Using continuous glucose monitoring to improve surgical outcomes for diabetic patients
Assessing the Effectiveness of Continuous Glucose Monitoring Compared with Conventional Monitoring in Enhancing Surgical Outcomes for Patients with Diabetes: a Multi-center, Parallel-arm, Randomized, Pragmatic Trial in China
This study is testing if using continuous glucose monitoring can help improve surgery results for people with diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10168 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tsinghua Chang Gung Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06331923 on ClinicalTrials.gov |
What this trial studies
This multi-center, pragmatic, randomized controlled trial aims to evaluate the effectiveness of continuous glucose monitoring (CGM) compared to conventional glucose monitoring in enhancing surgical outcomes for patients with diabetes or impaired glucose tolerance. The study will assess the impact of CGM on the comprehensive complication index (CCI) within 30 days post-surgery, considering factors such as age, type of surgery, and preoperative glycemic levels. Participants will use CGM for at least 6 hours before surgery and continue monitoring until 7 days post-surgery or discharge, allowing for real-time glucose management during the perioperative period.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with diabetes mellitus or impaired glucose tolerance scheduled for major thoracic, abdominal, orthopedic, or neurosurgery.
Not a fit: Patients who are not diabetic or do not have impaired glucose tolerance, or those with certain comorbidities affecting surgical outcomes, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for diabetic patients undergoing major surgeries.
How similar studies have performed: Previous smaller studies have shown promising results for CGM in intraoperative glycemic management, but this study aims to provide larger-scale real-world evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged above 18 years; 2. Patients with diabetes mellitus or impaired glucose tolerance; 3. Expected major thoracic and abdominal surgery (except cardiac surgery; including endoscopic surgery and robotic surgery), open orthopedic surgery, neurosurgery; 4. Volunteered for this study and written informed consent. Exclusion Criteria: 1. The patient refused; 2. The time between wearing CGM sensor and surgical skin incision cannot meet 6 hours or more; 3. Expected monitoring time less than 72 hours in CGM group; 4. Patients had comorbidities that affected the evaluation of endpoints; 5. The attending physician thought that the patient had inappropriate indications for enrollment; 6. Participants were involved in other studies that interfered with the evaluation of the results of this study.
Where this trial is running
Beijing, Beijing Municipality
- Zhifeng Gao — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Lan Yao — Peking University International Hospital
- Study coordinator: Zhi F Gao, M.D.
- Email: btchgzf@hotmail.com
- Phone: +86 15801249466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.