Analytic characteristics of three Bayer contour blood glucose monitoring systems in neonates.

Hypoglycemia in infants is common, is difficult to recognize, and may lead to permanent neurologic impairment. Low glucose concentrations and high hematocrits in newborns pose significant analytic challenges for whole blood glucose meters. Three Bayer glucose monitoring systems were evaluated using 211 blood samples from 162 neonates (age range 5 hours to 29 days, median age 3 days). Hematocrit and whole blood glucose were determined in heparinized whole blood, and plasma glucose was determined using the Roche Cobas 6000. Accuracy was evaluated against plasma concentrations using ISO 15197:2013 and CLSI POCT 12-A3 criteria. Glucose imprecision on the Cobas system was 1.8-2.6% (CV) from 26-610 mg/dL. Imprecision across all meter systems was 2.8% (CV) at 130 mg/dL. Glucose concentrations, hematocrit, and total bilirubin ranged from 20-150 mg/dL, 18 -75%, and 0.5-19.6 mg/dL, respectively. Linear regression analysis of whole blood versus plasma for the 3 combined systems yielded an average slope of 1.06 and correlation coefficient greater than 0.980. Bias between the Contour and Cobas was not significantly correlated with hematocrit. Greater than 99% of meter results were within 15 mg/dL and 20% of plasma results at glucose concentrations ≤ 75 and > 75 mg/dL, respectively. Of meter results, 97% were within 12.5 mg/dL of plasma results at concentrations ≤ 100 mg/dL, while 96% of meter results were within 12.5% of plasma at concentrations > 100 mg/dL. The Bayer CONTOUR Blood Glucose Monitoring Systems exceed ISO 15197:2013 and CLSI criteria in neonatal blood samples.

Advanced meter features improve postprandial and paired self-monitoring of blood glucose in individuals with diabetes: results of the Actions with the CONTOUR Blood Glucose Meter and Behaviors in Frequent Testers (ACT) study.

BACKGROUND: This study evaluated whether education and use of the advanced meter features of the CONTOUR(®) (Bayer HealthCare LLC, Diabetes Care, Tarrytown, NY) blood glucose monitoring system (BGMS) affect the frequency and pattern of blood glucose testing in insulin-using subjects with diabetes who routinely perform self-monitoring of blood glucose (SMBG). SUBJECTS AND METHODS: Insulin-using subjects with type 1 or type 2 diabetes were enrolled in this 6-month, multicenter, prospective study and randomized to one of two groups. The basic meter features group (BMF group) received basic instruction in the use of the BGMS, whereas the advanced meter features group (AMF group) also received training in the use of advanced features, including the meal marker and audible reminder, and were instructed to use these features. Both groups received education on the importance of postprandial testing. RESULTS: The AMF group (n=105) had significantly greater average weekly postprandial blood glucose testing than the BMF group (n=106) at each follow-up visit (P<0.001) and significantly increased the frequency of paired blood glucose testing (P<0.001) as well. In both groups, glycated hemoglobin decreased significantly as postprandial testing frequency increased (P<0.05). Subject reports indicated that use of advanced features made postmeal SMBG considerably easier to remember, helped them better understand how to make decisions on their own, and increased their confidence in meal choices. CONCLUSIONS: Study findings showed that advanced features of the CONTOUR BGMS increased structured testing as measured by postprandial and paired SMBG and were perceived as useful by patients.

Evaluation of an over-the-counter glycated hemoglobin (A1C) test kit.

BACKGROUND: Glycated hemoglobin (A1C) monitoring is an integral component of diabetes management. This study was conducted to evaluate the performance of the A1CNow® SELFCHECK device when used by lay users and health care professionals (HCPs) to measure A1C. METHODS: Subjects performed two A1CNow SELFCHECK finger-stick self-tests followed by a finger-stick test of the subject's blood by a HCP. The primary endpoint assessed accuracy of the subject and HCP A1CNow SELFCHECK readings. Secondary endpoints included precision, comprehension of instructional material (written material±DVD), and product satisfaction. For accuracy comparison, a venous blood sample was drawn from each subject and tested by laboratory (TOSOH) analysis. Subject comprehension of product instructional material was evaluated via first-time failure (FTF) rate as recorded by the HCP, and subject satisfaction was assessed through written survey. RESULTS: A total of 110 subjects with (n=93) and without (n=17) diabetes participated. Of 177 subject A1C values, 165 (93.2%) were within the acceptable range of ±13.5% of the laboratory reference value and considered accurate. Regression analysis showed good correlation of subject values to laboratory and HCP results (R2=0.93 for both). The average within-subject coefficient of variation was 4.57% (n=74). The FTF rates with and without instructional DVD were 11.3% (n=56) and 39.6% (n=54), respectively. Subjects with diabetes/prediabetes overwhelmingly indicated that they were "very" to "extremely" likely (93.5%) to discuss their home A1C results with their HCP. CONCLUSIONS: Lay users found the A1CNow SELFCHECK easy to use, and both lay users and HCPs were able to measure A1C accurately.