摘要
目的 评价动态血糖监测系统（CGMS）在正常人、糖调节异常和初诊2型糖尿病患者血糖监测中的准确性和安全性.方法 本研究纳入2007年11月至2009年10月期间在四川大学华西医院门诊/住院受试者162例,其中糖调节异常53例,初诊2型糖尿病患者56例,糖耐量正常53名.所有受试者佩戴CCMS 3 d,同时每天输入7次指尖血糖（SMBG）值进行校正,以评价CGMS的准确性及其与SMBG值的相关性,用Clarke误差表格进行两者一致性分析.结果 所有受试者均完成人均（75.6±8.3）h的动态血糖监测（CGM）,获得4324对CGM值和SMBG值,两者间差异无统计学意义（P〉0.05）,且具有良好的相关性（r=0.943,P=0.000）.87.16%的CGM值在SMBG值的±0.8 mmol/L或±20%范围内,CGM值与SMBG绝对差值的中位数为0.5（0.2～0.9）mmol/L,绝对差值的相对数的中位数为7.55%（3.33%～14.09%） Clarke误差表格分析显示CGM值87.5%在A区（临床准确区）,12.1%在B区（临床可接受区）.结论 CGMS具有良好的准确性、安全性和耐受性.
Objective To evaluate the accuracy and safety of continuous glucose monitoring system （CGMS） in subjects with normal glucose tolerance （NGT）, impaired glucose regulation （IGR） and newlydiagnosed type 2 diabetes mellitus （T2DM）. Methods A total of 162 subjects（53 NGT, 53 IGR and 56newly diagnosed T2DM） at 22 -72 years old were recruited. Each subject received a continuous glucose monitoring（CGM） of CGMS（R） SYSTEM GOLDTM （Medtronic Minimed, Northridge,CA） for 3 consecutive days and was instructed to self-calibrate the interstitial glucose levels with finger-stick blood glucose measurements （self-monitoring of blood glucose, SMBG）7 times daily. Means of median absolute difference （median AD） and median absolute relative difference （median RAD） were calculated to assess the difference between CGM and SMBG values. The correlation between CGM and SMBG values were analyzed with the liner regression analysis. The data were analyzed by the ISO criteria for home glucose meters and Clarke error grid analysis. Results All participants showed a good tolerance to the insertion of CGMS sensor and wearing the device. The mean duration of CGMS recording was （75.6±8.3） h. A total of 4324 glucose meter values were paired with glucose measurements from CGMS. Overall, a good relationship （r=0.943,P = 0.000） and no significant difference （P 〉0.05） over a wide range（2.2-22.2mmol/L） were found between CGM and SMBG values. The median AD was 0.5 （0.2-0.9） mmol/L and the median RAD 7.55% （3.33%-14.09%） with 87.16% of sensor values meeting the ISO home glucose meter criteria.The Clarke error grid analysts showed that 99. 58% of the readings from CGMS fell into the clinical acceptable zones including 87.5% values in zone A （clinical exact） and 12.1% values in zone B （benign error）. Conclusion Both safe and well-tolerated, continuous glucose monitoring provides comparatively accurate blood glucose values to guide the diagnosis and treatment of diabetes.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2010年第42期2967-2970,共4页
National Medical Journal of China
基金
基金项目：上海市市级医院新兴前沿技术联合攻关项目（SHDCl2006101）
关键词
糖尿病
血糖自我监测
准确度
安全性
Diabetes Blood glucose Self-monitoring Accuracy Safety
