The aim of this prospective cross-over study was to compare glycemic control on NPH insulin (NPH) and on glargine in unsatisfactorily controlled type 1 diabetic prepubertal children.
Material and methods: 14 patients, aged 6-12 years, on multiple insulin injections regimen were included. The study protocol: (i) a 6-month therapy with NPH as basal insulin and (ii) a 6-month therapy with glargine as basal insulin, in a random order.
Results: After 4 and 6 months mean blood glucose levels were similar on glargine and on NPH. After 6 months on NPH fasting blood glucose levels were similar to baseline (9.3+/-1.5 and 9.8+/-1.6 mmol/l respectively), while on glargine they were significantly lower compared to baseline (8.0+/-1.4 vs. 9.8+/-1.6 mmol/l, p=0.04) and markedly lower than after 6 months on NPH (8.0+/-1.4 vs. 9.3+/-1.5 mmol/l, p=0.077). HbA1c was lower on glargine compared to NPH, but only after 4 months the difference was statistically significant (7.1+/-0.16 vs. 7.74+/-0.25%, p=0.007). No severe hypoglycemia or ketoacidosis occurred.
Conclusion: In preadolescent children with unsatisfactorily controlled type 1 diabetes glargine constitutes a useful and safe alternative to NPH, providing better early morning and good total glycemic control, not increasing the risk of severe hypoglycemia; taking it into account the health care systems should participate in its costs for those who can not afford or tolerate an insulin pump.