Vettoretti Martina, Facchinetti Andrea, Del Favero Simone, Sparacino Giovanni, Cobelli Claudio
IEEE Trans Biomed Eng. 2016 Aug;63(8):1631-41. doi: 10.1109/TBME.2015.2426217. Epub 2015 Apr 24.
Minimally invasive continuous glucose monitoring (CGM) sensors measure in the subcutis a current signal, which is converted into interstitial glucose (IG) concentration by a calibration process periodically updated using fingerstick blood glucose (BG) references. Though important in diabetes management, CGM sensors still suffer from accuracy problems. Here, we propose a new online calibration method improving accuracy of CGM glucose profiles with respect to manufacturer calibration.
The proposed method fits CGM current signal against the BG references collected twice a day for calibration purposes, by a time-varying calibration function whose parameters are identified in a Bayesian framework using a priori second-order statistical knowledge. The distortion introduced by BG-to-IG kinetics is compensated before parameter identification via nonparametric deconvolution.
The method was tested on a database where 108 CGM signals were collected for 7 days by the Dexcom G4 Platinum sensor. Results show the new method drives to a statistically significant accuracy improvement as measured by three commonly used metrics: mean absolute relative difference reduced from 12.73% to 11.47%; percentage of accurate glucose estimates increased from 82.00% to 89.19%; and percentage of values falling in the "A" zone of the Clark error grid increased from 82.22% to 88.86%.
The new calibration method significantly improves CGM glucose profiles accuracy with respect to manufacturer calibration.
The proposed algorithm provides a real-time improvement of CGM accuracy, which can be crucial in several CGM-based applications, including the artificial pancreas, thus providing a potential great impact in the diabetes technology research community.
微创连续血糖监测(CGM)传感器在皮下测量电流信号,该信号通过使用指尖血糖(BG)参考值定期更新的校准过程转换为组织间液葡萄糖(IG)浓度。尽管在糖尿病管理中很重要,但CGM传感器仍存在准确性问题。在此,我们提出一种新的在线校准方法,相对于制造商校准提高CGM血糖曲线的准确性。
所提出的方法通过一个时变校准函数将CGM电流信号与每天收集两次用于校准目的的BG参考值进行拟合,该校准函数的参数在贝叶斯框架中使用先验二阶统计知识进行识别。在通过非参数反卷积进行参数识别之前,对BG到IG动力学引入的失真进行补偿。
该方法在一个数据库上进行了测试,其中Dexcom G4 Platinum传感器在7天内收集了108个CGM信号。结果表明,通过三个常用指标衡量,新方法在统计学上显著提高了准确性:平均绝对相对差异从12.73%降至11.47%;准确血糖估计的百分比从82.00%增加到89.19%;落在克拉克误差网格“A”区的值的百分比从82.22%增加到88.86%。
相对于制造商校准,新的校准方法显著提高了CGM血糖曲线的准确性。
所提出的算法实时提高了CGM的准确性,这在包括人工胰腺在内的几种基于CGM的应用中可能至关重要,从而在糖尿病技术研究领域产生潜在的重大影响。