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

Nagrebetsky 2013.

Study characteristics
Methods Stepwise self‐titration of oral glucose‐lowering medication using a mobile telephone‐based telehealth platform in type 2 diabetes: a feasibility trial in primary care
Patient RCT, conducted in 7 general practices in Oxfordshire and Buckinghamshire, United Kingdom
Two arms: 1. Control group (control arm) and 2. Intervention group (intervention arm)
Participants Control arm N: 9
Intervention arm N: 8
Diabetes type: type 2
Mean age: 58.0 ± 11.0
% Male: 71.0
Longest follow‐up: 12 months
Interventions Control arm:
1) Case management
Intervention arm:
1) Case management
2) Electronic patient registry
3) Facilitated relay of clinical information
4) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 8.2 (3.4), post 7.5 (3.6)
Intervention arm: pre 8.1 (3.1), post 7.0 (2.8)
2) Harms (hypoglycaemia), N (%)
Control arm: pre NR (NR), post 0 (0)
Intervention arm: pre NR (NR), post 1 (14)
Funding source This study was funded by the National Institute for Health Research School for Primary Care Research and the National Institute for Health Research Biomedical Research Centre Programme, Oxford, United Kingdom
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Minimisation.
Allocation concealment (selection bias) High risk We can predict next sequence with minimisation.
Patient's baseline characteristics (selection bias) Unclear risk Not reported in text or table.
Patient's baseline outcomes (selection bias) Unclear risk Not mentioned in text or table.
Incomplete outcome data (attrition bias) High risk Information not available.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk HbA1c objective measures not described and outcome assessor blinding not described.
Selective reporting (reporting bias) High risk < 2005 approach used since no protocol. They talked about measuring BP but did not provide results.
Risk of contamination (other bias) Low risk Information not available.
Other bias Low risk Information not available.