Nudge-Based Shared Decision Making and Self-Management in Type 2 Diabetes: A Randomized Trial

Yunxuan Li

Status: Enrolling

Conditions: Physician-Patient Relations; Self-management; Diabetes Mellitus, Type 2

Treatments: Behavioral: Linguistic Nudging Training; Device: Medication Preference App; Other: Standard Diabetes Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07129915

XAHLL2025049

Details and patient eligibility

About

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).

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Linguistic Nudging Group

Experimental group

Description:

Receives communication training + preference app

Treatment:

Other: Standard Diabetes Care

Device: Medication Preference App

Behavioral: Linguistic Nudging Training

Standard Care Group

Other group

Description:

Receives routine diabetes management only

Treatment:

Other: Standard Diabetes Care