Gaede 2008.
| Study characteristics | ||
| Methods |
Effect of a multifactorial intervention on mortality in type 2 diabetes Patient RCT, conducted in diabetes clinics in Denmark Two arms: 1. Conventional therapy (control arm) and 2. Intensive therapy (intervention arm) |
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| Participants | Control arm N: 80 Intervention arm N: 80 Diabetes type: type 2 Mean age: 55.1 ± 7.2 % Male: NR Longest follow‐up: 160 months (mean) |
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| Interventions |
Control arm: None Intervention arm: 1) Team changes |
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| Outcomes | 1) Aspirin, N users (%) Control arm: pre 10 (13), post 29 (76) Intervention arm: pre 11 (14), post 47 (85) 2) Statins, N users (%) Control arm: pre 2 (3), post 31 (82) Intervention arm: pre 0 (0), post 46 (84) 3) Antihypertensives (any), N users (%) Control arm: pre 33 (41), post 38 (100) Intervention arm: pre 33 (41), post 51 (93) 4) HbA1c, mean % (SD) Control arm: pre 8.8 (1.7), post 8.0 (1.4) Intervention arm: pre 8.4 (1.6), post 7.7 (1.2) 5) SBP, mean mmHg (SD) Control arm: pre 149.0 (19.0), post 146.0 (18.0) Intervention arm: pre 146.0 (11.0), post 140.0 (14.0) 6) DBP, mean mmHg (SD) Control arm: pre 86.0 (11.0), post 73.0 (7.0) Intervention arm: pre 85.0 (10.0), post 74.0 (8.0) 7) LDL, mean mg/dL (SD) Control arm: pre 137.0 (37.0), post 77.0 (28.0) Intervention arm: pre 133.0 (36.0), post 71.0 (29.0) 8) Smoking cessation, N smokers (%) Control arm: pre 28 (35), post 7 (18) Intervention arm: pre 32 (40), post 12 (22) |
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| Funding source | Supported by the Danish Health Research Council | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Information not available. |
| Allocation concealment (selection bias) | Unclear risk | Information not available. |
| Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | High risk | > 30% dropout. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Information not available. |
| Selective reporting (reporting bias) | Low risk | Information not available. |
| Risk of contamination (other bias) | Unclear risk | Information not available. |
| Other bias | Low risk | Information not available. |