Abstract

There are limited data on head-to-head performance of Freestyle Libre Pro (FSL-Pro) and blinded Medtronic iPro2 CGMS in pregnancy. In this prospective observational study, women with hyperglycemia in pregnancy (n=42) underwent simultaneous FSL-Pro and Medtronic iPro2 sensor insertion and SMBG using Contour Plus meter (reference). The overall MARD for iPro2 and FSL-Pro systems were 8.0 ± 9.2% and 19.0 ± 12.8%, respectively. At hypoglycemic range, both sensors performed less accurately (MARD: 18.1% and 16.8%, respectively), while iPro2 showed higher accuracy at euglycemic (8.2% and 19.3%, respectively) and hyperglycemic (6.8% and 18.0%, respectively) ranges. On Bland-Altman analysis, iPro2 and FSL-Pro underestimated glucose by 0.01 and 1.09 mmol/L, respectively. The ISO criteria were fulfilled for 83.4% and 36.2% of all values, respectively. To conclude, iPro2 was more accurate, however, both sensors demonstrated inaccuracy at hypoglycemic range, highlighting the need for refinements in the current generation of sensors to address this problem.

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