Long-term benefits of continuous subcutaneous insulin infusion in children with Type 1 diabetes: a 4-year follow-up.
Objective: To determine the safety and effectiveness of continuous subcutaneous insulin infusion (CSII) in attaining long-term glycaemic control in paediatric patients with Type 1 diabetes and to compare the results with those previously recorded in the same patients taking multiple daily injections (MDI) (four injections a day).
Methods: Forty-two patients (mean age 12.2 +/- 3.4 years; range 4.5-17 years; 24 males; mean duration of Type 1 diabetes 5.1 +/- 3.0 years) were studied. The following parameters were assessed in the year before starting CSII treatment (during MDI treatment) and during the 4 years of insulin pump treatment: annual mean HbA1c, insulin requirements (U/kg per day), annual mean of body mass index (BMI) z scores, and adverse events (severe hypoglycaemia and diabetic ketoacidosis/patient per year). Two patients discontinued pump therapy (after 1-year and 2-year follow-up, respectively) because of non-compliance with CSII therapy.
Results: Compared with the annual mean HbA1c observed prior to CSII therapy (8.9 +/- 1.0%), the mean HbA1c levels were lower during the first (8.2 +/- 0.9%; P = 0.00), second (8.6 +/- 1.0%; P = 0.05), third (8.4 +/- 0.9%; P = 0.01) and fourth (8.2 +/- 1%; P = 0.00) year of CSII therapy. The insulin requirements (U/kg per day) decreased during CSII treatment compared with MDI treatment. Compared with the annual mean of BMI z scores prior to CSII therapy, BMI z scores were significantly lower during the third and fourth years of CSII therapy. Through the first, second, third and fourth years of follow-up the number of episodes of severe hypoglycaemia (20.0, 20.0, 20.0 and 0 episodes/1000 patient-years, respectively) and diabetic ketoacidosis (0.05, 0.00, 0.03 and 0.00 episodes/patient per year, respectively), events were similar to that in the year preceding CSII therapy (20.0 and 0.03, respectively).
Conclusions: In this population of selected patients in our clinic, CSII appears to be a safe and effective therapeutic alternative to MDI treatment. This therapy may ensure a stable improvement in long-term glycaemic control in paediatric patients, with no increase in diabetic ketoacidosis and severe hypoglycaemic events and, on the other hand, with a trend of reduction in BMI z scores.