Orsama 2013.
| Study characteristics | ||
| Methods |
Active assistance technology reduces glycosylated hemoglobin and weight in individuals with type 2 diabetes: results of theory‐based randomized trial Patient RCT, conducted in Sipoo, Finland, Community Health Centre, Finland Two arms: 1. Control group (control arm) and 2. Intervention group (intervention arm) |
|
| Participants | Control arm N: 29 Intervention arm N: 27 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 10 months |
|
| Interventions |
Control arm: None Intervention arm: 1) Electronic patient registry 2) Facilitated relay of clinical information 3) Promotion of self‐management 4) Patient reminders |
|
| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.1 (1.5), post 7.1 (NR) Intervention arm: pre 6.9 (1.6), post 6.5 (NR) 2) SBP, mean mmHg (SD) Control arm: pre 146.5 (15.3), post 136.7 (NR) Intervention arm: pre 157.0 (15.6), post 136.5 (NR) 3) DBP, mean mmHg (SD) Control arm: pre 84.7 (9.1), post 78.4 (NR) Intervention arm: pre 88.5 (10.3), post 78.0 (NR) |
|
| Funding source | The Finnish Funding Agency for Technology and Innovation, Technical Research Centre of Finland, and Bayer HealthCare are acknowledged for funding the study. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Generated list of random numbers. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Low risk | Tables and text. |
| Patient's baseline outcomes (selection bias) | High risk | Secondary outcome: SBP (P = 0.029). |
| Incomplete outcome data (attrition bias) | High risk | ~17.7% lost to follow‐up in control; ~11% in intervention. N = 3 did not complete baseline in control; imbalanced reasons between groups. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | No objective laboratory methods described for primary (HbA1c); and secondary (SBP, DBP) outcomes. |
| 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. |