Diactive-1: Scaled-up Personalized mHealth Program for Youth With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diactive-1.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D). Basic parameters: 10 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device Diactive-1
Participants will engage in a 12-week resistance exercise program with the goal of maintaining at least 3 sessions per week, with 3-6 exercises per session (≈13-33 minutes). Participants will be able to choose among three training formats, traditional resistance training, Tabata/high-intensity intervals, or circuit training, and may perform the sessions individually or in pairs, depending on preference and feasibility at the center. The training intervention will comprise 3-4 sets of 6-12 repeti
Primary outcome measures
- Change in handgrip strength [Time frame: Baseline and 12 weeks]
Secondary outcome measures (12)
- Change in daily insulin dose requirement [Time frame: Baseline and 12 weeks]
- Change in glycated hemoglobin [Time frame: Baseline and 12 weeks]
- Number of participants with good glycemic control [Time frame: Baseline and 12 weeks]
- Change in time in range [Time frame: Baseline and 12 weeks]
- Change in time below range [Time frame: Baseline and 12 weeks]
- Change in time above range [Time frame: Baseline and 12 weeks]
- Change in glycemic variability [Time frame: Baseline and 12 weeks]
- Change in compliance with 24-hour movement behaviors [Time frame: Baseline and 12 weeks]
- Change in self-reported physical activity [Time frame: Baseline and 12 weeks]
- Change in self-reported physical fitness [Time frame: Baseline and 12 weeks]
- Change in sleep duration [Time frame: Baseline and 12 weeks]
- Change in physical literacy [Time frame: Baseline and 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Fundación Miguel Servet/ Navarrabiomed — Pamplona
Identifiers
NCT: NCT07290868 · AGH_Diactive1_2025