Ismail 2013.
| Study characteristics | ||
| Methods |
Usage of glucometer is associated with improved glycaemic control in type 2 diabetes mellitus patients in Malaysian public primary care clinics: an open‐label randomised controlled trial Patient RCT, conducted in 5 public primary care clinics in Malaysia Two arms: 1. Group 1 (control arm) and 2. Group 2 (intervention arm) |
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| Participants | Control arm N: 47 Intervention arm N: 58 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 6 months |
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| Interventions |
Control arm: 1) Patient education Intervention arm: 1) Case management 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.9 (2.0), post 9.3 (NR) Intervention arm: pre 9.2 (2.1), post 8.3 (NR) 2) SBP, mean mmHg (SD) Control arm: pre 131.7 (18.4), post 130.2 (NR) Intervention arm: pre 131.5 (15.2), post 128.2 (NR) 3) DBP, mean mmHg (SD) Control arm: pre 80.2 (6.9), post 79.2 (NR) Intervention arm: pre 79.2 (8.4), post 77.9 (NR) |
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| Funding source | NA | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not sure: nurses put 1 to 10 consecutively in envelopes and gave them to patients, pre‐specified that certain numbers would be in intervention and control. |
| Allocation concealment (selection bias) | High risk | Nurses were not blinded, so they may have known the next consecutive number in the stack. |
| Patient's baseline characteristics (selection bias) | Low risk | In text and in table. |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | Low risk | ~8.5% lost to follow‐up in control group and ~3% in intervention group; reasons seem balanced and do not seem to be influenced by intervention. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | HbA1c: no objective laboratory method described. For BP used sphygmomanometer. |
| Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; methods match results. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |