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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)*
Design Prospective multicentre, randomized clinical trial of standard vs. intensive insulin regimen Retrospective, medical records examined Retrospective questionnaire Population-based dataset analysis Prospective 
n 150 165 215 160 267 
Subjects All have type 2 diabetes All insulin treated: 114 type 2 and 51 type 1 diabetic subjects All insulin-treated type 2 diabetic subjects Type 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 ± 6 59 ± 10 68 (27–87) mean 53.8 (50.8–56.9) 66 (34–86) 
A1C (%) Conventional: 9.0%, intensive: 7.0% Not specified 8.6 ± 1.5 7.85 (7.57–8.14) 8.9 ± 1.41 
HbA1 (%) — — — — — 
Duration 18–35 months 3.3 years 1 year 1 year 1 month 
Definition of severe hypoglycemia Need for third party assistance or loss of consciousness or seizure Need for third party assistance and attendance at hospital Need for third party assistance Need for parenteral treatment by emergency services Need for third party assistance 
Oral antidiabetic agents: all hypoglycemia NA NA NA NA NA 
Oral antidiabetic agents: severe hypoglycemia NA NA NA Sulfonylureas: 0.009 episodes/patient/year; metformin: 0.0005 episodes/patient/year NA 
Insulin: all hypoglycemia 1.5 (standard therapy) and 16.5 (intensive therapy) NA NS NA 16.4 
Insulin: severe hypoglycemia 0.02 events/patient/year 0.15 events/patient/year 0.28 events/patient/year 0.12 events/patient/year (both type 1 and type 2 diabetes) 0.35 events/patient/year 
Main criticisms All male intensively managed group Only assessed severe hypoglycemia; incidence underestimated as included only events requiring hospital admission Recall bias for mild hypoglycemia Only assessed hypoglycemia requiring emergency service Short duration 
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)*
Design Prospective multicentre, randomized clinical trial of standard vs. intensive insulin regimen Retrospective, medical records examined Retrospective questionnaire Population-based dataset analysis Prospective 
n 150 165 215 160 267 
Subjects All have type 2 diabetes All insulin treated: 114 type 2 and 51 type 1 diabetic subjects All insulin-treated type 2 diabetic subjects Type 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 ± 6 59 ± 10 68 (27–87) mean 53.8 (50.8–56.9) 66 (34–86) 
A1C (%) Conventional: 9.0%, intensive: 7.0% Not specified 8.6 ± 1.5 7.85 (7.57–8.14) 8.9 ± 1.41 
HbA1 (%) — — — — — 
Duration 18–35 months 3.3 years 1 year 1 year 1 month 
Definition of severe hypoglycemia Need for third party assistance or loss of consciousness or seizure Need for third party assistance and attendance at hospital Need for third party assistance Need for parenteral treatment by emergency services Need for third party assistance 
Oral antidiabetic agents: all hypoglycemia NA NA NA NA NA 
Oral antidiabetic agents: severe hypoglycemia NA NA NA Sulfonylureas: 0.009 episodes/patient/year; metformin: 0.0005 episodes/patient/year NA 
Insulin: all hypoglycemia 1.5 (standard therapy) and 16.5 (intensive therapy) NA NS NA 16.4 
Insulin: severe hypoglycemia 0.02 events/patient/year 0.15 events/patient/year 0.28 events/patient/year 0.12 events/patient/year (both type 1 and type 2 diabetes) 0.35 events/patient/year 
Main criticisms All male intensively managed group Only assessed severe hypoglycemia; incidence underestimated as included only events requiring hospital admission Recall bias for mild hypoglycemia Only assessed hypoglycemia requiring emergency service Short 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.

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