Hypoglycemia symptoms and awareness of hypoglycemia in type 1 diabetes mellitus: cross-cultural adaptation and validation of the Portuguese version of three questionnaires and evaluation of its risk factors.

Background: To adapt and validate the Clarke and Gold questionnaires and the Edinburgh Hypoglycemia Symptom Scale (EHSS) to Brazilian Portuguese and to determine the prevalence and risk factors associated with impaired awareness of hypoglycemia (IAH) in patients with type 1 diabetes mellitus (T1DM).

Methods: The process of translation, cultural adaptation, and validation of the questionnaires followed the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)-Task Force for Translation and Cultural Adaptation. Patients with T1DM for a minimum of 12 months, aged 18 years or older, and with Brazilian nationality were selected to participate.