Precision Lifestyle Interventions Guided by Continuous Glucose Monitoring: Impact on Glycemic Outcomes in Type 2 Diabetes Mellitus

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHe Eye Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Precision Lifestyle Intervention (PLI) group

    Behavioral

    1. 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Precision Lifestyle Intervention (PLI) groupExperimental treatment 1 intervention
Group B: Health Education (HE) groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Time Frame:On the 0th, 28th, and 90th days of the trial.
2

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.

Time frame
Time Frame:On the 0th, 28th, and 90th days of the trial.

Secondary outcomes

1

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.

Time frame
Time Frame:On the 0th, 28th, and 90th days of the trial.
2

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.

Time frame
Time Frame:On the 0th, 28th, and 90th days of the trial.
3

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.

Time frame
Time Frame:On the 0th, 28th, and 90th days of the trial.
4

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.

Time frame
Time Frame:On the 0th, 28th, and 90th days of the trial.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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