title: 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).
abstract: BACKGROUND
  Avoidance of hypoglycemia is a key consideration in treating young children with type 1 diabetes (T1DM).
  To evaluate hypoglycemia with insulin glargine vs. neutral protamine Hagedorn (NPH) insulin in young children, using continuous glucose monitoring (CGM).
  
  
  METHODS
  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.
authors.affiliation: Kinder- und Jugendkrankenhaus "AUF DER BULT", Hannover, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Danne
authors.forename: Areti
authors.initials: A
authors.lastname: Philotheou
authors.forename: David
authors.initials: D
authors.lastname: Goldman
authors.forename: Xiang
authors.initials: X
authors.lastname: Guo
authors.forename: Lin
authors.initials: L
authors.lastname: Ping
authors.forename: Anna
authors.initials: A
authors.lastname: Cali
authors.forename: Peter
authors.initials: P
authors.lastname: Johnston
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D002940:Circadian Rhythm; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000139:chemically induced / Q000175:diagnosis*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D015994:Incidence; D007223:Infant; D000069036:Insulin Glargine; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects*; D049528:Insulin, Long-Acting / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D018670:Monitoring, Ambulatory
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine; D007336:Insulin, Isophane
keywords: NPH insulin; children; glargine; hypoglycemia; preschool; type 1 diabetes mellitus