Monitoring of the Analytical Performance of Four Different Blood Glucose Monitoring Systems: A Post-market Performance Follow-Up Study.

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.

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.

Plasma Glucose Concentrations in Different Sampling Tubes Measured on Different Glucose Analysers.

Introduction: The German Diabetes Association recommends using sampling tubes with citrate and fluoride additives to diagnose diabetes by oral glucose tolerance test to inhibit glycolysis. The effect of different tubes on measurement results was assessed.

Materials And Methods: In a first study, an oral glucose tolerance test was performed on 41 participants without anamnestically known diabetes.

Effect of Arterialization on Venous Blood Glucose Concentrations and Implications for Observed Continuous Glucose Monitoring Accuracy.

Heating of the arm and/or hand ("arterialization") is sometimes used in continuous glucose monitoring (CGM) performance studies with the reported aim of reducing differences between venous and capillary glucose concentrations. In this study, the effect of heating on venous glucose concentrations and CGM accuracy was investigated. A heating pad set to 50°C (122°F) was used with 20 participants to heat either the dominant or nondominant arm and hand.

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.

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.

Accuracy Evaluation of a Novel Reusable Patch Pump Prototype.

A prototype of an insulin patch pump that operates with a double pump mechanism was tested. Accuracy of bolus delivery of 0.2 U and 1.

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.

Description of a Novel Patch Pump for Insulin Delivery and Comparative Accuracy Evaluation.

A new insulin patch pump for continuous subcutaneous insulin infusion was developed. The pump is composed of reusable and disposable parts and operates with a stepping motor. This pump was compared to a patch pump and a durable pump regarding basal rate and bolus accuracy.

Evaluation of Trueness and Precision of a Bench-Top Laboratory Glucose Analyzer Using Reference Materials.

SUPER GL compact is a bench-top analyzer for glucose, lactate, and hemoglobin concentrations. Glucose measurements in the biosensor are based on an enzymatic-amperometric reaction of glucose with glucose oxidase.In this study, trueness and precision were assessed with Standard Reference Material 965b (National Institute of Standards and Technology, Gaithersburg, MD) for 2 SUPER GL compact (S1 and S2) and 1 YSI 2300 STAT Plus (Y) device, using a protocol based on CLSI EP05-A3.

Stability of Glucose Concentrations in Frozen Plasma.

Background: Conflicting information is available regarding the stability of glucose concentrations in frozen plasma samples. Clinical trials could benefit from such long-term storage because it would allow usage of a central laboratory with higher-quality laboratory analyzers in contrast to mobile analyzers in a decentralized setting.

Methods: In this study, venous blood samples were collected in lithium-heparin gel tubes.

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.

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.

Comment on "accuracy and precision of four main glucometers used in a sub-Saharan African country: a cross-sectional study" by Choukem .

In their article, Choukem . report of assessments of the analytical quality of blood glucose monitoring systems. Although there are some commendable aspects regarding the methodology, some major shortcomings could preclude the conclusions drawn by Choukem .

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.