A randomized trial comparing the rate of hypoglycemia-assessed using continuous glucose monitoring-in 125 preschool children with type 1 diabetes treated with insulin glargine or NPH insulin (the PRESCHOOL study)

Background: Avoidance of hypoglycemia is a key consideration in treating young children with type 1 diabetes (T1DM). Key Objective: To evaluate hypoglycemia with insulin glargine vs. neutral protamine Hagedorn (NPH) insulin in young children, using continuous glucose monitoring (CGM). Subjects: Children of 1 to <6yr treated with once-daily glargine vs. once- or twice-daily NPH, with bolus insulin lispro/regular human insulin provided to all. Methods: Twenty-four week, multicenter, randomized, open-label study. Primary endpoint was event rate of composite hypoglycemia [symptomatic hypoglycemia, low CGM excursions (<3.9mmol/L) or low fingerstick blood glucose (FSBG; <3.9mmol/L)]. Noninferiority of glargine vs. NPH was assessed for the primary endpoint. Results: One hundred and twenty-five patients (mean age, 4.2yr) were randomized to treatment (glargine, n=61; NPH, n=64). At baseline, mean HbA1c was 8.0 and 8.2% with glargine and NPH, respectively. Composite hypoglycemia episodes/100 patient-yr was 1.93 for glargine and 1.69 for NPH; glargine noninferiority was not met. Events/100 patient-yr of symptomatic hypoglycemia were 0.26 for glargine vs. 0.33 for NPH; low CGM excursions 0.75 vs. 0.72; and low FSBG 1.93 vs.1.68. There was a slight difference in between-group severe/nocturnal/severe nocturnal hypoglycemia and glycemic control. All glargine-treated patients received once-daily injections; on most study days NPH-treated patients received twice-daily injections. Conclusions: While glargine noninferiority was not achieved, in young children with T1DM, there was a slight difference in hypoglycemia outcomes and glycemic control between glargine and NPH. Once-daily glargine may therefore be a feasible alternative basal insulin in young populations, in whom administering injections can be problematic. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.