Table 1—

Epidemiological data on hypoglycemia in type 2 diabetes, expressed as incidence

StudyVA CSDM, 1995 (ref. 74)Gurlek, Erbas, and Gedik, 1999 (ref. 78)*Henderson et al., 2003 (ref. 82)Leese et al., 2003 (ref. 79)*Donnelly et al., 2005 (ref. 81)*
DesignProspective multicentre, randomized clinical trial of standard vs. intensive insulin regimenRetrospective, medical records examinedRetrospective questionnairePopulation-based dataset analysisProspective
n150165215160267
SubjectsAll have type 2 diabetesAll insulin treated: 114 type 2 and 51 type 1 diabetic subjectsAll insulin-treated type 2 diabetic subjectsType 1 (69) and type 2 diabetic subjects on sulfonylurea (22) or insulin (66)94 with type 1 diabetes; 173 with type 2 diabetes
Age (years)60 ± 659 ± 1068 (27–87)mean 53.8 (50.8–56.9)66 (34–86)
A1C (%)Conventional: 9.0%, intensive: 7.0%Not specified8.6 ± 1.57.85 (7.57–8.14)8.9 ± 1.41
HbA1 (%)
Duration18–35 months3.3 years1 year1 year1 month
Definition of severe hypoglycemiaNeed for third party assistance or loss of consciousness or seizureNeed for third party assistance and attendance at hospitalNeed for third party assistanceNeed for parenteral treatment by emergency servicesNeed for third party assistance
Oral antidiabetic agents: all hypoglycemiaNANANANANA
Oral antidiabetic agents: severe hypoglycemiaNANANASulfonylureas: 0.009 episodes/patient/year; metformin: 0.0005 episodes/patient/yearNA
Insulin: all hypoglycemia1.5 (standard therapy) and 16.5 (intensive therapy)NANSNA16.4
Insulin: severe hypoglycemia0.02 events/patient/year0.15 events/patient/year0.28 events/patient/year0.12 events/patient/year (both type 1 and type 2 diabetes)0.35 events/patient/year
Main criticismsAll male intensively managed groupOnly assessed severe hypoglycemia; incidence underestimated as included only events requiring hospital admissionRecall bias for mild hypoglycemiaOnly assessed hypoglycemia requiring emergency serviceShort duration
  • Data are means ± SD or median (range), unless otherwise indicated. NA, not applicable; VA CSDM, Veterans Affairs Cooperative Study in Type 2 Diabetes.

  • *

    * Only figures for type 2 diabetes given.