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

Peking University

Status: Enrolling

Conditions: Type 2 Diabetes (T2DM); Continuous Glucose Monitoring

Treatments: Device: Continuous blood glucose monitoring assisted blood glucose management

Study type: Interventional

Funder types: Other

Identifiers

NCT07097415

IRB00001052-24080

Details and patient eligibility

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ① Age ≥ 18 years old; ② There is a previous diagnosis of T2DM in the electronic medical record system of Qianhu Hospital and Fuming Street Community Health Service Center, and the diagnosis has been made for 1 year or more; ③ Resident with permanent registered residence registration who has filed in the health records of residents in Yinzhou District.

Exclusion criteria

• ① Pregnant women; ② Type 1 diabetes, adult latent autoimmune diabetes, special type diabetes (such as post pancreatic surgery, monogenic diabetes); ③ Patients who are currently using or have previously used hormone drugs that may affect blood sugar levels; ④ Patients with severe renal insufficiency (eGFR<30ml/m ^ 2, or undergoing hemodialysis); ⑤ Patients with severe liver dysfunction (ALT or AST greater than 3 times the upper limit of normal); ⑥ Tumor patients.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

CGM Group

Experimental group

Description:

(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.

Treatment:

Device: Continuous blood glucose monitoring assisted blood glucose management

control group

No Intervention group

Description:

1. Blood Glucose Monitoring Method Maintain Traditional Self-Monitoring of Blood Glucose (SMBG): Continue using existing traditional blood glucose monitoring methods throughout the 24-week trial period. Monitoring Flexibility: No restrictions on the frequency or method of daily home blood glucose measurements; No restrictions on the type of traditional blood glucose monitoring devices used Patients can perform blood glucose monitoring according to personal habits and physician recommendations. 2. Medical Management Routine Medical Care: The control group's routine medication and treatment are not restricted by the study. Treatment Adjustments: During the trial period, patients and physicians can make adjustments at any time based on actual blood glucose control status, including: Medication adjustments; Dietary modifications; Exercise modifications Non-Intervention Principle: This study does not intervene in any of the above adjustments but requires detailed recording of all changes.