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.

Introduction: The use of new technologies presents an opportunity to promote physical activity, especially among young people with type 1 diabetes (T1DM), who tend to be less active compared to their healthy counterparts. The aim of this study is to investigate the impact of a personalized resistance exercise program, facilitated by the Diactive-1 App, on insulin requirements among children and adolescents diagnosed with T1DM. Methods and analysis: A minimum of 52 children and adolescents aged 8-18 years, who were diagnosed with T1DM at least 6 months ago, will be randomly assigned to either a group engaging in an individualized resistance exercise program at least 3 times per week over a 24-week period or a waiting-list control group. The primary outcome will be the daily insulin dose requirement. The secondary outcomes will include glycemic control, cardiometabolic profile, body composition, vascular function, physical fitness, 24-hour movement behaviors, diet, and psychological parameters. The usability of the app will also be assessed. Ethics and dissemination: Ethical approval to conduct this study has been granted by the University Hospital of Navarra Research Board (PI_2020/140). Parents or legal guardians of minors participating in the study will provide written consent, while children and adolescents will sign an assent form to indicate their voluntary agreement. The trial's main findings will be shared through conference presentations, peer-reviewed publications, and communication directly with participating families. This study aims to offer valuable insights into the holistic management of children and adolescents with T1DM by utilizing personalized exercise interventions through an mHealth system. Trial registration: NCT06048757.

Is fear of hypoglycemia a major barrier to an active lifestyle in children and adolescents with type 1 diabetes? The Diactive-1 Study.

Studies on fear of hypoglycemia as a barrier to physical activity among youth with type 1 diabetes (T1D) have been limited and controversial, most of which used self-reported assessment. The aim of the study was to evaluate the relationship between fear of hypoglycemia and physical activity and glycemic metrics in children and adolescents with T1D. Seventy-four participants (6-18 years of age; 44.6% females) with T1D were included in the study. Physical activity was assessed through accelerometry on nine consecutive days, and blood glucose metrics were simultaneously tracked using continuous glucose monitoring (time-in-range and hypoglycemic events). A closed question was used to evaluate the avoidance of physical activity due to fear of hypoglycemia. Fifteen participants (20%) reported avoiding physical activity due to fear of hypoglycemia. The group reporting no fear of hypoglycemia showed lower total physical activity (-35.33 min/day, 95% confidence interval [CI] (-77.57 to -1.47)) and light physical activity (-29.81 min/day, 95% CI -64.01 to -2.75) and higher sedentary time (77.95 min/day, 95% CI 26.46-136.87) per day compared with those with fear of hypoglycemia. No difference was found between those patients with fear of hypoglycemia in terms of meeting the recommendations of glycated hemoglobin, glucose coefficient of variation, and time-in-range when compared to those with no fear of hypoglycemia. In conclusion, children and adolescents with fear of hypoglycemia were more active, less sedentary, and had similar glycemic metrics to those without fear. Our results therefore suggest that fear of hypoglycemia may be less of a barrier to an active lifestyle than previously believed.