Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07097415

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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