Evaluation of Commonly Used Blood Glucose Meters in Vietnam and Effect of Hematocrit on Device's Accuracy

Hung Vuong Hospital1 个研究点分布在 1 个国家目标入组 135 人开始时间: 2022年6月1日最近更新: 2024年1月29日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hung Vuong Hospital
入组人数: 135
试验地点: 1
主要终点: Hematocrit

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Rationale: Most BGM (blood glucose monitoring) devices in Vietnam are manufactured for home use only. However, they are commonly used in healthcare facility, primarily at point of care. We want to assess the validity of these devices by using CLSI (Clinical and Laboratory Standards Institute) POCT12-A3 to assess the accuracy.

Objective: To validate the accuracy and effect of hematocrit on these devices, along with the precision profile using CLSI EP15A3

Study design: This is a cross-sectional study.

Study population: Because we need a wide range of blood glucose level. We chose pregnant women who underwent 75g glucose tolerance test.

详细描述

Most blood glucose monitors circulating the market are manufactured after ISO 15197:2013 standard, which is intended for self-measurement. Medical organizations need to verify blood glucose monitors if they are designed for prescription point-of-care use or validate blood glucose monitors if they are designed for over-the-counter use.

Pregnant women are selected after consent, their blood are then drawn by phlebotomist into an EDTA (ethylenediamine tetraacetic acid) with NaF (sodium flouride) blood tube. Samples are run on alinity h hematology analyzer, manufactured by Abbott, to measure hematocrit. The analyzers are verified by laboratory procedure, recommended by CLSI (Clinical and Laboratory Standards Institute) method and quality control is checked before in accordance to the laboratory procedure. After that, blood tube is mixed thoroughly before being pipetted. Each BGM device will measure blood glucose level of the pipetted whole blood. Finally, samples will be run on a cobas c 502 analyzer to measure plasma glucose level, which is a reference method for determining the accuracy of the BGM devices.

Statistical analysis

Meter performance is acceptable for use in hospitals when 95% of the individual results from the POC glucose meter system agree within 0.67 mmol/L (12 mg/dL) of the laboratory analyzer values at glucose concentrations below 5.55 mmol/L (100 mg/dL) and within 12.5% of the laboratory analyzer values at glucose concentrations at or above 5.55 mmol/L (100 mg/dL). In addition, the sum of the number of individual results with 1) errors that exceed 0.83 mmol/L (15 mg/dL) at glucose concentrations below 4.2 mmol/L (75 mg/dL) and 2) errors that exceed 20% at glucose concentrations at or above 4.2 mmol/L (75 mg/dL) should not exceed 2% of all results. An ordinary linear regression is performed to see how well the glucose level of BGM devices correlates with the reference method. Bland-Altman difference plots are used to describe the difference along with the hematocrit of each sample.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Cross Sectional

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Pregnant women undergo 75g glucose tolerance test

排除标准

•Usage of anticoagulant drug
•History of bleeding disorders.