Actively Recruiting
The Application of Continuous Blood Glucose Monitoring in Optimizing the Management of Type 2 Diabetes
Led by Peking University · Updated on 2025-07-31
600
Participants Needed
2
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study investigates the effectiveness and implementation of continuous glucose monitoring (CGM) technology for type 2 diabetes management in Chinese community healthcare settings. Type 2 diabetes represents a significant public health challenge in China, with traditional blood glucose monitoring methods presenting limitations including patient discomfort, incomplete glucose data, and delayed information transmission to healthcare providers. CGM devices offer continuous, real-time glucose monitoring with the potential to improve patient outcomes and healthcare delivery efficiency. This quasi-experimental pragmatic trial employs an effectiveness-implementation Type II hybrid design, enrolling 800 adults with type 2 diabetes from two community health centers in Yinzhou District, Ningbo. Participants are randomly assigned to either a CGM intervention group or a control group using traditional self-monitoring blood glucose methods. The CGM group receives device training and wears CGM systems for three separate 2-week periods over 24 weeks, while the control group continues standard monitoring practices. The primary outcome is change in glycated hemoglobin (HbA1c) levels, with secondary outcomes including other metabolic markers, patient satisfaction, and quality of life measures. Simultaneously, the study explores implementation factors using the Consolidated Framework for Implementation Research (CFIR) through qualitative interviews with healthcare providers and quantitative surveys with patients. This comprehensive approach aims to provide evidence for CGM effectiveness in Chinese patients while identifying barriers and facilitators for successful implementation in community healthcare settings, ultimately informing strategies for improving diabetes management at the population level.
CONDITIONS
Official Title
The Application of Continuous Blood Glucose Monitoring in Optimizing the Management of Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with type 2 diabetes for at least 1 year according to medical records
- Permanent resident registered and with health records in Yinzhou District
You will not qualify if you...
- Pregnant women
- Diagnosis of type 1 diabetes, adult latent autoimmune diabetes, or special type diabetes (e.g., post pancreatic surgery, monogenic diabetes)
- Current or past use of hormone drugs affecting blood sugar
- Severe kidney problems (eGFR less than 30 ml/min/1.73 m² or on hemodialysis)
- Severe liver dysfunction (ALT or AST more than 3 times the upper normal limit)
- Cancer patients
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Qianhu Hospital
Ningbo, Zhejiang, China
Actively Recruiting
2
Fuming Street Community Health Service Center
Ningbo, China
Actively Recruiting
Research Team
Y
Yunxiao Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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