title: Real-world patient-reported rates of non-severe hypoglycaemic events in Germany.
abstract: OBJECTIVE
  Hypoglycaemia is a common side effect of insulin therapy in diabetes patients, with negative physical and emotional impacts. Despite this, there are few studies investigating the frequency of non-severe hypoglycaemic events from the perspective of patients in the real-world setting. We investigated self-reported NSHE frequency and levels of hypoglycaemia awareness in Germany.
  
  
  METHODS
  Respondents > 15 years with Type 1 or insulin-treated Type 2 diabetes (receiving basal only, basal-bolus or other insulin regimens) were recruited using online panels to complete ≤ 4 questionnaires. Questionnaires collected demographics, non-severe hypoglycaemic event rates and patient-reported level of hypoglycaemia awareness. Non-severe hypoglycaemic event rates are reported as respondent-week records and calculated using data from all respondents completing at least one questionnaire.
  
  
  RESULTS
  A total of 1,771 respondent-week records were obtained from 614 participants. Mean non-severe hypoglycaemic event rates per respondent-week were 1.6 for Type 1 and 0.6-0.8 for Type 2, with estimated annual rates of 83 and 31-42 respectively. Two-thirds of Type 1 (65%) and Type 2 (61-72%) respondents reported impaired levels of awareness or unawareness of hypoglycaemic events (inability or impaired ability to recognise the symptoms of hypoglycaemia). Respon­dents' self-reported hypoglycaemia-awareness was significantly associated with the proportion of asymptomatic non-severe hypoglycaemic events; respondents classified as being unaware of hypoglycaemia had a higher proportion of asymptomatic non-severe hypoglycaemic events than aware respondents.
  
  
  CONCLUSIONS
  Non-severe hypoglycaemic events are common in people with Type 1 or insulin-treated Type 2 diabetes in the real-world setting in Germany but may still be underestimated due to an inability to recognise the symptoms of hypoglycaemia.
authors.affiliation: Forschungsinstitut Diabetes-Akademie, Bad Mergentheim.
authors.forename: B
authors.initials: B
authors.lastname: Kulzer
authors.affiliation: Novo Nordisk Pharma GmbH, Mainz.
authors.forename: L
authors.initials: L
authors.lastname: Seitz
authors.affiliation: Endokrinologikum, Ulm.
authors.forename: W
authors.initials: W
authors.lastname: Kern
mesh_terms: D000328:Adult; D000368:Aged; D001364:Awareness; D015415:Biomarkers / Q000097:blood; D017281:Cost of Illness; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D005858:Germany / Q000453:epidemiology; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced* / Q000453:epidemiology* / Q000523:psychology; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires
chemical_list: D015415:Biomarkers; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human