Franciosi 2011.
| Study characteristics | ||
| Methods |
ROSES: role of self‐monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial. Patient RCT, conducted in 3 diabetes clinics and home self‐monitoring, Italy Two arms: 1. Usual care (control arm) and 2. Self‐monitoring (intervention arm) |
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| Participants | Control arm N: 16 Intervention arm N: 46 Diabetes type: type 2 Mean age: 48.9 ± 0.5 % Male: 74.2 Longest follow‐up: 6 months |
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| Interventions |
Control arm: 1) Patient education Intervention arm: 1) Case management 2) Clinician education 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (pre: SD, post: SE) Control arm: pre 7.9 (0.6), post 7.2 (0.2) Intervention arm: pre 7.9 (0.6), post 6.7 (0.1) 2) SBP, mean mmHg (SE) Control arm: pre 132.0 (4.0), post 125.0 (4.0) Intervention arm: pre 137.0 (3.0), post 133.0 (2.0) 3) DBP, mean mmHg (SE) Control arm: pre 80.0 (2.0), post 79.0 (2.1) Intervention arm: pre 80.0 (2.0), post 77.0 (1.0) 4) Harms (hypoglycaemic events), N (%) Control arm: pre NR (NR), post 0 (0) Intervention arm: pre NR (NR), post 0 (0) |
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| Funding source | The study was unconditionally supported by LifeScan Inc. Clinical Research Management and Monitoring; Miriam Valentini, Celeste Pirozzoli and Rosalia Di Lallo, Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, SantaMaria Imbaro, Italy. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated randomization tables". |
| Allocation concealment (selection bias) | Low risk | Quote: "Centrally randomized by telephone". |
| Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
| Patient's baseline outcomes (selection bias) | Low risk | HbA1c (%), P = 0.80; SBP (mmHg), P = 0.32; DBP (mmHg), P = 0.65. |
| Incomplete outcome data (attrition bias) | High risk | Intervention group had greater number of losses. Quote: "All of the efficacy analyses were performed on the intention‐to‐treat population." Number lost to follow‐up and reasons provided. Those lost to follow‐up in the intervention group likely related to outcome, and these numbers are not balanced. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary: HbA1c is objective measure using laboratory methods, assessors not blinded. Secondary: SBP, measurement not reported, and assessors were unblinded. |
| Selective reporting (reporting bias) | High risk | Checked clinical trials.gov and after proposal also included some more endpoints. |
| Risk of contamination (other bias) | Low risk | Not indication that there was contamination. |
| Other bias | Low risk | Information not available. |