Diactive-1: Scaled-up Personalized mHealth Program for Youth With Type 1 Diabetes (Diactive-1v2)

Fundacion Miguel Servet

Status: Not yet enrolling

Conditions: Type 1 Diabetes (T1D)

Treatments: Device: Diactive-1

Study type: Interventional

Funder types: Other

Identifiers

NCT07290868

AGH_Diactive1_2025

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

Diactive-1

Experimental group

Description:

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

Treatment:

Device: Diactive-1

Waiting-list control group

No Intervention group

Description:

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.