Type 2 Diabetes Mellitus (T2DM)PDENCT07793305
Precision Diabetes Education Guided by Diabetes Complication Risk Assessment
A study testing Precision Diabetes Education (PDE) in people with Type 2 Diabetes Mellitus (T2DM), run by Taiwanese Association of Diabetes Educators at 6 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Precision Diabetes Education (PDE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesTaiwan
- Study dates
- 1 Mar 2024to 18 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833401
Taichung Veterans General Hospital
Taichung, 407219
National Cheng Kung University Hospital
Tainan, 704302
National Taiwan University Hospital
Taipei, Taipei, 100225
MacKay Memorial Hospital
Taipei, Taipei, 104213
About this study
Official title: 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.
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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Precision Diabetes Education (PDE)
- Keywords
- Precision Diabetes Education, Diabetes Self-Management Education and Support, Diabetes Complication Risk Assessment, Personalized Diabetes Education, Risk Prediction, Diabetes Complications, Shared Decision-Making
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Diabetes Education (PDE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Precision Diabetes Education (PDE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1c
Change in hemoglobin A1c from baseline to the 6-month assessment, expressed in percentage points.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Mar 2024
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwanese Association of Diabetes Educators
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Mackay Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793305
- Sponsor's protocol ID
- TADE-PDE-2024-P1
- Acronym
- PDE
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Diabetes Education According to Diabetic Complication Risk Assessment Tool
- ClinicalTrials.gov ID
- NCT07793305
- Acronym / sponsor ID
- PDE / TADE-PDE-2024-P1
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Taiwanese Association of Diabetes EducatorsUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Mackay Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Chang Gung Memorial Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Precision Diabetes Education | Experimental | Behavioral: Precision Diabetes Education (PDE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precision 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. | Behavioural | Precision Diabetes Education |
Primary outcome
Change From Baseline in Hemoglobin A1c
Time frame: Baseline and Month 6
Change in hemoglobin A1c from baseline to the 6-month assessment, expressed in percentage points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Diabetes Education (PDE) in people with Type 2 Diabetes Mellitus (T2DM), run by Taiwanese Association of Diabetes Educators at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin A1c (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.