Objective

The aim of the TELESUR-GDM study was to demonstrate the non-inferiority of the onset of maternal, fœtal, and neonatal complications for patients with gestational diabetes mellitus (GDM) monitored by myDiabby HealthcareⓇ (app group) compared to patients with a classical glycaemic blood monitoring by diary (control group).

Materials and methods

TELESUR-GDM was a retrospective, monocentric, and non-inferiority study including 349 patients in the app group and 295 patients in the control group. The primary outcome was a composite score based on maternal, foetal, and neonatal complications. The statistical analysis used chi square or Student t tests for categorical or continuous variables, and Dunnett–Gent test for non-inferiority.

Results

In the app and control groups, 46.3 % and 53.7 % of the patients respectively, observed complications. Non-inferiority of telemonitoring by application vs diary was confirmed (odds ratio=0.79 [95 % CI 0.58;1.07], P < 0.001). Caesarean section, labour induction, and insulin treatment rates were: 20 vs 23 % (P = 0.4), 36 vs 28 % (P = 0.047), and 22 vs 23 % (P = 0.8) in the app vs control group, respectively. Macrosomia, intrauterine growth restriction, neonatal hypoglycaemia, and neonatal jaundice rates were: 4.3 vs 6.1 % (P = 0.4), 6.9 vs 3.1 % (P = 0.04), 1.7 vs 14 % (P < 0.001), and 8.6 vs 1.0 % (P < 0.001), in the app versus control group, respectively.

Conclusion

GDM glycaemic telemonitoring compared to patients with classic glycaemic monitoring by diary was not inferior in terms of maternal, fœtal, and neonatal complications. Neonatal hypoglycaemia, a life-threatening event, was significantly reduced despite the observation of more neonatal jaundice cases.

中文翻译：

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使用 myDiabby Healthcare® 智能手机应用程序与传统日记监测妊娠糖尿病患者。非劣效性 TELESUR-GDM 研究的结果

客观的

TELESUR-GDM 研究的目的是证明 myDiabby HealthcareⓇ（应用程序组）监测的妊娠期糖尿病 (GDM) 患者与传统糖尿病患者相比，其孕产妇、胎儿和新生儿并发症的发生率具有非劣效性。通过日记监测血糖血液（对照组）。

材料和方法

TELESUR-GDM 是一项回顾性、单中心、非劣效性研究，包括应用组 349 名患者和对照组 295 名患者。主要结局是基于孕产妇、胎儿和新生儿并发症的综合评分。统计分析使用卡方或学生t检验来分析分类变量或连续变量，并使用 Dunnett-Gent 检验来分析非劣效性。

结果

在应用程序组和对照组中，分别有 46.3% 和 53.7% 的患者出现并发症。证实了应用远程监控与日记相比的非劣效性（比值比=0.79 [95% CI 0.58;1.07]，P  < 0.001）。 应用组与对照组的剖腹产率、引产率和胰岛素治疗率分别为：20% vs 23% ( P  = 0.4)、36% vs 28% ( P  = 0.047) 和 22% vs 23% ( P = 0.8) 。巨大儿、宫内生长受限、新生儿低血糖和新生儿黄疸发生率分别为：4.3 vs 6.1% ( P =  0.4)、6.9 vs 3.1% ( P =  0.04)、1.7 vs 14% ( P  < 0.001) 和 8.6 vs 1.0% ( P  < 0.001)，分别在应用程序组与对照组中。

结论

与传统的日记血糖监测患者相比，GDM 血糖远程监测在孕产妇、胎儿和新生儿并发症方面并不逊色。尽管观察到更多的新生儿黄疸病例，但危及生命的新生儿低血糖事件却显着减少。