Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07097415

The Application of Continuous Blood Glucose Monitoring in Optimizing the Management of Early Onset and Late Onset Type 2 Diabetes: an Effectiveness - Implementation Type II Hybrid Design Quasi-experimental Pragmatic Trial

Led by Peking University · Updated on 2025-07-31

600

Participants Needed

2

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the use of continuous glucose monitoring (CGM) technology for managing type 2 diabetes in community healthcare settings in China. Type 2 diabetes poses a major public health challenge, and traditional blood glucose monitoring methods have limitations such as patient discomfort and delayed data sharing with healthcare providers. This study uses a quasi-experimental pragmatic trial design to assess CGM effectiveness and implementation in Chinese adults with type 2 diabetes. Participants include 800 adults randomly assigned to either a CGM intervention group or a control group using traditional blood glucose monitoring. The CGM group receives training and wears CGM devices for three separate 2-week periods over 24 weeks, supported by an integrated data platform and standardized healthcare protocols. The control group continues usual self-monitoring blood glucose practices and routine medical care with flexibility in medication and lifestyle adjustments. Throughout the 24-week study, researchers will measure changes in glycated hemoglobin (HbA1c) and other metabolic markers, patient satisfaction, and quality of life. Data collection includes repeated glucose measurements, healthcare provider and participant surveys, and qualitative interviews to explore implementation barriers and facilitators. The study tracks treatment costs and quality of life to inform strategies for improving diabetes care in community settings.

CONDITIONS

Brief 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
  • Previously diagnosed with type 2 diabetes for at least 1 year in the specified electronic medical record systems
  • Permanent resident registered and with health records filed in Yinzhou District
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Diagnosis of type 1 diabetes, adult latent autoimmune diabetes, or special types of diabetes (such as post pancreatic surgery or monogenic diabetes)
  • Current or previous use of hormone drugs affecting blood sugar levels
  • Severe kidney insufficiency (eGFR less than 30 ml/min/1.73 m2 or undergoing hemodialysis)
  • Severe liver dysfunction (ALT or AST more than 3 times the upper limit of normal)
  • Patients with tumors

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 24 weeks

Participants receive continuous blood glucose monitoring assisted blood glucose management including individualized health education, device setup, and integration with healthcare systems.

Visits at baseline, week 8, week 16, and week 24 for assessments and device use periods

Trial Site Locations

Total: 2 locations

1

Qianhu Hospital

Ningbo, Zhejiang, China

Actively Recruiting

2

Fuming Street Community Health Service Center

Ningbo, China

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Research Team

Y

Yunxiao Wu

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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