The Application of Continuous Blood Glucose Monitoring in Optimizing the Management of Type 2 Dia… (NCT07097415) | Clinical Trial Compass
CompletedNot Applicable
The Application of Continuous Blood Glucose Monitoring in Optimizing the Management of Type 2 Diabetes
China599 participantsStarted 2024-11-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used continuous glucose monitoring to try to improve HbA1c levels in Type 2 diabetes — do you think wearing a continuous glucose monitor could help me better manage my own blood sugar, and is that something we should consider for my care?
2Since this trial has already been completed, have the results been published yet, and what did they show about whether continuous glucose monitoring actually led to meaningful improvements in HbA1c compared to standard monitoring?
3This study is labeled Phase NA, which often means it's more of an observational or management study rather than a drug trial — does that mean the approach being tested here is something you could offer me outside of a clinical trial setting right now?
4Continuous glucose monitors require wearing a sensor on your body and reviewing data regularly — given my daily routine and how I currently manage my diabetes, do you think I'd be a realistic candidate for this kind of monitoring, and what would the commitment actually look like?
5Are there standard-of-care options for optimizing my Type 2 diabetes management that I should try first before exploring anything based on this trial's approach, or would continuous glucose monitoring fit naturally into what you'd already recommend for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.