Self-monitoring Of Blood Glucose Systems Research Articles

To Use or Not to Use a Self-monitoring of Blood Glucose System? Real-world Flash Glucose Monitoring Patterns Using a Cluster Analysis of the FGM-Japan Study.

Objective This study investigated self-monitoring of blood glucose (SMBG) adherence and flash glucose monitoring patterns using a cluster analysis in Japanese type 1 diabetes (T1D) patients with intermittently scanned continuous glucose monitoring (isCGM). Methods We measured SMBG adherence and performed a data-driven cluster analysis using a hierarchical clustering in T1D patients from Japan using the FreeStyle Libre system. Clusters were based on three variables (testing glucose frequency and referred Libre data for hyperglycemia or hypoglycemia). Patients We enrolled 209 participants. Inclusion criteria were patients with T1D, duration of isCGM use ≥3 months, age ≥20 years old, and regular attendance at the collaborating center. Results The rate of good adherence to SMBG recommended by a doctor was 85.0%. We identified three clusters: cluster 1 (low SMBG test frequency but high reference to Libre data, 17.7%), cluster 2 (high SMBG test frequency but low reference to Libre data, 34.0%), and cluster 3 (high SMBG test frequency and high reference to Libra data, 48.3%). Compared with other clusters, individuals in cluster 1 were younger, those in cluster 2 had a shorter Libre duration, and individuals in cluster 3 had lower time-in-range, higher severe diabetic distress, and high intake of snacks and sweetened beverages. There were no marked differences in the incidence of diabetic complications and rate of wearing the Libre sensor among the clusters. Conclusions We stratified the patients into three subgroups with varied clinical characteristics and CGM metrics. This new substratification might help tailor diabetes management of patients with T1D using isCGM.

Systems compared: Capillary glucose self-monitoring and Flash glucose monitoring system. Cross-sectional study

Introduction: In recent years, with the rapid advancement of technology, tools capable of minimising discomfort for the diabetic patient are becoming increasingly popular, thereby increasing adherence to treatment. The use of technology improves glycometabolic compensation and quality of life. Objective: The aim of the present study is to verify, in the group using the Flash Glucose Monitoring system, improved diabetes management and satisfaction in insulin-treated patients. Materials and Methods: A retrospective cross-sectional study was performed through the administration of the “Diabetes Treatment Satisfaction Questionnaire”. The study was performed from January to July 2019. 82 validated questionnaires were administered in the Italian version. Participants were 47 women (39 Type 1 Diabetes Mellitus and 8 Type 2 Diabetes Mellitus) and 35 men (19 Type 1 Diabetes Mellitus and 16 Type 2 Diabetes Mellitus). Results: Results show that subjects with the Flash Glucose Monitoring system have greater satisfaction than those using the Self-Monitoring of Blood Glucose system. Patients using Flash Glucose Monitoring showed 83.9% satisfaction, while patients using Self-Monitoring of Blood Glucose showed 33.3% complete satisfaction. The average glycosylated haemoglobin of the group of subjects using Flash Glucose Monitoring was 53.2 mmol/mol, while that of subjects with self-monitoring of capillary blood glucose was 60.3 mmol/mol. Conclusions: The adoption of new technologies has benefits for the patient that positively affect quality of life. The study showed better glycometabolic compensation in the group of patients using Flash Glucose Monitoring. Diabetes carries significant costs to public health, and prevention and improvement of care could be a primary goal for the community and health systems.

Differences in venous, capillary and interstitial glucose concentrations in individuals without diabetes after glucose load

Abstract Objectives Differences between capillary and venous glucose concentrations have been reported in the past. In continuous glucose monitoring (CGM) system performance studies, comparator measurements are often performed in venous samples, despite CGM systems typically aiming at providing capillary-like values. In this study, differences between venous, capillary and interstitial glucose concentrations, measured with a laboratory analyzer, a self-monitoring of blood glucose (SMBG) system and an intermittent-scanning CGM system were investigated in subjects without diabetes after glucose load. Methods During the study, an oral glucose tolerance test (oGTT) was performed with 41 participants who had no known history of diabetes (mean age 25.5 ± 9.7 years). Venous blood samples for measurement with a laboratory analyzer were collected before drinking the standardized 75 g glucose solution and after 60 and 120 min. In parallel, capillary blood was obtained for measurement with a laboratory analyzer and an SMBG system, and interstitial glucose values were measured with an intermittent-scanning CGM system. Results Glucose concentrations in the fasting state were slightly different for the three different compartments whereas considerable differences (some median differences exceeding 30 %) in glucose concentration were observed 60 and 120 min after the start of the oGTT. Conclusions Marked differences with a high inter-individual variability between venous, capillary, and interstitial fluid glucose concentrations were found especially after glucose load. These differences can affect perceived CGM accuracy in performance studies depending on the specific comparator method used, and they are potentially relevant in clinical practice, like diabetes diagnosis.

Accuracy of the Standard GlucoNavii Mentor in Blood Glucose Monitoring According to International Organization for Standardization 15197:2013 Criteria

This study was performed to assess the system accuracy of the blood glucose monitoring system SD GlucoNavii Mentor (SD Biosensor Inc, Korea). The study procedures were based on International Organization for Standardization 15197:2013, in that capillary blood samples from 100 participants’ fingertips were measured with three reagent system lots of the self-monitoring blood glucose system. Samples were collected for comparison measurements on a hexokinase-based glucose analyzer (Cobas Integra400 Plus, Roche Instrument Center, Switzerland). Glucose concentrations were distributed as required by International Organization for Standardization 15197. For each of the 100 evaluable samples, duplicate measurements were taken from three different reagent lots, for a total of 600 measurements. Overall, 98.3% (590/600) of individual measurement results (185/186, 99.5% for glucose values <100 mg/dl and 405/414, 97.8% for glucose values ≥100 mg/dl) were within ±15 mg/dl or ±15% of the corresponding comparison method results. All results (100%) fell into the consensus error grid zones A and B, indicating only clinically acceptable results. In conclusion, the blood glucose monitoring system SD GlucoNavii Mentor device fulfilled the system accuracy criteria of the International Organization for Standardization 15197, indicating measurement accuracy sufficient for diabetes therapy.

Self-Monitoring of Blood Glucose as an Integral Part in the Management of People with Type 2 Diabetes Mellitus.

For decades, self-monitoring of blood glucose (SMBG) has been considered a cornerstone of adequate diabetes management. Structured SMBG can follow different monitoring patterns, and it results in improved glycemic control, reduced hypoglycemia, and a better quality of life of people with diabetes. The technology, usability, and accuracy of SMBG systems have advanced markedly since their introduction a few decades ago. Current SMBG systems are small and easy to use, require small (capillary) blood sample volumes, and provide measurement results within seconds. In addition, devices are increasingly equipped with features such as connectivity to other devices and/or digital diaries and diabetes management tools. Although measurement quality can come close to or equal that of the glucose monitoring systems used by healthcare professionals, several available SMBG systems still do not meet internationally accepted accuracy standards, such as the International Organization for Standardization 15197 standard. Reports from China, India, and Brazil based on local experience suggest that in addition of the accuracy issues of SMBG systems, other obstacles also need to be overcome to optimize SMBG usage. Nonetheless, adequate usage of SMBG data is of high relevance for the management of people with type 2 diabetes mellitus.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01254-8.

Allergic Reaction Following Implantation of a Blood Glucose Sensor.

Increasing incidence and onset at a younger age has changed the treatment strategy of diabetes mellitus (DM) towards prevention, delaying the onset, and minimizing disease complications. Self-monitoring blood glucose systems and continuous glucose monitoring systems are routinely preferred in diabetic children.Flash glucose monitoring system has come as an entirely new concept in glucose monitoring by providing much greater data than blood glucose testing while being more affordable than the continuous glucose monitors. The FreeStyle Libre provides ‘flash glucose monitoring’ with glucose readings by scanning a sensor rather than pricking the patient’s finger. The sensor measures interstitial tissue glucose levels every minute via a disposable round sensor with a small catheter inserted under the skin that can be worn for up to 14 days. The entire system’s on-body sensor patch worn on the back of the upper arm is disposable. However, the mild erythema may occur on the skin and disappear spontaneously after 24 hours from the detachment of the sensor. Similar skin lesions were observed in diabetic patients, and there was moderate to severe itching in 0.5% of the cases and moderate erythema in 4% of cases

Real-world data from Europe and Africa suggest that accuracy of systems for self-monitoring of blood glucose is frequently impaired by low hematocrit

AimsCertain systems for self-monitoring of blood glucose (SMBG) demonstrate inaccuracy at low and high hematocrit (HCT). Manufacturers define HCT ranges for accurate performance. Our objective was to assess the frequency of HCT values that can lead to clinically relevant errors. MethodsIn this cross-sectional study, we collected real-world data representing over 360,000 outpatients from the Netherlands (NL), the Czech Republic (CZ), and South Africa (ZA). These were subsequently stratified by sex and age and compared to commonly specified HCT range limits, reference intervals, and data from 1780 healthy Czech subjects. ResultsHCT values were comparably distributed in NL and CZ. Outpatients had a higher dispersion of values than healthy subjects. Low HCT values in Europe were common in age groups with a high prevalence of diabetes. All ZA age groups showed a higher prevalence of low HCT than in Europe. ConclusionsReal-world data indicate that SMBG systems specified to perform only within the frequently used 30–55% HCT range would leave 3% of outpatients in Europe and 18% in South Africa at risk of false SMBG results, with individual age strata being substantially higher. This could affect their diabetes management. Adequate SMBG systems should thus be chosen.

1166-P: Cost Analysis of a Flash Glucose Monitoring System in Type 2 Diabetes Receiving ≥2 Insulin Doses a Day in Spain

FreeStyle Libre2 system is a sensor-based flash monitoring (FM) system, which assesses interstitial fluid glucose. The study aimed to estimate the cost associated with the use of FM compared to self-monitoring of blood glucose (SMBG) in type 2 diabetes mellitus (T2DM) population from the Spanish National Health System perspective. The cost for glucose monitoring in T2DM patients treated with ≥2 insulin doses a day was modelled. The cost estimation considered the annual resource consumption for glucose monitoring (strips, lancets and FM sensors) and clinical management of hypoglycemia episodes. Severe hypoglycemia episodes (SHE) and non-severe hypoglycemia episodes (NSHE) published event rates (2.5 and 17.0 episodes/patient/year) were considered. Event reductions associated to FM system use were applied (48.8% [SHE]; 27.7% [NSHE]), derived from REPLACE trial findings. Based on published evidence, hospital attendance was required in 20.5% of SHEs (further hospitalization in 16.0%). Daily strip and lancet-consumption in T2DM patients was fixed at 4.81 for SMBG users, and 0.2 for FM system users according the REPLACE findings. FM sensor annual consumption per patient was 26. Unitary costs (€,2019 excluding VAT) derived from national databases and literature were: €0.28/strip; €0.09/lancet; €3.09/daily FM sensor; €3,774/hospitalized SHE; €1,779/hospital-attended non-admitted SHE; €385/community attended SHE and €15/NSHE. Yearly cost was €2,779 and €2,295 per patient using SMBG or FM system, respectively. For a cohort of 1,000 T2DM patients using ≥2 insulin doses a day; 1,221 SHEs (48 hospitalizations for SHE) and 4,715 NSHEs, yearly could be avoided with FM use. The use of the FM system in 1,000 patients could generate annual cost-savings up to €483,031 compared to SMBG (-17.4% of cost reduction). In conclusion, FM system is a potential cost-saving strategy in T2DM patients treated with ≥2 insulin doses a day, in Spain. Disclosure F. Gomez-Peralta: Advisory Panel; Self; Abbott, Menarini Group, Novartis AG, Sanofi. Speaker’s Bureau; Self; Abbott, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novartis AG, Novo Nordisk A/S, Sanofi. I. Oyagüez: None. S. Artola: None. F. Carrasco: None. J. Carretero Gomez: None. F. Garcia-Soidan: None. R. Gomez-Huelgas: None. J. Merino Torres: None. A. Pérez: None. Funding Abbott Diabetes Care

Development and clinical trial of a smartphone-based colorimetric detection system for self-monitoring of blood glucose.

Blood glucose measurements help to guide insulin therapy, thus reducing disease severities, secondary complications, and related mortalities. Efforts are underway to allow diabetes patients to experience a more convenient way to measure blood glucose and consequently increase their adherence to regular self-monitoring of blood glucose (SMBG). This study demonstrated a new SMBG system that integrated all components of a glucometer via a smartphone's optical sensing module to detect the colorimetric blood strip and obtains the blood glucose concentration with calculations performed by an application install in the smartphone. To validate the accuracy and applicability of the new SMBG system regarding the ISO15197:2013 accuracy criteria and patient requirements, a clinical trial and usability survey involving participants from different age groups were conducted in collaboration with the China Medical University, where enrolled 120 diabetic patients were asked to operate the new SMBG system to measure their blood glucose concentration, and feedback was obtained from their user experience. The results showed that three different reagent system lots fulfilled the accuracy requirements with values of 97.4-97.5% , and all of the data were within zones A and B of the consensus error grid, which satisfies the ISO 15197:2013 requirement. The usability survey showed that 97.5% of the participants found the operations convenient, and 100% found the design easy for carrying. This new system could lead to improvements in blood glucose monitoring by people with diabetes, and thus, better management of the disease.

Basics and use of continuous glucose monitoring (CGM) in diabetes therapy

Abstract Background For a long time, self-monitoring of blood glucose (SMBG) was widely viewed as the essential glucose measurement procedure in the therapy of insulin-treated people with diabetes. With increasing accuracy and simplified handling of continuous glucose monitoring (CGM) systems, this evolving technology challenges and at least partly replaces SMBG systems. Content Sensors of all currently available CGM systems measure glucose levels in the subcutaneous interstitial fluid for 6–14 days. The only available implantable sensor facilitates a measurement span of up to 6 months. Depending on the used system, glucose levels are either shown in real time (rtCGM systems) or after scanning (iscCGM systems). Functions such as alerts, alarms and trend arrows and data presentation encourage independent self-management of diabetes therapy. The high frequency of glucose data and the multitude of existing functions require an extensive training of people with diabetes and their caregivers. Summary CGM systems provide a much more detailed picture of glycemia in people with diabetes. Educated patients can use these data to react adequately to their glucose levels and therefore avoid hypoglycemic and hyperglycemic events. Studies showed that glycated hemoglobin (HbA1c) levels and hypoglycemic events can be significantly reduced by frequent use of CGM systems.

104-LB: Post-Market Surveillance of 18 Blood Glucose Monitoring Systems’ Accuracy Based on ISO 15197:2013

High quality blood glucose monitoring systems are required for adequate self-monitoring of blood glucose (SMBG). In this study, system accuracy of 18 current-generation SMBG systems from different manufacturers was evaluated based on the international standard ISO 15197:2013 with 1 lot each against 2 comparison methods. Manufacturers were selected by their respective market share in Europe. Each lot was tested on 100 capillary blood samples from different subjects and compliance with accuracy criterion A stipulated in ISO 15197 (at least 95% of results within ±15% or ±15 mg/dL of the comparison method’s results for BG concentrations above or below 100 mg/dL, respectively) was assessed. Glucose oxidase (GOD) and hexokinase (HK) were used as comparison methods (GOD: YSI 2300 STAT Plus, YSI Incorporated, OH, U.S.A.; HK: Cobas Integra® 400 plus, Roche Instrument Center, Switzerland). In total, 14 of 18 systems had ≥95% of results within ±15% or ±15 mg/dL of the result obtained with the respective manufacturer’s measurement method. Individual systems showed 89 to 100% of results within these limits. Results within ±10% or ±10 mg/dL of the respective comparison method results ranged from 71 to 99.5% with 3 systems showing ≥95% of results within these more stringent limits. In this evaluation, 14 out of 18 systems met the minimum system accuracy criterion A of ISO 15197 with the tested lot. Although only current-generation systems available on the market were used, more than 20% of systems did not meet ISO 15197 accuracy criteria. Disclosure S. Pleus: None. A. Baumstark: None. N.R. Jendrike: None. J. Mende: None. C. Haug: None. G. Freckmann: Advisory Panel; Self; Abbott, Novo Nordisk Pharma GmbH, Sensile Medical AG. Consultant; Self; Metronom Health Europe, Roche Diabetes Care, Sanofi. Speaker’s Bureau; Self; Ascensia Diabetes Care, Dexcom, Inc., Ypsomed AG. Funding AgaMatrix Europe Limited; Ascensia Diabetes Care GmbH; Beurer GmbH: i-SENS GmbH; LifeScan Scotland Limited; Roche Diabetes Care GmbH

Accuracy Evaluation of Five Blood Glucose Monitoring Systems in Patients from Different Departments

Self-monitoring of blood glucose (SMBG) systems are expected to be accurate and provide reliable results. The international standard ISO (International Organization for Standardization) 15197:2013 is widely accepted for the accuracy evaluation for SMBG systems. Accuracy evaluation was performed for 5 different SMBG systems in patients from multi-departments at the hospital. A total of 120 patients from Changzhou Second People's Hospital (Changzhou, China) were randomized and enrolled in the study. Accuracy evaluation was performed for 5 different SMBG systems: Gold AQ (Sinocare), Freestyle Optium Xceed (Abbott), Contour TS (Bayer), OneTouch Ultra (J&J) and Accu-Chek Performa (Roche). For each system, comparison measurements were performed with YSI 2300 STAT PLUS Glucose and Lactate Analyzer and Roche Cobas 8000 Modular Analyzer. All 5 systems showed that 100% of results fall within consensus error grid Zones A and B. Compared with YSI 2300 or Roche Cobas 8000 Modular Analyzer, Gold AQ system showed the highest accuracy. The linearity analysis also showed that Gold AQ had the highest correlation coefficient. Compared with other SMBG systems, Gold AQ Glucose Monitoring System manufactured by Sinocare Inc. had the highest accuracy in measuring blood glucose level in patients from multi-departments at this hospital.

Type 1 diabetes mellitus prevalence and care in children under 15 years old in Asturias

IntroductionPrevalence of type 1 diabetes mellitus (T1DM) is increasing worldwide. Care provided appears to have an influence on the course of disease. The aim of this study was to ascertain the prevalence of T1DM and to collect data on the resources and care used in Asturias. Material and methodsA descriptive, cross-sectional study including patients born between 2000 and 2014 with diagnosis of T1DM at 31/12/2014. Patients were identified using two independent data sources. Information was collected from medical records. A descriptive data analysis was performed to provide frequency distributions and measures of position and dispersion. Results146 patients were identified, with a total prevalence of 1.25/1000 children. Prevalence rates by age group were 0.21, 1.15, and 2.40 by 1000 in children aged 0–4, 5–9, and 10–14 years respectively. Autoimmune thyroid disorders and celiac disease were found in 8.2% and 6.8% respectively, while 14.4% had a family history of T1DM and 29.4% of T2DM. Ninety-two children were treated by pediatricians and 34 by endocrinologists. All children were receiving multiple dose insulin treatment and none of them used self-monitoring blood glucose systems. Health education was provided to 37.7% of children. ConclusionsThis study reports the first data on T1DM prevalence in children under 15 years old in Asturias and provides care data that show the disparity in care received depending on healthcare area.

Assessing quality of glycemic control: Hypo- and hyperglycemia, and glycemic variability using mobile self-monitoring of blood glucose system.

Although mobile applications bring potential benefits of metabolic control for patients with diabetes, their effect on glycemic fluctuation has been less widely explored. The goal of this study was to utilize data from the Mobile Self-Monitoring of Blood Glucose System to obtain a picture of the metabolic progression. Twenty-seven adults with type 2 diabetes mellitus were recruited to receive a mobile diabetes self-care system for a six-week period. The approach to the interpretation of glycemic control patterns, utilizes the following methods: 1) Graphical displays of the percentage of hyper-and-hypoglycemia episodes; 2) Pattern recognition of glycemic variability based on a simple equation involving both the standard deviation and the mean. Analytical results reveal that short-term usage of the developed system stabilizes the week-by-week glycemic fluctuations. Four categories were established to distinguish different patterns of patients' glycemic variation. If patterns of glycemic control can be recognized or interpreted by newly designed mobile applications, then the collection and analysis of metabolic variation will greatly help both health care providers and patients in effective diabetes management.

Prevalencia y datos asistenciales de la diabetes mellitus tipo 1 en menores de 15 años en Asturias

IntroductionPrevalence of type 1 diabetes mellitus (T1DM) is increasing worldwide. Care provided appears to have an influence on the course of disease. The aim of this study was to ascertain the prevalence of T1DM and to collect data on the resources and care used in Asturias. Material and methodsA descriptive, cross-sectional study including patients born between 2000 and 2014 with diagnosis of T1DM at 31/12/2014. Patients were identified using two independent data sources. Information was collected from medical records. A descriptive data analysis was performed to provide frequency distributions and measures of position and dispersion. Results146 patients were identified, with a total prevalence of 1.25/1.000 children. Prevalence rates by age group were 0.21, 1.15, and 2.40 by 1000 in children aged 0-4, 5-9, and 10-14 years respectively. Autoimmune thyroid disorders and celiac disease were found in 8.2% and 6.8% respectively, while 14.4% had a family history of T1DM and 29.4% of T2DM. Ninety-two children were treated by pediatricians and 34 by endocrinologists. All children were receiving multiple dose insulin treatment and none of them used self-monitoring blood glucose systems. Health education was provided to 37.7% of children. ConclusionsThis study reports the first data on T1DM prevalence in children under 15 years old in Asturias and provides care data that show the disparity in care received depending on healthcare area.

User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors.

IntroductionThe international standard ISO 15197:2013 requires a user performance evaluation to assess if intended users are able to obtain accurate blood glucose measurement results with a self-monitoring of blood glucose (SMBG) system. In this study, user performance was evaluated for four SMBG systems on the basis of ISO 15197:2013, and possibly related insulin dosing errors were calculated. Additionally, accuracy was assessed in the hands of study personnel.MethodsAccu-Chek® Performa Connect (A), Contour® plus ONE (B), FreeStyle Optium Neo (C), and OneTouch Select® Plus (D) were evaluated with one test strip lot. After familiarization with the systems, subjects collected a capillary blood sample and performed an SMBG measurement. Study personnel observed the subjects’ measurement technique. Then, study personnel performed SMBG measurements and comparison measurements. Number and percentage of SMBG measurements within ± 15 mg/dl and ± 15% of the comparison measurements at glucose concentrations < 100 and ≥ 100 mg/dl, respectively, were calculated. In addition, insulin dosing errors were modelled.ResultsIn the hands of lay-users three systems fulfilled ISO 15197:2013 accuracy criteria with the investigated test strip lot showing 96% (A), 100% (B), and 98% (C) of results within the defined limits. All systems fulfilled minimum accuracy criteria in the hands of study personnel [99% (A), 100% (B), 99.5% (C), 96% (D)]. Measurements with all four systems were within zones of the consensus error grid and surveillance error grid associated with no or minimal risk. Regarding calculated insulin dosing errors, all 99% ranges were between dosing errors of − 2.7 and + 1.4 units for measurements in the hands of lay-users and between − 2.5 and + 1.4 units for study personnel. Frequent lay-user errors were not checking the test strips’ expiry date and applying blood incorrectly.ConclusionsData obtained in this study show that not all available SMBG systems complied with ISO 15197:2013 accuracy criteria when measurements were performed by lay-users.Trial RegistrationThe study was registered at ClinicalTrials.gov (NCT02916576).FundingAscensia Diabetes Care Deutschland GmbH.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0392-6) contains supplementary material, which is available to authorized users.

Self-measurement of Blood Glucose and Continuous Glucose Monitoring - Is There Only One Future?

Monitoring glycaemic control in patients with diabetes has evolved dramatically over the past decades. The introduction of easy-to-use systems for self-monitoring of blood glucose (SMBG) utilising capillary blood samples has resulted in the availability of a wide range of systems, providing different measurement quality. Systems for continuous glucose monitoring (CGM) – used mainly in patients with type 1 diabetes (T1D) – were made possible by the development of glucose sensors that measure glucose levels in the interstitial fluid (ISF) in the subcutaneous tissue of the skin. CGM readings might not correspond exactly to SMBG measurement results taken at the same time, especially during rapid changes in either blood glucose or ISF glucose levels. The mean absolute relative difference is the most popular method used for characterising the measurement performance of CGM systems. Unlike the International Organization for Standardization 15197:2013 criteria for SMBG systems, no accuracy standards for CGM systems exist. Measurement quality of CGM systems can vary based on several factors, limiting their safety and effective use in managing diabetes. Patients have to be trained adequately to make safe and efficient use of CGM systems (like with SMBG systems). Also, systems for CGM must be evaluated in terms of patient safety and the ability to provide accurate measurements regardless of the fluctuation of glucose levels. As new technological advancements in glucose monitoring are essential for improved management options of diabetes, such as automated insulin dosing systems, there is a need for a critical view of all such developments. It is likely that both, SMBG and CGM systems, will play important future roles in the treatment of diabetes.

Improved Glycemic Control in a Patient Group Performing 7-Point Profile Self-Monitoring of Blood Glucose and Intensive Data Documentation: An Open-Label, Multicenter, Observational Study.

IntroductionRegular self-monitoring of blood glucose (SMBG) is recommended as an integral part of therapy for all patients with diabetes treated with insulin. In the current study, the effects on glycemic control of taking 7-point SMBG profiles and using a diabetes management system (DMA) on a smartphone were investigated.MethodsIn a 12-week, open-label, multicenter, observational study, 51 patients [26 with type 1 diabetes mellitus (T1DM) and 25 with type 2 diabetes mellitus (T2DM)] were instructed to perform SMBG at least seven times a day using DMA combined with the iBGStar® SMBG system. HbA1c was measured at regular visits to the study sites. Patients reviewed and managed their data as well as their treatment on their own and there were no further assistance or treatment recommendations. Adverse events (AEs) were recorded throughout.ResultsOverall, mean (SD) change from baseline in HbA1c at week 12 was −0.46 (0.57)% [−5 (6) mmol/mol (p < 0.0001)]. The change in HbA1c was observed in patients with T1DM [−0.27 (0.45)% (−3 [5] mmol/mol; p = 0.0063)] and T2DM [−0.65 (0.62)% (−7 [7] mmol/mol; p < 0.0001)]. The change in HbA1c was not correlated with an increased number of hypoglycemic events (blood glucose less than 55 mg/dL). The majority of AEs were symptomatic hypoglycemic events (42 events; nine patients).ConclusionsGlycemic control can be improved, without receiving any recommendations or advice on insulin dose, by performing daily 7-point SMBG profiles and using electronic documentation with a smartphone app. These results must be confirmed in a larger controlled trial, but they already strengthen the importance of structured SMBG in diabetes therapy.FundingSanofi.

Seven-Year Surveillance of the Clinical Performance of a Blood Glucose Test Strip Product.

A key approach in enabling people with diabetes to better manage their condition is through self-monitoring of blood glucose (SMBG). Any functional SMBG system should demonstrate clinical accuracy across a broad glucose range and be insensitive to hematocrit. Furthermore, it should be incumbent on the manufacturer to demonstrate that their product continues to meet clinical accuracy claims during product lifetime. Test strips from a globally distributed SMBG product were sampled from randomly selected production batches as part of the manufacturer's routine product evaluation process. Clinical accuracy was assessed within diabetes patients at 3 clinic sites against a standard reference method and evaluated against system accuracy in accordance with the ISO 15197:2015 standard (unchanged from ISO 15197:2013 in terms of performance specifications). Data were collected over 7 years (2010-2016) and comprised 73,600 individual glucose results. Overall clinic performance was assessed, as was accuracy at low and high glucose levels and extremes of hematocrit. Across the 7-year surveillance period, overall test strip clinical accuracy was 97.8% versus the 95% ISO-defined minimum criterion with by-year values of 97.0-98.6%. Accuracy at the lowest (≤50 mg/dL) and highest (>400 mg/dL) ranges of glucose was 97.0% and 98.3% respectively. Within these low/high blood glucose subpopulations, accuracy at the lower and upper first percentile hematocrit ranges, was 98.9%, and 97.1% respectively. This 7-year surveillance program showed the test strips to have excellent clinical accuracy at the outer ranges of subject blood glucose and hematocrit, based on assessment against the ISO 15197:2015 clinical accuracy criterion.

Continuous Glucose Monitoring Sensors: Past, Present and Future Algorithmic Challenges.

Continuous glucose monitoring (CGM) sensors are portable devices that allow measuring and visualizing the glucose concentration in real time almost continuously for several days and are provided with hypo/hyperglycemic alerts and glucose trend information. CGM sensors have revolutionized Type 1 diabetes (T1D) management, improving glucose control when used adjunctively to self-monitoring blood glucose systems. Furthermore, CGM devices have stimulated the development of applications that were impossible to create without a continuous-time glucose signal, e.g., real-time predictive alerts of hypo/hyperglycemic episodes based on the prediction of future glucose concentration, automatic basal insulin attenuation methods for hypoglycemia prevention, and the artificial pancreas. However, CGM sensors’ lack of accuracy and reliability limited their usability in the clinical practice, calling upon the academic community for the development of suitable signal processing methods to improve CGM performance. The aim of this paper is to review the past and present algorithmic challenges of CGM sensors, to show how they have been tackled by our research group, and to identify the possible future ones.