The study was part of the Precision Diabetes Education program coordinated by the Taiwanese Association of Diabetes Educators and conducted at six participating hospitals in Taiwan. The first part of the study used a prospective, single-group interventional design with a 6-month follow-up period.
After providing written informed consent, participants underwent collection of demographic, clinical, laboratory, medication, and health-behavior information. These data were entered into a diabetes complication risk assessment model developed by investigators from the National Health Research Institutes, Kaohsiung Medical University Hospital, and National Chengchi University. The model estimated individualized absolute and relative risks for six diabetes-related complications: diabetic kidney disease, atherosclerotic cardiovascular disease, congestive heart failure, ischemic stroke, diabetic retinopathy, and lower-extremity amputation.
Based on the risk assessment results, diabetes educators used a standardized education manual to provide individualized education focused primarily on the complication with the highest predicted risk. Participants also continued to receive standard diabetes education and routine clinical care. Personalized education was provided at enrollment and repeated approximately 3 months later. At 6 months, complication-risk assessment, clinical measurements, laboratory data, medication information, and patient-reported measures were reassessed.
The original study protocol did not specify a hierarchy of primary and secondary outcome measures. For retrospective registration, change in hemoglobin A1c from baseline to 6 months was designated as the registry primary outcome; the other outcomes listed in the original protocol are reported as other pre-specified outcomes.
