Arushi Saini, Devidayal, Savita Verma and AK Bhalla
Objective: To compare the efficacy of insulin glargine and insulin NPH in terms of glycemic control and risk of hypoglycemia in children with Type 1 diabetes (T1D) mellitus.
Design: Prospective, randomized, open label, controlled trial.
Setting: Pediatric Diabetes Clinic of a tertiary care hospital.
Subjects: Eighty T1D children between 2 to12 years diagnosed for at least six months.
Randomization: Computer generated random number table was used to randomize the patients into Glargine (n=40) and NPH (n=40) groups.
Intervention: Patients received either once daily insulin glargine or twice daily NPH insulin as basal insulin. Monthly follow up was done for 6 consecutive months.
Results: In the glargine group, significant reductions were noted from baseline to endpoint in mean fasting blood glucose (FBG) (152.80 ± 22.92 versus 113.08 ± 14.71, p value < 0.001), mean blood glucose (MBG) (171.0 ± 23.02 versus 126.20 ± 13.29, p value < 0.001), glycated hemoglobin (HbA1c) (8.89 ± 1.48 versus 7.44 ± 0.74, p value < 0.001), mean total insulin dose (0.92 ± 0.37 units/kg/day versus 0.70 ± 0.29, p value < 0.043), mean basal insulin dose (0.78 ± 0.34 versus 0.53 ± 0.23, p value < 0.001) and mean number of all types of hypoglycemic episodes whereas, mean unmodified insulin dose (0.14 ± 0.14 versus 0.16 ± 0.14, p value 1.000) remained unchanged. The changes in all these parameters in the NPH group were not significant. The percentage of patients suffering at least one episode of hypoglycemia was significantly less with glargine in contrast to NPH (2.02 ± 0.43 versus 2.36 ± 0.47, p value 0.001).
Conclusion: Glargine was found to be more effective than NPH insulin for glycemic control and incidence of hypoglycemia in children with T1D.