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

Fundacion Miguel Servet

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Diactive-1 application

Study type: Interventional

Funder types: Other

Identifiers

NCT06048757

AGH_Diactive1_2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Experimental app intervention group

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 application

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.