Abstract
Objectives: The Tandem t:slim X2 insulin pump with the Control‐IQ technology (Control‐IQ) is an automated insulin delivery (AID) system for glycemic control but has limited data in Saudi pediatric and young adult populations. We aim to evaluate the efficacy and safety of Control‐IQ therapy in children with insulin‐dependent diabetes and previously treated with multiple daily injections (MDIs). The primary outcome is to assess the change in HbA1c 6 months after initiating Control‐IQ technology. Methods: This prospective observational study evaluated children aged 2–14 years with insulin‐dependent diabetes who transitioned from treatment with MDI to the Control‐IQ technology in the diabetes clinic at the King Faisal Specialist Hospital and Research Centre (KFSHRC) in Saudi Arabia. Results: A total of 100 patients (44 boys and 56 girls; median age was 11 years) were included. Most (82%) had a history of severe hypoglycemia. Following Control‐IQ initiation, median HbA1c significantly decreased from 9.2% to 6.9% at 6 months (−25.0%; p < 0.001), accompanied by a 24.4% reduction in the daily insulin dose. Time in range (TIR) (70–180 mg/dL) improved from 45.6% to 68.8% (+23.2%; p < 0.001), while time in significant hypoglycemia (p < 0.001). At 6 months, 83% achieved ≥60% TIR, and 54% reached ≥70%. Adherence and engagement were high, with no severe hypoglycemia or discontinuations. Only 3% experienced mild/moderate ketoacidosis due to technical issues in the Control‐IQ. Conclusions: The findings demonstrated that Control‐IQ technology is both effective and safe in improving glycemic outcomes in children with insulin‐dependent diabetes in a real‐world clinical setting. However, successful implementation requires comprehensive training and continuous support.

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