Effect of Diactive-1 mHealth-supported progressive resistance training on insulin requirements, glycaemic stability, and muscular strength in children and adolescents with type 1 diabetes mellitus: a parallel-group randomised controlled trial

Objective: To evaluate the effects of resistance training supported by the mHealth-application Diactive-1 on the daily insulin dose and glycaemic parameters in children and adolescents with type 1 diabetes. Research Design and Methods: In this 24-week randomised clinical trial, Diactive-1 generated progressive overload resistance training sessions tailored to real-time glycaemia and provided educational support. Insulin and glycaemic parameters were collected from LibreView or CareLink, whereas glycosylated haemoglobin was extracted from medical records. Muscle strength was assessed using a handgrip dynamometer and e-GYM machines, targeting pushing, pulling, and lower-limb movements. The effect was analysed using linear mixed models. Results. Sixty-two participants (age: 8–18 years, girls: 48%) with type 1 diabetes (HbA1c: 7.6 [60.4 mmol/mol]) were allocated to either the usual-care (n=32) or the Diactive-1 group (n=30). Daily insulin dose reductions were observed within Diactive-1 group (mean difference [MD]=-0.10 U/kg, 95% confidence interval [CI] -0.18 to -0.01), and when was compared to usual-care (MD=-0.17 U/kg, 95%CI -0.26 to -0.07). No adverse effects were observed on either the glycaemic-risk index or the incidence of hypoglycaemic events. Finally, handgrip strength (MD=2.90, 95%CI: 1.57 to 4.22), one-repetition maximum strength (MD=1.34, 95%CI: 0.21 to 2.46), and muscle power (MD=0.97, 95%CI: 0.01 to 1.93) increased. Four participants (6.5%) withdrew from the study Conclusions: 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 muscle strength, without increasing the risk of adverse glycaemic events.