Kim 2010.
Study characteristics | ||
Methods |
Insulin dose titration system in diabetes patients using a short messaging service automatically produced by a knowledge matrix Patient RCT, conducted with patients recruited from an outpatient clinic of Hallym University Sacred Heart Hospital, Republic of Korea Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
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Participants | Control arm N: 50 Intervention arm N: 50 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 3 months |
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Interventions |
Control arm: 1) Facilitated relay of clinical information 2) Patient education 3) Promotion of self‐management Intervention arm: 1) Facilitated relay of clinical information 2) Patient education 3) Promotion of self‐management |
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Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 9.8 (1.2), post 7.8 (0.8) Intervention arm: pre 9.8 (1.3), post 7.4 (0.7) 2a) Harms (symptomatic hypoglycaemia episodes), N (%) Control arm: pre NR (NR), post 39 (87) Intervention arm: pre NR (NR), post 42 (89) 2b) Harms (asymptomatic hypoglycaemia), N (%) Control arm: pre NR (NR), post 5 (11) Intervention arm: pre NR (NR), post 5 (11) 2c) Harms (nocturnal hypoglycaemia), N (%) Control arm: pre NR (NR), post 5 (11) Intervention arm: pre NR (NR), post 6 (13) |
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Funding source | NA | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "… by a computer generated allocation sequence using adaptive randomization." Low risk, since minimisation is a type of adaptive randomization. |
Allocation concealment (selection bias) | High risk | Adaptive: you can predict the next assignment. |
Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
Patient's baseline outcomes (selection bias) | Low risk | Quote: HbA1c (P = 0.759). |
Incomplete outcome data (attrition bias) | Unclear risk | Although loss to follow‐up per arm was under 10%, numbers who did not have visit at 12 weeks seemed larger for intervention group. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Blinding not described and likely not implemented. HbA1c measurement was not described, no laboratory description. |
Selective reporting (reporting bias) | Low risk | Found protocol on clinical trials.gov. |
Risk of contamination (other bias) | Low risk | Information not available. |
Other bias | Low risk | Information not available. |