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Usability Study of the Sensors and eMOM GDM Application

Study acronym: eMOMGDM
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 4 months later Oct 30, 2022 → Feb 28, 2026
See other at-risk trials from Helsinki University Central Hospital

Record History

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  1. Primary completion pushed from Oct 30, 2022 to Feb 28, 2026 Show 5 more changesShow less
    • Study completion pushed from Dec 30, 2026 to Dec 30, 2027
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Site details revised
    • Publications: details revised at 2 of 2 entries
  2. Enrollment target: 49 to 54
    • Study completion date: Dec 30, 2024 to Dec 30, 2026
    • Secondary endpoints: 8 to 7
    • Study description shortened, about 36 words
    v9
  3. Study completion date: Dec 30, 2023 to Dec 30, 2024v8
  4. Re-verified, no change to tracked fieldsv7
  5. Primary completion date: Oct 30, 2020 to Oct 30, 2022v6 Show 6 more changesShow less
    • Enrollment target: 34 to 49
    • Study completion date: Dec 30, 2022 to Dec 30, 2023
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 6 to 8
    • Study description expanded, about 116 words
    • Study arms: 3 to 4
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Enrollment target: estimated 50 to confirmed 34
    • Primary completion date changed from estimate of Jun 30, 2020 to Oct 30, 2020
    • Study completion date: Jun 30, 2020 to Dec 30, 2022
    • Site details revised
  2. Primary and study completion dates: Sep 30, 2019 to Jun 30, 2020v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 17, 2019 to May 27, 2019
    v3
  4. Primary endpoints: 2 to 1
    • Start date: May 1, 2019 to May 17, 2019
    • Secondary endpoints revised (6)
    • Study title shortened, about 2 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 principal aim of the eMOM GDM-project is to evaluate the effect of the eMOM GDM -application and the integrated service concept model on maternal and neonatal outcomes. In the first phase of the project the investigators evaluate the usability, functionality and acceptability of developed eMOM GDM application and used sensors (continuous glucose meter, accelerometer, speech-enabled food record, optical pulse, beat-to-beat heart rate). Two different user interfaces (one for the women with GDM and one for the health care professionals) of the eMOM GDM application will we be developed and evaluated.
Trial Details
NCT Number NCT03941652
Lead Sponsor Helsinki University Central Hospital
Collaborators: Business Finland, Aalto University, University of Helsinki, Fujitsu Finland Oy, Elisa Oyj, CleverHealth Network
Conditions
(from sponsor)		 Gestational Diabetes
Related terms Diabetes, Gestational, Motor Activity
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov