Abstract
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.
Highlights
Management of Type 1 diabetes (T1D) requires maintaining near-normalized blood glucose levels without the risk of significant hypoglycemia which delays the onset and progression of vascular and neurological complications as shown by the Diabetes Control & Complications trial [1]
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 percentage of patients suffering at least one episode of hypoglycemia was significantly less with glargine in contrast to Neutral Protamine Hagedorn (NPH) (2.02 ± 0.43 versus 2.36 ± 0.47, p value 0.001)
Summary
Management of T1D requires maintaining near-normalized blood glucose levels without the risk of significant hypoglycemia which delays the onset and progression of vascular and neurological complications as shown by the Diabetes Control & Complications trial [1]. A perfect glycemic control in T1D is achieved in less than one-third of children only [2], the major challenge being a steady supply of basal insulin that mimics the physiological endogenous pancreatic insulin secretion. The plasma concentration versus time profile of the long acting insulin analogue glargine is relatively constant, with no pronounced peak over 24 hours [5]. This allows once-daily administration as basal therapy and minimizes risk of nocturnal hypoglycemia which is of particular concern in children as severe hypoglycemic episodes can cause brain damage in younger children manifesting as various neurological handicaps in later life [6]. The flexibility of the glargine regimen in children, mainly defined by easier planning of meals, exercise, and deviation from daily routines and better quality of life has been especially appreciated by the patients and their parents [7]
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