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Obstetrics and gynaecology
Protocol
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)
  1. Mikko Kytö1,2,
  2. Lisa Torsdatter Markussen1,3,
  3. Pekka Marttinen4,
  4. Giulio Jacucci2,
  5. Sari Niinistö5,
  6. Suvi M Virtanen6,7,
  7. Tuuli E Korhonen5,
  8. Harri Sievänen8,
  9. Henri Vähä-Ypyä8,
  10. Ilkka Korhonen9,
  11. Seppo Heinonen10,
  12. Saila B Koivusalo10,11
  1. 1Department of IT Management, Helsinki University Hospital, Helsinki, Finland
  2. 2Department of Computer Science, University of Helsinki, Helsinki, Finland
  3. 3Department of Food and Nutrition, University of Helsinki, Helsinki, Finland
  4. 4Department of Computer Science, Aalto University, Aalto, Finland
  5. 5Department of Public Health, Welfare Finnish Institute for Health and Welfare, Helsinki, Finland
  6. 6Department of Public Health and Welfare, The National Institute for Health and Welfare, Helsinki, Finland
  7. 7Faculty of Social Sciences, Unit of Health Sciences, University of Tampere, Tampere, Finland
  8. 8UKK Institute for Health Promotion Research, Tampere, Finland
  9. 9Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland
  10. 10Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, Helsinki, Finland
  11. 11Department of Obstetrics and Gynecology, Turku University Hospital, Turku, Finland
  1. Correspondence to Dr Mikko Kytö; mikko.kyto{at}hus.fi

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.

  • OBSTETRICS
  • Diabetes in pregnancy
  • PERINATOLOGY
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2022-066292

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    Footnotes

    • Contributors SBK, SH, MK, PM and GJ planned the design of the study. MK, LTM, PM and SBK planned the analysis of the data and performed the power calculation. SN, SMV and TEK were responsible of methods of dietary data collection and calculations. HS, HV-Y and IK designed the collection of physical activity data. MK and SBK wrote the draft and all authors MK, SBK, LTM, PM, GJ, SN, SMV, HS, HV-Y, IK, TEK and SH have reviewed and approved the final manuscript.

    • Funding This work was supported by Business Finland grant number 860/31/2018 (eMOM GDM).

    • 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.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.