| Autor: |
Jafri RZ; Pediatric Endocrinology, Massachusetts General Hospital for Children, Boston, Massachusetts, USA.; Diabetes Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA., Balliro CA; Diabetes Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA., El-Khatib F; Department of Biomedical Engineering, Boston University, Boston, Massachusetts, USA., Maheno MM; Diabetes Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA., Hillard MA; Diabetes Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA., O'Donovan A; Department of Biomedical Engineering, Boston University, Boston, Massachusetts, USA., Selagamsetty R; Department of Biomedical Engineering, Boston University, Boston, Massachusetts, USA., Zheng H; Biostatistics Center, Massachusetts General Hospital, Boston, Massachusetts, USA., Damiano ER; Department of Biomedical Engineering, Boston University, Boston, Massachusetts, USA., Russell SJ; Diabetes Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA. |
| Abstrakt: |
Background: 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. Methods: 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 ( n = 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 ( n = 2277 sets). Results: 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 P = 0.004, other comparisons P = NS). There was a statistically significant difference ( P = 0.008) in the two-way comparison of the MARDs for Eversense (15.1%) and G5 (16.9%). Conclusions: The point accuracy of the Eversense was better than two other CGMs when compared with POC PG values. |
