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

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)
Participants Control arm N: 50
Intervention arm N: 50
Diabetes type: type 2
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 3 months
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
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)
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.