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Randomized Controlled Trial
. 2023 Sep;60(9):1171-1177.
doi: 10.1007/s00592-023-02091-2. Epub 2023 May 10.

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

Agata Majewska  1   2 , Paweł Jan Stanirowski  3   4 , Jacek Tatur  3 , Barbara Wojda  5 , Iwona Radosz  3 , Mirosław Wielgos  6 , Dorota Agata Bomba-Opon  7
Affiliations
Randomized Controlled Trial

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

Agata Majewska et al. Acta Diabetol. 2023 Sep.

Erratum in

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.

Keywords: Dysglycaemia; Flash glucose monitoring; Gestational diabetes mellitus; Macrosomia.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Mean difference in glycaemia between 14–28 and 1–13 days following GDM diagnosis On the left: Mean difference in fasting glycaemia between 14–28 and 1–13 days following GDM diagnosis. On the right: Mean difference in postprandial glycaemia between 14–28 and 1–13 days following GDM diagnosis. Abbreviations: GDM: gestational diabetes mellitus. SMBG: self-monitoring of blood glucose. FGM: flash glucose monitoring
Fig. 2
Fig. 2
Relationship between glycaemia during the first month of the study and birthweight A ROC curve for association between postprandial glucose concentration and fetal macrosomia. B Linear regression for relationship between: fasting glycaemia during the first month of the study and birthweight (on the left), and postprandial glycaemia during the first month of the study and birthweight (on the right). Abbreviations: ROC: receiver operating characteristic curve
See this image and copyright information in PMC

References

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