麦邦数据远程传输型血糖仪临床测量准确性的评价研究(1)
摘 要：目的 評价麦邦数据远程传输型血糖仪监测院外糖尿病患者血糖水平的准确性，为麦邦数据远程传输型血糖仪的临床使用提供数据参考。方法 应用等效性临床试验研究设计，按照纳入排除标准选取广州市天河区已诊断为糖尿病的患者，共计210例，采用麦邦数据远程传输型血糖仪和我院内分泌科所使用的美国雅培辅理善越佳型血糖仪，分别测量受试者指端血的血糖浓度，并与静脉血生化血糖值进行比较，分别计算两种血糖仪的测量结果与生化仪血糖值的相关系数和测量偏倚。上述的血糖检测控制在20 min内全部完成。结果 两种便携式血糖仪与全自动生化仪所测结果的相关系数分别为r=0.98、0.97，相关性均较好，且呈线性相关；两种血糖仪与生化仪测量值差值95%的置信区间均在标准等效区间(-0.83，0.83)mmol/L内，均满足临床等效性要求；麦邦数据远程传输型血糖仪95.28%的数据在临床可接受范围内，高于国家标准的要求，而雅培辅理善越佳型血糖仪低于此标准；各组检测结果之间差异虽无统计学意义(P>0.05)，但两种血糖仪检测的结果均高于生化仪检测的结果。结论 通过等效性分析，麦邦数据远程传输型血糖仪可以用于临床血糖监测及个人血糖检测，但不能取代实验室血糖检测结果作为临床诊断标准；麦邦数据远程传输型血糖仪的数据传输功能，方便医生根据患者情况适时调整血糖控制方案，降低并发症的发生。
, http://www.100md.com
关键词：便携式血糖仪；2型糖尿病；血浆血糖；指尖血糖
中图分类号：TP391.4；R714.256 文献标识码：A DOI：10.3969/j.issn.1006-1959.2018.15.020
文章编号：1006-1959(2018)15-0064-04
Evaluation of Accuracy of Clinical Measurement of Maibang Remote Data Transmission Glucometer
DING Xing，ZHAO Chang，ZHANG Hai-yan，CAI Dao-zhang
(Department of Arthroplasty，the Third Affiliated Hospital of Southern Medical University，Guangzhou 510630，Guangdong，China)
, 百拇医药
Abstract：Objective To evaluate the accuracy of blood glucose monitoring in patients with diabetes mellitus by Maibang remote data transmission，and to provide a data reference for the clinical use of remote data transmission glucometer.Methods Applying the equivalence clinical trial design and design，according to the inclusion exclusion criteria，210 patients with diabetes diagnosed in Tianhe District of Guangzhou city were selected，using the Maibang Data Remote Transmission Glucose Meter and the American Abbott Auxiliary Good Blood Glucose Meter used by the Department of Endocrinology，the blood glucose concentration of the finger blood was measured and compared with the venous blood biochemical blood glucose level.Calculate the correlation coefficient and measurement bias of the measurement results of the two blood glucose meters and the blood glucose level of the biochemical analyzer. The above blood glucose detection control was completed in 20 minutes.Results The correlation coefficient between the two kinds of portable blood glucose analyzer and the automatic biochemical instrument r was 0.98 and 0.97，with the good correlation，there was a linear correlation.The confidence intervals of 95% difference between the two blood glucose meters and biochemical instruments were within the standard equivalent interval(-0.83，0.83)mmol/L，which met the requirement of clinical equivalence 95.28% of the data of Maibang data remote transmission glucometer is higher than the requirement of national standard in the clinical acceptable range，but the American Abbott Assistant Good Health Blood glucometer is lower than this standard.Although there was no significant difference between each group(P>0.05)，the results of two kinds of blood glucose analyzer were higher than those of biochemical apparatus. Conclusion Based on the equivalence analysis， Maibang data remote transmission glucometer can be used in clinical blood glucose monitoring and personal blood glucose detection，but it can not replace the results of blood glucose detection in laboratory as the clinical diagnostic standard.The data transmission function of Maibang data remote transmission glucometer is convenient for doctors to adjust blood sugar control scheme according to the patients’condition and to reduce the incidence of complications., 百拇医药(丁星 赵畅 张海严 蔡道章)
, http://www.100md.com
关键词：便携式血糖仪；2型糖尿病；血浆血糖；指尖血糖
中图分类号：TP391.4；R714.256 文献标识码：A DOI：10.3969/j.issn.1006-1959.2018.15.020
文章编号：1006-1959(2018)15-0064-04
Evaluation of Accuracy of Clinical Measurement of Maibang Remote Data Transmission Glucometer
DING Xing，ZHAO Chang，ZHANG Hai-yan，CAI Dao-zhang
(Department of Arthroplasty，the Third Affiliated Hospital of Southern Medical University，Guangzhou 510630，Guangdong，China)
, 百拇医药
Abstract：Objective To evaluate the accuracy of blood glucose monitoring in patients with diabetes mellitus by Maibang remote data transmission，and to provide a data reference for the clinical use of remote data transmission glucometer.Methods Applying the equivalence clinical trial design and design，according to the inclusion exclusion criteria，210 patients with diabetes diagnosed in Tianhe District of Guangzhou city were selected，using the Maibang Data Remote Transmission Glucose Meter and the American Abbott Auxiliary Good Blood Glucose Meter used by the Department of Endocrinology，the blood glucose concentration of the finger blood was measured and compared with the venous blood biochemical blood glucose level.Calculate the correlation coefficient and measurement bias of the measurement results of the two blood glucose meters and the blood glucose level of the biochemical analyzer. The above blood glucose detection control was completed in 20 minutes.Results The correlation coefficient between the two kinds of portable blood glucose analyzer and the automatic biochemical instrument r was 0.98 and 0.97，with the good correlation，there was a linear correlation.The confidence intervals of 95% difference between the two blood glucose meters and biochemical instruments were within the standard equivalent interval(-0.83，0.83)mmol/L，which met the requirement of clinical equivalence 95.28% of the data of Maibang data remote transmission glucometer is higher than the requirement of national standard in the clinical acceptable range，but the American Abbott Assistant Good Health Blood glucometer is lower than this standard.Although there was no significant difference between each group(P>0.05)，the results of two kinds of blood glucose analyzer were higher than those of biochemical apparatus. Conclusion Based on the equivalence analysis， Maibang data remote transmission glucometer can be used in clinical blood glucose monitoring and personal blood glucose detection，but it can not replace the results of blood glucose detection in laboratory as the clinical diagnostic standard.The data transmission function of Maibang data remote transmission glucometer is convenient for doctors to adjust blood sugar control scheme according to the patients’condition and to reduce the incidence of complications., 百拇医药(丁星 赵畅 张海严 蔡道章)