First Department of Propaedeutic Internal Medicine, Athens University Medical School, Laiko General Hospital, Athens, Greece.
Diabetes Technol Ther. 2011 Jul;13(7):723-30. doi: 10.1089/dia.2011.0035.
The accuracy and precision of three blood glucose meters (BGMs) were evaluated in 600 hospitalized patients with type 1 (n = 200) or type 2 (n = 400) diabetes. Capillary blood glucose values were analyzed with Accu-Chek(®) Aviva [Roche (Hellas) S.A., Maroussi, Greece], Precision-Xceed(®) [Abbott Laboratories (Hellas) S.A., Alimos, Greece], and Glucocard X-Sensor(®) (Menarini Diagnostics S.A., Argyroupolis, Greece). At the same time plasma glucose was analyzed using the World Health Organization's glucose oxidase method.
Median plasma glucose values (141.2 [range, 13-553] mg/dL) were significantly different from that produced by the BGMs (P < 0.001). The Accu-Chek Aviva underestimated hypoglycemia (plasma glucose ≤55 mg/dL) by a mean difference of 4.1 mg/dL (95% confidence interval [CI] 0-28 mg/dL), and the Precision-Xceed did so by a mean difference of 6.2 mg/dL (95% CI 0-29 mg/dL); the same was true for the Glucocard X-Sensor by a mean difference of 9.1 mg/dL (CI 0-57 mg/dL) (P < 0.001 for all BGMs). Hyperglycemia (plasma glucose ≥250 mg/dL) was overestimated with the Accu-Chek Aviva and the Precision-Xceed by a mean difference of 4.8 mg/dL (95% CI 0-41 mg/dL) and 10.4 mg/dL (CI 0-92 mg/dL), respectively; the same was true for the Glucocard X-Sensor by a mean difference of 20.3 mg/dL (95% CI 0-100 mg/dL) (P < 0.001 for all BGMs). Asymptomatic hypoglycemia was detected in 28% of type 1 and in 18% of type 2 diabetes patients. In all cases, the BGMs were unreliable in sensing hypoglycemia. Multivariate linear regression analysis demonstrated that low blood pressure and hematocrit significantly affected glucose measurements obtained with all three BGMs (P < 0.05).
In hospitalized diabetes patients, all three frequently used BGMs undersensed hypoglycemia and oversensed hyperglycemia to some extent. Patients and caregivers should be aware of these restrictions of the BGMs.
本研究评估了三种血糖仪（BGM）在 600 例 1 型（n=200）或 2 型（n=400）糖尿病住院患者中的准确性和精密度。采用罗氏 Accu-Chek（®）Aviva、雅培 Precision-Xceed（®）和 Menarini Diagnostics 的 Glucocard X-Sensor（®）检测毛细血管血糖值。同时采用世界卫生组织的葡萄糖氧化酶法检测血浆血糖值。
中位血浆血糖值（141.2[范围，13-553]mg/dL）与 BGM 检测值存在显著差异（P<0.001）。Accu-Chek Aviva 平均低估低血糖（血浆血糖≤55mg/dL）4.1mg/dL（95%置信区间[CI]0-28mg/dL），而 Precision-Xceed 平均低估 6.2mg/dL（95%CI 0-29mg/dL）；Glucocard X-Sensor 平均低估 9.1mg/dL（95%CI 0-57mg/dL）（所有 BGM 均 P<0.001）。Accu-Chek Aviva 和 Precision-Xceed 平均高估高血糖（血浆血糖≥250mg/dL）4.8mg/dL（95%CI 0-41mg/dL）和 10.4mg/dL（95%CI 0-92mg/dL），Glucocard X-Sensor 平均高估 20.3mg/dL（95%CI 0-100mg/dL）（所有 BGM 均 P<0.001）。1 型和 2 型糖尿病患者无症状性低血糖的检出率分别为 28%和 18%。在所有情况下，BGM 都无法可靠地检测到低血糖。多变量线性回归分析显示，低血压和红细胞压积显著影响所有三种 BGM 的血糖测量值（P<0.05）。
在住院糖尿病患者中，三种常用的 BGM 均在一定程度上低估了低血糖，高估了高血糖。患者和护理人员应意识到 BGM 的这些局限性。
