ASSESSMENT OF THE EFFICACY AND SAFETY OF INSULIN DEGLUDEC IN CHILDREN AND ADOLESCENTS WITH TYPE 1 DIABETES MELLITUS IN REAL-LIFE CLINICAL PRACTICE

Despite the optimal drug provision for children with type 1 diabetes mellitus (DM1) in the Sverdlovsk Region with human insulin analogues, selfmonitoring tools and insulin pumps, the problem of achieving and maintaining compensation for carbohydrate metabolism still remains. The emergence of the innovative insulin analogue Degludec (Deg) in clinical practice offers prospects for improving DM1 compensation. Purpose of the study: to evaluate the efficacy and safety of the use of Deg in DM1 children in real-life clinical practice. Methods. In 12 DM1 children (mean age 14 [12.5-15] years, mean duration of DM1 3 [2-3.5] years) who did not achieve optimal glycemic control (glycated hemoglobin - HbA1c> 7.5%) on the previous basal bolus therapy with insulin analogues or with a high mean daily amplitude of plasma glucose level (DAPG >7 mmol/L) and/or hypoglycemia ≥1 times per week). The dynamics of HbA1c levels, fasting plasma glucose (FPG) levels, plasma glucose levels before sleep, DAPG, as well as changes in the average daily dose of insulin, the average frequency of all episodes of hypoglycemia, night hypoglycemia and severe hypoglycemia (per 1 week), the number of children experiencing hypoglycemia, and the proportion of children who achieved HbA1c <7.5% after transferring to Deg were analyzed. The efficacy and safety of therapy was assessed in 1, 2, 4, 8, 12 and 52 weeks. Results. By the end of the follow-up period, a significant decrease in HbA1c by 1.59%, and an increase of 66% in the proportion of children reaching HbAn <7.5% was observed. A significant decrease in the FPG level from 8.7 to 6.5 mmol/l, a significant decrease in DAPG by 4 mmol/l, a significant reduction in the incidence of diurnal hypoglycemia by 88% with the disappearance of episodes of night hypoglycemia, as well as a statistically significant reduction in the dose of basal insulin by 14 % were revealed. During the whole period of observation, there were no one episode of severe hypoglycemia, ketosis, and other side effects. Conclusion. In real-life clinical practice, switching to Deg from other basal insulin analogues in children with DM1 helps to achieve the most effective glycemic control with an optimal safety profile against a background of a reduction in the dose of basal insulin; this allows to recommend Deg for a wider use in clinical practice for the treatment of DM1 in children.

type 1 diabetes mellitus in children, deglude