Efficacy of Flash Glucose Monitoring in Pregnant Women with Poorly Controlled Pregestational Diabetes (FlashMom): A Randomized Pilot Study

Abstract Background and Aims Good glycemic control is crucial to reduce the risk of adverse pregnancy outcomes. Our aim was to evaluate the efficacy of Flash Glucose Monitoring (FGM) on glucose control in women with pregestational diabetes. Methods and Results Forty women with inadequately controlled type 1 (T1D, n=34) and type 2 (T2D, n=6) diabetes at conception were randomly assigned to two arms: the Flash Glucose group (FG, n=21) using FGM, and the control group (CG, n=19) using self-monitoring of blood glucose (SMBG). Glycated hemoglobin (HbA1c, %), time in (TIR), below (TBR) and above (TAR) range, glucose variability as well as the occurrence of maternal and neonatal adverse outcomes, were evaluated. HbA1c decreased significantly (p Conclusions In women with pregestational diabetes, FGM and SMBG had similar efficacy on glucose control during pregnancy. FGM showed additional advantages in terms of TBR and glucose variability. Achievement of good metabolic results depended on the adequate use of glucose sensor. Registration At ClinicalTrials.gov as NCT04666818 on December 14, 2020.