Introduction & Objective: Despite the increasing use of systems for subcutaneous glucose measurement very limited data exists on its use and glycemic targets in women with gestational diabetes (GDM). Therefore, the aim of our study was to analyze the impact of flash glucose monitoring system (FGM) on glycemic and perinatal outcomes in GDM.
Methods: In an ongoing single-center pilot randomized controlled trial, 37 women with GDM were randomly assigned to either the self-monitoring of blood glucose (SMBG) group or the SMBG + FGM group. The primary outcome was glycemic control, measured by mean glucose levels and the percentage of measurements within the target range by using SMBG data. Secondary outcomes included FGM glycemic control and perinatal data. Statistical comparison between the two groups was performed using the Mann-Whitney U test.
Results: The SMBG group (n=21,(age: 32.4 ± 4.9)) and the SMBG+FGM group (n=16, (age: 30.3 ± 4.9)) exhibited a significant difference solely in the percentage of measurements in target range postprandially (92.6% [84.0-1.0] vs. 80.1% [59.5-91.4], p=0.047). FGM data revealed minimal variations among participants, with an average time-in-range (TIR) of 95.5 ± 4.0%. Notably, 93.8% of participants achieved a TIR above 90%. The coefficient of variation (CV) was 4.2. In the SMBG cohort, two newborns were classified as large for gestational age (LGA), while none were reported in the FGM group.
Conclusion: Our data suggest better glycemic control 1-hour postprandially in the SMBG group, despite a vast majority within the SMBG+FGM group achieved TIR levels above 90%. Possibly stricter glycemic targets will be needed in this population of women, where even slight variations in glucose levels imply more significant therapeutic interventions. Given the limited sample size, definitive conclusions cannot be drawn; further research is warranted.
K. Zorko: None. A. Munda: None. T. Smid: None. A. Zajec: None. A. Janež: Advisory Panel; Novo Nordisk A/S. Speaker's Bureau; Abbott, Eli Lilly and Company, Boehringer-Ingelheim, Ascensia Diabetes Care, Medtronic, AstraZeneca. D. Pongrac Barlovic: None.
University Medical Centre Ljubljana 20230134 and 20220126