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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

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)
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
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
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)
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