title: Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: results from the DIALOG study.
abstract: OBJECTIVE
  DIALOG assessed the prevalence and predictors of hypoglycaemia in patients with type 1 (T1DM) or insulin-treated type 2 diabetes mellitus (T2DM) in a real-life setting.
  
  
  METHODS
  In this observational study, insulin-treated patients (n=3048) completed prospective daily questionnaires reporting the frequency and consequences of severe/confirmed non-severe hypoglycaemia over 30 days. Patients (n=3743) also retrospectively reported severe hypoglycaemia over the preceding year.
  
  
  RESULTS
  In this prospective survey, 85.3% and 43.6% of patients with T1DM and T2DM, respectively, reported experiencing at least one confirmed hypoglycaemic event over 30 days, while 13.4% and 6.4%, respectively, reported at least one severe event. Hypoglycaemia frequency increased with longer duration of diabetes and insulin therapy. Strongly predictive factors for hypoglycaemia were previous hypoglycaemia, >2 injections/day, BMI<30kg/m(2) and duration of insulin therapy>10 years. HbA1c level was not predictive of hypoglycaemia in either T1DM or T2DM. The confirmed hypoglycaemia rate was increased in the lowest compared with the highest tertile of HbA1c in T1DM, but not T2DM. At the time of enrolment, physicians reported severe hypoglycaemia in 23.6% and 11.9% of T1DM and T2DM patients, respectively, during the preceding year; the retrospective survey yielded frequencies of 31.5% and 21.7%, respectively. Also, severe hypoglycaemia led to medical complications in 10.7% and 7.8% of events in T1DM and T2DM patients, respectively, over 30 days.
  
  
  CONCLUSIONS
  Using a unique combined prospective and retrospective approach, the DIALOG study found a relatively high frequency of hypoglycaemia among insulin-treated patients. These findings emphasize the importance of a patient-centred approach for managing diabetes in which hypoglycaemia risk evaluation is critical.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01628341.
authors.affiliation: Department of Endocrinology, l'institut du Thorax, CHU de Nantes, hôpital Guillaume & René Laennec, boulevard Jacques-Monod, 44093 Nantes cedex 1, France. Electronic address: bertrand.cariou@univ-nantes.fr.
authors.forename: B
authors.initials: B
authors.lastname: Cariou
authors.affiliation: Department of Endocrinology and Diabetology, University Hospital of Lille, Lille, France.
authors.forename: P
authors.initials: P
authors.lastname: Fontaine
authors.affiliation: Inserm U-1018, Centre de Recherche en Epidémiologie et Santé des populations (CESP), Villejuif, France.
authors.forename: E
authors.initials: E
authors.lastname: Eschwege
authors.affiliation: Laennec Faculty of Medicine, Lyon, France.
authors.forename: M
authors.initials: M
authors.lastname: Lièvre
authors.affiliation: Hôpital Saint-Louis, centre hospitalier de La Rochelle, La Rochelle, France.
authors.forename: D
authors.initials: D
authors.lastname: Gouet
authors.affiliation: Hôpital Saint-Joseph, Paris, France.
authors.forename: D
authors.initials: D
authors.lastname: Huet
authors.affiliation: Novo Nordisk, Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Madani
authors.affiliation: ITEC Services SAS, Cenon, France.
authors.forename: S
authors.initials: S
authors.lastname: Lavigne
authors.affiliation: Department of Endocrinology, l'institut du Thorax, CHU de Nantes, hôpital Guillaume & René Laennec, boulevard Jacques-Monod, 44093 Nantes cedex 1, France.
authors.forename: B
authors.initials: B
authors.lastname: Charbonnel
mesh_terms: D000328:Adult; D000368:Aged; D003922:Diabetes Mellitus, Type 1 / Q000453:epidemiology*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D011446:Prospective Studies; D012189:Retrospective Studies; D012307:Risk Factors
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Hypoglycaemia; Observational study; Type 1 diabetes; Type 2 diabetes