DiabetesNCT07160972
AI-Based Lifestyle Guidance Study
A study testing Lifestyle Management in people with Diabetes, run by Li Huating at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Lifestyle Management
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lifestyle Management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after intervention initiation
Secondary outcomes (9)
Change in self-reported diabetes self-management behaviors
Diabetes self-care activities will be assessed using the SDSCA scale. Each item is rated on a scale of 0-7 days. Higher scores indicate better self-management behavior.
Measured: Baseline and 7 days after intervention initiation
Change in diabetes-related distress
Diabetes distress will be assessed using the DDS. Each item is rated on a 6-point Likert scale. Higher scores indicate greater distress.
Measured: Baseline and 7 days after intervention initiation
Change in self-efficacy
Self-efficacy will be assessed using the validated Self-Efficacy Scale. Each item is rated on a 10-point Likert scale. Higher scores indicate greater self-efficacy.
Measured: Baseline and 7 days after intervention initiation
Composite Wearable Device Metrics
Physiological and behavioral data will be captured by wearable devices. Each metric will be reported and analyzed separately: Daily activity level: Steps/day; Sleep duration: Hours/night; Sleep architecture: % of light/deep/REM sleep; Resting heart rate: Beats per minute, etc.
Measured: Baseline and 7 days after intervention initiation
Correlation between AI-predicted and actual CGM glucose values
intraclass correlation, mean absolute relative difference, RMSE, Bland-Altman analysis, etc.
Measured: From baseline to 7 days after intervention initiation
Change in psychological well-being
Psychological well-being will be assessed using the WHO-5 Well-Being Index, a validated 5-item questionnaire. Each item is rated on a 6-point Likert scale (0 = at no time, 5 = all of the time). Raw scores range from 0 to 25, which are multiplied by 4 to yield a final score ranging from 0 to 100. Higher scores indicate better well-being.
Measured: Baseline and 7 days after intervention initiation
Composite Continuous Glucose Monitoring (CGM) Metrics
Glycemic control and variability will be evaluated using multiple CGM-derived measures. Each metric will be reported and analyzed separately: Time in Range (TIR): % of glucose values within 3.9-7.8 (for individuals without diabetes) or 10.0 (for individuals with diabetes) mmol/L; Mean glucose: mmol/L; Coefficient of variation (CV): %; Time above range (TAR): % of glucose values >10.0 mmol/L; Time below range (TBR): % of glucose values <3.9 mmol/L, etc.
Measured: Baseline, 7 days after intervention initiation
Expert Panel Evaluation of AI-Generated Dietary Recommendations
Independent nutrition experts will score the AI-generated dietary recommendations using two validated diet-quality indices. Each index will be reported and analyzed separately: AHEI-2010: Overall score 0-110, higher = better diet quality. Standard 11 components (each 0-10), summed to total; DQI-I: Overall score 0-100, higher = better diet quality. Standard four domains (variety, adequacy, moderation, overall balance), etc.
Measured: 7 days after intervention initiation
Expert Panel Evaluation of AI-Generated Exercise Recommendations
Exercise recommendations generated by the system will be evaluated by an expert panel using a validated structured rating scale. The scale includes five dimensions (Timing, Glycemic Safety, Individualization, FITT principle and Feasibility \& Clarity), each scored independently, with a total score calculated as the weighted sum of all domains. Each domain scored 0-2 (0 = not met, 1 = partially met, 2 = fully met). Weighted composite score range: 0-10. Higher scores indicate better quality of exercise recommendations.
Measured: 7 days after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start7 Sep 2025
- Primary completion21 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Li Huating
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Huating, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160972
- Sponsor's protocol ID
- 2025-05
- Status last verified
- Nov 2025
- First submitted
- 21 Aug 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Based Lifestyle Guidance Study
- ClinicalTrials.gov ID
- NCT07160972
- Acronym / sponsor ID
- 2025-05
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Li HuatingUniversity, hospital or other
- Study start
- 7 Sep 2025 (actual)
- Primary completion
- 21 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 8 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X Life Intervention | Experimental | Other: Lifestyle ManagementParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Lifestyle ManagementParticipants 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 | X Life Intervention |
Primary outcome
User Experience Score
Time frame: 7 days after intervention initiation
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.
9 secondary outcomes
Change in self-reported diabetes self-management behaviors
Time frame: Baseline and 7 days after intervention initiation
Change in diabetes-related distress
Time frame: Baseline and 7 days after intervention initiation
Change in self-efficacy
Time frame: Baseline and 7 days after intervention initiation
Composite Wearable Device Metrics
Time frame: Baseline and 7 days after intervention initiation
Correlation between AI-predicted and actual CGM glucose values
Time frame: From baseline to 7 days after intervention initiation
Change in psychological well-being
Time frame: Baseline and 7 days after intervention initiation
Composite Continuous Glucose Monitoring (CGM) Metrics
Time frame: Baseline, 7 days after intervention initiation
Expert Panel Evaluation of AI-Generated Dietary Recommendations
Time frame: 7 days after intervention initiation
Expert Panel Evaluation of AI-Generated Exercise Recommendations
Time frame: 7 days after intervention initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Management in people with Diabetes, run by Li Huating 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 2 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Experience Score (time frame: 7 days after intervention initiation). 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 2 Dec 2025.