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

NCT07097415 | Recruiting

• 1 other identifier: IRB00001052-24080
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Continuous Glucose Monitoring; Type 2 Diabetes (T2DM)

Outcome Measures

Primary Outcomes (1)

• glycosylated hemoglobin

  Measurement method: Laboratory blood test analysis. Assessment timing: At baseline and at 24-week endpoint. Procedure: Venous blood samples collected by clinical physicians, processed at hospital laboratory facilities.

  At baseline and 24-week endpoint

Secondary Outcomes (7)

• Fasting plasma glucose (FPG)

  At baseline and 24-week endpoint

• Healthcare Provider and Participant Awareness and Acceptance of CGM

  at weeks 0, 8, 16, and 24 during the 24-week study period

• Time in Range (TIR)

  Three 2-week CGM wearing periods at weeks 0, 8, and 16

• Standard Deviation (SD)

  Three 2-week CGM wearing periods at weeks 0, 8, and 16

• Mean Amplitude of Glycemic Excursion (MAGE)

  Three 2-week CGM wearing periods at weeks 0, 8, and 16

Study Arms (2)

CGM Group

EXPERIMENTAL

(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.

Device: Continuous blood glucose monitoring assisted blood glucose management

control group

NO INTERVENTION

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.

Interventions

Continuous blood glucose monitoring assisted blood glucose management DEVICE

(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.

CGM Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (2)

Qianhu Hospital

Ningbo, Zhejiang, China

RECRUITING

Fuming Street Community Health Service Center

Ningbo, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Yunxiao Wu

CONTACT

+8618811381925; 2411110188@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 31, 2025
• Study Start: November 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)