NCT06048757

Mobile Application-delivered Resistance Program for Children and Adolescents With Type 1 Diabetes (Diactive-1)

Effectiveness of the Mobile Application-delivered Resistance Program for Children and Adolescents With Type 1 Diabetes (Diactive-1) on Insulin Requirements: Protocol for a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Fundacion Miguel Servet · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to evaluate the effectiveness of the Diactive-1 mobile application, which offers personalized resistance training, in reducing daily insulin requirements among children and adolescents with type 1 diabetes. To achieve this objective, researchers will conduct a 24 weeks randomized controlled trial involving at least 52 participants diagnosed with type 1 diabetes. The study will consist of two groups: an experimental group utilizing the Diactive-1 application and a control group receiving standard treatment. Participant allocation to either group will be determined through central randomization. The Diactive-1 intervention encompasses several key features, including: (i) tailoring exercises based on initial physical fitness levels; (ii) adjusting the previous exercise to the glucose level measured through an interstitial glucose monitor or entered manually before the training session; (iii) monitoring heart rate during exercise; (iv) providing the flexibility to train with or without equipment, individually or with a partner; (v) dispensing diabetes management advice before and after each training session; and (vi) adapting training progressions based on session adherence. A face-to-face session will be conducted before commencing the intervention to ensure that participants are familiar with the fundamental movements, thus reducing the risk of potential muscle injuries.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Diactive-1 application	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.

Timeline

• Start date: 2023-08-20
• Primary completion: 2024-03-01
• Completion: 2024-10-01
• First posted: 2023-09-21
• Last updated: 2025-12-17

Locations

2 sites across 1 country: Spain