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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanxi Bethune Hospital
  Taiyuan, Shanxi, China Recruiting

Study contacts

• Study coordinator: Shiwei Liu, Doctor
• Email: lswspring6@aliyun.com
• Phone: +86 13191072733

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.