Comprehensive self-tracking of blood glucose and lifestyle with a mobile application in the management of gestational diabetes: a study protocol for a randomised controlled trial (eMOM GDM study)

Mikko Kytö, Lisa Torsdatter Markussen, Pekka Marttinen, Giulio Jacucci, Sari Niinistö, Suvi M Virtanen, Tuuli E Korhonen, Harri Sievänen, Henri Vähä-Ypyä, Ilkka Korhonen, Seppo Heinonen, Saila B Koivusalo, Mikko Kytö, Lisa Torsdatter Markussen, Pekka Marttinen, Giulio Jacucci, Sari Niinistö, Suvi M Virtanen, Tuuli E Korhonen, Harri Sievänen, Henri Vähä-Ypyä, Ilkka Korhonen, Seppo Heinonen, Saila B Koivusalo

Abstract

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.

Keywords: Diabetes in pregnancy; OBSTETRICS; PERINATOLOGY.

Conflict of interest statement

Competing interests: IK is a shareholder of Firstbeat Technologies and products of Firstbeat Technologies are used in the present study. These are sold on commercial basis to researchers. Firstbeat does not fund or supervise the study as an organization.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Design of the randomised controlled trial.
Figure 2
Figure 2
Screenshots of main views in the eMOM GDM APP. (A) A week view for self-tracking data (Copyright: Fujitsu Finland), (B) a day view for self-tracking data (Copyright: Fujitsu Finland), (C) pregnancy and GDM related information (Copyright: Helsinki university hospital), (D) detailed glucose view (Copyright: Fujitsu Finland) and (E) detailed nutrition view (Copyright: Fujitsu Finland). GDM, gestational diabetes.
Figure 3
Figure 3
The sensors used in the study. The sensors on the left (1. HRV sensor and 4. movement sensor) are worn by both control and intervention group. The movement sensor is a small box, which is attached either to a belt or to a bracelet. sensors on the right (2. CGM and 3. activity bracelet) are part of the intervention.

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