Kim 2009.

Methods	Parallel randomised controlled clinical trial (RCT): delayed intervention design used (control group received intervention after trial was complete) Randomisation ratio: 41:42 Superiority design
Participants	Inclusion criteria: Self‐identification as Korean American immigrant Age 30 years or older Self‐identification as having diabetes with an uncontrolled glucose level (A1C) > 7.5% within the past 6 months Resident of the Baltimore‐Washington area Ability to give written consent to participate in the intervention study Exclusion criteria: None specifically stated Diagnostic criteria: HbA1c over 7.5% on dry blood test (A1CNOW+) and serum sample 2 weeks later
Interventions	Number of study centres: 1 Treatment before study: not mentioned Intervention: Two‐hour weekly education sessions for 6 weeks (6 wk). Aimed at enhancing diabetes knowledge and promoting self‐care. Centred on the following 6 topics: (1) overview of type 2 diabetes and general diabetes management guidelines; (2) short‐ and long‐term complications of uncontrolled type 2 diabetes; (3) healthy eating and nutrition; (4) reading food labels and exercise; (5) medications and food‐drug interactions; (6) problem‐solving and communication skills with a primary care physician Home glucose monitoring (HGMT) with teletransmission (24 wk). Each participant received a glucometer, an electronic BP monitor and a teletransmission system. This transmission system allowed participant data to be stored on a website and was used to guide nurses counselling the participant. Monthly updates were generated Monthly telephone counselling by a bilingual nurse (24 wk). This aimed to reinforce new knowledge learned through the education programme, help find solutions to problems or issues raised and provide emotional support. Each session lasted about 10‐25 minutes Control: delayed intervention; received intervention after trial was complete Provider: education sessions run by trained bilingual nurses and a nutritionist; telephone counselling provided by a bilingual nurse
Outcomes	Outcomes reported in abstract of publication: All measured at baseline, 18 weeks and 30 weeks: HbA1C Fasting glucose (mg/dL and mmol/L) Systolic blood pressure (mm Hg) Diastolic blood pressure (mm Hg) Cholesterol (mg/dL and mmol/L) HDL (mg/dL and mmol/L) LDL (mg/dL and mmol/L) Triglyceride (mg/dL and mmol/L) BMI (kg/m2) Diabetes Knowledge (measured using a Korean version of the validated Diabetes Knowledge Test) Self‐efficacy in diabetes management (measured using a Korean version of the Stanford Chronic Disease Self‐Efficacy Scale) Diabetes self‐care activities (measured using the Summary of Diabetes Self‐Care Activities, SDSCA) Depression (measured using Kim Depression Scale for Korean Americans, KDSKA) Quality of Life (measured using the Diabetes Quality of Life Measure, DQOL)
Study details	Run‐in period: not stated. No dates given for when study was carried out, although recruitment target was reached within 3 months, and follow‐up was 6 months (so whole study lasted about 9 months) Study terminated before regular end: no
Publication details	Language of publication: English Funding: National Institutes of Health, Lifescan, Johns Hopkins University School of Medicine General Clinical Research Center, National Center for Research Resources/National Institutes of Health Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To empower Korean American Immigrants (KAIs) who have type 2 diabetes with greater knowledge, self‐efficacy and self‐help skills concerning diabetes"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: sequence generated by computer‐automated random assignment
Allocation concealment (selection bias)	Unclear risk	Comment: not mentioned
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: participants not blinded to which group they were in, not feasible because of the nature of the intervention
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: participants not blinded to which group they were in, not feasible because of the nature of the intervention
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Unclear risk	Comment: does not say whether research staff or laboratory staff were blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: participants unlikely to have been blinded
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: low attrition rate but not an ITT analysis, and no mention of reasons for dropping out of study
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: low attrition rate but not an ITT analysis, and no mention of reasons for dropping out of study
Selective reporting (reporting bias)	Unclear risk	Comment: all stated outcomes reported but protocol not seen
Other bias	Unclear risk	Comment: none