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CLINICAL TRIAL
JOURNAL ARTICLE
[Metabolic control in young children with type 1 diabetes treated with continuous subcutaneous insulin infusion (insulin pump)].
UNLABELLED: Intensive insulin therapy is a method of choice in the management of patients with type 1 diabetes. Its administration in the youngest children is limited by little or no acceptance of multiple injections and a typical fear of needles and syringes. In recent years more and more frequently the method of multiple daily injections (MDI) of insulin is being replaced by the method of continuous subcutaneous insulin infusion (CSII) even in the youngest children.
OBJECTIVE: Evaluation of the safety and efficacy of CSII method in children at prepubertal age.
MATERIAL AND METHODS: There were 61 children under 10 years of age with type 1 diabetes recruited for the study (33 boys, 28 girls). CSII method was implemented for the period of minimum 6 months. In the group of 21 children CSII method was the first method of their therapy (it was administered at the time of diagnosis). Mean duration of diabetes was 3.0 years +/-1.87 year, mean age at diagnosis was 3.82+/-2.19 years and mean duration of CSII treatment was 1.4 +/-0.75 year. The average HbA1c at the baseline for all children was 8.7+/-1.4%.
RESULTS: In the group where CSII therapy was implemented as the first method of management, mean duration of treatment was 1.5 years, mean HbA1c decreased after first 3 months from 9.6+/-1.68% to 7.22+/-0.99% (p<0.05). After 12 and 24 months the value further decreased to 7.01+/-0.57%. In the group that was earlier treated with MDI method (n=40), mean value of HbA1c decreased after 3 months from 8.27+/-1.4% to 7.6 +/-0.86% (p<0.05), after 12 months it further decreased to 7.37+/-0.86%, after 24 months its mean value was 7.53%. The number of patients with HbA1c >8% decreased from 58.4% to 10%. Adverse events were observed only in the group that was earlier treated with the MDI method. There were 3 incidences of severe hypoglycaemia, 2 incidences of diabetic ketoacidosis, 2 incidences of infection at the needle site (in one case the surgical attention was necessary). After two years of the trial there was a statistically significant difference in the mean value of HbA1c between children that used CSII method from the moment of their diagnosis (HbA1c=7.01%) and those who were earlier treated with MDI method (HbA1c=7.53 +/-0.73%). In both groups the daily insulin requirement was similar (CSII method 0.69+/-0.2 unit/kg/day, MDI method 0.75+/-0.19 unit/kg/day).
CONCLUSIONS: The method of continuous subcutaneous insulin infusion (CSII) provides good and sustained metabolic control in the youngest children with type 1 diabetes. Administering of that method from the very beginning of the diabetes treatment may decrease the risk of acute complications.
OBJECTIVE: Evaluation of the safety and efficacy of CSII method in children at prepubertal age.
MATERIAL AND METHODS: There were 61 children under 10 years of age with type 1 diabetes recruited for the study (33 boys, 28 girls). CSII method was implemented for the period of minimum 6 months. In the group of 21 children CSII method was the first method of their therapy (it was administered at the time of diagnosis). Mean duration of diabetes was 3.0 years +/-1.87 year, mean age at diagnosis was 3.82+/-2.19 years and mean duration of CSII treatment was 1.4 +/-0.75 year. The average HbA1c at the baseline for all children was 8.7+/-1.4%.
RESULTS: In the group where CSII therapy was implemented as the first method of management, mean duration of treatment was 1.5 years, mean HbA1c decreased after first 3 months from 9.6+/-1.68% to 7.22+/-0.99% (p<0.05). After 12 and 24 months the value further decreased to 7.01+/-0.57%. In the group that was earlier treated with MDI method (n=40), mean value of HbA1c decreased after 3 months from 8.27+/-1.4% to 7.6 +/-0.86% (p<0.05), after 12 months it further decreased to 7.37+/-0.86%, after 24 months its mean value was 7.53%. The number of patients with HbA1c >8% decreased from 58.4% to 10%. Adverse events were observed only in the group that was earlier treated with the MDI method. There were 3 incidences of severe hypoglycaemia, 2 incidences of diabetic ketoacidosis, 2 incidences of infection at the needle site (in one case the surgical attention was necessary). After two years of the trial there was a statistically significant difference in the mean value of HbA1c between children that used CSII method from the moment of their diagnosis (HbA1c=7.01%) and those who were earlier treated with MDI method (HbA1c=7.53 +/-0.73%). In both groups the daily insulin requirement was similar (CSII method 0.69+/-0.2 unit/kg/day, MDI method 0.75+/-0.19 unit/kg/day).
CONCLUSIONS: The method of continuous subcutaneous insulin infusion (CSII) provides good and sustained metabolic control in the youngest children with type 1 diabetes. Administering of that method from the very beginning of the diabetes treatment may decrease the risk of acute complications.
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