Guo 2014.
| Study characteristics | ||
| Methods |
Efficacy of structured education in patients with type 2 diabetes mellitus receiving insulin treatments Patient RCT, conducted in 48 centres throughout China Two arms: 1. Control (control arm) and 2. Education (intervention arm) |
|
| Participants | Control arm N: NR Intervention arm N: NR Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 4 months |
|
| Interventions |
Control arm: 1) Patient education 2) Promotion of self‐management Intervention arm: 1) Case management 2) Patient education 3) Promotion of self‐management 4) Patient reminders |
|
| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 9.5 (1.9), post 7.4 (1.1) Intervention arm: pre 9.4 (2.0), post 7.2 (1.0) 2a) Harms (hypoglycaemia), N (%) Control arm: pre NR (NR), post 156 (24) Intervention arm: pre NR (NR), post 191 (30) 2b) Harms (nocturnal hypoglycaemia), N (%) Control arm: pre NR (NR), post 30 (5) Intervention arm: pre NR (NR), post 52 (8) 2c) Harms (severe hypoglycaemia), N (%) Control arm: pre NR (NR), post 0 (0) Intervention arm: pre NR (NR), post 2 (0.3) |
|
| Funding source | This study was funded by the Bayer Healthcare Company and by grants from the Chinese Medical Association Foundation and the Chinese Diabetes Society | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomly generated numbers sequence. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Low risk | Text and table. |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | High risk | Reasons not provided for losses. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Objective laboratory methods not described for HbA1c. |
| Selective reporting (reporting bias) | Low risk | Matches protocol. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | No evidence of other bias |