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
Shanxi Bethune Hospital
40 participants
Apr 15, 2025
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
Inclusion Criteria4
- 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.
Exclusion Criteria11
- Patients with diabetic emergencies, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.
- Patients with type 1 diabetes or other special types of diabetes.
- Patients with severe cardiac and renal dysfunction: those with cardiac function above grade III; those with serum creatinine exceeding 442 μmol/L.
- Patients with diseases that affect glucose metabolism, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
- Patients who are allergic to the drugs involved in the clinical diagnosis and treatment plan.
- Populations and contraindications that are not suitable for insulin pump treatment.
- Patients with allergic constitution and those who are allergic to adhesive tape.
- Patients with skin diseases such as rashes and prurigo, or those with abnormal coagulation function.
- Patients with impaired consciousness or mental diseases, who lack self-control and cannot express themselves clearly.
- Other situations that the researcher deems inappropriate for participating in the clinical trial.
- Patients who develop severe complications during or after surgery and are judged by the researcher as unfit for enrollment.
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Interventions
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)
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NCT06909071