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) |
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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 |
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Interventions |
Control arm: None Intervention arm: 1) Case management 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management |
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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) |
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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. |