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Diabetes (DM)NCT07758413

Pilot RCT of a Chinese Medicine Diabetes Education Programme

A study testing Chinese Medicine Diabetes Education Programme in people with Diabetes (DM) and Medicine, Chinese Traditional, run by The Hong Kong Polytechnic University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if a Chinese medicine diabetes education programme is feasible and acceptable, and to explore its preliminary effects on self-management, for adults with type 2 diabetes in Hong Kong. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes (DM), Medicine, Chinese Traditional
What is being tested?
Chinese Medicine Diabetes Education Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
30 Jul 2026to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 above
  • Diagnosed with type 2 diabetes mellitus
  • Able to understand and communicate in Cantonese, and able to read Chinese
  • Willing and able to provide written informed consent
  • Able to attend the education sessions at the designated venues

Who cannot join

  • Severe cognitive impairment that would prevent meaningful participation in group education
  • Acute or unstable medical conditions, or serious chronic illnesses currently under active treatment (e.g., ongoing cancer treatment), that may preclude safe participation in group activities
  • Currently participating in another structured diabetes education research programme
  • Pregnancy

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yuen-Shan Ho, PhD contact

852 2766 6410

janice.ys.ho@polyu.edu.hk

About this study

Official title: Development and Pilot Test of a Chinese Medicine Diabetes Education Program 中醫糖尿病個人管理教育方案建構及初步試驗

The goal of this clinical trial is to learn if a Chinese medicine diabetes education programme is feasible and acceptable, and to explore its preliminary effects on self-management, for adults with type 2 diabetes in Hong Kong. The main questions it aims to answer are:

  1. Is the Chinese medicine diabetes education programme feasible to deliver in a community setting (recruitment, retention and adherence)?
  2. Is the programme acceptable to participants?
  3. Does the programme show early signals of improving diabetes management self-efficacy and related outcomes?
Read more

Researchers will compare the Chinese medicine education programme to usual care to see if the programme is feasible, acceptable and shows preliminary benefits.

Participants will:

  1. Be randomly assigned to either a 4-week Chinese medicine diabetes education programme (four group sessions, total 4-6 hours) or usual care
  2. Complete assessments at baseline, after the programme, and at 2-month follow-up.
  3. Attend a focus group interview at the end of the study (selected participants)

Outcome assessors will be blinded to group allocation.

Read the detailed description

This pilot randomised controlled trial evaluates the feasibility, acceptability and preliminary effects of a Chinese medicine diabetes education programme for adults with type 2 diabetes in Hong Kong.

While Western-medicine-based diabetes education is well established locally, systematic and interactive Chinese medicine education remains limited. The programme integrates Chinese medicine concepts (body constitution, pattern differentiation, dietary therapy, emotional regulation, acupressure and lifestyle advice) with modern self-management principles. Content was refined through literature review, patient input and Delphi consensus.

Forty adults with type 2 diabetes will be randomly allocated (1:1) to either a 4-week group education programme (four sessions, total 4-6 hours) or usual care. The control group will be offered the programme after final follow-up. Participants and facilitators are not blinded due to the nature of the educational intervention; outcome assessors will remain blinded to group allocation.

Primary aims are to assess feasibility (recruitment, retention, adherence) and acceptability. Exploratory outcomes, measured at baseline, post-intervention and 2-month follow-up, include diabetes management self-efficacy (Chinese version of the Diabetes Management Self-Efficacy Scale, C-DMSES; Wu et al., 2008), self-management behaviours, blood glucose, lipids, BMI and blood pressure. Focus group interviews will gather qualitative feedback.

Being tested
Chinese Medicine Diabetes Education Programme
Keywords
Diabetes Mellitus, patient education, self-management, medicine, chinese traditional
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chinese Medicine Diabetes Education ProgrammeBehavioural

    A structured 4-week group education programme (four sessions, total contact time 4-6 hours) that integrates Chinese medicine concepts (body constitution, pattern differentiation, dietary therapy, emotional regulation, acupressure, and lifestyle advice) with modern diabetes self-management education.

Study groups in NCT07758413
Study groupRoleWhat they receive
Usual CareNo interventionParticipants will continue their usual medical care and any existing diabetes education or support. No additional structured Chinese medicine diabetes education programme will be provided during the study. After the final follow-up, they will be offered the same education programme.
Chinese Medicine Diabetes Education ProgrammeExperimentalParticipants will receive a 4-week Chinese medicine diabetes education programme consisting of four weekly group sessions (total 4-6 hours). Content includes Chinese medicine concepts of diabetes, body constitution, diet, emotional regulation, acupressure, skin and foot care, and physical activity.
Receives: Behavioral: Chinese Medicine Diabetes Education Programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Proportion of eligible individuals who provide informed consent and are randomised into the study.

    Measured: From start of recruitment to end of recruitment period

  2. Retention rate

    Proportion of randomised participants who complete the post-intervention assessment (T1) and the 2-month follow-up assessment (T2).

    Measured: From randomisation to 2-month follow-up

  3. Adherence to the education programme

    Proportion of participants in the intervention group who attend at least 3 out of the 4 scheduled education sessions.

    Measured: During the 4-week intervention period

  4. Acceptability of the programme

    Participant-reported acceptability and satisfaction with the Chinese medicine diabetes education programme, assessed by a structured questionnaire at the end of the programme. Additional qualitative feedback will be collected through focus group interviews at 2-month follow-up.

    Measured: At the end of the 4-week education programme

Secondary outcomes (6)

  1. Diabetes management self-efficacy

    Measured by the Chinese version of the Diabetes Management Self-Efficacy Scale (C-DMSES).

    Measured: Baseline, post-intervention (T1), and 2-month follow-up (T2)

  2. Diabetes self-management behaviours

    Self-reported diabetes self-management behaviours, assessed using a participant logbook recording the frequency of exercise, acupressure, blood glucose monitoring and other self-care activities.

    Measured: Baseline, post-intervention (T1), and 2-month follow-up (T2)

  3. Blood glucose level

    Fasting blood glucose level, HbA1c

    Measured: Baseline and 2-month follow-up (T2)

  4. Blood lipid levels

    Total cholesterol, triglycerides, HDL-C and LDL-C

    Measured: Baseline and 2-month follow-up (T2)

  5. Body mass index (BMI)

    Calculated from measured height and weight.

    Measured: Baseline, post-intervention (T1), and 2-month follow-up (T2)

  6. Blood pressure

    Systolic and diastolic blood pressure.

    Measured: Baseline, post-intervention (T1), and 2-month follow-up (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2026
  2. Study start30 Jul 2026 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07758413
Sponsor's protocol ID
P0046606
Status last verified
Aug 2026
First submitted
6 Aug 2026
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Chinese Medicine Diabetes Education Programme in people with Diabetes (DM) and Medicine, Chinese Traditional, run by The Hong Kong Polytechnic University.

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 4 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: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuen-Shan Ho, PhD (852 2766 6410, janice.ys.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: From start of recruitment to end of recruitment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07758413.

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 11 Aug 2026.

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