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RECRUITING
NCT06909071
NA

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

Sponsor: Shanxi Bethune Hospital

View on ClinicalTrials.gov

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

DEVICE

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