Faccioli Simone, Del Favero Simone, Visentin Roberto, Bonfanti Riccardo, Iafusco Dario, Rabbone Ivana, Marigliano Marco, Schiaffini Riccardo, Bruttomesso Daniela, Cobelli Claudio
1 Department of Information Engineering, University of Padua, Padua, Italy.
2 Diabetologia Pediatrica e Diabetes Research Institute (OSR-DRI), Ospedale San Raffaele, Milan, Italy.
J Diabetes Sci Technol. 2017 Nov;11(6):1147-1154. doi: 10.1177/1932296817706377. Epub 2017 May 9.
Patients with diabetes, especially pediatric ones, sometimes use continuous glucose monitoring (CGM) sensor in different positions from the approved ones. Here we compare the accuracy of Dexcom® G5 CGM sensor in three different sites: abdomen, gluteus (both approved) and arm (off-label).
Thirty youths, 5-9 years old, with type 1 diabetes (T1D) wore the sensor during a clinical trial where frequent self-monitoring of blood glucose (SMBG) measurements were obtained. Sensor was inserted in different sites according to the patient habit. Accuracy metrics include absolute relative difference (ARD) and absolute difference (AD) of CGM with respect to SMBG. The three sites were compared with ANOVA. If the test detected a difference, an additional pair-wise comparison was performed.
Overall, no accuracy difference was detected: the mean ARD was 13.3% (SD = 13.5%) for abdomen, 13.4% (12.9%) for arm and 12.9% (20.2%) for gluteus ( P value = .83); the mean AD was 17.0 mg/dl (17.2 mg/dl) for abdomen, 17.2 mg/dl (17.1 mg/dl) for arm and 18.3 mg/dl (18.5 mg/dl) for gluteus ( P value = .30). In hypo- and euglycemia ARD ( P value = .87 and .15, respectively), and AD ( P value = .68 and .37, respectively) were not statistically different. At variance, in hyperglycemia, a significant difference was detected between the two approved sites, abdomen and gluteus (ΔARD = -2.2% [CI = -4.2%, -0.1%], P value = .04), whereas the comparisons with the off-label location, arm-abdomen, and arm-gluteus were not significant.
These results suggest that the accuracy of the sensor placed on the arm was not significantly different with respect to the two approved insertion sites (abdomen and gluteus). Larger, randomized trials are needed to draw final conclusions.
糖尿病患者，尤其是儿童患者，有时会将连续血糖监测（CGM）传感器放置在批准位置以外的不同部位。在此，我们比较了德康G5 CGM传感器在三个不同部位（腹部、臀部（均为批准部位）和手臂（未标注部位））的准确性。
30名5至9岁的1型糖尿病（T1D）青少年在一项临床试验中佩戴该传感器，期间进行了频繁的自我血糖监测（SMBG）测量。根据患者习惯将传感器插入不同部位。准确性指标包括CGM相对于SMBG的绝对相对差异（ARD）和绝对差异（AD）。对这三个部位进行方差分析（ANOVA）比较。如果测试检测到差异，则进行额外的两两比较。
总体而言，未检测到准确性差异：腹部的平均ARD为13.3%（标准差=13.5%），手臂为13.4%（12.9%）,臀部为12.9%（20.2%）（P值=0.83）；腹部的平均AD为17.0mg/dl（17.2mg/dl），手臂为17.2mg/dl（17.1mg/dl），臀部为18.3mg/dl（18.5mg/dl）（P值=0.30）。在低血糖和血糖正常时，ARD（P值分别为0.87和0.15）以及AD（P值分别为0.68和0.37）无统计学差异。不同的是在高血糖时, 在两个批准部位，即腹部和臀部之间检测到显著差异（ΔARD = -2.2% [CI = -4.2%, -0.1%]，P值=0.04），而与未标注部位（手臂 -腹部和手臂 -臀部）的比较无显著差异。
这些结果表明，放置在手臂上的传感器的准确性与两个批准的插入部位（腹部和臀部）相比无显著差异。需要进行更大规模的随机试验以得出最终结论。
