NCT06048757Completed
Mobile Application-delivered Resistance Program for Children and Adolescents With Type 1 Diabetes (Diactive-1)
Effectiveness of the Mobile Application-delivered Resistance Program for Children and Adolescents With Type 1 Diabetes (Diactive-1) on Insulin Requirements: Protocol for a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
This project involves a two-arm randomized controlled trial (RCT) designed to assess the feasibility, acceptability, and preliminary efficacy of a mobile application aimed at prescribing resistance training for children and adolescents with type 1 diabetes (Diactive-1). The program will span 24 weeks, with a minimum weekly frequency of 3 sessions. The researchers aim to recruit 52 participants but will enroll additional participants to account for potential withdrawals and ensure compliance with the desired sample size. The primary objective of the study is to evaluate the impact of the Diactive-1 mobile application on insulin requirements in children and adolescents with Type 1 Diabetes. Additionally, the researchers will investigate the effects of the Diactive-1 program on secondary parameters such as glycemic control, cardiometabolic indicators, physical fitness, and daily physical activity, among others. The hypothesis posits that personalized training through a mobile application, primarily focusing on muscular strength, will effectively reduce the daily insulin dosage in children and adolescents with type 1 diabetes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 28 Aug 2023
- Start date
- 20 Aug 2023
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Fundacion Miguel Servet
- Diseases
- Type 1 diabetes
- NCT number
- NCT06048757
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 20 Aug 2023 to the primary completion date, 1 Mar 2024
- 2 sites 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
- Any comorbidity limiting the capacity to participate in physical activity or inadequate understanding of the Spanish language.
- Participants will be excluded if they don't have access to the internet, lack a smartphone or tablet, or are unable to use the application.
Who the study is looking for
- Aged 8-18 years old
- At least 6 months post-diagnosis for type 1 diabetes
- Ability to complete measures and intervention program in Spanish
- Access to broadband or cellular internet
- Patients who signed the informed consent form prior to participation; for minors, a legal representative must provide consent and sign the informed consent form.
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (2)
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 |
| Paediatric Endocrinology Unit at Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
Related publications
- Effects of Diactive-1-Supported Progressive Resistance Training on Body Composition in Youth With Type 1 Diabetes.J Cachexia Sarcopenia Muscle · 2026 · PMID 41854192
This page is information, not medical advice. Discuss any trial with your doctor.