Epidemiological data on hypoglycemia in type 2 diabetes, expressed as incidence
| Study . | VA 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 |
| Study . | VA 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.