AI-Based Lifestyle Guidance Study

NCT07160972 | Completed DMC

• 1 other identifier: 2025-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• User Experience Score

  User experience will be assessed using a validated questionnaire covering usability, usefulness, satisfaction, and acceptability. Each item is rated on a 5-point Likert scale. Higher scores indicate better user experience.

  7 days after intervention initiation

Secondary Outcomes (9)

• Change in self-reported diabetes self-management behaviors

  Baseline and 7 days after intervention initiation

• Change in diabetes-related distress

  Baseline and 7 days after intervention initiation

• Change in self-efficacy

  Baseline and 7 days after intervention initiation

• Composite Wearable Device Metrics

  Baseline and 7 days after intervention initiation

• Correlation between AI-predicted and actual CGM glucose values

  From baseline to 7 days after intervention initiation

Study Arms (1)

X Life Intervention

EXPERIMENTAL

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.

Other: Lifestyle Management

Interventions

Lifestyle Management 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.

X Life Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Li Huating: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 8, 2025
• Study Start: September 7, 2025
• Primary Completion: September 21, 2025
• Study Completion: September 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CN (1)