Del Prato 2012.
Study characteristics | ||
Methods |
Telecare provides comparable efficacy to conventional self‐monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine‐the ELEONOR Study Patient RCT, an Italian, multi‐centre, parallel‐group RCT, Italy Two arms: 1. Self‐monitored blood glucose (control arm) and 2. Telecare (intervention arm) |
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Participants | Control arm N: 149 Intervention arm N: 142 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 11.5 months |
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Interventions |
Control arm: 1) Facilitated relay of clinical information 2) Promotion of self‐management Intervention arm: 1) Facilitated relay of clinical information 2) Promotion of self‐management |
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Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.9 (1.0), post 8.2 (0.8) Intervention arm: pre 8.8 (0.9), post 8.1 (0.8) |
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Funding source | This study was supported by Sanofi‐Aventis | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Patient's baseline characteristics (selection bias) | Unclear risk | Quote: "Patient characteristics at screening were comparable in the telecare and conventional Self‐Monitoring of Blood Glucose (SMBG) groups." but not in table. |
Patient's baseline outcomes (selection bias) | Low risk | Quote: "Patient characteristics at screening were comparable in the telecare and conventional Self‐Monitoring of Blood Glucose (SMBG) groups." |
Incomplete outcome data (attrition bias) | High risk | Not a true intention‐to‐treat analysis (despite being stated, since they had criteria on what was considered an intention‐to‐treat analysis: i.e. had to have at least one follow‐up value, etc.). Numbers and reasons for loss to follow‐up were provided and seem balanced. Baseline based on those analysed. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Blinding of patients or outcome assessors was not described. HbA1c methods not described. |
Selective reporting (reporting bias) | Low risk | Checked protocol and everything matches. |
Risk of contamination (other bias) | Low risk | Information not available. |
Other bias | Low risk | No evidence of other bias |