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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Change in handgrip strength [Срок оценки: Baseline and 12 weeks]

Вторичные конечные точки (12)

• Change in daily insulin dose requirement [Срок оценки: Baseline and 12 weeks]
• Change in glycated hemoglobin [Срок оценки: Baseline and 12 weeks]
• Number of participants with good glycemic control [Срок оценки: Baseline and 12 weeks]
• Change in time in range [Срок оценки: Baseline and 12 weeks]
• Change in time below range [Срок оценки: Baseline and 12 weeks]
• Change in time above range [Срок оценки: Baseline and 12 weeks]
• Change in glycemic variability [Срок оценки: Baseline and 12 weeks]
• Change in compliance with 24-hour movement behaviors [Срок оценки: Baseline and 12 weeks]
• Change in self-reported physical activity [Срок оценки: Baseline and 12 weeks]
• Change in self-reported physical fitness [Срок оценки: Baseline and 12 weeks]
• Change in sleep duration [Срок оценки: Baseline and 12 weeks]
• Change in physical literacy [Срок оценки: Baseline and 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Fundación Miguel Servet/ Navarrabiomed — Pamplona

Идентификаторы

NCT: NCT07290868 · AGH_Diactive1_2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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