Pediatric Endocrinology, Massachusetts General Hospital for Children, Boston, Massachusetts, USA.
Diabetes Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
Diabetes Technol Ther. 2020 Nov;22(11):846-852. doi: 10.1089/dia.2019.0449.
There is a dearth of comparative accuracy studies of continuous glucose monitoring (CGM) devices in the home-use setting, and none with the Eversense implantable CGM. We evaluated the accuracy of the Dexcom G5, Abbott Freestyle Libre Pro, and Senseonics Eversense during a 6-week free-living home-use bionic pancreas study involving 23 subjects with type 1 diabetes who wore all three devices concurrently. The primary outcome was the mean absolute relative difference (MARD) between CGM readings and point-of-care (POC) plasma-glucose (PG) values obtained approximately twice daily by the subjects. We compared PG values with CGM readings when available from all three CGMs in the 5 min preceding the PG values ( = 829 sets). Since the Libre Pro records readings every 15 min, we also did a two-way comparison between the G5 and the Eversense with a higher number of comparisons ( = 2277 sets). All three CGM systems produced higher average MARDs than during in-clinic studies. However, since all three CGM systems were worn by the same individuals and used the same meter for comparator PG measurements, we could directly compare their performances. In the three-way comparison, Eversense achieved the lowest nominal MARD (14.8%) followed by Dexcom G5 (16.3%) and Libre Pro (18.0%) (Eversense vs. Libre Pro = 0.004, other comparisons = NS). There was a statistically significant difference ( = 0.008) in the two-way comparison of the MARDs for Eversense (15.1%) and G5 (16.9%). The point accuracy of the Eversense was better than two other CGMs when compared with POC PG values.
在家庭使用环境中,连续血糖监测(CGM)设备的准确性比较研究很少,而使用 Eversense 植入式 CGM 的研究则没有。我们评估了 Dexcom G5、雅培 Freestyle Libre Pro 和 Senseonics Eversense 在一项为期 6 周的家庭使用仿生胰腺研究中的准确性,该研究涉及 23 名 1 型糖尿病患者,他们同时佩戴所有三种设备。主要结果是 CGM 读数与患者每天两次通过即时血糖仪(POC)测量的血浆葡萄糖(PG)值之间的平均绝对相对差异(MARD)。我们比较了所有三种 CGM 在测量 PG 值前 5 分钟内的可用读数与 PG 值之间的差异(=829 组)。由于 Libre Pro 每 15 分钟记录一次读数,我们还在 G5 和 Eversense 之间进行了两次比较,比较次数更多(=2277 组)。所有三种 CGM 系统的平均 MARD 均高于在诊所进行的研究。然而,由于所有三种 CGM 系统均由同一批患者佩戴,且使用相同的即时血糖仪测量比较 PG 值,因此我们可以直接比较它们的性能。在三种方式的比较中,Eversense 的 MARD 最低(14.8%),其次是 Dexcom G5(16.3%)和 Libre Pro(18.0%)(Eversense 与 Libre Pro 的比较=0.004,其他比较=NS)。Eversense 的 MARD(15.1%)与 G5 的 MARD(16.9%)之间的比较存在统计学差异(=0.008)。与 POC PG 值相比,Eversense 的点准确性优于另外两种 CGM。