Evaluation of a new blood glucose monitoring system with auto-calibration for home and hospital bedside use
Evaluation of a new blood glucose monitoring system with auto-calibration for home and hospital bedside use
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DOI：
10.1016/j.diabres.2006.02.012
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发表时间：
2006-10-01
影响因子：
5.1
通讯作者：
Parker, Donald R.
中科院分区：
文献类型：
--
作者：
Kilo, Charles, Sr.;Dickey, William T., Jr.;Parker, Donald R.
通过对流动受试者和住院患者进行的一系列临床研究，对新型自校准血糖监测系统 (BGMS) 进行了评估。新的 BGMS 需要 0.6 μL 样品量，可在 15 秒内提供结果，并使用不依赖于氧气的葡萄糖脱氢酶化学物质。在第一项研究中，医疗保健专业人员 (HCP) 和非专业用户在两个临床中心对根据全血校准的 Ascensia (R) Contour (TM) 测量仪进行了测试。 HCP 和非专业用户均获得了符合 ISO 15197:2003 标准的结果，即 95% 的自我监测血糖 (SMBG) 测量结果应落在实验室值的 20% 范围内（血糖 (BG) 浓度 >= 4.2 mmol/L 或 +/- 0.83 mmol/L，BG 浓度 < 4.2 mmol/L）。非专业用户和 HCP 分别获得了符合 ISO 标准的 97.2% 和 96.7% 的血糖结果。在第二项研究中，医护人员在医院床边使用校准后的全血糖仪和校准后的血浆葡萄糖仪对患者的血样进行了分析。总体而言，94.7% 的测量结果符合 ISO 15197:2003 标准。大多数非专业受试者在问卷中将 BGMS 评为优秀或非常好，并且无需培训即可正确使用它。这些研究结果表明，这种新型 BGMS 是一种方便、准确的仪器系统，适合 HCP 的医院床边使用和定期监测血糖的人的 SMBG。 (c) 2006 Elsevier Ireland Ltd. 保留所有权利。
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 0.6 mu L sample volume, provides results in 15 s, and uses a glucose dehydrogenase chemistry that is oxygen independent. In the first study, Ascensia (R) Contour (TM) meters calibrated to whole blood were tested by health care professionals (HCP) and lay users at two clinical sites. Both HCPs and lay users obtained results that fulfilled the ISO 15197:2003 criteria that 95% of self-monitoring blood glucose (SMBG) measurements should fall within 20% (for blood glucose (BG) concentrations >= 4.2 mmol/L or +/- 0.83 mmol/L for BG concentrations < 4.2 mmol/L) of the laboratory value. Lay users and HCPs obtained 97.2 and 96.7% of glucose results within ISO criteria, respectively. In a second study, HCPs assayed blood samples from patients at the hospital bedside using meters calibrated to give whole blood glucose and meters calibrated to give plasma glucose results. Overall, 94.7% of the measurements met the ISO 15197:2003 criteria. Most lay subjects rated the BGMS as either excellent or very good in a questionnaire, and were able to use it properly without training. These findings indicate that this new BGMS is a convenient and accurate instrument system suitable for both hospital bedside use by HCPs and for SMBG by people who routinely monitor their blood glucose. (c) 2006 Elsevier Ireland Ltd. All rights reserved.