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.

To evaluate the effects of resistance training supported by the mobile health application Diactive-1 on the daily insulin dose and glycemic parameters in children and adolescents with type 1 diabetes. In this 24-week randomized clinical trial, Diactive-1 generated progressive overload resistance training sessions tailored to real-time glycemia and provided educational support. Insulin and glycemic parameters were collected from LibreView or CareLink, whereas glycosylated hemoglobin (HbA1c) was extracted from medical records. Muscular strength was assessed using a handgrip dynamometer and e-GYM machines, targeting pushing, pulling, and lower-limb movements. The effect was analyzed using linear mixed models. Sixty-two participants (age: 8-18 years, girls: 48%) with type 1 diabetes (HbA1c: 7.6% [60.4 mmol/mol]) were allocated to the usual care (n = 32) or the Diactive-1 group (n = 30). Daily insulin dose reductions were observed within the Diactive-1 group (mean difference [MD] -0.10 units/kg, 95% CI -0.18 to -0.01) and when compared with usual care (MD -0.17 units/kg, 95% CI -0.26 to -0.07). No adverse effects were observed on the glycemic risk index or the incidence of hypoglycemic events. Finally, handgrip strength (MD 2.90 kg, 95% CI 1.57-4.22), one-repetition maximum strength (MD 1.34, 95% CI 0.21-2.46), and muscular power (MD 0.97, 95% CI 0.01-1.93) increased. Four participants (6.5%) withdrew from the study. Diactive-1 appears to be a safe and feasible adjunct to standard care in children and adolescents with type 1 diabetes. Its resistance training component effectively reduced insulin requirements and improved muscular strength, without increasing the risk of adverse glycemic events.