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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fuming Street Community Health Service Center
RECRUITING
Ningbo
Qianhu Hospital
RECRUITING
Ningbo
Contact Information
Primary
Yunxiao Wu
2411110188@pku.edu.cn
+8618811381925
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 600
Treatments
Experimental: CGM Group
(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.
No_intervention: control group
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.
Related Therapeutic Areas
Sponsors
Leads: Peking University

This content was sourced from clinicaltrials.gov