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Introduction: A sizeable minority of commercially available blood glucose monitoring (BGM) systems fail to satisfy regulatory accuracy requirements, such as ISO 15197:2013, after approval. This study assessed whether the BGMs tested could consistently meet these ISO requirements by investigating their accuracy in a non-standardized setting. Methods: In this 18-month post-market performance study, using the ISO criteria, healthcare professionals tested the accuracy of four CE-marked BGM systems (Roche Diabetes Care, Mannheim, Germany) on European adults with diabetes mellitus. ISO criteria included 95% of blood glucose (BG) values being within ± 15 mg/dl of a reference measurement for BG < 100 mg/dl or ± 15% for BG ≥ 100 mg/dl and, in the Parkes Consensus Error grid for type 1 diabetes comparing capillary BGM measurements versus reference method, 99% of BG values falling within zone A (no effect on clinical action or outcome) and zone B (altered clinical action with little or no effect on clinical outcome). Results: BGM readings were obtained from 1650 participants, and the number of readings per BGM system was between 1712 and 2376. The percentage of BGM readings that fell within ISO 15197:2013 limits ranged from 99.4 to 99.9%. For all meter types, 100% of data points fell within zone A or zone B, and most data points for each meter (≥ 99.9%) were in zone A. Conclusion: All four CE-marked BGM models showed results within the accuracy limits defined by ISO 15197 in a non-standardized setting and thus consistently met regulatory accuracy requirements. [ABSTRACT FROM AUTHOR]

Objective: Goal of the study was to systematically review competitive advantages of medical devices for glucose monitoring in diabetic patients. Method. The review is done systematically according to SALSA criteria and PRISMA guidelines. The search for eligible articles was held from February 16th 2023 to March 1st 2023 in Russian and English languages. The results were synthesized narratively, tabularly, and visually. The search was conducted in the following databases of scientific literature: PubMed, IEEE Xplore, Google Scholar, CyberLeninka, and eLibrary. Results. Twenty-two out of fifty-two manuscripts met the inclusion criteria. The most promising and advantageous characteristics of the evaluated devices, as identified by researchers, include the following: the capability for noninvasive examination; features that facilitate use by patients with fine motor, hearing, and visual impairments; add-ons and software designed to improve patient compliance, including in pediatric populations; and device attributes that enhance the speed and accuracy of analysis while being free of iatrogenic effects. Conclusions. With increasing prevalence of diabetes, glycemic control is crucial for preventing complications. The market offers numerous glucose monitoring devices (GMDs) with varying features, making selection challenging. Our study systematically categorized the strengths of each GMD model for diabetic patients, aiding informed device selection. [ABSTRACT FROM AUTHOR]

Introduction: The OneTouch Verio Reflect® (OTVR) Blood Glucose Meter features a color range indicator and provides on-meter guidance, insights, and encouragement. Diabetes management is enhanced by the OneTouch Reveal® (OTR) Mobile App. We sought to provide real-world evidence (RWE) that combining devices improves glycemia. Methods: Anonymized glucose and app analytics from more than 55,000 people with diabetes (PWDs) were extracted from a server. Data from their first 14 days using OTVR Meter and OTR App was compared with 14 days prior to 90- and 180-day timepoints using paired within-subject differences. Results: In people with type 1 (PwT1D) or type 2 diabetes (PwT2D), readings in-range (RIR 70–180 mg/dL) improved by 7.8 percentage points (57.9–65.7%) and 12.0 percentage points (72.8–84.8%), respectively, over 180 days and hyperglycemia (> 180 mg/dL) was reduced by − 8.4 percentage points (37.9–29.5%) and − 12.2 percentage points (26.2–14.1%). RIR improved by > 10 percentage points in 38% of PwT1D and 39% of PwT2D. PwT1D spending > 2 to 4 sessions or > 10 to 20 min per week on the app improved RIR by 7.0 and 8.2 percentage points, respectively. PwT2D spending > 2 to 4 sessions or > 10 to 20 min per week on the app improved RIR by 12.6 and 12.1 percentage points, respectively. In PwT1D or T2D, mean blood glucose reduced by − 14.3 and − 19.8 mg/dL, respectively, from baseline to 180 days, with no clinically meaningful changes in percentage of hypoglycemic readings (< 70 mg/dL). PwT1D 65 years and older performed the most app sessions (10 per week) and improved RIR by 7.9 percentage points. PwT2D 65 years and older spent more time on the app (45 min per week) than PwT2D of any other age and improved RIR by 7.6 percentage points. All glycemic changes were statistically significant (p < 0.0005). Conclusion: Real-world data from more than 55,000 PWDs demonstrates sustained improvements in readings in-range in PWDs using the OneTouch Verio Reflect Blood Glucose Meter and OneTouch Reveal App. [ABSTRACT FROM AUTHOR]

Paper-based microfluidic fuel cells (PMFCs) gradually become alternative energy sources due to their advanced features, including simple structure, low cost, without requiring auxiliary equipment. However, the applications of PMFCs are limited by the poor power density and expensive cost. Therefore, a novel design of catalyst layer with stepped Pd distribution is proposed to improve the PMFC performance and reduce the cost. An experimental investigation is performed to understand the underlying influence mechanism of the catalyst layer properties, including Nafion solution content catalyst layer area, catalyst loading and catalyst distribution. We found that the proportioin choice of 4.76% Nafion solution in preparing catalyst layer achieves a shortest reaction time and a highest output performance. In addition, choosing a small catalyst layer area and high catalyst loading is beneficial to improve the current density. With the hybrid arrangement of stepped catalyst layers, the PMFC reduces the cost and presents highest current density of 44.10 mA cm−2 and peak power density of 12.87 mWcm−2. Finally, our designed PMFC stack is employed to power a thermohygrograph and a blood glucose meter for at least 5 h. These practical applications are in favor of supporting the developments of integrated device with energy generation and electrochemical detection.

Measuring the glycemic index (GI) of rice in vivo is time consuming and costly. A simple, reliable, and cost‐effective in vitro digestion assay suitable for use during rice breeding and rice product development is required. The purpose of this study is to propose the use of an in vitro enzymatic starch digestion assay based on a glucometer to determine the estimated GI (eGI) of rice in both raw and cooked forms. Four rice cultivars differing in amylose contents are examined. The known GI rice cultivar, Doongara, is used as the reference. The assay includes the digestion of ground rice using all of the enzymes require to simulate the human digestive tract. The glucose released during digestion is determined using a portable hand‐held glucometer over a 120‐min period. The obtained starch digestograms are modeled using a first‐order kinetic model, and eGI values are calculated. The assay is applicable to both raw and cooked rice samples. It can be used to classify rice according to its eGI as affected by cultivars and cooking methods. The protocol is robust, high‐throughput, and adaptable to non‐laboratory settings. It can benefit rice breeders, farmers, and manufacturers of rice products. [ABSTRACT FROM AUTHOR]

Glycemic self-monitoring is essential in the treatment of diabetes mellitus. Compliance with the recommendations for selfmonitoring of glycemia is an important condition for the prevention of diabetes complications. The article provides a review of the problems associated with blood glucose self-monitoring faced by diabetic patients and doctors. These include low frequency of blood glucose self-monitoring, technical errors in glucose measurements, errors in keeping a diary and errors in using measurement data to diabetes control. The blood glucose monitoring system, which includes the glucometer, test strips, application, сloud for data storage can be used for blood glucose self-monitoring in patients with diabetes mellitus. The article discusses the features and advantages of the blood glucose monitoring system. The advantages of the glucometer are the no сoding technology and the following options: аpplication of additional amount of blood to the test strip; adding meal marks, testing as the measurement results compare with targets and informing about it; storage a large number of measurement results. In addition to the standard blood glucose measurement, the glucose meter and the application offer many features to improve blood glucose self-monitoring that can help to improve diabetes management: automatic transferring measurement results to smartphone or tablet; saving notes in logbook; display of glucose trends and testing as they compare with targets; offering quick and valuable tips for critical high/low glucose values.

Abstract Background Self-monitoring of blood glucose (SMBG) has been shown to reduce hemoglobin A1C (HbA1C). Accordingly, guidelines recommend SMBG up to 4–10 times daily for adults with type 2 diabetes (T2DM) on insulin. For persons not on insulin, recommendations are equivocal. Newer technology-enabled blood glucose monitoring (BGM) devices can facilitate remote monitoring of glycemic data. New evidence generated by remote BGM may help to guide best practices for frequency and timing of finger-stick blood glucose (FSBG) monitoring in uncontrolled T2DM patients managed in primary care settings. This study aims to evaluate the impact of SMBG utility and frequency on glycemic outcomes using a novel BGM system which auto-transfers near real-time FSBG data to a cloud-based dashboard using cellular networks. Methods Secondary analysis of the intervention arm of a comparative non-randomized trial with propensity-matched chart controls. Adults with T2DM and HbA1C > 9% receiving care in five primary care practices in a healthcare system participated in a 3-month diabetes boot camp (DBC) using telemedicine and a novel BGM to support comprehensive diabetes care management. The primary independent variable was frequency of FSBG. Secondary outcomes included frequency of FSBG by insulin status, distribution of FSBG checks by time of day, and hypoglycemia rates. Results 48,111 FSBGs were transmitted by 359 DBC completers. Participants performed 1.5 FSBG checks/day; with 1.6 checks/day for those on basal/bolus insulin. Higher FSBG frequency was associated with greater improvement in HbA1C independent of insulin treatment status (p = 0.0003). FSBG frequency was higher in patients treated with insulin (p = 0.003). FSBG checks were most common pre-breakfast and post-dinner. Hypoglycemia was rare (1.2%

In recent decades, there has been a significant increase in the incidence and prevalence of diabetes mellitus. Diabetes mellitus is characterized by the development of vascular complications leading to early disability and a decrease in the life expectancy of patients. Aging of the body inevitably leads to the occurrence of age-related diseases, including the cardiovascular system, and increases the risk of death. Metabolic and structural and functional disorders of the cardiovascular system arising in diabetes mellitus have common pathophysiological mechanisms with aging of the body. Chronic hyperglycemia can accelerate the aging process and play a decisive role in the occurrence and prognosis of cardiovascular events in patients with diabetes mellitus. Achieving target glycemic values is an important step towards preventing vascular complications in patients with diabetes mellitus. Improved models of glucometers, equipped with a number of additional functions, allow for structured self-control of glycemia, analyze the data obtained and carry out timely correction of therapy, actively involve patients in the process of diabetes management, which will significantly increase the efficiency of disease management, reduce the risk of complications in patients and improve the quality of life.

Obesity is one of the socially significant diseases of our time and is a generally recognized risk factor for the development of carbohydrate metabolism disorders, including type 2 diabetes mellitus (DM), the prevalence of which in the pediatric population is rapidly increasing.Aim of the study. To demonstrate the most frequent types of carbohydrate metabolism disorders in children and adolescents with obesity.Materials and methods. 123 obese patients under 18 years old were examined and the structure of obesity complications was analyzed.Results. Carbohydrate metabolism disorders were identified in 24 patients (19%): impaired fasting glycemia (IFG) (8 girls, 6 boys (11%)), type 2 DM (6 girls, 3 boys (7%)), and type 1 DM (1 boy (1%)). Descriptions of 4 clinical cases are given: 1) patient, 17 years old, with constitutional-exogenous obesity of 3rd degree, arterial hypertension (AH), dyslipidemia and nonalcoholic fatty liver disease (NAFLD) and a history of transient IFG; 2) patient, 16 years old, with morbid obesity, NAFLD, AH, polycystic ovarian syndrome (PCOS), type 2 DM, compensated on metformin therapy; 3) patient, 17 years old, with constitutional-exogenous obesity of the 3rd degree, AH, dyslipidemia, NAFLD, type 2 DM (on insulin pump therapy), complicated by diabetic nephropathy and diabetic polyneuropathy; 4) patient, 12 years old, with type 1 DM, manifested against the background of obesity.Conclusion. When screening for obesity complications in children and adolescents, carbohydrate metabolism disorders may be detected in one in five patients. Prediabetes in childhood can be transient. When a child with obesity is identified, differential diagnosis of type 1 and type 2 DM should be made. It is necessary to teach patients with type 2 DM the skills of self-monitoring on a par with patients with type 1 DM and motivate them to control glycemia regularly at home.

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BACKGROUND: Portable blood glucose meters are the main method for detecting the blood glucose status of clinical patients. OBJECTIVE: To investigate the accuracy of detecting blood glucose in haemodialysis patients by sampling two blood glucose meters through the haemodialysis line. METHODS: Convenient sampling was used to select 80 patients with maintenance haemodialysis. The patients were sampled through the arterial end of the haemodialysis line within three minutes of being put on the machine. One specimen was tested by glycemeter1, which can identify the type of blood in the arteries and veins, and glycemeter2, which can only detect blood glucose in the capillaries for bedside blood glucose testing. The other specimen was sent to the laboratory biochemical analyser for blood glucose testing. RESULTS: When the blood glucose value of the first blood glucose meter (No. 1) was compared with the laboratory biochemical analyser, the correlation coefficient was r = 0.805 (p < 0.05), the out of value of the first blood glucose meter accounted for 4.4%, and the consistency reached 95% (p < 0.05). When the blood glucose value of the second blood glucose meter (No. 2) was compared with the laboratory biochemical analyser, the correlation coefficient was r = 0.800 (p < 0.05), the out of value of the second blood glucose meter accounted for 4.4%, and the consistency reached 95% (p < 0.05). CONCLUSIONS: For patients with maintenance haemodialysis, the blood glucose values detected by the two bedside blood glucose meters using arteriovenous mixed blood in the pipeline do not affect the accuracy and can respond more realistically. [ABSTRACT FROM AUTHOR]

Patients with diabetes mellitus (DM 1.2) are at high risk for changing the epidemiological situation during seasonal diseases (influenza, SARS), which mainly occur in the autumn-winter period. Under the current conditions in connection with the pandemic – СOVID-19, these patients turned out to be the most vulnerable, since the “isolation period” limits the possibility of dynamic observation of the patient by a general practitioner, an ophthalmologist, a specialist in the diabetic foot cabinet, and timely prescribing for preferential sugar-lowering drugs and resolving issues of planned hospitalization in specialized medical institutions. Patients who, for a numerous reasons have already have a low level of compliance with their chronic disease, were un-able to consult with a doctor on the topic of correction of sugar-lowering therapy in a short period of time. Any restriction on doctor’s consultation seriously affects the psycho-emotional state of patients with various types of diabetes, which often leads to an increase in blood glucose levels above the target level (5.5–6.5 mmol/L) and, as a result, leads to the development of acute and the progression of chronic diabetes complications. Modern technology in the form of a mobile diabetes management guide can serve as a helpful tool for patients during the “self-isolation”. In addition to the established communication with the doctor, the instructions will give patient the opportunity to make their own decisions and be involved in the treatment process. New time dictates the needs introduction of a new medical format consultation “doctor-patient”. The article presents the experience of providing counseling for patients with diabetes in the “mobile health care” format using the Contour Diabetes mobile app for the Contour™ Plus One meter (Contour Plus One).

Background: Self-monitoring of blood glucose (SMBG) has been shown to reduce hemoglobin A1C (HbA1C). Accordingly, guidelines recommend SMBG up to 4–10 times daily for adults with type 2 diabetes (T2DM) on insulin. For persons not on insulin, recommendations are equivocal. Newer technology-enabled blood glucose monitoring (BGM) devices can facilitate remote monitoring of glycemic data. New evidence generated by remote BGM may help to guide best practices for frequency and timing of finger-stick blood glucose (FSBG) monitoring in uncontrolled T2DM patients managed in primary care settings. This study aims to evaluate the impact of SMBG utility and frequency on glycemic outcomes using a novel BGM system which auto-transfers near real-time FSBG data to a cloud-based dashboard using cellular networks. Methods: Secondary analysis of the intervention arm of a comparative non-randomized trial with propensity-matched chart controls. Adults with T2DM and HbA1C > 9% receiving care in five primary care practices in a healthcare system participated in a 3-month diabetes boot camp (DBC) using telemedicine and a novel BGM to support comprehensive diabetes care management. The primary independent variable was frequency of FSBG. Secondary outcomes included frequency of FSBG by insulin status, distribution of FSBG checks by time of day, and hypoglycemia rates. Results: 48,111 FSBGs were transmitted by 359 DBC completers. Participants performed 1.5 FSBG checks/day; with 1.6 checks/day for those on basal/bolus insulin. Higher FSBG frequency was associated with greater improvement in HbA1C independent of insulin treatment status (p = 0.0003). FSBG frequency was higher in patients treated with insulin (p = 0.003). FSBG checks were most common pre-breakfast and post-dinner. Hypoglycemia was rare (1.2% < 70 mg/dL). Conclusions: Adults with uncontrolled T2DM achieved significant HbA1C improvement performing just 1.5 FSBGs daily during a technology-enabled diabetes care intervention. Among the 40% taking insulin, this improvement was achieved with a lower FSBG frequency than guidelines recommend. For those not on insulin, despite a lower frequency of FSBG, they achieved a greater reduction in A1C compared to patients on insulin. Low frequency FSBG monitoring pre-breakfast and post-dinner can potentially support optimization of glycemic control regardless of insulin status in the primary care setting. Trial registration: Trial registration number:NCT02925312 (10/19/2016). [ABSTRACT FROM AUTHOR]

BACKGROUND: In recent years, there has been an active introduction of telecommunication technologies in various spheres of scientific and practical knowledge, including medicine. Diabetes mellitus (DM) is one of the most common chronic non-communicable diseases requiring constant monitoring of the patient’s condition. For telemedicine monitoring of patients with DM, glucose self-monitoring devices with the option of transmitting patient’s measurements via GSM channel or via the Internet have been developed. AIM: To evaluate the clinical effectiveness of telemedicine observation of patients with DM using individual glucose self-monitoring devices with option of transmitting patient’s measurements via a GSM channel or via the Internet. MATERIALS AND METHODS: Publications about clinical trials were searched in PubMed. The search, selection and evaluation of the methodological quality of clinical trials were carried out by two independent researchers. Clinical trials were included in the review if the clinical efficacy of remote monitoring of patients with DM using individual glucose self-monitoring devices with the option of transmitting the results of measurements taken by the patient via a GSM channel or via the Internet was evaluated in comparison with traditional observation methods. RESULTS: As a result of the systematic search, 10 original randomized controlled trials (RCTs) with different methodological quality were selected. It was found that the use of remote technologies for 12 months does not affect the level of glycated hemoglobin, however, it allows to increase the frequency of achieving individual therapeutic goals in patients with type 2 DM. In addition, it was found that the use of remote technologies allows to reduce the frequency of outpatient visits of patients with type 2 DM, but does not reduce the length of hospitalization and the frequency of an emergency calls of these patients. CONCLUSION: Thus, evidence was obtained of the potential therapeutic benefits of remote observation of patients with diabetes based on data from foreign clinical studies. Based on the results obtained, a Russian clinical trial of this medical technology can be recommended.

Diabetes mellitus (DM) type 2 (type 2 diabetes) is one of the most common non-infectious diseases worldwide. Chronic hyperglycemia is a leading factor in a development of vascular complications of diabetes which involve various organs, particularly the eyes, kidney, cardiovascular system and nervous system. One of the most common complications of DM is diabetic nephropathy. Presence of chronic renal disease in a patient with DM limits options of glucose-lowering therapy. Dipeptidyl peptidase-4 inhibitors are currently among medications of choice for glucose-lowering therapy in patients with chronic renal disease. All currently available dipeptidyl peptidase-4 inhibitors can be administrated to patients with end-stage kidney disease on dialysis, and a rate of their use is continuously increasing. Given a high risk of hypoglycemic conditions in patients with chronic renal disease, a regular self-monitoring of glycemia is an essential component of a treatment. Glucometer Contour Plus One is one of the most recent devices developed for self-monitoring of blood glucose. Its advantage over all other blood glucose meters is an ability to synchronize with a mobile application Contour™ Diabetes (Contour Diabetes).

Blood glucose measurement is central to the diagnosis and management of patients with diabetes. Considering that a clinician relies heavily on blood (or rarely other body fluid) glucose values for decision making, an understanding of the basic aspects of glucose measurement in body fluids is necessary. A literature search was conducted in PubMed for articles in English on measurement of glucose in body fluids. Glucose can be measured in several body fluids, namely blood, interstitial fluid, urine, cerebrospinal fluid, pleural fluid and ascitic fluid in appropriate clinical settings. For blood glucose measurement, the present-day enzymatic methods have replaced the older reducing and condensation methods on account of their better accuracy. It is important to consider preanalytical factors such as sample collection, storage and transport when analyzing a laboratory blood glucose report. The measurement of glucose in interstitial fluid using continuous glucose monitoring system (CGMS) enables better understanding of glucose trends and fluctuations. The CGMS data should be reported using standard metrics which include parameters such as mean 24-h glucose, glycemic variability and time-in, below and above range. The measurement of glucose in urine sample is rarely ever used these days and should be reserved for exceptional circumstances. This review provides a detailed account of various aspects of glucose measurement including their evolution, pitfalls, and their utility in current clinical practice. • Accurate glucose measurement is critical for diagnosis and management of patients with diabetes. • The commonly used enzymatic methods for blood glucose measurement are glucose oxidase, hexokinase and glucose dehydrogenase. • Measurement of glucose in interstitial fluid using CGMS enables better understanding of glucose trends and fluctuations. [ABSTRACT FROM AUTHOR]

Commonly used lactose assays [enzymatic spectrophotometric absorbance (EZA) and HPLC] for dairy ingredients are relatively expensive and time consuming. A blood glucose meter (BGM)-based method has successfully been documented as a rapid lactose assay in milk. However, the BGM-based method has not been evaluated in dairy ingredients. The objective of this study was to evaluate the BGM-based lactose analysis method in whey-derived (WD) and skim milk-derived (SMD) ingredients. The study was carried out in 4 phases. In phase 1, the effect of pH and lactose concentrations on the BGM reading was investigated using a factorial design with 2 factors: pH (6.02–7.50) and lactose (0.2 or 0.4%). We found that BGM readings were significantly affected by lower pH values at both lactose levels. In phase 2, the effect of total solids and ingredient type was investigated using a factorial design with 2 factors: ingredient type (WD or SMD) and total solids (0–8%). It was observed that the BGM reading was significantly affected by ingredient type and total solids. Phase 3 involved developing a linear relationship between the BGM reading and the EZA reference method to ascertain the accuracy of the proposed BGM method. Different ingredient types (WD or SMD) and non-lactose solids (0.5–27%) model ingredient dilutions prepared over a range of lactose contents (0.08–0.62%) were measured using the BGM and EZA methods. The average absolute percentage bias difference between the BGM method and EZA reference method results for these model dilutions was found to be between 2.2 and 7.3%. In phase 4, 15 samples procured from commercial sources ranging from 0.01 to 81.9% lactose were evaluated using the BGM method and EZA reference method. The average absolute percentage bias difference for lactose results between the 2 methods ranged from 3.6 to 5.0% and 5.3 to 9.7% for well-performing and poorly performing meters, respectively. Overall, the BGM method is a promising tool for rapid and low-cost analysis of lactose in both high-lactose and low-lactose dairy ingredients. [ABSTRACT FROM AUTHOR]

Background: Safe and effective self-management of glucose levels requires immediate access to accurate data. We assessed the point accuracy of the Dexcom G7 Continuous Glucose Monitoring System (Dexcom, Inc., San Diego, CA, USA) and FreeStyle Libre 3 (Abbott Diabetes Care, Alameda, CA, USA) sensors in a head-to-head comparison., Method: Multicenter, single-arm, prospective, nonsignificant risk evaluation enrolled adults (≥ 18 years) with diagnosed type 1 diabetes (T1D) or type 2 diabetes (T2D). Accuracy was assessed by comparing sensor data to laboratory reference values Yellow Springs Instrument [YSI] and capillary blood glucose values. Outcome measures were differences in mean absolute relative difference (MARD), number and percentage of matched glucose pairs within ±20 mg/dL/±20 of reference values within glucose ranges: < 54, 54 to 69, 70 to 180, 181 to 250, > 250 mg/dL, and combined., Results: Data from 55 adults were included in the analysis. Analysis showed significantly lower MARD with the FreeStyle Libre 3 sensor vs the Dexcom G7 sensor (8.9% vs 13.6%, respectively, P < .0001) with a higher percentage of glucose values within ±20 mg/dL/±20 of reference (91.4% vs 78.6%). The MARD values for both continuous glucose monitoring (CGM) sensors were similar during the first 12 hours; however, the FreeStyle Libre 3 MARD was notably lower than the Dexcom G7 MARD during the next 12 hours (10.0% vs 15.1%, respectively, P < .0001) and throughout the study period., Conclusions: The FreeStyle Libre 3 sensor was more accurate than the Dexcom G7 sensor in all metrics evaluated throughout the study period. This is the first head-to-head study to our knowledge that compares the flagship products currently in widespread use of the two largest CGM manufacturers., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: KH is an employee of Eastside Research Associates. MK is an employee of Diabetes & Glandular Disease Clinic. HT in an employee of Texas Diabetes and Endocrinology.

Background: Self-monitoring of blood glucose (SMBG) can play a key role in diabetes management. The CONTOUR®NEXT ONE (Ascensia Diabetes Care, Parsippany, NJ, USA) blood glucose monitoring system (BGMS) has been developed for use with CONTOUR®NEXT test strips. The meter connects to the CONTOUR™ Diabetes application on a mobile device, and the Second-Chance® sampling feature recognizes insufficient sample volume, prompting the patient to apply more blood to the same strip if needed (sample re-application). Research design and methods: Two studies evaluated CONTOUR®NEXT ONE BGMS accuracy with sample re-application: a laboratory study (performance under various controlled conditions) and a clinical study (performance in the hands of 52 people with diabetes). A formal International Organization for Standardization (ISO) evaluation has been reported previously; here, accuracy criteria in the laboratory and clinical studies were aligned with ISO 15197:2013 sections 6.3.3 and 8.2, respectively. Results: All results under all conditions in the laboratory study, and with glucose concentrations <100 and ≥100 mg/dL in the clinical study, were within ±15 mg/dL or ±15% of reference measurements. In both studies, all results were within Zone A of the Parkes-Consensus Error Grid. Conclusions: These data demonstrate that the accuracy of the CONTOUR®NEXT ONE BGMS was maintained with sample re-application. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study is to detect the mistakes elderly patients with diabetes mellitus make while using a blood glucose meter at home and the frequency of such mistakes, and the factors that impact such mistakes, and to research the effect of individual training on the mistakes. Materials and Methods: Elderly diabetic patients who used blood glucose meter were included in the study.. The patients were asked to measure their blood glucose with their personal blood glucose meter. Accordingly, an assessment form of 13 parameters which assessed the correct use of blood glucose meter was filled in. The patients were given an education on the proper use of glucometers, which lasted 45 minutes on average. The same patients were reassessed one month later in terms of correct use of blood glucose meter. Results: A total of 73 patients were recruited in the study. A total of 21 patients, 10 of whom were female and 11 of whom were male, were excluded from the study since they did not come to control. A total of 52 patients, 33 female, and 19 male, were included in the study. After the training, the number of patients who checked meter code increased from 50% to 80%, who washed and dried their hands before measuring from increased 58% to 96%, who replaced the needle of blood glucose meter from increased 44% to 96% There was no correlation between age, education, duration of diabetes, number of drugs used, type of treatment, number of diseases, and device proper use rates. Conclusion: Incorrect use of glucometers by elderly diabetic patients is a common problem. This problem may be solved utilizing detailed, one-to-one, and repeated education. [ABSTRACT FROM AUTHOR]

Background: We evaluated the Wellion Galileo GLU/KET blood and ketone (ß-Hydroxybutyrate, ß-OHB) meter to demonstrate that it meets ISO15107:2015 regulatory approval criteria. Research Design and Methods: A total of 100 subjects (52 female, age: 30 to 84 years, diabetes: 10 type 1/90 type 2) with blood glucose levels distributed over the entire measurement range as required by the ISO15197 protocol were tested (double determinations with 3 strip lots and two devices). A similar test protocol was followed to test ß-OHB strip performance (reference devices: YSI 2300plus for glucose and STANBIO ß-HOB LiquiColor TestKit for ß-OHB). Precision was tested for glucose with 3 blood glucose concentrations (ß-OHB: 2 control solutions). Results: All glucose test-strip lots met the strict ISO acceptance criteria. Mean absolute relative difference (MARD) was 4.9% and all data pairs were in zone A of the consensus error grid. The ß-OHB test-strips also met the pre-defined acceptance criteria. Within-run and between-run precision was calculated to be 2.3% and 0.7% for the glucose strips (3.7%/0.8% for the ketone strips). Conclusions: When tested according to the ISO15197:2015 guideline, the device showed very accurate measurement performance for glucose and ß-OHB testing and fully met regulatory accuracy approval criteria. [ABSTRACT FROM AUTHOR]

Excessive lead ions (Pb2+) would make the human body suffer from anemia and neurological disorders. Therefore, it was of great significance to study an efficient method for the point-of-care (POC) detection of Pb2+. In this paper, an innovative method for sensitive detection of Pb2+ in river water was proposed, which combined blood glucose meter signal transduction with terminal deoxynucleotidyl transferase (TdT) mediated DNA extension amplification strategy. The gold nanoparticle-modified electrode was used as the sensing interface, which was fabricated through the choline monolayer electrodeposition method. The target Pb2+ initiated DNAzyme cyclic cleavage reaction on the magnetic bead, causing the substrate probe to generate 3′-OH terminus, which would induce the formation of polyadenine (polyA) sequences with the assistance of TdT. Ultimately, the numerous invertase tags on magnetic beads would be loaded on the sensing interface through the interaction between polyA and gold nanoparticles, which would catalyze the hydrolysis of sucrose to glucose with highly efficient enzymatic turnover, enabling the blood glucose meter for detection of Pb2+. The method exhibited a detection limit down to 0.6 pM, and can be used to detect Pb2+ in river water and tap water with high selectivity, offering the method great potential to be applied in environmental monitoring and point-of-care diagnostic applications. • A point-of-care (POC) testing sensor for Pb2+ detection was constructed. • This sensor displayed a low detection limit of 0.6 pM with the advantages of portability, convenience, and low cost. • The excellent selectivity and anti-interference ability achieved the detection of Pb2+ in tap water and river water. • The gold nanoparticle-modified electrode was fabricated through the choline monolayer electrodeposition method. • The sensor was promising for application in environmental monitoring and point-of-care diagnosis. [ABSTRACT FROM AUTHOR]

Background: Accurate self-monitoring of blood glucose (BG) is a key component of effective self-management of glycemic control. Methods: The OneTouch Select Plus Simple™ (OTSPS) BG monitoring system (BGMS) was evaluated for accuracy in a clinical setting. Results: OTSPS was accurate over a wide glucose range and met lay user and system accuracy BG standards described in ISO 15197:2013. Patients also used OTSPS for a 1-week trial period and reported their level of satisfaction with meter features. In a separate study, health-care professionals (HCPs) in India naïve to OTSPS experienced OTSPS online using a variety of interactive demonstrations of the BGMS and answered questions about its potential utility to their patients. Summary: Patients and HCPs felt the features of OTSPS, including a color range indicator, could provide significant benefits to them and their patients.

The article tells about the use of blood glucose meters for patients with diabetes, results of a survey of patients about the most important characteristics of new blood glucose meters. The advantages of the new glucose meter Contour Plus in pediatric practice including compliance with the new accuracy standard for measuring blood glucose ISO 15197:2013 and the possibility of reapplying blood drop if the test strip is underfilled, are discussed.

The role of hyperglycemia as an independent predictor of adverse course and prognosis of acute coronary syndrome (ACS) in patients with diabetes mellitus (DM) and without it [1] can hardly be overestimated. This relationship is thoroughly covered in the literature [2-- 13], and the discussions on the subject are underway. A simple summation of risks results in higher than expected rates of morbidity and mortality from CAD in DM patients, demonstrating a direct effect of hyperglycemia on the atherosclerotic process [14--16]. It is worth noting that in patients without DM hyperglycemia is associated with worse clinical outcomes and higher mortality from all causes compared with patients suffering from diabetes mellitus [17--21]. Increased blood sugar levels at the time of admission are usually seen as a reaction to stress in acute condition, but in some cases may serve as a marker of an existing though not yet diagnosed type 2 diabetes or impaired glucose tolerance (IGT) [22]. According to observational studies, hyperglycemia occurs in 32--38% of patients in hospitals [23, 24], 41% of severe patients with acute coronary syndrome[25], 44% of patients with heart failure [25] and 80% of patients after coronary intervention [26, 27].

A blood glucose meter is an electronic medical device used for determining the concentration of glucose in blood. These meters have undergone five phases of development: washed blood glucose meters, wiped blood glucose meters, colorimetric blood glucose meters, electrochemical blood glucose meters, and micro, multiple site blood glucose meters. Thanks to their speed, portability, low cost, and easy operation, blood glucose meters have been widely available for use in clinical diagnosis. Recently, coupling of target recognition elements (antibody-antigen recognition, nucleic acid hybridization, enzyme recognition, and click chemistry) with signal transduction and amplification strategies (glucose-generating enzymes, nicotinamide adenine dinucleotide (NADH)-generating enzymes, encapsulated glucose, nanomaterials, and cyclic amplification of DNA) has allowed various targets to be determined via the relationship between the signal of the blood glucose meter and the concentration of targets. In this paper, a brief review of the development and mechanism of blood glucose meters is given first. Then, more details on the application of blood glucose meters in analysis are described, including biomedical analysis, food analysis, and environmental analysis. Finally, the prospect of future development of blood glucose meters is also discussed.ᅟ [ABSTRACT FROM AUTHOR]

Self-monitoring of blood glucose remains the cornerstone in the treatment of diabetes. The primary aim of diabetes treatment is target level of glycemia, which can not be achieved without effective self-moniroting with a glucose meter. The state-of-the art device CONTOUR TS meets all modern requirements for blood glucose meters, is simple and easy to use and can be manipulated in regular self-monitoring and in urgent situations.

Self-monitoring of blood glucose is the main tool in the management of diabetes mellitus (DM) utilized by both doctor and patient. On the one hand, self-monitoring of blood glucose is necessary to achieve and maintain adequate glycemic control; on the other hand, it is an invasive and stressful procedure. In order to make self-monitoring of glucose effective, both doctor and patient need to be aware of its relevance, while blood glucose meters should be highly accurate and reproducible, as well as pain-minimizing and user-friendly.

Diabetes and its complications is one of the main causes of mortality in most of developed countries; there is solid evidence that, as its incidence continues to grow, diabetes could become epidemic for developing countries as well. Uncontrolled diabetes mellitus is associated with macrovascular complications, vision loss, chronic renal failure, neuropathy and an increase in lower limb amputations [2-6]. Macrovascular complications are the main cause of death in diabetic patients [7].

Diabetes mellitus type 2 (DM) is a chronic progressive disease leading to microangiopathy and macroangiopathy. Specific vascular complications are associated with 4 to 5-fold increased cardiovascular mortality of patients with DM type 2 compared with the general population. Large randomized studies support the importance of glycemic control in reducing the risk of progressive diabetic vascular complications.

The global increase in the prevalence of diabetes mellitus (DM) is a serious public health problem. DM is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both (WHO, 1999). Currently, there are 382 million people with diabetes worldwide; forecasts are disappointing: by 2035, the figure will exceed 592 million [8]. The vast majority are patients with type 2 diabetes (DM 2). According to the State Register, in Russia (2013), the number of diabetic patients was 3 million 770 thousand, of whom 3.5 million had DM 2 [1].

Background: Accurate self.monitoring of blood glucose (BG) is a key component of effective self.management of glycemic control. Methods: The OneTouch Select Plus Simple. (OTSPS) BG monitoring system (BGMS) was evaluated for accuracy in a clinical setting. Results: OTSPS was accurate over a wide glucose range and met lay user and system accuracy BG standards described in ISO 15197:2013. Patients also used OTSPS for a 1.week trial period and reported their level of satisfaction with meter features. In a separate study, health.care professionals (HCPs) in India naive to OTSPS experienced OTSPS online using a variety of interactive demonstrations of the BGMS and answered questions about its potential utility to their patients. Summary: Patients and HCPs felt the features of OTSPS, including a color range indicator, could provide significant benefits to them and their patients. [ABSTRACT FROM AUTHOR]

New European medical device regulations require the performance of postmarketing surveillance evaluations for blood glucose meters (BGMs). We conducted an ISO15197:2015-conform system performance evaluation with the approved glucose dehydrogenase (GDH)-based Wellion NEWTON BGM. One hundred subjects were enrolled into the study (44 female, 56 male, 43 healthy subjects, 23 type 1 diabetes, 34 type 2 diabetes, age: 53.7 ± 15.8 years). In addition, manipulated heparinized whole blood was used for a laboratory interference test with ten selected substances (interference definition: substance-induced bias > 10%). The mean absolute relative difference (MARD) was 4.7%, and 100% of the values were in zones A (99.7%) and B (0.3%), respectively, of the consensus error grid. Interference was observed with xylose only, which is a known interfering substance for GDH-based BGMs., Competing Interests: Declaration of Conflicting InterestsAPF has received a research grant from Medtrust GmbH. SW is an employee of Medtrust GmbH. The other author declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The theory based on the supposition that for the effective treatment of diabetes patients should largely take responsibility for their health, is of no doubt. This is only possible if patients are properly trained to perform continuous monitoring of their disease and have at their disposal some modern easily manageable blood glucose meters that meet international standards and. The present article highlights the changes in the last revision of national guidelines related to the treatment of self-control, as well as existing modern demands in instrumentation for glycemic control.

The article is an overview of glucose self-monitoring (GSM) in the treatment of diabetes. It article tells about the following: therapeutic targets of GSM before and after meals, adopted in Russia, providing individualized monitoring depending on age, presence of severe complications and risk of hypoglycemia; frequency of GSM at different types of glucose-lowering therapy; the significance of GSM for patient and physician; the functioning of photometric and electrochemical blood glucose meters; the issues of accuracy of measuring blood glucose adopted by the International Organization for Standardization of GSM systems; reasons of mistakes in measuring blood glucose related to contact of fingers with glucose particles, errors in code setting of test strips, external conditions (altitude, temperature, humidity), hematocrit, acidosis, hyperlipidemia and concentration of oxygen in blood, intake of a number of drugs; the process and guidelines of managing a diary as a primary method of storing GSM results; the data of global and Russian studies on the effectiveness of GSM. New methods of GSM are discussed in the section about continuous monitoring.

Over the past 30 years or maybe more, diabetes treatment is impossible without control or, better said, self-monitoring of blood glucose levels. No other chronic disease requires as much participation of the patient as diabetes.

Background: Diabetes mellitus (DM) is considered a global epidemic, and patient self-management education and support are critical in preventing and reducing the risk of complications. Self-monitoring of blood glucose (SMBG) is essential for care of individuals with DM, helping patients to achieve and maintain target blood glucose levels. The purpose of this study is to compare the satisfaction of insulinized DM patients on SMBG with use of investigational blood glucose meter (BGM) versus their routine device. Methods: A national, multicenter, open-label, phase 4 study was conducted on patients with type 1 or 2 DM under insulin therapy regimen, who were asked to use investigational BGM instead of their usual BGM device. The study was performed in 12 centers in Brazil for 12 weeks, with an extension period of 12 weeks. The primary endpoint was to measure the variation on the patients' level of satisfaction with investigational versus routine BGM, between visits, using a Visual Analogue Scale (VAS). Secondary endpoints addressed handling aspects, satisfaction, adherence and level of functionality and safety of investigational BGM. Results: The study included 292 patients (36.6 % DM1 and 63.4 % DM2), mean age 50.9 years old (±17.3 years), 57.5 % females. There was statistically signiicant improvement in global satisfaction with investigational BGM compared with routine BGM according to VAS [mean VAS score raised from 78.8 mm (SD = 18.0) to 90.8 mm (SD = 12.2) between visits]. After 12 weeks, level of satisfaction with investigational BGM according to questionnaires was superior to routine BGM regardless of age group (p < 0.001), type of DM (p < 0.001) or insulin regimen (p < 0.001). Investigational BGM was also regarded as safe, with 10 patients (3.4 %) reporting a total of 13 adverse events during the study. Conclusions: Levels of satisfaction during SMBG were higher with use of investigational BGM and the device was deemed safe and easy to handle. [ABSTRACT FROM AUTHOR]

Introduction Near-continuous glucose monitoring is expected to increase time in range (TIR) of 80–120 mg/dL and to avoid hypoglycemia without increasing workload. We investigated a near-continuous glucose monitor in surgical critically ill and trauma patients. Methods Patients were enrolled at a surgical intensive care unit associated with a level 1 trauma center. Glucose measurements were compared to the gold standard Yellow Springs Instrument (YSI). The technology withdraws 0.13 mL of blood every 15 min from a central venous line, centrifuges the sample, and uses mid-infrared spectroscopy to measure glucose. We plotted a Clarke Error Grid, calculated Mean Absolute Relative Deviation (MARD) to analyze trend accuracy, and we present a Bland Altman plot of device versus standard glucose measurements. Results 24 patients were enrolled. One patient was withdrawn due to poor blood return from central venous line. A total of 347 glucose measurements from 23 patients were compared to the gold standard. 94.8% of the data points were in zone A of the Clarke Error Grid and 5.2% in zone B. The MARD was 8.02%. The majority of data points achieved the benchmark for accuracy. The remaining 5.2% are clinically benign. The MARD was below 10%. The Bland Altman plot shows good agreement between the device and reference glucose measurements. There were no device related adverse events. Conclusion Our data suggests that near continuous monitoring via infrared spectroscopy is safe and accurate for use in critically ill surgical and trauma patients. A large scale multi-center study is underway to confirm these findings. [ABSTRACT FROM AUTHOR]

Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. The OneTouch VerioFlex™(OTVF) blood glucose monitoring system (BGMS) was evaluated for accuracy in a clinical setting. Patients also used OTVF for a 1-wk trial period and reported their level of satisfaction with meter features. In a separate study, healthcare professionals used an on-line simulator of the BGMS and answered questions about its potential utility to their patients. OTVF was accurate over a wide glucose range and met lay user and system accuracy blood glucose standards described in ISO15197:2013 as well as the accuracy requirements to fulfill US FDA expectations for 510(k) clearance of BGMS. Patients and healthcare professionals felt the features of OTVF, which has the capability to connect wirelessly to mobile devices and interact wirelessly with diabetes management software, could provide significant benefits to them or their patients. [ABSTRACT FROM AUTHOR]

Recent advances in mobile network and smartphones have provided an enormous opportunity for transforming in vitro diagnostics (IVD) from central labs to home or other points of care (POC). A major challenge to achieving the goal is a long time and high costs associated with developing POC IVD devices in mobile Health (mHealth). Instead of developing a new POC device for every new IVD target, we and others are taking advantage of decades of research, development, engineering and continuous improvement of the blood glucose meter (BGM), including those already integrated with smartphones, and transforming the BGM into a general healthcare meter for POC IVDs of a wide range of biomarkers, therapeutic drugs and other analytical targets. In this review, we summarize methods to transduce and amplify selective binding of targets by antibodies, DNA/RNA aptamers, DNAzyme/ribozymes and protein enzymes into signals such as glucose or NADH that can be measured by commercially available BGM, making it possible to adapt many clinical assays performed in central labs, such as immunoassays, aptamer/DNAzyme assays, molecular diagnostic assays, and enzymatic activity assays onto BGM platform for quantification of non-glucose targets for a wide variety of IVDs in mHealth. [ABSTRACT FROM AUTHOR]

Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. Accurate self-monitoring of blood glucose results are required for optimal insulin dosing and detection of hypoglycemia. However, blood glucose monitoring systems may be susceptible to error from test strip, user, environmental and pharmacological factors. This report evaluated 5 blood glucose monitoring systems that each use Verio glucose test strips for precision, effect of hematocrit and interferences in laboratory testing, and lay user and system accuracy in clinical testing according to the guidelines in ISO15197:2013(E). Performance of OneTouch® VerioVue™ met or exceeded standards described in ISO15197:2013 for precision, hematocrit performance and interference testing in a laboratory setting. Performance of OneTouch® Verio IQ™, OneTouch® Verio Pro™, OneTouch® Verio™, OneTouch® VerioVue™ and Omni Pod each met or exceeded accuracy standards for user performance and system accuracy in a clinical setting set forth in ISO15197:2013(E). [ABSTRACT FROM AUTHOR]