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

NCT06960512 | Not Yet Recruiting

• 1 other identifier: QTK 2025-0001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

lifestyle medicine; Type 2 Diabetes Mellitus; continuous glucose monitoring; HBA1c; Glycosylated hemoglobin

Outcome Measures

Primary Outcomes (2)

• 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: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.

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

Secondary Outcomes (5)

• Total Cholesterol/TC

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

• Triglycerides/TG

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

• Blood Pressure/BP

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

• urinalysis/UA

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

• Diabetic Retinopathy Screening (DRS) via Fundus Photography

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

Study Arms (2)

Precision Lifestyle Intervention (PLI) group

EXPERIMENTAL

Behavioral: Precision Lifestyle Intervention (PLI) group

Health Education (HE) group

NO INTERVENTION

Interventions

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.

Precision Lifestyle Intervention (PLI) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• He Eye Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

tongtong zhang Principal Investigator

CONTACT

086-13840113609; hzhangtongtong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 7, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share