title: Severe hypoglycaemia in patients with type 1 diabetes and impaired awareness of hypoglycaemia: a comparative study of insulin lispro and regular human insulin.
abstract: OBJECTIVE
  To assess the potential of insulin lispro to limit the frequency of severe hypoglycaemia without compromising glycaemic control in a cohort of patients with type 1 diabetes who are at a high risk of severe hypoglycemia. Research design and methods An open-label, randomised, 12-month comparative crossover study of insulin lispro and regular human insulin was performed in 33 patients with type 1 diabetes with impaired hypoglycaemia awareness. The efficacy of each treatment was evaluated by glycaemic control (HbA(1c)), eight-point home blood glucose profiles, and the frequency and severity of hypoglycaemic episodes and quality of life.
  
  
  RESULTS
  Eighteen (55%) patients experienced one or more episodes of severe hypoglycaemia in the 48 weeks of study. There was a trend to a lower incidence of severe hypoglycaemia during treatment with insulin lispro in comparison with regular human insulin (55 vs 84 episodes, p=0.087). This resulted principally from a 47% lower incidence of nocturnal severe hypoglycaemia with insulin lispro (25 vs 47 episodes, p=0.11). The lower frequency of severe hypoglycaemia associated with insulin lispro was not explained by differences in glycated haemoglobin between insulin treatments (HbA(1c) 9.1% insulin lispro vs 9.3% regular human insulin).
  
  
  CONCLUSIONS
  In individuals with type 1 diabetes, who have impaired awareness of hypoglycaemia, treatment with insulin lispro may be associated with a lower incidence of severe hypoglycaemia manifested predominantly through less frequent nocturnal episodes. Insulin lispro may have a beneficial role in the management of patients with diabetes at risk of severe hypoglycaemia, although a larger study is required to confirm these findings.
authors.affiliation: Department of Diabetes, Royal Infirmary of Edinburgh, 1 Lauriston Place, Edinburgh EH3 9YW, Scotland, UK.
authors.forename: S C
authors.initials: SC
authors.lastname: Ferguson
authors.forename: M W
authors.initials: MW
authors.lastname: Strachan
authors.forename: J M
authors.initials: JM
authors.lastname: Janes
authors.forename: B M
authors.initials: BM
authors.lastname: Frier
mesh_terms: D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced* / Q000175:diagnosis*; D007328:Insulin / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061268:Insulin Lispro; D008297:Male; D008875:Middle Aged; D010465:Perception; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D006442:Glycated Hemoglobin; D007328:Insulin; D061268:Insulin Lispro