RecruitingNot ApplicableNCT06909071

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

Application of the Hybrid Closed-Loop Artificial Pancreas System in Neurosurgical Perioperative Hyperglycemic Patients: An Open, Randomized Controlled Trial


Sponsor

Shanxi Bethune Hospital

Enrollment

40 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Hybrid Closed-Loop Artificial Pancreas System for people with t2dm patients with traumatic brain injury. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHybrid 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

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NCT06909071