title: Insulin lispro versus regular insulin in children with type 1 diabetes on twice daily insulin.
abstract: OBJECTIVE
  The aim of this study was to compare the clinical efficacy and safety of insulin lispro with regular insulin in 5- to 10-yr-old prepubertal children on twice daily insulin.
  
  
  METHODS
  Thirty-five children (16 M, 19 F) completed an open-label randomised crossover study, with each child receiving insulin lispro for 3 months and regular insulin for 3 months in addition to their intermediate-acting insulin. Families were instructed to give regular insulin 30 min before meals and insulin lispro immediately before meals. Glycaemic control was monitored by eight-point blood glucose profiles and six weekly hemoglobin A1cs (HbA1cs) and the frequency and severity of hypoglycaemia was documented.
  
  
  RESULTS
  The endpoint HbA1c after 3 months on insulin lispro (8.33%, SD+/-0.89) was not significantly different to that on regular insulin (8.14%, SD+/-0.77). No significant differences were found in blood glucose levels before or after meals, 2-h postprandial glucose excursions or in blood glucose levels before bed between the treatments. However, blood glucose levels at 3 am were significantly lower on regular insulin than on insulin lispro (mean difference -2.35 mmol/L (95%CI: -3.98, -0.72, p=0.01). There was no significant difference in the frequency of hypoglycaemic episodes between the groups.
  
  
  CONCLUSIONS
  The main advantage of insulin lispro in children on twice daily insulin was found to be its greater convenience, this being achieved without a deterioration in glycaemic control. The higher 3 am blood glucose levels in those on insulin lispro could translate to reduced nocturnal hypoglycaemia in some individuals.
authors.affiliation: The Ray Williams Institute of Paediatric Endocrinology, Diabetes and Metabolism, The New Children's Hospital, Westmead, Parramatta, NSW, Australia. janf@nch.edu.au
authors.forename: J M
authors.initials: JM
authors.lastname: Fairchild
authors.forename: G R
authors.initials: GR
authors.lastname: Ambler
authors.forename: C H
authors.initials: CH
authors.lastname: Genoud-Lawton
authors.forename: E A
authors.initials: EA
authors.lastname: Westman
authors.forename: A
authors.initials: A
authors.lastname: Chan
authors.forename: N J
authors.initials: NJ
authors.lastname: Howard
authors.forename: P A
authors.initials: PA
authors.lastname: Crock
authors.forename: E A
authors.initials: EA
authors.lastname: Nunn
authors.forename: M
authors.initials: M
authors.lastname: Silink