School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.
School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia
Diabetes Care. 2018 Oct;41(10):2053-2058. doi: 10.2337/dc18-0833.
Blood glucose monitoring is fundamental for hyperglycemia management during pregnancy, but are the devices up to the job? Studies assessing the accuracy of 10 commercially available glucose meters during pregnancy showed that although >98-99% of the meter values were in the acceptable zones of the error grid for the majority of the meters, the meter performance varied, with the majority showing positive bias and a few showing minimal negative bias. The mean difference between meter and laboratory plasma values varied between -0.33 and 0.73 mmol/L. Three meters showed deviations from laboratory results with a change in maternal hematocrit levels. No meters had a total analytical error <5%, and no studies evaluated meters using recent International Organization for Standardization 15197:2013 criteria. The Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT) recently showed that an antenatal continuous glucose monitoring system (CGMS), as an adjunct to capillary monitoring, was associated with a lower incidence of large-for-gestational-age babies, fewer neonatal intensive care unit admissions (>24 h), and a lower incidence of neonatal hypoglycemia. The flash glucose monitoring system shows good accuracy in pregnant women but has not been marketed widely in the U.S. We suggest that meters cannot be assumed to be sufficiently accurate during pregnancy and that manufacturers should ensure a total error <5%, with bias and imprecision <2% during pregnancy. Large studies are needed to evaluate the usefulness of CGMS among pregnant women with type 2 diabetes and gestational diabetes mellitus.
血糖监测是妊娠期间高血糖管理的基础,但这些设备是否胜任这项工作?评估 10 种市售血糖仪在妊娠期间准确性的研究表明,尽管大多数血糖仪的 98-99%以上的测量值处于误差网格的可接受范围内,但血糖仪的性能存在差异,大多数血糖仪表现出正偏差,少数血糖仪表现出微小的负偏差。血糖仪与实验室血浆值之间的平均差值在-0.33 至 0.73mmol/L 之间。有 3 种血糖仪的测量值与实验室结果存在偏差,与母体血细胞比容水平的变化有关。没有任何血糖仪的总分析误差<5%,也没有研究根据最近的国际标准化组织 15197:2013 标准评估血糖仪。最近的妊娠 1 型糖尿病妇女连续血糖监测试验(CONCEPTT)表明,产前连续血糖监测系统(CGMS)作为毛细血管监测的辅助手段,与巨大儿的发生率降低、新生儿重症监护病房入住时间减少(>24 小时)以及新生儿低血糖发生率降低有关。瞬态葡萄糖监测系统在孕妇中表现出良好的准确性,但尚未在美国广泛销售。我们建议不能假设血糖仪在妊娠期间足够准确,制造商应确保总误差<5%,偏差和不精密度<2%。需要进行大型研究来评估 CGMS 在妊娠 2 型糖尿病和妊娠期糖尿病妇女中的有用性。