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View article: Investigation of the Effect of 70 Potential Interferents on Measurement Results of Two Blood Glucose Monitoring Systems
Investigation of the Effect of 70 Potential Interferents on Measurement Results of Two Blood Glucose Monitoring Systems Open
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 diag…
View article: Performance Assessment of Three Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes
Performance Assessment of Three Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Open
Background: FIND, the global alliance for diagnostics, identified the nonmarket-approved continuous glucose monitoring (CGM) system, FiberSense system (FBS), as a potential device for use in low- and middle-income countries. Together with …
View article: User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results
User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results Open
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 wa…
View article: Accuracy Evaluation of a Novel Reusable Patch Pump Prototype
Accuracy Evaluation of a Novel Reusable Patch Pump Prototype Open
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 1.0 U, and a basal rate of 1.0 U/h were evaluated with a microgravimetric method. In addition, occlusion de…
View article: Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197
Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197 Open
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 some…
View article: Description of a Novel Patch Pump for Insulin Delivery and Comparative Accuracy Evaluation
Description of a Novel Patch Pump for Insulin Delivery and Comparative Accuracy Evaluation Open
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 regard…
View article: Evaluation of the Accuracy of Current Tubeless Pumps for Continuous Subcutaneous Insulin Infusion
Evaluation of the Accuracy of Current Tubeless Pumps for Continuous Subcutaneous Insulin Infusion Open
Background: Recently two new tubeless pumps for insulin therapy were introduced. They were tested for accuracy and occlusion detection and compared with the established patch pump Omnipod® (OP). Methods: Using a modified setup for tubeless…
View article: Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems
Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems Open
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 lev…
View article: System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015
System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015 Open
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…
View article: Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197
Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197 Open
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 acc…
View article: Continuous glucose monitoring: data management and evaluation by patients and health care professionals – current situation and developments
Continuous glucose monitoring: data management and evaluation by patients and health care professionals – current situation and developments Open
Continuous glucose monitoring (CGM) technology represents a valuable tool for diabetic patients to control and regulate their blood glucose (BG) levels and to reduce adverse metabolic states, for example, by defining glucose alarm threshol…
View article: Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision
Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision Open
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…