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

NCT07290868 | Not Yet Recruiting

• 1 other identifier: AGH_Diactive1_2025
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes (T1D)

Keywords

mHealth; Resistance training; Education; Handgrip strength

Outcome Measures

Primary Outcomes (1)

• Change in handgrip strength

  Handgrip strength measured in kilograms using the Takei III Smedley Type Digital Dynamometer

  Baseline and 12 weeks

Secondary Outcomes (23)

• Change in daily insulin dose requirement

  Baseline and 12 weeks

• Change in glycated hemoglobin

  Baseline and 12 weeks

• Number of participants with good glycemic control

  Baseline and 12 weeks

• Change in time in range

  Baseline and 12 weeks

• Change in time below range

  Baseline and 12 weeks

Study Arms (2)

Diactive-1

EXPERIMENTAL

The intervention in the experimental group will center around the use of a mobile application (i.e., device), namely the Diactive-1 app.

Device: Diactive-1

Waiting-list control group

NO INTERVENTION

This arm will not complete an intervention. Participants will be instructed to continue to follow their normal daily diabetes care plan (i.e., standard care). This group will be granted access to the app following the intervention.

Interventions

Diactive-1 DEVICE

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 repetitions and will consist of a combination of exercises for the upper body, lower body, and core, using primarily the participants' own body weight. The load and intensity of the exercise will be adjusted according to the number of repetitions and the difficulty/progression of the selected exercises. A mobile application (Diactive-1) will be used to deliver, monitor, and record the sessions.

Diactive-1

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Universidad Pública de Navarra: collaborator
• University of Valencia: collaborator
• Fundación Instituto de Investigación Sanitaria de Navarra: collaborator

Study Sites (1)

Fundación Miguel Servet/ Navarrabiomed

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Antonio García Hermoso, PhD

CONTACT

+34948 166194; antonio.garciah@unavarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)