Type 2 Diabetes Mellitus (T2DM)NCT06960512
Precision Lifestyle Interventions Guided by Continuous Glucose Monitoring: Impact on Glycemic Outcomes in Type 2 Diabetes Mellitus
A study testing Precision Lifestyle Intervention (PLI) group in people with Type 2 Diabetes Mellitus (T2DM), run by He Eye Hospital.
Trial summary
This study is an interventional research. Through scientific evaluation, it explores the effect of precise lifestyle intervention based on CGM data on the control of chronic type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Precision Lifestyle Intervention (PLI) group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Comply with the diagnostic criteria for T2DM in the 'Clinical guidelines for prevention and treatment of type 2 diabetes mellitus in the elderly in China (2020 edition)', and be diagnosed with type 2 diabetes mellitus, i.e., mainly due to insulin resistance and insufficient relative insulin secretion, and have the typical symptoms of diabetes mellitus (irritable thirst and excessive drinking, excessive urination, excessive food intake, and unexplained weight loss) plus a random glucose level ≥11.1 mmol/L (200 mg/dl), or plus a fasting Blood glucose level ≥ 7.0 mmol/L (126 mg/dl), or plus random blood glucose or OGTT (Oral Glucose Tolerance Test) 2-hour blood glucose level ≥ 11.1 mmol/L (200 mg/dl), or plus glycated hemoglobin (HbA1c) level ≥ 6.5%;
- Age 18～65 years old (including the threshold), gender is not limited;
- Can skillfully operate a smartphone by themselves, or their family members can help to use the phone to give feedback on their daily life situation;
- Willing to participate in this study with good compliance;
- Agree to authorize He Eye Specialist Hospital to make cases of health management content.
Who cannot join
- Pregnant women, lactating women, and women of childbearing age who do not wish to use contraception during the research period;
- Severe skin disease, adhesive tape or adhesive allergy at the sensor placement site;
- People with a history of specific allergies, or allergies (e.g., allergic to two or more drugs, food, or pollen);
- Patients who meet the criteria for Grade 3 hypertension according to the ratings in the' Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 Revision)', i.e., blood pressure over 180/110 mmHg, or low blood pressure of 110 mmHg or more;
- Suffering from severe cardiovascular and cerebrovascular diseases (including ST-segment elevation myocardial infarction, unstable angina up to Braunwald classification III (one or more episodes of resting angina within 48 hours), transient ischemic attack, stroke treatment accompanied by various degrees of sequelae (e.g.,hemiplegia,aphasia,impaired consciousness, epilepsy, and even dementia), coronary artery stenosis of moderate stenosis (50%) and above, hemodialysis reconstruction surgery less than 6 months, cerebral embolism and cerebral hemorrhage less than 6 months or with varying degrees of movement disorders after the treatment, cognitive disorders, speech and swallowing disorders, and other sequelae, etc.), or daily accompanied by frequent episodes of angina pectoris, chest tightness, chest pain and other symptoms;
- Renal insufficiency up to stage III and above (blood creatinine level more than 450μmol/L);
- History of psychoSsis or psychotropic substance abuse;
- Any condition judged by the investigator to be unsuitable for participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Precision Lifestyle Intervention on Blood Glucose Control in Type 2 Diabetes Mellitus
This study is an interventional research. Through scientific evaluation, it explores the effect of precise lifestyle intervention based on CGM data on the control of chronic type 2 diabetes mellitus. By formulating a safe and effective precise lifestyle intervention plan, lifestyle medicine is integrated into the management of chronic diseases. Through multidimensional evaluations, it is expected to improve patients' self-management ability and provide a reference for the development of chronic diabetes management.
Read the detailed description
Internationally, significant breakthroughs have been made in diabetes research. The 'Standards of Care in Diabetes-2024' released by the ADA has shifted treatment goals from solely lowering blood glucose to comprehensive control of blood sugar, protecting target organs, reducing complications, and improving the overall prognosis for diabetes patients. It also emphasizes the importance of medical care providers mastering new technologies, such as using artificial intelligence for retinal screening and making necessary referrals, adopting telemedicine and digital tools for diabetes self-management education, personalized guidance, and the chronic disease management model is increasingly maturing. In China, diabetes management models include hospital management, community management,'hospital-community integration', and information technology-assisted management, etc. They face issues such as inconsistent standards and low efficiency. At the same time, they tend to focus more on the control of physical and chemical indicators, while lacking sufficient attention to the related symptoms, quality of life, and psychological state of diabetes patients.
This study is an interventional research.With the main purpose of 'exploring the impact of precise lifestyle interventions based on CGM data on blood glucose control in T2DM patients', this study aims to scientifically evaluate the effects of precise lifestyle interventions based on CGM data on chronic disease control in type2 diabetes diabetes mellitus. By formulating a safe and effective precise lifestyle intervention plan, lifestyle medicine is integrated into the management of chronic diseases. Through multidimensional evaluations, such as target management, lifestyle intervention, dietary intervention, exercise therapy, mental health, monitoring of diabetes-susceptible genes, and intervention of gut microbiota gene detection, it is expected to improve patients' self-management ability and provide a reference for the development of chronic diabetes management.
The purpose is to enhance patients' self-management capabilities, improve the quality of primary healthcare services, assist medical staff in developing and refining personalized treatment plans, reduce the incidence of diabetes complications, enhance patients' quality of life and life expectancy, promote scientific progress in the field of diabetes management, and effectively address the challenges of chronic diseases in an aging society.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Precision Lifestyle Intervention (PLI) group
- Keywords
- lifestyle medicine, Type 2 Diabetes Mellitus, continuous glucose monitoring, HBA1c, Glycosylated hemoglobin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Lifestyle Intervention (PLI) groupBehavioural
- Device Application: Participants in the intervention group will wear the GX-01S continuous glucose monitoring system, with data transmitted in real-time to a secure cloud platform.
- Multidisciplinary Management: A specialized team (health managers, nutritionists, endocrinologists, and Counselor) will analyze glucose fluctuations, dietary patterns, sleep health, physical activity and to formulate personalized adjustment plans. Modifications may include meal timing optimization, sleep duration regulation, and exercise frequency adaptations.
- Telehealth Follow-up: Participants will receive structured guidance via telephone/telemedicine consultations throughout the 28-day intervention period. Type 2 Diabetes Mellitus (T2DM) patient compliance will be systematically monitored and documented.
- Tailored Recommendations: Evidence-based lifestyle recommendations will be provided post-intervention, informed by quantitative biomarker data and adherence metrics collected.
| Study group | Role | What they receive |
|---|---|---|
| Precision Lifestyle Intervention (PLI) group | Experimental | Not described Receives: Behavioral: Precision Lifestyle Intervention (PLI) group |
| Health Education (HE) group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin/ HbA1c
It reflects average blood glucose levels over the past 2-3 months and is used to diagnose and monitor diabetes management and will be done 3 times at every assessment session and the median value will be recorded.
Measured: Time Frame:On the 0th, 28th, and 90th days of the trial.
fasting blood glucose/FBG
Fasting blood glucose measures blood sugar levels after an 8-hour fast and is primarily used to diagnose diabetes or prediabetes. The measurements will be done 3 times at every assessment session and the median value will be recorded.
Measured: Time Frame:On the 0th, 28th, and 90th days of the trial.
Secondary outcomes (5)
Total Cholesterol/TC
TC (Total Cholesterol) measures the total concentration of cholesterol in the blood, including LDL, HDL, and triglycerides, and is used to evaluate cardiovascular health, lipid metabolism status and guide lipid management.
Measured: Time Frame:On the 0th, 28th, and 90th days of the trial.
Triglycerides/TG
TG (Triglycerides) measures the level of triglycerides in the blood and is used to evaluate cardiovascular risk, metabolic disorders, or abnormalities in lipid metabolism.
Measured: Time Frame:On the 0th, 28th, and 90th days of the trial.
Blood Pressure/BP
BP (Blood Pressure)measures the pressure exerted by blood on arterial walls during heart contractions (systolic) and relaxations (diastolic), and is used to assess cardiovascular health, hypertension, or hypotension.
Measured: Time Frame:On the 0th, 28th, and 90th days of the trial.
urinalysis/UA
A urinalysis analyzes the physical, chemical, and microscopic properties of a urine sample to detect abnormalities and help diagnose conditions such as urinary tract infections, kidney disorders, or metabolic diseases.
Measured: Time Frame:On the 0th, 28th, and 90th days of the trial.
Diabetic Retinopathy Screening (DRS) via Fundus Photography
Fundus photography is a non-invasive imaging method that captures high-resolution images of the retina, optic disc, and blood vessels. It is utilized to evaluate the presence and severity of diabetic retinopathy (e.g., microaneurysms, hemorrhages, neovascularization) and monitor diabetes-related ocular complications.The assessment will be performed once at each session, with results documented for analysis.Retinal Image Biomarker Analysis is about to get digits like Retinal vessel diameter,Retinal vessel tortuosity,Retinal vascular fractal dimension,Retinal vessel bifurcation patterns, etc.These microvascular metrics will be analyzed to evaluate diabetes-induced alterations in retinal microcirculation, providing objective biomarkers for early microvascular dysfunction and disease progression monitoring. All parameters will be measured using validated automated image analysis software.
Measured: Time Frame:On the 0th, 28th, and 90th days of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960512
- Sponsor's protocol ID
- QTK 2025-0001
- Status last verified
- May 2025
- First submitted
- 26 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Precision Lifestyle Intervention on Blood Glucose Control in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06960512
- Acronym / sponsor ID
- QTK 2025-0001
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- lifestyle medicine, Type 2 Diabetes Mellitus, continuous glucose monitoring, HBA1c, Glycosylated hemoglobin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 May 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 study is an interventional research. Through scientific evaluation, it explores the effect of precise lifestyle intervention based on CGM data on the control of chronic type 2 diabetes mellitus. By formulating a safe and effective precise lifestyle intervention plan, lifestyle medicine is integrated into the management of chronic diseases. Through multidimensional evaluations, it is expected to improve patients' self-management ability and provide a reference for the development of chronic diabetes management.
Detailed description
Internationally, significant breakthroughs have been made in diabetes research. The 'Standards of Care in Diabetes-2024' released by the ADA has shifted treatment goals from solely lowering blood glucose to comprehensive control of blood sugar, protecting target organs, reducing complications, and improving the overall prognosis for diabetes patients. It also emphasizes the importance of medical care providers mastering new technologies, such as using artificial intelligence for retinal screening and making necessary referrals, adopting telemedicine and digital tools for diabetes self-management education, personalized guidance, and the chronic disease management model is increasingly maturing. In China, diabetes management models include hospital management, community management,'hospital-community integration', and information technology-assisted management, etc. They face issues such as inconsistent standards and low efficiency. At the same time, they tend to focus more on the control of physical and chemical indicators, while lacking sufficient attention to the related symptoms, quality of life, and psychological state of diabetes patients.
This study is an interventional research.With the main purpose of 'exploring the impact of precise lifestyle interventions based on CGM data on blood glucose control in T2DM patients', this study aims to scientifically evaluate the effects of precise lifestyle interventions based on CGM data on chronic disease control in type2 diabetes diabetes mellitus. By formulating a safe and effective precise lifestyle intervention plan, lifestyle medicine is integrated into the management of chronic diseases. Through multidimensional evaluations, such as target management, lifestyle intervention, dietary intervention, exercise therapy, mental health, monitoring of diabetes-susceptible genes, and intervention of gut microbiota gene detection, it is expected to improve patients' self-management ability and provide a reference for the development of chronic diabetes management.
The purpose is to enhance patients' self-management capabilities, improve the quality of primary healthcare services, assist medical staff in developing and refining personalized treatment plans, reduce the incidence of diabetes complications, enhance patients' quality of life and life expectancy, promote scientific progress in the field of diabetes management, and effectively address the challenges of chronic diseases in an aging society.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision Lifestyle Intervention (PLI) group | Experimental | Behavioral: Precision Lifestyle Intervention (PLI) group |
| Health Education (HE) group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Comply with the diagnostic criteria for T2DM in the 'Clinical guidelines for prevention and treatment of type 2 diabetes mellitus in the elderly in China (2020 edition)', and be diagnosed with type 2 diabetes mellitus, i.e., mainly due to insulin resistance and insufficient relative insulin secretion, and have the typical symptoms of diabetes mellitus (irritable thirst and excessive drinking, excessive urination, excessive food intake, and unexplained weight loss) plus a random glucose level ≥11.1 mmol/L (200 mg/dl), or plus a fasting Blood glucose level ≥ 7.0 mmol/L (126 mg/dl), or plus random blood glucose or OGTT (Oral Glucose Tolerance Test) 2-hour blood glucose level ≥ 11.1 mmol/L (200 mg/dl), or plus glycated hemoglobin (HbA1c) level ≥ 6.5%;
- Age 18～65 years old (including the threshold), gender is not limited;
- Can skillfully operate a smartphone by themselves, or their family members can help to use the phone to give feedback on their daily life situation;
- Willing to participate in this study with good compliance;
- Agree to authorize He Eye Specialist Hospital to make cases of health management content.
Key exclusion criteria (8 listed)
- Pregnant women, lactating women, and women of childbearing age who do not wish to use contraception during the research period;
- Severe skin disease, adhesive tape or adhesive allergy at the sensor placement site;
- People with a history of specific allergies, or allergies (e.g., allergic to two or more drugs, food, or pollen);
- Patients who meet the criteria for Grade 3 hypertension according to the ratings in the' Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 Revision)', i.e., blood pressure over 180/110 mmHg, or low blood pressure of 110 mmHg or more;
- Suffering from severe cardiovascular and cerebrovascular diseases (including ST-segment elevation myocardial infarction, unstable angina up to Braunwald classification III (one or more episodes of resting angina within 48 hours), transient ischemic attack, stroke treatment accompanied by various degrees of sequelae (e.g.,hemiplegia,aphasia,impaired consciousness, epilepsy, and even dementia), coronary artery stenosis of moderate stenosis (50%) and above, hemodialysis reconstruction surgery less than 6 months, cerebral embolism and cerebral hemorrhage less than 6 months or with varying degrees of movement disorders after the treatment, cognitive disorders, speech and swallowing disorders, and other sequelae, etc.), or daily accompanied by frequent episodes of angina pectoris, chest tightness, chest pain and other symptoms;
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 |
|---|---|---|
| Precision Lifestyle Intervention (PLI) group1. Device Application: Participants in the intervention group will wear the GX-01S continuous glucose monitoring system, with data transmitted in real-time to a secure cloud platform. 2. Multidisciplinary Management: A specialized team (health managers, nutritionists, endocrinologists, and Counselor) will analyze glucose fluctuations, dietary patterns, sleep health, physical activity and to formulate personalized adjustment plans. Modifications may include meal timing optimization, sleep duration regulation, and exercise frequency adaptations. 3. Telehealth Follow-up: Participants will receive structured guidance via telephone/telemedicine consultations throughout the 28-day intervention period. Type 2 Diabetes Mellitus (T2DM) patient compliance will be systematically monitored and documented. 4. Tailored Recommendations: Evidence-based lifestyle recommendations will be provided post-intervention, informed by quantitative biomarker data and adherence metrics collected. | Behavioural | Precision Lifestyle Intervention (PLI) group |
Primary outcome
Glycosylated hemoglobin/ HbA1c
Time frame: Time Frame:On the 0th, 28th, and 90th days of the trial.
It reflects average blood glucose levels over the past 2-3 months and is used to diagnose and monitor diabetes management and will be done 3 times at every assessment session and the median value will be recorded.
fasting blood glucose/FBG
Time frame: Time Frame:On the 0th, 28th, and 90th days of the trial.
Fasting blood glucose measures blood sugar levels after an 8-hour fast and is primarily used to diagnose diabetes or prediabetes. The measurements will be done 3 times at every assessment session and the median value will be recorded.
5 secondary outcomes
Total Cholesterol/TC
Time frame: Time Frame:On the 0th, 28th, and 90th days of the trial.
Triglycerides/TG
Time frame: Time Frame:On the 0th, 28th, and 90th days of the trial.
Blood Pressure/BP
Time frame: Time Frame:On the 0th, 28th, and 90th days of the trial.
urinalysis/UA
Time frame: Time Frame:On the 0th, 28th, and 90th days of the trial.
Diabetic Retinopathy Screening (DRS) via Fundus Photography
Time frame: Time Frame:On the 0th, 28th, and 90th days of the trial.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Lifestyle Intervention (PLI) group in people with Type 2 Diabetes Mellitus (T2DM), run by He Eye Hospital.
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 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: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact tongtong zhang Principal Investigator (086-13840113609, hzhangtongtong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin/ HbA1c (time frame: Time Frame:On the 0th, 28th, and 90th days of the trial.). The study lists 2 primary outcomes in all. 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 7 May 2025.