BACKGROUND: Self-monitoring of blood glucose is an important component of therapy for diabetes mellitus. The aim of this study was to evaluate the analytic performance evaluation of blood monitoring system G400 according to ISO 15197:2013. METHODS: We evaluated the G400 according to the ISO 15197:2013 guideline, we measured precision, accuracy, interference of hematocrit and interfering substances, user performance. RESULTS: Repeatability and intermediate precision of G400 showed standard deviation 2.7–3.8 mg/dL, 2.4–3.6 mg/dL and coefficient of variation 1.9-2.9% and 1.7–3.7%, respectively. Accuracy measured 98–98.5%, satisfied acceptable criteria. Error grid analysis showed that all results of this study were in zone A. Hematocrit between 20% to 60% did not cause interference. Three of 24 interfering substances were not acceptable criteria, and dose-response evaluation was needed. CONCLUSIONS: This study showed that G400 was considered reliable results satisfying the ISO 15197:2013 criteria
Blood Glucose ; Blood Glucose Self-Monitoring ; Diabetes Mellitus ; Hematocrit

Blood Glucose Self-Monitoring ; Blood Glucose ; Cornea ; Microscopy, Confocal

The continuous glucose monitoring system (CGMS) has been clinically applied to monitor the dynamic change of the subcutaneous interstitial glucose concentration which is a function of the blood glucose level by glucose sensors. It can track blood glucose levels all day along, and thus provide comprehensive and reliable information about blood glucose dynamics. The clinical application of CGMS enables monitoring of blood glucose fluctuations and the discovery of hidden hyperglycemia and hypoglycemia that are difficult to be detected by traditional methods. As a CGMS needs to work subcutaneously for a long time, a series of factors such as biocompatibility, enzyme inactivation, oxygen deficiency, foreign body reaction, implant size, electrode flexibility, error correction, comfort, device toxicity, electrical safety, et al. should be considered beforehand. The study focused on the difficulties in the technology, and compared the products of Abbott, Medtronic and DexCom, then summarized their cutting-edge. Finally, this study expounded some key technologies in dynamic blood glucose monitoring and therefore can be utilized as a reference for the development of CGMS.
Blood Glucose ; Blood Glucose Self-Monitoring/methods* ; Humans ; Hyperglycemia ; Hypoglycemia ; Monitoring, Ambulatory/methods* ; Monitoring, Physiologic

Blood glucose monitoring is of great significance to diabetic patients, and the development of rapid, accurate and real-time glucose detection technology has become a research hotspot nowadays. This study introduces the concept and classification of the enzyme-free glucose sensor, expounds enzymefree glucose sensor electrode characterization methods and the application progress of different materials in enzyme-free blood glucose sensors. Meanwhile, some problems of enzyme-free glucose sensor existing in the current research and its future application prospects also will be discussed.
Blood Glucose ; Blood Glucose Self-Monitoring ; Electrodes ; Glucose ; Humans ; Monitoring, Physiologic

Blood glucose monitoring has become the weakest point in the overall management of diabetes in China. Long-term monitoring of blood glucose levels in diabetic patients has become an important means of controlling the development of diabetes and its complications, so that technological innovations in blood glucose testing methods have far-reaching implications for accurate blood glucose testing. This article discusses the basic principles of minimally invasive and non-invasive blood glucose testing assays, including urine glucose assays, tear assays, methods of extravasation of tissue fluid, and optical detection methods, etc., focuses on the advantages of minimally invasive and non-invasive blood glucose testing methods and the latest relevant results, and summarizes the current problems of various testing methods and prospects for future development trends.
Humans ; Blood Glucose ; Blood Glucose Self-Monitoring/methods* ; Diabetes Mellitus/diagnosis* ; Monitoring, Physiologic/methods* ; Tears

OBJECTIVE: To investigate the mechanism of self-efficacy between self-management ability and self-management behavior and its differences among patients with different disease courses through mediation tests. METHODS: In the study, 489 patients with type 2 diabetes who attended the endocrinology departments of four hospitals in Shanxi Province and Inner Mongolia Autonomous Region from July to September 2022 were enrolled as the study population. They were investigated by General Information Questionnaire, Diabetes Self-Management Scale, Chinese version of Diabetes Empowerment Simplified Scale, and Diabetes Self-Efficacy Scale. Mediation analyses were performed using the linear regression model, Sobel test, and Bootstrap test in the software Stata version 15.0 and divided the patients into different disease course groups for subgroup analysis according to whether the disease course was > 5 years. RESULTS: In this study, the score of self-management behavior in the patients with type 2 diabetes was 6.16±1.41, the score of self-management ability was 3.99±0.74, and the score of self-efficacy was 7.05±1.90. The results of the study showed that self-efficacy was positively correlated with self-management ability (r=0.33) as well as self-management behavior (r=0.47) in the patients with type 2 diabetes (P < 0.01). The mediating effect of self-efficacy accounted for 38.28% of the total effect of self-management ability on self-management behaviors and was higher in the behaviors of blood glucose monitoring (43.45%) and diet control (52.63%). The mediating effect of self-efficacy accounted for approximately 40.99% of the total effect for the patients with disease course ≤ 5 years, while for the patients with disease course > 5 years, the mediating effect accounted for 39.20% of the total effect. CONCLUSION Self-efficacy enhanced the effect of self-management ability on the behavior of the patients with type 2 diabetes, and this positive effect was more significant for the patients with shorter disease course. Targeted health education should be carried out to enhance patients' self-efficacy and self-management ability according to their disease characteristics, to stimulate their inner action, to promote the development of their self-management behaviors, and to form a more stable and long-term mechanism for disease management.
Humans ; Diabetes Mellitus, Type 2/therapy* ; Self Efficacy ; Self-Management ; Blood Glucose Self-Monitoring ; Blood Glucose ; Self Care

A portable glucose meter based on PIC microcomputer with data storage, analysis and historical data curve display functions, is presented. The concentration of blood glucose is detected with a glucose oxidase electrode. Test records may be stored and historic data can be displayed on the LCD with a fitting curve.
Blood Glucose Self-Monitoring ; instrumentation ; Computer-Aided Design

BACKGROUND

Diabetes Mellitus Type 2 is a significant global health issue with a high prevalence in the Philippines. Managing this condition effectively is crucial, and digital technologies, particularly smartphone (mHealth) applications, have emerged as a potential tool in diabetes self-management.

This study evaluated the effectiveness of smartphone (mHealth) application use in achieving glycemic control among adults with Type 2 Diabetes Mellitus, focusing on HbA1c levels and medication adherence.

This systematic review and meta-analysis, adhering to PRISMA guidelines, analyzed randomized controlled trials from databases like PubMed and Embase, comparing interventions using mHealth applications with standard care. The primary measures were HbA1c levels and medication adherence.

Ten studies involving 20,984 participants were included in the meta-analysis. Using mHealth applications led to an average HbA1c reduction of 0.36%, indicating improved glycemic control. There was considerable heterogeneity (I2 = 91%) because of the clinical and methodological diversity of the included studies. Subgroup analysis showed that the younger and older age groups, shorter and longer T2DM duration, and lower and higher HbA1c baseline benefited from its use. Sensitivity analysis still showed high heterogeneity (95%-97%), reflecting clinical diversity. A narrative analysis of two studies highlighted the utility of mHealth applications in tracking diet, physical activity, and vital stats, aiding medication adherence through reminders and data sharing with healthcare providers.

This systematic review and meta-analysis showed the effectiveness of mHealth application use in achieving glycemic control among adults with Type 2 Diabetes Mellitus by improving HbA1c levels and medication adherence. Integrating mHealth applications as adjuncts in family and community medicine as part of personalized care for managing type 2 diabetes in the Philippines can help achieve glycemic control and medication adherence. Future studies should focus on longitudinal assessments, exploring cultural and linguistic factors in the Filipino context to optimize diabetes care within this specialized medical framework.

BACKGROUND: We evaluated the analytical performance of Barozen H (i-SENS Inc., Korea), a new glucometer equipped with networking function for medical institutions, according to the ISO 15197:2003 and ISO/DIS 15197:2011 guidelines. METHODS: We measured the precision of 10 Barozen H glucometers, in terms of repeatability and intermediate precision, and determined their accuracy relative to that of automatic chemistry analyzer AU5421 (Beckman Coulter, USA). Three other glucometers-Precision PCx (Abbott, USA), Glucocard Sigma (Arkray, Japan), and SureStep Flexx (Johnson & Johnson, USA) were also evaluated, and their accuracies and hematocrit interferences were compared. RESULTS: The standard deviation and coefficient of variation of Barozen H for repeatability and intermediate precision were 0.11-0.15 mmol/L and 2.3-3.6%, respectively. With respect to accuracy, in accordance with ISO 15197:2003 criteria, Barozen H yielded 98.0% of results within +/-0.83 mmol/L or +/-20%. Further, per the ISO/DIS 15197:2011 criteria, 95.2% of results were within +/-0.83 mmol/L or +/-15%; Barozen H was the only glucometer satisfying the more stringent ISO/DIS 15197:2011 criteria. Error grid analysis showed that all results from Barozen H were in zone A, indicating its excellent clinical accuracy. Hematocrit, ranging from 20% to 60% did not cause any significant interference. CONCLUSIONS: Barozen H showed excellent analytical performance, and it was the most clinically accurate glucometer tested. It can be expected to provide reliable results satisfying ISO/DIS 15197:2011 as well as ISO 15197:2003 criteria.
Blood Glucose Self-Monitoring ; Blood Glucose* ; Chemistry ; Diabetes Mellitus ; Glucose Oxidase ; Hematocrit ; Point-of-Care Systems

BACKGROUND: We evaluated the analytical performance of Barozen H (i-SENS Inc., Korea), a new glucometer equipped with networking function for medical institutions, according to the ISO 15197:2003 and ISO/DIS 15197:2011 guidelines. METHODS: We measured the precision of 10 Barozen H glucometers, in terms of repeatability and intermediate precision, and determined their accuracy relative to that of automatic chemistry analyzer AU5421 (Beckman Coulter, USA). Three other glucometers-Precision PCx (Abbott, USA), Glucocard Sigma (Arkray, Japan), and SureStep Flexx (Johnson & Johnson, USA) were also evaluated, and their accuracies and hematocrit interferences were compared. RESULTS: The standard deviation and coefficient of variation of Barozen H for repeatability and intermediate precision were 0.11-0.15 mmol/L and 2.3-3.6%, respectively. With respect to accuracy, in accordance with ISO 15197:2003 criteria, Barozen H yielded 98.0% of results within +/-0.83 mmol/L or +/-20%. Further, per the ISO/DIS 15197:2011 criteria, 95.2% of results were within +/-0.83 mmol/L or +/-15%; Barozen H was the only glucometer satisfying the more stringent ISO/DIS 15197:2011 criteria. Error grid analysis showed that all results from Barozen H were in zone A, indicating its excellent clinical accuracy. Hematocrit, ranging from 20% to 60% did not cause any significant interference. CONCLUSIONS: Barozen H showed excellent analytical performance, and it was the most clinically accurate glucometer tested. It can be expected to provide reliable results satisfying ISO/DIS 15197:2011 as well as ISO 15197:2003 criteria.
Blood Glucose Self-Monitoring ; Blood Glucose* ; Chemistry ; Diabetes Mellitus ; Glucose Oxidase ; Hematocrit ; Point-of-Care Systems