eHealth in Treatment of Gestational Diabetes (eMOMGDM)

NCT04714762 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-12-12

No results posted yet for this study

Summary

The overall aim of the eMOM GDM-project is to develop and evaluate a novel system to clinical decision making and patient behavior change in treatment of GDM, combining diet, physical activity, sleep, heart rate (e.g. stress), and glucose monitoring within a single system (the eMOM GDM application), and linking the developed application tool for the normal health care system in a new way.

In this second phase of the project, the effect of eMOM GDM application on maternal and neonatal outcomes will be evaluated in a randomized controlled study design. The follow-up study continues until 3 months postpartum.

Conditions

  • Gestational Diabetes
  • Mobile Application

Interventions

DEVICE

eMOM GDM application

Participants in the intervention group will use the eMOM GDM -application one week/month. eMOM GDM application includes: * continuous glucose monitor (CGM, Medtronic) * diet (digital food tracker) (min 3 days during one application week) * heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3) * weight measured once a week The sensors can be worn and the application used during the whole pregnancy (if a mother is interested in)

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER
  • Aalto University

    collaborator OTHER
  • UKK Institute

    collaborator OTHER
  • Tampere University

    collaborator OTHER
  • Finnish Institute for Health and Welfare

    collaborator OTHER_GOV
  • Fujitsu

    collaborator UNKNOWN
  • Elisa Oyj

    collaborator UNKNOWN
  • Business Finland

    collaborator OTHER
  • Helsinki University Central Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2022-12-12
Completion
2026-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714762 on ClinicalTrials.gov