Bonet Jacopo, Guiducci Silvia, Res Giulia, Brigadoi Sabrina, Sen Sarbattama, Montaldo Paolo, Priante Elena, Santoro Nicola, Trevisanuto Daniele, Baraldi Eugenio, Dalla Man Chiara, Galderisi Alfonso
Department of Bioengineering, University of Padova, Padova, Italy.
Department of Woman and Child's Health, University of Padova, Padova, Italy.
J Pediatr. 2025 Mar;278:114416. doi: 10.1016/j.jpeds.2024.114416. Epub 2024 Nov 22.
To evaluate the accuracy of a device for continuous glucose monitoring (CGM) among infants born preterm admitted to the neonatal intensive care unit.
We analyzed paired CGM sensor glucose (SG) and point-of-care blood glucose (BG) measurements collected in infants born at ≤32 weeks of gestation or with a birth weight ≤1500 g. CGM was initiated within 48 hours from birth and maintained for 5 days. BG was performed every 12 hours and used to calibrate the sensor. Measures of CGM accuracy were computed from SG and BG pairs.
We included 501 SG-BG paired measurements from 51 infants (age 30.5 weeks [IQR 29.0-31.0 weeks], birth weight 1400 g [IQR 1100-1500 g] with at least 24 hours of CGM data. The mean absolute relative difference (MARD) between SG and point-of-care BG measures was 7.1% [IQR 5.6-9.3], corresponding to a difference of -5.6 mg/dL [95% CI -25 to +14 mg/dl]. The median sensor use was 96 hours [IQR 72-120] with 2.0 [IQR 1.7-2.4] calibrations per day.
Accuracy of SG measurements compared with BG measurements appears to be acceptable in a clinical study setting, with a negligible difference between SG and BG. Our data suggest that SG use may be clinically acceptable when the sensor is regularly calibrated.
评估一种用于新生儿重症监护病房收治的早产婴儿的连续血糖监测（CGM）设备的准确性。
我们分析了孕周≤32周或出生体重≤1500g的早产婴儿的配对CGM传感器血糖（SG）和即时血糖（BG）测量值。出生后48小时内开始进行CGM，并持续5天。每12小时进行一次BG测量，并用于校准传感器。根据SG和BG配对数据计算CGM准确性指标。
我们纳入了51名婴儿（年龄30.5周[四分位间距29.0 - 31.0周]，出生体重1400g[四分位间距1100 - 1500g]）的501对SG - BG配对测量值，这些测量值至少有24小时的CGM数据。SG与即时BG测量值之间的平均绝对相对差异（MARD）为7.1%[四分位间距5.6 - 9.3]，相当于差异为 - 5.6mg/dL[95%置信区间 - 25至 + 14mg/dl]。传感器的中位使用时间为96小时[四分位间距72 - 120]，每天校准2.0次[四分位间距1.7 - 2.4]。
在临床研究环境中，与BG测量值相比，SG测量值的准确性似乎是可以接受的，SG与BG之间的差异可忽略不计。我们的数据表明，当传感器定期校准时，SG的使用在临床上可能是可以接受的。
