Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT
NCT ID: NCT06909071
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-04-15
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Traditional insulin pump group
Based on the patient's weight, the total daily insulin requirement is calculated at 0.3\~0.6U/(kg\*d) and distributed before meals according to the specific conditions of the patient. Continuous glucose monitoring system is used along with daily capillary blood glucose monitoring (fasting, 2 hours after breakfast, lunch, and dinner, totaling 4 times). Insulin doses are adjusted according to the patient's blood glucose level until the target blood glucose level is achieved.
Hybrid Closed-Loop Artificial Pancreas System
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).
Hybrid Closed-Loop Artificial Pancreas System Group
The open-source hybrid closed-loop artificial pancreas system, utilizing ultra-rapid-acting insulin, was employed for perioperative blood glucose management in neurosurgery. Insulin requirements were calculated based on patient weight. The system auto-adjusted basal rates according to blood glucose, while bolus treatments were manually inputted by nurses following physician instructions. Continuous and daily capillary blood glucose monitoring were conducted.
Hybrid Closed-Loop Artificial Pancreas System
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).
Interventions
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Hybrid Closed-Loop Artificial Pancreas System
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).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanxi Bethune Hospital
OTHER
Responsible Party
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Locations
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Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YXLL-2025-083
Identifier Type: -
Identifier Source: org_study_id
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