• The study presented, which has led to the development of the application, was awarded second prize in the Health or Social Care category of the 2024 NAOS Awards.

This morning, the Department of Health, through the Miguel Servet-Navarrabiomed Foundation, presented a study carried out by its Physical Activity for Children and Youth Unit, which has succeeded in reducing the daily dose of insulin with no adverse effects in paediatric patients with type 1 diabetes by means of digital health and gamification techniques. Along with the Regional Minister of Health, Fernando Domínguez, the event was attended by representatives of those participating in the study: the University Hospital of Navarra (HUN)’s Paediatric Endocrinology Unit, Navarrabiomed’s Physical Activity Unit for Children and Young People, and the Navarra Diabetes Association (ANADI).

Minister of Health Domínguez underlined “the importance of collaboration between the biomedical research centre, the HUN healthcare service and the association for the development of this type of innovative initiative in the bio-health field, aimed at improving the quality of life of child and adolescent patients.” He also congratulated the entire team for winning second prize in the Health or Social Care category of the 2024 NAOS Awards organised by the Food Safety and Nutrition Agency, part of the Ministry of Social Rights, Consumer Affairs and the 2030 Agenda. 

The Navarrabiomed team has developed a comprehensive physical exercise programme using digital health techniques via a mobile app for children and young people with type 1 diabetes. The tool integrates physical activity with the monitoring of different health parameters that enable users to better control their glucose levels, improve their physical fitness, and also improves their ability to control the disease in a positive manner in their daily routine, accompanied by an improvement in their mental health. 

Type 1 diabetes is a chronic disease that often manifests itself at an early age—in Navarra, the average age of diagnosis is 7 years old—and is characterised by the attacking and destruction of the beta cells in the pancreas by the immune system. This action leads to insufficient insulin production and can trigger a dangerous increase in glucose. Every year, between 1,200 and 1,500 new cases of type 1 diabetes are diagnosed in children under the age of 15 in Spain. There are currently 175 people under the age of 15 in Navarra diagnosed with type 1 diabetes. The World Health Organisation lists Spain as one of the countries with a very high incidence of type 1 diabetes in the paediatric age group. 

The research shows that young people with type 1 diabetes have lower levels of muscle strength and a more sedentary lifestyle due to their condition and their fear of hypoglycaemia. The principal investigator of the Physical Activity in Children and Adolescents Unit and tenured professor at the UPNA, Antonio García-Hermoso, highlights the importance of working with these patients during childhood: “Overcoming this challenge involves tailoring exercise routines to each individual case to improve muscle strength and educate patients about how to manage glucose during physical activity, providing them with comprehensive support and follow-up care.”  
 
Participation of 61 minors with type 1 diabetes

The research was conducted between 2022 and 2024 and was funded by the Carlos III Health Institute, and was managed and coordinated by the Miguel Servet-Navarrabiomed Foundation. In the initial phase, Navarrabiomed conducted an epidemiological surveillance study in children and adolescents with type 1 diabetes, examining various health indicators and healthy habits, including physical activity levels and dietary patterns over a three-year period. 

Every year, patients and their families have received an exhaustive report that includes various parameters evaluated in order to raise their awareness of the need to improve or maintain these parameters. After evaluating 83 young people with type 1 diabetes, it was found that only 18% carried out the recommended three muscle-strengthening sessions per week. 

A total of 61 children with type 1 diabetes participated in the randomised controlled trial. Participants were randomly assigned to one of two groups: one group carried out an individualised strength training programme at least three times a week (following WHO and ADA guidelines) for 24 weeks using the Diactive-1 app, and a control group on a waiting list, which received the necessary materials and the app for use at the end of the trial period. The app has over 350 exercises, all guided by a 3D avatar that gives patients detailed instructions during each exercise, specifying the weights, sets, and reps to do.

The study found a significant reduction of 0.17 U/kg in daily insulin doses and a downward trend in glycated haemoglobin in patients compared to the control group that did not use the app. This improvement in glycemic control helps prevent adverse glucose-related events, such as hypoglycaemia, offering greater stability for patients and a reduction in the medication associated with the disease.

In terms of body composition, significant improvements have been achieved in total lean mass and bone mineral content, indicators directly linked to healthy development in children and adolescents with type 1 diabetes. An improvement in muscle strength and power is observed, evidenced by an increase in handgrip strength and a rise of more than 14 percentiles compared to European references according to age and sex.
It is important to note that several participants in the intervention and control groups continue to use the app today, demonstrating a good adherence to the app among children and adolescents. These results indicate that Diactive-1 not only contributes to improving clinical parameters, but also promotes treatment adherence and motivates the study population, establishing itself as an innovative tool with a positive impact on overall health and quality of life, which promotes the empowerment of these patients. 

The results of the study have been published in the scientific journal Diabetes Care under the title Effect of Diactive-1 mHealth-Supported Progressive Resistance Training on Insulin Requirements, Glycemic Stability, and Muscular Strength in Children and Adolescents With Type 1 Diabetes: A Parallel-Group Randomized Controlled Trial. 

The tool has also enabled a detailed record of more than 2,000 physical exercise sessions to be compiled, including data on pre- and post-exercise blood glucose levels, trends, training times, exercises performed and heart rate during the session. This volume of information, combined with machine learning techniques, will allow interventions to be personalised even further, maximising the app’s impact on health and the management of type 1 diabetes.
 
Continuity and sustainability of the project 

During 2024, the research team once again obtained funding from the Carlos III Health Institute to implement the app developed in 11 hospitals: the University Hospital of Navarra (Pamplona / Iruña), University Hospital of Cruces (Barakaldo), Barbastro Hospital (Huesca), San Jorge General Hospital (Huesca), Araba University Hospital (Vitoria-Gasteiz), Marqués de Valdecilla University Hospital (Santander), Cabueñes University Hospital (Gijón), San Millán-San Pedro Hospital (Logroño), Lozano Blesa University Clinical Hospital (Zaragoza), Central University Hospital of Asturias (Oviedo) and Miguel Servet University Hospital (Zaragoza), all of which are members of the Northern Paediatric Endocrinology Group.
This new project, which will be managed by the Healthcare Research Institute of Navarra (IdiSNA), aims to reach more than 200 patients from different geographical contexts, in order to extrapolate and evaluate the data obtained in Navarra and position the Diactive-1 app as a nationwide clinical benchmark tool for the management of type 1 diabetes in children and adolescents. 
 
18th NAOS Strategy Awards, 2024 edition

This project was recently awarded second prize in the Health or Social Care category of the Awards organised by the Spanish Agency for Food Safety and Nutrition, part of the Ministry of Social Rights, Consumer Affairs and the 2030 Agenda. This acknowledgement highlights digital innovation serving children’s health and supports the work of Navarrabiomed's Physical Activity in Children and Adolescents Unit in improving the non-pharmacological management of type 1 diabetes through personalised technological solutions.