Cho 2017.
Study characteristics | ||
Methods |
An Internet‐based health gateway device for interactive communication and automatic data uploading: clinical efficacy for type 2 diabetes in a multi‐centre trial RCT (NA clusters and NA providers), conducted in 1) Internet‐based communication and data management device. outpatient clinics of the Diabetes Center of Seoul St. Mary’s Hospital, the Seoul Asan Hospital’s Diabetes Center, and Kangbook Samsung Hospital’s Diabetes Center. 2) For the programme, the staff consisted of 2 nurses and 2 diabetologists per institute. There was a separate centre for nutrition and exercise counselling, which included 3 dietitians and 3 exercise experts. The medical team provided consultation to patients who decided to receive additional individualised education for lifestyle management in South Korea. 2 arms: 1) Control (usual care) (control arm) and 2) Intervention (Internet‐based communication) (intervention arm) |
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Participants | Control arm N: 240 Intervention arm N: 244, NA, NA Diabetes type: 2 Mean age: 53.15 ± 8.92 % Male: 63.43 Longest follow‐up: 6 months |
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Interventions |
Control arm: (usual care) 1) Patient education 2) Promotion of self‐management Intervention arm: (Internet‐based communication) 1) Case management 2) Team change 3) Electronic patient registry 4) Facilitated relay of clinical information 5) Patient education 6) Promotion of self‐management 7) Patient reminders |
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Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein |
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Funding source | The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: this work was supported by the Korean Ministries of Health and Welfare and of Trade, Industry and Energy. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were assigned to the intervention or control group using adaptive randomisation based on the stratified block randomisation design |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1. P values > 0.05. |
Patient's baseline outcomes (selection bias) | Low risk | Table 1. P values > 0.05. |
Incomplete outcome data (attrition bias) | Unclear risk | 444/484 (91.7%) completed the study. Unclear as to how many were lost in each arm. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure for HbA1c, BP, LDL. |
Selective reporting (reporting bias) | Unclear risk | There is no published protocol. Some of the outcomes (BUN, Cr) are not reported in the results. |
Risk of contamination (other bias) | Unclear risk | The patients were followed with the same physicians in both arms. As conventional management in the outpatient clinic, patients in the control group visited the diabetes centre and were provided with recommendations about medication, medication dosage and lifestyle modification from the diabetologist. |
Other bias | Low risk | None. |