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eHealth in Treatment of Gestational Diabetes (eMOMGDM)

Study acronym: eMOMGDM
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study completion pushed from Dec 31, 2026 to Dec 31, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 7 of 18 entries
    • Study description expanded, about 27 words
    • Publications: details revised at 2 of 2 entries
  2. Minor Study completion date: Dec 2024 to Dec 31, 2026v10
  3. Minor Secondary endpoints: 17 to 18v9
  4. Minor Primary completion date: Dec 13, 2022 to Dec 12, 2022v8
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 31, 2022 to Dec 13, 2022
    • Study completion date: Dec 2023 to Dec 2024
    • Site details revised
    v7
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  1. Minor Secondary endpoints: 16 to 17
    • Eligibility criteria expanded, about 2 words
    v6
  2. Minor Study description shortened, about 62 wordsv5
  3. Minor Primary completion date: Jul 2022 to Dec 31, 2022
    • Secondary endpoints: 13 to 16
    v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2021 to Mar 10, 2021
    v3
  5. Minor Start date: Feb 2021 to Mar 2021v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04714762
Lead Sponsor Helsinki University Central Hospital
Collaborators: University of Helsinki, Aalto University, UKK Institute, Tampere University, Finnish Institute for Health and Welfare, Fujitsu, Elisa Oyj, Business Finland
Conditions
(from sponsor)
Gestational Diabetes, Mobile Application
Related terms Diabetes, Gestational, Motor Activity
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov