NCT06960512

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

The Impact of Precision Lifestyle Intervention on Blood Glucose Control in Type 2 Diabetes Mellitus

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: He Eye Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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)

Interventions

Type	Name	Description
BEHAVIORAL	Precision Lifestyle Intervention (PLI) group	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-05-07
• Last updated: 2025-05-07