To provide a comprehensive review of
insulin lispro administered by continuous subcutaneous
insulin infusion (CSII) in children and adolescents.
METHODS: Twenty-six studies involving 2521 pediatric patients with
type 1 diabetes mellitus met inclusion criteria. Of these, 10 were randomized controlled trials (RCTs), 6 of which compared
insulin lispro CSII with multiple daily injection (MDI)
therapy. We identified 7 additional prospective, nonrandomized studies and 9 retrospective studies. Within the RCTs, endpoint
hemoglobin A1c levels ranged from 6.3% to 8.5% for
insulin lispro CSII
therapy and from 6.2% to 8.7% for those trials with MDI comparator arms. In those trials that compared
insulin lispro CSII with MDI, the endpoint
hemoglobin A1c achieved with
insulin lispro was similar or improved compared with observations in the MDI treatment arm. In the RCTs, severe
hypoglycemia rates of 0.1 to 0.3 episodes/patient per year were reported for
insulin lispro CSII
therapy; those trials with MDI comparator arms reported relatively similar severe
hypoglycemia rates (0.1 to 0.5 episodes/patient per year). Events of
diabetic ketoacidosis (DKA) were rare. Where reported,
insulin lispro CSII and MDI
therapy demonstrated a similar occurrence of DKA and incidence of severe
hypoglycemia. Prospective and retrospective studies demonstrated results similar to the RCT findings.
CONCLUSIONS: In 26 studies of more than 2500 pediatric and adolescent patients with
type 1 diabetes, with more than 1000 patients specifically receiving
insulin lispro CSII,
insulin lispro CSII
therapy consistently demonstrated similar or improved efficacy and safety vs studied comparators.