Kim 2016a.
Study characteristics | ||
Methods |
Clinical evaluation of OneTouch diabetes management software system in patients with type 2 diabetes mellitus RCT, 1) This study was conducted in a single centre for diabetes education in Korea (outpatient clinic). 2) Intervention patients were assigned into the OneTouch Diabetes Management Software (OTDMS) group. Nurses provided an OTDMS’s report sheet. Doctors explained and educated patients using OTDMS’s report during consultation hours. Two arms: 1. Control (conventional medical treatment and education) and 2. Intervention (OneTouch Diabetes Management Software‐OTDMS) |
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Participants | Participants Control arm N: 58 Intervention arm N: 63 Diabetes type: 2 Mean age: 56.68 ± 10.39 % Male: 45.65 Longest follow‐up: 6 months |
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Interventions |
Control arm: (conventional medical treatment and education) 1) Electronic patient registry 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management Intervention arm: (OneTouch Diabetes Management Software‐OTDMS) 1) Team change 2) Electronic patient registry 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management |
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Outcomes | 1) Glycated haemoglobin 2) Harms (frequency of hypoglycaemia) |
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Funding source | This work was supported by the 2011 Inje University research grant | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. A total of 121 patients with type 2 DM were randomly assigned into 2 groups: 63 patients were assigned into the OTDMS group and 58 patients were assigned into the control group. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Unclear risk | We compared baseline characteristics of all patients (Table 5). There was no significant difference in age, sex and duration of diabetes. However, they only report data for the patients who completed the study (n = 92) and not for all the patients randomised (n = 121). |
Patient's baseline outcomes (selection bias) | Unclear risk | We compared baseline characteristics of all patients (Table 5). There was no significant difference in the level of HbA1c, BMI and the type of treatment between the OTDMS and control groups. There was no significant difference in knowledge, compliance, reliability and satisfaction. However, they only report data for the patients who completed the study (n = 92) and not for all the patients randomised (n = 121). |
Incomplete outcome data (attrition bias) | High risk | 92 patients completed the study out of 121 randomised (24% lost). 50/58 patients in the control group (lost 14%) and 42/63 in the intervention group (lost 33%) completed the study. High and unbalanced numbers. Reasons reported but not for each arm. Quote: "Excluded were patients (total 29) who were under 20 years of age (n = 3), and who had incomplete data in compliance (n = 9), HbA1c (n = 13), and BMI (n = 4)." |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | HbA1c was objectively measured. Method to measure hypoglycaemia not reported (but secondary outcome). |
Selective reporting (reporting bias) | Unclear risk | No registered or published protocol. Results match with methods. |
Risk of contamination (other bias) | Unclear risk | We provided all patients conventional education and a home blood glucose meter that automatically transmits blood glucose data to the hospital. It is unclear if doctors had access to transmitted data from their control patients. Study delivered in a single centre for diabetes. It is possible that doctors changed their approach with their control patients after providing tailored education to their patients in the intervention group. |
Other bias | Low risk | No evidence of other bias. |