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Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT
Sponsor: Shanxi Bethune Hospital
Summary
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.
Official title: Application of the Hybrid Closed-Loop Artificial Pancreas System in Neurosurgical Perioperative Hyperglycemic Patients: An Open, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-04-15
Completion Date
2027-08-31
Last Updated
2025-04-23
Healthy Volunteers
No
Interventions
Hybrid Closed-Loop Artificial Pancreas System
The total daily insulin requirement is calculated as 0.3 - 0.6 U/(kg·d) according to patient's weight. The system automatically adjusts the basal rate during operation. Nurses enter bolus dose orders in AAPS software as directed by physicians. Blood glucose is monitored via continuous glucose monitoring and 4 daily fingerstick measurements (fasting and 2 hours after each meal).
Locations (1)
Shanxi Bethune Hospital
Taiyuan, Shanxi, China