AI-Based Lifestyle Guidance Study

NCT ID: NCT07160972

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-07
• Study Completion Date: 2025-09-30

Brief Summary

The X Life model is an innovative AI-based lifestyle guidance system designed to provide tailored health management recommendations for individuals with T2DM or prediabetes, leveraging continuous glucose monitoring (CGM) data, wearable activity and sleep metrics, and baseline clinical information. Despite its potential, a lack of in-depth understanding of real-world user experiences remains a key barrier to clinical adoption.

This exploratory user study aims to systematically assess the usability, acceptability, and user experience of the X Life model in the target population, to identify facilitators and barriers to adoption, and to preliminarily explore the association between X Life use and changes in user-reported outcomes, behavior patterns, and device-monitored health metrics.

Conditions

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

X Life Intervention

Participants will use the X Life system via AR glasses or mobile terminal (smartphone/tablet) for 7 days. The system provides personalized dietary and exercise recommendations at dynamic trigger points (before/after meals, before/after exercise, before bedtime) using baseline clinical data, real-time CGM readings, dietary images, activity data, and wearable monitoring (activity, sleep, heart rate). Standard care guidance will also be provided in accordance with national dietary and physical activity guidelines.

Group Type: EXPERIMENTAL

Lifestyle Management

Intervention Type: OTHER

Participants will use the X Life system via AR glasses or mobile terminal (smartphone/tablet) for 7 days. The system provides personalized dietary and exercise recommendations at dynamic trigger points (before/after meals, before/after exercise, before bedtime) using baseline clinical data, real-time CGM readings, dietary images, activity data, and wearable monitoring (activity, sleep, heart rate). Standard care guidance will also be provided in accordance with national dietary and physical activity guidelines.

Interventions

Lifestyle Management

Participants will use the X Life system via AR glasses or mobile terminal (smartphone/tablet) for 7 days. The system provides personalized dietary and exercise recommendations at dynamic trigger points (before/after meals, before/after exercise, before bedtime) using baseline clinical data, real-time CGM readings, dietary images, activity data, and wearable monitoring (activity, sleep, heart rate). Standard care guidance will also be provided in accordance with national dietary and physical activity guidelines.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18-70 years.
• Prediabetes or Type 2 diabetes mellitus (diagnosed according to recognized clinical criteria).
• Owns and is proficient in using a smartphone with compatible applications.
• Willing and able to wear study devices (CGM, activity tracker).
• Willing to use the X Life model terminal and comply with study procedures.
• Able to understand and provide written informed consent (including participation in interviews).

Exclusion Criteria

• Severe chronic diabetic complications or recent acute diabetic complications.
• Early-onset adult T2DM.
• Recent severe hypoglycemic events.
• Cognitive impairment.
• Pregnancy, severe hepatic/renal/thyroid disease, acute infection, psychiatric disorders affecting participation.
• Planned major surgery or treatment likely to significantly impact glucose or weight during the study period.
• Allergy to device materials (CGM sensor, activity tracker, AI terminal).
• Any condition deemed unsuitable by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Li Huating

OTHER

Sponsor Role: lead

Responsible Party

Li Huating

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shanghai Sixth People's Hospital

Shanghai, , China

Countries

China

Other Identifiers

2025-05

Identifier Type: -

Identifier Source: org_study_id