TY - JOUR T1 - 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). AU - Danne,Thomas, AU - Philotheou,Areti, AU - Goldman,David, AU - Guo,Xiang, AU - Ping,Lin, AU - Cali,Anna, AU - Johnston,Peter, Y1 - 2013/06/03/ PY - 2013/01/25/received PY - 2013/03/21/revised PY - 2013/04/18/accepted PY - 2013/6/5/entrez PY - 2013/6/5/pubmed PY - 2014/8/26/medline KW - NPH insulin KW - children KW - glargine KW - hypoglycemia KW - preschool KW - type 1 diabetes mellitus SP - 593 EP - 601 JF - Pediatric diabetes JO - Pediatr Diabetes VL - 14 IS - 8 N2 - 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. SN - 1399-5448 UR - https://www.unboundmedicine.com/medline/citation/23730996/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__ L2 - https://doi.org/10.1111/pedi.12051 DB - PRIME DP - Unbound Medicine ER -