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Diactive-1: Scaled-up Personalized mHealth Program for Youth With Type 1 Diabetes

Study acronym: Diactive-1v2
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Not Yet Recruiting → Active, Not Recruiting Start date changed from estimate of Jan 2026 to Jan 28, 2026 · Eligibility criteria expanded, about 8 words · Secondary endpoints: details revised at 14 of 23 entries · 2 more Show 5 more changesShow less
    • Start date changed from estimate of Jan 2026 to Jan 28, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 14 of 23 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Diactive-1 project aims to establish the Diactive-1 mobile application as a clinical tool for managing type 1 diabetes in children and adolescents in several hospitals from Spain. The successful implementation of the app in new healthcare centers nationwide represents a key step toward the development of a comprehensive and scalable program. This approach seeks not only to optimize current patient care but also to democratize access to an innovative, evidence-based intervention that supports daily diabetes management. In this new phase, the project will integrate the application into routine clinical care for patients with type 1 diabetes through the use of a simple handgrip strength measurement. A dedicated web platform (www.diactive.es) is being developed to allow clinicians to enter basic patient data, including handgrip strength, sex, and email address. Based on this information, the system will automatically generate a personalized download link for the Diactive-1 app, accompanied by tailored guidance and an initial fitness level classification (low, medium, or high) according to European reference values. This process will define each user's baseline fitness level and facilitate the use of Diactive-1 as an integrated and individualized disease management tool. The ultimate goal is to strengthen clinical decision-making, improve patient engagement, and extend the benefits of digital health to a broader pediatric population living with type 1 diabetes.
Trial Details
NCT Number NCT07290868
Lead Sponsor Fundacion Miguel Servet
Collaborators: Universidad Pública de Navarra, University of Valencia, Fundación Instituto de Investigación Sanitaria de Navarra
Conditions Type 1 Diabetes (T1D)
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov