, lower daytime time in range (TIR) and higher nighttime TIR were associated with higher steatosis degree, with ORs (95% CIs) of 0.83 (0.73, 0.95) and 1.16 (1.00, 1.33), respectively. For moderate/severe steatosis (vs. healthy) prediction, the average area under the receiver operating characteristic curves were higher for the nighttime (0.69) and daytime (0.66) metrics than that of all-day metrics (0.63, P < 0.001 for all comparisons). The model combining both nighttime and daytime metrics achieved the highest predictive capacity (0.73), with nighttime MODD emerging as the most important predictor. CONCLUSIONS: Higher CGM-derived mean glucose and glycemic variability were linked with higher steatosis degree. CGM-derived metrics during nighttime and daytime provided distinct and complementary insights into hepatic steatosis.

Impact of hematocrit levels on the accuracy of specific blood glucose meters: A hospital-based study.

AIMS/INTRODUCTION: Blood glucose meters are commonly used at the bedside, but most of the meters used in Hung Vuong Hospital (Ho Chi Minh City, Vietnam) are built for self-monitoring and might not be suitable for determining glucose levels in patients. In this study, we aimed to validate the performance of six frequently used meters in our hospital using the Clinical & Laboratory Standards Institute (CLSI) standard, and investigate the hematocrit impact on the accuracy of these meters. MATERIALS AND METHODS: A total of 135 pregnant women who underwent a 75-g oral glucose tolerance test consented to participate in the study at Hung Vuong Hospital. Whole blood glucose levels were measured in duplicate using meters, and hematocrit levels were measured using an Alinity h-series analyzer. Within 5 min, plasma glucose levels were measured twice in a row using the Cobas c502 reference analyzer. For accuracy and precision, the hematocrit effect was assed using CLSI POCT12-A3. RESULTS: Out of six evaluated meters, three meters qualified. For CLSI criterion at glucose concentration of 5.55 mmol/L, Accu-Chek Inform II, Accu-Chek Performa and OneTouch VerioVue achieved 97.31%, 98.08% and 99.62%, respectively. For CLSI criterion at 4.17 mmol/L, these three achieved 100%. Accu-Chek Inform II and Accu-Chek Performa showed an inverse correlation between glucose level and hematocrit with slopes of -0.500 (95% confidence interval -0.678 to -0.322) and -0.396 (95% confidence interval -0.569 to -0.224), whereas OneTouch VerioVue was not affected by hematocrit, with a slope of 0.207 (95% confidence interval -0.026 to 0.440). CONCLUSIONS: Blood glucose meters' measurements can be affected by hematocrit, and might provide readings not within an acceptable bias. Medical organizations need to verify or validate before using on patients.

Clinical evidence for high-risk CE-marked medical devices for glucose management: A systematic review and meta-analysis.

AIMS: To conduct a systematic review and meta-analysis, within the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, evaluating CE-marked high-risk devices for glucose management. MATERIALS AND METHODS: We identified interventional and observational studies evaluating the efficacy and safety of eight automated insulin delivery (AID) systems, two implantable insulin pumps, and three implantable continuous glucose monitoring (CGM) devices. We meta-analysed randomized controlled trials (RCTs) comparing AID systems with other treatments. RESULTS: A total of 182 studies published between 2009 and 2024 were included, comprising 166 studies on AID systems, six on insulin pumps, and 10 on CGM devices; 26% reported industry funding; 18% were pre-market; 37% had a comparator group. Of the studies identified, 29% were RCTs, 24% were non-randomized trials, and 47% were observational studies. The median (interquartile range) sample size was 48 (28-102), age 34.8 (14-44.2) years, and study duration 17.5 (12-26) weeks. AID systems lowered glycated haemoglobin by 0.5 percentage points (absolute mean difference [MD] = -0.5; 21 RCTs; I2 = 86%) and increased time in target range for sensor glucose level by 13.4 percentage points (MD = 13.4; 14 RCTs; I2 = 90%). At least one safety outcome was assessed in 71% of studies. CONCLUSIONS: High-risk devices for glucose monitoring or insulin dosing, in particular AID systems, improve glucose control safely, but evidence on diabetes-related end-organ damage is lacking due to short study durations. Methodological heterogeneity highlights the need for developing standards for future pre- and post-market investigations of diabetes-specific high-risk medical devices.

Performance of a Novel Continuous Glucose Monitoring Device in People With Diabetes.

BACKGROUND: In this multicenter study, performance of a novel continuous glucose monitoring (CGM) system was evaluated. METHODS: Adult participants with diabetes were included in the study. They each wore three sensors of the CGM system on the upper arms for up to 14 days. During four in-clinic visits, frequent comparison measurements with capillary blood glucose (BG) samples were performed. The primary endpoint was the 20/20 agreement rate (AR): the percentage of CGM readings within ±20 mg/dL (at BG values <100 mg/dL) or ±20% (at BG values ≥100 mg/dL) of the comparator. Further evaluations included mean absolute relative difference (MARD) and 20/20 AR in different BG ranges and across the wear time. RESULTS: Data from 48 participants and 139 sensors were analyzed. During in-clinic sessions the 20/20 AR was 90.5% and the MARD was 9.2%. For BG ranges <70, 70-180, and >180 mg/dL, 20/20 AR was 94.3%, 89.0%, and 92.5%, respectively. At the beginning, middle, and end of sensor wear time, 20/20 AR was 92.8%, 91.5%, and 85.9%, respectively. The 14-day survival probability was 82.4%. Pain and bleeding after sensor insertion were within the expected range. Based on the study outcome, the use of the device is regarded as safe. CONCLUSIONS: The system showed a good performance compared to capillary BG measurements. This level of accuracy could be shown over the entire measurement range, especially in the low glycemic range, and the whole wear time of the sensors. The results of this study are supporting a non-adjunctive use of the device.