Evaluating the clinical accuracy of two continuous glucose sensors using continuous glucose-error grid analysis

Evaluating the clinical accuracy of two continuous glucose sensors using continuous glucose-error grid analysis
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DOI:
10.2337/diacare.28.10.2412
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发表时间:
2005-10-01
期刊:
影响因子:
16.2
通讯作者:
Kovatchev, B
Kovatchev, B
中科院分区:
医学1区
文献类型:
--
作者:
Clarke, WL;Anderson, S;Kovatchev, B

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目的-使用连续血糖误差网格分析(CG-EGA)比较两种不同的连续血糖传感器(CGS)在正常血糖和低血糖期间的临床准确性。研究设计和方法- FreeStyle Navigator(Abbott Laboratories,阿拉米达,CA)和MiniMed CGMS(Medtronic,Northridge,CA)在研究开始前12小时将CGS应用于16名1型糖尿病受试者(年龄42 +/-3岁)的肾脏。根据制造商的建议校准每个系统。每个受试者经历高胰岛素-正常血糖钳夹(血糖目标110 mg/dl)70-210 min,随后1 mg中心点dl(-1)中心点min(-1)控制血糖朝向40 mg/dl的最低点降低。使用Beckman葡萄糖分析仪(Fullerton,CA)每5分钟测定动脉化血糖。将CGS葡萄糖记录与参考血糖匹配,精确度为30秒,并计算5分钟间隔的葡萄糖变化率。CG-EGA被用来量化两个系统的临床准确性,通过估计每个系统在正常血糖(70-180 mg/dl)和低血糖(< 70 mg/dl)范围内的组合点和速率准确性。两种系统的CGS和参考葡萄糖之间的总体相关性相似(Navigator,r = 0.84; CGMS,r = 0.79,NS)。在正常血糖期间,两种CGS系统具有相似的临床准确性(Navigator A + B区,88.8%; CGMS A + B区,89.3%,NS)。然而,在低血糖期间,Navigator的临床准确性显著高于CGMS(A区+ B区= 82.4 vs. 61.6%,Navigator和CGMS,分别为P < 0.0005)。结论- CG-EGA是一种用于评估和比较不同血糖范围内CGS系统临床准确性的有用工具。CG-EGA提供了超出其他评估方法的准确性细节,包括相关分析和原始EGA。
OBJECTIVE - To compare the clinical accuracy of two different continuous glucose sensors (CGS) during euglycemia and hypoglycermia using continuous glucose-error grid analysis (CG-EGA).RESEARCH DESIGN AND METHODS - FreeStyle Navigator (Abbott Laboratories, Alameda, CA) and MiniMed CGMS (Medtronic, Northridge, CA) CGSs were applied to the abdomens of 16 type 1 diabetic subjects (age 42 +/- 3 years) 12 h before the initiation of the study. Each system was calibrated according to the manufacturer's recommendations Each subject underwent a hyperinsulinemic-euglycemic clamp (blood glucose goal 110 mg/dl) for 70-210 min followed by a 1-mg center dot dl(-1)center dot min(-1) controlled reduction in blood glucose toward a nadir of 40 mg/dl. Arterialized blood glucose was determined every 5 min using a Beckman Glucose Analyzer (Fullerton, CA). CGS glucose recordings were matched to the reference blood glucose, with 30-s precision, and rates of glucose change were calculated for 5-min intervals. CG-EGA was used to quantify the clinical accuracy of both systems by estimating Combined point and rate accuracy of each system in the euglycemic (70-180 mg/dl) And hypoglycemic (< 70 mg/dl) ranges.RESULTS - A total of 1,104 data pairs were recorded in the euglycemic range and 2 50 data pairs in the hypoglycemic range. Overall correlation between CGS and reference glucose was similar for both systems (Navigator, r = 0.84; CGMS, r = 0.79, NS). During euglycermia, both CGS systems had similar clinical accuracy (Navigator zones A + B, 88.8%; CGMS zones A + B, 89.3%, NS). However, during hypoglycemia, the Navigator was significantly more clinically accurate than the CGMS (zones A + B = 82.4 vs. 61.6%, Navigator and CGMS, respectively, P < 0.0005).CONCLUSIONS - CG-EGA is a helpful tool for evaluating and comparing the clinical accuracy of CGS systems in different blood glucose ranges. CG-EGA provides accuracy details beyond other methods of evaluation, including correlational analysis and the original EGA.