Huhn Evelyn Annegret, Linder Tina, Eppel Daniel, Weißhaupt Karen, Klapp Christine, Schellong Karen, Henrich Wolfgang, Yerlikaya-Schatten Gülen, Rosicky Ingo, Husslein Peter, Chalubinski Kinga, Mittlböck Martina, Rust Petra, Hoesli Irene, Winzeler Bettina, Jendle Johan, Fehm T, Icks Andrea, Vomhof Markus, Greiner Gregory Gordon, Szendrödi Julia, Roden Michael, Tura Andrea, Göbl Christian S
Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland.
Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria.
BMJ Open. 2020 Nov 30;10(11):e040498. doi: 10.1136/bmjopen-2020-040498.
Real-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study.
Open-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG). Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6-8 days. The third visit will be scheduled 8-10 days later and then every 2 weeks. At every visit, glucose measurements will be evaluated and all patients will be treated according to the standard care. The control group will receive a blinded CGM for 10 days between the second and third visit and between week 36+0 and 38+6. Cord blood will be sampled immediately after delivery. 48 hours after delivery neonatal biometry and maternal glycosylated haemoglobin A1c (HbA1c) will be assessed, and between weeks 8 and 16 after delivery all patients receive a re-examination of glucose metabolism including blinded CGM for 8-10 days.
This study received ethical approval from the main ethic committee in Vienna. Data will be presented at international conferences and published in peer-reviewed journals.
NCT03981328; Pre-results.
实时连续血糖监测（rt-CGM）可让使用者了解当前的组织间液葡萄糖水平，并能早期发现血糖波动，并通过行为改变或药物干预及时进行调整。目前尚缺乏有足够效力的随机对照研究来评估长期应用rt-CGM系统对降低妊娠期糖尿病（GDM）女性不良产科结局的影响。我们旨在评估使用rt-CGM的女性与自我监测血糖的女性相比，巨大儿比例的差异（主要结局）。新生儿低血糖、剖宫产和肩难产的发生率为次要结局。本研究还将比较妊娠期间及产后的葡萄糖代谢情况和生活质量。
开放标签多中心随机对照试验，分为两个平行组，纳入372例近期诊断为GDM的女性患者（妊娠24+0周至31+6周）：186例使用rt-CGM（德康G6），186例自我监测血糖（SMBG）。患有GDM的女性将在经过6-8天的导入期后连续招募，并随机分为rt-CGM组或对照组（SMBG）。第三次访视安排在8-10天后，之后每2周进行一次。每次访视时，将评估血糖测量值，所有患者将按照标准护理进行治疗。对照组将在第二次和第三次访视之间以及妊娠36+0周至38+6周之间接受10天的盲法CGM。分娩后立即采集脐血。产后48小时评估新生儿生物测量指标和母亲糖化血红蛋白A1c（HbA1c），产后8至16周，所有患者接受葡萄糖代谢复查，包括8-10天的盲法CGM。
本研究获得了维也纳主要伦理委员会的伦理批准。数据将在国际会议上展示，并发表在同行评审期刊上。
NCT03981328；预结果。
