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

Abstract

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.

The Benefits Of Continuous Glucose Monitoring In Pregnancy

“…Recently, one study showed a benefit of is-CGM for perinatal complications in GDM [ 17 ]. That study found that the SMBG group had a 5.63 times higher risk of fetal macrosomia than the is-CGM group, who used it intermittently in the first 4 weeks after a GDM diagnosis [ 17 ].…”

“…Recently, one study showed a benefit of is-CGM for perinatal complications in GDM [ 17 ]. That study found that the SMBG group had a 5.63 times higher risk of fetal macrosomia than the is-CGM group, who used it intermittently in the first 4 weeks after a GDM diagnosis [ 17 ]. These results indicate that GDM patients not taking insulin might benefit by using is-CGM to provide valuable feedback and reinforce optimal self-management of diet and physical activity.…”

“…Even intermittent use of CGM can be beneficial. The flash glucose monitoring in gestational diabetes mellitus (FLAMINGO) study compared fasting glucose and 1-hour postprandial glucose between an is-CGM group (FreeStyle Libre 1) and an SMBG group for the first 4 weeks after a GDM diagnosis [ 17 ]. The risk of fetal macrosomia was 5.63-fold higher in the SMBG group than the CGM group (20% vs. 4.1%) due to the difference in postprandial glucose, even though the mean glucose did not differ between the groups.…”

“…Continuous glucose monitoring (CGM) has emerged as a promising technology that can diagnose the full range of glycemic status by measuring glucose levels accurately every 1 to 5 minutes replacing frequent fingerstick monitoring. Numerous studies have shed new light on its benefits for glycemic outcomes [ 10 - 14 ], including evidence that CGM could be useful in pregnancy, improving maternal glycemia and neonatal outcomes [ 8 , 15 - 17 ]. CGM also can detect hidden hypoglycemia and hyperglycemia, which fingerstick monitoring cannot find.…”

It’s high time to change our management of gestational diabetes

“…A meta-analysis of the conducted research showed that the use of continuous monitoring systems promotes adherence to dietary recommendations and lower weight gain during pregnancy [9]. In the recently published randomized study FLAMIGO, in which the study group used only flash glucose monitoring (FGM) for the first month of GDM therapy, a significantly lower rate of neonatal macrosomia was observed compared to the SMBG control group (4% vs 20%) [10]. Women with gestational diabetes using FGM also achieved lower fasting and postprandial glucose levels after two weeks of therapy.…”