ClinicalTrials.gg
CompletedNCT07793305PDEUpdated Aug 28, 2026

Precision Diabetes Education Guided by Diabetes Complication Risk Assessment

An interventional study of Precision Diabetes Education (PDE) in Type 2 Diabetes Mellitus (T2DM), sponsored by Taiwanese Association of Diabetes Educators. Completed at 6 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Taiwanese Association of Diabetes Educators · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Mar 2024, registered Aug 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 277 studies in Diabetes Mellitus, Type 2 with a site in Taiwan — 36 open to participants now, 41 under way, 14 of them phase 3. Diabetes Mellitus, Type 2 · Taiwan.

Enrollment
162nd of 244
180 · median 436
Started
2024
with 9 others
No phase
56 of 277
12 open now
Registered
275th of 277
by date

Among the 277 studies in Diabetes Mellitus, Type 2 with a site in Taiwan, this one is the 162nd largest by enrollment of the 244 interventional ones that give a count, is one of 10 that started in 2024, is one of 56 with no phase, and was the 275th registered.

Diabetes Mellitus, Type 2

10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

36 of the 277 studies in Diabetes Mellitus, Type 2 with a site in Taiwan are open now. Recruiting first, the newest first:

31 more — sign in →

All 36 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Type 2 Diabetes Mellitus (T2DM)

Keywords

  • Precision Diabetes Education
  • Diabetes Self-Management Education and Support
  • Diabetes Complication Risk Assessment
  • Personalized Diabetes Education
  • Risk Prediction
  • Diabetes Complications
  • Shared Decision-Making
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults aged 18 years or older with a diagnosis of type 2 diabetes mellitus and without established chronic diabetes complications.
  2. 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 .

Exclusion criteria

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 .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    Precision Diabetes Education

    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

  • BehavioralPrecision Diabetes Education (PDE)

    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.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c

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

    Time frame: Baseline and Month 6

Other outcomes

  1. Change From Baseline in Systolic Blood Pressure

    Change in systolic blood pressure from baseline to the 6-month assessment, expressed in mmHg.

    Time frame: Baseline and Month 6

  2. Change From Baseline in Diastolic Blood Pressure

    Change in diastolic blood pressure from baseline to the 6-month assessment, expressed in mmHg.

    Time frame: Baseline and Month 6

  3. Change From Baseline in Body Weight

    Change in body weight from baseline to the 6-month assessment, expressed in kilograms.

    Time frame: Baseline and Month 6

  4. Change From Baseline in Total Cholesterol

    Change in serum total cholesterol from baseline to the 6-month assessment, expressed in mg/dL.

    Time frame: Baseline and Month 6

  5. Change From Baseline in Low-Density Lipoprotein Cholesterol

    Change in serum low-density lipoprotein cholesterol from baseline to the 6-month assessment, expressed in mg/dL.

    Time frame: Baseline and Month 6

  6. Change From Baseline in High-Density Lipoprotein Cholesterol

    Change in serum high-density lipoprotein cholesterol from baseline to the 6-month assessment, expressed in mg/dL.

    Time frame: Baseline and Month 6

  7. Change From Baseline in Triglycerides

    Change in serum triglyceride concentration from baseline to the 6-month assessment, expressed in mg/dL.

    Time frame: Baseline and Month 6

  8. Change From Baseline in Serum Creatinine

    Change in serum creatinine from baseline to the 6-month assessment, expressed in mg/dL.

    Time frame: Baseline and Month 6

  9. Change From Baseline in Urinary Albumin-to-Creatinine Ratio

    Change in urinary albumin-to-creatinine ratio from baseline to the 6-month assessment, expressed in mg/g.

    Time frame: Baseline and Month 6

  10. Change From Baseline in Medication Adherence Score

    Change in the 6-item self-reported medication adherence score from baseline to Month 6. Total scores range from 0 to 12, with higher scores indicating better medication adherence.

    Time frame: Baseline and Month 6

  11. Change From Baseline in Diabetes-Related Emotional Distress

    Change in the 8-item Problem Areas in Diabetes Short Form (PAID-SF-8) score from baseline to Month 6. Total scores range from 0 to 32, with higher scores indicating greater diabetes-related emotional distress.

    Time frame: Baseline and Month 6

  12. Change From Baseline in Dietary Quality Score

    Change in the study-specified 10-item dietary quality score from baseline to Month 6. Total scores range from 10 to 50, with lower scores indicating healthier dietary behaviors.

    Time frame: Baseline and Month 6

  13. Change From Baseline in Neuropathic Pain Score

    Change in Douleur Neuropathique 4 (DN4) score from baseline to Month 6. Total scores range from 0 to 10, with higher scores indicating a greater burden of neuropathic pain symptoms.

    Time frame: Baseline and Month 6

07

Study locations

6 sites
  • National Taiwan University Hospital
    Taipei, Taipei 100225, Taiwan
  • MacKay Memorial Hospital
    Taipei, Taipei 104213, Taiwan
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung City, 80756, Taiwan
  • Kaohsiung Chang Gung Memorial Hospital
    Kaohsiung City, 833401, Taiwan
  • Taichung Veterans General Hospital
    Taichung, 407219, Taiwan
  • National Cheng Kung University Hospital
    Tainan, 704302, Taiwan
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Feb 2025, 11 months.

Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 11 months is below that.

Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2026
First posted
Aug 28, 2026
StartActual
Mar 1, 2024
Primary completionActual
Feb 18, 2025
CompletionActual
Feb 18, 2025
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07793305
Lead sponsor
Taiwanese Association of Diabetes Educators
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Mar 1, 2024
Primary completion
Feb 18, 2025
Completion
Feb 18, 2025
Last update
Aug 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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