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)

作者：Danne Thomas^*; Philotheou Areti; Goldman David; Guo Xiang; Ping Lin; Cali Anna; Johnston Peter

来源：Pediatric Diabetes, 2013, 14(8): 593-601.

DOI：10.1111/pedi.12051

• children
• glargine
• hypoglycemia
• NPH insulin
• preschool
• type 1 diabetes mellitus

BackgroundAvoidance of hypoglycemia is a key consideration in treating young children with type 1 diabetes (T1DM). %26lt;br%26gt;Key ObjectiveTo evaluate hypoglycemia with insulin glargine vs. neutral protamine Hagedorn (NPH) insulin in young children, using continuous glucose monitoring (CGM). %26lt;br%26gt;SubjectsChildren of 1 to %26lt;6yr treated with once-daily glargine vs. once- or twice-daily NPH, with bolus insulin lispro/regular human insulin provided to all. %26lt;br%26gt;MethodsTwenty-four week, multicenter, randomized, open-label study. Primary endpoint was event rate of composite hypoglycemia [symptomatic hypoglycemia, low CGM excursions (%26lt;3.9mmol/L) or low fingerstick blood glucose (FSBG; %26lt;3.9mmol/L)]. Noninferiority of glargine vs. NPH was assessed for the primary endpoint. %26lt;br%26gt;ResultsOne 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. %26lt;br%26gt;ConclusionsWhile 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.

• 出版日期2013-12