Using a hybrid closed-loop system to manage blood sugar in neurosurgery patients with diabetes

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

This study is testing if a new hybrid closed-loop system can help manage blood sugar better than a traditional insulin pump for patients with type 2 diabetes who are having neurosurgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanxi Bethune Hospital (other)
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT06909071 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a hybrid closed-loop artificial pancreas system for managing blood glucose levels in patients with type 2 diabetes mellitus (T2DM) undergoing neurosurgery. A total of 40 patients will be randomly assigned to either the hybrid system or a traditional insulin pump combined with continuous glucose monitoring (CGM). The study aims to compare the blood glucose control and postoperative complications between the two treatment regimens. Data will be collected during and after treatment to assess the clinical efficacy and safety of the hybrid system.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with T2DM who are undergoing neurosurgical procedures and meet specific blood glucose criteria.

Not a fit: Patients with diabetic emergencies or those with type 1 diabetes or other special types of diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved blood glucose control and reduced complications for T2DM patients undergoing neurosurgery.

How similar studies have performed: Other studies have shown promise with hybrid closed-loop systems in diabetes management, suggesting potential for success in this approach.

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.

Where this trial is running

Taiyuan, Shanxi

• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (RECRUITING)

Study contacts

• Study coordinator: Shiwei Liu, Doctor

Conditions: T2DM Patients With Traumatic Brain Injury