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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)
Author(s) -
Danne Thomas,
Philotheou Areti,
Goldman David,
Guo Xiang,
Ping Lin,
Cali Anna,
Johnston Peter
Publication year - 2013
Publication title -
pediatric diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.678
H-Index - 75
eISSN - 1399-5448
pISSN - 1399-543X
DOI - 10.1111/pedi.12051
Subject(s) - medicine , insulin glargine , hypoglycemia , nph insulin , glycemic , clinical endpoint , type 1 diabetes , type 2 diabetes , diabetes mellitus , insulin , randomized controlled trial , endocrinology , pediatrics
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 <6 yr 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 (<3.9 mmol/L) or low fingerstick blood glucose ( FSBG ; <3.9 mmol/L)]. Noninferiority of glargine vs. NPH was assessed for the primary endpoint. Results One hundred and twenty‐five patients (mean age, 4.2 yr) 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.