Pressman 2014.
| Study characteristics | ||
| Methods |
A novel telemonitoring device for improving diabetes control: protocol and results from a randomized clinical trial RCT (NA clusters and NA providers), conducted in 1) Patients recruited at the Kaiser Permanente Northern California (KPNC) in the Santa Rosa, CA clinic. KPNC is an integrated healthcare delivery system with > 3.3 million members across a 14‐county region in northern California. Within the San Francisco and Greater Bay Area, approximately one‐third of insured adults receive their care through KPNC. 2) Intervention delivered by diabetes nurse care managers using a Samsung (Seoul, Korea) Health Diary (SHD) telemonitoring device. In United States of America 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (telemonitoring by nurses) (intervention arm) |
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| Participants | Control arm N: 128 Intervention arm N: 126, NA, NA Diabetes type: 2 Mean age: 55.2 ± 10.87 % Male: 62 Longest follow‐up: 6 months |
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| Interventions |
Control arm: (usual care) 1) Promotion of self‐management Intervention arm: (telemonitoring by nurses) 1) Electronic patient registry 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management |
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| Outcomes | Glycated haemoglobin Systolic blood pressure Low‐density lipoprotein |
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| Funding source | This project was partially funded by a grant from the Samsung Group, Inc. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported. Utilising a blocked design with variable block sizes, participants were randomly assigned either to have an SHD installed in their home or to receive usual care. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Unclear risk | Baseline data only for those who completed the study (Table 1). There were no significant differences between the 2 treatment arms in terms of age, gender, weight or body mass index at study entry. P values are not significant too. |
| Patient's baseline outcomes (selection bias) | Unclear risk | Baseline data only for those who completed the study (Table 1). There were no baseline differences between groups in outcome measures of systolic BP, LDL‐C, fructosamine, HbA1c, or self‐efficacy score. P values are also not significant. |
| Incomplete outcome data (attrition bias) | High risk | Removed many patients after randomisation (ineligible, 11.4%). Baseline data only for those who completed the study (Table 1). The proportion of participants who were lost to follow‐up differed by treatment arm (9% telemonitoring versus 16% usual care; P < 0.05). |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | All our outcomes of interest were objectively measured (HbA1c, SBP and LDL). Outcome assessments were made and analysed without knowledge of the randomisation allocation. |
| Selective reporting (reporting bias) | High risk | No registered protocol. Main outcome: BP control, but they only assessed SBP and not DBP. |
| Risk of contamination (other bias) | Low risk | Unlikely that control group received intervention. |
| Other bias | Low risk | None. |