Efficacy and Safety of Ultra-long-acting Insulin Degludec in the Achievement of Good Disease Control in Children with Type 1 Diabetes Mellitus

Study Objective: To evaluate the efficacy and safety of the long-acting insulin degludec in children with type 1 diabetes mellitus with the use of continuous daily glucose monitoring.

Study Design: Single-center, interventional, dynamic, prospective, single-sample, uncontrolled study.

Material and methods. A total of 20 children aged 5 to 15 years who were treated by intensive insulin therapy with the use of basal insulin analogs glargin 100 and detemir, who were admitted to the pediatric endocrinology department with non-adequate control of type 1 diabetes mellitus without ketosis, were examined. HbA1c determination and continuous glucose monitoring (CGM) were performed before and 3 months after switching patients to insulin degludec. CGM was performed in both cases for five days. During its implementation, the number of episodes of hypoglycemia, distributed by se-verity and time of day, was assessed.

Study Results. During degludec therapy, the mean HbA1c level has significantly decreased from 10.83 ± 1.34% to 8.81 ± 1.99% (t = 2.084; p = 0.041); the mean time of glycemia in the target range significantly increased from 58.7 ± 6.44% to 65.7% ± 4.33% (t = 2.070; p < 0.0429). The improvement of these two indicators during degludec therapy was achieved by avoiding nocturnal hypoglycemia and by 2.2 times reducing the number of episodes of mild hypoglycemia episodes, as well as significantly reducing the SD indicator (assessment of glycemic variability) from 4.91 ± 2.08 mmol/l to 4.06 ± 1.23 (p < 0.04).

Conclusion. The use of long-acting insulin degludec provides more effective and safer glycemic control compared to previous generation of basal insulin analogues.

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