Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors.

Objective: Cleared blood glucose monitors (BGMs) for personal use may not always deliver levels of accuracy currently specified by international and U.S. regulatory bodies.

Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.

Background: Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs.

Accuracy Evaluation of CONTOUR(®)PLUS Compared With Four Blood Glucose Monitoring Systems.

Introduction: The aim of this study was to compare the accuracy of 5 blood glucose monitoring systems (BGMSs; CONTOUR(®)PLUS [CP], Accu-Chek(®) Active [ACA], Accu-Chek(®) Performa [ACP], FreeStyle Freedom™ [FF], OneTouch(®) SelectSimple™ [OTSS]).

Methods: Study staff tested fingerstick samples from 106 subjects aged ≥18 years using the 5 BGMSs. Some samples were modified to achieve blood glucose concentrations throughout the measuring range.

The surveillance error grid.

Currently used error grids for assessing clinical accuracy of blood glucose monitors are based on out-of-date medical practices. Error grids have not been widely embraced by regulatory agencies for clearance of monitors, but this type of tool could be useful for surveillance of the performance of cleared products. Diabetes Technology Society together with representatives from the Food and Drug Administration, the American Diabetes Association, the Endocrine Society, and the Association for the Advancement of Medical Instrumentation, and representatives of academia, industry, and government, have developed a new error grid, called the surveillance error grid (SEG) as a tool to assess the degree of clinical risk from inaccurate blood glucose (BG) monitors.

Accuracy evaluation of contour next compared with five blood glucose monitoring systems across a wide range of blood glucose concentrations occurring in a clinical research setting.

Background: This study evaluated the accuracy of Contour(®) Next (CN; Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) compared with five blood glucose monitoring systems (BGMSs) across a wide range of clinically occurring blood glucose levels.

Subjects And Methods: Subjects (n=146) were ≥ 18 years and had type 1 or type 2 diabetes. Subjects' glucose levels were safely lowered or raised to provide a wide range of glucose values.

Testing versus guessing blood glucose values: impact on self-care behaviors in type 2 diabetes.

Objective: To assess differences between estimated blood glucose values and those measured on a blood glucose meter and the impact on self-care behavior in type 2 diabetes.

Research Design And Methods: Subjects ≥18 years with type 2 diabetes (N = 297) attending a Taking Control of Your Diabetes conference were asked questions about diabetes management and to estimate their current blood glucose. Study staff tested subjects' blood glucose on a meter.

A new test strip technology platform for self-monitoring of blood glucose.

In the management of diabetes, accuracy of devices used for self-monitoring of blood glucose (SMBG) is critical because SMBG results can affect patient diabetes-related health outcomes. A new blood glucose monitoring system (BGMS) platform has been developed that is based on the new CONTOUR® NEXT (CN) test strip. This BGMS platform uses a proprietary electron mediator and algorithm to minimize errors at different steps in the testing process, thus minimizing outliers and significantly improving accuracy from prior-generation blood glucose meter systems.

Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial.

Background: This study evaluated differences in accuracy between the CONTOUR® NEXT EZ (EZ) blood glucose monitoring system (BGMS) and four other BGMSs [ACCU-CHEK® Aviva (ACAP), FreeStyle Freedom Lite® (FFL), ONE TOUCH® Ultra®2 (OTU2), and TRUEtrack® (TT)].

Methods: Up to three capillary blood samples (N = 393) were collected from 146 subjects with and without diabetes. One sample per subject was tested with fresh (natural) blood; the other samples were glycolyzed to lower blood glucose to <70 mg/dl.

Technical aspects of the Parkes error grid.

Background: The Parkes error grid, which was developed in 1994, presented performance zones for blood glucose (BG) monitors with borders that were not mathematically specified at the time the grid was published.

Methods: In this article, we (1) review the history of the Parkes error grid, (2) present the never-before-published exact coordinates and specifications of the grid so that others may produce an exact replica of the original grid, and (3) discuss our suggestions how this metric should be applied.

Results: The new ISO15197:2013 guideline for system accuracy assessment of BG meters for patient self-measurement incorporates use of this metric for defining acceptable accuracy of BG monitors.

Performance of a new blood glucose monitoring system in the hands of intended users.

Background: This study assessed the performance of a blood glucose monitoring system (BGMS) in development that uses a new generation of blood glucose test strips with capillary and venous blood in the hands of its intended users, people with diabetes and healthcare professionals (HCPs).

Subjects And Methods: In total, 93 subjects ≥ 18 years old (median age, 33 years) with type 1 (78%) or type 2 (22%) diabetes participated. Untrained subjects performed self-test fingersticks using a Microlet(®)2 lancing device (Bayer HealthCare LLC, Diabetes Care, Tarrytown, NY) followed by testing of their own capillary blood on the BGMS.

Performance of the DIDGET blood glucose monitoring system in children, teens, and young adults.

Background: This study evaluated the performance of the DIDGET® blood glucose monitoring system (BGMS) in the hands of its intended users: children, teens, and young adults with diabetes.

Methods: Finger stick capillary blood samples were tested in duplicate by subjects (with parent/guardian assistance, if needed) and health care professionals using the DIDGET BGMS, and results were compared with those obtained using a Yellow Springs Instruments (YSI) glucose analyzer. Modified venous blood samples (i.

Performance evaluation and labeling comprehension of a new blood glucose monitoring system with integrated information management.

Background: This study evaluated performance and product labeling of CONTOUR® USB, a new blood glucose monitoring system (BGMS) with integrated diabetes management software and a universal serial bus (USB) port, in the hands of untrained lay users and health care professionals (HCPs).

Method: Subjects and HCPs tested subject's finger stick capillary blood in parallel using CONTOUR USB meters; deep finger stick blood was tested on a Yellow Springs Instruments (YSI) glucose analyzer for reference. Duplicate results by both subjects and HCPs were obtained to assess system precision.

Evaluation of a novel continuous glucose measurement device in patients with diabetes mellitus across the glycemic range.

Background: This glucose clamp study assessed the performance of an electrochemical continuous glucose monitoring (CGM) system for monitoring levels of interstitial glucose. This novel system does not require use of a trocar or needle for sensor insertion.

Method: Continuous glucose monitoring sensors were inserted subcutaneously into the abdominal tissue of 14 adults with type 1 or type 2 diabetes.

Performance of the CONTOUR® TS Blood Glucose Monitoring System.

Background: Self-monitoring of blood glucose (SMBG) remains an important component of diabetes management, engendering a need for affordable blood glucose (BG) meters that are accurate, precise, and convenient. The CONTOUR® TS is a BG meter that endeavors to meet this need. It uses glucose dehydrogenase/flavin dinucleotide chemistry, automatic test strip calibration, and autocompensation for hematocrit along with the ease of use that has come to be expected of a modern meter.

Predicted blood glucose from insulin administration based on values from miscoded glucose meters.

Objectives: The proper use of many types of self-monitored blood glucose (SMBG) meters requires calibration to match strip code. Studies have demonstrated the occurrence and impact on insulin dose of coding errors with SMBG meters. This paper reflects additional analyses performed with data from Raine et al.

Significant insulin dose errors may occur if blood glucose results are obtained from miscoded meters.

Objective: The objective of this study was to determine inaccuracies of miscoded blood glucose (BG) meters and potential errors in insulin dose based on values from these meters.

Research Design: Fasting diabetic subjects at three clinical centers participated in a 2-hour meal tolerance test. At various times subjects' blood was tested on five BG meters and on a Yellow Springs Instruments laboratory glucose analyzer.

Ascensia WinGLUCOFACTS Professional Software improves diabetes health outcomes.

Background: Traditionally, people with diabetes keep handwritten blood glucose (BG) logs. Although a useful, and a necessary component of diabetes management, logbooks can be incomplete, inaccurate and illegible, which may lead to faulty analyses of BG trends associated with meals, medications and daily activities. Ascensia, WinGLUCOFACTS, Professional Software (WinGLUCOFACTS) from Bayer HealthCare was developed to assist in diabetes management by providing text and graphic presentations of downloaded data.

Evaluation of a new blood glucose monitoring system with auto-calibration for home and hospital bedside use.

A new self-calibrating blood glucose monitoring system (BGMS) was evaluated in a series of clinical studies with both ambulatory subjects and with hospitalized patients. The new BGMS requires a 0.6microL sample volume, provides results in 15s, and uses a glucose dehydrogenase chemistry that is oxygen independent.

Evaluation of a new blood glucose monitoring system with auto-calibration.

Background: The Ascensia CONTOUR System (Bayer HealthCare LLC, Elkhart, IN) is a new blood glucose (BG) monitoring system (BGMS) that uses glucose dehydrogenase chemistry and that combines low sample volume, fast response time, an auto-control marking feature, and an auto-calibration function in a small package.

Methods: The system was evaluated at four diabetes clinics with ambulatory subjects who had diabetes. The BGMS was tested by both health care professionals (HCPs) and lay users.

Accuracy and utility of a 10-test disk blood glucose meter.

We evaluated the clinical accuracy, precision, and ease-of-use of a whole blood referenced glucose meter system that uses a 10-test disk (Ascensia Confirm Blood Glucose Monitoring System, Bayer Healthcare LLC). The meter system was tested by 100 subjects and eight health care professionals at two separate diabetes centers. Meter blood glucose test results, obtained by the subjects and health care professionals, were accurate and correlated well when compared with laboratory results.

The clinical performance and ease of use of a blood glucose meter that uses a 10-test disk.

Patient and health care provider evaluations are critical in establishing the accuracy and usability of new blood glucose meter systems. The objective of our study was to evaluate the clinical performance and ease of use of a blood glucose meter that uses a 10-test disk (Ascensia Breeze meter system, Bayer Healthcare LLC, Elkhart, IN). Meter capillary blood glucose results were compared with laboratory glucose results from 100 subjects with diabetes at two diabetes centers.