Department of IT Management, Helsinki University Hospital, Helsinki, Finland
Department of Computer Science, University of Helsinki, Helsinki, Finland.
BMJ Open. 2022 Nov 7;12(11):e066292. doi: 10.1136/bmjopen-2022-066292.
INTRODUCTION: Gestational diabetes (GDM) causes various adverse short-term and long-term consequences for the mother and child, and its incidence is increasing globally. So far, the most promising digital health interventions for GDM management have involved healthcare professionals to provide guidance and feedback. The principal aim of this study is to evaluate the effects of comprehensive and real-time self-tracking with eMOM GDM mobile application (app) on glucose levels in women with GDM, and more broadly, on different other maternal and neonatal outcomes. METHODS AND ANALYSIS: This randomised controlled trial is carried out in Helsinki metropolitan area. We randomise 200 pregnant women with GDM into the intervention and the control group at gestational week (GW) 24-28 (baseline, BL). The intervention group receives standard antenatal care and the eMOM GDM app, while the control group will receive only standard care. Participants in the intervention group use the eMOM GDM app with continuous glucose metre (CGM) and activity bracelet for 1 week every month until delivery and an electronic 3-day food record every month until delivery. The follow-up visit after intervention takes place 3 months post partum for both groups. Data are collected by laboratory blood tests, clinical measurements, capillary glucose measures, wearable sensors, air displacement plethysmography and digital questionnaires. The primary outcome is fasting plasma glucose change from BL to GW 35-37. Secondary outcomes include, for example, self-tracked capillary fasting and postprandial glucose measures, change in gestational weight gain, change in nutrition quality, change in physical activity, medication use due to GDM, birth weight and fat percentage of the child. ETHICS AND DISSEMINATION: The study has been approved by Ethics Committee of the Helsinki and Uusimaa Hospital District. The results will be presented in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: NCT04714762.
简介:妊娠糖尿病(GDM)会给母婴带来各种短期和长期的不良后果,其全球发病率正在上升。到目前为止,最有前途的 GDM 管理数字健康干预措施涉及医疗保健专业人员提供指导和反馈。本研究的主要目的是评估 eMOM GDM 移动应用程序(app)全面实时自我跟踪对 GDM 女性血糖水平的影响,更广泛地说,对不同的母婴和新生儿结局的影响。
方法和分析:本随机对照试验在赫尔辛基大都市区进行。我们在妊娠 24-28 周(基线,BL)时将 200 名 GDM 孕妇随机分为干预组和对照组。干预组接受标准产前护理和 eMOM GDM 应用程序,而对照组仅接受标准护理。干预组的参与者使用 eMOM GDM 应用程序和连续血糖计(CGM)以及活动手环,每月 1 周,直到分娩,并每月 1 次电子 3 天食物记录,直到分娩。两组在干预后 3 个月进行随访。数据通过实验室血液检查、临床测量、毛细血管血糖测量、可穿戴传感器、空气置换体积描记法和数字问卷收集。主要结局是从 BL 到 GW 35-37 的空腹血浆葡萄糖变化。次要结局包括自我跟踪毛细血管空腹和餐后血糖测量、妊娠体重增加、营养质量变化、身体活动变化、因 GDM 而使用药物、出生体重和儿童体脂百分比等。
伦理和传播:该研究已获得赫尔辛基和乌西玛地区医院伦理委员会的批准。研究结果将在同行评议期刊和会议上发表。
试验注册号:NCT04714762。
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