RecruitingNot ApplicableNCT07097415

The Application of Continuous Blood Glucose Monitoring in Optimizing the Management of Type 2 Diabetes

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


Sponsor

Peking University

Enrollment

600 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether continuous blood sugar monitoring — wearing a small device that tracks your glucose levels around the clock — can help people with type 2 diabetes manage their condition better compared to traditional finger-stick testing. **You may be eligible if...** - You are 18 or older - You have been diagnosed with type 2 diabetes for at least 1 year - You are a registered resident in Yinzhou District, China with records at a local health center **You may NOT be eligible if...** - You are pregnant - You have type 1 diabetes, or a special form of diabetes (such as after pancreatic surgery) - You take hormone medications that affect blood sugar - You have severe kidney disease or are on dialysis - You have severe liver problems - You have been diagnosed with cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous blood glucose monitoring assisted blood glucose management

(1) individualized health education sessions conducted by endocrinology healthcare providers covering CGM concepts, usage methods, advantages, risks, and precautions, along with hands-on device demonstration and provision of written materials and user manuals; (2) development of an integrated CGM data management platform that connects with community healthcare information systems for real-time data transmission, storage, and analysis; (3) establishment of standardized CGM response protocols for healthcare providers, including glucose target setting, dietary and exercise recommendations, personalized medication adjustments based on glucose fluctuations, and management procedures for hypoglycemic and hyperglycemic alerts; and (4) mobile application setup and data transmission configuration for patients.


Locations(2)

Qianhu Hospital

Ningbo, Zhejiang, China

Fuming Street Community Health Service Center

Ningbo, China

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NCT07097415


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