Clinical trial NCT06909071: Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT
Official title: Application of the Hybrid Closed-Loop Artificial Pancreas System in Neurosurgical Perioperative Hyperglycemic Patients: An Open, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: T2DM Patients With Traumatic Brain Injury
Lead sponsor: Shanxi Bethune Hospital
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Time in Range (TIR)
timeFrame: During the 5- to 7-day period of hospitalization
Secondary outcomes:
measure: Blood glucose target criteria
timeFrame: During the 5- to 7-day period of hospitalization
measure: Time Below Range (TBR)、Time Above Range (TAR)
timeFrame: During the 5- to 7-day period of hospitalization
measure: Hypoglycemia Incidence Rate
timeFrame: During the 5- to 7-day period of hospitalization
measure: Blood glucose fluctuation level (IQR)
timeFrame: During the 5- to 7-day period of hospitalization
measure: Perioperative Infection Rate and Inflammatory Markers
timeFrame: During the 5- to 7-day period of hospitalization
measure: Adverse event（AE）、Serious adverse event（SAE）
timeFrame: During the 5- to 7-day period of hospitalization
measure: Perioperative infection rate and inflammatory markers
timeFrame: During the 5- to 7-day period of hospitalization
measure: Suture removal time, total hospital stay days, and postoperative hospital stay days
timeFrame: During the 5- to 7-day period of hospitalization
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
Study officials:
References: