Kilo Charles, Pinson Mary, Joynes Judy Ostrom, Joseph Hal, Monhaut Nanette, Parkes Joan Lee, Baum John
West County Internal Medicine, St. Louis, Missouri, USA.
Diabetes Technol Ther. 2005 Apr;7(2):283-94. doi: 10.1089/dia.2005.7.283.
The Ascensia CONTOUR System (Bayer HealthCare LLC, Elkhart, IN) is a new blood glucose (BG) monitoring system (BGMS) that uses glucose dehydrogenase chemistry and that combines low sample volume, fast response time, an auto-control marking feature, and an auto-calibration function in a small package.
The system was evaluated at four diabetes clinics with ambulatory subjects who had diabetes. The BGMS was tested by both health care professionals (HCPs) and lay users. It was also evaluated at high altitude (10,200 feet) and, in conjunction with the Ascensia MICROLET VACULANCE (Bayer), for use with samples obtained from four alternative anatomical sites.
When the system was used with blood from fingersticks, both lay users and HCPs obtained results that fulfilled the International Organization for Standardization (ISO) 15197:2003 accuracy criteria, which advocate that 95% of BG measurements should fall within +/-15 mg/dL (for BG concentrations <75 mg/dL) or +/-20% (for BG concentrations > or = 75 mg/dL) of the laboratory value. Lay users obtained 96.9% of glucose results, and HCPs obtained 96.4% of glucose results, within ISO accuracy criteria. People with diabetes who had no prior experience using the system also obtained acceptable results (97.0%), as did the HCP using fingerstick samples from subjects in the high altitude study (97.0%). Among the alternative anatomical sites tested, only the results from the palm met the ISO criteria (97.5%), although the results from all four sites (palm, thigh, abdomen, and forearm) were clinically acceptable when assessed using error grid analysis. Most 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 the Ascensia CONTOUR System, which does not require calibration by the user, is a convenient and accurate instrument with useful features for people who routinely monitor BG.
拜耳医疗保健有限责任公司（位于印第安纳州埃尔克哈特）生产的Ascensia CONTOUR系统是一种新型血糖监测系统（BGMS），它采用葡萄糖脱氢酶化学法，具备低样本量、快速响应时间、自动控制标记功能以及自动校准功能，整体体积小巧。
该系统在四家糖尿病诊所对患有糖尿病的门诊患者进行了评估。医疗保健专业人员（HCPs）和非专业用户都对该血糖监测系统进行了测试。此外，还在高海拔地区（10200英尺）进行了评估，并与Ascensia MICROLET VACULANCE（拜耳公司产品）配合使用，以检测从四个不同解剖部位采集的样本。
当该系统与指尖血样本配合使用时，非专业用户和医疗保健专业人员所获得的结果均符合国际标准化组织（ISO）15197:2003的准确性标准，该标准主张95%的血糖测量值应落在实验室值的±15mg/dL范围内（血糖浓度<75mg/dL时）或±20%范围内（血糖浓度≥75mg/dL时）。非专业用户获得的血糖结果中有96.9%符合ISO准确性标准，医疗保健专业人员获得的血糖结果中有96.4%符合该标准。此前没有使用过该系统经验的糖尿病患者也获得了可接受的结果（97.0%），高海拔研究中使用受试者指尖血样本的医疗保健专业人员获得的结果同样如此（97.0%）。在所测试的不同解剖部位中，只有手掌部位的结果符合ISO标准（97.5%），不过，使用误差网格分析评估时，所有四个部位（手掌、大腿、腹部和前臂）的结果在临床上都是可接受的。在一份调查问卷中，大多数受试者将该血糖监测系统评为优秀或非常好，并且无需培训就能正确使用。
这些研究结果表明，Ascensia CONTOUR系统无需用户进行校准，对于常规监测血糖的人来说，是一种方便、准确且功能实用的仪器。
