Pre-diabetesNCT07160985
AI-Assisted Blood Glucose Management Study
A study testing AI-based Lifestyle Management and Lifestyle Management in people with Pre-diabetes, run by Li Huating at 1 site in China.
Trial summary
AI-driven health management tools can leverage continuous glucose monitoring (CGM), physical activity, and dietary data to provide real-time, individualized feedback, improving self-management and adherence. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- AI-based Lifestyle Management and Lifestyle Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2025to 30 Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Prediabetes (per ADA or WHO criteria)
- Stable lifestyle and body weight (±5%) for ≥3 months
- Owns and can operate a smartphone
- Able to understand and sign informed consent
Who cannot join
- Current glucose-lowering medication use
- Severe cardiovascular disease, liver/kidney dysfunction, or active malignancy
- Psychiatric or cognitive disorders affecting participation
- Planned major surgery or long-distance travel during the study
- Allergy/intolerance to CGM sensor materials
Trial locations and contacts
1 site in 1 country.
About this study
AI-driven health management tools can leverage continuous glucose monitoring (CGM), physical activity, and dietary data to provide real-time, individualized feedback, improving self-management and adherence. The X Life model integrates AI algorithms with wearable devices to dynamically adjust dietary and exercise recommendations. Preliminary user studies suggest good usability and user experience, with potential to promote positive behavior change.
This trial aims to preliminarily evaluate whether the X Life AI system can improve glucose tolerance (measured by oral glucose tolerance test [OGTT] incremental area under the curve [iAUC]) in adults with prediabetes, providing effect size and protocol design reference for a future confirmatory randomized controlled trial. The investigators designed this trial with the assistance of a digital twin-based clinical research system (termed X Town).
- Conditions
- Pre-diabetes
- Being tested
- AI-based Lifestyle Management, Lifestyle Management
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based Lifestyle ManagementOther
Participants will use the X Life system for 28 days, receiving real-time, personalized dietary and exercise recommendations triggered by glucose level and activity tracker data. Participants can interact with the system by uploading meal images, physical activity data, and wearable-derived metrics.
Lifestyle ManagementOther
Participants will receive guideline-based lifestyle counseling according to national prediabetes prevention guidelines, delivered via mobile terminal, without AI-generated recommendations.
| Study group | Role | What they receive |
|---|---|---|
| X Life Lifestyle Guidance | Experimental | Not described Receives: Other: AI-based Lifestyle Management |
| Standard Care | Active comparator | Not described Receives: Other: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OGTT Glucose Incremental Area Under the Curve (iAUC)
Difference between groups in the incremental area under the curve for plasma glucose concentration during a 2-hour oral glucose tolerance test (OGTT), calculated from measurements at 0, 60, and 120 minutes, adjusting for baseline values.
Measured: Baseline and at the end of the 28-day intervention period.
Secondary outcomes (8)
Change in OGTT Plasma Glucose Levels
Difference between groups in plasma glucose levels at 0, 60, and 120 minutes during OGTT, adjusting for baseline values.
Measured: Baseline and at the end of the 28-day intervention period.
Change in Continuous Glucose Monitoring (CGM) Metrics
Difference between groups in CGM-derived metrics, including mean glucose, daytime TIR, nighttime TIR, glucose standard deviation (SD), coefficient of variation (CV), time above range (TAR >10.0 mmol/L), and time below range (TBR <3.9 mmol/L and <3.0 mmol/L).
Measured: Baseline (7-day run-in period) and during the 28-day intervention period.
Change in OGTT Plasma Insulin Levels
Difference between groups in plasma insulin concentrations at 0, 60, and 120 minutes during OGTT, adjusting for baseline values.
Measured: Baseline and at the end of the 28-day intervention period.
Composite Body Composition Outcomes
Body composition will be assessed and each measurement will be reported separately: Body weight, BMI (calculated from weight and height), Body fat percentage, Fat-free mass, Waist circumference, Hip circumference, Thigh circumference, Blood pressure (systolic and diastolic, reported separately).
Measured: Baseline and at the end of the 28-day intervention period.
Composite Metabolic Parameters
Metabolic outcomes will be assessed and each laboratory parameter will be reported separately: Blood lipids: Total cholesterol, LDL-C, HDL-C, triglycerides; Liver function tests: ALT, AST, GGT; Kidney function tests: Serum creatinine, eGFR, etc.
Measured: Baseline and at the end of the 28-day intervention period.
Composite Patient-Reported Outcomes
Patient-reported outcomes will be assessed using validated questionnaires. Each scale will be reported and analyzed separately: WHO-5 Well-being Index: 0-25, higher = better well-being; Self-Efficacy: 10 items, each rated 1-4. Total score range 10-40; higher scores indicate stronger self-efficacy, etc.
Measured: Baseline, at the end of the 28-day intervention period and at the end of the 7-day follow-up period.
User Experience Score with the X Life Model
User experience will be assessed using a questionnaire covering Knowledge \& Awareness, Acceptability, Usability, Motivations \& Barriers, Perceived Benefits and Perceived Risks. Each item is rated on a 5-point Likert scale. Higher scores indicate better user experience.
Measured: At the end of the 28-day intervention period.
Safety and Tolerability
Incidence and frequency of adverse events (AEs), serious adverse events (SAEs), symptomatic and asymptomatic hypoglycemia (<3.9 mmol/L and <3.0 mmol/L).
Measured: From baseline to the end of the 28-day intervention period.
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 completion23 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 131 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
- NCT07160985
- Sponsor's protocol ID
- 2025-06
- Status last verified
- Feb 2026
- First submitted
- 21 Aug 2025
- Last updated
- 12 Feb 2026
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Assisted Blood Glucose Management Study
- ClinicalTrials.gov ID
- NCT07160985
- Acronym / sponsor ID
- 2025-06
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Li HuatingUniversity, hospital or other
- Study start
- 7 Sep 2025 (actual)
- Primary completion
- 23 Nov 2025 (actual)
- Study completion
- 30 Nov 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.
AI-driven health management tools can leverage continuous glucose monitoring (CGM), physical activity, and dietary data to provide real-time, individualized feedback, improving self-management and adherence. The X Life model integrates AI algorithms with wearable devices to dynamically adjust dietary and exercise recommendations. Preliminary user studies suggest good usability and user experience, with potential to promote positive behavior change.
This trial aims to preliminarily evaluate whether the X Life AI system can improve glucose tolerance (measured by oral glucose tolerance test [OGTT] incremental area under the curve [iAUC]) in adults with prediabetes, providing effect size and protocol design reference for a future confirmatory randomized controlled trial. The investigators designed this trial with the assistance of a digital twin-based clinical research system (termed X Town).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X Life Lifestyle Guidance | Experimental | Other: AI-based Lifestyle Management |
| Standard Care | Active comparator | Other: Lifestyle Management |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years
- Prediabetes (per ADA or WHO criteria)
- Stable lifestyle and body weight (±5%) for ≥3 months
- Owns and can operate a smartphone
- Able to understand and sign informed consent
Key exclusion criteria (5 listed)
- Current glucose-lowering medication use
- Severe cardiovascular disease, liver/kidney dysfunction, or active malignancy
- Psychiatric or cognitive disorders affecting participation
- Planned major surgery or long-distance travel during the study
- Allergy/intolerance to CGM sensor materials
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 |
|---|---|---|
| AI-based Lifestyle ManagementParticipants will use the X Life system for 28 days, receiving real-time, personalized dietary and exercise recommendations triggered by glucose level and activity tracker data. Participants can interact with the system by uploading meal images, physical activity data, and wearable-derived metrics. | Other | X Life Lifestyle Guidance |
| Lifestyle ManagementParticipants will receive guideline-based lifestyle counseling according to national prediabetes prevention guidelines, delivered via mobile terminal, without AI-generated recommendations. | Other | Standard Care |
Primary outcome
Change in OGTT Glucose Incremental Area Under the Curve (iAUC)
Time frame: Baseline and at the end of the 28-day intervention period.
Difference between groups in the incremental area under the curve for plasma glucose concentration during a 2-hour oral glucose tolerance test (OGTT), calculated from measurements at 0, 60, and 120 minutes, adjusting for baseline values.
8 secondary outcomes
Change in OGTT Plasma Glucose Levels
Time frame: Baseline and at the end of the 28-day intervention period.
Change in Continuous Glucose Monitoring (CGM) Metrics
Time frame: Baseline (7-day run-in period) and during the 28-day intervention period.
Change in OGTT Plasma Insulin Levels
Time frame: Baseline and at the end of the 28-day intervention period.
Composite Body Composition Outcomes
Time frame: Baseline and at the end of the 28-day intervention period.
Composite Metabolic Parameters
Time frame: Baseline and at the end of the 28-day intervention period.
Composite Patient-Reported Outcomes
Time frame: Baseline, at the end of the 28-day intervention period and at the end of the 7-day follow-up period.
User Experience Score with the X Life Model
Time frame: At the end of the 28-day intervention period.
Safety and Tolerability
Time frame: From baseline to the end of the 28-day intervention period.
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 12 Feb 2026.
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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 AI-based Lifestyle Management and Lifestyle Management in people with Pre-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 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: finished, as of the sponsor's last update on 12 Feb 2026. 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?
Change in OGTT Glucose Incremental Area Under the Curve (iAUC) (time frame: Baseline and at the end of the 28-day intervention period.). 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 12 Feb 2026.