Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT

In this study, we plan to use an open-source hybrid closed-loop artificial pancreas system and a combination of a traditional insulin pump and continuous glucose monitoring (CGM) respectively to conduct short-term intensive insulin treatment for patients with type 2 diabetes mellitus (T2DM) during the perioperative period who are hospitalized in the Department of Neurosurgery of Shanxi Bethune Hospital. By comparing the blood glucose control status of patients under different intensive insulin treatment regimens and other clinical indicators such as postoperative complications, we will comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop artificial pancreas system.

NCT Number	NCT06909071
Lead Sponsor	Shanxi Bethune Hospital
Conditions	T2DM Patients With Traumatic Brain Injury
Enrollment	40 participants
Start Date	2025-04-15
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-23