DiabetesX LifeNCT07160998
An Active Health-Based Comprehensive Study on Diabetes Management
A study testing Digital Lifestyle Therapeutic in people with Diabetes, run by Li Huating at 1 site in China.
Trial summary
This randomized, open-label, multicenter trial evaluates the efficacy and safety of the AI-based lifestyle guidance system (X-Life) compared to standard care in adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Digital Lifestyle Therapeutic
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2025to 6 Dec 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Diagnosed type 2 diabetes
- Stable medication regimen ≥ 3 months
- HbA1c 7-10%
- Smartphone access and ability to operate app
- Willing to wear CGM and activity tracker
- Able to provide informed consent
Who cannot join
- Insulin therapy
- Severe chronic/acute diabetic complications
- Early-onset diabetes (<40 years at diagnosis)
- Severe cardiovascular disease, uncontrolled hypertension, active liver disease, malignancy
- Severe psychiatric or cognitive disorders
- Allergy to CGM materials
- Planned surgery or long-term travel during study
Trial locations and contacts
1 site in 1 country.
About this study
This randomized, open-label, multicenter trial evaluates the efficacy and safety of the AI-based lifestyle guidance system (X-Life) compared to standard care in adults with type 2 diabetes. X-Life integrates glucose level, wearable devices, and AI-driven decision models to provide personalized lifestyle recommendations. The primary endpoint is the percentage of time in glucose target range (TIR).
Read the detailed description
Type 2 diabetes imposes a global health burden. Traditional care has limitations in accessibility, personalization, and long-term adherence. AI-driven digital therapeutics may overcome these barriers. X-Life is an innovative AI system providing individualized lifestyle guidance using glucose level and wearable data. User studies demonstrated usability and acceptability. This multicenter randomized controlled trial will rigorously test whether X-Life improves glycemic control compared with standard care, while also evaluating metabolic outcomes, patient-reported measures, and safety. The investigators designed this trial with the assistance of a digital twin-based clinical research system (termed X Town).
- Conditions
- Diabetes
- Being tested
- Digital Lifestyle Therapeutic, Standard Care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Lifestyle TherapeuticOther
Personalized real-time lifestyle recommendations are delivered via via smartphone, tablet, etc., integrating glucose level and wearable data.
Standard CareBehavioural
Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines.
| Study group | Role | What they receive |
|---|---|---|
| X Life AI Lifestyle Guidance | Experimental | Personalized real-time lifestyle recommendations delivered via smartphone, tablet, etc., integrating glucose level and wearable data. Receives: Other: Digital Lifestyle Therapeutic |
| Standard Care | Active comparator | Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range (TIR, %)
Percentage of glucose readings within 3.9-10 mmol/L measured by CGM
Measured: Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28)
Secondary outcomes (20)
Other CGM metrics
mean glucose, SD, CV, TAR (>10 mmol/L), TBR (<3.9 and <3.0 mmol/L), daytime/nighttime TIR, MAGE, MODD, AUC, etc.
Measured: Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28)
Patient-reported outcomes
Using DDS, DSCS, Self-Efficacy, WHO-5 scales, etc.
Measured: Baseline and 28 days
User Experience Score
Evaluation in X Life group only. 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: At 28 days
Safety outcomes
Number of participants with CGM-recorded or symptomatic hypoglycemia (<3.9 mmol/L). Number of participants experiencing any AE/SAE.
Measured: Day 1-28 (intervention period)
OGTT Glucose Concentration
Plasma glucose at 0, 60, and 120 minutes during OGTT.
Measured: Baseline and 28 days
OGTT Insulin Concentration
Serum insulin at 0, 60, and 120 minutes during OGTT.
Measured: Baseline and 28 days
OGTT C-peptide Concentration
Serum C-peptide at 0, 60, and 120 minutes during OGTT.
Measured: Baseline and 28 days
Body Weight
Body weight (kg) measured using digital scale.
Measured: Baseline and 28 days
Body Mass Index (BMI)
Calculated as weight (kg) / height (m²).
Measured: Baseline and 28 days
Waist Circumference
Measured at the midpoint between the lowest rib and iliac crest.
Measured: Baseline and 28 days
Hip Circumference
Hip circumference measured at the widest part of the buttocks using a non-stretchable tape.
Measured: Baseline and 28 days
Thigh Circumference
Mid-thigh circumference measured at the midpoint between the inguinal crease and the proximal border of the patella.
Measured: Baseline and 28 days
Systolic Blood Pressure
Average of two seated measurements.
Measured: Baseline and 28 days
Diastolic Blood Pressure
Average of two seated measurements.
Measured: Baseline and 28 days
Resting Heart Rate
Measured by automated device after 5 minutes rest.
Measured: Baseline and 28 days
Blood Lipids
Total cholesterol, LDL-C, HDL-C, and triglycerides.
Measured: Baseline and 28 days
Liver Function
ALT, AST, GGT, etc.
Measured: Baseline and 28 days
Kidney Function
Serum creatinine, eGFR, etc.
Measured: Baseline and 28 days
Inflammatory Markers
C-reactive protein
Measured: Baseline and 28 days
Composite Psychological and Behavioral Outcomes
Psychological and behavioral outcomes will be assessed using multiple validated questionnaires. Each scale will be reported and analyzed separately: Diabetes Distress Scale (DDS): 17 items, scored 1-6; higher scores indicate greater distress; General Self-Efficacy Scale (GSES): 10 items, scored 1-4, total 10-40; higher scores indicate stronger self-efficacy; WHO-5 Well-Being Index: 5 items, raw score 0-25 transformed to 0-100; higher scores indicate better well-being; Summary of Diabetes Self-Care Activities (SDSCA): Items scored 0-7 days per week; higher scores indicate better diabetes self-management behaviors.
Measured: Run-in end (Day 0), Intervention end (Day 28), Follow-up end (Day 35)
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 completion28 Nov 2025
- Study completion6 Dec 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 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
- NCT07160998
- Sponsor's protocol ID
- 2025-122
- Acronym
- X Life
- Status last verified
- Feb 2026
- First submitted
- 22 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
- An Active Health-Based Comprehensive Study on Diabetes Management
- ClinicalTrials.gov ID
- NCT07160998
- Acronym / sponsor ID
- X Life / 2025-122
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Li HuatingUniversity, hospital or other
- Study start
- 7 Sep 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 6 Dec 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.
This randomized, open-label, multicenter trial evaluates the efficacy and safety of the AI-based lifestyle guidance system (X-Life) compared to standard care in adults with type 2 diabetes. X-Life integrates glucose level, wearable devices, and AI-driven decision models to provide personalized lifestyle recommendations. The primary endpoint is the percentage of time in glucose target range (TIR).
Detailed description
Type 2 diabetes imposes a global health burden. Traditional care has limitations in accessibility, personalization, and long-term adherence. AI-driven digital therapeutics may overcome these barriers. X-Life is an innovative AI system providing individualized lifestyle guidance using glucose level and wearable data. User studies demonstrated usability and acceptability. This multicenter randomized controlled trial will rigorously test whether X-Life improves glycemic control compared with standard care, while also evaluating metabolic outcomes, patient-reported measures, and safety. 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 AI Lifestyle Guidance | Experimental | Other: Digital Lifestyle TherapeuticPersonalized real-time lifestyle recommendations delivered via smartphone, tablet, etc., integrating glucose level and wearable data. |
| Standard Care | Active comparator | Behavioral: Standard CareParticipants receive standard diabetes management including medications and lifestyle recommendations based on guidelines. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-70 years
- Diagnosed type 2 diabetes
- Stable medication regimen ≥ 3 months
- HbA1c 7-10%
- Smartphone access and ability to operate app
Key exclusion criteria (7 listed)
- Insulin therapy
- Severe chronic/acute diabetic complications
- Early-onset diabetes (<40 years at diagnosis)
- Severe cardiovascular disease, uncontrolled hypertension, active liver disease, malignancy
- Severe psychiatric or cognitive disorders
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 |
|---|---|---|
| Digital Lifestyle TherapeuticPersonalized real-time lifestyle recommendations are delivered via via smartphone, tablet, etc., integrating glucose level and wearable data. | Other | X Life AI Lifestyle Guidance |
| Standard CareParticipants receive standard diabetes management including medications and lifestyle recommendations based on guidelines. | Behavioural | Standard Care |
Primary outcome
Time in Range (TIR, %)
Time frame: Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28)
Percentage of glucose readings within 3.9-10 mmol/L measured by CGM
20 secondary outcomes
Other CGM metrics
Time frame: Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28)
Patient-reported outcomes
Time frame: Baseline and 28 days
User Experience Score
Time frame: At 28 days
Safety outcomes
Time frame: Day 1-28 (intervention period)
OGTT Glucose Concentration
Time frame: Baseline and 28 days
OGTT Insulin Concentration
Time frame: Baseline and 28 days
OGTT C-peptide Concentration
Time frame: Baseline and 28 days
Body Weight
Time frame: Baseline and 28 days
Body Mass Index (BMI)
Time frame: Baseline and 28 days
Waist Circumference
Time frame: Baseline and 28 days
Hip Circumference
Time frame: Baseline and 28 days
Thigh Circumference
Time frame: Baseline and 28 days
Systolic Blood Pressure
Time frame: Baseline and 28 days
Diastolic Blood Pressure
Time frame: Baseline and 28 days
Resting Heart Rate
Time frame: Baseline and 28 days
Blood Lipids
Time frame: Baseline and 28 days
Liver Function
Time frame: Baseline and 28 days
Kidney Function
Time frame: Baseline and 28 days
Inflammatory Markers
Time frame: Baseline and 28 days
Composite Psychological and Behavioral Outcomes
Time frame: Run-in end (Day 0), Intervention end (Day 28), Follow-up end (Day 35)
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 Digital Lifestyle Therapeutic 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 7 inclusion and 7 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?
Time in Range (TIR, %) (time frame: Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28)). 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.