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

Launched by SHANXI BETHUNE HOSPITAL · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage blood sugar levels in patients with type 2 diabetes who are undergoing brain surgery. Researchers will compare two systems: a hybrid closed-loop artificial pancreas, which automatically adjusts insulin delivery based on blood sugar levels, and a traditional insulin pump combined with continuous glucose monitoring. The goal is to see which method works better in keeping blood sugar stable and reducing complications after surgery.

To be eligible for the trial, participants must be between 18 and 75 years old, have had surgery for certain types of brain bleeding, and have a confirmed diagnosis of type 2 diabetes with specific blood sugar levels. Those who join will receive intensive insulin treatment during their hospital stay and will be monitored closely. It's important to note that not everyone can participate; individuals with certain health conditions or complications will be excluded for safety reasons. If you or someone you know is interested in this trial, please consider discussing it with a healthcare provider for more information.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged between 18 and 75 years old.
• • 2. 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) .
• • 3. Fasting blood glucose ≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L.
• • 4. Those who have signed the informed consent form and are willing to participate in this clinical trial voluntarily.
• Exclusion Criteria:
• • 1. Patients with diabetic emergencies, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.
• • 2. Patients with type 1 diabetes or other special types of diabetes.
• • 3. Patients with severe cardiac and renal dysfunction: those with cardiac function above grade III; those with serum creatinine exceeding 442 μmol/L.
• • 4. Patients with diseases that affect glucose metabolism, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
• • 5. Patients who are allergic to the drugs involved in the clinical diagnosis and treatment plan.
• • 6. Populations and contraindications that are not suitable for insulin pump treatment.
• • 7. Patients with allergic constitution and those who are allergic to adhesive tape.
• • 8. Patients with skin diseases such as rashes and prurigo, or those with abnormal coagulation function.
• • 9. Patients with impaired consciousness or mental diseases, who lack self-control and cannot express themselves clearly.
• • 10. Other situations that the researcher deems inappropriate for participating in the clinical trial.
• • 11. Patients who develop severe complications during or after surgery and are judged by the researcher as unfit for enrollment.