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

Kirwan 2013.

Study characteristics
Methods Diabetes self‐management smartphone application for adults with type 1 diabetes: randomized controlled trial
Patient RCT, conducted with patients registered with Diabetes Australia in New South Wales, Queensland, as well as advertisements in a type 1 diabetes national newsletter. In Australia.
Two arms: 1. Control (control arm) and 2. Intervention (intervention arm)
Participants Control arm N: 36
Intervention arm N: 36
Diabetes type: type I
Mean age: 35.2 ± 10.4
% Male: 39.0
Longest follow‐up: 9 months
Interventions Control arm:
None
Intervention arm:
1) Case management
2) Facilitated relay of clinical information
3) Patient education
4) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 8.5 (0.9), post 8.6 (1.2)
Intervention arm: pre 9.1 (1.2), post 7.8 (0.8)
Funding source This study was funded by Central Queensland University, Australia. C Vandelanotte is supported by a National Health and Medical Research Council of Australia (#519778) and National Heart Foundation of Australia (#PH 07B 3303) postdoctoral research fellowship. M Kirwan is supported by a Queensland Government, Department of Tourism, Regional Development and Industry, SmartFutures PhD Scholarship.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "…randomized patients using a freely available online randomization program."
Allocation concealment (selection bias) Unclear risk Assuming they are being randomised as they are enrolled. Quote: "…was used during the 3 month rolling recruitment to ensure roughly equal number of patients were allocated to each comparison group."
Patient's baseline characteristics (selection bias) Low risk More females in control group (P = 0.02).
Patient's baseline outcomes (selection bias) High risk HbA1c P = 0.02.
Incomplete outcome data (attrition bias) High risk ~22% lost to follow‐up in control and ~31% in intervention; reasons for loss to follow‐up could not be provided, since study participants could not be re‐contacted.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Primary outcome: HbA1c, collected through a pathology laboratory, need to describe method.
Selective reporting (reporting bias) Low risk < 2005 approach used since no protocol; methods match results.
Risk of contamination (other bias) High risk Quote: "Although patients in the control group were instructed not to use any mobile applications to self‐manage their diabetes during the study period, it is possible they did."
Other bias Low risk Information not available.