Application of the Hybrid Closed-Loop Artificial Pancreas System in Neurosurgical Perioperative Hyperglycemic Patients: An Open, Randomized Controlled Trial
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.
• Aged between 18 and 75 years old.
• Patients who have undergone neurosurgical procedures for intracranial hemorrhage (including subdural hemorrhage, basal ganglia hemorrhage, and subarachnoid hemorrhage), have a Glasgow Coma Scale score of 12 or higher after leaving the intensive care unit, receive enteral nutrition postoperatively, and have a previously established diagnosis of type 2 diabetes mellitus, or meet the diagnostic criteria for type 2 diabetes mellitus in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition) .
• Fasting blood glucose ≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L.
• Those who have signed the informed consent form and are willing to participate in this clinical trial voluntarily.