title: Implications of new European Union driving regulations on patients with Type 1 diabetes who participated in the Diabetes Control and Complications Trial.
abstract: OBJECTIVE
  Recurrent severe hypoglycaemia in a patient with diabetes is strongly associated with a crash risk while driving. To help ensure road safety, recent changes were made to European Union driving regulations for patients with diabetes. These included the recommendation that more than one episode of severe hypoglycaemia within 12 months would lead to the loss of a driving licence. This study has assessed the impact of this regulation if applied to patients who participated in the Diabetes Control and Complications Trial.
  
  
  METHODS
  All patients in the Diabetes Control and Complications Trial were assumed to be drivers. Repeated hypoglycaemic episodes within a year were determined during the mean 6.5 years of the study.
  
  
  RESULTS
  Of the 1441 patients in the Diabetes Control and Complications Trial, 439 (30%) had more than one severe hypoglycaemic episode during a 12-month period of their study participation. Amongst the study groups, 312/711 (44%) of intensively treated and 127/730 (17%) of conventionally treated patients would have lost their licence at some point during the trial. The risk of licence loss increased with lower mean HbA1c , longer duration of diabetes and younger age (all P < 0.001).
  
  
  CONCLUSIONS
  More than one episode of severe hypoglycaemia within a year was a frequent event in subjects in the Diabetes Control and Complications Trial, especially in intensively treated patients. If applied to current practice, improving road safety through these changes to European Union regulations could have a substantial impact on drivers who have Type 1 diabetes. This emphasizes the need to take into account the potential effects of severe hypoglycaemia in those who rely on a driving licence.
authors.affiliation: Department of Clinical Biochemistry, Hull Royal Infirmary, Hull, UK. Eric.Kilpatrick@hey.nhs.uk
authors.forename: E S
authors.initials: ES
authors.lastname: Kilpatrick
authors.forename: A S
authors.initials: AS
authors.lastname: Rigby
authors.forename: R E
authors.initials: RE
authors.lastname: Warren
authors.forename: S L
authors.initials: SL
authors.lastname: Atkin
mesh_terms: D000063:Accidents, Traffic / Q000517:prevention & control*; D000328:Adult; D001334:Automobile Driving / Q000331:legislation & jurisprudence* / Q000523:psychology; D015190:Blood Glucose Self-Monitoring; D048909:Diabetes Complications / Q000097:blood; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000453:epidemiology / Q000523:psychology; D005062:European Union; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000097:blood* / Q000139:chemically induced / Q000453:epidemiology / Q000523:psychology; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects*; D008004:Licensure / Q000331:legislation & jurisprudence*; D008297:Male; D015995:Prevalence; D012307:Risk Factors; D012646:Self Administration
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin