Diabetes Mellitus, Type 2NCT07129915
Nudge-Based Shared Decision Making and Self-Management in Type 2 Diabetes: A Randomized Trial
A study testing Linguistic Nudging Training, Medication Preference App and Standard Diabetes Care in people with Diabetes Mellitus, Type 2 and Physician-Patient Relations, run by Yunxuan Li at 1 site in China.
Trial summary
This study aims to test whether a communication strategy called "linguistic nudging" can help doctors and patients with type 2 diabetes make better treatment decisions together, and whether this improves patients' ability to manage their condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Physician-Patient Relations, Self-management
- What is being tested?
- Linguistic Nudging Training, Medication Preference App and Standard Diabetes Care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to Jun 2026
- 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
- Confirmed diagnosis of type 2 diabetes
- Age ≥ 18 years
- Normal cognitive function (assessed by Mini-Cog score ≥ 3)
- Basic smartphone operation ability (can independently use WeChat)
- Willing to participate and sign informed consent
Who cannot join
- Severe acute complications (e.g., ketoacidosis, hyperosmolar coma)
- Documented cognitive impairment (dementia, Alzheimer's, etc.)
- Currently participating in other clinical trials
- Life expectancy < 6 months
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiang'an Hospital Affiliated to Xiamen University
Xiamen, Fujian, 0592361101
Yunxuan Li, Student, +8613939809540, 1737178679@qq.com
1737178679@qq.com
About this study
Official title: Effect of Nudge-Based Shared Decision Making on Self-Management Among Patients With Type 2 Diabetes: A Randomized Controlled Trial
This study aims to test whether a communication strategy called "linguistic nudging" can help doctors and patients with type 2 diabetes make better treatment decisions together, and whether this improves patients' ability to manage their condition.
What will happen in the study? - 250 adults with type 2 diabetes from Xiang'an Hospital (Xiamen) will be randomly assigned to one of two groups:
Read more
Intervention group:Doctors will receive special training in "linguistic nudging" techniques to encourage shared decision-making. Patients will use a mobile app to record medication preferences, and doctors will adjust advice based on these preferences.
Control group:Patients will receive standard diabetes care without these additional strategies.
- All participants will be followed for 6 months.
What is the study aiming to find out?
The main goal is to see if patients in the intervention group:
Better follow medication plans Improve blood sugar monitoring Have better blood sugar control Feel more satisfied with doctor-patient communication
Why is this important? Good self-management is key to controlling diabetes, but many patients struggle with it. Effective communication during shared decision-making may empower patients to manage their condition day-to-day with greater confidence.
Patient safety and rights:
Participation is completely voluntary All personal information will be kept strictly confidential Medical support will be provided if any health problems occur during the study Participants may withdraw at any time
This research has been approved by the Ethics Committee of Xiang'an Hospital (Approval date: October 2025).
- Being tested
- Linguistic Nudging Training, Medication Preference App, Standard Diabetes Care
- Keywords
- Linguistic Nudging, Shared Decision Making, Randomized Controlled Trial, Mobile Health Application, Chinese Population
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linguistic Nudging TrainingBehavioural
Physicians receive 4-hour communication training to optimize shared decision-making using behavioral nudging techniques
Medication Preference AppDevice
Patients use WeChat-based mini-program to record daily medication preferences and concerns
Standard Diabetes CareOther
Routine follow-up visits, HbA1c monitoring, and basic health education per hospital protocol
| Study group | Role | What they receive |
|---|---|---|
| Linguistic Nudging Group | Experimental | Receives communication training + preference app Receives: Behavioral: Linguistic Nudging Training; Device: Medication Preference App; Other: Standard Diabetes Care |
| Standard Care Group | Other | Receives routine diabetes management only Receives: Other: Standard Diabetes Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c) Level
Absolute change in HbA1c (%) from baseline to 6 months, measured by high-performance liquid chromatography (HPLC). Reflects average blood glucose control over 3 months.
Measured: Baseline and Month 6
Diabetes Self-Management Capacity Scale Score
Composite score (0-100) based on validated 20-item scale assessing medication adherence, dietary control, physical activity, and blood glucose monitoring. Higher scores indicate better self-management capacity.
Measured: Baseline, Month 3, Month 6
Shared Decision Making Questionnaire (SDM-Q-9) Score
Patient-reported evaluation of shared decision quality using 9-item Likert scale (0-45). Assesses physician-patient collaboration in treatment choices. Higher scores indicate better shared decision-making.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Nov 2025
- Primary completion31 May 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunxuan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunxuan Li, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129915
- Sponsor's protocol ID
- XAHLL2025049
- Status last verified
- Nov 2025
- First submitted
- 1 Aug 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nudge-Based Shared Decision Making on Self-Management Among Patients With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07129915
- Acronym / sponsor ID
- XAHLL2025049
- Keywords
- Linguistic Nudging, Shared Decision Making, Randomized Controlled Trial, Mobile Health Application, Chinese Population
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Yunxuan LiUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Aug 2025 (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 study aims to test whether a communication strategy called "linguistic nudging" can help doctors and patients with type 2 diabetes make better treatment decisions together, and whether this improves patients' ability to manage their condition.
What will happen in the study? - 250 adults with type 2 diabetes from Xiang'an Hospital (Xiamen) will be randomly assigned to one of two groups:
Intervention group:Doctors will receive special training in "linguistic nudging" techniques to encourage shared decision-making. Patients will use a mobile app to record medication preferences, and doctors will adjust advice based on these preferences.
Control group:Patients will receive standard diabetes care without these additional strategies.
- All participants will be followed for 6 months.
What is the study aiming to find out?
The main goal is to see if patients in the intervention group:
Better follow medication plans Improve blood sugar monitoring Have better blood sugar control Feel more satisfied with doctor-patient communication
Why is this important? Good self-management is key to controlling diabetes, but many patients struggle with it. Effective communication during shared decision-making may empower patients to manage their condition day-to-day with greater confidence.
Patient safety and rights:
Participation is completely voluntary All personal information will be kept strictly confidential Medical support will be provided if any health problems occur during the study Participants may withdraw at any time
This research has been approved by the Ethics Committee of Xiang'an Hospital (Approval date: October 2025).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linguistic Nudging Group | Experimental | Behavioral: Linguistic Nudging Training, Device: Medication Preference App, Other: Standard Diabetes CareReceives communication training + preference app |
| Standard Care Group | Other | Other: Standard Diabetes CareReceives routine diabetes management only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of type 2 diabetes
- Age ≥ 18 years
- Normal cognitive function (assessed by Mini-Cog score ≥ 3)
- Basic smartphone operation ability (can independently use WeChat)
- Willing to participate and sign informed consent
Key exclusion criteria (5 listed)
- Severe acute complications (e.g., ketoacidosis, hyperosmolar coma)
- Documented cognitive impairment (dementia, Alzheimer's, etc.)
- Currently participating in other clinical trials
- Life expectancy < 6 months
- Pregnancy or lactation
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 |
|---|---|---|
| Linguistic Nudging TrainingPhysicians receive 4-hour communication training to optimize shared decision-making using behavioral nudging techniques | Behavioural | Linguistic Nudging Group |
| Medication Preference AppPatients use WeChat-based mini-program to record daily medication preferences and concerns | Device | Linguistic Nudging Group |
| Standard Diabetes CareRoutine follow-up visits, HbA1c monitoring, and basic health education per hospital protocol | Other | Linguistic Nudging Group, Standard Care Group |
Primary outcome
Change in Glycated Hemoglobin (HbA1c) Level
Time frame: Baseline and Month 6
Absolute change in HbA1c (%) from baseline to 6 months, measured by high-performance liquid chromatography (HPLC). Reflects average blood glucose control over 3 months.
Diabetes Self-Management Capacity Scale Score
Time frame: Baseline, Month 3, Month 6
Composite score (0-100) based on validated 20-item scale assessing medication adherence, dietary control, physical activity, and blood glucose monitoring. Higher scores indicate better self-management capacity.
Shared Decision Making Questionnaire (SDM-Q-9) Score
Time frame: Baseline
Patient-reported evaluation of shared decision quality using 9-item Likert scale (0-45). Assesses physician-patient collaboration in treatment choices. Higher scores indicate better shared decision-making.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linguistic Nudging Training, Medication Preference App and Standard Diabetes Care in people with Diabetes Mellitus, Type 2 and Physician-Patient Relations, run by Yunxuan Li at 1 site in China.
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 5 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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 Wei WANG, M.D. (+8613939809540, wwei19742007@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) Level (time frame: Baseline and Month 6). The study lists 3 primary outcomes in all. 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 Nov 2025.