Kim 2016.
Study characteristics | ||
Methods |
Randomized, open‐label, parallel group study to evaluate the effect of internet‐based glucose management system on subjects with diabetes in China RCT (NA clusters and NA providers), conducted in 1) First Bethune Hospital at Jilin University, China. 2) Nurses provided recommendations regarding blood sugar control. Participants who completed less than half of the recommended tests or who exhibited low blood sugar levels were provided with doctor consultations through text messaging or phone calls. In China. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (IBGMS) (intervention arm) |
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Participants | Control arm N: 110 Intervention arm N: 110, NA, NA Diabetes type: 2 Mean age: 54.03 ± 8.51 % Male: 48.35 Longest follow‐up: 6 months |
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Interventions |
Control arm: (usual care) 1) Patient education 2) Promotion of self‐management Intervention arm: (IBGMS) 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 | This work was supported in part by a research grant from the Investigator Initiated Study Program of UBcare. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | A block randomisation design with a block size of 4 and a ratio of 1:1 was used to ensure a balanced distribution. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | High risk | Table 1. Sex looks unbalanced (43% vs 53%). Average age is balanced but age breakdown is not (over 60 = 42% vs 25%). Antidiabetes medication not balanced between arms. |
Patient's baseline outcomes (selection bias) | Unclear risk | Table 1. Triglycerides P = 0.004 but looks balanced. All other outcomes look balanced. |
Incomplete outcome data (attrition bias) | High risk | A total of 220 participants were assigned to the IBGMS (n = 110) or control (n = 110) groups. During the 6‐month study period, 20 participants were excluded from the control group (18.2%) and 18 participants were excluded from the IBGMS group (16.4%), which left 90 participants in the control group and 92 participants in the IBGMS group for the final analysis. The dropout rate in this study was higher than in other studies. Patients were excluded from the study if they failed to upload data after 3 consecutive warning messages or phone calls. High but balanced numbers. |
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 | No registered or published protocol. Both the IBGMS and the control groups visited the hospital every 3 months for laboratory testing and a clinical examination to evaluate the safety and efficacy of their treatment. Laboratory testing included baseline HbA1c levels, white blood cell counts with the differential counts, red blood cell counts, haemoglobin and hematocrit levels, platelet counts, fasting blood sugar, blood urea nitrogen, creatinine, aspartate transaminase (AST), alanine transaminase (ALT), sodium, and potassium levels. In addition, the patients’ lipid profiles were evaluated, which included total cholesterol (TC), triglycerides (TG), high‐density lipoprotein cholesterol (HDL‐C), and low‐density lipoprotein cholesterol (LDL‐C). The participants’ height and weight were evaluated. Many outcomes are not reported (white and red blood cell counts, haemoglobin, hematocrit levels, platelet counts, sodium, and potassium levels). |
Risk of contamination (other bias) | Low risk | It is unlikely that control group used and received feedback from the Internet‐based glucose monitoring system (IBGMS). |
Other bias | Unclear risk | "We excluded patients who had not taken their medication regularly in the 3 months before enrollment." Selection bias. |