Discussion
pre-gestational diabetes, macrosomia, diabetes, GDM, weight gain, hypoglycaemia
GESTATIONAL DIABETES MELLITUS, RECRUITMENT, GDM, DIABETES, NEONATAL HYPOGLYCAEMIA, EVENTS, HYPOGLYCAEMIA
Our study revealed, that FGM might improve glycaemic control, when compared to SMBG. Although mean glycaemia did not differ significantly between the groups, and when separately analysed, postprandial glycaemia was significantly lower in the control group, glycaemia through the first month of the study improved more significantly in the study group (delta mean glucose concentration showed a pattern of decreasing changes in glycaemia in FGM group). As in previous studies on pre-gestational diabetes population, we found that FGM system led to strict glycaemic control, that consequently decreased mean fasting and postprandial glycaemias at follow up visits.FLAMINGO revealed, that FGM had an impact on decreasing incidence of fetal macrosomia (birthweight > 4000 g) in GDM patients. It is consistent with the randomised controlled trial (RCT) by Murphy et al., evaluating effectiveness of CGM in pregnant women with type 1 and 2 diabetes [The CONCEPTT trial provided evidence that CGM led to clinically significant reduction in neonatal hypoglycaemia and NICU (neonatal intensive care unit) admission incidence [We found higher detection rate of hypoglycaemia in FGM group; however, these hypoglycaemic events were in most cases qualified as mild and none of them were symptomatic. As presented in previous studies continuous glucose monitoring detects masked hypoglycaemic events in pregnancy, that if qualified as mild, are clinically non-significant[Interestingly, we found, that the study group was more prone to modify their diet habits, compared to the control group; however, it had no impact on gestational weight gain and qualification to insulin therapy. Our data differ from the previous studies, in which these outcomes were improved, when CGM systems were used [Our study has several strengths. To our knowledge, this is the first study with such a long assessment of glycaemia with FGM system in gestational diabetes mellitus. The data were derived from a randomised controlled trial, that diminishes the risk of bias that might be the consequence of the recruitment process. Furthermore, the baseline characteristics of the participants did not differ significantly between the groups and therefore adjustments had no significant impact on the analysed outcomes. All the additional results, including diet modifications, physical activity, were assessed using standardised tools. For the control group, we used one type of glucose meters to diminish the influence of different types of devices on primary outcome [We also acknowledge some limitations. In FLAMINGO trial, the analysed time-period of glycaemic control was only 4 weeks, and therefore did not include glycaemic fluctuations occurring after the first month from GDM diagnosis till birth. Additionally, the EAT questionnaire was filled in by the patients and the diet scheme was not unified for all participants, that might produce the risk of bias.