Precision Diabetes Education Guided by Diabetes Complication Risk Assessment

Precision Diabetes Education According to Diabetic Complication Risk Assessment Tool

This prospective, multicenter interventional study evaluated the implementation of precision diabetes education guided by individualized diabetes complication risk assessment in adults with type 2 diabetes. The study was conducted at six hospitals in Taiwan.

Participants underwent assessment of their predicted risks for six major diabetes-related complications: diabetic kidney disease, atherosclerotic cardiovascular disease, congestive heart failure, ischemic stroke, diabetic retinopathy, and lower-extremity amputation. Diabetes educators used the risk assessment results to identify the complication with the highest predicted risk and to provide individualized education focused on prevention and modification of relevant health behaviors. Participants continued to receive standard diabetes education and routine clinical care. Personalized education was provided at enrollment and again during follow-up, with clinical information, complication-risk assessment, and patient-reported measures collected during the 6-month study period.

The study aimed to establish a personalized diabetes education model based on complication-risk assessment and to improve the quality of diabetes complication prevention and care.

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.

Inclusion Criteria:

1. Adults aged 18 years or older with a diagnosis of type 2 diabetes mellitus and without established chronic diabetes complications.
2. Hemoglobin A1c between 7% and 9%.
3. Stable type and dosage of glucose-lowering medications during the preceding 6 months.
4. Ability to independently understand the study information and procedures and to make an informed decision regarding participation.
5. Willingness to provide written informed consent.

Exclusion Criteria:

1. Clinically unstable conditions, including acute diabetes-related conditions such as diabetic ketoacidosis, hyperosmolar hyperglycemic state, severe hypoglycemia, acute infection, or acute organ injury.
2. Terminal illness requiring palliative care or other conditions for which active treatment is no longer appropriate.
3. Unwillingness or inability to provide written informed consent.