Jeong 2018.
Study characteristics | ||
Methods |
Smart care based on telemonitoring and telemedicine for type 2 diabetes care: multi‐center randomized controlled trial RCT (NA clusters and NA providers), conducted in 1) Volunteers with diabetes were recruited from the outpatient clinic of 4 urban university hospitals in South Korea (Kyungpook National University Hospital, Yeungnam University Medical Center, Yonsei Severance Hospital and Gangnam Severance Hospital). Intervention delivered by telemonitoring or telemedicine. 2) In the 2 intervention groups, the physicians and diabetes specialist nurses at the Smart Care Center were responsible for responses to patients’ telephone calls and management of remote glucose monitoring and feedback. In the telemedicine group, assessment by outpatient visits was replaced by video conferencing with an endocrinologist. In South Korea. 3 arms: 1. Control (conventional face‐to‐face care) (control arm) and 2. Intervention 1 (telemonitoring care) (intervention arm), 3. Intervention 2 (telemedicine care) (other arm) |
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Participants | Control arm N: 113 Intervention arm N: 113, 112, NA Diabetes type: 2 Mean age: 53.09 ± 12.29 % Male: 67.46 Longest follow‐up: 5.54 months |
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Interventions |
Control arm: (conventional face‐to‐face care) 1) Patient education 2) Promotion of self‐management Intervention arm: (telemonitoring care) 1) Case management 2) Electronic patient registry 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management Intervention arm: (telemedicine care) 1) Case management 2) Electronic patient registry 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management |
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Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein Harms |
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Funding source | This research was supported by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, funded by the Ministry of Health & Welfare, Republic of Korea (HI16C1501) and a 2010 consignment research grant from LG Electronics through the Ministry of Trade, Industry and Energy of South Korea (1003518) | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not reported. Patients were randomised to 3 groups: a conventional care group (n = 113), a telemonitoring group (n = 113) and a telemedicine group (n = 112). |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1. All patient characteristics have P values higher than 0.05. Quote: "These parameters were statistically not different among three groups, as indicated in Table 1 (P > 0.05)." |
Patient's baseline outcomes (selection bias) | Low risk | Table 1. All baseline outcomes are not significant but no P values reported for the primary outcome (HbA1c, Tables 1 and 2). |
Incomplete outcome data (attrition bias) | Low risk | Figure 1. 101/113 patients in the control group (11% lost) completed the study while 99/113 and 99/112 did in the telemonitoring (12% lost) and the telemedicine (12% lost) groups, respectively. Reasons reported and balanced. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcome (HbA1c) was objectively measured as well as blood pressure and LDL. It is assumed that hypoglycaemia events were also objectively collected (auto‐transmitter system for glucose concentration, as determined by a glucometer). |
Selective reporting (reporting bias) | High risk | Prospectively registered protocol. They added a lot of subgroup analyses for HbA1c based on sex, age, education level, etc. that were not planned in the methods section and protocol. |
Risk of contamination (other bias) | Unclear risk | Patient‐randomised. It is likely that most endocrinologists were taking care of patients from all groups. In the 2 interventions groups, the same physicians and nurses at the Smart Care Center were responsible for responses to patients’ telephone calls and management of remote glucose monitoring and feedback. All groups significantly improved for HbA1c level at the end of the intervention (Table 2, P < 0.0001). |
Other bias | Low risk | No evidence of other risk of bias. |