NCT06048757

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

August 28, 2023

Last Update Submit

December 15, 2025

Conditions

Type 1 Diabetes

Keywords

mHealthResistance exerciseInsulin sensitivityGlycemic control

Outcome Measures

Primary Outcomes (1)

  • Change in daily insulin dose requirement

    The daily insulin dose requirements will be measured in units per kilogram of body weight. Assessment will rely on participant-reported data from insulin pumps or injection logs, gathered for 9 days prior to the intervention, at 12 weeks, and after the intervention.

    Baseline, 12 and 24 weeks

Secondary Outcomes (42)

  • Change in glycated hemoglobin

    Baseline and 24 weeks

  • Number of participants with good glycemic control

    Baseline and 24 weeks

  • Change in time in range

    Baseline and 24 weeks

  • Change in time below range

    Baseline and 24 weeks

  • Change in time above range

    Baseline and 24 weeks

  • +37 more secondary outcomes

Study Arms (2)

Experimental app intervention group

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 application

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 applicationDEVICE

Participants will engage in 24 weeks resistance exercise program with goal of maintaining at least 3 sessions per week with 4-5 exercises per session (13-33 minutes). The training intervention will comprise 3-4 sets of 6-12 repetitions and will consist of a combination of exercises for the upper and lower body and the core, utilizing the participants' body weight as the primary resistance or auxiliary materials such as elastic bands and a water-fillable kettlebell. The load and intensity of the exercise will be based on the number of repetitions, the resistance of the elastic bands and/or the weight of the aquaball, as well as the difficulty of the exercises. A mobile application known as Diactive-1 will be utilized.

Experimental app intervention group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundación Miguel Servet/ Navarrabiomed

Pamplona, Navarre, 31008, Spain

Location

Paediatric Endocrinology Unit at Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (2)

  • Munoz-Pardeza J, Lopez-Gil JF, Hormazabal-Aguayo I, Izquierdo M, Agostinis-Sobrinho C, Ezzatvar Y, Garcia-Hermoso A. Effects of Diactive-1-Supported Progressive Resistance Training on Body Composition in Youth With Type 1 Diabetes. J Cachexia Sarcopenia Muscle. 2026 Apr;17(2):e70257. doi: 10.1002/jcsm.70257.

    PMID: 41854192DERIVED

  • Hormazabal-Aguayo I, Munoz-Pardeza J, Lopez-Gil JF, Huerta-Uribe N, Chueca-Guindulain MJ, Berrade-Zubiri S, Burillo Sanchez E, Izquierdo M, Ezzatvar Y, Garcia-Hermoso A. Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol. Front Endocrinol (Lausanne). 2024 Feb 6;15:1354734. doi: 10.3389/fendo.2024.1354734. eCollection 2024.

    PMID: 38379866DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Study Officials

  • Antonio García-Hermoso, PhD

    Fundación Miguel Servet - Navarrabiomed

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 21, 2023

Study Start

August 20, 2023

Primary Completion

March 1, 2024

Study Completion

October 1, 2024

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)