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

Last updated: April 22, 2025
Sponsor: Shanxi Bethune Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

Hybrid Closed-Loop Artificial Pancreas System

Clinical Study ID

NCT06909071
YXLL-2025-083
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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 subarachnoidhemorrhage), have a Glasgow Coma Scale score of 12 or higher after leaving theintensive care unit, receive enteral nutrition postoperatively, and have apreviously established diagnosis of type 2 diabetes mellitus, or meet the diagnosticcriteria for type 2 diabetes mellitus in the "Chinese Guidelines for the Preventionand 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 inthis clinical trial voluntarily.

Exclusion

Exclusion Criteria:

  1. Patients with diabetic emergencies, such as diabetic ketoacidosis, hyperglycemichyperosmolar 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 functionabove 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 andtreatment 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 abnormalcoagulation function.

  9. Patients with impaired consciousness or mental diseases, who lack self-control andcannot express themselves clearly.

  10. Other situations that the researcher deems inappropriate for participating in theclinical trial.

  11. Patients who develop severe complications during or after surgery and are judged bythe researcher as unfit for enrollment.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Hybrid Closed-Loop Artificial Pancreas System
Phase:
Study Start date:
April 15, 2025
Estimated Completion Date:
August 31, 2027

Study Description

According to the inclusion and exclusion criteria, 40 perioperative patients with type 2 diabetes mellitus (T2DM) will be screened and enrolled from the neurosurgical ward of Shanxi Bethune Hospital. They will be randomly divided into two groups: 20 patients in the hybrid closed-loop artificial pancreas system group and 20 patients in the traditional pump combined with continuous glucose monitoring (CGM) group. Both groups of patients will use continuous glucose monitoring to measure blood glucose levels. After collecting baseline data, the two groups of patients will receive short-term intensive insulin therapy according to the above-mentioned plans. Relevant clinical data will be collected during and after the treatment to compare the advantages and disadvantages of the two intensive insulin treatment plans in controlling blood glucose levels in perioperative T2DM patients undergoing neurosurgery and their impact on complications.

Connect with a study center

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030000
    China

    Active - Recruiting

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