1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Warsaw, Poland.
1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Warsaw, Poland
BMJ Open. 2021 Mar 2;11(3):e041486. doi: 10.1136/bmjopen-2020-041486.
Gestational diabetes mellitus (GDM) is a glucose intolerance occurring in 3%-10% of pregnant women and being a risk factor for multiple maternal and fetal complications. The risk of perinatal complications is proportional to the level of maternal hyperglycaemia. Proper glycaemic control is therefore one of the key elements of GDM therapy. Until recently, determination of blood glucose concentration was performed using glucose meters, which involved multiple fingerpricks. Nowadays, due to the flash glucose monitoring (FGM) availability, it is possible to collect measurements at any time without routine puncturing. The aim of the presented study is to assess the impact of FGM on the efficacy of treatment in population of patients diagnosed with GDM.
This is a prospective, randomised study, that will recruit 100 women at 24-28 weeks of gestation at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland. Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomised to the FGM or self-monitoring of blood glucose groups. Further on, clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy. Primary outcome is mean glycaemia result in each group after 1 month analysis and percentage of results in the target glycaemic range. The secondary objectives will be to compare the two groups for maternal and neonatal outcomes in conjunction with long-term glycaemic control using blood glycated haemoglobin and fructosamine serum concentrations.
The study is exempt from regional ethics review due to its nature of quality improvement in patient care. The study has been approved by the Bioethics Committee at the Medical University of Warsaw and the patient privacy protection boards governing over the recruitment sites. Results of the study will be presented in peer-reviewed journals and at conferences.
NCT04422821.
妊娠糖尿病（GDM）是一种在 3%-10%的孕妇中发生的葡萄糖不耐受，是多种母婴并发症的危险因素。围产期并发症的风险与母体高血糖水平成正比。因此，适当的血糖控制是 GDM 治疗的关键要素之一。直到最近，血糖浓度的测定都是使用血糖仪进行的，这需要多次刺破手指。如今，由于闪光血糖监测（FGM）的可用性，我们可以在任何时间进行测量，而无需常规穿刺。本研究旨在评估 FGM 对 GDM 患者治疗效果的影响。
这是一项前瞻性、随机研究，将在波兰华沙医科大学第一妇产科招募 100 名 24-28 周妊娠的妇女。诊断为 GDM 且符合纳入标准的妇女将被单独随机分为 FGM 组或自我监测血糖组。进一步收集母亲及其新生儿的临床和实验室结果，以便在妊娠期间进行分析。主要结局是两组在 1 个月分析后平均血糖结果和目标血糖范围内的结果百分比。次要目标是比较两组的母婴结局，并结合使用血液糖化血红蛋白和血清果糖胺来比较长期血糖控制。
由于该研究是改善患者护理质量的性质，因此无需进行区域伦理审查。该研究已获得华沙医科大学生物伦理委员会以及负责招募地点的患者隐私保护委员会的批准。研究结果将在同行评议的期刊和会议上发表。
NCT04422821。
