NCT07290868Active, not recruiting
Diactive-1: Scaled-up Personalized mHealth Program for Youth With Type 1 Diabetes
Scaling up Personalized mHealth-supported Resistance Training and Education for Children and Adolescents With Type 1 Diabetes: The Diactive-1 v2.0 Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 28 Jan 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Fundacion Miguel Servet
- Diseases
- Type 1 diabetes
- NCT number
- NCT07290868
What you commit to
- Study type: Interventional
- Planned participants: 158
- From 28 Jan 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Comorbidities that limit the ability to engage in physical activity.
- Lack of internet access when using the application, whether due to Wi-Fi, mobile data, or international roaming issues.
- Absence of a mobile phone or tablet with an Android or iOS (Apple) operating system, or no family member willing to lend a device for each session using the application for study-related purposes.
Who the study is looking for
- Diagnosed with Type 1 Diabetes Mellitus (T1DM) for 6 months or longer (requiring \>0.5 U/kg/day of insulin and having HbA1c \>6%, i.e., not in the "honeymoon phase").
- Receiving multiple daily injection (MDI) therapy or insulin pump therapy (CSII).
- Signed informed consent authorizing legal participation in the research project (child/adolescent and parent(s)/legal guardian).
- Availability to participate in the study using an m-Health application (Diactive-1) designed for the programming of muscle-bone strengthening physical exercise.
- Understanding of Spanish.
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación Miguel Servet/ Navarrabiomed Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.