title: Severe hypoglycaemia in adults with insulin-treated diabetes: impact on healthcare resources.
abstract: OBJECTIVE
  To assess resource utilization associated with severe hypoglycaemia across three insulin regimens in a large phase 3a clinical programme involving people with Type 1 diabetes treated with basal-bolus insulin, people with Type 2 diabetes treated with multiple daily injections and people with Type 2 diabetes treated with basal-oral therapy.
  
  
  METHODS
  Data relating to severe hypoglycaemia events (defined as episodes requiring external assistance) from the insulin degludec and insulin degludec/insulin aspart programme (15 trials) were analysed using descriptive statistics. Comparators included insulin glargine, biphasic insulin aspart, insulin detemir and sitagliptin. Mealtime insulin aspart was used in some regimens. This analysis used the serious adverse events records, which documented the use of ambulance/emergency teams, a hospital/emergency room visit ≤ 24 h, or a hospital visit > 24 h.
  
  
  RESULTS
  In total, 536 severe hypoglycaemia events were analysed, of which 157 (29.3%) involved an ambulance/emergency team, 64 (11.9%) led to hospital/emergency room attendance of ≤ 24 h and 36 (6.7%) required hospital admission (> 24 h). Although there were fewer events in people with Type 2 diabetes compared with Type 1 diabetes, once a severe episode occurred, the tendency to utilize healthcare resources was higher in Type 2 diabetes vs. Type 1 diabetes. A higher proportion (47.6%) in the basal-oral therapy group required hospital treatment for > 24 h versus the Type 1 diabetes (5.0%) and Type 2 diabetes multiple daily injections (5.3%) groups.
  
  
  CONCLUSIONS
  This analysis suggests that severe hypoglycaemia events often result in emergency/ambulance calls and hospital treatment, incurring a substantial health economic burden, and were associated with all insulin regimens.
authors.affiliation: Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.
authors.forename: S R
authors.initials: SR
authors.lastname: Heller
authors.affiliation: The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
authors.forename: B M
authors.initials: BM
authors.lastname: Frier
authors.affiliation: Medical & Science, Novo Nordisk A/S, Søborg, Denmark.
authors.forename: M L
authors.initials: ML
authors.lastname: Hersløv
authors.affiliation: Health Economics & HTA, Novo Nordisk A/S, Søborg, Denmark.
authors.forename: J
authors.initials: J
authors.lastname: Gundgaard
authors.affiliation: Oxford Centre for Diabetes Endocrinology and Metabolism, Academic Health Science Network, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.
authors.forename: S C L
authors.initials: SC
authors.lastname: Gough
mesh_terms: D000284:Administration, Oral; D000328:Adult; D017326:Clinical Trials, Phase III as Topic; D015331:Cohort Studies; D003365:Costs and Cost Analysis; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy* / Q000191:economics; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000191:economics; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000191:economics / Q000503:physiopathology / Q000628:therapy*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use; D061267:Insulin Aspart / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D000069057:Insulin Detemir / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D000069036:Insulin Glargine / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D049528:Insulin, Long-Acting / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D008875:Middle Aged; D012720:Severity of Illness Index; D000068900:Sitagliptin Phosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D004338:Drug Combinations; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; C578220:insulin degludec, insulin aspart drug combination; D000069036:Insulin Glargine; D000069057:Insulin Detemir; C571886:insulin degludec; D061267:Insulin Aspart; D000068900:Sitagliptin Phosphate