Flash glucose monitoring in gestational diabetes mellitus (FLAMINGO): a randomised controlled trial.

AIMS

Gestational diabetes mellitus (GDM) is the most common type of hyperglycaemia in pregnancy. GDM is a risk factor of adverse perinatal outcomes, with the incidence rate increasing proportionally to the level of maternal dysglycaemia. Therefore, glycaemic control plays an important role in management of GDM. The aim of this study was to assess the efficacy of flash glucose monitoring (FGM) in GDM.

MATERIALS AND METHODS

This was a non-blinded, randomised controlled trial, that recruited 100 pregnant women diagnosed with GDM between 24 and 28 weeks of gestation at the 1st Department of Obstetrics and Gynaecology, Medical University of Warsaw. After meeting the inclusion criteria patients were randomly allocated to the study group (FGM, n = 50) or control group (self-monitoring of blood glucose-SMBG, n = 50). Clinical and laboratory results were assessed at four follow-up visits. The primary outcome was mean fasting and postprandial glycaemia. The secondary outcomes were perinatal outcomes.

RESULTS

There was no significant difference in mean glycaemia between the groups (p = 0.437) Compared to the control group, the study group significantly reduced their fasting (p = 0.027) and postprandial glycaemia (p = 0.034) during the first 4 weeks following GDM diagnosis, with no significant difference in progression to insulin therapy (OR 1.09, 95% CI 0.47-2.57). Incidence of fetal macrosomia was significantly higher in SMBG as compared to FGM group (OR 5.63, 95% CI 1.16-27.22).

CONCLUSIONS

Study results indicate that FGM has an impact on glycaemic control, dietary habits and incidence of fetal macrosomia in patients with GDM. Trial registration clinicaltrials.gov ID: NCT04422821.