eHealth in Treatment of Gestational Diabetes (eMOMGDM)
NCT04714762 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-12-12
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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