Investigation of the Effect of 70 Potential Interferents on Measurement Results of Two Blood Glucose Monitoring Systems.

Background: Reliable blood glucose (BG) measurements are important for people with diabetes to manage their therapy as well as in point-of-care testing (POCT) performed by health care professionals to monitor BG of patients or even to diagnose diabetes. Among other factors, endogenous and exogenous substances present in blood samples can impact the measurement results. To ensure and prove that blood glucose monitoring systems (BGMSs) are robust in terms of potential interferents, manufacturers have to perform extensive evaluations.

Evaluation of System Accuracy, Precision, Hematocrit Influence, and User Performance of Two Blood Glucose Monitoring Systems Based on ISO 15197:2013/EN ISO 15197:2015.

Introduction: Sufficiently high analytical quality of blood glucose monitoring systems (BGMS) is a prerequisite for efficient diabetes therapy. In this study we assessed system accuracy, measurement repeatability, intermediate measurement precision, user performance, and the influence of hematocrit on two CE-marked blood glucose monitoring systems. For one BGMS, measurement accuracy using venous samples was additionally investigated.

Accurate Post-Calibration Predictions for Noninvasive Glucose Measurements in People Using Confocal Raman Spectroscopy.

In diabetes prevention and care, invasiveness of glucose measurement impedes efficient therapy and hampers the identification of people at risk. Lack of calibration stability in non-invasive technology has confined the field to short-term proof of principle. Addressing this challenge, we demonstrate the first practical use of a Raman-based and portable non-invasive glucose monitoring device used for at least 15 days following calibration.

User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results.

Background: Blood glucose monitoring systems (BGMSs) are a cornerstone in diabetes management. They have to provide sufficiently accurate results in the hands of lay users, particularly in insulin-treated patients. The aim of this study was user performance evaluation and system accuracy assessment of four BGMSs with color coding of results.

Continuous Glucose Profiles in Healthy People With Fixed Meal Times and Under Everyday Life Conditions.

Background: The increased use of continuous glucose monitoring (CGM) and automated insulin delivery systems raises the question about therapeutic targets for glucose profiles in people with diabetes. This study aimed to assess averaged pre- and postprandial glucose profiles in people without diabetes to provide guidance for normal glucose patterns in clinical practice. For that, number and timing of meal intake were predefined.

Evaluation of Meal Carbohydrate Counting Errors in Patients with Type 1 Diabetes.

Aim: Correct estimation of meal carbohydrate content is a prerequisite for successful intensified insulin therapy in patients with diabetes. In this survey, the counting error in adult patients with type 1 diabetes was investigated.

Methods: Seventy-four patients with type 1 diabetes estimated the carbohydrate content of 24 standardized test meals.

Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197.

Background: The analytical quality of a blood glucose monitoring system (BGMS) is often assessed according to the requirements described in the international standard ISO 15197. However, the mean absolute relative difference (MARD) is sometimes used as well. This analysis aims at providing empirical data from BGMS evaluation studies conducted according to ISO 15197 and at providing an estimation of how MARD and percentage of measurement results within ISO accuracy limits are related.

Choice of Continuous Glucose Monitoring Systems May Affect Metrics: Clinically Relevant Differences in Times in Ranges.

Background: Continuous glucose monitoring-derived parameters are becoming increasingly important in the treatment of people with diabetes. The aim of this study was to assess whether these parameters, as calculated from different continuous glucose monitoring systems worn in parallel, are comparable. In addition, clinical relevance of differences was investigated.

Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems.

Background: Measurement accuracy has been assessed for many different blood glucose monitoring systems (BGMS) over the years by different study groups. However, the choice of the comparison measurement procedure may impact the apparent level of accuracy found in such studies.

Materials And Methods: Measurement accuracy of 18 different BGMS was assessed in a setting based on ISO 15197 using two different comparison methods in parallel: a glucose oxidase (GOD)-based and a hexokinase (HK)-based method.

Proof of Concept for a New Raman-Based Prototype for Noninvasive Glucose Monitoring.

Background: Noninvasive glucose monitoring (NIGM) in diabetes is a long-sought-for technology. Among the many attempts Raman spectroscopy was considered as the most promising because of its glucose specificity. In this study, a recently developed prototype (GlucoBeam, RSP Systems A/S, Denmark) was tested in patients with type 1 diabetes to establish calibration models and to demonstrate proof of concept for this device in real use.

Time in Specific Glucose Ranges, Glucose Management Indicator, and Glycemic Variability: Impact of Continuous Glucose Monitoring (CGM) System Model and Sensor on CGM Metrics.

Background: International consensus recommends a set of continuous glucose monitoring (CGM) metrics to assess quality of diabetes therapy. The impact of individual CGM sensors on these metrics has not been thoroughly studied yet. This post hoc analysis aimed at comparing time in specific glucose ranges, coefficient of variation (CV) of glucose concentrations, and glucose management indicator (GMI) between different CGM systems and different sensors of the same system.

Skin Reaction Report Form: Development and Design of a Standardized Report Form for Skin Reactions Due to Medical Devices for Diabetes Management.

Background: Skin reactions due to medical devices for diabetes management have become a common problem in diabetes technology. There is a varying degree in how detailed skin reactions are described in scientific literature and diabetes practice, and no uniform structured documentation is given. Whereas most articles only describe findings, some others already document final diagnoses, such as contact dermatitis.

System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015.

Objective: Accuracy of 18 current-generation blood glucose monitoring systems (BGMS) available in Europe was evaluated applying criteria adapted from EN ISO 15197:2015 with one reagent system lot. BGMS were selected based on market research data.

Research Design And Methods: The BGMS ABRA, Accu-Chek Guide, AURUM, CareSens Dual, CERA-CHEK 1CODE, ContourNext One, eBsensor, FreeStyle Freedom Lite, GL50 evo, GlucoCheck GOLD, GlucoMen areo 2K, GluNEO, MyStar DoseCoach, OneTouch Verio Flex, Pic GlucoTest, Rightest GM700S, TRUEyou, and WaveSense JAZZ Wireless were tested using capillary blood from 100 different subjects and assessing the percentage of results within ±15 mg/dL (0.

Measurement accuracy of two professional-use systems for point-of-care testing of blood glucose.

Background The professional-use systems HemoCue® Glucose 201+ (HC201+) and HemoCue® Glucose 201 RT (HC201RT) are widely used for point-of-care testing (POCT) of blood glucose (BG). HC201RT utilizes unit-use microcuvettes which can be stored at room temperature, whereas HC201+ microcuvettes have to be stored at <8 °C. In this study, system accuracy of HC201+ and HC201RT was evaluated using capillary and venous blood samples.

Proof of Concept Study to Assess the Influence of Oxygen Partial Pressure in Capillary Blood on SMBG Measurements.

Background: Measurement results provided by blood glucose monitoring systems (BGMS) can be affected by various influencing factors. For some BGMS using glucose oxidase (GOx)-based test strips, one of these factors is the oxygen partial pressure (pO) of the applied blood sample. Because assessing the potential influence of pO when measuring capillary blood samples is not straight-forward, we performed a proof of concept study.

Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197.

Background: Analytical quality of blood glucose monitoring systems (BGMS) is an important aspect for many diabetes patients. Sufficiently high analytical quality is required for adequate diabetes therapy.

Methods: In this study, system accuracy and measurement precision of a BGMS were assessed based on ISO 15197:2013.

Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision.

Introduction: Blood glucose monitoring systems (BGMS) should provide sufficient analytical quality to allow adequate therapy for diabetes patients. Besides system accuracy, measurement precision is an important aspect of a BGMS' analytical quality.

Methods: Based on ISO 15197:2013/EN ISO 15197:2015, system accuracy, measurement repeatability, and intermediate measurement precision were assessed.

Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors.

Objective: In this study, accuracy in the hands of intended users was evaluated for five self-monitoring of blood glucose (SMBG) systems based on ISO 15197:2013, and possibly related insulin dosing errors were calculated. In addition, accuracy was assessed in the hands of study personnel.

Methods: For each system (Accu-Chek Aviva Connect [A], Contour Next One [B], FreeStyle Freedom Lite [C], GlucoMen areo [D] and OneTouch Verio [E]) one test strip lot was evaluated as required by ISO 15197:2013, clause 8.

Evaluation of Four Blood Glucose Monitoring Systems for Self-Testing with Built-in Insulin Dose Advisor Based on ISO 15197:2013: System Accuracy and Hematocrit Influence.

Background: Self-monitoring of blood glucose (SMBG) is important in diabetes therapy; however, not all SMBG systems are sufficiently accurate. In addition, some SMBG systems are influenced by the user's hematocrit value.

Methods: System accuracy and hematocrit influence was evaluated for four SMBG systems with built-in insulin dose advisors (Accu-Chek Aviva Expert [1], FreeStyle InsuLinx [2], FreeStyle Precision Neo [3], MyStar DoseCoach [4]) based on International Organization for Standardization (ISO) 15197:2013 section 6.

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

Introduction: The 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.

System Accuracy and User Performance Evaluation of an Improved System for Self-Monitoring of Blood Glucose.

An improved test cassette for the integrated Accu-Chek® Mobile system (Roche Diabetes Care GmbH, Mannheim, Germany) has been developed. System accuracy of this improved system was evaluated based on ISO 15197:2013, clause 6.3, for three reagent system lots.