NCT07793305

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2025

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 25, 2026

Last Update Submit

August 25, 2026

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Precision Diabetes EducationDiabetes Self-Management Education and SupportDiabetes Complication Risk AssessmentPersonalized Diabetes EducationRisk PredictionDiabetes ComplicationsShared Decision-Making

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Hemoglobin A1c

    Change in hemoglobin A1c from baseline to the 6-month assessment, expressed in percentage points.

    Baseline and Month 6

Other Outcomes (13)

  • Change From Baseline in Systolic Blood Pressure

    Baseline and Month 6

  • Change From Baseline in Diastolic Blood Pressure

    Baseline and Month 6

  • Change From Baseline in Body Weight

    Baseline and Month 6

  • +10 more other outcomes

Study Arms (1)

Precision Diabetes Education

EXPERIMENTAL

Participants underwent individualized diabetes complication risk assessment and received personalized diabetes education based primarily on the complication with the highest predicted risk. Standard diabetes education and routine clinical care were continued throughout the study. Personalized education was provided at enrollment and repeated approximately 3 months later, with reassessment at 6 months.

Behavioral: Precision Diabetes Education (PDE)

Interventions

Precision Diabetes Education (PDE)BEHAVIORAL

Participants underwent individualized risk assessment for six major diabetes-related complications: diabetic kidney disease, atherosclerotic cardiovascular disease, congestive heart failure, ischemic stroke, diabetic retinopathy, and lower-extremity amputation. Based on the predicted risk profile, diabetes educators used a standardized education manual to provide personalized education focused primarily on the complication with the highest predicted risk and relevant modifiable health behaviors. Participants 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 and relevant clinical and patient-reported measures were reassessed.

Precision Diabetes Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

National Taiwan University Hospital

Taipei, Taipei, 100225, Taiwan

Location

MacKay Memorial Hospital

Taipei, Taipei, 104213, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833401, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704302, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All participants were assigned to a single intervention group and received individualized diabetes complication risk assessment followed by personalized diabetes education based on the complication with the highest predicted risk.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 28, 2026

Study Start

March 1, 2024

Primary Completion

February 18, 2025

Study Completion

February 18, 2025

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the original study protocol did not include a plan for external IPD sharing. Study findings may be reported in aggregate form.

Locations

TW(6)